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This guidance explains and answers questions about key elements of the requirements of

Rule). The Department of Health and Human Services (HHS) published the Privacy Rule on

December 28, 2000, and adopted modifications of the Rule on August 14, 2002.

The Privacy Rule (45 CFR Part 160 and Subparts A and E of Part 164) provides the first

comprehensive Federal protection for the privacy of health information. All segments of the

health care industry have expressed support for the objective of enhanced patient privacy in the

health care system. The Privacy Rule, as modified, is carefully balanced to provide strong

privacy protections that do not interfere with patient access to, or the quality of, health care

delivery.

The guidance that follows is meant to communicate as clearly as possible the privacy

policies contained in the Privacy Rule. For a particular segment in the Privacy Rule, the

guidance will provide a brief explanation of the segment and how the Rule works, followed by

“Frequently Asked Questions” about that provision. The guidance does not address all of the

relevant provisions in the Rule, although we anticipate adding segments in the future as we

develop guidance on more Privacy Rule standards. We will also be adding to the “Frequently

Asked Questions” on an ongoing basis as new questions arise. HHS plans to work expeditiously

to address these additional questions to facilitate understanding of the Rule and to encourage

voluntary compliance with its requirements. However, for a full understanding of one’s rights

and responsibilities under the Rule, it is important to consult the Rule itself.

General Overview

Incidental Uses and Disclosures (45 CFR 164.502(a))

Minimum Necessary (45 CFR 164.502(b), 164.514(d))

Personal Representatives (45 CFR 164.502(g))

Business Associates (45 CFR 164.502(e), 164.504(e), 164.532(d) and (e))

Uses and Disclosures for Treatment, Payment, and Health Care Operations (45 CFR 164.506)

Marketing (45 CFR 164.501, 164.508(a))

Public Health (45 CFR 164.512(b))

Research (45 CFR 164.501, 164.508, 164.512(i), 164.514(e), 164.528, 164.532)

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Notice (45 CFR 164.520)

Government Access (45 CFR Part 160, Subpart C, 164.512(f))

Miscellaneous FAQs

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the Department of Health and Human Services (HHS).

To improve the efficiency and effectiveness of the health care system, the Health

Insurance Portability and Accountability Act (HIPAA) of 1996, Public Law 104-191, included

“Administrative Simplification” provisions that required HHS to adopt national standards for

electronic health care transactions. At the same time, Congress recognized that advances in

electronic technology could erode the privacy of health information. Consequently, Congress

incorporated into HIPAA provisions that mandated the adoption of Federal privacy protections

for individually identifiable health information.

In response to the HIPAA mandate, HHS published a final regulation in the form of the

Privacy Rule in December 2000, which became effective on April 14, 2001. This Rule set

national standards for the protection of health information, as applied to the three types of

covered entities: health plans, health care clearinghouses, and health care providers who conduct

certain health care transactions electronically. By the compliance date of April 14, 2003 (April

14, 2004, for small health plans), covered entities must implement standards to protect and guard

against the misuse of individually identifiable health information. Failure to timely implement

these standards may, under certain circumstances, trigger the imposition of civil or criminal

penalties.

Secretary Tommy Thompson called for an additional opportunity for public comment on

the Privacy Rule to ensure that the Privacy Rule achieves its intended purpose without adversely

affecting the quality of, or creating new barriers to, patient care. After careful consideration of

these comments, in March 2002 HHS published proposed modifications to the Rule, to improve

workability and avoid unintended consequences that could have impeded patient access to

delivery of quality health care. Following another round of public comment, in August 2002, the

Department adopted as a final Rule the modifications necessary to ensure that the Privacy Rule

worked as intended.

The Privacy Rule establishes, for the first time, a foundation of Federal protections for the

privacy of protected health information. The Rule does not replace Federal, State, or other law

that grants individuals even greater privacy protections, and covered entities are free to retain or

adopt more protective policies or practices.

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comply with the new requirements by April 14, 2003.

The HIPAA Privacy Rule for the first time creates national standards to protect

individuals’ medical records and other personal health information.

• It gives patients more control over their health information.

• It sets boundaries on the use and release of health records.

• It establishes appropriate safeguards that health care providers and others must

achieve to protect the privacy of health information.

• It holds violators accountable, with civil and criminal penalties that can be

imposed if they violate patients’ privacy rights

• And it strikes a balance when public responsibility supports disclosure of some

forms of data – for example, to protect public health.

For patients – it means being able to make informed choices when seeking care and

reimbursement for care based on how personal health information may be used.

certain disclosures of their information that have been made.

the purpose of the disclosure.

health records and request corrections.

information.

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privacy of individually identifiable health information. When it comes to personal

information that moves across hospitals, doctors’ offices, insurers or third party payers,

and State lines, our country has relied on a patchwork of Federal and State laws. Under

the patchwork of laws existing prior to adoption of HIPAA and the Privacy Rule,

personal health information could be distributed—without either notice or

authorization—for reasons that had nothing to do with a patient's medical treatment or

health care reimbursement. For example, unless otherwise forbidden by State or local

law, without the Privacy Rule patient information held by a health plan could, without the

patient’s permission, be passed on to a lender who could then deny the patient's

application for a home mortgage or a credit card, or to an employer who could use it in

personnel decisions. The Privacy Rule establishes a Federal floor of safeguards to protect

the confidentiality of medical information. State laws which provide stronger privacy

protections will continue to apply over and above the new Federal privacy standards.

Health care providers have a strong tradition of safeguarding private health information.

However, in today’s world, the old system of paper records in locked filing cabinets is not

enough. With information broadly held and transmitted electronically, the Rule provides

clear standards for the protection of personal health information.

such as:

• Notifying patients about their privacy rights and how their information can be

used.

• Adopting and implementing privacy procedures for its practice, hospital, or plan.

• Training employees so that they understand the privacy procedures.

• Designating an individual to be responsible for seeing that the privacy procedures

are adopted and followed.

• Securing patient records containing individually identifiable health information so

that they are not readily available to those who do not need them.

Responsible health care providers and businesses already take many of the kinds of steps

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required by the Rule to protect patients’ privacy. Covered entities of all types and sizes

are required to comply with the Privacy Rule. To ease the burden of complying with the

new requirements, the Privacy Rule gives needed flexibility for providers and plans to

create their own privacy procedures, tailored to fit their size and needs. The scalability of

the Rule provides a more efficient and appropriate means of safeguarding protected health

information than would any single standard. For example,

• The privacy official at a small physician practice may be the office manager, who

will have other non-privacy related duties; the privacy official at a large health

plan may be a full-time position, and may have the regular support and advice of a

privacy staff or board.

• The training requirement may be satisfied by a small physician practice’s

providing each new member of the workforce with a copy of its privacy policies

and documenting that new members have reviewed the policies; whereas a large

health plan may provide training through live instruction, video presentations, or

interactive software programs.

• The policies and procedures of small providers may be more limited under the

Rule than those of a large hospital or health plan, based on the volume of health

information maintained and the number of interactions with those within and

outside of the health care system.

• Health plans

• Health care clearinghouses

• Health care providers who conduct certain financial and administrative

transactions electronically. These electronic transactions are those for which

standards have been adopted by the Secretary under HIPAA, such as electronic

billing and fund transfers.

These entities (collectively called “covered entities”) are bound by the new privacy

standards even if they contract with others (called “business associates”) to perform some

of their essential functions. The law does not give the Department of Health and Human

Services (HHS) the authority to regulate other types of private businesses or public

agencies through this regulation. For example, HHS does not have the authority to

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regulate employers, life insurance companies, or public agencies that deliver social

security or welfare benefits. See the fact sheet and frequently asked questions on this web

site about the standards on “Business Associates” for a more detailed discussion of the

covered entities’ responsibilities when they engage others to perform essential functions

or services for them.

into compliance with these standards, as modified by the August, 2002 final Rule. Small

health plans will have an additional year – until April 14, 2004 – to come into

compliance.

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is

providing assistance to help covered entities prepare to comply with the Rule. For

example, OCR maintains a web site with helpful information, such as the Guidance,

Frequently Asked Questions, sample “business associate” contract provisions, significant

reference documents, and other technical assistance information for consumers and the

health care industry, at http://www.hhs.gov/ocr/hipaa/.

hearings, meetings at the request of industry and other stakeholders, as well as other

communications, HHS identified a number of areas in which the Privacy Rule, as issued

in December 2000, would have had potential unintended effects on health care quality or

access. As a result, HHS proposed modifications that would maintain strong protections

for the privacy of individually identifiable health information, address the unintended

negative effects of the Privacy Rule on health care quality or access to health care, and

relieve unintended administrative burdens created by the Privacy Rule.

Final modifications to the Rule were adopted on August 14, 2002. Among other things,

the modifications addressed the following aspects of the Privacy Rule:

• Uses and disclosures for treatment, payment and health care operations, including

eliminating the requirement for the individual’s consent for these activities;

• The notice of privacy practices that covered entities must provide to patients;

• Uses and disclosures for marketing purposes;

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• Minimum necessary uses and disclosures;

• Parents as the personal representatives of unemancipated minors;

• Uses and disclosures for research purposes; and

• Transition provisions, including business associate contracts.

In addition to these key areas, the modifications included changes to certain other

provisions where necessary to clarify the Privacy Rule, and a list of technical corrections

intended as editorial or typographical corrections to the Privacy Rule.

For more information about the final modifications to the Privacy Rule, see the Fact Sheet

from providing timely, quality health care to individuals in a variety of circumstances.

The most troubling and pervasive problem was that health care providers would not have

been able to use or disclose protected health information for treatment, payment, or health

care operations purposes prior to the initial face-to-face encounter with the patient, which

is routinely done to provide timely access to quality health care. The following are some

examples of how the consent requirement would have posed barriers to health care:

• Pharmacists would not have been able to fill a prescription, search for potential

drug interactions, determine eligibility, or verify coverage before the individual

arrived at the pharmacy to pick up the prescription if the individual had not

already provided consent under the Privacy Rule.

• Hospitals would not have been able to use information from a referring physician

to schedule and prepare for procedures before the individual presented at the

hospital for such procedure, or the patient would have had to make a special trip

to the hospital to sign the consent form.

• Providers who do not provide treatment in person (such as a provider prescribing

over the telephone) may have been unable to provide care because they would

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have had difficulty obtaining prior written consent to use protected health

information at the first service delivery.

• Emergency medical providers were concerned that, even if a situation was urgent,

they would have had to try to obtain consent to comply with the Privacy Rule,

even if that would be inconsistent with the appropriate practice of emergency

medicine.

• Emergency medical providers were also concerned that the requirement that they

attempt to obtain consent as soon as reasonably practicable after an emergency

would have required significant efforts and administrative burden which might

have been viewed as harassing by patients, because these providers typically do

not have ongoing relationships with individuals.

To eliminate such barriers to health care, mandatory consent was replaced with the

voluntary consent provision that permits health care providers to obtain consent for

treatment, payment and healthcare operations, at their option, and enables them to obtain

consent in a manner that does not disrupt needed treatment. Although consent is no

longer mandatory, the Rule still affords individuals the opportunity to engage in

important discussions regarding the use and disclosure of their health information through

the strengthened notice requirement, while allowing activities that are essential to quality

health care to occur unimpeded. These modifications will ensure that the Rule protects

patient privacy as intended without harming consumers’ access to care or the quality of

that care. Further, the individual’s right to request restrictions on the use or disclosure of

his or her protected health information is retained in the Rule as modified.

most health plans, covered health care providers, and health care clearinghouses, and

April 14, 2004, for small health plans. Under HIPAA, compliance with a modification to

an existing standard or implementation specification is required by a date set by the

Secretary, but not earlier than 180 days from the adoption of the modification. By

publishing the modifications to the Privacy Rule in August 2002, the original compliance

date of April 2003 is maintained for the entire Rule, as modified.

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may deem appropriate. However, a standard can be modified only once in a 12-month

period.

As a general rule, future modifications to the Privacy Rule must be made in accordance

with the Administrative Procedure Act (APA). HHS will comply with the APA by

Proposed Rulemaking and will invite comment from the public. After reviewing and

addressing those comments, HHS will issue a modified final rule.

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Many customary health care communications and practices play an important or even

essential role in ensuring that individuals receive prompt and effective health care. Due to the

nature of these communications and practices, as well as the various environments in which

individuals receive health care or other services from covered entities, the potential exists for an

individual’s health information to be disclosed incidentally. For example, a hospital visitor may

overhear a provider’s confidential conversation with another provider or a patient, or may

glimpse a patient’s information on a sign-in sheet or nursing station whiteboard. The HIPAA

Privacy Rule is not intended to impede these customary and essential communications and

practices and, thus, does not require that all risk of incidental use or disclosure be eliminated to

satisfy its standards. Rather, the Privacy Rule permits certain incidental uses and disclosures of

protected health information to occur when the covered entity has in place reasonable safeguards

and minimum necessary policies and procedures to protect an individual’s privacy.

General Provision. The Privacy Rule permits certain incidental uses and disclosures that

occur as a by-product of another permissible or required use or disclosure, as long as the covered

where applicable, with respect to the primary use or disclosure. See 45 CFR 164.502(a)(1)(iii).

An incidental use or disclosure is a secondary use or disclosure that cannot reasonably be

prevented, is limited in nature, and that occurs as a result of another use or disclosure that is

permitted by the Rule. However, an incidental use or disclosure is not permitted if it is a byproduct

of an underlying use or disclosure which violates the Privacy Rule.

Reasonable Safeguards. A covered entity must have in place appropriate administrative,

technical, and physical safeguards that protect against uses and disclosures not permitted by the

Privacy Rule, as well as that limit incidental uses or disclosures. See 45 CFR 164.530(c). It is

not expected that a covered entity’s safeguards guarantee the privacy of protected health

information from any and all potential risks. Reasonable safeguards will vary from covered

entity to covered entity depending on factors, such as the size of the covered entity and the nature

of its business. In implementing reasonable safeguards, covered entities should analyze their

own needs and circumstances, such as the nature of the protected health information it holds, and

assess the potential risks to patients’ privacy. Covered entities should also take into account the

potential effects on patient care and may consider other issues, such as the financial and

administrative burden of implementing particular safeguards.

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Many health care providers and professionals have long made it a practice to ensure

reasonable safeguards for individuals’ health information – for instance:

a waiting room or other public area;

signs to remind employees to protect patient confidentiality;

personal information.

Protection of patient confidentiality is an important practice for many health care and

health information management professionals; covered entities can build upon those codes of

conduct to develop the reasonable safeguards required by the Privacy Rule.

Minimum Necessary. Covered entities also must implement reasonable minimum

necessary policies and procedures that limit how much protected health information is used,

disclosed, and requested for certain purposes. These minimum necessary policies and procedures

also reasonably must limit who within the entity has access to protected health information, and

under what conditions, based on job responsibilities and the nature of the business. The

minimum necessary standard does not apply to disclosures, including oral disclosures, among

health care providers for treatment purposes. For example, a physician is not required to apply

the minimum necessary standard when discussing a patient’s medical chart information with a

specialist at another hospital. See 45 CFR 164.502(b) and 164.514(d), and the fact sheet and

frequently asked questions on this web site about the minimum necessary standard, for more

information.

An incidental use or disclosure that occurs as a result of a failure to apply reasonable

safeguards or the minimum necessary standard, where required, is not permitted under the

Privacy Rule.

For example:

the entity has access to protected health information, based on who needs access

to perform their job duties. If a hospital employee is allowed to have routine,

unimpeded access to patients’ medical records, where such access is not necessary

for the hospital employee to do his job, the hospital is not applying the minimum

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necessary standard. Therefore, any incidental use or disclosure that results from

this practice, such as another worker overhearing the hospital employee’s

conversation about a patient’s condition, would be an unlawful use or disclosure

under the Privacy Rule.

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other and to their patients. Provisions of this Rule requiring covered entities to

implement reasonable safeguards that reflect their particular circumstances and

exempting treatment disclosures from certain requirements are intended to ensure that

providers’ primary consideration is the appropriate treatment of their patients. The

Privacy Rule recognizes that oral communications often must occur freely and quickly in

treatment settings. Thus, covered entities are free to engage in communications as

required for quick, effective, and high quality health care. The Privacy Rule also

recognizes that overheard communications in these settings may be unavoidable and

allows for these incidental disclosures.

For example, the following practices are permissible under the Privacy Rule, if reasonable

precautions are taken to minimize the chance of incidental disclosures to others who may

be nearby:

the phone with the patient, a provider, or a family member.

provider in a joint treatment area.

patient’s semi-private room.

in an academic or training institution.

or with a physician or the patient over the phone.

In these circumstances, reasonable precautions could include using lowered voices or

talking apart from others when sharing protected health information. However, in an

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emergency situation, in a loud emergency room, or where a patient is hearing impaired,

such precautions may not be practicable. Covered entities are free to engage in

communications as required for quick, effective, and high quality health care.

facilities.

Covered entities must have in place appropriate administrative, technical, and physical

safeguards to protect the privacy of protected health information. This standard requires

that covered entities make reasonable efforts to prevent uses and disclosures not

permitted by the Rule. The Department does not consider facility restructuring to be a

requirement under this standard.

For example, the Privacy Rule does not require the following types of structural or

systems changes:

can be intercepted by scanners.

Covered entities must implement reasonable safeguards to limit incidental, and avoid

prohibited, uses and disclosures. The Privacy Rule does not require that all risk of

protected health information disclosure be eliminated. Covered entities must review their

own practices and determine what steps are reasonable to safeguard their patient

information. In determining what is reasonable, covered entities should assess potential

risks to patient privacy, as well as consider such issues as the potential effects on patient

care, and any administrative or financial burden to be incurred from implementing

particular safeguards. Covered entities also may take into consideration the steps that

other prudent health care and health information professionals are taking to protect

patient privacy.

Examples of the types of adjustments or modifications to facilities or systems that may

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constitute reasonable safeguards are:

used for patient counseling.

cubicles, dividers, shields, curtains, or similar barriers may constitute a reasonable

safeguard. For example, a large clinic intake area may reasonably use cubicles or

shield-type dividers, rather than separate rooms, or providers could add curtains or

screens to areas where discussions often occur between doctors and patients or

among professionals treating the patient.

patients regarding their health care. This includes communicating with patients at their

homes, whether through the mail or by phone or in some other manner. In addition, the

Rule does not prohibit covered entities from leaving messages for patients on their

answering machines. However, to reasonably safeguard the individual’s privacy, covered

entities should take care to limit the amount of information disclosed on the answering

machine. For example, a covered entity might want to consider leaving only its name and

number and other information necessary to confirm an appointment, or ask the individual

to call back.

A covered entity also may leave a message with a family member or other person who

answers the phone when the patient is not home. The Privacy Rule permits covered

entities to disclose limited information to family members, friends, or other persons

regarding an individual’s care, even when the individual is not present. However,

covered entities should use professional judgment to assure that such disclosures are in

the best interest of the individual and limit the information disclosed. See 45 CFR

164.510(b)(3).

In situations where a patient has requested that the covered entity communicate with him

in a confidential manner, such as by alternative means or at an alternative location, the

covered entity must accommodate that request, if reasonable. For example, the

Department considers a request to receive mailings from the covered entity in a closed

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envelope rather than by postcard to be a reasonable request that should be accommodated.

Similarly, a request to receive mail from the covered entity at a post office box rather than

at home, or to receive calls at the office rather than at home are also considered to be

reasonable requests, absent extenuating circumstances. See 45 CFR 164.522(b).

out patient names in waiting rooms, so long as the information disclosed is appropriately

limited. The HIPAA Privacy Rule explicitly permits the incidental disclosures that may

result from this practice, for example, when other patients in a waiting room hear the

identity of the person whose name is called, or see other patient names on a sign-in sheet.

However, these incidental disclosures are permitted only when the covered entity has

implemented reasonable safeguards and the minimum necessary standard, where

appropriate. For example, the sign-in sheet may not display medical information that is

not necessary for the purpose of signing in (e.g., the medical problem for which the

patient is seeing the physician). See 45 CFR 164.502(a)(1)(iii).

common and important health care practices; nor does it specify the specific measures

that must be applied to protect an individual’s privacy while engaging in these practices.

Covered entities must implement reasonable safeguards to protect an individual’s privacy.

In addition, covered entities must reasonably restrict how much information is used and

disclosed, where appropriate, as well as who within the entity has access to protected

health information. Covered entities must evaluate what measures make sense in their

environment and tailor their practices and safeguards to their particular circumstances.

For example, the Privacy Rule does not prohibit covered entities from engaging in the

following practices, where reasonable precautions have been taken to protect an

individual’s privacy:

• Maintaining patient charts at bedside or outside of exam rooms, displaying patient

names on the outside of patient charts, or displaying patient care signs (e.g., “high

fall risk” or “diabetic diet”) at patient bedside or at the doors of hospital rooms.

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ensuring that the area is supervised, escorting non-employees in the area, or

placing patient charts in their holders with identifying information facing the wall

or otherwise covered, rather than having health information about the patient

visible to anyone who walks by.

• Announcing patient names and other information over a facility’s public

announcement system.

system, such as referring the patients to a reception desk where they can receive

further instructions in a more confidential manner.

• Use of X-ray lightboards or in-patient logs, such as whiteboards, at a nursing

station.

not accessible by the public, or if the nursing station whiteboard is not readily

visible to the public, or any other safeguard which reasonably limits incidental

disclosures to the general public.

The above examples of possible safeguards are not intended to be exclusive.

Covered entities may engage in any practice that reasonably safeguards protected

health information to limit incidental uses and disclosures.

appropriate measures to protect the patient’s privacy. The physician or other health care

professionals use the patient charts for treatment purposes. Incidental disclosures to

others that might occur as a result of the charts being left in the box are permitted, if the

minimum necessary and reasonable safeguards requirements are met. See 45 CFR

164.502(a)(1)(iii). As the purpose of leaving the chart in the box is to provide the

physician with access to the medical information relevant to the examination, the

minimum necessary requirement would be satisfied. Examples of measures that could be

reasonable and appropriate to safeguard the patient chart in such a situation would be

limiting access to certain areas, ensuring that the area is supervised, escorting nonemployees

in the area, or placing the patient chart in the box with the front cover facing

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the wall rather than having protected health information about the patient visible to

anyone who walks by. Each covered entity must evaluate what measures are reasonable

and appropriate in its environment. Covered entities may tailor measures to their

particular circumstances. See 45 CFR 164.530(c).

of an otherwise permitted disclosure—for example, the disclosure to other

patients in a waiting room of the identity of the person whose name is called. In this

case, disclosure of patient names by posting on the wall is permitted by the Privacy Rule,

if the use or disclosure is for treatment (for example, to ensure that patient care is

provided to the correct individual) or health care operations purposes (for example, as a

service for patients and their families). The disclosure of such information to other

persons (such as other visitors) that will likely also occur due to the posting is an

incidental disclosure.

Incidental disclosures are permitted only to the extent that the covered entity has applied

reasonable and appropriate safeguards and implemented the minimum necessary standard,

where appropriate. See 45 CFR 164.502(a)(1)(iii). In this case, it would appear that the

disclosure of names is the minimum necessary for the purposes of the permitted uses or

disclosures described above, and there do not appear to be additional safeguards that

would be reasonable to take in these circumstances. However, each covered entity must

evaluate what measures are reasonable and appropriate in its environment. Covered

entities may tailor measures to their particular circumstances.

disclosures and, thus, may be made without an individual’s authorization. Furthermore,

the HIPAA Privacy Rule generally permits a covered entity to disclose protected health

information to a family member or other person involved in the individual’s care. Where

the individual is present during the disclosure, the covered entity may disclose protected

health information if it is reasonable to infer from the circumstances that the individual

does not object to the disclosure. Absent countervailing circumstances, the individual’s

agreement to participate in group therapy or family discussions is a good basis for

inferring the individual’s agreement.

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incidental disclosures permitted by the Rule. See 45 CFR 164.528(a)(1).

any use or disclosure permitted under the Privacy Rule, and not just to incidental uses and

disclosures resulting from treatment communications, or only to communications among

health care providers or other medical staff. For example:

particular procedure, and may be overheard by one or more persons in the waiting

room.

be overheard by another employee who is not authorized to handle patient

information.

If the provider and the health plan employee made reasonable efforts to avoid being

overheard and reasonably limited the information shared, an incidental use or disclosure

resulting from such conversations would be permissible under the Rule.

be eliminated to satisfy its standards. Rather, the Rule requires only that covered entities

implement reasonable safeguards to limit incidental uses or disclosures. See 45 CFR

164.530(c)(2).

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The minimum necessary standard, a key protection of the HIPAA Privacy Rule, is derived

from confidentiality codes and practices in common use today. It is based on sound current

practice that protected health information should not be used or disclosed when it is not

necessary to satisfy a particular purpose or carry out a function. The minimum necessary

standard requires covered entities to evaluate their practices and enhance safeguards as needed to

limit unnecessary or inappropriate access to and disclosure of protected health information. The

Privacy Rule’s requirements for minimum necessary are designed to be sufficiently flexible to

accommodate the various circumstances of any covered entity.

The Privacy Rule generally requires covered entities to take reasonable steps to limit the

use or disclosure of, and requests for, protected health information to the minimum necessary to

accomplish the intended purpose. The minimum necessary standard does not apply to the

following:

and Accountability Act (HIPAA) Administrative Simplification Rules.

disclosure of information is required under the Privacy Rule for enforcement

purposes.

The implementation specifications for this provision require a covered entity to develop

and implement policies and procedures appropriate for its own organization, reflecting the

entity’s business practices and workforce. While guidance cannot anticipate every question or

factual application of the minimum necessary standard to each specific industry context, where it

would be generally helpful we will seek to provide additional clarification on this issue in the

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future. In addition, the Department will continue to monitor the workability of the minimum

necessary standard and consider proposing revisions, where appropriate, to ensure that the Rule

does not hinder timely access to quality health care.

Uses and Disclosures of, and Requests for, Protected Health Information. For uses of

protected health information, the covered entity’s policies and procedures must identify the

persons or classes of persons within the covered entity who need access to the information to

carry out their job duties, the categories or types of protected health information needed, and

conditions appropriate to such access. For example, hospitals may implement policies that

permit doctors, nurses, or others involved in treatment to have access to the entire medical

record, as needed. Case-by-case review of each use is not required. Where the entire medical

record is necessary, the covered entity’s policies and procedures must state so explicitly and

include a justification.

For routine or recurring requests and disclosures, the policies and procedures may be

standard protocols and must limit the protected health information disclosed or requested to that

which is the minimum necessary for that particular type of disclosure or request. Individual

review of each disclosure or request is not required.

For non-routine disclosures and requests, covered entities must develop reasonable

criteria for determining and limiting the disclosure or request to only the minimum amount of

protected health information necessary to accomplish the purpose of a non-routine disclosure or

request. Non-routine disclosures and requests must be reviewed on an individual basis in

accordance with these criteria and limited accordingly.

Of course, where protected health information is disclosed to, or requested by, health care

providers for treatment purposes, the minimum necessary standard does not apply.

Reasonable Reliance. In certain circumstances, the Privacy Rule permits a covered entity

to rely on the judgment of the party requesting the disclosure as to the minimum amount of

information that is needed. Such reliance must be reasonable under the particular circumstances

of the request. This reliance is permitted when the request is made by:

minimum necessary for a purpose permitted under 45 CFR 164.512 of the Rule,

such as for public health purposes (45 CFR 164.512(b)).

entity holding the information and who states that the information requested is the

23

minimum necessary for the stated purpose.

(IRB) or Privacy Board.

The Rule does not require such reliance, however, and the covered entity always retains

discretion to make its own minimum necessary determination for disclosures to which the

standard applies.

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use, disclosure of, and requests for protected health information to the minimum

necessary to accomplish the intended purpose. To allow covered entities the flexibility to

address their unique circumstances, the Rule requires covered entities to make their own

assessment of what protected health information is reasonably necessary for a particular

purpose, given the characteristics of their business and workforce, and to implement

policies and procedures accordingly. This is not an absolute standard and covered entities

need not limit information uses or disclosures to those that are absolutely needed to serve

the purpose. Rather, this is a reasonableness standard that calls for an approach

consistent with the best practices and guidelines already used by many providers and

plans today to limit the unnecessary sharing of medical information.

The minimum necessary standard requires covered entities to evaluate their practices and

enhance protections as needed to limit unnecessary or inappropriate access to protected

health information. It is intended to reflect and be consistent with, not override,

professional judgment and standards. Therefore, it is expected that covered entities will

utilize the input of prudent professionals involved in health care activities when

developing policies and procedures that appropriately limit access to personal health

information without sacrificing the quality of health care.

health care providers are explicitly exempted from the minimum necessary requirements.

Uses of protected health information for treatment are not exempt from the minimum

necessary standard. However, the Privacy Rule provides the covered entity with

substantial discretion with respect to how it implements the minimum necessary standard,

and appropriately and reasonably limits access to identifiable health information within

the covered entity. The Rule recognizes that the covered entity is in the best position to

know and determine who in its workforce needs access to personal health information to

perform their jobs. Therefore, the covered entity may develop role-based access policies

25

that allow its health care providers and other employees, as appropriate, access to patient

information, including entire medical records, for treatment purposes.

“conducting training programs in which students, trainees, or practitioners in areas of

health care learn under supervision to practice or improve their skills as health care

providers.” Covered entities can shape their policies and procedures for minimum

necessary uses and disclosures to permit medical trainees access to patients’ medical

information, including entire medical records.

minimum necessary requirements. For example, if a covered health care provider

receives an individual’s authorization to disclose medical information to a life insurer for

underwriting purposes, the provider is permitted to disclose the information requested on

the authorization without making any minimum necessary determination. The

authorization must meet the requirements of 45 CFR 164.508.

from the HIPAA Privacy Rule’s minimum necessary requirements. Furthermore, use of

the provider’s own authorization form is not required. Providers can accept an agency’s

authorization form as long as it meets the requirements of 45 CFR 164.508 of the Privacy

Rule. For example, disclosures to SSA (or its affiliated State agencies) for purposes of

determining eligibility for disability benefits are currently made subject to an individual’s

completed SSA authorization form. After the compliance date, the current process may

continue subject only to modest changes in the SSA authorization form to conform to the

requirements in 45 CFR 164.508.

26

disclosures that are required for compliance with the applicable requirements of the

transactions standards, including disclosures of all data elements that are required or

situationally required in those transactions. See 45 CFR 164.502(b)(2)(vi). However,

covered entities have significant discretion as to the information included in the

transactions as optional data elements. Therefore, the minimum necessary standard does

apply to the optional data elements. The transactions standard adopted for the outpatient

pharmacy sector is an example of a standard that uses optional data elements. The health

plan, or payer, currently specifies which of the optional data elements are needed for

payment of its particular pharmacy claims. The health plan or its business associates

must apply the minimum necessary standard when requesting this information. In this

example, a pharmacist may reasonably rely on the health plan’s request for information as

the minimum necessary for the intended disclosure. For example, as part of a routine

protocol, the name of the individual may be requested by the payer as the minimum

necessary to validate the identity of the claimant or for drug interaction or other patient

safety reasons.

medical record; and a covered entity may use, disclose, or request an entire medical

record without a case-by-case justification, if the covered entity has documented in its

policies and procedures that the entire medical record is the amount reasonably necessary

for certain identified purposes. For uses, the policies and procedures would identify those

persons or classes of person in the workforce that need to see the entire medical record

and the conditions, if any, that are appropriate for such access. Policies and procedures

for routine disclosures and requests and the criteria used for non-routine disclosures and

requests would identify the circumstances under which disclosing or requesting the entire

medical record is reasonably necessary for particular purposes.

The Privacy Rule does not require that a justification be provided with respect to each

distinct medical record.

Finally, no justification is needed in those instances where the minimum necessary

standard does not apply, such as disclosures to or requests by a health care provider for

treatment purposes or disclosures to the individual who is the subject of the protected

health information.

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medical record including portions that were created by another provider, assuming that

the disclosure is for a purpose permitted by the Privacy Rule, such as treatment.

reasonable efforts to limit access to protected health information to those in the workforce

that need access based on their roles in the covered entity.

The Department generally does not consider facility redesigns as necessary to meet the

reasonableness standard for minimum necessary uses. However, covered entities may

need to make certain adjustments to their facilities to minimize access, such as isolating

and locking file cabinets or records rooms, or providing additional security, such as

passwords, on computers maintaining personal information.

Covered entities should also take into account their ability to configure their record

systems to allow access to only certain fields, and the practicality of organizing systems

to allow this capacity. For example, it may not be reasonable for a small, solo

practitioner who has largely a paper-based records system to limit access of employees

with certain functions to only limited fields in a patient record, while other employees

have access to the complete record. In this case, appropriate training of employees may

be sufficient. Alternatively, a hospital with an electronic patient record system may

reasonably implement such controls, and therefore, may choose to limit access in this

manner to comply with the Privacy Rule.

requests for protected health information. One covered entity may reasonably rely on

another covered entity’s request as the minimum necessary, and then does not need to

engage in a separate minimum necessary determination. See 45 CFR 164.514(d)(3)(iii).

28

However, if a covered entity does not agree that the amount of information requested by

another covered entity is reasonably necessary for the purpose, it is up to both covered

entities to negotiate a resolution of the dispute as to the amount of information needed.

Nothing in the Privacy Rule prevents a covered entity from discussing its concerns with

another covered entity making a request, and negotiating an information exchange that

meets the needs of both parties. Such discussions occur today and may continue after the

compliance date of the Privacy Rule.

researcher’s documentation of an Institutional Review Board (IRB) or Privacy Board

waiver of authorization pursuant to 45 CFR 164.512(i) that the information requested is

the minimum necessary for the research purpose. See 45 CFR 164.514(d)(3)(iii). This is

true regardless of whether the documentation is obtained from an external IRB or Privacy

Board or from one that is associated with the covered entity.

associate to use or further disclose the information in a manner that would violate the

HIPAA Privacy Rule if done by the covered entity. See 45 CFR 164.504(e)(2)(i). Thus,

a business associate contract must limit the business associate’s uses and disclosures of,

as well as requests for, protected health information to be consistent with the covered

entity’s minimum necessary policies and procedures. Given that a business associate

contract must limit a business associate’s requests for protected health information on

behalf of a covered entity to that which is reasonably necessary to accomplish the

intended purpose, a covered entity is permitted to reasonably rely on such requests from a

business associate of another covered entity as the minimum necessary.

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The HIPAA Privacy Rule establishes a foundation of Federally-protected rights which

permit individuals to control certain uses and disclosures of their protected health information.

Along with these rights, the Privacy Rule provides individuals with the ability to access and

amend this information, and the right to an accounting of certain disclosures. The Department

recognizes that there may be times when individuals are legally or otherwise incapable of

exercising their rights, or simply choose to designate another to act on their behalf with respect to

these rights. Under the Rule, a person authorized (under State or other applicable law, e.g., tribal

or military law) to act on behalf of the individual in making health care related decisions is the

individual’s “personal representative.” Section 164.502(g) provides when, and to what extent,

the personal representative must be treated as the individual for purposes of the Rule. In addition

to these formal designations of a personal representative, the Rule at 45 CFR 164.510(b)

addresses situations in which persons are involved in the individual’s health care but are not

expressly authorized to act on the individual’s behalf.

General Provisions. Except as otherwise provided in 45 CFR 164.502(g), the Privacy

Rule requires covered entities to treat an individual’s personal representative as the individual

with respect to uses and disclosures of the individual’s protected health information, as well as

the individual’s rights under the Rule.

The personal representative stands in the shoes of the individual and has the ability to act

for the individual and exercise the individual’s rights. For instance, covered entities must

provide the individual’s personal representative with an accounting of disclosures in accordance

with 45 CFR 164.528, as well as provide the personal representative access to the individual’s

protected health information in accordance with 45 CFR 164.524 to the extent such information

is relevant to such representation. In addition to exercising the individual’s rights under the

Rule, a personal representative may also authorize disclosures of the individual’s protected health

information.

In general, the scope of the personal representative’s authority to act for the individual

under the Privacy Rule derives from his or her authority under applicable law to make health care

decisions for the individual. Where the person has broad authority to act on the behalf of a living

individual in making decisions related to health care, such as a parent with respect to a minor

child or a legal guardian of a mentally incompetent adult, the covered entity must treat the

personal representative as the individual for all purposes under the Rule, unless an exception

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applies. (See below with respect to abuse, neglect or endangerment situations, and the

application of State law in the context of parents and minors). Where the authority to act for the

individual is limited or specific to particular health care decisions, the personal representative is

to be treated as the individual only with respect to protected health information that is relevant to

the representation. For example, a person with an individual’s limited health care power of

attorney regarding only a specific treatment, such as use of artificial life support, is that

individual’s personal representative only with respect to protected health information that relates

to that health care decision. The covered entity should not treat that person as the individual for

other purposes, such as to sign an authorization for the disclosure of protected health information

for marketing purposes. Finally, where the person has authority to act on the behalf of a

deceased individual or his estate, which does not have to include the authority to make decisions

related to health care, the covered entity must treat the personal representative as the individual

for all purposes under the Rule. State or other law should be consulted to determine the authority

of the personal representative to receive or access the individual’s protected health information.

Who Must Be Recognized as the Individual’s Personal Representative. The following

chart displays who must be recognized as the personal representative for a category of

individuals:

If the Individual Is: The Personal Representative Is:

An Adult or A person with legal authority to make health

An Emancipated Minor care decisions on behalf of the individual

Court appointed legal guardian

General power of attorney

decisions on behalf of the minor child

below.

Deceased A person with legal authority to act on behalf of the

decedent or the estate (not restricted to health care

decisions)

Next of kin or other family member

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Durable power of attorney

Parents and Unemancipated Minors. The Privacy Rule defers to State or other applicable

(collectively, “parent”) to obtain health information about a minor child. In most cases under the

Rule, the parent is the personal representative of the minor child and can exercise the minor’s

rights with respect to protected health information, because the parent usually has the authority to

make health care decisions about his or her minor child. Regardless of whether a parent is the

personal representative, the Privacy Rule permits a covered entity to disclose to a parent, or

provide the parent with access to, a minor child’s protected health information when and to the

extent it is expressly permitted or required by State or other laws (including relevant case law).

Likewise, the Privacy Rule prohibits a covered entity from disclosing a minor child’s protected

health information to a parent, or providing a parent with access to, such information when and

to the extent it is expressly prohibited under State or other laws (including relevant case law).

Thus, State and other applicable law governs when such law explicitly requires, permits, or

prohibits the disclosure of, or access to, the health information about a minor child.

The Privacy Rule specifies three circumstances in which the parent is not the “personal

representative” with respect to certain health information about his or her minor child. These

exceptions generally track the ability of certain minors to obtain specified health care without

parental consent under State or other laws, or standards of professional practice. In these

situations, the parent does not control the minor’s health care decisions, and thus under the Rule,

does not control the protected health information related to that care. The three exceptional

circumstances when a parent is not the minor’s personal representative are:

health treatment without the consent of his or her parent, and the

adolescent consents to such treatment without the parent’s consent.

minor to an adult other than the parent, to the minor, or the court

may make the decision(s) itself.

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talk with the child confidentially about a medical condition and the

parent agrees.

Even in these exceptional circumstances, where the parent is not the “personal

representative” of the minor, the Privacy Rule defers to State or other laws that require, permit,

or prohibit the covered entity to disclose to a parent, or provide the parent access to, a minor

child’s protected health information. Further, in these situations, if State or other law is silent or

unclear concerning parental access to the minor’s protected health information, a covered entity

has discretion to provide or deny a parent with access to the minor’s health information, if doing

so is consistent with State or other applicable law, and provided the decision is made by a

licensed health care professional in the exercise of professional judgment.

Abuse, Neglect, and Endangerment Situations. When a physician or other covered entity

reasonably believes that an individual, including an unemancipated minor, has been or may be

subjected to domestic violence, abuse or neglect by the personal representative, or that treating a

person as an individual’s personal representative could endanger the individual, the covered

entity may choose not to treat that person as the individual’s personal representative, if in the

exercise of professional judgment, doing so would not be in the best interests of the individual.

For example, if a physician reasonably believes that disclosing information about an incompetent

elderly individual to the individual’s personal representative would endanger that individual, the

Privacy Rule permits the physician to decline to make such disclosure.

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person power of attorney for health care decisions. State law (or other law) regarding

health care powers of attorney continue to apply. The intent of the provisions regarding

personal representatives was to complement, not interfere with or change, current practice

regarding health care powers of attorney or the designation of other personal

representatives. Such designations are formal, legal actions which give others the ability

to exercise the rights of, or make treatment decisions related to, an individual. The

Privacy Rule provisions regarding personal representatives generally grant persons, who

have authority to make health care decisions for an individual under other law, the ability

to exercise the rights of that individual with respect to health information.

to access the medical records of the individual related to such representation to the extent

permitted by the HIPAA Privacy Rule at 45 CFR 164.524. However, when a physician or

other covered entity reasonably believes that an individual, including an unemancipated

minor, has been or may be subjected to domestic violence, abuse or neglect by the

personal representative, or that treating a person as an individual’s personal representative

could endanger the individual, the covered entity may choose not to treat that person as

the individual’s personal representative, if in the exercise of professional judgment, doing

so would not be in the best interests of the individual.

as the individual for purposes of the Rule regarding the health care matters that relate to

the representation, including the right of access under 45 CFR 164.524. The scope of

access will depend on the authority granted to the personal representative by other law. If

the personal representative is authorized to make health care decisions, generally, then the

personal representative may have access to the individual’s protected health information

regarding health care in general. On the other hand, if the authority is limited, the

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personal representative may have access only to protected health information that may be

relevant to making decisions within the personal representative’s authority. For example,

if a personal representative’s authority is limited to authorizing artificial life support, then

the personal representative’s access to protected health information is limited to that

information which may be relevant to decisions about artificial life support.

There is an exception to the general rule that a covered entity must treat an adult or

emancipated minor’s personal representative as the individual. Specifically, the Privacy

Rule does not require a covered entity to treat a personal representative as the individual

if, in the exercise of professional judgment, it believes doing so would not be in the best

interest of the individual because of a reasonable belief that the individual has been or

may be subject to domestic violence, abuse or neglect by the personal representative, or

that doing so would otherwise endanger the individual. This exception applies to adults

and both emancipated and unemancipated minors who may be subject to abuse or neglect

by their personal representatives.

information may be relevant to a family member’s health care. The Rule provides two

ways for a surviving family member to obtain the protected health information of a

deceased relative. First, disclosures of protected health information for treatment

purposes—even the treatment of another individual—do not require an authorization;

thus, a covered entity may disclose a decedent’s protected health information, without

authorization, to the health care provider who is treating the surviving relative. Second, a

covered entity must treat a deceased individual’s legally authorized executor or

administrator, or a person who is otherwise legally authorized to act on the behalf of the

deceased individual or his estate, as a personal representative with respect to protected

health information relevant to such representation. Therefore, if it is within the scope of

such personal representative’s authority under other law, the Rule permits the personal

representative to obtain the information or provide the appropriate authorization for its

disclosure.

to act on an individual’s behalf. However, a covered entity does not have to treat a

personal representative as the individual when it reasonably believes, in the exercise of

professional judgment, the individual is subject to domestic violence, abuse or neglect by

35

the personal representative, or doing so would otherwise endanger the individual.

representative as the individual only when that person has authority under other law to act

on the individual’s behalf on matters related to health care. A power of attorney that does

not include decisions related to health care in its scope would not authorize the holder to

exercise the individual’s rights under the HIPAA Privacy Rule. Further, a covered entity

does not have to treat a personal representative as the individual if, in the exercise of

professional judgment, it believes doing so would not be in the best interest of the

individual because of a reasonable belief that the individual has been or may be subject to

domestic violence, abuse or neglect by the personal representative, or that doing so would

otherwise endanger the individual.

With respect to personal representatives of deceased individuals, the Privacy Rule

requires a covered entity to treat the personal representative as the individual as long as

the person has the authority under law to act for the decedent or the estate. The power of

attorney would have to be valid after the individual’s death to qualify the holder as the

personal representative of the decedent.

to the extent State or other law permits them to act on their own behalf. Further, even if

an individual is deemed incompetent under State or other law to act on his or her own

behalf, covered entities may decline a request by a personal representative for protected

health information if the individual objects to the disclosure (or for any other reason), and

the disclosure is merely permitted, but not required, under the Rule.

However, covered entities must make disclosures that are required under the Rule (i.e.,

disclosures to the Secretary under subpart C of part 160 regarding enforcement of the

Rule, and to the individual under 45 CFR 164.524 and 164.528 with respect to the

individual’s right of access to his or her protected health information and an accounting

of disclosures, respectively). Consequently, with respect to the individual’s right of

access to protected health information and for an accounting of disclosures, covered

entities must provide the individual’s personal representative access to the individual’s

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protected health information or an accounting of disclosures upon the request of the

personal representative, unless the covered entity, in the exercise of professional

judgment, believes doing so would not be in the best interest of the individual because of

a reasonable belief that the individual may be subject to domestic violence, abuse or

neglect by the personal representative, or that doing so would otherwise endanger the

individual. The Rule allows a specified time period before a covered entity must act on

such a request; and during this interim period, an individual and his personal

representative will have an opportunity to resolve any dispute they may have concerning

the request.

Privacy Rule does not address how personal representatives should be identified.

Covered entities should continue to identify personal representatives the same way they

have in the past. However, the HIPAA Privacy Rule does require covered entities to

verify a personal representative’s authority in accordance with 45 CFR 164.514(h).

about his or her child, as his or her minor child’s personal representative when such

access is not inconsistent with State or other law.

There are three situations when the parent would not be the minor’s personal

representative under the Privacy Rule. These exceptions are: (1) when the minor is the

one who consents to care and the consent of the parent is not required under State or other

applicable law; (2) when the minor obtains care at the direction of a court or a person

appointed by the court; and (3) when, and to the extent that, the parent agrees that the

minor and the health care provider may have a confidential relationship. However, even

in these exceptional situations, the parent may have access to the medical records of the

minor related to this treatment when State or other applicable law requires or permits

such parental access. Parental access would be denied when State or other law prohibits

such access. If State or other applicable law is silent on a parent’s right of access in these

cases, the licensed health care provider may exercise his or her professional judgment to

the extent allowed by law to grant or deny parental access to the minor’s medical

information.

Finally, as is the case with respect to all personal representatives under the Privacy Rule,

a provider may choose not to treat a parent as a personal representative when the provider

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reasonably believes, in his or her professional judgment, that the child has been or may be

subjected to domestic violence, abuse or neglect, or that treating the parent as the child’s

personal representative could endanger the child.

the parent would be the child’s personal representative under the HIPAA Privacy Rule.

This would not be so when the parent does not have authority to act for the child (e.g.,

parental rights have been terminated), when expressly prohibited by State or other

applicable law, or when the covered entity, in the exercise of professional judgment,

believes that providing such information would not be in the best interest of the

individual because of a reasonable belief that the individual may be subject to abuse or

neglect by the personal representative, or that doing so would otherwise endanger the

individual.

change State or other laws that address consent to treatment. The Rule addresses access

to, and disclosure of, health information, not the underlying treatment.

rights granted by the HIPAA Privacy Rule with respect to all protected health information

about him or her, including information obtained while the individual was an

unemancipated minor consistent with State or other law. Generally, the parent would no

longer be the personal representative of his or her child once the child reaches the age of

majority or becomes emancipated, and therefore, would no longer control the health

information about his or her child. Of course, any individual can have a personal

representative – which may include a parent – who can exercise rights on his or her

behalf.

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disclosure of health information to a parent about a minor child. If the minor child is

permitted, under State law, to consent to such health care without the consent of her

parent and does consent to such care, the provider may notify the parent when the State

law explicitly requires or permits the health provider to do so. If State law permits the

minor child to consent to such health care without parental consent, but is silent on

parental notification, the provider would need the child’s permission to notify a parent.

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By law, the HIPAA Privacy Rule applies only to covered entities – health plans, health

care clearinghouses, and certain health care providers. However, most health care providers and

health plans do not carry out all of their health care activities and functions by themselves.

Instead, they often use the services of a variety of other persons or businesses. The Privacy Rule

allows covered providers and health plans to disclose protected health information to these

“business associates” if the providers or plans obtain satisfactory assurances that the business

associate will use the information only for the purposes for which it was engaged by the covered

entity, will safeguard the information from misuse, and will help the covered entity comply with

some of the covered entity’s duties under the Privacy Rule. Covered entities may disclose

covered entity carry out its health care functions – not for the business associate’s independent

use or purposes, except as needed for the proper management and administration of the business

associate.

General Provision. The Privacy Rule requires that a covered entity obtain satisfactory

assurances from its business associate that the business associate will appropriately safeguard the

protected health information it receives or creates on behalf of the covered entity. The

satisfactory assurances must be in writing, whether in the form of a contract or other agreement

between the covered entity and the business associate.

What Is a “Business Associate?” A “business associate” is a person or entity that

performs certain functions or activities that involve the use or disclosure of protected health

information on behalf of, or provides services to, a covered entity.

business associate of another covered entity.

The Privacy Rule lists some of the functions or activities, as well as the particular

services, that make a person or entity a business associate, if the activity or service involves the

use or disclosure of protected health information. The types of functions or activities that may

make a person or entity a business associate include payment or health care operations activities,

as well as other functions or activities regulated by the Administrative Simplification Rules.

40

administration; data analysis, processing or administration; utilization review;

quality assurance; billing; benefit management; practice management; and

repricing.

aggregation; management; administrative; accreditation; and financial.

See the definition of “business associate” at 45 CFR 160.103.

Examples of Business Associates.

protected health information.

health information.

into a standard transaction on behalf of a health care provider and forwards the

processed transaction to a payer.

physician.

Business Associate Contracts. A covered entity’s contract or other written arrangement

with its business associate must contain the elements specified at 45 CFR 164.504(e). For

example, the contract must:

business associate;

health information other than as permitted or required by the contract or as

required by law; and

41

disclosure of the protected health information other than as provided for by the

contract.

Where a covered entity knows of a material breach or violation by the business associate

of the contract or agreement, the covered entity is required to take reasonable steps to cure the

breach or end the violation, and if such steps are unsuccessful, to terminate the contract or

arrangement. If termination of the contract or agreement is not feasible, a covered entity is

required to report the problem to the Department of Health and Human Services (HHS) Office

for Civil Rights (OCR).

Sample business associate contract language is available on the HHS OCR Privacy of

Transition Provisions for Existing Contracts. Covered entities (other than small health

plans) that have an existing contract (or other written agreement) with a business associate prior

to October 15, 2002, are permitted to continue to operate under that contract for up to one

additional year beyond the April 14, 2003 compliance date, provided that the contract is not

renewed or modified prior to April 14, 2003. This transition period applies only to written

contracts or other written arrangements. Oral contracts or other arrangements are not eligible for

the transition period. Covered entities with contracts that qualify are permitted to continue to

operate under those contracts with their business associates until April 14, 2004, or until the

contract is renewed or modified, whichever is sooner, regardless of whether the contract meets

the Rule’s applicable contract requirements at 45 CFR 164.502(e) and 164.504(e). A covered

entity must otherwise comply with the Privacy Rule, such as making only permissible disclosures

to the business associate and permitting individuals to exercise their rights under the Rule.

See 45 CFR 164.532(d) and (e).

Exceptions to the Business Associate Standard. The Privacy Rule includes the following

exceptions to the business associate standard. See 45 CFR 164.502(e). In these situations, a

covered entity is not required to have a business associate contract or other written agreement in

place before protected health information may be disclosed to the person or entity.

individual.

For example:

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specialist to whom it refers a patient and transmits the patient’s medical

chart for treatment purposes.

laboratory as a condition of disclosing protected health information for the

treatment of an individual.

to disclose protected health information to a reference laboratory for

treatment of the individual.

or by the health insurance issuer or HMO that provides the health insurance

benefits or coverage for the group health plan, provided that the group health

plan’s documents have been amended to limit the disclosures or one of the

exceptions at 45 CFR 164.504(f) have been met.

a public benefits program, such as Medicare, and an agency other than the agency

administering the health plan, such as the Social Security Administration, that

collects protected health information to determine eligibility or enrollment, or

determines eligibility or enrollment, for the government program, where the joint

activities are authorized by law.

Other Situations in Which a Business Associate Contract Is NOT Required.

plan for payment purposes, or when the health care provider simply accepts a

discounted rate to participate in the health plan’s network. A provider that

submits a claim to a health plan and a health plan that assesses and pays the claim

are each acting on its own behalf as a covered entity, and not as the “business

associate” of the other.

functions or services do not involve the use or disclosure of protected health

information, and where any access to protected health information by such

persons would be incidental, if at all.

information, for example, the US Postal Service, certain private couriers, and their

electronic equivalents.

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(OHCA) to make disclosures that relate to the joint health care activities of the

OHCA.

HMO. The relationship between the group health plan and the health insurance

issuer or HMO is defined by the Privacy Rule as an OHCA, with respect to the

individuals they jointly serve or have served. Thus, these covered entities are

permitted to share protected health information that relates to the joint health care

activities of the OHCA.

example, reinsurance, from an insurer. Each entity is acting on its own behalf

when the covered entity purchases the insurance benefits, and when the covered

entity submits a claim to the insurer and the insurer pays the claim.

either with patient authorization, pursuant to a waiver under 45 CFR 164.512(i),

or as a limited data set pursuant to 45 CFR 164.514(e). Because the researcher is

not conducting a function or activity regulated by the Administrative

Simplification Rules, such as payment or health care operations, or providing one

of the services listed in the definition of “business associate” at 45 CFR 160.103,

the researcher is not a business associate of the covered entity, and no business

associate agreement is required.

by debit, credit, or other payment card, clears checks, initiates or processes

electronic funds transfers, or conducts any other activity that directly facilitates or

effects the transfer of funds for payment for health care or health plan premiums.

When it conducts these activities, the financial institution is providing its normal

banking or other financial transaction services to its customers; it is not

performing a function or activity for, or on behalf of, the covered entity.

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Secretary authority to directly regulate health plans, health care clearinghouses, and

certain health care providers. It also grants the Department explicit authority to regulate

the uses and disclosures of protected health information maintained and transmitted by

covered entities. Therefore, the Department does have the authority to condition the

disclosure of protected health information by a covered entity to a business associate on

the covered entity’s having a written contract with that business associate.

or otherwise cause business associates to comply with the terms of the Rule. The

assurances that covered entities must obtain prior to disclosing protected health

information to business associates create a set of contractual obligations far narrower than

the provisions of the Rule, to protect information generally and help the covered entity

comply with its obligations under the Rule.

Business associates, however, are not subject to the requirements of the Privacy Rule, and

the Secretary cannot impose civil monetary penalties on a business associate for breach of

its business associate contract with the covered entity, unless the business associate is

itself a covered entity. For example, covered entities do not need to ask their business

associates to agree to appoint a privacy officer, or develop policies and procedures for use

and disclosure of protected health information.

responsibilities with respect to protected health information held by their business

associates:

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business associate, as necessary for the Secretary to determine compliance by the

covered entity.

information contained in a designated record set, including information held by a

business associate, if appropriate, and receive an accounting of disclosures by a

business associate.

entity of an impermissible use or disclosure of protected health information by its

business associate.

Covered entities are required to ensure, in whatever reasonable manner deemed effective

by the covered entity, the appropriate cooperation by their business associates in meeting

these requirements during the transition period.

However, a covered entity is not required to obtain the satisfactory assurances required by

the Privacy Rule from a business associate to which the transition period applies.

Of course, even during the transition period, covered entities still may only disclose

protected health information to a business associate for a purpose permitted under the

Rule and must apply the minimum necessary standard, as appropriate, to such disclosures.

other action by the parties and that exist by October 15, 2002, are eligible for the

transition period. The automatic renewal of a contract itself does not terminate

qualification for the transition period, or the transition period itself. Renewal or

modification for the purposes of the transition provisions requires action by the parties

involved. For example, an automatic inflation adjustment to the price of a contract does

not trigger the end of the transition period, nor make the contract ineligible for the

transition period if the adjustment occurs before April 14, 2003.

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other arrangements with business associates which protect the privacy of protected health

information; but covered entities are not required to monitor or oversee the means by

which their business associates carry out privacy safeguards or the extent to which the

business associate abides by the privacy requirements of the contract. Nor is the covered

entity responsible or liable for the actions of its business associates. However, if a

covered entity finds out about a material breach or violation of the contract by the

business associate, it must take reasonable steps to cure the breach or end the violation,

and, if unsuccessful, terminate the contract with the business associate. If termination is

not feasible (e.g., where there are no other viable business alternatives for the covered

entity), the covered entity must report the problem to the Department of Health and

Human Services Office for Civil Rights. See 45 CFR 164.504(e)(1).

With respect to business associates, a covered entity is considered to be out of compliance

with the Privacy Rule if it fails to take the steps described above. If a covered entity is

out of compliance with the Privacy Rule because of its failure to take these steps, further

disclosures of protected health information to the business associate are not permitted. In

cases where a covered entity is also a business associate, the covered entity is considered

to be out of compliance with the Privacy Rule if it violates the satisfactory assurances it

provided as a business associate of another covered entity.

with a business associate that meets the requirements at 45 CFR 164.504(e).

entities as business associates. See the definition of “business associate” at 45 CFR

160.103. Like other business associates, accreditation organizations provide a service to

the covered entity which requires the sharing of protected health information. The

business associate provisions may be satisfied by standard or model contract forms which

could require little or no modification for each covered entity. As an alternative to the

business associate contract, covered entities may disclose a limited data set of protected

health information, not including direct identifiers, to an accreditation organization,

subject to a data use agreement. See 45 CFR 164.514(e). If only a limited data set of

protected health information is disclosed, the satisfactory assurances required of the

business associate are satisfied by the data use agreement.

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require a business associate contract, even in those instances where the covered entity has

hired the researcher to perform research on the covered entity’s own behalf. A business

associate agreement is required only where a person or entity is conducting a function or

activity regulated by the Administrative Simplification Rules on behalf of a covered

entity, such as payment or health care operations, or providing one of the services listed

in the definition of “business associate” at 45 CFR 160.103. However, the HIPAA

Privacy Rule does not prohibit a covered entity from entering into a business associate

contract with a researcher if the covered entity wishes to do so. Notwithstanding the

above, a covered entity is only permitted to disclose protected health information to a

researcher as permitted by Rule, that is, with an individual’s authorization pursuant to 45

CFR 164.508, without an individual’s authorization as permitted by 45 CFR 164.512(i),

or as a limited data set provided that a data use agreement is in place as permitted by 45

CFR 164.514(e).

disclosures by a covered entity to a health care provider for treatment purposes. See 45

CFR 164.502(e)(1). Therefore, any covered health care provider (or other covered entity)

may share protected health information with a health care provider for treatment purposes

without a business associate contract. However, this exception does not preclude one

health care provider from establishing a business associate relationship with another

health care provider for some other purpose. For example, a hospital may enlist the

services of another health care provider to assist in the hospital’s training of medical

students. In this case, a business associate contract would be required before the hospital

could allow the health care provider access to patient health information.

information with another covered entity, the covered entity is permitted to make the

disclosure directly to a business associate acting on behalf of that other covered entity.

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information for the joint health care activities of the OHCA without entering into

business associate contracts with each other. Of course, each such entity is independently

required to observe its obligations under the HIPAA Privacy Rule with respect to

protected health information.

functions, activities, or services do not involve the use or disclosure of protected health

information, and where any access to protected health information by such persons would

be incidental, if at all. Generally, janitorial services that clean the offices or facilities of a

covered entity are not business associates because the work they perform for covered

entities does not involve the use or disclosure of protected health information, and any

disclosure of protected health information to janitorial personnel that occurs in the

performance of their duties (such as may occur while emptying trash cans) is limited in

nature, occurs as a by-product of their janitorial duties, and could not be reasonably

prevented. Such disclosures are incidental and permitted by the HIPAA Privacy Rule.

See 45 CFR 164.502(a)(1).

If a service is hired to do work for a covered entity where disclosure of protected health

information is not limited in nature (such as routine handling of records or shredding of

documents containing protected health information), it likely would be a business

associate. However, when such work is performed under the direct control of the covered

entity (e.g., on the covered entity’s premises), the Privacy Rule permits the covered entity

to treat the service as part of its workforce, and the covered entity need not enter into a

business associate contract with the service.

protected health information to perform their services for a physician’s office, so they do

not meet the definition of a “business associate”. Under the HIPAA Privacy Rule,

“business associates” are contractors or other non-workforce members hired to do the

work of, or for, a covered entity that involves the use or disclosure of protected health

information. See the definition of “business associate” at 45 CFR 160.103.

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Any disclosure of protected health information to such technicians that occurs in the

performance of their duties (such as may occur walking through or working in file rooms)

is limited in nature, occurs as a by-product of their duties, and could not be reasonably

prevented. Such disclosures are incidental and permitted by the Privacy Rule. See 45

CFR 164.502(a)(1).

contracts with organizations, such as the US Postal Service, certain private couriers and

their electronic equivalents that act merely as conduits for protected health information.

A conduit transports information but does not access it other than on a random or

infrequent basis as necessary for the performance of the transportation service or as

required by law. Since no disclosure is intended by the covered entity, and the probability

of exposure of any particular protected health information to a conduit is very small, a

conduit is not a business associate of the covered entity.

covered entities to include specific provisions in agreements with business associates to

safeguard protected health information, and addresses how covered entities may share this

information with business associates. Covered entities are responsible for fulfilling

Privacy Rule requirements with respect to individual rights, including the rights of access,

amendment, and accounting, as provided for by 45 CFR 164.524, 164.526, and 164.528.

With limited exceptions, a covered entity is required to provide an individual access to

his or her protected health information in a designated record set. This includes

information in a designated record set of a business associate, unless the information held

by the business associate merely duplicates the information maintained by the covered

entity. Therefore, the Rule requires covered entities to specify in the business associate

contract that the business associate must make such protected health information

available if and when needed by the covered entity to provide an individual with access to

the information. However, the Privacy Rule does not prevent the parties from agreeing

through the business associate contract that the business associate will provide access to

individuals, as may be appropriate where the business associate is the only holder of the

designated record set, or part thereof.

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Under 45 CFR 164.526, a covered entity must amend protected health information about

an individual in a designated record set, including any designated record sets (or copies

thereof) held by a business associate. Therefore, the Rule requires covered entities to

specify in the business associate contract that the business associate must amend

protected health information in such records (or copies) when requested by the covered

entity. The covered entity itself is responsible for addressing requests from individuals

for amendment and coordinating such requests with its business associate. However, the

Privacy Rule also does not prevent the parties from agreeing through the contract that the

business associate will receive and address requests for amendment on behalf of the

covered entity.

Under 45 CFR 164.528, the Privacy Rule requires a covered entity to provide an

accounting of certain disclosures, including certain disclosures by its business associate,

to the individual upon request. The business associate contract must provide that the

business associate will make such information available to the covered entity in order for

the covered entity to fulfill its obligation to the individual. As with access and

amendment, the parties can agree through the business associate contract that the business

associate will provide the accounting to individuals, as may be appropriate given the

protected health information held by, and the functions of, the business associate.

contract law. The Privacy Rule generally allows for electronic documents, including

business associate contracts, to qualify as written documents for purposes of meeting the

Rule’s requirements. However, currently, no standards exist under HIPAA for electronic

signatures. In the absence of specific standards, covered entities must ensure any

electronic signature used will result in a legally binding contract under applicable State or

other law.

defines as an organized health care arrangement (OHCA). Thus, they may use and

disclose protected health information for the joint health care activities of the OHCA

without entering into a business associate agreement.

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the covered entity’s data contains only the postal address of the individual, a business

associate may be used to convert the covered entity’s geographical information into that

needed by the researcher. In addition, the covered entity may hire the intended recipient

of the limited data set as the business associate for this purpose in accordance with the

business associate requirements. That is, the covered entity may provide protected health

information, including direct identifiers, to a business associate who is also the intended

data recipient, to create a limited data set of the information responsive to the recipient’s

request. However, the data recipient, as a business associate, must agree to return or

destroy the information that includes the direct identifiers once it has completed the

conversion for the covered entity.

single agreement that meets the requirements of both provisions of the HIPAA Privacy

Rule. In the above situation, because the covered entity is providing the recipient with

protected health information that includes direct identifiers, a business associate

agreement would be required in addition to the data use agreement to protect the

information. For example, the agreement must require that the recipient agree to return or

destroy the information that includes the direct identifiers once it has completed the

conversion for the covered entity.

the business associate to carry out a health care operations function, the covered entity

satisfies the Rule’s requirements that it obtain satisfactory assurances from its business

associate with the data use agreement. For example, where a State hospital association

receives only limited data sets of protected health information from its member hospitals

for the purposes of conducting and sharing comparative quality analyses with these

hospitals, the member hospitals need only have data use agreements in place with the

State hospital association.

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associate to use or further disclose the information in a manner that would violate the

HIPAA Privacy Rule if done by the covered entity. See 45 CFR 164.504(e)(2)(i). Thus,

a business associate contract must limit the business associate’s uses and disclosures of,

as well as requests for, protected health information to be consistent with the covered

entity’s minimum necessary policies and procedures. Given that a business associate

contract must limit a business associate’s requests for protected health information on

behalf of a covered entity to that which is reasonably necessary to accomplish the

intended purpose, a covered entity is permitted to reasonably rely on such requests from a

business associate of another covered entity as the minimum necessary.

member of a health plan network and the only relationship between the health plan

(payer) and the provider is one where the provider submits claims for payment to the

plan, then the provider is not a business associate of the health plan. Each covered entity

is acting on its own behalf when a provider submits a claim to a health plan, and when the

health plan assesses and pays the claim. However, a business associate relationship could

arise if the provider is performing another function on behalf of, or providing services to,

the health plan (e.g., case management services) that meet the definition of “business

associate” at 45 CFR 160.103.

providing health insurance or health coverage to a group health plan. The relationship

between the group health plan and the health insurance issuer or HMO is defined by the

Privacy Rule as an organized health care arrangement (OHCA), with respect to the

individuals they jointly serve or have served. Thus, these covered entities are permitted

to share protected health information that relates to the joint health care activities of the

OHCA. However, where a group health plan contracts with a health insurance issuer or

HMO to perform functions or activities or to provide services that are in addition to or

not directly related to the joint activity of providing insurance, the health insurance issuer

or HMO may be a business associate with respect to those additional functions, activities,

or services.

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by selling a reinsurance policy to a health plan and paying claims under the reinsurance

policy. Each entity is acting on its own behalf when the health plan purchases the

reinsurance benefits, and when the health plan submits a claim to a reinsurer and the

reinsurer pays the claim. However, a business associate relationship could arise if the

reinsurer is performing a function on behalf of, or providing services to, the health plan

that do not directly relate to the provision of the reinsurance benefits.

business associate relationship if the vendor does not have access to the protected health

information of the covered entity. If the vendor does need access to the protected health

information of the covered entity in order to provide its service, the vendor would be a

business associate of the covered entity. For example, a software company that hosts the

software containing patient information on its own server or accesses patient information

when troubleshooting the software function, is a business associate of a covered entity. In

these examples, a covered entity would be required to enter into a business associate

agreement before allowing the software company access to protected health information.

However, when an employee of a contractor, like a software or information technology

vendor, has his or her primary duty station on-site at a covered entity, the covered entity

may choose to treat the employee of the vendor as a member of the covered entity’s

workforce, rather than as a business associate. See the definition of “workforce” at 45

CFR 160.103.

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The HIPAA Privacy Rule establishes a foundation of Federal protection for personal

health information, carefully balanced to avoid creating unnecessary barriers to the delivery of

quality health care. As such, the Rule generally prohibits a covered entity from using or

disclosing protected health information unless authorized by patients, except where this

prohibition would result in unnecessary interference with access to quality health care or with

certain other important public benefits or national priorities.

Ready access to treatment and efficient payment for health care, both of which require use

and disclosure of protected health information, are essential to the effective operation of the

health care system. In addition, certain health care operations—such as administrative, financial,

legal, and quality improvement activities—conducted by or for health care providers and health

plans, are essential to support treatment and payment. Many individuals expect that their health

information will be used and disclosed as necessary to treat them, bill for treatment, and, to some

extent, operate the covered entity’s health care business. To avoid interfering with an

individual’s access to quality health care or the efficient payment for such health care, the

Privacy Rule permits a covered entity to use and disclose protected health information, with

certain limits and protections, for treatment, payment, and health care operations activities.

What are Treatment, Payment, and Health Care Operations? The core health care

activities of “Treatment,” “Payment,” and “Health Care Operations” are defined in the Privacy

Rule at 45 CFR 164.501.

health care and related services among health care providers or by a health care

provider with a third party, consultation between health care providers regarding a

patient, or the referral of a patient from one health care provider to another.

payment or be reimbursed for their services and of a health plan to obtain

premiums, to fulfill their coverage responsibilities and provide benefits under the

plan, and to obtain or provide reimbursement for the provision of health care.

In addition to the general definition, the Privacy Rule provides examples of

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common payment activities which include, but are not limited to:

justification of charges, and the like;

identifying information about the individual, his or her payment history,

and identifying information about the covered entity).

improvement activities of a covered entity that are necessary to run its business

and to support the core functions of treatment and payment. These activities,

which are limited to the activities listed in the definition of “health care

operations” at 45 CFR 164.501, include:

activities relating to improving health or reducing health care costs,

and case management and care coordination;

evaluating provider and health plan performance, training health care and

non-health care professionals, accreditation, certification, licensing, or

credentialing activities;

replacement of a contract of health insurance or health benefits, and

ceding, securing, or placing a contract for reinsurance of risk relating to

health care claims;

including fraud and abuse detection and compliance programs;

and planning analyses related to managing and operating the entity; and

those related to implementing and complying with the Privacy Rule and

other Administrative Simplification Rules, customer service, resolution of

internal grievances, sale or transfer of assets, creating de-identified health

information or a limited data set, and fundraising for the benefit of the

covered entity.

General Provisions at 45 CFR 164.506. A covered entity may, without the individual’s

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authorization:

health care operations activities.

For example:

provide health care to the individual and may consult with other health

care providers about the individual’s treatment.

individual as part of a claim for payment to a health plan.

service to its enrollees.

activities of any health care provider (including providers not covered by the

Privacy Rule).

For example:

to a specialist who needs the information to treat the individual.

to which the patient is transferred.

entity or a health care provider (including providers not covered by the Privacy

Rule) for the payment activities of the entity that receives the information.

For example:

a laboratory who needs the information to bill for services it provided to

the physician with respect to the individual.

information to an ambulance service provider that transported the patient

to the hospital in order for the ambulance provider to bill for its treatment

services.

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entity for certain health care operation activities of the entity that receives the

information if:

subject of the information, and the protected health information pertains to

the relationship; and

the activities listed in paragraphs (1) and (2) of the definition of “health

care operations” at 45 CFR 164.501) or for the purpose of health care

fraud and abuse detection or compliance.

For example:

health plan for the plan’s Health Plan Employer Data and Information Set

(HEDIS) purposes, provided that the health plan has or had a relationship

with the individual who is the subject of the information.

(OHCA) may disclose protected health information about an individual to another

covered entity that participates in the OHCA for any joint health care operations

of the OHCA.

For example:

hospital’s training of medical students.

Uses and Disclosures of Psychotherapy Notes. Except when psychotherapy notes are

used by the originator to carry out treatment, or by the covered entity for certain other limited

health care operations, uses and disclosures of psychotherapy notes for treatment, payment, and

health care operations require the individual’s authorization. See 45 CFR 164.508(a)(2).

Minimum Necessary. A covered entity must develop policies and procedures that

reasonably limit its disclosures of, and requests for, protected health information for payment and

health care operations to the minimum necessary. A covered entity also is required to develop

role-based access policies and procedures that limit which members of its workforce may have

access to protected health information for treatment, payment, and health care operations, based

on those who need access to the information to do their jobs. However, covered entities are not

required to apply the minimum necessary standard to disclosures to or requests by a health care

provider for treatment purposes. See the fact sheet and frequently asked questions on this web

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site about the minimum necessary standard for more information.

Consent. A covered entity may voluntarily choose, but is not required, to obtain the

individual’s consent for it to use and disclose information about him or her for treatment,

payment, and health care operations. A covered entity that chooses to have a consent process has

complete discretion under the Privacy Rule to design a process that works best for its business

and consumers.

A “consent” document is not a valid permission to use or disclose protected health

information for a purpose that requires an “authorization” under the Privacy Rule (see 45 CFR

164.508), or where other requirements or conditions exist under the Rule for the use or disclosure

of protected health information.

Right to Request Privacy Protection. Individuals have the right to request restrictions on

how a covered entity will use and disclose protected health information about them for treatment,

payment, and health care operations. A covered entity is not required to agree to an individual’s

request for a restriction, but is bound by any restrictions to which it agrees. See 45 CFR

164.522(a).

Individuals also may request to receive confidential communications from the covered

entity, either at alternative locations or by alternative means. For example, an individual may

confidential communications, if the individual clearly states that not doing so could endanger

him or her. See 45 CFR 164.522(b).

Notice. Any use or disclosure of protected health information for treatment, payment, or

health care operations must be consistent with the covered entity’s notice of privacy practices. A

covered entity is required to provide the individual with adequate notice of its privacy practices,

including the uses or disclosures the covered entity may make of the individual’s information and

the individual’s rights with respect to that information. See the fact sheet and frequently asked

questions on this web site about the notice standard for more information.

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consent to use or disclose his or her health information and, therefore, presents no barrier

to the entity’s ability to comply with State law requirements.

whether a patient consents to the health care itself. As such, the Privacy Rule does not

affect informed consent for treatment, which is addressed by State law.

and the HIPAA Privacy Rule does not require covered entities to obtain an individual’s

consent prior to using or disclosing protected health information about him or her for

treatment, payment, or health care operations.

consent prior to using or disclosing protected health information about him or her for

treatment, payment, or health care operations.

Privacy Rule’s definition of “treatment” and, therefore, is permissible. In addition, a

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health care provider (or other covered entity) is expressly permitted to disclose protected

health information about an individual to a health care provider for that provider’s

treatment of the individual. See 45 CFR 164.506.

The Privacy Rule permits a covered entity to disclose protected health information about

an individual to the individual. See 45 CFR 164.502(a)(1)(i).

to make reasonable inferences of the patient’s best interest in allowing a person, other that

the patient, to pick up a prescription. See 45 CFR 164.510(b). For example, the fact that

a relative or friend arrives at a pharmacy and asks to pick up a specific prescription for an

individual effectively verifies that he or she is involved in the individual’s care, and the

HIPAA Privacy Rule allows the pharmacist to give the filled prescription to the relative

or friend. The individual does not need to provide the pharmacist with the names of such

persons in advance.

patient consent for uses and disclosures of protected health information for treatment,

payment, and health care operations. Covered entities that do so have complete discretion

to design a process that best suits their needs.

By contrast, an “authorization” is required by the Privacy Rule for uses and disclosures of

protected health information not otherwise allowed by the Rule. Where the Privacy Rule

requires patient authorization, voluntary consent is not sufficient to permit a use or

disclosure of protected health information unless it also satisfies the requirements of a

valid authorization. An authorization is a detailed document that gives covered entities

permission to use protected health information for specified purposes, which are generally

other than treatment, payment, or health care operations, or to disclose protected health

information to a third party specified by the individual. An authorization must specify a

number of elements, including a description of the protected health information to be

used and disclosed, the person authorized to make the use or disclosure, the person to

whom the covered entity may make the disclosure, an expiration date, and, in some cases,

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the purpose for which the information may be used or disclosed. With limited

exceptions, covered entities may not condition treatment or coverage on the individual

providing an authorization.

to a health plan for the quality-related health care operations of the health plan, provided

that the health plan has or had a relationship with the individual who is the subject of the

information, and the protected health information requested pertains to the relationship.

See 45 CFR 164.506(c)(4). Thus, a provider may disclose protected health information to

a health plan for the plan’s Health Plan Employer Data and Information Set (HEDIS)

purposes, so long as the period for which information is needed overlaps with the period

for which the individual is or was enrolled in the health plan.

of a covered entity (e.g., a collection agency), to disclose protected health information as

necessary to obtain payment for health care, and does not limit to whom such a disclosure

may be made. Therefore, a covered entity, or its business associate, may contact persons

other than the individual as necessary to obtain payment for health care services. See 45

CFR 164.506(c) and the definition of “payment” at 45 CFR 164.501. However, the

Privacy Rule requires a covered entity, or its business associate, to reasonably limit the

amount of information disclosed for such purposes to the minimum necessary, as well as

to abide by any reasonable requests for confidential communications and any agreed-to

restrictions on the use or disclosure of protected health information. See 45 CFR

164.502(b), 164.514(d), and 164.522.

reporting agencies. These disclosures, however, are limited to the following protected

health information about the individual: name and address; date of birth; social security

number; payment history; and account number. In addition, disclosure of the name and

address of the health care provider or health plan making the report is allowed. The

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covered entity may perform this payment activity directly, or may carry out this function

through a third party, such as a collection agency, under a business associate arrangement.

The Privacy Rule permits uses and disclosures by the covered entity or its business

associate as may be required by the Fair Credit Reporting Act (FCRA) or other law.

Therefore, the Department does not believe there is a conflict between the Privacy Rule

and legal duties imposed on data furnishers by FCRA.

collection agencies. Debt collection is recognized as a payment activity within the

“payment” definition. See the definition of “payment” at 45 CFR 164.501. Through a

business associate arrangement, the covered entity may engage a debt collection agency to

perform this function on its behalf. Disclosures to collection agencies are governed by

other provisions of the Privacy Rule, such as the business associate and minimum

necessary requirements.

The Department is not aware of any conflict between the Privacy Rule and the Fair Debt

Collection Practices Act. Where a use or disclosure of protected health information is

necessary for the covered entity to fulfill a legal duty, the Privacy Rule would permit such

use or disclosure as required by law.

obtain premiums or obtain or provide reimbursements for the provision of health care.

The activities specified are by way of example and are not intended to be an exclusive

listing. Billing, claims management, collection activities and related data processing are

expressly included in the definition of “payment.” See the definition of “payment” at 45

CFR 164.501. Obtaining information about the location of the individual is a routine

activity to facilitate the collection of amounts owed and the management of accounts

receivable, and, therefore, would constitute a payment activity. See 45 CFR 164.501.

The covered entity and its business associate would also have to comply with any

limitations placed on location information services by the Fair Debt Collection Practices

Act.

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contact lenses for the purpose of confirming a contact lens prescription is a treatment

disclosure, and is permitted under the Privacy Rule at 45 CFR 164.506.

information about an individual, without the individual’s authorization, to another health

care provider for that provider’s treatment of the individual. See 45 CFR 164.506 and the

definition of “treatment” at 45 CFR 164.501.

information about an individual, without the individual’s authorization, to another health

care provider for that provider’s treatment or payment purposes, as well as to another

covered entity for certain health care operations of that entity. See 45 CFR 164.506 and

the definitions of “treatment,” “payment,” and “health care operations” at 45 CFR

164.501.

provider to disclose protected health information about an individual, without the

individual’s authorization, to another health care provider, such as a hospital, for that

provider’s treatment of the individual. See 45 CFR 164.506 and the definition of

“treatment” at 45 CFR 164.501.

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“health care operations” purposes, subject to certain requirements. Disclosures by a

covered health care provider to a professional liability insurer or a similar entity for the

purpose of obtaining or maintaining medical liability coverage or for the purpose of

obtaining benefits from such insurance, including the reporting of adverse events, fall

within “business management and general administrative activities” under the definition

of “health care operations.” Therefore, a covered health care provider may disclose

individually identifiable health information to a professional liability insurer to the same

extent as the provider is able to disclose such information for other health care operations

purposes. See 45 CFR 164.502(a)(1)(ii) and the definition of “health care operations” at

45 CFR 164.501.

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The HIPAA Privacy Rule gives individuals important controls over whether and how

their protected health information is used and disclosed for marketing purposes. With limited

exceptions, the Rule requires an individual’s written authorization before a use or disclosure of

his or her protected health information can be made for marketing. So as not to interfere with

core health care functions, the Rule distinguishes marketing communications from those

communications about goods and services that are essential for quality health care.

The Privacy Rule addresses the use and disclosure of protected health information for

marketing purposes by:

• Defining what is “marketing” under the Rule;

• Excepting from that definition certain treatment or health care operations

activities;

• Requiring individual authorization for all uses or disclosures of protected health

information for marketing purposes with limited exceptions.

What is “Marketing”? The Privacy Rule defines “marketing” as making “a

communication about a product or service that encourages recipients of the communication to

purchase or use the product or service.” Generally, if the communication is “marketing,” then

the communication can occur only if the covered entity first obtains an individual’s

“authorization.” This definition of marketing has certain exceptions, as discussed below.

Examples of “marketing” communications requiring prior authorization are:

• A communication from a hospital informing former patients about a cardiac

facility, that is not part of the hospital, that can provide a baseline EKG for $39,

when the communication is not for the purpose of providing treatment advice.

• A communication from a health insurer promoting a home and casualty insurance

product offered by the same company.

What Else is “Marketing”? Marketing also means: “An arrangement between a covered

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entity and any other entity whereby the covered entity discloses protected health information to

the other entity, in exchange for direct or indirect remuneration, for the other entity or its affiliate

to make a communication about its own product or service that encourages recipients of the

communication to purchase or use that product or service.” This part of the definition to

marketing has no exceptions. The individual must authorize these marketing communications

before they can occur.

Simply put, a covered entity may not sell protected health information to a business

associate or any other third party for that party’s own purposes. Moreover, covered entities may

not sell lists of patients or enrollees to third parties without obtaining authorization from each

person on the list.

For example, it is “marketing” when:

• A health plan sells a list of its members to a company that sells blood glucose

monitors, which intends to send the plan’s members brochures on the benefits of

purchasing and using the monitors.

• A drug manufacturer receives a list of patients from a covered health care provider

and provides remuneration, then uses that list to send discount coupons for a new

anti-depressant medication directly to the patients.

What is NOT “Marketing”? The Privacy Rule carves out exceptions to the definition of

marketing under the following three categories:

(1) A communication is not “marketing” if it is made to describe a health-related

product or service (or payment for such product or service) that is provided by, or

included in a plan of benefits of, the covered entity making the communication,

including communications about:

network;

that add value to, but are not part of, a plan of benefits.

This exception to the marketing definition permits communications by a covered

entity about its own products or services.

For example, under this exception, it is not “marketing” when:

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group (e.g., orthopedic) or the acquisition of new equipment (e.g., x-ray

machine or magnetic resonance image machine) through a general mailing

or publication.

eligible age with materials describing its Medicare supplemental plan and

an application form.

(2) A communication is not “marketing” if it is made for treatment of the individual.

For example, under this exception, it is not “marketing” when:

reminders to patients, or contracts with a mail house to do so.

test or provides free samples of a prescription drug to a patient.

(3) A communication is not “marketing” if it is made for case management or care

coordination for the individual, or to direct or recommend alternative treatments,

therapies, health care providers, or settings of care to the individual.

For example, under this exception, it is not “marketing” when:

management programs to determine which program best suits the ongoing

needs of the individual patient.

nursing homes in the course of recommending that the patient be

transferred from a hospital bed to a nursing home.

For any of the three exceptions to the definition of marketing, the activity must otherwise

be permissible under the Privacy Rule, and a covered entity may use a business associate to make

the communication. As with any disclosure to a business associate, the covered entity must

obtain the business associate’s agreement to use the protected health information only for the

communication activities of the covered entity.

Marketing Authorizations and When Authorizations are NOT Necessary. Except as

discussed below, any communication that meets the definition of marketing is not permitted,

unless the covered entity obtains an individual’s authorization. To determine what constitutes an

acceptable “authorization,” see 45 CFR 164.508. If the marketing involves direct or indirect

remuneration to the covered entity from a third party, the authorization must state that such

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remuneration is involved. See 45 CFR 164.508(a)(3).

A communication does not require an authorization, even if it is marketing, if it is in the

form of a face-to-face communication made by a covered entity to an individual; or a

promotional gift of nominal value provided by the covered entity.

For example, no prior authorization is necessary when:

• A hospital provides a free package of formula and other baby products to new

mothers as they leave the maternity ward.

• An insurance agent sells a health insurance policy in person to a customer and

proceeds to also market a casualty and life insurance policy as well.

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information for marketing purposes do not exist in most States today. For example, the

Rule requires patients’ authorization for the following types of uses or disclosures of

protected health information for marketing:

• Selling protected health information to third parties for their use and re-use. Thus,

under the Rule, a hospital or other provider may not sell names of pregnant

women to baby formula manufacturers or magazines without an authorization.

• Disclosing protected health information to outsiders for the outsiders’ independent

marketing use. Under the Rule, doctors may not provide patient lists to

pharmaceutical companies for those companies’ drug promotions without an

authorization.

Without these Privacy Rule restrictions, these activities could occur with no authorization

from the individual in most jurisdictions. In addition, if a State law provided additional

limitations on disclosures of information for related activities, the Privacy Rule generally

would not interfere with those laws.

Moreover, under the “business associate” provisions of the Privacy Rule, a covered entity

may not give protected health information to a telemarketer, door-to-door salesperson, or

other third party it has hired to make permitted communications (for example, about a

covered entities’ own goods and services) unless that third party has agreed by contract to

use the information only for communicating on behalf of the covered entity. Without the

Privacy Rule, there may be no restrictions on how third parties re-use information they

obtain from health plans and providers. See the fact sheet and frequently asked questions

on this web site about the business associate standard for more information.

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who meet the definition of “business associates” under the HIPAA Privacy Rule, that

definition is limited to contractors that obtain protected health information to perform or

Thus, business associates, with limited exceptions, cannot use protected health

information for their own purposes. Although, under the HIPAA statute, the Privacy

Rule cannot govern contractors directly, the Rule does set clear parameters for how

covered entities may contract with business associates. See 45 CFR 164.502(e) and

164.504(e), and the definition of “business associate” at 45 CFR 160.103.

Further, the Privacy Rule expressly prohibits health plans and covered health care

providers from selling protected health information to third parties for the third party’s

own marketing activities, without authorization. So, for example, a pharmacist cannot,

without patient authorization, sell a list of patients to a pharmaceutical company, for the

pharmaceutical company to market its own products to the individuals on the list.

with a telemarketer only if the covered entity has either obtained the individual’s prior

written authorization to do so, or has entered into a business associate relationship with

the telemarketer for the purpose of making a communication that is not marketing, such

as to inform individuals about the covered entity’s own goods or services.

If the telemarketer is a business associate under the Privacy Rule, it must agree by

contract to use the information only for communicating on behalf of the covered entity,

and not to market its own goods or services (or those of another third party).

protected health information for ALL marketing communications, except in two

circumstances: (1) when the communication occurs in a face-to-face encounter between

the covered entity and the individual; or (2) the communication involves a promotional

gift of nominal value.

If the marketing communication involves direct or indirect remuneration to the covered

entity from a third party, the authorization must state that such remuneration is involved.

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and “marketing” is unavoidable. For instance, in recommending treatments, providers

and health plans sometimes advise patients to purchase goods and services. Similarly,

when a health plan explains to its members the benefits it provides, it too is encouraging

the use or purchase of goods and services.

The HIPAA Privacy Rule defines these terms specifically, so they can be distinguished.

For example, the Privacy Rule excludes treatment communications and certain health

care operations activities from the definition of “marketing.” If a communication falls

under one of the definition’s exceptions, the marketing rules do not apply. In these cases,

covered entities may engage in the activity without first obtaining an authorization. See

the fact sheet on this web site about marketing, as well as the definition of “marketing” at

45 CFR 164.501, for more information.

However, if a health care operation communication does not fall within one of these

specific exceptions to the marketing definition, and the communication falls under the

definition of “marketing,” the Privacy Rule’s provisions restricting the use or disclosure

of protected health information for marketing purposes will apply. For these marketing

communications, the individual’s authorization is required before a covered entity may

use or disclose protected health information.

the covered entity directly or by a business associate, communications about such

programs are not marketing because they are about the covered entity’s own healthrelated

services. So, for example, a hospital’s Wellness Department could start a weightloss

program and send a flyer to all patients seen in the hospital over the past year who

meet the definition of obese, even if those individuals were not specifically seen for

obesity when they were in the hospital.

Moreover, a communication that merely promotes health in a general manner and does

not promote a specific product or service from a particular provider does not meet the

definition of “marketing.” Such communications may include population-based activities

in the areas of health education or disease prevention. Examples of general health

promotional material include mailings reminding women to get an annual mammogram;

mailings providing information about how to lower cholesterol, new developments in

health care (e.g., new diagnostic tools), support groups, organ donation, cancer

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prevention, and health fairs.

communications made to describe a covered entity’s health-related product or service (or

payment for such product or service) that is provided by, or included in a plan of benefits

of, the covered entity making the communication. Thus, it would not be marketing for a

physician who has developed a new anti-snore device to send a flyer describing it to all of

her patients (whether or not each patient has actually sought treatment for snoring). Nor

would it be marketing for an ophthalmologist or health plan to send existing patients or

members discounts for eye-exams or eye-glasses available only to the patients and

members. Similarly, it would not be marketing for an insurance plan to send its members

a description of covered benefits, payment schedules, and claims procedures.

communications by a covered entity to describe the entities participating in a health care

provider network or a health plan network. Thus, it would not be marketing for a health

plan or insurer to mail its members or enrollees a list of health care providers in the health

plan network or for an independent physicians association to send its patients a preferred

provider list.

communications about replacements of, or enhancements to, a health plan. Therefore,

notices about changes in deductibles, co-pays and types of coverage, such as prescription

drugs, are not marketing. Likewise, a notice to a family warning that a student reaching

the age of majority on a parental policy will lose coverage, then offering continuation

coverage, would not be considered marketing. Nor are special health care policies such

as guaranteed issue products and conversion policies considered marketing. Similarly,

notices from a health plan about its long term care benefits would not be considered

marketing.

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It would be considered marketing, however, for a health plan to send to its members

promotional material about insurance products that are considered to be “excepted

benefits” (described in section 2791(c)(1) of the Public Health Service Act), such as

accident only policies. It would likewise be marketing for health plans to describe other

lines of insurance, such as life insurance policies. Generally, such communications

require authorizations.

particularly for managed care organizations. Under the HIPAA Privacy Rule,

communications may qualify under the marketing exception for a communication about a

health plan’s plan of benefits, even if the VAIS are not considered plan benefits for the

Adjusted Community Rate purposes. To qualify for this exclusion, however, the VAIS

must meet two conditions. First, they must be health-related. Therefore, discounts

offered by Medicare + Choice or other managed care organizations for eyeglasses may be

considered part of the plan’s benefits, whereas discounts to attend movie theaters will not.

Second, such items and services must demonstrably “add value” to the plan’s

membership and not merely be a pass-through of a discount or item available to the

public at large.

So, a Medicare + Choice or other managed care organization could offer its members a

special discount opportunity for eyeglasses and contact lenses without obtaining

authorizations if the discount were only available through membership in the managed

care organization. However, such communications would need an authorization if the

members would be able to obtain such discounts directly from the eyeglass store.

Similarly, a Medicare + Choice or other managed care organization could offer its

members a special discount opportunity for a prescription drug card benefit or for a

health/fitness club membership, which is not available to consumers on the open market.

On the other hand, a Medicare+Choice or other managed care organization would need an

authorization to notify its members of a discount to a movie theater available only to its

members.

party pays for the communication. The prescription refill reminder is considered

treatment. The communication is therefore excluded from the definition of marketing

and does not require a prior authorization. Similarly, it is not marketing when a doctor or

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pharmacy is paid by a pharmaceutical company to recommend an alternative medication

to patients. Communications about alternative treatments are excluded from the

definition of marketing and do not require a prior authorization. The simple receipt of

remuneration does not transform a treatment communication into a commercial

promotion of a product or service.

Furthermore, covered entities may use a legitimate business associate to assist them in

making such permissible communications. For instance, if a pharmacist that has been

paid by a third party contracts with a mail house to send out prescription refill reminders

to the pharmacist’s patients, neither the mail house nor the pharmacist needs a prior

authorization. However, a covered entity would require an authorization if it sold

protected health information to a third party for the third party’s marketing purposes.

therefore, can be made without an authorization.

available to an individual. For example, it would be an alternative treatment

communication if a doctor, in response to an inquiry from a patient with skin rash about

the range of treatment options, mails the patient a letter recommending that the patient

purchase various ointments and medications described in brochures enclosed with the

letter. Alternative treatment could also include alternative medicine. Thus, alternative

treatments would include communications by a nurse midwife who recommends or sells

vitamins and herbal preparations, dietary and exercise programs, massage services, music

or other alternative types of therapy to her pregnant patients.

items commonly known as promotional gifts of nominal value without prior

authorization, even if such items are distributed with the intent of encouraging the

receiver to buy the products or services. This authorization exception generally applies to

items and services of a third party, whether or not they are health-related, or items and

services of the covered entity that are not health-related. A covered doctor, for instance,

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may send patients items such as pens, note-pads, and cups embossed with a health plan’s

logo without prior authorization. Similarly, dentists may give patients free toothbrushes,

floss and toothpaste.

or discuss products or services, even when not health-related, to patients without a prior

authorization. This exception prevents unnecessary intrusion into the doctor-patient

relationship. Physicians may give out free pharmaceutical samples, regardless of their

value. Similarly, hospitals may give infant supplies to new mothers. Moreover, the faceto-

face exception would allow providers to leave general circulation materials in their

offices for patients to pick up during office visits.

health plans and their business associates to market both health and non-health insurance

products to individuals.

Rule are to be construed as amending, modifying, or changing any rule or requirement

related to any other Federal or State statutes or regulations, including specifically antikickback,

fraud and abuse, or self-referral statutes or regulations, or to authorize or permit

any activity or transaction currently proscribed by such statutes and regulations.

Examples of such laws include the anti-kickback statute (section 1128B(b) of the Social

Security Act), safe harbor regulations (42 CFR Parts 411 and 424), and HIPAA statute on

self-referral (section 1128C of the Social Security Act). The definition of “marketing” is

applicable solely to the Privacy Rule and the permissions granted by the Rule are only for

a covered entity’s use or disclosure of protected health information. In particular,

although the Privacy Rule defines the term “marketing” to exclude communications to an

individual to recommend, purchase, or use a product or service as part of the treatment of

the individual or for case management or care coordination of that individual, such

communication by a health care professional may violate the anti-kickback statute.

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Similar examples of pharmacist communications with patients relating to the marketing

of products on behalf of pharmaceutical companies were identified by the Office of the

Inspector General (OIG) as problematic in a 1994 Special Fraud Alert (December 19,

1994, 59 FR 65372). Other violations have involved home health nurses and physical

therapists acting as marketers for durable medical equipment companies. Although a

particular communication under the Privacy Rule may not require patient authorization

because it is not “marketing,” or may require patient authorization because it is

“marketing” as the Rule defines it, the arrangement may nevertheless violate other

statutes and regulations administered by the Department of Health and Human Services,

Department of Justice, or other Federal or State agencies.

coordination, or the recommendation of alternative therapies. The HIPAA Privacy Rule

permits the use of clinical information to the extent it is reasonably necessary for these

communications. Similarly, population-based activities in the areas of health education

or disease prevention are not considered marketing when they promote health in a general

manner. Again clinical information may be used for such communications, such as in

targeting a public education campaign.

within the definition of “marketing.” There is no commercial component to

communications about benefits available through public programs. Therefore, a covered

entity is permitted to use and disclose protected health information to communicate about

eligibility for such programs as Medicare, Medicaid, or the State Children’s Health

Insurance Program (SCHIP).

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The HIPAA Privacy Rule recognizes the legitimate need for public health authorities and

others responsible for ensuring public health and safety to have access to protected health

information to carry out their public health mission. The Rule also recognizes that public health

reports made by covered entities are an important means of identifying threats to the health and

safety of the public at large, as well as individuals. Accordingly, the Rule permits covered

entities to disclose protected health information without authorization for specified public health

purposes.

General Public Health Activities. The Privacy Rule permits covered entities to disclose

protected health information, without authorization, to public health authorities who are legally

authorized to receive such reports for the purpose of preventing or controlling disease, injury, or

disability. This would include, for example, the reporting of a disease or injury; reporting vital

events, such as births or deaths; and conducting public health surveillance, investigations, or

interventions. See 45 CFR 164.512(b)(1)(i). Also, covered entities may, at the direction of a

public health authority, disclose protected health information to a foreign government agency that

is acting in collaboration with a public health authority. See 45 CFR 164.512(b)(1)(i). Covered

entities who are also a public health authority may use, as well as disclose, protected health

information for these public health purposes. See 45 CFR 164.512(b)(2).

A “public health authority” is an agency or authority of the United States government, a

State, a territory, a political subdivision of a State or territory, or Indian tribe that is responsible

for public health matters as part of its official mandate, as well as a person or entity acting under

a grant of authority from, or under a contract with, a public health agency. See 45 CFR 164.501.

Examples of a public health authority include State and local health departments, the Food and

Drug Administration (FDA), the Centers for Disease Control and Prevention, and the

Occupational Safety and Health Administration (OSHA).

Generally, covered entities are required reasonably to limit the protected health

information disclosed for public health purposes to the minimum amount necessary to

accomplish the public health purpose. However, covered entities are not required to make a

minimum necessary determination for public health disclosures that are made pursuant to an

individual’s authorization, or for disclosures that are required by other law. See 45 CFR

164.502(b). For disclosures to a public health authority, covered entities may reasonably rely on

a minimum necessary determination made by the public health authority in requesting the

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protected health information. See 45 CFR 164.514(d)(3)(iii)(A). For routine and recurring

public health disclosures, covered entities may develop standard protocols, as part of their

minimum necessary policies and procedures, that address the types and amount of protected

health information that may be disclosed for such purposes. See 45 CFR 164.514(d)(3)(i).

Other Public Health Activities. The Privacy Rule recognizes the important role that

persons or entities other than public health authorities play in certain essential public health

activities. Accordingly, the Rule permits covered entities to disclose protected health

information, without authorization, to such persons or entities for the public health activities

discussed below.

• Child abuse or neglect. Covered entities may disclose protected health

information to report known or suspected child abuse or neglect, if the report is

made to a public health authority or other appropriate government authority that is

authorized by law to receive such reports. For instance, the social services

department of a local government might have legal authority to receive reports of

child abuse or neglect, in which case, the Privacy Rule would permit a covered

entity to report such cases to that authority without obtaining individual

authorization. Likewise, a covered entity could report such cases to the police

department when the police department is authorized by law to receive such

reports. See 45 CFR 164.512(b)(1)(ii). See also 45 CFR 512(c) for information

regarding disclosures about adult victims of abuse, neglect, or domestic violence.

• Quality, safety or effectiveness of a product or activity regulated by the FDA.

Covered entities may disclose protected health information to a person subject to

FDA jurisdiction, for public health purposes related to the quality, safety or

effectiveness of an FDA-regulated product or activity for which that person has

responsibility. Examples of purposes or activities for which such disclosures may

be made include, but are not limited to:

food and dietary supplements), product defects or problems (including

problems regarding use or labeling), or biological product deviations;

locating and notifying individuals who received recalled or withdrawn

products or products that are the subject of lookback); and

See 45 CFR 164.512(b)(1)(iii). The “person” subject to the jurisdiction of the

FDA does not have to be a specific individual. Rather, it can be an individual or

79

an entity, such as a partnership, corporation, or association. Covered entities may

identify the party or parties responsible for an FDA-regulated product from the

product label, from written material that accompanies the product (know as

labeling), or from sources of labeling, such as the Physician’s Desk Reference.

disclose protected health information to a person who is at risk of contracting or

spreading a disease or condition if other law authorizes the covered entity to

notify such individuals as necessary to carry out public health interventions or

investigations. For example, a covered health care provider may disclose

protected health information as needed to notify a person that (s)he has been

exposed to a communicable disease if the covered entity is legally authorized to

do so to prevent or control the spread of the disease. See 45 CFR

164.512(b)(1)(iv).

health care service to an individual at the request of the individual’s employer, or

provides the service in the capacity of a member of the employer’s workforce,

may disclose the individual’s protected health information to the employer for the

purposes of workplace medical surveillance or the evaluation of work-related

illness and injuries to the extent the employer needs that information to comply

with OSHA, the Mine Safety and Health Administration (MSHA), or the

requirements of State laws having a similar purpose. The information disclosed

must be limited to the provider’s findings regarding such medical surveillance or

work-related illness or injury. The covered health care provider must provide the

individual with written notice that the information will be disclosed to his or her

employer (or the notice may be posted at the worksite if that is where the service

is provided). See 45 CFR 164.512(b)(1)(v).

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public health officials. The HIPAA Privacy Rule permits disclosures that are required by

law. Furthermore, disclosures to public health authorities that are authorized by law to

collect or receive information for public health purposes are also permissible under the

Privacy Rule. In order to do their job of protecting the health of the public, it is

frequently necessary for public health officials to obtain information about the persons

affected by a disease. In some cases they may need to contact those affected in order to

determine the cause of the disease to allow for actions to prevent further illness.

The Privacy Rule continues to allow for the existing practice of sharing protected health

information with public health authorities that are authorized by law to collect or receive

such information to aid them in their mission of protecting the health of the public.

Examples of such activities include those directed at the reporting of disease or injury,

reporting deaths and births, investigating the occurrence and cause of injury and disease,

and monitoring adverse outcomes related to food (including dietary supplements), drugs,

biological products, and medical devices. See the fact sheet and frequently asked

questions on this web site about the public health provision for more information.

entities to make such disclosures. This provision is intended to allow covered entities to

continue current voluntary reporting practices that are critically important to public health

and safety. The Rule also permits covered entities to disclose protected health

information when State or other law requires covered entities to make disclosures for

public health purposes. For instance, many State laws require health care providers to

report certain diseases, cases of child abuse, births, or deaths, and the Privacy Rule

permits covered entities to disclose protected health information, without authorization,

to make such reports. See the fact sheet and frequently asked questions on this web site

about the public health provision for more information.

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of protected health information that is needed for public health purposes. In some cases,

the disclosure will be required by other law, in which case, covered entities may make the

required disclosure pursuant to 45 CFR 164.512(a) of the Rule. For disclosures that are

not required by law, covered entities may disclose, without authorization, the information

that is reasonably limited to that which is minimally necessary to accomplish the intended

purpose of the disclosure. For routine or recurring public health disclosures, a covered

entity may develop protocols as part of its minimum necessary policies and procedures to

address the type and amount of information that may be disclosed for such purposes.

Covered entities may also rely on the requesting public health authority’s determination

of the minimally necessary information. See the fact sheet and frequently asked questions

on this web site about the public health and minimum necessary standards for more

information.

include the responsibility for public health matters. The mandate can be responsibility for

public health matters, generally, or it can be for specific public health programs.

Furthermore, an agency’s official mandate does not have to be exclusively or primarily

for public health. Therefore, to the extent a government agency has public health matters

as part of its official mandate, it qualifies as a public health authority. For instance,

various Department of Health and Human Service agencies, such as NIH and the Health

Resources and Services Administration (HRSA), are authorized by law to assist the

Secretary of Health and Human Services in carrying out the purposes of section 301 of

the Public Health Service Act. Those agencies are public health authorities under the

Rule, even if they have other non-public health mandates. To the extent a public health

authority is authorized by law to collect or receive information for the public health

purposes specified in the public health provision, covered entities may disclose protected

health information to such public health authorities without authorization pursuant to the

public health provision. See the fact sheet and frequently asked questions on this web site

about the public health provision for more information.

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the product label, the literature that accompanies the product, or other sources of labeling,

such as the Physician’s Desk Reference. If multiple persons are named, covered entities

may choose any of the persons named by these sources. See the fact sheet and frequently

asked questions on this web site about the public health provision for more information.

responsible for an FDA-regulated product, the covered entity will suspect, but not know,

the product is the cause of the event. Determining whether the product is related to the

adverse event almost always requires follow up with the covered entity which in turn may

need further contact with the patient. FDA and product manufacturers receive a great

deal of important information about the safety of regulated products from these reports.

To limit such reports to those instances where the covered entity is convinced of the link

between the product and the event would reduce the amount of useful safety, quality and

effectiveness data available to the agency as well as to product manufacturers. This

would limit significantly FDA’s ability to protect the public health by helping to assure

that only safe and effective products are marketed in the U.S. Accordingly, covered

entities may disclose the minimum amount of protected health information that is

reasonably necessary to report suspected adverse events associated with an

FDA-regulated product. See the fact sheet and frequently asked questions on this web

site about the public health and minimum necessary standards for more information.

essential to the FDA’s public health mission. The provision does not permit covered

entities to disclose protected health information to a manufacturer for the manufacturer’s

commercial purposes, or for any other non-public health purpose. For example, the Rule

does not permit a covered entity to provide a drug manufacturer with a list of persons

who prefer a different flavored cough syrup over the flavor of the manufacturer’s product.

Rather, this provision permits covered entities to disclose protected health information as

necessary to continue current voluntary reporting of adverse events and similar reports

that are necessary to ensure the quality, safety, or effectiveness of an FDA-regulated

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product. For instance, a covered entity would be permitted to report a concern to a drug

manufacturer that its cough syrup might be unsafe based on the belief that a difference in

the taste could be due to drug tampering or a manufacturing problem. Likewise, a

covered health care provider would be permitted to disclose protected health information

to a drug manufacturer to report that the failure of a patient’s medical condition to

improve may be due to the drug’s ineffectiveness. In making such a report, the covered

entity may disclose the protected health information that is reasonably necessary to

achieve the purpose of the report. See the fact sheet and frequently asked questions on

this web site about the public health and minimum necessary standards for more

information.

individual’s protected health information to the individual’s employer without

authorization in very limited circumstances. First, the covered health care provider must

provide the health care service to the individual at the request of the individual’s

employer or as a member of the employer’s workforce. Second, the health care service

provided must relate to the medical surveillance of the workplace or an evaluation to

determine whether the individual has a work-related illness or injury. Third, the

employer must have a duty under the Occupational Safety and Health Administration

(OSHA), the Mine Safety and Health Administration (MSHA), or the requirements of a

similar State law, to keep records on or act on such information. For example, OSHA

requires employers to monitor employees’ exposures to certain substances and to take

specific actions when an employee’s exposure level exceeds a specified limit. A covered

entity which tests an individual for such an exposure level at the request of the

individual’s employer may disclose that test result to the employer without authorization.

Generally, pre-placement physicals, drug tests, and fitness-for-duty examinations are not

performed for such purposes. However, to the extent such an examination is conducted at

the request of the employer for the purpose of such workplace medical surveillance or

work-related illness or injury, and the employer needs the information to comply with the

requirements of OSHA, MSHA, or similar State law, the protected health information the

employer needs to meet such legal obligation may be disclosed to the employer without

authorization. Covered health care providers who make such disclosures must provide

the individual with written notice that the information is to be disclosed to his or her

employer (or by posting the notice at the worksite if the service is provided there).

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When a health care service does not meet the above requirements, covered entities may

not disclose an individual’s protected health information to the individual’s employer

without an authorization, unless the disclosure is otherwise permitted without

authorization by other provisions of the Rule. However, nothing in the Rule prohibits an

employer from conditioning employment on an individual providing an authorization for

the disclosure of such information.

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The HIPAA Privacy Rule establishes the conditions under which protected health

information may be used or disclosed by covered entities for research purposes. Research is

defined in the Privacy Rule as, “a systematic investigation, including research development,

testing, and evaluation, designed to develop or contribute to generalizable knowledge.” See 45

CFR 164.501. A covered entity may always use or disclose for research purposes health

information which has been de-identified (in accordance with 45 CFR 164.502(d), and

164.514(a)-(c) of the Rule) without regard to the provisions below.

The Privacy Rule also defines the means by which individuals will be informed of uses

and disclosures of their medical information for research purposes, and their rights to access

information about them held by covered entities. Where research is concerned, the Privacy Rule

protects the privacy of individually identifiable health information, while at the same time

ensuring that researchers continue to have access to medical information necessary to conduct

vital research. Currently, most research involving human subjects operates under the Common

Rule (45 CFR Part 46, Subpart A) and/or the Food and Drug Administration’s (FDA) human

subject protection regulations (21 CFR Parts 50 and 56), which have some provisions that are

similar to, but separate from, the Privacy Rule’s provisions for research. These human subject

protection regulations, which apply to most Federally-funded and to some privately funded

research, include protections to help ensure the privacy of subjects and the confidentiality of

information. The Privacy Rule builds upon these existing Federal protections. More

importantly, the Privacy Rule creates equal standards of privacy protection for research governed

by the existing Federal human subject regulations and research that is not.

In the course of conducting research, researchers may obtain, create, use, and/or disclose

individually identifiable health information. Under the Privacy Rule, covered entities are

permitted to use and disclose protected health information for research with individual

authorization, or without individual authorization under limited circumstances set forth in the

Privacy Rule.

Research Use/Disclosure Without Authorization. To use or disclose protected health

information without authorization by the research participant, a covered entity must obtain one of

the following:

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Documentation that an alteration or waiver of research participants’ authorization

for use/disclosure of information about them for research purposes has been

approved by an IRB or a Privacy Board. See 45 CFR 164.512(i)(1)(i). This

provision of the Privacy Rule might be used, for example, to conduct records

research, when researchers are unable to use de-identified information, and the

research could not practicably be conducted if research participants’ authorization

were required.

A covered entity may use or disclose protected health information for research

purposes pursuant to a waiver of authorization by an IRB or Privacy Board,

alteration or waiver of authorization was approved;

alteration or waiver of authorization, in whole or in part, satisfies the three

criteria in the Rule;

access has been determined to be necessary by the IRB or Privacy Board;

reviewed and approved under either normal or expedited review

procedures; and

the IRB or the Privacy Board, as applicable.

The following three criteria must be satisfied for an IRB or Privacy Board to

approve a waiver of authorization under the Privacy Rule:

than a minimal risk to the privacy of individuals, based on, at least, the

presence of the following elements:

A: an adequate plan to protect the identifiers from improper use and

disclosure;

B: an adequate plan to destroy the identifiers at the earliest

opportunity consistent with conduct of the research, unless there is

a health or research justification for retaining the identifiers or such

retention is otherwise required by law; and

C: adequate written assurances that the protected health information

will not be reused or disclosed to any other person or entity, except

as required by law, for authorized oversight of the research project,

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or for other research for which the use or disclosure of protected

health information would be permitted by this subpart;

alteration; and

of the protected health information.

• Preparatory to Research. Representations from the researcher, either in writing or

orally, that the use or disclosure of the protected health information is solely to

prepare a research protocol or for similar purposes preparatory to research, that the

researcher will not remove any protected health information from the covered

sought is necessary for the research purpose. See 45 CFR 164.512(i)(1)(ii). This

provision might be used, for example, to design a research study or to assess the

feasibility of conducting a study.

• Research on Protected Health Information of Decedents. Representations from

the researcher, either in writing or orally, that the use or disclosure being sought is

solely for research on the protected health information of decedents, that the

request of the covered entity, documentation of the death of the individuals about

whom information is being sought. See 45 CFR 164.512(i)(1)(iii).

• Limited Data Sets with a Data Use Agreement. A data use agreement entered into

by both the covered entity and the researcher, pursuant to which the covered entity

may disclose a limited data set to the resercher for research, public health, or

health care operations. See 45 CFR 164.514(e). A limited data set excludes

specified direct identifiers of the individual or of relatives, employers, or

household members of the individual. The data use agreement must:

recipient, consistent with the purposes of the research, and which may not

include any use or disclosure that would violate the Rule if done by the

covered entity;

A: Not to use or disclose the information other than as permitted by

the data use agreement or as otherwise required by law;

B: Use appropriate safeguards to prevent the use or disclosure of the

information other than as provided for in the data use agreement;

C: Report to the covered entity any use or disclosure of the

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information not provided for by the data use agreement of which

the recipient becomes aware;

D: Ensure that any agents, including a subcontractor, to whom the

recipient provides the limited data set agrees to the same

restrictions and conditions that apply to the recipient with respect

to the limited data set; and

E: Not to identify the information or contact the individual.

Research Use/Disclosure With Individual Authorization. The Privacy Rule also permits

covered entities to use or disclose protected health information for research purposes when a

research participant authorizes the use or disclosure of information about him or herself. Today,

for example, a research participant’s authorization will typically be sought for most clinical trials

and some records research. In this case, documentation of IRB or Privacy Board approval of a

waiver of authorization is not required for the use or disclosure of protected health information.

To use or disclose protected health information with authorization by the research

participant, the covered entity must obtain an authorization that satisfies the requirements of 45

CFR 164.508. The Privacy Rule has a general set of authorization requirements that apply to all

uses and disclosures, including those for research purposes. However, several special provisions

apply to research authorizations:

• Unlike other authorizations, an authorization for a research purpose may state that

the authorization does not expire, that there is no expiration date or event, or that

the authorization continues until the “end of the research study;” and

• An authorization for the use or disclosure of protected health information for

research may be combined with a consent to participate in the research, or with

any other legal permission related to the research study.

Accounting for Research Disclosures. In general, the Privacy Rule gives individuals the

right to receive an accounting of certain disclosures of protected health information made by a

covered entity. See 45 CFR 164.528. This accounting must include disclosures of protected

health information that occurred during the six years prior to the individual’s request for an

accounting, or since the applicable compliance date (whichever is sooner), and must include

specified information regarding each disclosure. A more general accounting is permitted for

subsequent multiple disclosures to the same person or entity for a single purpose. See 45 CFR

164.528(b)(3). Among the types of disclosures that are exempt from this accounting requirement

are:

• Research disclosures made pursuant to an individual’s authorization;

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• Disclosures of the limited data set to researchers with a data use agreement under

45 CFR 164.514(e).

In addition, for disclosures of protected health information for research purposes without

the individual’s authorization pursuant to 45 CFR164.512(i), and that involve at least 50 records,

the Privacy Rule allows for a simplified accounting of such disclosures by covered entities.

Under this simplified accounting provision, covered entities may provide individuals with a list

of all protocols for which the patient’s protected health information may have been disclosed

under 45 CFR 164.512(i), as well as the researcher’s name and contact information. Other

requirements related to this simplified accounting provision are found in 45 CFR 164.528(b)(4).

Transition Provisions. Under the Privacy Rule, a covered entity may use and disclose

protected health information that was created or received for research, either before or after the

compliance date, if the covered entity obtained any one of the following prior to the compliance

date:

• An authorization or other express legal permission from an individual to use or

disclose protected health information for the research;

• The informed consent of the individual to participate in the research; or

• A waiver of informed consent by an IRB in accordance with the Common Rule or

an exception under FDA’s human subject protection regulations at 21 CFR 50.24.

However, if a waiver of informed consent was obtained prior to the compliance date, but

informed consent is subsequently sought after the compliance date, the covered entity must

obtain the individual’s authorization as required at 45 CFR 164.508. For example, if there was a

temporary waiver of informed consent for emergency research under the FDA’s human subject

protection regulations, and informed consent was later sought after the compliance date,

individual authorization would be required before the covered entity could use or disclose

protected health information for the research after the waiver of informed consent was no longer

valid.

The Privacy Rule allows covered entities to rely on such express legal permission,

informed consent, or IRB-approved waiver of informed consent, which they create or receive

before the applicable compliance date, to use and disclose protected health information for

specific research studies, as well as for future unspecified research that may be included in such

permission.

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and health plan members should be more willing to authorize disclosures of their

information for research and to participate in research when they know their information

is protected. For example, in genetic studies conducted at the National Institutes of

Health, nearly 32 percent of eligible people offered a test for breast cancer risk declined

to take it. The overwhelming majority of those who refuse cite concerns about health

insurance discrimination and loss of privacy as the reason. The Privacy Rule both

permits important research and, at the same time, encourages patients to participate in

research by providing much needed assurances about the privacy of their health

information.

The Privacy Rule will require some covered health care providers and health plans to

change their current practices related to documenting research uses and disclosures. It is

possible that some covered health care providers and health plans may conclude that the

Rule’s requirements for research uses and disclosures are too burdensome and will

choose to limit researchers’ access to protected health information. We believe few

providers will take this route, however, because the Common Rule includes similar, and

more rigorous requirements, that have not impaired the willingness of researchers to

undertake Federally-funded research. For example, unlike the Privacy Rule, the Common

Rule requires an Institutional Review Board (IRB) review for all research proposals under

its purview, even if informed consent is to be sought. The Privacy Rule requires

documentation of IRB or Privacy Board approval only if patient authorization for the use

or disclosure of protected health information for research purposes is to be altered or

waived. See the fact sheet and frequently asked questions about the research provisions

on this web site for more information about the Common Rule and Institutional Review

and Privacy Boards.

to whether the waiver criteria have been satisfied. Several of the waiver criteria are

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closely modeled on the Common Rule’s criteria for the waiver of informed consent and

for the approval of a research study. Thus, it is anticipated that IRBs already have

experience in making the necessarily subjective assessments of risks. While IRBs or

Privacy Boards may reach different determinations, the assessment of the waiver criteria

through this deliberative process is a crucial element in the current system of

safeguarding research participants’ privacy. The entire system of local IRBs is, in fact,

predicated on a deliberative process that permits local IRB autonomy. The Privacy Rule

builds upon this principle; it does not change it. Nonetheless, the Department will

consider issuing guidance as necessary and appropriate to address concerns that may arise

during implementation of these provisions. See the fact sheet and frequently asked

questions about the research provisions on this web site for more information about the

Common Rule and Institutional Review and Privacy Boards.

Therefore, the Privacy Rule in no way prohibits researchers from conditioning enrollment

in a research study on the execution of an authorization for the use of pre-existing health

information.

individuals’ authorizations for the creation of a research database, provided the covered

entity obtains documentation that an IRB or Privacy Board has determined that the

specified waiver criteria were satisfied. Protected health information maintained by a

covered entity in such a research database could be used or disclosed for future research

studies as permitted by the Privacy Rule – that is, for future studies in which individual

authorization has been obtained or where the Rule would permit research without an

authorization, such as pursuant to an IRB or Privacy Board waiver. See the fact sheet and

frequently asked questions about the research provisions on this web site for more

information about Institutional Review and Privacy Boards.

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health information from existing databases or repositories for research purposes either

with individual authorization as required at 45 CFR 164.508, or with a waiver of

individual authorization as permitted at 45 CFR 164.512(i). See the fact sheet and

frequently asked questions about the research provisions on this web site for more

information about Institutional Review Boards.

the expertise needed to review research that requires consideration of risks to privacy, the

Privacy Rule permits the covered entity to accept documentation of waiver of

authorization from an alternative body called a Privacy Board–which could have fewer

members, and members with different expertise than IRBs. See the fact sheet and

frequently asked questions about the research provisions on this web site for more

information about Institutional Review and Privacy Boards.

In addition, the Rule allows an IRB to use expedited review procedures as permitted by

the Common Rule to review and approve requests for waiver of authorizations.

Similarly, the Rule permits Privacy Boards to use an expedited review process when the

research involves no more than a minimal privacy risk to the individuals. An expedited

review process permits covered entities to accept documentation of waiver of

authorization when only one or more members of the IRB or Privacy Board have

conducted the review. See the fact sheet and frequently asked questions about the

research provisions on this web site for more information about the Common Rule.

followed. The Privacy Rule regulates only the content and conditions of the

documentation that covered entities must obtain before using or disclosing protected

health information for research purposes. See the fact sheet and frequently asked

questions about the research provisions on this web site for more information about the

Common Rule.

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the research provisions on this web site for more information about Institutional Review

and Privacy Boards.

researcher, or it could be an independent board. See the fact sheet and frequently asked

questions about the research provisions on this web site for more information about

Institutional Review and Privacy Boards.

copy of health information about themselves that is maintained by a covered entity or its

business associate in a “designated record set.” A designated record set is basically a

group of records which a covered entity uses to make decisions about individuals, and

includes a health care provider’s medical records and billing records, and a health plan’s

enrollment, payment, claims adjudication, and case or medical management record

systems. While it may be unlikely that a researcher would be maintaining a designated

record set, any research records or results that are actually maintained by the covered

entity as part of a designated record set would be accessible to research participants

unless one of the Privacy Rule’s permitted exceptions applies.

One of the permitted exceptions applies to protected health information created or

obtained by a covered health care provider/researcher for a clinical trial. The Privacy

access when consenting to participate in the clinical trial. In addition, the health care

provider/researcher must inform the research participant that the right to access protected

health information will be reinstated at the conclusion of the clinical trial.

care providers to provide an individual access to information if CLIA prohibits them from

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doing so. CLIA permits clinical laboratories to provide clinical laboratory test records

and reports only to “authorized persons,” as defined primarily by State law. The

individual who is the subject of the information is not always included as an authorized

person. Therefore, the Privacy Rule includes an exception to individuals’ general right to

access protected health information about themselves if providing an individual such

access would be in conflict with CLIA.

In addition, for certain research laboratories that are exempt from the CLIA regulations,

the Privacy Rule does not require such research laboratories, if they are also a covered

health care provider, to provide individuals with access to protected health information

because doing so may result in the research laboratory losing its CLIA exemption.

protected health information for research purposes. In contrast, an individual’s informed

consent, as required by the Common Rule and the Food and Drug Administration’s

(FDA) human subjects regulations, is a consent to participate in the research study as a

whole, not simply a consent for the research use or disclosure of protected health

information. See the fact sheet and frequently asked questions about the research

provisions on this web site for more information about the Common Rule. For this

reason, there are important differences between the Privacy Rule’s requirements for

individual authorization, and the Common Rule’s and FDA’s requirements for informed

consent. However, the Privacy Rule’s authorization elements are compatible with the

Common Rule’s informed consent elements. Thus, both sets of requirements can be met

by use of a single, combined form, which is permitted by the Privacy Rule. For example,

the Privacy Rule allows the research authorization to state that the authorization will be

valid until the conclusion of the research study, or to state that the authorization will not

have an expiration date or event. This is compatible with the Common Rule’s

requirement for an explanation of the expected duration of the research subject’s

participation in the study. It should be noted that where the Privacy Rule, the Common

Rule, and/or FDA’s human subjects regulations are applicable, each of the applicable

regulations will need to be followed.

individuals, including the subjects of research, and transmits any health information in

electronic form in connection with a transaction covered by the Transactions Rule. See

45 CFR 160.102, 160.103. For example, a researcher who conducts a clinical trial that

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involves the delivery of routine health care, such as an MRI or liver function test, and

transmits health information in electronic form to a third party payer for payment, would

be a covered health care provider under the Privacy Rule. Researchers who provide

health care to the subjects of research or other individuals would be covered health care

providers even if they do not themselves electronically transmit information in connection

with a HIPAA transaction, but have other entities, such as a hospital or billing service,

conduct such electronic transactions on their behalf. For further assistance in

determining covered entity status, see the “decision tool” at www.hhs.gov/ocr/hipaa/.

entity that performs both covered and non-covered functions, may choose whether it

wants to be a hybrid entity. If such a covered entity decides not to be a hybrid entity then

it, and all of its components, are subject to the Privacy Rule in its entirety. Therefore, if a

researcher is an employee or workforce member of a covered entity that has decided not

to be a hybrid entity, the researcher is part of the covered entity and is, therefore, subject

to the Privacy Rule.

If a covered entity decides to be a hybrid entity, it must define and designate as its health

care component(s) those parts of the entity that engage in covered functions. “Covered

functions” are those functions of a covered entity that make the entity a health plan, a

health care provider, or a health care clearinghouse. Thus, research components of a

hybrid entity that function as health care providers and engage in standard electronic

transactions must be included in the hybrid entity's health care component(s), and be

subject to the Privacy Rule.

However, research components that function as health care providers, but do not engage

in standard electronic transactions may, but are not required to, be included in the health

care component(s) of the hybrid entity. For example, a hybrid entity, such as a university,

has the option to include or exclude a research laboratory, that functions as a health care

provider but does not engage in electronic transactions, as part of the hybrid entity’s

health care component. If such a research laboratory is included in the hybrid entity’s

health care component, then the employees or workforce members of the laboratory must

comply with the Privacy Rule. But if the research laboratory is excluded from the hybrid

entity’s health care component, the employees or workforce members of the laboratory

are not subject to the Privacy Rule.

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obtained prior to the time the individual revoked his or her authorization, as necessary to

maintain the integrity of the research study. An individual may not revoke an

authorization to the extent the covered entity has acted in reliance on the authorization.

For research uses and disclosures, this reliance exception at 45 CFR 164.508(b)(5)(i)

permits the continued use and disclosure of protected health information already obtained

pursuant to a valid authorization to the extent necessary to preserve the integrity of the

research study. For example, the reliance exception would permit the continued use and

disclosure of protected health information to account for a subject’s withdrawal from the

research study, as necessary to incorporate the information as part of a marketing

application submitted to the Food and Drug Administration, to conduct investigations of

scientific misconduct, or to report adverse events.

However, the reliance exception would not permit a covered entity to continue disclosing

additional protected health information to a researcher or to use for its own research

purposes information not already gathered at the time an individual withdraws his or her

authorization.

health information for purposes preparatory to research, such as to aid study recruitment.

However, the provision at 45 CFR 164.512(i)(1)(ii) does not permit the researcher to

remove protected health information from the covered entity’s site. As such, a researcher

who is an employee or a member of the covered entity’s workforce could use protected

health information to contact prospective research subjects. The preparatory research

provision would allow such a researcher to identify prospective research participants for

purposes of seeking their authorization to use or disclose protected health information for

a research study. In addition, the Rule permits a covered entity to disclose protected

health information to the individual who is the subject of the information. See 45 CFR

164.502(a)(1)(i). Therefore, covered health care providers and patients may continue to

discuss the option of enrolling in a clinical trial without patient authorization, and without

an Institutional Review Board (IRB) or Privacy Board waiver of the authorization. See

the fact sheet and frequently asked questions about the research provisions on this web

site for more information about Institutional Review and Privacy Boards.

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However, a researcher who is not a part of the covered entity may not use the preparatory

research provision to contact prospective research subjects. Rather, the outside researcher

could obtain contact information through a partial waiver of individual authorization by

an IRB or Privacy Board as permitted at 45 CFR164.512(i)(1)(i). The IRB or Privacy

Board waiver of authorization permits the partial waiver of authorization for the purposes

of allowing a researcher to obtain protected health information as necessary to recruit

potential research subjects. For example, even if an IRB does not waive informed

consent and individual authorization for the study itself, it may waive such authorization

to permit the disclosure of protected health information as necessary for the researcher to

be able to contact and recruit individuals into the study.

individual authorization is only needed before a covered entity may use or disclose

protected health information under 45 CFR 164.512(i)(1)(i). See the fact sheet and

frequently asked questions about the research provisions on this web site for more

information about Institutional Review and Privacy Boards.

informed consent) is obtained from research subjects after the compliance date, the

covered entity must obtain individual authorization as required at 45 CFR 164.508 for the

use or disclosure of protected health information once the consent obtained before the

compliance date is no longer valid for the research. The revised informed consent

document may be combined with the authorization elements required by 45 CFR

164.508. See the fact sheet and frequently asked questions about the research provisions

on this web site for more information about Institutional Review Boards.

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HIPAA Privacy Rule. Therefore, covered entities can continue to disclose protected

health information to report adverse events to the Office for Human Research Protections

either with patient authorization as provided at 45 CFR 164.508, or without patient

authorization for public health activities as permitted at 45 CFR 164.512(b).

HIPAA Privacy Rule. Therefore, covered entities can continue to disclose protected

health information to the Office for Human Research Protections for such compliance

investigations either with patient authorization as provided at 45 CFR 164.508, or without

patient authorization for health oversight activities as permitted at 45 CFR 164.512(d).

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The HIPAA Privacy Rule does not apply to entities that are either workers’ compensation

insurers, workers’ compensation administrative agencies, or employers, except to the extent they

may otherwise be covered entities. However, these entities need access to the health information

of individuals who are injured on the job or who have a work-related illness to process or

adjudicate claims, or to coordinate care under workers’ compensation systems. Generally, this

health information is obtained from health care providers who treat these individuals and who

may be covered by the Privacy Rule. The Privacy Rule recognizes the legitimate need of insurers

and other entities involved in the workers’ compensation systems to have access to individuals’

health information as authorized by State or other law. Due to the significant variability among

such laws, the Privacy Rule permits disclosures of health information for workers’ compensation

purposes in a number of different ways.

Disclosures Without Individual Authorization. The Privacy Rule permits covered entities

to disclose protected health information to workers’ compensation insurers, State administrators,

employers, and other persons or entities involved in workers’ compensation systems, without the

individual’s authorization:

workers’ compensation or similar programs established by law that provide

benefits for work-related injuries or illness without regard to fault. This includes

programs established by the Black Lung Benefits Act, the Federal Employees’

Compensation Act, the Longshore and Harbor Workers’ Compensation Act, and

the Energy Employees’ Occupational Illness Compensation Program Act. See 45

comply with and be limited to what the law requires. See 45 CFR 164.512(a).

ill worker. See 45 CFR 164.502(a)(1)(ii) and the definition of “payment” at 45

CFR 164.501.

Disclosures With Individual Authorization. In addition, covered entities may disclose

protected health information to workers’ compensation insurers and others involved in workers’

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compensation systems where the individual has provided his or her authorization for the release

of the information to the entity. The authorization must contain the elements and otherwise meet

the requirements specified at 45 CFR 164.508.

Minimum Necessary. Covered entities are required reasonably to limit the amount of

protected health information disclosed under 45 CFR 164.512(l) to the minimum necessary to

accomplish the workers’ compensation purpose. Under this requirement, protected health

information may be shared for such purposes to the full extent authorized by State or other law.

In addition, covered entities are required reasonably to limit the amount of protected

health information disclosed for payment purposes to the minimum necessary. Covered entities

are permitted to disclose the amount and types of protected health information that are necessary

to obtain payment for health care provided to an injured or ill worker.

Where a covered entity routinely makes disclosures for workers’ compensation purposes

protocols as part of its minimum necessary policies and procedures that address the type and

amount of protected health information to be disclosed for such purposes.

Where protected health information is requested by a State workers’ compensation or

other public official, covered entities are permitted to reasonably rely on the official’s

representations that the information requested is the minimum necessary for the intended

purpose. See 45 CFR 164.514(d)(3)(iii)(A).

Covered entities are not required to make a minimum necessary determination when

disclosing protected health information as required by State or other law, or pursuant to the

individual’s authorization. See 45 CFR 164.502(b).

The Department will actively monitor the effects of the Privacy Rule, and in particular,

the minimum necessary standard, on the workers’ compensation systems and consider proposing

modifications, where appropriate, to ensure that the Rule does not have any unintended negative

effects that disturb these systems.

Refer to the fact sheet and frequently asked questions on this web site about the minimum

necessary standard, or to 45 CFR 164.502(b) and 164.514(d), for more information.

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who need it to process or adjudicate claims, or coordinate care, for injured or ill workers

under workers’ compensation systems. The minimum necessary standard generally

requires covered entities to make reasonable efforts to limit uses and disclosures of, as

well as requests for, protected health information to the minimum necessary to

accomplish the intended purpose. For disclosures of protected health information made

standard permits covered entities to disclose information to the full extent authorized by

State or other law. In addition, where protected health information is requested by a State

workers’ compensation or other public official for such purposes, covered entities are

permitted reasonably to rely on the official’s representations that the information

requested is the minimum necessary for the intended purpose. See 45 CFR

164.514(d)(3)(iii)(A).

For disclosures of protected health information for payment purposes, covered entities

may disclose the type and amount of information necessary to receive payment for any

health care provided to an injured or ill worker.

The minimum necessary standard does not apply to disclosures that are required by State

or other law or made pursuant to the individual’s authorization.

that a covered entity restrict a disclosure of protected health information about them for

workers’ compensation purposes when that disclosure is required by law or authorized

by, and necessary to comply with, a workers’ compensation or similar law. See 45 CFR

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as authorized by, and to the extent necessary to comply with, workers’ compensation law.

to disclose protected health information in the course of any judicial or administrative

proceeding in response to a court order, subpoena, or other lawful process. See 45 CFR

164.512(e).

information as necessary to comply with State law. No minimum necessary

determination is required. See 45 CFR 164.512(a) and 164.502(b).

information as necessary to comply with and to the full extent authorized by workers’

authorization has been obtained, consistent with the Privacy Rule’s requirements at 45

CFR 164.508. Thus, a covered entity would be permitted to make the above disclosure if

the individual signed such an authorization.

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The HIPAA Privacy Rule gives individuals a fundamental new right to be informed of the

privacy practices of their health plans and of most of their health care providers, as well as to be

informed of their privacy rights with respect to their personal health information. Health plans

and covered health care providers are required to develop and distribute a notice that provides a

clear explanation of these rights and practices. The notice is intended to focus individuals on

privacy issues and concerns, and to prompt them to have discussions with their health plans and

health care providers and exercise their rights.

General Rule. The Privacy Rule provides that an individual has a right to adequate notice

of how a covered entity may use and disclose protected health information about the individual,

as well as his or her rights and the covered entity’s obligations with respect to that information.

Most covered entities must develop and provide individuals with this notice of their privacy

practices.

The Privacy Rule does not require the following covered entities to develop a notice:

receive is as a business associate of another covered entity. See 45 CFR

164.500(b)(1).

care provider component).

insurance with health insurance issuers or HMOs, and that does not create or

receive protected health information other than summary health information or

enrollment or disenrollment information.

See 45 CFR 164.520(a).

that describes:

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an individual.

may exercise these rights, including how the individual may complain to the

covered entity.

statement that the covered entity is required by law to maintain the privacy of

protected health information.

privacy policies.

The notice must include an effective date. See 45 CFR 164.520(b) for the specific

requirements for developing the content of the notice.

A covered entity is required to promptly revise and distribute its notice whenever it makes

material changes to any of its privacy practices. See 45 CFR 164.520(b)(3), 164.520(c)(1)(i)(C)

for health plans, and 164.520(c)(2)(iv) for covered health care providers with direct treatment

relationships with individuals.

Providing the Notice.

site it maintains that provides information about its customer services or benefits.

April 14, 2003 (April 14, 2004, for small health plans) and to new

enrollees at the time of enrollment.

days of a material revision.

to obtain the notice at least once every three years.

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delivery (after the April 14, 2003 compliance date of the Privacy Rule)

and, except in an emergency treatment situation, make a good faith effort

to obtain the individual’s written acknowledgment of receipt of the notice.

If an acknowledgment cannot be obtained, the provider must document his

or her efforts to obtain the acknowledgment and the reason why it was not

obtained.

through e-mail, or otherwise electronically, the provider must send an

electronic notice automatically and contemporaneously in response to the

individual’s first request for service. The provider must make a good faith

effort to obtain a return receipt or other transmission from the individual in

response to receiving the notice.

reasonably practicable to do so after the emergency situation has ended. In

these situations, providers are not required to make a good faith effort to

obtain a written acknowledgment from individuals.

policies) available at the provider’s office or facility for individuals to

request to take with them, and post it in a clear and prominent location at

the facility.

receive an electronic notice.

See 45 CFR 164.520(c) for the specific requirements for providing the notice.

Organizational Options.

choose to develop more than one notice, such as when an entity performs different

types of covered functions (i.e., the functions that make it a health plan, a health

care provider, or a health care clearinghouse) and there are variations in its

privacy practices among these covered functions. Covered entities are encouraged

to provide individuals with the most specific notice possible.

choose to produce a single, joint notice if certain requirements are met. For

example, the joint notice must describe the covered entities and the service

delivery sites to which it applies. If any one of the participating covered entities

provides the joint notice to an individual, the notice distribution requirement with

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respect to that individual is met for all of the covered entities. See 45 CFR

164.520(d).

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with individuals are not required to provide their notices to patients at the time they are

providing emergency treatment. In these situations, the HIPAA Privacy Rule requires

only that providers give patients a notice when it is practical to do so after the emergency

situation has ended. In addition, where notice is delayed by an emergency treatment

situation, the Privacy Rule does not require that providers make a good faith effort to

obtain the patient’s written acknowledgment of receipt of the notice.

treatment relationship with individuals make a good faith effort to obtain written

acknowledgments from those individuals that they have received the provider’s notice,

regardless of whether the provider also chooses to obtain the individuals’ consent.

However, those providers that choose to obtain consent from individuals have discretion

to design one form that includes both a consent and the acknowledgment of receipt of the

notice.

special or separate mailings or distributions are required to satisfy the Privacy Rule’s

notice distribution requirements. Thus, a health plan distributing its notice through the

mail, in accordance with 45 CFR 164.520(c)(1), may do so as part of another mailing to

the individual (e.g., by including the notice with Summary Plan Descriptions). Similarly,

a covered entity that e-mails its notice to an individual, in accordance with 45 CFR

164.520(c)(3), may include additional materials in the e-mail. No separate e-mail is

required. However, the Privacy Rule continues to prohibit covered entities from

combining the notice in a single document with an authorization form (see 45 CFR

164.508(b)(3)); and direct treatment providers, other than in emergency situations, must

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provide the notice at or before the date of first service delivery, and must make a good

faith effort to obtain the individual’s written acknowledgment of receipt of the notice.

is required to make a good faith effort to obtain an individual’s acknowledgment of

receipt of the notice only at the time the provider first gives the notice to the individual--

that is, at first service delivery. See 45 CFR 164.520(c)(2).

transmission from the individual is considered a valid written acknowledgment of the

notice. A provider who gives his paper notice to a patient during a face-to-face encounter

with the individual at first service delivery may also obtain an electronic acknowledgment

from the individual, provided that the individual’s acknowledgment is in writing. Thus, a

receptionist’s notation in the provider’s computer system of the individual’s receipt of the

notice would not be considered a valid written acknowledgment of the individual.

associate that the business associate’s uses and disclosures of protected health

information and other actions are consistent with the covered entity’s privacy policies, as

stated in covered entity’s notice. Also, a covered entity may use a business associate to

distribute its notice to individuals.

Rule’s requirements, so long as the elements required by 45 CFR 164.520(b) are included

in the document that is provided to the individual. For example, a covered entity may

satisfy the notice requirements by providing the individual with both a short notice that

briefly summarizes the individual’s rights, as well as other information; and a longer

notice, layered beneath the short notice, that contains all of the elements required by the

Privacy Rule. Providing the notice in this fashion is a helpful tool to assure that more

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individuals will realize that important information is contained in the notice. In addition

to ensuring the notice is in plain language (as required by the Privacy Rule), covered

entities are encouraged to develop notices that maximize readability and clarity.

treatment relationship with individuals are required to make a good faith effort to obtain

the individual’s acknowledgment of receipt of the notice. See 45 CFR 164.520(c)(2)(ii).

relationships that covered health care providers may have with the individuals they treat,

including those treatment situations that are not face-to-face. For example, a health care

provider who first treats a patient over the phone satisfies the notice provision

requirements of the Privacy Rule by mailing the notice to the individual the same day, if

possible. To satisfy the requirement that the provider also make a good faith effort to

obtain the individual’s acknowledgment of the notice, the provider may include a tear-off

sheet or other document with the notice that requests that the acknowledgment be mailed

back to the provider. The health care provider is not in violation of the Rule if the

individual chooses not to mail back an acknowledgment; and a file copy of the form sent

to the patient would be adequate documentation of the provider’s good faith effort to

obtain the acknowledgment.

Where a health care provider’s initial contact with the patient is simply to schedule an

appointment or a procedure, the notice provision and acknowledgment requirements may

be satisfied at the time the individual arrives at the provider’s facility for his or her

appointment.

For service provided electronically, the notice must be sent electronically automatically

and contemporaneously in response to the individual’s first request for service. In this

situation, an electronic return receipt or other return transmission from the individual is

considered a valid written acknowledgment of the notice.

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care arrangement (OHCA) may use a single, joint notice that covers all of the

participating covered entities (provided that the conditions at 45 CFR 164.520(d) are

met), or may each maintain separate notices. Where a joint notice is provided to an

individual by any one of the covered entities to which the joint notice applies, the Privacy

Rule’s requirements for providing the notice are satisfied for all others covered by the

joint notice. If the joint notice is provided to an individual by a direct treatment provider

participating in the OHCA, the provider must make a good faith effort to obtain the

individual’s written acknowledgment of receipt of the joint notice. Where the joint notice

is provided to the individual by a participating covered entity other than a direct treatment

provider, no acknowledgment need be obtained.

However, where covered entities participating in an OHCA choose to maintain separate

notices, each covered entity from which an individual obtains services must provide its

notice to the individual in accordance with the applicable requirements of 45 CFR

164.520(c). In addition, each direct treatment provider within the OHCA must make a

good faith effort to obtain the individual’s acknowledgment of the notice he or she

provides.

notice by distributing its notice only to the named insured of a policy under which

coverage is provided both to the named insured and his or her dependents. See 45 CFR

164.520(c)(1)(iii).

covered by the plan. Health plans may arrange to have another person or entity, for

example, a group administrator or a plan sponsor, distribute the notice on their behalf.

However, if the other person or entity fails to distribute the notice to the plan’s enrollees,

the health plan may be in violation of the Privacy Rule.

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relationship with the individual to provide the notice to the individual receiving treatment

no later than the date of first service delivery. In cases where the individual has a

personal representative, as is generally the case when a parent brings a child in for

treatment, the provider satisfies the notice distribution requirements by providing the

notice to the personal representative (e.g., the child’s parent), and making a good faith

effort to obtain the personal representative’s acknowledgment of the notice. In the

limited cases where the parent is not the personal representative of the unemancipated

minor, such as when the minor is authorized under State law to consent to the treatment

and does so, the provider must give its notice to the minor and make a good faith effort to

obtain the minor's acknowledgment of the notice. See 45 CFR 164.502(g)(3) and

164.520(c)(2).

provide health care directly to individuals are required to post their entire notice at the

facility in a clear and prominent location. The Privacy Rule, however, does not prescribe

any specific format for the posted notice, just that it include the same information that is

distributed directly to the individual. Covered health care providers have discretion to

design the posted notice in a manner that works best for their facility, which may be to

simply post a copy of the pages of the notice that is provided directly to individuals.

Covered entities are required to obtain the individual’s written authorization for any use

or disclosure of protected health information not permitted or required by the Privacy

Rule. See 45 CFR 164.508. Simply including in the notice a description of such a use or

disclosure does not obviate the need for the covered entity to obtain the individual’s prior

written authorization, when that authorization is required by the Rule. Instead, the notice

must reflect the uses and disclosures a covered entity may make without the individual’s

authorization, as permitted by Privacy Rule, as well as state that any other uses or

disclosures only will be made with the individual’s written authorization. See 45 CFR

164.520(b).

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its revised notice or otherwise notify patients by mail of changes to the notice. Rather,

when a covered health care provider with a direct treatment relationship with individuals

makes a change to his notice, he must make the notice available upon request to patients

or other persons on or after the effective date of the revision, and, if he maintains a

physical service delivery site, post the revised notice in a clear and prominent location in

his facility. See 45 CFR 164.520(c)(2)(iv). In addition, the provider must ensure that the

current notice, in effect at that time, is provided to patients at first service delivery, and

made available on his customer service web site, if he has one. See 45 CFR 164.520(c).

relationships with individuals to give the notice to every individual no later than the date

of first service delivery to the individual and to make a good faith effort to obtain the

individual’s written acknowledgment of receipt of the notice. If the provider maintains

an office or other physical site where she provides health care directly to individuals, the

provider must also post the notice in the facility in a clear and prominent location where

individuals are likely to see it, as well as make the notice available to those who ask for a

copy. See 45 CFR 164.520(c) for other notice provision requirements.

initial contact with a patient is simply to schedule an appointment or a procedure, or to

collect information in anticipation of an appointment or a procedure, the Privacy Rule’s

requirements for providing the notice and obtaining a patient’s acknowledgment of the

notice may be satisfied at the time the individual arrives at the provider’s facility for his

or her appointment or procedure.

acknowledging and the acknowledgment is not also used as a waiver or permission for

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something else that also appears on the log book (such as a waiver to consult with the

pharmacist). The HIPAA Privacy Rule provides covered health care providers with

discretion to design an acknowledgment process that works best for their businesses.

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Under the HIPAA Privacy Rule, government-operated health plans and health care

providers must meet substantially the same requirements as private ones for protecting the

privacy of individual identifiable health information. For instance, government-run health plans,

such as Medicare and Medicaid plans, must take virtually the same steps to protect the claims

and health information that they receive from beneficiaries as private insurance plans or health

maintenance organizations (HMO). In addition, all Federal agencies must also meet the

requirements of the Privacy Act of 1974, which restricts what information about individual

citizens – including any personal health information – can be shared with other agencies and with

the public.

The only new authority for government involves enforcement of the protections in the

Privacy Rule itself. To ensure that covered entities protect patients’ privacy as required, the Rule

requires that health plans, hospitals, and other covered entities cooperate with efforts by the

Department of Health and Human Services (HHS) Office for Civil Rights (OCR) to investigate

complaints or otherwise ensure compliance.

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information to the government for a government data base or similar operation. This

Rule does not require or allow any new government access to medical information, with

one exception: the Rule does give the Department of Health and Human Services Office

for Civil Rights (OCR) the authority to investigate complaints that Privacy Rule

protections or rights have been violated, and otherwise to ensure that covered entities

comply with the Rule.

For enforcement purposes, OCR may need to look at how a covered entity handled

medical records and other personal health information, as is typical in many enforcement

settings. This investigative authority is needed so that the Rule can be enforced, and to

ensure the independent review of consumers’ concerns over privacy violations. Even so,

the Privacy Rule limits disclosures to OCR to information that is “pertinent to

ascertaining compliance.” OCR will maintain stringent controls to safeguard any

individually identifiable health information that it receives. If covered entities could

avoid or ignore enforcement requests, consumers would not have a way to ensure an

independent review of their concerns about privacy violations under the Rule.

of Health and Human Services’ (HHS) responsibility to investigate complaints that the

Rule has been violated and to follow up on other information regarding noncompliance.

At times, this responsibility entails seeing personal health information, such as when an

individual indicates to the Department that they believe a covered entity has not properly

handled their medical records.

What information would be needed depends on the circumstances and the alleged

violations. The Privacy Rule limits HHS Office for Civil Rights’ (OCR) access to

information that is “pertinent to ascertaining compliance.” In some cases, no personal

health information may be needed. For instance, OCR would need to review only a

business contract to determine whether a health plan included appropriate language to

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protect privacy when it hired an outside company to help process claims.

Examples of investigations that may require OCR to have access to protected health

information include:

patient’s medical record, or did not provide complete access to a patient’s medical

records to that patient.

without first obtaining the individuals’ authorization when required by the Rule.

OCR may need to review information in the marketing department that contains

personal health information, to determine whether a violation has occurred.

identifiable health information. In fact, it limits access to a greater degree than currently

exists, since the Rule establishes new procedures and safeguards that restrict the

circumstances under which a covered entity may give such information to law

enforcement officers.

For example, the Rule limits the type of information that covered entities may disclose to

law enforcement, absent a warrant or other prior process, when law enforcement is

seeking to identify or locate a suspect. It specifically prohibits disclosure of DNA

information for this purpose, absent some other legal requirements such as a warrant.

Similarly, under most circumstances, the Privacy Rule requires covered entities to obtain

permission from persons who have been the victim of domestic violence or abuse before

disclosing information about them to law enforcement. In most States, such permission is

not required today.

Where State law imposes additional restrictions on disclosure of health information to

law enforcement, those State laws continue to apply. This Rule sets a national floor of

legal protections; it is not a set of “best practices.”

Even in those circumstances when disclosure to law enforcement is permitted by the

Rule, the Privacy Rule does not require covered entities to disclose any information.

Some other Federal or State law may require a disclosure, and the Privacy Rule does not

interfere with the operation of these other laws. However, unless the disclosure is

required by some other law, covered entities should use their professional judgment to

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decide whether to disclose information, reflecting their own policies and ethical

principles. In other words, doctors, hospitals, and health plans could continue to follow

their own policies to protect privacy in such instances.

or any other covered entity to send medical information to the Federal government for a

government database or similar operation.

Federal government. Covered entities that are Federal agencies or Federal contractors

that maintain records that are covered by the Privacy Act not only must obey the Privacy

Rule’s requirements but also must comply with the Privacy Act.

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electronic transactions, health plans, and health care clearinghouses, (collectively,

“covered entities”) have until April 14, 2003, to comply with the HIPAA Privacy Rule.

(Small health plans have until April 14, 2004, to comply). Activities occurring before

April 14, 2003, are not subject to the Office for Civil Rights (OCR) enforcement actions.

After that date, a person who believes a covered entity is not complying with a

requirement of the Privacy Rule may file with OCR a written complaint, either on paper

or electronically. This complaint must be filed within 180 days of when the complainant

knew or should have known that the act had occurred. The Secretary may waive this 180-

day time limit if good cause is shown. See 45 CFR 160.306 and 164.534. OCR will

provide further information on its web site about how to file a complaint

In addition, after the compliance dates above, individuals have a right to file a complaint

directly with the covered entity. Individuals should refer to the covered entity’s notice of

privacy practices for more information about how to file a complaint with the covered

entity.

fee may include only the cost of copying (including supplies and labor) and postage, if the

patient requests that the copy be mailed. If the patient has agreed to receive a summary or

explanation of his or her protected health information, the covered entity may also charge

a fee for preparation of the summary or explanation. The fee may not include costs

associated with searching for and retrieving the requested information. See 45 CFR

164.524.

health information, to be protected it must meet the definition of protected health

information: it must be individually identifiable and maintained by a covered health care

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provider, health plan, or health care clearinghouse. See 45 C.F.R 160.103 and 164.501.

medical record including portions that were created by another provider, assuming that

the disclosure is for a purpose permitted by the Privacy Rule, such as treatment.

another health care provider for treatment purposes. This can be done by fax or by other

means. Covered entities must have in place reasonable and appropriate administrative,

technical, and physical safeguards to protect the privacy of protected health information

that is disclosed using a fax machine. Examples of measures that could be reasonable

and appropriate in such a situation include the sender confirming that the fax number to

be used is in fact the correct one for the other physician’s office, and placing the fax

machine in a secure location to prevent unauthorized access to the information. See 45

CFR164.530(c).

has been informed of this use and disclosure, and does not object. The Privacy Rule

provides that a hospital or other covered health care provider may maintain in a directory

the following information about that individual: the individual’s name; location in the

facility; health condition expressed in general terms; and religious affiliation. The facility

may disclose this directory information to members of the clergy. Thus, for example, a

hospital may disclose the names of Methodist patients to a Methodist minister unless a

patient has restricted such disclosure. Directory information, except for religious

affiliation, may be disclosed only to other persons who ask for the individual by name.

When, due to emergency circumstances or incapacity, the patient has not been provided

an opportunity to agree or object to being included in the facility’s directory, these

disclosures may still occur, if such disclosure is consistent with any known prior

expressed preference of the individual and the disclosure is in the individual’s best

interest as determined in the professional judgment of the provider. See 45 CFR

164.510(a).

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covered entity, or otherwise meets the definition of a covered entity. For example, a state

Medicaid program is a covered entity (i.e., a health plan) as defined in the Privacy Rule.

Some health departments operate health care clinics and thus are health care providers. If

these health care providers transmit health information electronically in connection with a

transaction covered in the HIPAA Transactions Rule, they are covered entities. For more

information, see the definitions of covered entity, health care provider, health plan and

health care clearinghouse in 45 CFR 160.103. See also, the “Covered Entity Decision

Tools” posted at

tools address the question of whether a person, business or agency is a covered health

care provider, health care clearinghouse or health plan.

If the health department performs some covered functions (i.e., those activities that make

it a provider that conducts certain transactions electronically, a health plan or a health

care clearinghouse) and other non-covered functions, it may designate those components

(or parts thereof) that perform covered functions as the health care component(s) of the

organization and thereby become a type of covered entity known as a “hybrid entity.”

Most of the requirements of the Privacy Rule apply only to the hybrid entity’s health care

component(s). If a health department elects to be a hybrid entity, there are restrictions on

how its health care component(s) may disclose protected health information to other

components of the health department. See 45 CFR 164.504 (a) – (c) for more

information about hybrid entities.

Simplification regulations specifically exclude from the definition of a “health plan” any

policy, plan, or program to the extent that it provides, or pays for the cost of, excepted

benefits, which are listed in section 2791(c)(1) of the Public Health Service Act, 42

U.S.C. 300gg-91(c)(1). See 45 CFR 160.103. As described in the statute, excepted

benefits are one or more (or any combination thereof) of the following policies, plans or

programs:

• Coverage only for accident, or disability income insurance, or any combination

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thereof.

• Coverage issued as a supplement to liability insurance.

• Liability insurance, including general liability insurance and automobile liability

insurance.

• Workers’ compensation or similar insurance.

• Automobile medical payment insurance.

• Credit-only insurance.

• Coverage for on-site medical clinics

• Other similar insurance coverage, specified in regulations, under which benefits

for medical care are secondary or incidental to other insurance benefits.

party administrator (TPA) into a covered entity. Generally, a TPA of a group health plan

would be acting as a business associate of the group health plan. Of course, the TPA may

meet the definition of a covered entity based on its other activities (such as by providing

group health insurance). See 45 CFR 160.103.

information is not a factor in determining whether an entity is a covered entity. Covered

entities are defined in HIPAA; they are (1) health plans, (2) health care clearinghouses,

and (3) health care providers that transmit any health information in electronic form in

connection with a transaction covered in the HIPAA Transactions Rule. These terms are

defined in detail at 45 CFR 160.103.

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plans, April 14, 2004. ASCA does not apply to the HIPAA Privacy Rule. Rather, ASCA

delays compliance with the Transaction and Code Set standards adopted by the HIPAA

Transactions Rule for covered entities that file a compliance plan. More information

about ASCA can be found on the web site for the Centers for Medicare and Medicaid

should use the guidance provided by the Small Business Administration at 13 CFR

121.104 to calculate annual receipts. Health plans that do not report receipts to the IRS -

for example, ERISA group health plans that are exempt from filing income tax returns -

should use proxy measures to determine their annual receipts. Further information about

the relevant provisions of 13 CFR 121.104 and these proxy measures, and additional

information related to “small health plans,” may be found at

protected health information about themselves that is contained in their “designated

record sets.” The term “record” in the term “designated record set” does not include oral

information; rather, it connotes information that has been recorded in some manner.

The Rule does not require covered entities to tape or digitally record oral

communications, nor retain digitally or tape recorded information after transcription. But

if such records are maintained and used to make decisions about the individual, they may

meet the definition of “designated record set.” For example, a health plan is not required

to provide a member access to tapes of a telephone “advice line” interaction if the tape is

maintained only for customer service review and not to make decisions about the

member.

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including oral information, that is used or disclosed for treatment, payment or health care

operations.

The Rule includes, however, documentation requirements for some information

disclosures for other purposes. For example, some disclosures must be documented in

order to meet the standard for providing a disclosure history to an individual upon

request. Where a documentation requirement exists in the Rule, it applies to all relevant

communications, whether in oral or some other form. For example, if a covered

physician discloses information about a case of tuberculosis to a public health authority as

permitted by the Rule at 45 CFR 164.512, then he or she must maintain a record of that

disclosure regardless of whether the disclosure was made orally, by phone, or in writing.