SUMMARY OF THE 

HIPAA PRIVACY RULE

HIPAA Compliance Assistance 

OCR PRIVACY BRIEF 
i 

SUMMARY OF 

THE HIPAA PRIVACY RULE 

Contents 

Introduction ......................................................................................................................... 1

Statutory & Regulatory Background................................................................................... 1

Who is Covered by the Privacy Rule .................................................................................. 2

Business Associates............................................................................................................. 3

What Information is Protected ............................................................................................ 3

General Principle for Uses and Disclosures........................................................................ 4

Permitted Uses and Disclosures .......................................................................................... 4

Authorized Uses and Disclosures........................................................................................ 9

Limiting Uses and Disclosures to the Minimum Necessary ............................................. 10

Notice and Other Individual Rights .................................................................................. 11

Administrative Requirements............................................................................................ 14

Organizational Options ..................................................................................................... 15

Other Provisions: Personal Representatives and Minors .................................................. 16

State Law........................................................................................................................... 17

Enforcement and Penalties for Noncompliance................................................................ 17

Compliance Dates ............................................................................................................. 18

Copies of the Rule & Related Materials............................................................................ 18

End Notes .......................................................................................................................... 19 
OCR Privacy Rule Summary 1 Last Revised 05/03 

SUMMARY OF 

THE HIPAA PRIVACY RULE 

Introduction The Standards for Privacy of Individually Identifiable Health Information (“Privacy 

Rule”) establishes, for the first time, a set of national standards for the protection of 

certain health information. The U.S. Department of Health and Human Services 

(“HHS”) issued the Privacy Rule to implement the requirement of the Health 

Insurance Portability and Accountability Act of 1996 (“HIPAA”). 1 The Privacy Rule 

standards address the use and disclosure of individuals’ health information—called 

“protected health information” by organizations subject to the Privacy Rule — called 

“covered entities,” as well as standards for individuals' privacy rights to understand 

and control how their health information is used. Within HHS, the Office for Civil 

Rights (“OCR”) has responsibility for implementing and enforcing the Privacy Rule 

with respect to voluntary compliance activities and civil money penalties. 

A major goal of the Privacy Rule is to assure that individuals’ health information is 

properly protected while allowing the flow of health information needed to provide 

and promote high quality health care and to protect the public's health and well being. 

The Rule strikes a balance that permits important uses of information, while 

protecting the privacy of people who seek care and healing. Given that the health 

care marketplace is diverse, the Rule is designed to be flexible and comprehensive to 

cover the variety of uses and disclosures that need to be addressed. 

This is a summary of key elements of the Privacy Rule and not a complete or 

comprehensive guide to compliance. Entities regulated by the Rule are obligated to 

comply with all of its applicable requirements and should not rely on this summary as 

a source of legal information or advice. To make it easier for entities to review the 

complete requirements of the Rule, provisions of the Rule referenced in this summary 

are cited in notes at the end of this document. To view the entire Rule, and for other 

additional helpful information about how it applies, see the OCR website: 

http://www.hhs.gov/ocr/hipaa. In the event of a conflict between this summary 

and the Rule, the Rule governs. 

Links to the OCR Guidance Document are provided throughout this paper. Provisions 

of the Rule referenced in this summary are cited in endnotes at the end of this 

document. To review the entire Rule itself, and for other additional helpful 

information about how it applies, see the OCR website: 

http://www.hhs.gov/ocr/hipaa. 

Statutory & 

Regulatory 

Background 

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public 

Law 104-191, was enacted on August 21, 1996. Sections 261 through 264 of HIPAA 

require the Secretary of HHS to publicize standards for the electronic exchange, 

privacy and security of health information. Collectively these are known as the 

Administrative Simplification provisions. 

HIPAA required the Secretary to issue privacy regulations governing individually 

identifiable health information, if Congress did not enact privacy legislation within 
OCR Privacy Rule Summary 2 Last Revised 05/03 

three years of the passage of HIPAA. Because Congress did not enact privacy 

legislation, HHS developed a proposed rule and released it for public comment on 

November 3, 1999. The Department received over 52,000 public comments. The 

final regulation, the Privacy Rule, was published December 28, 2000.2

 

In March 2002, the Department proposed and released for public comment 

modifications to the Privacy Rule. The Department received over 11,000 comments. 

The final modifications were published in final form on August 14, 2002.3

 A text 

combining the final regulation and the modifications can be found at 45 CFR Part 

160 and Part 164, Subparts A and E on the OCR website: 

http://www.hhs.gov/ocr/hipaa.

Who is 

Covered by the 

Privacy Rule 

The Privacy Rule, as well as all the Administrative Simplification rules, apply to 

health plans, health care clearinghouses, and to any health care provider who 

transmits health information in electronic form in connection with transactions for 

which the Secretary of HHS has adopted standards under HIPAA (the “covered 

entities”). For help in determining whether you are covered, use the decision tool at: 

http://www.cms.hhs.gov/hipaa/hipaa2/support/tools/decisionsupport/default.asp.

Health Plans. Individual and group plans that provide or pay the cost of medical 

care are covered entities.4

 Health plans include health, dental, vision, and 

prescription drug insurers, health maintenance organizations (“HMOs”), Medicare, 

Medicaid, Medicare+Choice and Medicare supplement insurers, and long-term care 

insurers (excluding nursing home fixed-indemnity policies). Health plans also 

include employer-sponsored group health plans, government and church-sponsored 

health plans, and multi-employer health plans. There are exceptions—a group health 

plan with less than 50 participants that is administered solely by the employer that 

established and maintains the plan is not a covered entity. Two types of governmentfunded programs are not health plans: (1) those whose principal purpose is not 

providing or paying the cost of health care, such as the food stamps program; and (2) 

those programs whose principal activity is directly providing health care, such as a 

community health center,5

 or the making of grants to fund the direct provision of 

health care. Certain types of insurance entities are also not health plans, including 

entities providing only workers’ compensation, automobile insurance, and property 

and casualty insurance. 

Health Care Providers. Every health care provider, regardless of size, who 

electronically transmits health information in connection with certain transactions, is 

a covered entity. These transactions include claims, benefit eligibility inquiries, 

referral authorization requests, or other transactions for which HHS has established 

standards under the HIPAA Transactions Rule.6

 Using electronic technology, such as 

email, does not mean a health care provider is a covered entity; the transmission must 

be in connection with a standard transaction. The Privacy Rule covers a health care 

provider whether it electronically transmits these transactions directly or uses a 

billing service or other third party to do so on its behalf. Health care providers 

include all “providers of services” (e.g., institutional providers such as hospitals) and 

“providers of medical or health services” (e.g., non-institutional providers such as 

physicians, dentists and other practitioners) as defined by Medicare, and any other 

person or organization that furnishes, bills, or is paid for health care. 
OCR Privacy Rule Summary 3 Last Revised 05/03 

Health Care Clearinghouses. Health care clearinghouses are entities that process 

nonstandard information they receive from another entity into a standard (i.e., 

standard format or data content), or vice versa. 7 In most instances, health care 

clearinghouses will receive individually identifiable health information only when 

they are providing these processing services to a health plan or health care provider as 

a business associate. In such instances, only certain provisions of the Privacy Rule are 

applicable to the health care clearinghouse’s uses and disclosures of protected health 

information.8

 Health care clearinghouses include billing services, repricing 

companies, community health management information systems, and value-added 

networks and switches if these entities perform clearinghouse functions. 

Business 

Associates 

Business Associate Defined. In general, a business associate is a person or 

organization, other than a member of a covered entity's workforce, that performs 

certain functions or activities on behalf of, or provides certain services to, a covered 

entity that involve the use or disclosure of individually identifiable health 

information. Business associate functions or activities on behalf of a covered entity 

include claims processing, data analysis, utilization review, and billing.9

 Business 

associate services to a covered entity are limited to legal, actuarial, accounting, 

consulting, data aggregation, management, administrative, accreditation, or financial 

services. However, persons or organizations are not considered business associates if 

their 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. A covered entity can be the business associate of 

another covered entity. 

Business Associate Contract. When a covered entity uses a contractor or other nonworkforce member to perform "business associate" services or activities, the Rule 

requires that the covered entity include certain protections for the information in a 

business associate agreement (in certain circumstances governmental entities may use 

alternative means to achieve the same protections). In the business associate contract, 

a covered entity must impose specified written safeguards on the individually 

identifiable health information used or disclosed by its business associates.10

Moreover, a covered entity may not contractually authorize its business associate to 

make any use or disclosure of protected health information that would violate the 

Rule. Covered entities that have an existing written contract or agreement with 

business associates prior to October 15, 2002, which is not renewed or modified prior 

to April 14, 2003, are permitted to continue to operate under that contract until they 

renew the contract or April 14, 2004, whichever is first.11 Sample business associate 

contract language is available on the OCR website at: 

http://www.hhs.gov/ocr/hipaa/contractprov.html. Also see OCR “Business 

Associate” Guidance. 

What 

Information is 

Protected 

Protected Health Information. The Privacy Rule protects all "individually 

identifiable health information" held or transmitted by a covered entity or its business 

associate, in any form or media, whether electronic, paper, or oral. The Privacy Rule 

calls this information "protected health information (PHI)."12 
OCR Privacy Rule Summary 4 Last Revised 05/03 

“Individually identifiable health information” is information, including demographic 

data, that relates to: 

• the individual’s past, present or future physical or mental health or 

condition, 

• the provision of health care to the individual, or 

• the past, present, or future payment for the provision of health care to the 

individual, 

and that identifies the individual or for which there is a reasonable basis to believe 

can be used to identify the individual.13 Individually identifiable health information 

includes many common identifiers (e.g., name, address, birth date, Social Security 

Number). 

The Privacy Rule excludes from protected health information employment records 

that a covered entity maintains in its capacity as an employer and education and 

certain other records subject to, or defined in, the Family Educational Rights and 

Privacy Act, 20 U.S.C. §1232g. 

De-Identified Health Information. There are no restrictions on the use or 

disclosure of de-identified health information.14 De-identified health information 

neither identifies nor provides a reasonable basis to identify an individual. There are 

two ways to de-identify information; either: 1) a formal determination by a qualified 

statistician; or 2) the removal of specified identifiers of the individual and of the 

individual’s relatives, household members, and employers is required, and is 

adequate only if the covered entity has no actual knowledge that the remaining 

information could be used to identify the individual.15

General 

Principle for 

Uses and 

Disclosures 

Basic Principle. A major purpose of the Privacy Rule is to define and limit the 

circumstances in which an individual’s protected heath information may be used or 

disclosed by covered entities. A covered entity may not use or disclose protected 

health information, except either: (1) as the Privacy Rule permits or requires; or (2) as 

the individual who is the subject of the information (or the individual’s personal 

representative) authorizes in writing.16 

Required Disclosures. A covered entity must disclose protected health information

in only two situations: (a) to individuals (or their personal representatives) 

specifically when they request access to, or an accounting of disclosures of, their 

protected health information; and (b) to HHS when it is undertaking a compliance 

investigation or review or enforcement action.17 See OCR “Government Access” 

Guidance. 

Permitted Uses 

and Disclosures 

Permitted Uses and Disclosures. A covered entity is permitted, but not required, to 

use and disclose protected health information, without an individual’s authorization, 

for the following purposes or situations: (1) To the Individual (unless required for 

access or accounting of disclosures); (2) Treatment, Payment, and Health Care 

Operations; (3) Opportunity to Agree or Object; (4) Incident to an otherwise 

permitted use and disclosure; (5) Public Interest and Benefit Activities; and 
OCR Privacy Rule Summary 5 Last Revised 05/03 

(6) Limited Data Set for the purposes of research, public health or health care 

operations.18 Covered entities may rely on professional ethics and best judgments in 

deciding which of these permissive uses and disclosures to make. 

(1) To the Individual. A covered entity may disclose protected health information to 

the individual who is the subject of the information. 

(2) Treatment, Payment, Health Care Operations. A covered entity may use and 

disclose protected health information for its own treatment, payment, and health care 

operations activities.19 A covered entity also may disclose protected health 

information for the treatment activities of any health care provider, the payment 

activities of another covered entity and of any health care provider, or the health care 

operations of another covered entity involving either quality or competency assurance 

activities or fraud and abuse detection and compliance activities, if both covered 

entities have or had a relationship with the individual and the protected health 

information pertains to the relationship. See OCR “Treatment, Payment, Health Care 

Operations” Guidance. 

Treatment is the provision, coordination, or management of health care and 

related services for an individual by one or more health care providers, 

including consultation between providers regarding a patient and referral of a 

patient by one provider to another.20

Payment encompasses activities of a health plan to obtain premiums, 

determine or fulfill responsibilities for coverage and provision of benefits, 

and furnish or obtain reimbursement for health care delivered to an 

individual21 and activities of a health care provider to obtain payment or be 

reimbursed for the provision of health care to an individual. 

Health care operations are any of the following activities: (a) quality 

assessment and improvement activities, including case management and care 

coordination; (b) competency assurance activities, including provider or 

health plan performance evaluation, credentialing, and accreditation; (c) 

conducting or arranging for medical reviews, audits, or legal services, 

including fraud and abuse detection and compliance programs; (d) specified 

insurance functions, such as underwriting, risk rating, and reinsuring risk; (e) 

business planning, development, management, and administration; and (f) 

business management and general administrative activities of the entity, 

including but not limited to: de-identifying protected health information, 

creating a limited data set, and certain fundraising for the benefit of the 

covered entity.22

Most uses and disclosures of psychotherapy notes for treatment, payment, and health 

care operations purposes require an authorization as described below.23 

Obtaining “consent” (written permission from individuals to use and disclose their 

protected health information for treatment, payment, and health care operations) is 

optional under the Privacy Rule for all covered entities.24 The content of a consent 

form, and the process for obtaining consent, are at the discretion of the covered entity 

electing to seek consent. 
OCR Privacy Rule Summary 6 Last Revised 05/03 

(3) Uses and Disclosures with Opportunity to Agree or Object. Informal 

permission may be obtained by asking the individual outright, or by circumstances 

that clearly give the individual the opportunity to agree, acquiesce, or object. Where 

the individual is incapacitated, in an emergency situation, or not available, covered 

entities generally may make such uses and disclosures, if in the exercise of their 

professional judgment, the use or disclosure is determined to be in the best interests 

of the individual. 

Facility Directories. It is a common practice in many health care facilities, 

such as hospitals, to maintain a directory of patient contact information. A 

covered health care provider may rely on an individual’s informal permission 

to list in its facility directory the individual’s name, general condition, 

religious affiliation, and location in the provider’s facility.25 The provider 

may then disclose the individual’s condition and location in the facility to 

anyone asking for the individual by name, and also may disclose religious 

affiliation to clergy. Members of the clergy are not required to ask for the 

individual by name when inquiring about patient religious affiliation. 

For Notification and Other Purposes. A covered entity also may rely on an 

individual’s informal permission to disclose to the individual’s family, 

relatives, or friends, or to other persons whom the individual identifies, 

protected health information directly relevant to that person’s involvement in 

the individual’s care or payment for care. 26 This provision, for example, 

allows a pharmacist to dispense filled prescriptions to a person acting on 

behalf of the patient. Similarly, a covered entity may rely on an individual’s 

informal permission to use or disclose protected health information for the 

purpose of notifying (including identifying or locating) family members, 

personal representatives, or others responsible for the individual’s care of the 

individual’s location, general condition, or death. In addition, protected 

health information may be disclosed for notification purposes to public or 

private entities authorized by law or charter to assist in disaster relief efforts. 

(4) Incidental Use and Disclosure. The Privacy Rule does not require that every 

risk of an incidental use or disclosure of protected health information be eliminated. 

A use or disclosure of this information that occurs as a result of, or as “incident to,” 

an otherwise permitted use or disclosure is permitted as long as the covered entity has 

adopted reasonable safeguards as required by the Privacy Rule, and the information 

being shared was limited to the “minimum necessary,” as required by the Privacy 

Rule.27 See OCR “Incidental Uses and Disclosures” Guidance. 

(5) Public Interest and Benefit Activities. The Privacy Rule permits use and 

disclosure of protected health information, without an individual’s authorization or 

permission, for 12 national priority purposes.28 These disclosures are permitted, 

although not required, by the Rule in recognition of the important uses made of health 

information outside of the health care context. Specific conditions or limitations 

apply to each public interest purpose, striking the balance between the individual 

privacy interest and the public interest need for this information. 

Required by Law. Covered entities may use and disclose protected health 

information without individual authorization as required by law (including by
OCR Privacy Rule Summary 7 Last Revised 05/03 

statute, regulation, or court orders).29

Public Health Activities. Covered entities may disclose protected health 

information to: (1) public health authorities authorized by law to collect or 

receive such information for preventing or controlling disease, injury, or 

disability and to public health or other government authorities authorized to 

receive reports of child abuse and neglect; (2) entities subject to FDA 

regulation regarding FDA regulated products or activities for purposes such 

as adverse event reporting, tracking of products, product recalls, and postmarketing surveillance; (3) individuals who may have contracted or been 

exposed to a communicable disease when notification is authorized by law; 

and (4) employers, regarding employees, when requested by employers, for 

information concerning a work-related illness or injury or workplace related 

medical surveillance, because such information is needed by the employer to 

comply with the Occupational Safety and Health Administration (OHSA), 

the Mine Safety and Health Administration (MHSA), or similar state law.30

See OCR “Public Health” Guidance; CDC Public Health and HIPAA 

Guidance. 

Victims of Abuse, Neglect or Domestic Violence. In certain circumstances, 

covered entities may disclose protected health information to appropriate 

government authorities regarding victims of abuse, neglect, or domestic 

violence.31 

Health Oversight Activities. Covered entities may disclose protected health 

information to health oversight agencies (as defined in the Rule) for purposes 

of legally authorized health oversight activities, such as audits and 

investigations necessary for oversight of the health care system and 

government benefit programs.32

Judicial and Administrative Proceedings. Covered entities may disclose 

protected health information in a judicial or administrative proceeding if the 

request for the information is through an order from a court or administrative 

tribunal. Such information may also be disclosed in response to a subpoena 

or other lawful process if certain assurances regarding notice to the individual 

or a protective order are provided.33

Law Enforcement Purposes. Covered entities may disclose protected health 

information to law enforcement officials for law enforcement purposes under 

the following six circumstances, and subject to specified conditions: (1) as 

required by law (including court orders, court-ordered warrants, subpoenas) 

and administrative requests; (2) to identify or locate a suspect, fugitive, 

material witness, or missing person; (3) in response to a law enforcement 

official’s request for information about a victim or suspected victim of a

crime; (4) to alert law enforcement of a person’s death, if the covered entity 

suspects that criminal activity caused the death; (5) when a covered entity 

believes that protected health information is evidence of a crime that 

occurred on its premises; and (6) by a covered health care provider in a 

medical emergency not occurring on its premises, when necessary to inform 

law enforcement about the commission and nature of a crime, the location of 

the crime or crime victims, and the perpetrator of the crime.34
OCR Privacy Rule Summary 8 Last Revised 05/03 

Decedents. Covered entities may disclose protected health information to 

funeral directors as needed, and to coroners or medical examiners to identify 

a deceased person, determine the cause of death, and perform other functions 

authorized by law.35

Cadaveric Organ, Eye, or Tissue Donation. Covered entities may use or 

disclose protected health information to facilitate the donation and 

transplantation of cadaveric organs, eyes, and tissue.36 

Research. “Research” is any systematic investigation designed to develop or 

contribute to generalizable knowledge.37 The Privacy Rule permits a covered 

entity to use and disclose protected health information for research purposes, 

without an individual’s authorization, provided the covered entity obtains 

either: (1) documentation that an alteration or waiver of individuals’ 

authorization for the use or disclosure of protected health information about 

them for research purposes has been approved by an Institutional Review 

Board or Privacy Board; (2) representations from the researcher that the use 

or disclosure of the protected health information is solely to prepare a 

research protocol or for similar purpose preparatory to research, that the 

researcher will not remove any protected health information from the covered 

entity, and that protected health information for which access is sought is 

necessary for the research; or (3) representations from the researcher that the 

use or disclosure sought is solely for research on the protected health 

information of decedents, that the protected health information sought is 

necessary for the research, and, at the request of the covered entity, 

documentation of the death of the individuals about whom information is 

sought.38 A covered entity also may use or disclose, without an individuals’ 

authorization, a limited data set of protected health information for research 

purposes (see discussion below).39 See OCR “Research” Guidance; NIH 

Protecting PHI in Research. 

Serious Threat to Health or Safety. Covered entities may disclose protected 

health information that they believe is necessary to prevent or lessen a serious 

and imminent threat to a person or the public, when such disclosure is made 

to someone they believe can prevent or lessen the threat (including the target 

of the threat). Covered entities may also disclose to law enforcement if the 

information is needed to identify or apprehend an escapee or violent 

criminal.40

Essential Government Functions. An authorization is not required to use or 

disclose protected health information for certain essential government 

functions. Such functions include: assuring proper execution of a military 

mission, conducting intelligence and national security activities that are 

authorized by law, providing protective services to the President, making 

medical suitability determinations for U.S. State Department employees, 

protecting the health and safety of inmates or employees in a correctional 

institution, and determining eligibility for or conducting enrollment in certain 

government benefit programs.41
OCR Privacy Rule Summary 9 Last Revised 05/03 

Workers’ Compensation. Covered entities may disclose protected health 

information as authorized by, and to comply with, workers’ compensation 

laws and other similar programs providing benefits for work-related injuries 

or illnesses.42 See OCR “Workers’ Compensation” Guidance. 

(6) Limited Data Set. A limited data set is protected health information from which 

certain specified direct identifiers of individuals and their relatives, household 

members, and employers have been removed.43 A limited data set may be used and 

disclosed for research, health care operations, and public health purposes, provided 

the recipient enters into a data use agreement promising specified safeguards for the 

protected health information within the limited data set. 

Authorized 

Uses and 

Disclosures 

Authorization. A covered entity must obtain the individual’s written authorization 

for any use or disclosure of protected health information that is not for treatment, 

payment or health care operations or otherwise permitted or required by the Privacy 

Rule.44 A covered entity may not condition treatment, payment, enrollment, or 

benefits eligibility on an individual granting an authorization, except in limited 

circumstances.45

An authorization must be written in specific terms. It may allow use and disclosure 

of protected health information by the covered entity seeking the authorization, or by 

a third party. Examples of disclosures that would require an individual’s 

authorization include disclosures to a life insurer for coverage purposes, disclosures 

to an employer of the results of a pre-employment physical or lab test, or disclosures 

to a pharmaceutical firm for their own marketing purposes. 

All authorizations must be in plain language, and contain specific information 

regarding the information to be disclosed or used, the person(s) disclosing and 

receiving the information, expiration, right to revoke in writing, and other data. The 

Privacy Rule contains transition provisions applicable to authorizations and other 

express legal permissions obtained prior to April 14, 2003. 46

Psychotherapy Notes47. A covered entity must obtain an individual’s authorization 

to use or disclose psychotherapy notes with the following exceptions48: 

• The covered entity who originated the notes may use them for treatment. 

• A covered entity may use or disclose, without an individual’s authorization, 

the psychotherapy notes, for its own training, and to defend itself in legal 

proceedings brought by the individual, for HHS to investigate or determine 

the covered entity’s compliance with the Privacy Rules, to avert a serious and 

imminent threat to public health or safety, to a health oversight agency for 

lawful oversight of the originator of the psychotherapy notes, for the lawful 

activities of a coroner or medical examiner or as required by law. 

Marketing. Marketing is any communication about a product or service that 

encourages recipients to purchase or use the product or service.49 The Privacy Rule 

carves out the following health-related activities from this definition of marketing: 

• Communications to describe health-related products or services, or payment 
OCR Privacy Rule Summary 10 Last Revised 05/03 

for them, provided by or included in a benefit plan of the covered entity 

making the communication;

• Communications about participating providers in a provider or health plan 

network, replacement of or enhancements to a health plan, and health-related 

products or services available only to a health plan’s enrollees that add value 

to, but are not part of, the benefits plan;

• Communications for treatment of the individual; and

• Communications for case management or care coordination for the 

individual, or to direct or recommend alternative treatments, therapies, 

health care providers, or care settings to the individual. 

Marketing also is an arrangement between a covered entity and any other entity 

whereby the covered entity discloses protected health information, in exchange for 

direct or indirect remuneration, for the other entity to communicate about its own 

products or services encouraging the use or purchase of those products or services. 

A covered entity must obtain an authorization to use or disclose protected health 

information for marketing, except for face-to-face marketing communications 

between a covered entity and an individual, and for a covered entity’s provision of 

promotional gifts of nominal value. No authorization is needed, however, to make a 

communication that falls within one of the exceptions to the marketing definition. 

An authorization for marketing that involves the covered entity’s receipt of direct or 

indirect remuneration from a third party must reveal that fact. See OCR "Marketing" 

Guidance. 

Limiting Uses 

and Disclosures 

to the 

Minimum 

Necessary 

Minimum Necessary. A central aspect of the Privacy Rule is the principle of 

“minimum necessary” use and disclosure. A covered entity must make reasonable 

efforts to use, disclose, and request only the minimum amount of protected health 

information needed to accomplish the intended purpose of the use, disclosure, or 

request.50 A covered entity must develop and implement policies and procedures to 

reasonably limit uses and disclosures to the minimum necessary. When the minimum 

necessary standard applies to a use or disclosure, a covered entity may not use, 

disclose, or request the entire medical record for a particular purpose, unless it can 

specifically justify the whole record as the amount reasonably needed for the purpose. 

See OCR “Minimum Necessary” Guidance. 

The minimum necessary requirement is not imposed in any of the following 

circumstances: (a) disclosure to or a request by a health care provider for treatment; 

(b) disclosure to an individual who is the subject of the information, or the 

individual’s personal representative; (c) use or disclosure made pursuant to an 

authorization; (d) disclosure to HHS for complaint investigation, compliance review 

or enforcement; (e) use or disclosure that is required by law; or (f) use or disclosure 

required for compliance with the HIPAA Transactions Rule or other HIPAA 

Administrative Simplification Rules. 

Access and Uses. For internal uses, a covered entity must develop and implement 

policies and procedures that restrict access and uses of protected health information 

based on the specific roles of the members of their workforce. These policies and 

procedures must identify the persons, or classes of persons, in the workforce who 

need access to protected health information to carry out their duties, the categories of 
OCR Privacy Rule Summary 11 Last Revised 05/03 

protected health information to which access is needed, and any conditions under 

which they need the information to do their jobs. 

Disclosures and Requests for Disclosures. Covered entities must establish and 

implement policies and procedures (which may be standard protocols) for routine, 

recurring disclosures, or requests for disclosures, that limits the protected health 

information disclosed to that which is the minimum amount reasonably necessary to 

achieve the purpose of the disclosure. Individual review of each disclosure is not 

required. For non-routine, non-recurring disclosures, or requests for disclosures that 

it makes, covered entities must develop criteria designed to limit disclosures to the 

information reasonably necessary to accomplish the purpose of the disclosure and 

review each of these requests individually in accordance with the established criteria. 

Reasonable Reliance. If another covered entity makes a request for protected health 

information, a covered entity may rely, if reasonable under the circumstances, on the 

request as complying with this minimum necessary standard. Similarly, a covered 

entity may rely upon requests as being the minimum necessary protected health 

information from: (a) a public official, (b) a professional (such as an attorney or 

accountant) who is the covered entity’s business associate, seeking the information to 

provide services to or for the covered entity; or (c) a researcher who provides the 

documentation or representation required by the Privacy Rule for research. 

Notice and 

Other 

Individual 

Rights 

Privacy Practices Notice. Each covered entity, with certain exceptions, must 

provide a notice of its privacy practices.51 The Privacy Rule requires that the notice 

contain certain elements. The notice must describe the ways in which the covered 

entity may use and disclose protected health information. The notice must state the 

covered entity’s duties to protect privacy, provide a notice of privacy practices, and 

abide by the terms of the current notice. The notice must describe individuals’ rights, 

including the right to complain to HHS and to the covered entity if they believe their 

privacy rights have been violated. The notice must include a point of contact for 

further information and for making complaints to the covered entity. Covered entities 

must act in accordance with their notices. The Rule also contains specific 

distribution requirements for direct treatment providers, all other health care 

providers, and health plans. See OCR “Notice” Guidance. 

• Notice Distribution. A covered health care provider with a direct treatment 

relationship with individuals must deliver a privacy practices notice to 

patients starting April 14, 2003 as follows: 

o Not later than the first service encounter by personal delivery (for 

patient visits), by automatic and contemporaneous electronic 

response (for electronic service delivery), and by prompt mailing (for 

telephonic service delivery); 

o By posting the notice at each service delivery site in a clear and 

prominent place where people seeking service may reasonably be 

expected to be able to read the notice; and 

o In emergency treatment situations, the provider must furnish its 

notice as soon as practicable after the emergency abates. 
OCR Privacy Rule Summary 12 Last Revised 05/03 

Covered entities, whether direct treatment providers or indirect treatment 

providers (such as laboratories) or health plans must supply notice to anyone 

on request.52 A covered entity must also make its notice electronically 

available on any web site it maintains for customer service or benefits 

information. 

The covered entities in an organized health care arrangement may use a joint 

privacy practices notice, as long as each agrees to abide by the notice content 

with respect to the protected health information created or received in 

connection with participation in the arrangement.53 Distribution of a joint 

notice by any covered entity participating in the organized health care 

arrangement at the first point that an OHCA member has an obligation to 

provide notice satisfies the distribution obligation of the other participants in 

the organized health care arrangement. 

A health plan must distribute its privacy practices notice to each of its 

enrollees by its Privacy Rule compliance date. Thereafter, the health plan 

must give its notice to each new enrollee at enrollment, and send a reminder 

to every enrollee at least once every three years that the notice is available 

upon request. A health plan satisfies its distribution obligation by furnishing 

the notice to the “named insured,” that is, the subscriber for coverage that 

also applies to spouses and dependents. 

• Acknowledgement of Notice Receipt. A covered health care provider with 

a direct treatment relationship with individuals must make a good faith effort 

to obtain written acknowledgement from patients of receipt of the privacy 

practices notice.54 The Privacy Rule does not prescribe any particular content 

for the acknowledgement. The provider must document the reason for any 

failure to obtain the patient’s written acknowledgement. The provider is 

relieved of the need to request acknowledgement in an emergency treatment 

situation. 

Access. Except in certain circumstances, individuals have the right to review and 

obtain a copy of their protected health information in a covered entity’s designated 

record set.

55 The “designated record set” is that group of records maintained by or 

for a covered entity that is used, in whole or part, to make decisions about 

individuals, or that is a provider’s medical and billing records about individuals or a 

health plan’s enrollment, payment, claims adjudication, and case or medical 

management record systems.56 The Rule excepts from the right of access the 

following protected health information: psychotherapy notes, information compiled 

for legal proceedings, laboratory results to which the Clinical Laboratory 

Improvement Act (CLIA) prohibits access, or information held by certain research 

laboratories. For information included within the right of access, covered entities 

may deny an individual access in certain specified situations, such as when a health 

care professional believes access could cause harm to the individual or another. In 

such situations, the individual must be given the right to have such denials reviewed 

by a licensed health care professional for a second opinion.57 Covered entities may 

impose reasonable, cost-based fees for the cost of copying and postage. 

Amendment. The Rule gives individuals the right to have covered entities amend 

their protected health information in a designated record set when that information is 
OCR Privacy Rule Summary 13 Last Revised 05/03 

inaccurate or incomplete. 58 If a covered entity accepts an amendment request, it must 

make reasonable efforts to provide the amendment to persons that the individual has 

identified as needing it, and to persons that the covered entity knows might rely on 

the information to the individual’s detriment.59 If the request is denied, covered 

entities must provide the individual with a written denial and allow the individual to 

submit a statement of disagreement for inclusion in the record. The Rule specifies 

processes for requesting and responding to a request for amendment. A covered 

entity must amend protected health information in its designated record set upon 

receipt of notice to amend from another covered entity. 

Disclosure Accounting. Individuals have a right to an accounting of the disclosures 

of their protected health information by a covered entity or the covered entity’s 

business associates.60 The maximum disclosure accounting period is the six years 

immediately preceding the accounting request, except a covered entity is not 

obligated to account for any disclosure made before its Privacy Rule compliance date. 

The Privacy Rule does not require accounting for disclosures: (a) for treatment, 

payment, or health care operations; (b) to the individual or the individual’s personal 

representative; (c) for notification of or to persons involved in an individual’s health 

care or payment for health care, for disaster relief, or for facility directories; (d) 

pursuant to an authorization; (e) of a limited data set; (f) for national security or 

intelligence purposes; (g) to correctional institutions or law enforcement officials for 

certain purposes regarding inmates or individuals in lawful custody; or (h) incident to 

otherwise permitted or required uses or disclosures. Accounting for disclosures to 

health oversight agencies and law enforcement officials must be temporarily 

suspended on their written representation that an accounting would likely impede 

their activities. 

Restriction Request. Individuals have the right to request that a covered entity 

restrict use or disclosure of protected health information for treatment, payment or 

health care operations, disclosure to persons involved in the individual’s health care 

or payment for health care, or disclosure to notify family members or others about the 

individual’s general condition, location, or death.61 A covered entity is under no 

obligation to agree to requests for restrictions. A covered entity that does agree must 

comply with the agreed restrictions, except for purposes of treating the individual in a 

medical emergency.62

Confidential Communications Requirements. Health plans and covered health 

care providers must permit individuals to request an alternative means or location for 

receiving communications of protected health information by means other than those 

that the covered entity typically employs.63 For example, an individual may request 

that the provider communicate with the individual through a designated address or 

phone number. Similarly, an individual may request that the provider send 

communications in a closed envelope rather than a post card. 

Health plans must accommodate reasonable requests if the individual indicates that 

the disclosure of all or part of the protected health information could endanger the 

individual. The health plan may not question the individual’s statement of 

endangerment. Any covered entity may condition compliance with a confidential 

communication request on the individual specifying an alternative address or method 

of contact and explaining how any payment will be handled.
OCR Privacy Rule Summary 14 Last Revised 05/03 

Administrative 

Requirements 

HHS recognizes that covered entities range from the smallest provider to the largest, 

multi-state health plan. Therefore the flexibility and scalability of the Rule are 

intended to allow covered entities to analyze their own needs and implement 

solutions appropriate for their own environment. What is appropriate for a particular 

covered entity will depend on the nature of the covered entity’s business, as well as 

the covered entity’s size and resources. 

Privacy Policies and Procedures. A covered entity must develop and implement 

written privacy policies and procedures that are consistent with the Privacy Rule.64

Privacy Personnel. A covered entity must designate a privacy official responsible 

for developing and implementing its privacy policies and procedures, and a contact 

person or contact office responsible for receiving complaints and providing 

individuals with information on the covered entity’s privacy practices.65

Workforce Training and Management. Workforce members include employees, 

volunteers, trainees, and may also include other persons whose conduct is under the 

direct control of the entity (whether or not they are paid by the entity).66 A covered 

entity must train all workforce members on its privacy policies and procedures, as 

necessary and appropriate for them to carry out their functions.67 A covered entity 

must have and apply appropriate sanctions against workforce members who violate 

its privacy policies and procedures or the Privacy Rule.68

Mitigation. A covered entity must mitigate, to the extent practicable, any harmful 

effect it learns was caused by use or disclosure of protected health information by its 

workforce or its business associates in violation of its privacy policies and procedures 

or the Privacy Rule.69

Data Safeguards. A covered entity must maintain reasonable and appropriate 

administrative, technical, and physical safeguards to prevent intentional or 

unintentional use or disclosure of protected health information in violation of the 

Privacy Rule and to limit its incidental use and disclosure pursuant to otherwise 

permitted or required use or disclosure.70 For example, such safeguards might 

include shredding documents containing protected health information before 

discarding them, securing medical records with lock and key or pass code, and 

limiting access to keys or pass codes. See OCR “Incidental Uses and Disclosures” 

Guidance. 

Complaints. A covered entity must have procedures for individuals to complain 

about its compliance with its privacy policies and procedures and the Privacy Rule.71

The covered entity must explain those procedures in its privacy practices notice.72 

Among other things, the covered entity must identify to whom individuals can submit 

complaints to at the covered entity and advise that complaints also can be submitted 

to the Secretary of HHS. 

Retaliation and Waiver. A covered entity may not retaliate against a person for 

exercising rights provided by the Privacy Rule, for assisting in an investigation by 

HHS or another appropriate authority, or for opposing an act or practice that the 

person believes in good faith violates the Privacy Rule.73 A covered entity may not 
OCR Privacy Rule Summary 15 Last Revised 05/03 

require an individual to waive any right under the Privacy Rule as a condition for 

obtaining treatment, payment, and enrollment or benefits eligibility.74

Documentation and Record Retention. A covered entity must maintain, until six 

years after the later of the date of their creation or last effective date, its privacy 

policies and procedures, its privacy practices notices, disposition of complaints, and 

other actions, activities, and designations that the Privacy Rule requires to be 

documented.75

Fully-Insured Group Health Plan Exception. The only administrative obligations 

with which a fully-insured group health plan that has no more than enrollment data 

and summary health information is required to comply are the (1) ban on retaliatory 

acts and waiver of individual rights, and (2) documentation requirements with respect 

to plan documents if such documents are amended to provide for the disclosure of 

protected health information to the plan sponsor by a health insurance issuer or HMO 

that services the group health plan.76

Organizational 

Options 

The Rule contains provisions that address a variety of organizational issues that may 

affect the operation of the privacy protections. 

Hybrid Entity. The Privacy Rule permits a covered entity that is a single legal entity 

and that conducts both covered and non-covered functions to elect to be a “hybrid 

entity.”77 (The activities that make a person or organization a covered entity are its 

“covered functions.”78) To be a hybrid entity, the covered entity must designate in 

writing its operations that perform covered functions as one or more “health care 

components.” After making this designation, most of the requirements of the Privacy 

Rule will apply only to the health care components. A covered entity that does not 

make this designation is subject in its entirety to the Privacy Rule. 

Affiliated Covered Entity. Legally separate covered entities that are affiliated by 

common ownership or control may designate themselves (including their health care 

components) as a single covered entity for Privacy Rule compliance.79 The 

designation must be in writing. An affiliated covered entity that performs multiple 

covered functions must operate its different covered functions in compliance with the 

Privacy Rule provisions applicable to those covered functions. 

Organized Health Care Arrangement. The Privacy Rule identifies relationships in 

which participating covered entities share protected health information to manage and 

benefit their common enterprise as “organized health care arrangements.”80 Covered 

entities in an organized health care arrangement can share protected health 

information with each other for the arrangement’s joint health care operations.81

Covered Entities With Multiple Covered Functions. A covered entity that 

performs multiple covered functions must operate its different covered functions in 

compliance with the Privacy Rule provisions applicable to those covered functions.82

The covered entity may not use or disclose the protected health information of an 

individual who receives services from one covered function (e.g., health care 

provider) for another covered function (e.g., health plan) if the individual is not 

involved with the other function. 
OCR Privacy Rule Summary 16 Last Revised 05/03 

Group Health Plan disclosures to Plan Sponsors. A group health plan and the 

health insurer or HMO offered by the plan may disclose the following protected 

health information to the “plan sponsor”—the employer, union, or other employee 

organization that sponsors and maintains the group health plan83: 

• Enrollment or disenrollment information with respect to the group health 

plan or a health insurer or HMO offered by the plan.

• If requested by the plan sponsor, summary health information for the plan 

sponsor to use to obtain premium bids for providing health insurance 

coverage through the group health plan, or to modify, amend, or terminate 

the group health plan. “Summary health information” is information that 

summarizes claims history, claims expenses, or types of claims experience of 

the individuals for whom the plan sponsor has provided health benefits 

through the group health plan, and that is stripped of all individual identifiers 

other than five digit zip code (though it need not qualify as de-identified 

protected health information).

• Protected health information of the group health plan’s enrollees for the plan 

sponsor to perform plan administration functions. The plan must receive 

certification from the plan sponsor that the group health plan document has 

been amended to impose restrictions on the plan sponsor’s use and disclosure 

of the protected health information. These restrictions must include the 

representation that the plan sponsor will not use or disclose the protected 

health information for any employment-related action or decision or in 

connection with any other benefit plan.

Other 

Provisions: 

Personal 

Representatives 

and Minors 

Personal Representatives. The Privacy Rule requires a covered entity to treat a 

"personal representative" the same 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.84 A personal representative is a person legally 

authorized to make health care decisions on an individual’s behalf or to act for a 

deceased individual or the estate. The Privacy Rule permits an exception when a 

covered entity has a reasonable belief that the personal representative may be abusing 

or neglecting the individual, or that treating the person as the personal representative 

could otherwise endanger the individual. 

Special case: Minors. In most cases, parents are the personal representatives for 

their minor children. Therefore, in most cases, parents can exercise individual rights, 

such as access to the medical record, on behalf of their minor children. In certain 

exceptional cases, the parent is not considered the personal representative. In these 

situations, the Privacy Rule defers to State and other law to determine the rights of 

parents to access and control the protected health information of their minor children. 

If State and other law is silent concerning parental access to the minor’s protected 

health information, a covered entity has discretion to provide or deny a parent access 

to the minor’s health information, provided the decision is made by a licensed health 

care professional in the exercise of professional judgment. See OCR “Personal 

Representatives” Guidance.
OCR Privacy Rule Summary 17 Last Revised 05/03 

State Law Preemption. In general, State laws that are contrary to the Privacy Rule are 

preempted by the federal requirements, which means that the federal requirements 

will apply.85 “Contrary” means that it would be impossible for a covered entity to 

comply with both the State and federal requirements, or that the provision of State 

law is an obstacle to accomplishing the full purposes and objectives of the 

Administrative Simplification provisions of HIPAA.86 The Privacy Rule provides 

exceptions to the general rule of federal preemption for contrary State laws that (1) 

relate to the privacy of individually identifiable health information and provide 

greater privacy protections or privacy rights with respect to such information, (2) 

provide for the reporting of disease or injury, child abuse, birth, or death, or for 

public health surveillance, investigation, or intervention, or (3) require certain health 

plan reporting, such as for management or financial audits. 

Exception Determination. In addition, preemption of a contrary State law will not 

occur if HHS determines, in response to a request from a State or other entity or 

person, that the State law: 

• Is necessary to prevent fraud and abuse related to the provision of or payment 

for health care,

• Is necessary to ensure appropriate State regulation of insurance and health 

plans to the extent expressly authorized by statute or regulation,

• Is necessary for State reporting on health care delivery or costs,

• Is necessary for purposes of serving a compelling public health, safety, or 

welfare need, and, if a Privacy Rule provision is at issue, if the Secretary 

determines that the intrusion into privacy is warranted when balanced against 

the need to be served; or

• Has as its principal purpose the regulation of the manufacture, registration, 

distribution, dispensing, or other control of any controlled substances (as 

defined in 21 U.S.C. 802), or that is deemed a controlled substance by State 

law.

Enforcement 

and Penalties 

for 

Noncompliance 

Compliance. Consistent with the principles for achieving compliance provided in 

the Rule, HHS will seek the cooperation of covered entities and may provide 

technical assistance to help them comply voluntarily with the Rule.87 The Rule 

provides processes for persons to file complaints with HHS, describes the 

responsibilities of covered entities to provide records and compliance reports and to 

cooperate with, and permit access to information for, investigations and compliance 

reviews. 

Civil Money Penalties. HHS may impose civil money penalties on a covered entity 

of $100 per failure to comply with a Privacy Rule requirement.88 That penalty may 

not exceed $25,000 per year for multiple violations of the identical Privacy Rule 

requirement in a calendar year. HHS may not impose a civil money penalty under 

specific circumstances, such as when a violation is due to reasonable cause and did 

not involve willful neglect and the covered entity corrected the violation within 30 

days of when it knew or should have known of the violation. 
OCR Privacy Rule Summary 18 Last Revised 05/03 

Criminal Penalties. A person who knowingly obtains or discloses individually 

identifiable health information in violation of HIPAA faces a fine of $50,000 and up 

to one-year imprisonment.89 The criminal penalties increase to $100,000 and up to 

five years imprisonment if the wrongful conduct involves false pretenses, and to 

$250,000 and up to ten years imprisonment if the wrongful conduct involves the 

intent to sell, transfer, or use individually identifiable health information for 

commercial advantage, personal gain, or malicious harm. Criminal sanctions will be 

enforced by the Department of Justice. 

Compliance 

Dates 

Compliance Schedule. All covered entities, except “small health plans,” must be 

compliant with the Privacy Rule by April 14, 2003.90 Small health plans, however, 

have until April 14, 2004 to comply. 

Small Health Plans. A health plan with annual receipts of not more than $5 million 

is a small health plan.91 Health plans that file certain federal tax returns and report 

receipts on those returns should use the guidance provided by the Small Business 

Administration at 13 Code of Federal Regulations (CFR) 121.104 to calculate annual 

receipts. Health plans that do not report receipts to the Internal Revenue Service 

(IRS), for example, group health plans regulated by the Employee Retirement Income 

Security Act 1974 (ERISA) that are exempt from filing income tax returns, should 

use proxy measures to determine their annual receipts.92

See What constitutes a small health plan?

Copies of the 

Rule & Related 

Materials 

The entire Privacy Rule, as well as guidance and additional materials, may be found 

on our website, http://www.hhs.gov/ocr/hipaa.
OCR Privacy Rule Summary 19 Last Revised 05/03 

End Notes 

 

1

 Pub. L. 104-191. 

2

 65 FR 82462. 

3

 67 FR 53182. 

4

 45 C.F.R. §§ 160.102, 160.103.

5

 Even if an entity, such as a community health center, does not meet the definition of a health 

plan, it may, nonetheless, meet the definition of a health care provider, and, if it transmits health 

information in electronic form in connection with the transactions for which the Secretary of HHS 

has adopted standards under HIPAA, may still be a covered entity. 

6

 45 C.F.R. §§ 160.102, 160.103; see Social Security Act § 1172(a)(3), 42 U.S.C. § 1320d-1(a)(3). 

The transaction standards are established by the HIPAA Transactions Rule at 45 C.F.R. Part 162. 

7

 45 C.F.R. § 160.103. 

8

 45 C.F.R. § 164.500(b). 

9

 45 C.F.R. § 160.103. 

10 45 C.F.R. §§ 164.502(e), 164.504(e). 

11 45 C.F.R. § 164.532 

12 45 C.F.R. § 160.103. 

13 45 C.F.R. § 160.103 

14 45 C.F.R. §§ 164.502(d)(2), 164.514(a) and (b). 

15 The following identifiers of the individual or of relatives, employers, or household members of 

the individual must be removed to achieve the “safe harbor” method of de-identification: (A) 

Names; (B) All geographic subdivisions smaller than a State, including street address, city, 

county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip 

code if, according to the current publicly available data from the Bureau of Census (1) the 

geographic units formed by combining all zip codes with the same three initial digits contains 

more than 20,000 people; and (2) the initial three digits of a zip code for all such geographic units 

containing 20,000 or fewer people is changed to 000; (C) All elements of dates (except year) for 

dates directly related to the individual, including birth date, admission date, discharge date, date of 

death; and all ages over 89 and all elements of dates (including year) indicative of such age, except 

that such ages and elements may be aggregated into a single category of age 90 or older; (D) 

Telephone numbers; (E) Fax numbers; (F) Electronic mail addresses: (G) Social security numbers; 

(H) Medical record numbers; (I) Health plan beneficiary numbers; (J) Account numbers; (K) 

Certificate/license numbers; (L) Vehicle identifiers and serial numbers, including license plate 

numbers; (M) Device identifiers and serial numbers; (N) Web Universal Resource Locators 

(URLs); (O) Internet Protocol (IP) address numbers; (P) Biometric identifiers, including finger 

and voice prints; (Q) Full face photographic images and any comparable images; and ® any other 

unique identifying number, characteristic, or code, except as permitted for re-identification 

purposes provided certain conditions are met. In addition to the removal of the above-stated 

identifiers, the covered entity may not have actual knowledge that the remaining information could 

be used alone or in combination with any other information to identify an individual who is 

subject of the information. 45 C.F.R. § 164.514(b). 

16 45 C.F.R. § 164.502(a). 

17 45 C.F.R. § 164.502(a)(2). 
OCR Privacy Rule Summary 20 Last Revised 05/03 

 18 45 C.F.R. § 164.502(a)(1). 

19 45 C.F.R. § 164.506(c). 

20 45 C.F.R. § 164.501. 

21 45 C.F.R. § 164.501. 

22 45 C.F.R. § 164.501. 

23 45 C.F.R. § 164.508(a)(2) 

24 45 C.F.R. § 164.506(b). 

25 45 C.F.R. § 164.510(a). 

26 45 C.F.R. § 164.510(b). 

27 45 C.F.R. §§ 164.502(a)(1)(iii). 

28 See 45 C.F.R. § 164.512. 

29 45 C.F.R. § 164.512(a). 

30 45 C.F.R. § 164.512(b). 

31 45 C.F.R. § 164.512(a), (c). 

32 45 C.F.R. § 164.512(d). 

33 45 C.F.R. § 164.512(e). 

34 45 C.F.R. § 164.512(f). 

35 45 C.F.R. § 164.512(g). 

36 45 C.F.R. § 164.512(h). 

37 The Privacy Rule defines research as, “a systematic investigation, including research 

development, testing, and evaluation, designed to develop or contribute to generalizable 

knowledge.” 45 C.F.R. § 164.501. 

38 45 C.F.R. § 164.512(i). 

39 45 CFR § 164.514(e). 

40 45 C.F.R. § 164.512(j). 

41 45 C.F.R. § 164.512(k). 

42 45 C.F.R. § 164.512(l). 

43 45 C.F.R. § 164.514(e). A limited data set is protected health information that excludes the 

following direct identifiers of the individual or of relatives, employers, or household members of 

the individual: (i) Names; (ii) Postal address information, other than town or city, State and zip 

code; (iii) Telephone numbers; (iv) Fax numbers; (v) Electronic mail addresses: (vi) Social 

security numbers; (vii) Medical record numbers; (viii) Health plan beneficiary numbers; (ix) 

Account numbers; (x) Certificate/license numbers; (xi) Vehicle identifiers and serial numbers, 

including license plate numbers; (xii) Device identifiers and serial numbers; (xiii) Web Universal 

Resource Locators (URLs); (xiv) Internet Protocol (IP) address numbers; (xv) Biometric 

identifiers, including finger and voice prints; (xvi) Full face photographic images and any 

comparable images. 45 C.F.R. § 164.514(e)(2). 

44 45 C.F.R. § 164.508. 

45 A covered entity may condition the provision of health care solely to generate protected health 

information for disclosure to a third party on the individual giving authorization to disclose the 
OCR Privacy Rule Summary 21 Last Revised 05/03 

 

information to the third party. For example, a covered entity physician may condition the 

provision of a physical examination to be paid for by a life insurance issuer on an individual’s 

authorization to disclose the results of that examination to the life insurance issuer. A health plan 

may condition enrollment or benefits eligibility on the individual giving authorization, requested 

before the individual’s enrollment, to obtain protected health information (other than 

psychotherapy notes) to determine the individual’s eligibility or enrollment or for underwriting or 

risk rating. A covered health care provider may condition treatment related to research (e.g., 

clinical trials) on the individual giving authorization to use or disclose the individual’s protected 

health information for the research. 45 C.F.R. 508(b)(4).

46 45 CFR § 164.532. 

47 “Psychotherapy notes” means notes recorded (in any medium) by a health care provider who is 

a mental health professional documenting or analyzing the contents of conversation during a 

private counseling session or a group, joint, or family counseling session and that are separated 

from the rest of the of the individual’s medical record. Psychotherapy notes excludes medication 

prescription and monitoring, counseling session start and stop times, the modalities and 

frequencies of treatment furnished, results of clinical tests, and any summary of the following 

items: diagnosis, functional status, the treatment plan, symptoms, prognosis, and progress to date. 

45 C.F.R. § 164.501. 

48 45 C.F.R. § 164.508(a)(2). 

49 45 C.F.R. §§ 164.501 and 164.508(a)(3). 

50 45 C.F.R. §§ 164.502(b) and 164.514 (d). 

51 45 C.F.R. §§ 164.520(a) and (b). A group health plan, or a health insurer or HMO with respect 

to the group health plan, that intends to disclose protected health information (including 

enrollment data or summary health information) to the plan sponsor, must state that fact in the 

notice. Special statements are also required in the notice if a covered entity intends to contact 

individuals about health-related benefits or services, treatment alternatives, or appointment 

reminders, or for the covered entity’s own fundraising. 

52 45 C.F.R. § 164.520(c). 

53 45 C.F.R. § 164.520(d). 

54 45 C.F.R. § 164.520(c). 

55 45 C.F.R. § 164.524. 

56 45 C.F.R. § 164.501. 

57 A covered entity may deny an individual access, provided that the individual is given a right to 

have such denials reviewed by a licensed health care professional (who is designated by the 

covered entity and who did not participate in the original decision to deny), when a licensed health 

care professional has determined, in the exercise of professional judgment, that: (a) the access 

requested is reasonably likely to endanger the life or physical safety of the individual or another 

person; (b) the protected health information makes reference to another person (unless such other 

person is a health care provider) and the access requested is reasonably likely to cause substantial 

harm to such other person; or (c) the request for access is made by the individual’s personal 

representative and the provision of access to such personal representative is reasonably likely to 

cause substantial harm to the individual or another person. 

A covered entity may deny access to individuals, without providing the individual an opportunity 

for review, in the following protected situations: (a) the protected health information falls under 

an exception to the right of access; (b) an inmate request for protected health information under 

certain circumstances; (c) information that a provider creates or obtains in the course of research 

that includes treatment for which the individual has agreed not to have access as part of consenting 
OCR Privacy Rule Summary 22 Last Revised 05/03 

 

to participate in the research (as long as access to the information is restored upon completion of 

the research); (d) for records subject to the Privacy Act, information to which access may be 

denied under the Privacy Act, 5 U.S.C. § 552a; and (e) information obtained under a promise of 

confidentiality from a source other than a health care provider, if granting access would likely 

reveal the source. 45 C.F.R. § 164.524. 

58 45 C.F.R. § 164.526. 

59 Covered entities may deny an individual’s request for amendment only under specified 

circumstances. A covered entity may deny the request if it: (a) may exclude the information from 

access by the individual; (b) did not create the information (unless the individual provides a 

reasonable basis to believe the originator is no longer available); (c) determines that the 

information is accurate and complete; or (d) does not hold the information in its designated record 

set. 164.526(a)(2). 

60 45 C.F.R. § 164.528. 

61 45 C.F.R. § 164.522(a). 

62 45 C.F.R. § 164.522(a). In addition, a restriction agreed to by a covered entity is not effective 

under this subpart to prevent uses or disclosures permitted or required under §§ 164.502(a)(2)(ii), 

164.510(a) or 164.512. 

63 45 C.F.R. § 164.522(b). 

64 45 C.F.R. § 164.530(i). 

65 45 C.F.R. § 164.530(a). 

66 45 C.F.R. §160.103. 

67 45 C.F.R. § 164.530(b). 

68 45 C.F.R. § 164.530(e). 

69 45 C.F.R. § 164.530(f). 

70 45 C.F.R. § 164.530(c). 

71 45 C.F.R. § 164.530(d). 

72 45 C.F.R. § 164.520(b)(1)(vi). 

73 45 C.F.R. § 164.530(g). 

74 45 C.F.R. § 164.530(h). 

75 45 C.F.R. § 164.530(j). 

76 45 C.F.R. § 164.530(k). 

77 45 C.F.R. §§ 164.103, 164.105. 

78 45 C.F.R. § 164.103. 

79 45 C.F.R. §164.105. Common ownership exists if an entity possesses an ownership or equity 

interest of five percent or more in another entity; common control exists if an entity has the direct 

or indirect power significantly to influence or direct the actions or policies of another entity. 45 

C.F.R. §§ 164.103. 

80 The Privacy Rule at 45 C.F.R. § 160.103 identifies five types of organized health care 

arrangements: 

• A clinically-integrated setting where individuals typically receive health care from more 

than one provider. 

• An organized system of health care in which the participating covered entities hold 

themselves out to the public as part of a joint arrangement and jointly engage in 
OCR Privacy Rule Summary 23 Last Revised 05/03 

 

utilization review, quality assessment and improvement activities, or risk-sharing 

payment activities. 

• A group health plan and the health insurer or HMO that insures the plan’s benefits, with 

respect to protected health information created or received by the insurer or HMO that 

relates to individuals who are or have been participants or beneficiaries of the group 

health plan. 

• All group health plans maintained by the same plan sponsor. 

• All group health plans maintained by the same plan sponsor and all health insurers and 

HMOs that insure the plans’ benefits, with respect to protected health information created 

or received by the insurers or HMOs that relates to individuals who are or have been 

participants or beneficiaries in the group health plans. 

81 45 C.F.R. § 164.506(c)(5). 

82 45 C.F.R. § 164.504(g). 

83 45 C.F.R. § 164.504(f). 

84 45 C.F.R. § 164.502(g). 

85 45 C.F.R. §160.203. 

86 45 C.F.R. § 160.202. 

87 45 C.F.R.§ 160.304 

88 Pub. L. 104-191; 42 U.S.C. §1320d-5. 

89 Pub. L. 104-191; 42 U.S.C. §1320d-6. 

90 45 C.F.R. § 164.534. 

91 45 C.F.R. § 160.103. 

92 Fully insured health plans should use the amount of total premiums that they paid for health 

insurance benefits during the plan’s last full fiscal year. Self-insured plans, both funded and 

unfunded, should use the total amount paid for health care claims by the employer, plan sponsor or 

benefit fund, as applicable to their circumstances, on behalf of the plan during the plan’s last full 

fiscal year. Those plans that provide health benefits through a mix of purchased insurance and 

self-insurance should combine proxy measures to determine their total annual receipts.