www.hhs.gov Open in urlscan Pro
2a02:26f0:ea:48f::219c  Public Scan

Form analysis
1 forms found in the DOM

Name: HHS — GET //search.hhs.gov/searchblox/ocr_hipaa/index.html

<form name="HHS" method="get" action="//search.hhs.gov/searchblox/ocr_hipaa/index.html">
  <label class="sr-only" for="global-search">Search</label>
  <div class="auto-suggest">
    <input type="text" name="query" class="global-search" maxlength="256" autocomplete="off" placeholder="I'm looking for..." value="" id="global-search" title="Search Text">
    <input type="submit" class="global-search-btn" name="HHS" id="HHS" alt="Search" value="Search">
  </div>
  <input type="hidden" name="page" value="1">
  <input type="hidden" name="pagesize" value="10">
  <input type="hidden" name="sortdir" value="desc">
  <input type="hidden" name="sort" value="relevance">
  <input type="hidden" name="adsCol" value="38">
  <input type="hidden" name="adsDisplay" value="false">
  <input type="hidden" name="col" value="38">
  <input type="hidden" name="default" value="AND">
  <input type="hidden" name="tune" value="true">
  <input type="hidden" name="tune.0" value="60">
  <input type="hidden" name="tune.1" value="40">
  <input type="hidden" name="tune.2" value="15">
  <input type="hidden" name="tune.3" value="1">
  <input type="hidden" name="tune.4" value="75">
  <input type="hidden" name="tune.5" value="20">
</form>

Text Content

Skip to main content
 
HHS.gov Health Information Privacy
Search
U.S. Department of Health & Human Services
Menu
 * HIPAA for Individuals
 * Filing a Complaint
 * HIPAA for Professionals
 * Newsroom

Search

Close
A-Z Index
 * HIPAA for Individuals
 * Filing a Complaint
 * HIPAA for Professionals
 * Newsroom


BREADCRUMB

HHS > HIPAA Home > For Professionals > Privacy > Summary of the HIPAA Privacy
Rule

 * Text Resize A A A
 * Print
 * Share


LEFT NAV: /HIPAA/FOR-PROFESSIONALS

 * HIPAA for Professionals
 * Regulatory Initiatives
 * Privacy has sub items, about Privacy
   * Summary of the Privacy Rule
   * Guidance
   * Combined Text of All Rules
   * HIPAA Related Links
 * Security has sub items, about Security
   * Summary of the Security Rule
   * Security Guidance
   * Cyber Security Guidance
 * Breach Notification has sub items, about Breach Notification
   * Breach Reporting
   * Guidance
   * Reports to Congress
   * Regulation History
 * Compliance & Enforcement has sub items, about Compliance & Enforcement
   * Enforcement Rule
   * Enforcement Process
   * Enforcement Data
   * Resolution Agreements
   * Case Examples
   * Audit
   * Reports to Congress
   * State Attorneys General
 * Special Topics has sub items, about Special Topics
   * HIPAA and COVID-19
   * Gender Affirming Care, Civil Rights, and Privacy
   * HIPAA and Reproductive Health
   * HIPAA and Telehealth
   * HIPAA and FERPA
   * Mental Health & Substance Use Disorders
   * Research
   * Public Health
   * Emergency Response
   * Health Information Technology
   * Health Apps
 * Patient Safety has sub items, about Patient Safety
   * Statute & Rule
     * PSQIA Statute
     * Patient Safety Rule
   * Enforcement
   * Guidance
 * Covered Entities & Business Associates has sub items, about Covered Entities
   & Business Associates
   * Business Associate Contracts
   * Business Associates
 * Training & Resources
 * FAQs for Professionals
 * Other Administrative Simplification Rules

SUMMARY OF THE HIPAA PRIVACY RULE

This is a summary of key elements of the Privacy Rule including who is covered,
what information is protected, and how protected health information can be used
and disclosed.  Because it is an overview of the Privacy Rule, it does not
address every detail of each provision.

Summary of the Privacy Rule PDF - PDF


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 the end notes.
   Visit our  Privacy Rule section to view the entire Rule, and for other
   additional helpful information about how the Rule applies. In the event of a
   conflict between this summary and the Rule, the Rule governs.

Statutory and 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 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.

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 CMS's decision
tool.

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 government-funded 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. If an insurance entity has separable lines of business, one of which
is a health plan, the HIPAA regulations apply to the entity with respect to the
health plan line of business.

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.
 

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
non-workforce 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 had an existing written contract or agreement with business associates
prior to October 15, 2002, which was not renewed or modified prior to April 14,
2003, were permitted to continue to operate under that contract until they
renewed the contract or April 14, 2004, whichever was first.11   See additional
guidance on  Business Associates and  sample business associate contract
language.
 

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

“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 it 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
additional guidance on  Government Access.

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 (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 additional guidance on  Treatment, Payment, & Health Care Operations.


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.

(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 additional guidance on
Incidental Uses and Disclosures.

(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
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
post-marketing 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 additional guidance on
 Public Health Activities and CDC's web pages on 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

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
additional guidance on  Research and NIH's publication of "Protecting Personal
Health Information in Research: Understanding the HIPAA Privacy Rule." - PDF

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

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 additional guidance on  Workers’ Compensation.

(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
   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 additional guidance on  Marketing.

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 additional guidance on  Minimum
Necessary.

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 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 additional guidance on Notice.

 * Notice Distribution. A covered health care provider with a direct treatment
   relationship with individuals must have delivered a privacy practices notice
   to patients starting April 14, 2003 as follows:
   * 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);
   * 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
   * In emergency treatment situations, the provider must furnish its notice as
     soon as practicable after the emergency abates.

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 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.

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 additional guidance
on  Incidental Uses and Disclosures.

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 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.

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
additional guidance on  Personal Representatives.

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. The Standards for Privacy of Individually Identifiable Health
Information (Privacy Rule) establishes a set of national standards for the use
and disclosure of an individual’s health information – called protected health
information – by covered entities, as well as standards for providing
individuals with privacy rights to understand and control how their health
information is used.  The Department of Health and Human Services, Office for
Civil Rights (OCR) is responsible for administering and enforcing these
standards and may conduct complaint investigations and compliance reviews.

Consistent with the principles for achieving compliance provided in the Privacy
Rule, OCR will seek the cooperation of covered entities and may provide
technical assistance to help them comply voluntarily with the Privacy Rule. 
Covered entities that fail to comply voluntarily with the standards may be
subject to civil money penalties.  In addition, certain violations of the
Privacy Rule may be subject to criminal prosecution.  These penalty provisions
are explained below.

Civil Money Penalties.  OCR may impose a penalty on a covered entity for a
failure to comply with a requirement of the Privacy Rule.  Penalties will vary
significantly depending on factors such as the date of the violation, whether
the covered entity knew or should have known of the failure to comply, or
whether the covered entity’s failure to comply was due to willful neglect. 
Penalties may not exceed a calendar year cap for multiple violations of the same
requirement.

Category

For violations occurring prior to 2/18/2009

For violations occurring on or after 2/18/2009

Penalty Amount

Up to $100

per violation

$100 to $50,000 or more

per violation

Calendar Year Cap

$25,000

$1,500,000

 

A penalty will not be imposed for violations in certain circumstances, such as
if:

 * the failure to comply was not due to willful neglect, and was corrected
   during a 30-day period after the entity knew or should have known the failure
   to comply had occurred (unless the period is extended at the discretion of
   OCR); or
 * the Department of Justice has imposed a criminal penalty for the failure to
   comply (see below).

In addition, OCR may choose to reduce a penalty if the failure to comply was due
to reasonable cause and the penalty would be excessive given the nature and
extent of the noncompliance. 

Before OCR imposes a penalty, it will notify the covered entity and provide the
covered entity with an opportunity to provide written evidence of those
circumstances that would reduce or bar a penalty.  This evidence must be
submitted to OCR within 30 days of receipt of the notice.  In addition, if OCR
states that it intends to impose a penalty, a covered entity has the right to
request an administrative hearing to appeal the proposed penalty.

Criminal Penalties.  A person who knowingly obtains or discloses individually
identifiable health information in violation of the Privacy Rule may face a
criminal penalty of up to $50,000 and up to one-year imprisonment.  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 10 years
imprisonment if the wrongful conduct involves the intent to sell, transfer, or
use identifiable health information for commercial advantage, personal gain or
malicious harm.  The Department of Justice is responsible for criminal
prosecutions under the Priv

Compliance Dates

Compliance Schedule. All covered entities, except “small health plans,” must
have been compliant with the Privacy Rule by April 14, 2003.90 Small health
plans, however, had 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.92See What constitutes a small health plan?

Copies of the Rule & Related Materials

See our  Combined Regulation Text of All Rules section of our site for the full
suite of HIPAA Administrative Simplification Regulations and  Understanding
HIPAA for additional guidance material.

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).
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 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 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 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.

Frequently Asked Questions for Professionals - Please see the HIPAA FAQs for
additional guidance on health information privacy topics.

Content created by Office for Civil Rights (OCR)
Content last reviewed July 26, 2013



CONNECT WITH OCR




SIGN UP FOR OCR UPDATES

To sign up for updates or to access your subscriber preferences, please enter
your contact information below.

Sign Up


OFFICE FOR CIVIL RIGHTS HEADQUARTERS

U.S. Department of Health & Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Toll Free Call Center: 1-800-368-1019
TTD Number: 1-800-537-7697

 * Contact HHS
 * Careers
 * HHS FAQs
 * Nondiscrimination Notice

 * HHS Archive
 * Accessibility
 * Privacy Policy
 * Viewers & Players

 * Budget/Performance
 * Guidance Portal
 * Inspector General
 * EEO/No Fear Act

 * FOIA
 * The White House
 * USA.gov
 * Vulnerability Disclosure Policy


Back to Top
Building Preview ...