HIPAA Privacy Rule and Public Health

Guidance from CDC and the U.S. Department of Health and Human Services*

The material in this report originated in the Epidemiology Program Office, Stephen B. Thacker, M.D., M.Sc., Director.

Summary

New national health information privacy standards have been issued by the U.S. Department of Health and Human Services (DHHS), pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The new regulations provide protection for the privacy of certain individually identifiable health data, referred to as protected health information (PHI). Balancing the protection of individual health information with the need to protect public health, the Privacy Rule expressly permits disclosures without individual authorization to public health authorities authorized by law to collect or receive the information for the purpose of preventing or controlling disease, injury, or disability, including but not limited to public health surveillance, investigation, and intervention.

Public health practice often requires the acquisition, use, and exchange of PHI to perform public health activities (e.g., public health surveillance, program evaluation, terrorism preparedness, outbreak investigations, direct health services, and public health research). Such information enables public health authorities to implement mandated activities (e.g., identifying, monitoring, and responding to death, disease, and disability among populations) and accomplish public health objectives. Public health authorities have a long history of respecting the confidentiality of PHI, and the majority of states as well as the federal government have laws that govern the use of, and serve to protect, identifiable information collected by public health authorities.

The purpose of this report is to help public health agencies and others understand and interpret their responsibilities under the Privacy Rule. Elsewhere, comprehensive DHHS guidance is located at the HIPAA website of the Office for Civil Rights (http://www.hhs.gov/ocr/hipaa/).

Introduction

The shift of medical records from paper to electronic formats has increased the potential for individuals to access, use, and disclose sensitive personal health data. Although protecting individual privacy is a long-;standing tradition among health-;care providers and public health practitioners in the United States, previous legal protections at the federal, tribal, state, and local levels were inconsistent and inadequate. A patchwork of laws provided narrow privacy protections for selected health data and certain keepers of that data (1).

The U.S. Department of Health and Human Services (DHHS) has addressed these concerns with new privacy standards that set a national minimum of basic protections, while balancing individual needs with those of society. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was adopted to ensure health insurance coverage after leaving an employer and also to provide standards for facilitating health-;care--related electronic transactions. To improve the efficiency and effectiveness of the health-care system, HIPAA included administrative simplification provisions that required DHHS to adopt national standards for electronic health-care transactions (2). At the same time, Congress recognized that advances in electronic technology could erode the privacy of health information. Consequently, Congress incorporated into HIPAA provisions that mandated adoption of federal privacy protections for certain individually identifiable health information.

The HIPAA Privacy Rule (Standards for Privacy of Individually Identifiable Health Information) (3) provides the first national standards for protecting the privacy of health information. The Privacy Rule regulates how certain entities, called covered entities, use and disclose certain individually identifiable health information, called protected health information (PHI). PHI is individually identifiable health information that is transmitted or maintained in any form or medium (e.g., electronic, paper, or oral), but excludes certain educational records and employment records. Among other provisions, the Privacy Rule

• gives patients more control over their health information;
• sets boundaries on the use and release of health records;
• establishes appropriate safeguards that the majority of health-;care providers and others must achieve to protect the privacy of health information;
• holds violators accountable with civil and criminal penalties that can be imposed if they violate patients' privacy rights;
• strikes a balance when public health responsibilities support disclosure of certain forms of data;
• enables patients to make informed choices based on how individual health information may be used;
• enables patients to find out how their information may be used and what disclosures of their information have been made;
• generally limits release of information to the minimum reasonably needed for the purpose of the disclosure;
• generally gives patients the right to obtain a copy of their own health records and request corrections; and
• empowers individuals to control certain uses and disclosures of their health information.

The deadline to comply with the Privacy Rule is April 14, 2003, for the majority of the three types of covered entities specified by the rule [45 CFR § 160.102]. The covered entities are

• health plans,
• health-;care clearinghouses, and
• health-;care providers who transmit health information in electronic form in connection with certain transactions.

At DHHS, the Office for Civil Rights (OCR) has oversight and enforcement responsibilities for the Privacy Rule. Comprehensive guidance and OCR answers to hundreds of questions are available at http://www.hhs.gov/ocr/hipaa (4).

Impact on Public Health

Public health practice and research, including such traditional public health activities as program operations, public health surveillance, program evaluation, terrorism preparedness, outbreak investigations, direct health services, and public health research, use PHI to identify, monitor, and respond to disease, death, and disability among populations. Public health authorities have a long history of protecting and preserving the confidentiality of individually identifiable health information. They also recognize the importance of protecting individual privacy and respecting individual dignity to maintaining the quality and integrity of health data. CDC and others have worked to consistently strengthen federal and state public health information privacy practices and legal protections (5).

DHHS recognized the importance of sharing PHI to accomplish essential public health objectives and to meet certain other societal needs (e.g., administration of justice and law enforcement). Therefore, the Privacy Rule expressly permits PHI to be shared for specified public health purposes. For example, covered entities may disclose PHI, without individual authorization, to a public health authority legally authorized to collect or receive the information for the purpose of preventing or controlling disease, injury, or disability [45 CFR § 164.512(b)] (Box 1). Further, the Privacy Rule permits covered entities to make disclosures that are required by other laws, including laws that require disclosures for public health purposes.

Thus, the Privacy Rule provides for the continued functioning of the U.S public health system. Covered entities should become fully aware of the scope of permissible disclosures for public health activities as well as state and local reporting laws and regulations. Moreover, a public health authority may also be a covered entity. For example, a public health agency that operates a health clinic, providing essential health-;care services and performing covered transactions electronically, is a covered entity.

This report provides guidance to public health authorities and their authorized agents, researchers, and health-;care providers in interpreting the Privacy Rule as it affects public health. CDC recommends that public health authorities share the information in this report with covered health-;care providers and other covered entities and work closely with those entities to ensure implementation of the rule consistent with its intent to protect privacy while permitting authorized public health activities to continue.

Overview of the Privacy Rule

Who Is Covered

The authority of DHHS to issue health-;information privacy regulations was limited by Congress in HIPAA to a defined set of covered entities. More complete definitions of these, and other terms, are located elsewhere in this report (Appendix A). Covered entities are as follows:

• Health plans. An individual or group plan that provides, or pays the cost of, medical care that includes the diagnosis, cure, mitigation, treatment, or prevention of disease. Health plans include private entities (e.g., health insurers and managed care organizations) and government organizations (e.g., Medicaid, Medicare, and the Veterans Health Administration).
• Health-;care clearinghouses. A public or private entity, including a billing service, repricing company, or community health information system, that processes nonstandard data or transactions received from another entity into standard transactions or data elements, or vice versa.
• Health-;care providers. A provider of health-;care services and any other person or organization that furnishes, bills, or is paid for health care in the normal course of business. Health-;care providers (e.g., physicians, hospitals, and clinics) are covered entities if they transmit health information in electronic form in connection with a transaction for which a HIPAA standard has been adopted by DHHS.

The Privacy Rule also establishes requirements for covered entities with regard to their nonemployee business associates (e.g., lawyers, accountants, billing companies, and other contractors) whose relationship with covered entities requires sharing of PHI. The Privacy Rule allows a covered provider or health plan to disclose PHI to a business associate if satisfactory written assurance is obtained that the business associate will use the information only for the purposes for which it was engaged, will safeguard the information from misuse, and will help the covered entity comply with certain of its duties under the Privacy Rule.

The Privacy Rule does not apply to all persons or entities that regularly use, disclose, or store individually identifiable health information. For example, the Privacy Rule does not cover employers, certain insurers (e.g., auto, life, and worker compensation), or those public agencies that deliver social security or welfare benefits, when functioning solely in these capacities.

Types of Health Information

Protected Health Information

The Privacy Rule protects certain information that covered entities use and disclose. This information is called protected health information (PHI), which is generally individually identifiable health information that is transmitted by, or maintained in, electronic media or any other form or medium. This information must relate to 1) the past, present, or future physical or mental health, or condition of an individual; 2) provision of health care to an individual; or 3) payment for the provision of health care to an individual. If the information identifies or provides a reasonable basis to believe it can be used to identify an individual, it is considered individually identifiable health information.

De-;Identified Information

De-;identified data (e.g., aggregate statistical data or data stripped of individual identifiers) require no individual privacy protections and are not covered by the Privacy Rule. De-;identifying can be conducted through

• statistical de-;identification --- a properly qualified statistician using accepted analytic techniques concludes the risk is substantially limited that the information might be used, alone or in combination with other reasonably available information, to identify the subject of the information [45 CFR § 164.514(b)]; or the
• safe-;harbor method --- a covered entity or its business associate de-;identifies information by removing 18 identifiers (Box 2) and the covered entity does not have actual knowledge that the remaining information can be used alone or in combination with other data to identify the subject [45 CFR § 164.514(b)].

In certain instances, working with de-;identified data may have limited value to clinical research and other activities. When that is the case, a limited data set may be useful.

Limited Data Sets

Health information in a limited data set is not directly identifiable, but may contain more identifiers than de-identified data that has been stripped of the 18 identifiers [45 CFR § 164.514] (Box 3). A data-;use agreement must establish who is permitted to use or receive the limited data set, and provide that the recipient will

• not use or disclose the information other than as permitted by the agreement or as otherwise required by law;
• use appropriate safeguards to prevent uses or disclosures of the information that are inconsistent with the data-use agreement;
• report to the covered entity any use or disclosure of the information, in violation of the agreement, of which it becomes aware;
• ensure that any agents to whom it provides the limited data set agree to the same restrictions and conditions that apply to the limited data set recipient with respect to such information; and
• not attempt to re-identify the information or contact the individual.

What is Required

For covered entities using or disclosing PHI, the Privacy Rule establishes a range of health-;information privacy requirements and standards that attempt to balance individual privacy interests with the community need to use such data [45 CFR § 164.504]. Among its provisions, the Privacy Rule requires covered entities to

• notify individuals regarding their privacy rights and how their PHI is used or disclosed;
• adopt and implement internal privacy policies and procedures;
• train employees to understand these privacy policies and procedures as appropriate for their functions within the covered entity;
• designate individuals who are responsible for implementing privacy policies and procedures, and who will receive privacy-related complaints;
• establish privacy requirements in contracts with business associates that perform covered functions;
• have in place appropriate administrative, technical, and physical safeguards to protect the privacy of health information; and
• meet obligations with respect to health consumers exercising their rights under the Privacy Rule.

With respect to individuals, they are vested with the following rights:

• Receive access to PHI. Individual rights include inspections of records and the provision for copies of PHI about the individual in a designated record set, for as long as the PHI is maintained in the designated record set, except for psychotherapy notes, information complied for use in civil, criminal, or administrative actions, and PHI maintained by a covered entity subject to the Clinical Laboratory Improvement Amendments of 1988 [42 CFR § 263(a)]. In the majority of cases, covered entities must accommodate a request or provide a process of denial, subject to review [45 CFR § 164.524].
• Request amendments to PHI. Individuals can request that covered entities amend PHI about the individual in a designated record set for as long as the PHI is maintained in a designated record set. If the covered entity agrees to the amendment, it must 1) identify the records affected; 2) append or provide a link to the amendment; 3) inform the individual the amendment has been made; and 4) work with other covered entities or business associates who possess or receive the data to make the amendments [45 CFR § 164.526]. If the covered entity denies this request, the Privacy Rule provides a process for contesting the denial [45 CFR § 164.526].
• Receive adequate notice. With limited exceptions, individuals have the right to receive a notice of the uses and disclosures the covered entity will make of their PHI, their rights under the Privacy Rule, and the covered entity's obligations with respect to that information. In certain cases, notice may be provided electronically. The notice must be in plain language (e.g., "your health information may be shared with public health authorities for public health purposes . . ." ) and posted where it is likely to be seen by patients [45 CFR § 164.520].
• Receive an accounting of disclosures. Upon request, covered entities are required to provide individuals with an accounting for certain types of disclosures of PHI, although the rule contains certain exceptions, including disclosures with individual authorization, disclosures related to providers' treatment, payment and health-;care operations (TPO), and other exceptions. A typical a ccounting includes the name of the person or entity who received the information, date of the disclosure, a brief description of the information disclosed, and a brief e xplanation of the reasons for disclosure or copy of the request [45 CFR § 164.528]. However, requirements for accounting of public health disclosures may vary (see Accounting for Public Health Disclosures).
• Request restrictions. Individuals have the right to request a restriction on certain uses or disclosures of their PHI; however, the covered entity is not obligated to agree to such a request. If the covered entity does agree to a restriction, it must generally abide by the agreement, except for emergency treatment situations. But such an agreement is not effective to prevent certain permitted uses or disclosures [CFR 45 § 164.512].

Required PHI Disclosures

A covered entity is required by the Privacy Rule to disclose PHI in only two instances: 1) when an individual has a right to access an accounting of his or her PHI (see previous paragraph); and 2) when DHHS needs PHI to determine compliance with the Privacy Rule [45 CFR § 164.502(a)(2)]. Certain other uses and disclosures of PHI may be permitted without authorization, but are not required by the Privacy Rule. However, other federal, tribal, state, or local laws may compel disclosure.

Permitted PHI Disclosures Without Authorization

The Privacy Rule permits a covered entity to use and disclose PHI, with certain limits and protections, for TPO activities [45 CFR § 164.506]. Certain other permitted uses and disclosures for which authorization is not required follow. Additional requirements and conditions apply to these disclosures. The Privacy Rule text and OCR guidance should be consulted for a full understanding of the following:

• Required by law. Disclosures of PHI are permitted when required by other laws, whether federal, tribal, state, or local.
• Public health. PHI can be disclosed to public health authorities and their authorized agents for public health purposes including but not limited to public health surveillance, investigations, and interventions.
• Health research. A covered entity can use or disclose PHI for research without authorization under certain conditions, including 1) if it obtains documentation of a waiver from an institutional review board (IRB) or a privacy board, according to a series of considerations; 2) for activities preparatory to research; and 3) for research on a decedent's information.
• Abuse, neglect, or domestic violence. PHI may be disclosed to report abuse, neglect, or domestic violence under specified circumstances.
• Law enforcement. Covered entities may, under specified conditions, disclose PHI to law enforcement officials pursuant to a court order, subpoena, or other legal order, to help identify and locate a suspect, fugitive, or missing person; to provide information related to a victim of a crime or a death that may have resulted from a crime, or to report a crime.
• Judicial and administrative proceedings. A covered entity may disclose PHI in the course of a judicial or administrative proceeding under specified circumstances.
• Cadaveric organ, eye, or tissue donation purposes. Organ-;procurement agencies may use PHI for the purposes of facilitating transplant.
• Oversight. Covered entities may usually disclose PHI to a health oversight agency for oversight activities authorized by law.
• Worker's compensation. The Privacy Rule permits disclosure of work-;related health information as authorized by, and to the extent necessary to comply with, workers' compensation programs.

Other Authorized Disclosures

A valid authorization is required for any use or disclosure of PHI that is not required or otherwise permitted without authorization by the Privacy Rule. In general, these authorizations must

• specifically identify the PHI to be used or disclosed;
• provide the names of persons or organizations, or classes of persons or organizations, who will receive, use, or disclose the PHI;
• state the purpose for each request;
• notify individuals of their right to refuse to sign the authorization without negative consequences to treatment, payment, or health plan enrollment or benefit eligibility, except under specific circumstances;
• be signed and dated by the individual or the individual's personal representative;
• be written in plain language;
• include an expiration date or event;
• notify the individual of the right to revoke authorization at any time in writing, and how to exercise that right, and any applicable exceptions to that right under the Privacy Rule; and
• explain the potential for the information to be subject to redisclosure by recipient and no longer protected by the Privacy Rule.

The Privacy Rule and Public Health

The Privacy Rule recognizes 1) the legitimate need for public health authorities and others responsible for ensuring the public's health and safety to have access to PHI to conduct their missions; and 2) the importance of public health reporting by covered entities to identify threats to the public and individuals. Accordingly, the rule 1) permits PHI disclosures without a written patient authorization for specified public health purposes to public health authorities legally authorized to collect and receive the information for such purposes, and 2) permits disclosures that are required by state and local public health or other laws. However, because the Privacy Rule affects the traditional ways PHI is used and exchanged among covered entities (e.g., doctors, hospitals, and health insurers), it can affect public health practice and research in multiple ways. To prevent misconceptions, understanding the Privacy Rule is important for public health practice. Some illustrative examples are presented in this report (Box 4). Also provided are sample letters that might prove useful in clarifying relationships involving public health and the Privacy Rule (Appendix B).

A public health authority is broadly defined as including agencies or authorities of the United States, states, territories, political subdivisions of states or territories, American Indian tribes, or an individual or entity acting under a grant of authority from such agencies and responsible for public health matters as part of an official mandate. Public health authorities include federal public health agencies (e.g., CDC, National Institutes of Health [NIH], Health Resources and Services Administration [HRSA], Substance Abuse and Mental Health Services Administration [SAMHSA], Food and Drug Administration [FDA], or Occupational Safety and Health Administration [OSHA]); tribal health agencies; state public health agencies (e.g., public health departments or divisions, state cancer registries, and vital statistics departments); local public health agencies; and anyone performing public health functions under a grant of authority from a public health agency [45 CFR § 164.501].

Public health agencies often conduct their authorized public health activities with other entities by using different mechanisms (e.g., contracts and memoranda or letters of agreement). These other entities are public health authorities under the Privacy Rule with respect to the activities they conduct under a grant of authority from such a public health agency. A covered entity may disclose PHI to public health authorities and to these designated entities pursuant to the public health provisions of the Privacy Rule.

The Privacy Rule permits covered entities to disclose PHI, without authorization, to public health authorities or other entities who are legally authorized to receive such reports for the purpose of preventing or controlling disease, injury, or disability. This includes the reporting of disease or injury; reporting vital events (e.g., births or deaths); conducting public health surveillance, investigations, or interventions; reporting child abuse and neglect; and monitoring adverse outcomes related to food (including dietary supplements), drugs, biological products, and medical devices [45 CFR 164.512(b)]. Covered entities may report adverse events related to FDA-regulated products or activities to public agencies and private entities that are subject to FDA jurisdiction [45 CFR 164.512(b)(1)(iii)]. To protect the health of the public, public health authorities might need to obtain information related to the individuals affected by a disease. In certain cases, they might need to contact those affected to determine the cause of the disease to allow for actions to prevent further illness. Also, covered entities may, at the direction of a public health authority, disclose protected health information to a foreign government agency that is acting in collaboration with a public health authority [45 CFR 164.512(b)(1)(i)].

To receive PHI for public health purposes, public health authorities should be prepared to verify their status and identity as public health authorities under the Privacy Rule. To verify its identity, an agency could provide any one of the following:

• if the request is made in person, presentation of an agency identification badge, other official credentials, or other proof of government status;
• if the request is in writing, the request is on the appropriate government letterhead;
• if the disclosure is to a person acting on behalf of a public health authority, a written statement on appropriate government letterhead that the person is acting under the government's authority [45 CFR § 164.514(h)(2)].

Public health authorities receiving information from covered entities as required or authorized by law [45 CFR 164.512(a)] [45 CFR 164.512(b)] are not business associates of the covered entities and therefore are not required to enter into business associate agreements. Public health authorities that are not covered entities also are not required to enter into business associate agreements with their public health partners and contractors. Also, after PHI is disclosed to a public health authority pursuant to the Privacy Rule, the public health authority (if it is not a covered entity) may maintain, use, and disclose the data consistent with the laws, regulations, and policies applicable to the public health authority.

Disclosures for Public Health Purposes

The Privacy Rule allows covered entities to disclose PHI to public health authorities when required by federal, tribal, state, or local laws [45 CFR 164.512(a)]. This includes state laws (or state procedures established under such law) that provide for receiving reporting of disease or injury, child abuse, birth, or death, or conducting public health surveillance, investigation, or intervention.

For disclosures not required by law, covered entities may still disclose, without authorization, to a public health authority authorized by law to collect or receive the information for the purpose of preventing or controlling disease, injury, or disability, the minimum necessary information to accomplish the intended public health purpose of the disclosure [45 CFR 164.512 (b)] (Box 1).

For example, to protect the health of the public, public health officials might need to obtain information related to persons affected by a disease. In certain cases, they might need to contact those affected to determine the cause of the disease to allow for actions to prevent further illness. The Privacy Rule continues to allow for the existing practice of sharing PHI with public health authorities who are authorized by law to collect or receive such information to aid them in their mission of protecting the health of the public. Examples of such activities include those directed at the reporting of disease or injury, reporting adverse events, reporting births and deaths, and investigating the occurrence and cause of injury and disease (1).

Although it is not a defined term, DHHS interpreted the phrase "authorized by law" to mean that a legal basis exists for the activity. Further, DHHS called the phrase "a term of art," including both actions that are permitted and actions that are required by law [64 FR 59929, November 3, 1999]. This does not mean a public health authority at the federal, tribal, state, or local level must have multiple disease or condition-;specific laws that authorize each collection of information. Public health authorities operate under broad mandates to protect the health of their constituent populations.

Requirements for Covered Entities

Accounting for Public Health Disclosures

Although the Privacy Rule permits disclosures of PHI to public health authorities, covered entities must comply with certain requirements related to these disclosures. One such requirement is that a covered entity must be able to provide an individual, upon request, with an accounting of certain disclosures of PHI. The covered entity is not required to account for all disclosures of PHI. For example, an accounting is not required for disclosures made

• prior to the covered entity's compliance date;
• for TPO purposes;
• to the individual or pursuant to the individual's written authorization; or
• as part of a limited data set.

However, usually an accounting is required for disclosures made without authorization, including public health purposes.

The required accounting for disclosures may be accomplished in different ways. Typically, the covered entity must provide the individual with an accounting of each disclosure by date, the PHI disclosed, the identity of the recipient of the PHI, and the purpose of the disclosure. However, where the covered entity has, during the accounting period, made multiple disclosures to the same recipient for the same purpose, the Privacy Rule provides for a simplified means of accounting. In such cases, the covered entity need only identify the recipient of such repetitive disclosures, the purpose of the disclosure, and describe the PHI routinely disclosed. The date of each disclosure need not be tracked. Rather, the accounting may include the date of the first and last such disclosure during the accounting period, and a description of the frequency or periodicity of such disclosures. For example, the vast amount of data exchanged between covered entities and public health authorities is made through ongoing, regular reporting or inspection requirements. A covered health-care provider may routinely report all cases of measles it diagnoses to the local public health authority. An accounting of such disclosures to a requesting individual would need to identify the local public health authority receiving the PHI, the PHI disclosed, the purpose of the disclosure (required for communicable disease surveillance), the periodicity (weekly), and the first and last dates of such disclosures during the accounting period (May 1, 2003 to June 1, 2003). Thus, the covered entity would not need to annotate each patient's medical record whenever a routine public health disclosure was made.

Notice of Privacy Practices

With certain exceptions, under the Privacy Rule, individuals have the right to adequate notice of the uses and disclosures of PHI that may be made by the covered entity, as well as their rights and the covered entity's legal obligations. Notices must be in plain language and clearly posted. Certain covered entities must make a good faith effort to obtain an individual's acknowledgment of receipt of this notice. In certain cases, notice may be provided electronically.

Minimum Necessary Standard

The Privacy Rule usually directs covered entities to limit the amount of information disclosed to the minimum necessary to achieve the specified goal [45 CFR § 164.514(d)(1)]. This requirement usually applies to disclosures to a public health agency. It would not apply, however, if the disclosure were required by law, authorized by the individual, or for treatment purposes. A covered entity may also reasonably rely on a public official's determination that the information requested is the minimum necessary for the public health purpose.

Public Health Authorities Performing Covered Functions

Public health authorities at the federal, tribal, state, or local levels that perform covered functions (e.g., providing health care or insuring individuals for health-;care costs), may be subject to the Privacy Rule's provisions as covered entities. For example, a local public health authority that operates a health clinic providing essential health-;care services to low-;income persons and performs certain electronic transactions might be defined under the Privacy Rule as a covered health-;care provider and therefore a covered entity. Flow charts and interactive tools designed to help determine covered entity status are provided online by the Centers for Medicare and Medicaid Services, available at http://www.cms.gov/hipaa/hipaa2/support/tools/decisionsupport/default.asp.

The following are examples of public health authority functions that make them covered entities:

• Public health authorities as covered health-;care providers. A public health authority that conducts health care as part of its activities is a covered health-;care provider if it also performs electronic transactions covered by the HIPAA Transactions Rule as part of these activities. The fact that these activities are conducted in pursuit of a public health goal (e.g., vaccinating children or screening a targeted population for sexually transmitted diseases) does not preclude the public health authority from being a covered entity.
• Public health authorities as health plans. Under the Privacy Rule, a health plan is an individual or group plan that provides, or pays the cost of, medical care. This specifically includes government health plans (e.g., Medicare, Medicaid, or Veterans Health Administration). However, the Privacy Rule defines health plan to exclude government-funded programs whose principal activity is the direct provision of health care to persons or the making of grants to fund the direct provision of health care to persons [45 CFR § 160.103]. Examples include the Ryan White Comprehensive AIDS Resources Emergency Act. Although certain government programs that fund providers directly may not be health plans, government programs that reimburse providers or otherwise fund providers to perform direct health-;care services should carefully analyze the details of their programs to determine if they are performing covered functions.
• Public health authorities as health-;care clearinghouses. Although unlikely, a public health authority might be a health-;care clearinghouse if it receives health information from another entity and translates that information from a nonstandard format into a standard transaction or standard data elements (or vice versa). Operators of community health information systems should carefully consider whether they meet the definition for a health-;care clearinghouse.
• Public health agencies as hybrid entities. A public health agency that is a covered entity, and has both covered and noncovered functions may become a hybrid entity by designating its health-care components. By designating itself as a hybrid entity, a public health authority can carve out its noncovered functions, so that the majority of Privacy Rule provisions apply only to its health-care component, which is required to comply with the Privacy Rule requirements, including using and disclosing PHI only as authorized, meeting the administrative requirements, accounting for disclosure of PHI, and providing a notice of practices. However, such a designation does not preclude the public health authority from continuing to conduct authorized public health functions. A covered entity that is also a public health authority may use, as well as disclose, PHI for public health purposes to the same extent it would be permitted to disclose the PHI as a public health authority.

The Privacy Rule and Public Health Research

The topic of research under the Privacy Rule is covered in depth in the DHHS report, Protecting Personal Health Information in Research --- Understanding the HIPAA Privacy Rule (6). The Privacy Rule provides separate provisions for disclosure without individual authorization for public health purposes and for certain research [45 CFR § 164.512(b)] [45 CFR § 164.512(i)]. Other federal law pertaining to research stresses the importance of distinguishing between research and practice to ensure that human subjects are appropriately protected [45 CFR Part 46]. For certain activities, this distinction is not always clear. A full discussion of the distinctions between public health practice and research is beyond the scope of this document. However, CDC and others provide guidance in this area (7--9).

Research Versus Practice

The definition of research is the same for the Privacy Rule and the Common Rule (10) --- systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Research is designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge. The majority of public health activities (e.g., public health surveillance, and disease prevention and control projects) are based on scientific evidence and data collection or analytic methods similar to those used in research. However, they are not designed to contribute to generalizable knowledge. Their primary purpose is to protect the health of the population through such activities as disease surveillance, prevention, or control.

The Belmont Report (11) defines practice as interventions designed solely to enhance the well-;being of a person, patient, or client, and which have reasonable expectation of success. The report further states that the purpose of medical or behavioral practice is to provide diagnosis, preventive treatment, or therapy to particular patients. For public health agencies, the patient is the community. Public health practice activities (e.g., public health surveillance, disease control, or program evaluation) are undertaken with the intent to benefit a specific community, although occasionally they may provide unintended generalizable benefits to others.

Some public health activities that are initially public health practice may subsequently evolve into a research activity (e.g., an investigation to determine the cause of an outbreak that incorporates a research study evaluating the efficacy of a new drug to treat the illness). When that is the case, the disclosures may be made initially under the public health provisions of the Privacy Rule. But when the activity becomes an ongoing research activity, the entity should consider application of the relevant research disclosures provisions to continue to obtain information for this purpose. Moreover, there may be cases where the activity is both research and public health practice (e.g., an ongoing survey to monitor health conditions in the population, data from which can also be analyzed for research purposes). In those cases, disclosures may be made either under the research provisions or the public health provisions, as appropriate --- the covered entity need not comply with both sets of requirements.

The Privacy Rule and Other Laws

• Federal laws. Covered entities subject to the Privacy Rule are also subject to other federal statutes and regulations. The specific relationship of the Privacy Rule and certain federal laws is discussed in the preamble to the December 2000 Final Rule [65 Fed.Reg. 82481]. In certain instances, the Privacy Rule imposes requirements in direct conflict with other federal laws or regulations. In those instances, an analysis will be necessary to determine whether the later provision was intended to overrule the prior law or regulation.
• State laws. As a federal regulatory standard, the Privacy Rule preempts only those contrary state laws relating to the privacy of individually identifiable health information that have less stringent requirements or standards than the Privacy Rule (i.e., more stringent laws remain in effect). In addition, DHHS may, upon specific request from a state or other entity or person, determine that a provision of state law that is contrary to the federal requirements and that meets certain additional criteria, will not be preempted by the federal requirements. Thus, preemption of a contrary state law will not occur if the Secretary or designated DHHS official determines, in response to a request, that the state law 1) is necessary to prevent fraud and abuse related to the provision of or payment for health care; 2) is necessary to ensure appropriate state regulation of insurance and health plans to the extent expressly authorized by statute or regulation; 3) is necessary for state reporting on health-care delivery or costs; 4) is necessary to serve 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 5) has as its principal purpose the regulation of the manufacture, registration, distribution, dispensing, or other control of any controlled substances. The Privacy Rule specifically does not preempt contrary state public health laws that provide for the reporting of disease or injury, child abuse, birth or death, or for the conduct of public health surveillance, investigation, or intervention [45 CFR § 160.202].

Online Resources

References to non-DHHS sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of these sites. URL addresses listed in MMWR were current as of the date of publication.

Federal Government Resources

DHHS Office for Civil Rights --- HIPAA guidelines
  http://www.hhs.gov/ocr/hipaa

CDC --- Privacy Rule guidelines
  http://www.cdc.gov/privacyrule

Centers for Medicare and Medicaid Services
  http://www.cms.gov/hipaa/
  http://www.cms.gov/hipaa/hipaa2/support/tools/decisionsupport/default.asp

Health Resources and Services Administration --- HIPAA
  http://www.hrsa.gov/website.htm

National Center for Health Statistics
  http://www.cdc.gov/nchs/otheract/phdsc/phdsc.htm

National Committee on Vital and Health Statistics
  http://www.ncvhs.hhs.gov/

National Health Information Infrastructure
  http://www.health.gov/ncvhs-;nhii/

Indian Health Service --- HIPAA
  http://www.ihs.gov/AdminMngrResources/HIPAA/index.cfm

National Institutes of Health
  http://privacyruleandresearch.nih.gov

Substance Abuse and Mental Health Services Administration --- HIPAA
  http://www.samhsa.gov/hipaa/

State Government Resources

California
  http://www.dhs.ca.gov/hipaa/
  http://www.ohi.ca.gov/state/calohi/ohiHome.jsp
  http://www.dmh.ca.gov/hipaa/

Colorado
  http://www.cdphe.state.co.us/HIPAA/

Florida
  http://www.myflorida.com/myflorida/sto/hipaa/

Illinois
  http://www.state.il.us/dpa/hipaa.html

Kentucky
  http://chs.state.ky.us/dms/HIPAA/default.htm
  http://dmhmrs.chr.state.ky.us/hipaa.asp

Maryland
  http://www.mhcc.state.md.us/edi/hipaa/_hipaa.htm
  http://dhmh.state.md.us/HIPAA/

Minnesota
  http://www.dhs.state.mn.us/hipaa/

Missouri
  http://www.health.state.mo.us/HIPAA/

New York
  http://www.oft.state.ny.us/hipaa/index.htm

North Carolina
  http://dirm.state.nc.us/hipaa/

Ohio
  http://www.state.oh.us/hipaa/

Pennsylvania
  http://www.dpw.state.pa.us/omap/hipaa/omaphipaa.asp
  http://www.insurance.state.pa.us/html/hipaa.html

South Carolina
  http://www.hipaa.state.sc.us/

Texas
  http://www.hhsc.state.tx.us/NDIS/NDISTaskForce.html 

Virginia
  http://www.dmas.state.va.us/hpa-;home.htm

Wisconsin
  http://www.dhfs.state.wi.us/HIPAA/

Associations, Nonprofit Organizations, and Academic Resources

American Hospital Association --- HIPAA
  http://www.hospitalconnect.com/aha/key_issues/hipaa/resources/resources.html

American Medical Association --- HIPAA
  http://www.ama-;assn.org/ama/pub/category/4234.html

Association of State and Territorial Health Officials --- HIPAA
  http://www.astho.org/?template=hipaa.html

Georgetown University Health Privacy Project
  http://www.healthprivacy.org/

Joint Healthcare Information Technology Alliance
  http://www.jhita.org/

National Association of Health Data Organizations
  http://www.nahdo.org/

National Association of Insurance Commissioners
  http://www.naic.org/1privacy/initiatives/health_privacy.htm

National Governors Association --- HIPAA
  http://www.nga.org/center/topics/1,1188,C_CENTER_ISSUE^D_4324,00.html

North Carolina Healthcare Information and Communications Alliance
  http://www.nchica.org/

Public Health Grand Rounds HIPAA Privacy Rule: Enhancing or Harming Public Health?
  http://www.publichealthgrandrounds.unc.edu/

Stanford University Medical School --- HIPAA
  http://www.med.stanford.edu/HIPAA/

Workgroup for Electronic Data Interchange --- Strategic National Implementation Process
  http://www.wedi.org/snip/

Acknowledgments

This report was prepared by Salvatore Lucido, M.P.A., and Denise Koo, M.D., Office of the Associate Director for Science, Epidemiology Program Office, CDC, in collaboration with James G. Hodge, Jr., J.D., Center for Law and the Public's Health, Georgetown and Johns Hopkins Universities, Baltimore, Maryland. The preparers are grateful for the participation of Deborah Tress, J.D., Kenya Ford, J.D., and Heather Horton, J.D., Office of the General Counsel, Department of Health and Human Services, CDC/ATSDR Branch; the CDC Working Group on the Privacy Rule; and Beverly Dozier, J.D., Lance A. Gable, J.D., Lawrence O. Gostin, J.D., Gail Horlick, J.D., and Jennifer Kurle.

The preparers also thank the following partners for their valuable input: Association of State and Territorial Health Officers, Council of State and Territorial Epidemiologists, National Association of County and City Health Officials, National Association of Health Data Organizations, Association of Public Health Laboratories, and National Association for Public Health Statistics and Information Systems.

References

1. Gostin LO, Hodge JG Jr. Personal privacy and common goods: a framework. Minnesota Law Review 2002;86:1439--80.

2. Health Insurance Portability and Accountability Act of 1996. Pub. L. No. 104-;191, 110 Stat. 1936 (1996).
3. Office for Civil Rights, Department of Health and Human Services. Title 45 of the Code of Federal Regulations Parts 160 and 164. Available at http://www.dhhs.gov/ocr/combinedregtext.pdf.
4. Office for Civil Rights. OCR guidance explaining significant aspects of the Privacy Rule, 2002. Department of Health and Human Services. Available at http://www.hhs.gov/ocr/hipaa.
5. Gostin, LO, Hodge JG Jr. Privacy Law Advisory Committee. Model state public health information privacy act, 1999. Available at http://www.publichealthlaw.net/Resources/ResourcesPDFs/modelprivact.pdf.
6. Department of Health and Human Services. Protecting personal health information in research --- understanding the HIPAA Privacy Rule. Department of Health and Human Services. Washington, D.C.: 2003 (in press).
7. Snider DE, Stroup DF. Defining research when it comes to public health. Public Health Rep 1997:112:29--32.
8. CDC. Guidelines for defining public health research and public health nonresearch. Available at http://www.cdc.gov/od/ads/opspoll1.htm.
9. Amoroso PJ, Middaugh JP. Research vs. public health practice: when does a study require IRB review? Prev Med 2003;36:250--3.
10. Office for Protection from Research Risks, National Institutes of Health, Department of Health and Human Services. Public welfare: protection of human subjects, 2001. [45 CFR 46]. Available at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.
11. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont report: ethical principles and guidelines for the protection of human subjects of research. Department of Health, Education and Welfare. Available at http://www.med.umich.edu/irbmed/ethics/belmont/BELMONTR.HTM.

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