![]() ![]() If, however, researchers are employees or other workforce members of a covered entity (e.g., a hospital or health insurer), they may have to comply with that entity's HIPAA privacy policies and procedures. Researchers are not themselves covered entities, unless they are also health care providers and engage in any of the covered electronic transactions. Covered entities are health plans, health care clearinghouses, and health care providers that transmit health information electronically in connection with certain defined HIPAA transactions, such as claims or eligibility inquiries. With certain exceptions, the Privacy Rule applies to individually identifiable health information created or maintained by a covered entity. PHI is a subset of what is termed individually identifiable health information. The Privacy Rule establishes a category of health information, referred to as PHI, which may be used or disclosed to others only in certain circumstances or under certain conditions. ![]() The Privacy Rule is a response to public concern over potential abuses of the privacy of health information. For most covered entities, compliance with these regulations, known as the Privacy Rule, was required as of April 14, 2003. In response to a congressional mandate in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), HHS issued regulations entitled Standards for Privacy of Individually Identifiable Health Information. Privacy Boards and the HIPAA Privacy Rule.Institutional Review Boards and the HIPAA Privacy Rule.Research Repositories, Databases, and the HIPAA Privacy Rule.Health Services Research and the HIPAA Privacy Rule.Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule.Additional information about the Privacy Rule's potential impact on other research activities, such as repositories, databases, health services research, Institutional Review Boards (IRBs), and Privacy Boards can be found in related publications, including: It places specific emphasis on the Authorization that is generally required for research uses and disclosures of PHI by covered entities. This fact sheet discusses the Privacy Rule and its impact on covered entities that conduct clinical research. As the Federal privacy standards are implemented throughout the country, one benefit is that many clinical researchers and hospitals may adhere to a common set of national standards for protecting the privacy of patients and clinical research subjects. Where a covered entity conducts clinical research involving protected health information (PHI), physician-investigators need to understand the Privacy Rule's restrictions on the use and disclosure of PHI for research purposes. The Privacy Rule adds to these existing obligations. ![]() ![]() For the treating physician, duties of confidentiality have long been established under well-known legal and ethical standards. Moreover, in clinical research, physician-investigators often stand in dual roles to the subject: As a treating physician and as a researcher. In fact, many have been required under the Department of Health and Human Services (HHS) or the Food and Drug Administration (FDA) Protection of Human Subjects Regulations (45 CFR part 46 or 21 CFR parts 50 and 56, respectively) to take measures to protect such personal health information from inappropriate use or disclosure. Even before the Privacy Rule, of course, physician-investigators have been concerned about the privacy of the medical and research-related information of their patients and subjects. Researchers who conduct interventional clinical research have questioned how the Privacy Rule will affect their research activities.
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