Distinction between HIPAA, HHS & FDA Protection of Human Subjects Regulations

Apart from HIPAA Privacy Rule, there are other human subject regulatory requirements, which apply to most federally funded and to some privately funded research, to help ensure the privacy of subjects and the confidentiality of information. Much of the biomedical and behavioral research conducted in the United States is governed either by the rule entitled “Federal Policy for the Protection of Human Subjects” (also known as the “Common Rule,” which is codified for HHS at subpart A of Title 45 CFR Part 46) and/or the Food and Drug Administration’s (FDA) Protection of Human Subjects Regulations at Title 21 CFR Parts 50 and 56.3 FDA, a component of HHS, has additional human subject protection regulations, which apply to research involving products regulated by FDA.

The Privacy Rule does not replace or act in lieu of these human subject protection regulations which means that the researchers who are also (or who work for) covered entities may find themselves responsible for complying with multiple sets of regulations. There are some basic points of distinctions among the Privacy Rule, the HHS Protection of Human Subjects Regulations, and the FDA Protection of Human Subjects Regulations.

On the basis of their overall objectives, it can be said that The HHS Protection of Human Subjects Regulations are intended to protect the rights and welfare of human subjects involved in research conducted or supported by HHS. On the other hand, the FDA Protection of Human Subjects Regulations are intended to protect the rights, safety, and welfare of participants involved in studies subject to FDA jurisdiction under 21 U.S.C. 355(i) and 21 U.S.C. 360g(j). And lastly, HIPAA Privacy Rule intends to establish a Federal floor of privacy protections for most individually identifiable health information by establishing conditions for its use and disclosure by certain health care providers, health plans, and health care clearing houses.

On the basis of applicability, it can be said that HHS Protection of Human Subjects Regulations applies to human subjects research conducted or supported by HHS. The FDA Protection of Human Subjects Regulations applies to research involving products regulated by FDA. Federal support is not necessary for FDA regulations to be applicable. When research subject to FDA jurisdiction is federally funded, both the HHS Protection of Human Subjects Regulations and the FDA Protection of Human Subjects Regulations apply. On the other hand, HIPAA Privacy Rule applies to HIPAA-defined covered entities, regardless of the source of funding.