Do HIPAA regulations apply to all types of research studies?
No. HIPAA regulations apply only to research activities that involve the use or disclosure of individually identifiable health information. I’m planning to conduct a study. How will I know whether HIPAA regulations apply? It is important to first determine whether the study is indeed a research investigation. The Privacy Rule has provisions that pertain to research activities as well as to quality improvement activities. (It is important to note that HIPAA provisions about quality improvement would also apply to program evaluations that contain quality improvement elements or activities.) Next, determine if the research study involves use of protected health data and whether these data are or will be de-identified. HIPAA regulations apply to the use or disclosure of protected health information or datasets that contain individually identifiable health information. • What does de-identified mean? De-identified protected health information contains no identifiers of an individual, of rel
