For investigators, IRB members, and IRB staff alike, the revised Common Rule’s new exempt category at 45 CFR 46.104(d)(4)(iii) was a dream come true. The so-called HIPAA Exemption eliminates IRB review for research use of retrospectively or prospectively collected “identifiable health information when that use is regulated by the HIPAA Privacy Rule as health care operations, research, or for public health activities […].” Applying the HIPAA Exemption is not quite as simple as it might seem, though, as I learned at the 2018 Advancing Ethical Research Conference (AER18) session, appropriately titled “Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996.” Read more