To the Editor: The study of the influence of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule on health research by Dr Ness1 and the accompanying Editorial by Drs Fost and Levine2 critiqued the institutional review board (IRB) process and the influence of the HIPAA requirements. The study conclusion that the HIPAA regulations make epidemiological research more burdensome with little benefit to privacy protections may be more reflective of ineffective alignment of HIPAA implementation with the IRB process by institutions rather than the regulations themselves.
Tilden SJ. Health Research and the HIPAA Privacy Rule. JAMA. 2008;299(11):1259-1260. doi:10.1001/jama.299.11.1259-a