Health Insurance Portability and Accountability Act (HIPAA)
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 mandates privacy and confidentiality protections for human research subjects. There is much information on this Act regarding how it impacts patient care and human subject research and the protected health information of these persons:
Tufts Medical Center is a covered entity. All research at Tufts Medical Center is subject to HIPAA. Tufts University is a hybrid entity, which means parts of Tufts University are subject to HIPAA and parts are not. At Tufts University, HIPAA applies to Tufts University School of Dental Medicine, Student Services in the Medford/Somerville Campus, and if a researcher at Tufts University generates protected health information at a covered entity.
For all new studies submitted after April 1, 2012, if HIPAA applies, a combined ICF/RAF document must be submitted. A separate ICF and RAF will no longer be accepted.
For existing studies, at continuing review investigators can convert to the combined ICF/RAF document or continue to use a separate ICF and RAF.