Guidance on HIPAA and Individual Authorization of Uses and Disclosures of Protected Health Information for Research

The Cures Act requires the Secretary of the Department of Health and Human Services (HHS) to issue “Guidance Related to Streamlining Authorization” under HIPAA for uses and disclosures of protected health information (PHI) for research.  The HHS Office for Civil Rights (OCR) provided guidance, consisting of background on the HIPAA Privacy Rule’s provisions on authorizations to use and disclose PHI for research and detailed discussion of each of the three topics identified in the Cures Act.   The guidance issued is interim guidance, while additional inquiries and discussions proceed.

https://www.hhs.gov/sites/default/files/hipaa-future-research-authorization-guidance-06122018%20v2.pdf