The document is a formal letter from the Council on Governmental Relations (COGR), representing over 145 research-intensive U.S. universities, addressed to Secretary Tommy G. Thompson of the U.S. Department of Health and Human Services (HHS). Authored by Katharina Phillips, the letter responds to proposed modifications of the HIPAA Privacy Rule, specifically as they relate to research activities involving individually identifiable health information. COGR expresses appreciation for HHS's efforts to clarify and streamline the Privacy Rule but strongly advocates for exempting research subject to the Federal Common Rule (which already has robust privacy and confidentiality safeguards overseen by Institutional Review Boards) from the additional HIPAA Privacy Rule requirements. The organization argues that the Common Rule's framework suffices for protecting research participants' privacy and that layering additional HIPAA regulations imposes unnecessary burdens that could impede vital research activities.
The letter supports certain proposed modifications, such as permitting combined authorizations and eliminating expiration date requirements for research-related data uses, and requests further changes like removing statements about potential re-disclosure and easing documentation and record-keeping burdens on institutions. COGR also seeks parity for academic and non-profit researchers in access to health data registries, similar to allowances granted for FDA-regulated activities, and suggests more flexible de-identification standards. The letter emphasizes that the incremental regulatory burdens brought by HIPAA may discourage research participation by covered entities, particularly smaller institutions, without materially enhancing participant protection. COGR concludes by urging HHS to incorporate HIPAA's privacy requirements into guidance under the Common Rule or, preferably, to exempt federally regulated research from HIPAA, in order to sustain a productive research environment while maintaining participant confidentiality.
