In this third post on the forthcoming HIPAA/HITECH regulations, we will discuss potential modifications to the rules regarding authorization for future research. In earlier posts, we covered the Department of Health and Human Service’s (HHS) proposed treatment of communications about currently prescribed drugs and remunerated treatment communications.
In the proposed rule issued last July, HHS stated that it is “considering whether to modify its interpretation that an authorization for the use or disclosure of protected health information for research be research-study specific.” The agency was prompted to revisit this issue after hearing concerns from covered entities and researchers about how the current interpretation encumbers secondary research, results in individuals being re-contacted to sign multiple authorization forms at different points in the future, and is inconsistent with the Common Rule.
HHS stated that it is considering a number of options in this area, but requested comments on three options in particular:
- Option #1. Amend the HIPAA Privacy Rule to permit an authorization for uses and disclosures for future research purposes to the extent there is an adequate description of such purposes.
- Option #2. Amend the HIPAA Privacy Rule to permit an authorization for uses and disclosures for future research purposes to the extent the description of the future research includes specific elements or statements specified by the Privacy Rule.
- Option #3. Amend the HIPAA Privacy Rule to permit the first option as the general rule, but require certain disclosure statements in cases where the future research may involve certain types of sensitive research activities (e.g., genetic analyses, mental health research).
HHS’s final determination on this issue could have a significant impact on the conduct of clinical trials and, as science evolves, the ability of researchers to use data for research purposes that could not have been contemplated at the time the data was gathered, but which hold great promise to expand the base of general knowledge.