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. 

Future Research

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.

Tags: Health Privacy, HIPAA, HITECH Act, research
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Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into…

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Anna is co-chair of the firm’s Health Care Industry practice group.

Anna regularly advises clients on Medicare reimbursement matters, particularly those arising under Part B and the Part D prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She assists numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act.

Anna is a trusted adviser on health information privacy, security and breach notification issues, including those arising under the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Her background in this area dates back to the issuance of the original HIPAA privacy regulations.

Anna’s clients depend on her to guide them through compliance with the Anti-Kickback statute, the Stark regulations, and other laws preventing fraud and abuse in the health care industry. Her deep knowledge of these laws has made her an important component of the firm’s representation of pharmaceutical companies and health care organizations under federal investigation or facing allegations under the False Claims Act. In addition, clients contemplating acquisitions in the health care sector rely on her to guide due diligence efforts.

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