As we discussed in a prior post, the April 29, 2015, draft House 21st Century Cures bill would make several changes to federal health privacy law. This post focuses on provisions that would allow remote access to PHI for purposes preparatory to research and that would permit individuals to make a one-time authorization of the use and disclosure of their PHI for research purposes.

Remote Access for Purposes Preparatory to Research

Section 1124 of the Cures bill would add a new section 13444 to the HITECH Act to modify the rules governing the use and disclosure of PHI for purposes preparatory to research. Current law allows covered entities to use or disclose PHI for such purposes as long as no PHI is removed from the covered entity by the researcher. The Cures bill would permit researchers to “remote[ly] access” health information, as long as the covered entity and researcher maintain “appropriate security and privacy safeguards” and the PHI “is not copied or otherwise retained by the researcher.” The draft bill does not define what it means to “copy” or “retain” PHI, or for example, whether the temporary caching of files on a remote portal would violate the new requirements.

Individual One-Time Authorization for Uses and Disclosures of PHI for Research

Cures section 1124 would also add a new section 13445 to the HITECH Act to permit individuals to make a one-time authorization allowing their PHI to be used or disclosed for “future research purposes.” Under current law, covered entities must, as a general rule, obtain authorization from the subject individual in order to use or disclose PHI for purposes other than treatment, payment, or health care operations. However, covered entities may use or disclose PHI for “research purposes” without obtaining authorization if the covered entity complies with certain requirements such as getting a waiver of the authorization requirement from an institutional review board (IRB) or privacy board.

The Cures bill would consider an authorization for future research purposes valid if it met certain conditions, such as sufficiently describing the future purposes (at least in general terms); providing an expiration date for the authorization or stating that the authorization will not expire; and informing the individual about how to revoke the authorization. Although a prior draft of the Cures bill specified that the authorization would apply both to already-existing PHI as well as PHI collected after the date of the authorization, the April draft does not contain this language. Additionally, the new provision is somewhat unclear as to the impact that a revocation of the authorization would have on ongoing research using the individual’s PHI.

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Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus has a multi-disciplinary practice advising clients 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…

Anna Durand Kraus has a multi-disciplinary practice advising clients 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 health information privacy. Ms. Kraus regularly advises clients on Medicare reimbursement matters, the Medicaid Drug Rebate program, health information privacy issues (including under HIPAA and the HITECH Act), and the challenges and opportunities presented by the Affordable Care Act.

Photo of Paige Jennings Paige Jennings

Paige Jennings is an associate in Covington’s Washington office. She works with the firm’s Federal–State Programs, Health Care, Antitrust, and Litigation practice groups. Ms. Jennings joined the firm after a number of years working on health policy matters in the government and private…

Paige Jennings is an associate in Covington’s Washington office. She works with the firm’s Federal–State Programs, Health Care, Antitrust, and Litigation practice groups. Ms. Jennings joined the firm after a number of years working on health policy matters in the government and private sectors. Prior to earning her law degree and Master of Public Affairs, she worked in the U.S. Senate for over four years, advising Senators John Breaux and Tom Carper on health and social policy matters. Ms. Jennings later handled federal health policy issues at WellPoint, Inc. During law school, she worked with the U.S. Office of Management and Budget during consideration of the Affordable Care Act, and with the Federal Trade Commission for then-Chairman Jon Leibowitz.