On April 29, 2015, members of the U.S. House Energy and Commerce Committee released a revised discussion draft of the 21st Century Cures Act (“Cures”). The draft bill includes a number of provisions intended to facilitate drug, biologic, and medical device discovery and development through greater collection and dissemination of data and the use of information technology. This posts discusses provisions of the “Discovery” title of the bill focused on expanding access to NIH research data (Subtitle F) and “facilitating collaborative research” (Subtitle G).

Sharing NIH-Funded Research Data: Section 1101 would allow the NIH to require grant recipients to share data generated from research supported by NIH funding. The NIH could not require recipients to share individually identifiable information about human research subjects, or trade secrets or privileged or confidential commercial or financial information.

Facilitating Patient Searches for Clinical Trials: Section 1102 would require greater standardization of and accessibility to information regarding eligibility for clinical trials in the existing clinical trial registry data bank established under section 402(j) of the Public Health Service Act. The Committee section-by-section of the bill explains that the provision is intended to enhance patient searches for clinical trials.

Collecting and Disseminating HHS-Funded Clinical Trial Data: Section 1121 would provide for the creation of a “Clinical Trial Data System” to collect standardized data from HHS-sponsored trials of drugs, biological products, and medical devices. The provision would require HHS to work with one or more entities to establish the system and make de-identified clinical trial data available for research. The chosen entity would compile data in standardized formats from clinical trials sponsored solely by an HHS agency with respect to drugs, medical devices, or biological products approved, cleared, licensed, or with an exemption for investigational use. A central goal of the provision appears to be the dissemination of data to facilitate future drug, biologic, and device development. Section 1121 does not provide for funding—rather, it appears that the entity implementing the system would have to secure funding from governmental and private sources.

Establishing a National Neurological Diseases Surveillance System: Section 1122 would require HHS to create a surveillance system to track the epidemiology of illnesses such as multiple sclerosis and Parkinson’s disease. Collected information could include incidence and prevalence data, demographic information, risk factors, and diagnosis and progression markers. The Secretary would be required to implement privacy and security protections at least as stringent as those under HIPAA and would make information and analysis in the System available to the public and researchers.

Creating a “Natural History of Diseases” Information Technology System: Section 1123 would establish a public-private information technology system to “collect, maintain, analyze, and interpret data on the natural history of diseases,” particularly rare diseases. Subject to compliance with federal and state privacy laws, the collected data would be available to the public, including researchers, “to help reduce the time and size of drug development programs.

Expanding Use and Disclosure of Health Information for Research: Section 1124 of the bill would make a number of changes to federal privacy regulations to expand the use and disclosure of protected health information (PHI) for “research purposes.” Proposed changes include expanding the use or disclosure of PHI without individual authorization; allowing remote access to PHI for certain research purposes; allowing one-time authorizations of the use and disclosure of PHI for research; eliminating limitations on remuneration for PHI disclosed for research purposes; and allowing disclosure of PHI to FDA-regulated entities for research purposes such as comparative effectiveness analysis. We discuss these provisions in further detail on Covington’s InsidePrivacy blog here, here, and here.