Senator Lamar Alexander (R-TN), Chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, recently announced that the committee will hold the first of three executive sessions to consider legislation to address biomedical innovation. The legislation affects the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The bills would serve as the companion legislation to the 21st Century Cures Act passed by the House last summer (see Update, July 14, 2015). The executive sessions are planned for February 9, March 9, and April 6. Alexander stressed that the Committee worked throughout 2015 to produce the bills that are now ready for the full committee to consider, emphasizing the urgency required by the Senate to “finish its work and turn into law these ideas.”
Alexander specifically highlighted the committee’s work on legislation “to achieve interoperability of electronic health records” (EHRs). The Committee recently released a discussion draft of legislation along with a summary addressing health information technology (HIT), including EHRs, and is seeking comments. The discussion draft includes provisions to assist doctors and hospitals in improving quality of care for patients, establish Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT), provide the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing, foster a “network of networks” including establishing “an initial set of common data elements,” ensure that registries are certified to transmit and receive from certified HIT, provide “certification and development of patient-centered health record technology so that patients can access their health information through secure and user-friendly software, which may update automatically,” secure EHRs, and direct the Governmental Accountability Office (GAO) “to review methods for securely matching patient records to the correct patient.” (more…)