The Senate Health, Education, Labor and Pensions (HELP) Committee has approved several bipartisan health policy bills, including health information technology (HIT) legislation and bills aimed at spurring biomedical innovation to complement the "House 21st Century Cures" initiative. Specifically, on February 9, 2016, the Committee approved:
- S. 2511, the Improving Health Information Technology Act – intended to: streamline HIT documentation requirements; establish a rating system for HIT products; allow the HHS OIG to address information blocking practices; develop a voluntary model framework for network interoperability; promote exchange of data with registries; and promote patient-centered health record technology, among other things.
- S. 2030, the Advancing Targeted Therapies for Rare Diseases Act of 2015 – to allow the sponsor of a genetically targeted drug to rely upon data previously developed by the sponsor for a previously-approved targeted therapy.
- S. 1622, the FDA Device Accountability Act of 2015 – to encourage FDA staff to use the least burdensome requirements in the premarket review of devices, permit non-local institutional review boards, and require the HHS Secretary to revise Clinical Laboratory Improvement Amendments of 1988 waiver study design guidance to address the appropriate use of comparable performance between a waived user and a moderately-complex laboratory user to demonstrate accuracy.
- S. 2014, Next Generation Researchers Act – to require the National Institutes of Health to develop policies and programs to promote opportunities for new researchers and earlier research independence.
- S. 800, the Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act – to require the National Center for Medical Rehabilitation Research to develop and periodically update a comprehensive research plan for rehabilitation research and research training.
- S. 849, Advancing Research for Neurological Diseases Act of 2015 – to provide for systematic data collection and analysis and epidemiological research regarding neurological diseases S. 2503, Preventing Superbugs and Protecting Patients Act – to clarify FDA requirements for cleaning of reusable medical devices and direct the FDA to issue guidance on when device changes require regulatory clearance.
The HELP Committee will continue work on its biomedical innovation agenda at a March 9 meeting. The following legislation currently is scheduled to be considered:
- S. 1878 – the Advancing Hope Act of 2015;
- S. 1101 – the Medical Electronic Data Technology Enhancement for Consumer's Health (MEDTECH) Act S. 2055 – the Medical Countermeasures Innovation Act of 2015;
- S. 1767 – the Combination Products Innovation Act of 2015; and
- S. 1077 – The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S.1077).
This article is presented for informational purposes only and is not intended to constitute legal advice.