Senate HELP committee passes bills with HIT impact

The Senate health committee kicked off the first of three committee meetings on its biomedical innovation agenda by passing seven bills with bipartisan support. The next meeting is scheduled for March 9, where the committee will debate and vote on at least five bipartisan bills.

The Improving Health Information Technology Act (S. 2511) has the most impact on health IT professionals and establishes several health IT provisions including:

  • Reduces documentation burdens by convening public and private stakeholders to develop goals, a strategy and recommendations to minimize the documentation burden on providers while maintaining quality.
  • Allows and encourages health professionals to practice at the top of their license, allowing non-physician members of the care team to document on behalf of physicians.
  • Encourages the certification of health IT for specialty providers and sites of service, like pediatric care, where more specialized technology is needed.
  • Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT) establishes an unbiased rating system for health IT products.
  • Gives the Department of Health and Human Services (HHS) Office of the Inspector General the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing of electronic health information
  • Convenes existing data sharing networks to develop a voluntary model framework and common agreement for the secure exchange of health information across existing networks to help foster bridging between networks.
  • Requires that HHS give deference to standards developed in the private sector.
  • Leveraging Health Information Technology to Improve Patient Care that requires that certified HIT exchange data with registries if registries are certified to use standards endorsed by the Office of the National Coordinator for Health IT.
  • Includes vendors in Patient Safety Organizations to allow for improvements in the safety and effectiveness of HIT.
  • Empowering Patients and Improving Patient Access to Their Electronic Health Information, which supports the certification and development of patient-centered health record technology so that patients can access their health information through secure and user-friendly software that may update automatically.
  • Encourages the use of health information exchanges to promote patient access by educating providers and clarifying misunderstandings.
  • GAO Study on Patient Matching which directs the Governmental Accountability Office to conduct a study to review methods for securely matching patient records to the correct patient

The following bills also were passed by the committee with bipartisan support:

The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S. 2030): Advance therapies to patients with serious or life-threatening rare genetic diseases by allowing innovators to rely on their own data used for a previously approved targeted therapies to develop subsequent targeted therapies.

The FDA Device Accountability Act of 2015 (S. 1622): Ensure Americans benefit from new medical devices more quickly by reducing unnecessary burdens in device evaluations and streamlining the review process for clinical trials. Additionally, this legislation modernizes the regulation of diagnostic tests to create a path for rapid diagnostics.

The Next Generation Researchers Act (S. 2014): Help attract talented young scientists to the National Institutes of Health.

The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act (S. 800): Update rehabilitation research for the first time in more than 20 years and require the National Center for Medical Rehabilitation Research to develop and periodically update a comprehensive research plan for rehabilitation research and report to Congress on an annual basis regarding benchmarks in that plan.

The Advancing Research for Neurological Diseases Act of 2015 (S. 849): Advance understanding of neurological diseases and help researchers access data on these diseases in order to discover new therapies and cures.

The Preventing Superbugs and Protecting Patients Act (S. 2503): Further encourage and clarify that the FDA requires cleaning and validation data for reusable medical devices and to direct the FDA to clarity when device changes require regulatory clearance.