Washington, D.C. – The Bipartisan Policy Center is encouraged by today’s passage of the Senate Health, Education, Labor, and Pensions (HELP) Committee’s health innovation legislation that aligns with our policy recommendations. Over the past year, BPC’s initiative FDA: Advancing Medical Innovation, has been providing technical assistance to the HELP Committee on ways to improve the medical product development process, increase regulatory clarity, strengthen the ability of the U.S. Food and Drug Administration (FDA) to carry out its mission, and increase investment in treatments for unmet and public health needs.
“We are particularly pleased that legislation to improve health information technology (IT) interoperability successfully passed through committee today,” said Janet Marchibroda, BPC health innovation director. “Rapidly emerging new models of care delivery and payment, advances in biomedical innovation, and increasing consumer demand are driving the need for greater electronic information sharing and interoperable health IT systems. Despite federal investments of more than $30 billion in electronic health record technology, nationwide interoperability across care settings has yet to be achieved.”
The Improving Health Information Technology Act, sponsored by HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA), contains several provisions included in BPC recommendations and reports, including:
- Advancing electronic information sharing and interoperability of health IT systems to support improvements in health and health care, by:
- Outlining a process for prioritizing and advancing adoption of standards, implementation specifications, and certification criteria that will support interoperability, giving deference to standards developed by the private sector;
- Improving transparency regarding the interoperability of health IT systems;
- Discouraging information blocking;
- Accelerating actions needed to improve the accuracy of patient matching, including a Government Accountability Office within two years;
- Facilitating agreement on and voluntary adoption of policies and practices for trusted exchange between health information networks; and
- Establishing or adopting a provider directory.
- Improving patient safety, health care quality, and health care outcomes, by:
- Treating health IT developers as providers for purposes of reporting and conducting patient safety activities; and
- Facilitating the sharing of best practices and current trends by patient safety organizations.
- Improving patient access to health information by:
- Encouraging health information exchange organizations and networks to partner with providers, health plans, and other entities to offer patients access to their electronic health information in a single longitudinal format;
- Increasing education about federal policies that assure accessibility of electronic health information for patients and;
- Facilitating the sharing of best practices related to the sharing of electronic health information with patients.
BPC submitted comments and held an event on this issue bringing together public- and private-sector stakeholders to identify the key barriers to, and possible solutions for, achieving interoperability.
Additionally, the Advancing Targeted Therapies for Rare Diseases Act of 2015 (S. 2030), sponsored by Senators Michael Bennet (D-CO), Richard Burr (R-NC), Elizabeth Warren (D-MA), and Orrin Hatch (R-UT) also contains provisions that align with the principles of BPC’s recommendations associated with advancing medical innovation legislation. This bill is aimed at streamlining the approval process for targeted drugs for patients with serious or life-threatening rare genetic diseases. More specifically, it would allow innovators to use their own data from previously approved targeted drugs to support the application for approval of a new targeted drug. In doing so, FDA and medical innovators could also maximize the use of scientific tools or methods, including surrogate endpoints and other biomarkers.
Janet Marchibroda, BPC health innovation director, is available for comment.
Learn more about BPC’s FDA: Advancing Health Innovation Initiative here.