Cures 2.0: Building a Modern Health Data Infrastructure
Seeking to build on past efforts and incorporate lessons learned from the COVID‐19 pandemic, policymakers are working to identify opportunities to accelerate medical research and foster patient access to innovative medical products and novel technologies. The recently released discussion draft for The 21st Century Cures Act 2.0 (“Cures 2.0 Act”) is one such effort.
The Cures 2.0 Act seeks to build on the bipartisan successes of the 21st Century Cures Act (2016) to support more effective medical product development and regulation. The Cures 2.0 Act includes provisions on long‐COVID research, future pandemic preparedness, development of antimicrobial innovations, clinical trial representativeness, digital health technologies, cell and gene therapies, accelerated approval, and the proposed Advanced Research Projects Agency for Health (ARPA‐H).
The Cures 2.0 Act also includes several provisions related to the use of real‐world evidence (RWE) as well as improving communication between the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). Among these provisions are:
- the creation of a new US Department of Health and Human Services (HHS)‐led RWE Task Force,
- a requirement for HHS to generate a framework to expand the use of RWE, and
- the establishment of an automatic communication requirement between FDA and CMS for products designated by FDA as breakthrough therapies, fast track products, or products eligible for accelerated approval so that the agencies may share information regarding product approval and coverage decisions more efficiently.
While provisions in the Cures 2.0 Act represent another step forward for the implementation and use of RWE by Federal agencies, the legislation should go further to support the improvement and modernization of the entirety of US health data infrastructure. This data infrastructure is essential to collecting the high‐quality real‐world data (RWD) that is needed to generate RWE for decision making.
The Cures 2.0 Act is an opportunity to lay the data infrastructure foundation needed to support a learning health care system,2 while supporting alignment between FDA, CMS, and other Federal agencies like the Centers for Disease Control and Prevention (CDC) as they make their respective regulatory, payment, and public health decisions.
The Duke‐Margolis Center for Health Policy’s (“Duke‐Margolis” or “Center”) Real‐World Evidence Collaborative (the “Collaborative”) and Value‐Based Payment for Medical Products Consortium (the “Consortium”) have explored many issues impacting health data infrastructure in the US over the last several
years. This issue brief, informed by these multistakeholder groups and one of several Cures 2.0 Act focused issue briefs developed by Duke‐Margolis, offers
recommendations for further improving US health data infrastructure to inform policy and legislation, accelerate medical research, and foster patient access
to novel technologies.
Duke-Margolis Affiliated Authors
Trevan Locke, PhD
Assistant Research Director
Rebecca (Becky) Ray
Senior Policy Analyst
Rachele Hendricks-Sturrup, DHSc, MSc, MA
Senior Team Member
Marianne Hamilton Lopez, PhD, MPA
Senior Research Director, Biomedical Innovation
Faculty Director of the Duke-Margolis Postdoctoral Associates & Affiliated Fellows Program
Adjunct Associate Professor
Senior Team Member
Margolis Core Faculty
Morgan Romine, MPA
Chief of Staff
Senior Team Member
Mark McClellan, MD, PhD
Director of Margolis Center
Robert J. Margolis, MD, Professor of Business, Medicine and Policy
Margolis Executive Core Faculty