On June 22, 2021, Congressional leaders Diana DeGette (D-DO) and Fred Upton (R-MI) released a bipartisan follow-up to the 2016 21st Century Cures Act“Cures 2.0”—a “discussion draft” at this stage—is intended to build upon the Cures Act.  The draft lays out several notable policies related to digital health, real-world data/evidence (RWD/E), and telehealth, among other provisions:

  • Sec. 301: Report on Collaboration and Alignment in Regulating Digital Health Technologies.  This provision requires FDA to submit a report to Congress on the efforts to ensure collaboration and alignment across FDA offices with respect to the regulation of digital health technologies.  The report must include recommendations on topics such as the use of digital endpoints for regulatory review, the use of digital health technologies in patient-focused development of products, and the use and validation of digital health technology tools (e.g., wearable devices, virtual reality headsets, artificial intelligence-/machine learning-based analytics, cloud services, etc.).  The report also must describe how FDA coordinates with foreign regulators to ensure harmonized regulation and use of such digital health technologies.
  • Sec. 302: Grants for Novel Trial Designs and Other Innovations in Drug Development.  Sec. 302 directs FDA to award grants for “incorporating complex adaptive and other novel trial designs into clinical protocols and applications for drugs pursuant to an exemption for investigational use under section 505(i) of the Federal Food, Drug, and Cosmetic Act . . . or section 351(a) of the Public Health Service Act” and “the collection of patient experience data with respect to drugs and the use of such data and related information in drug development.”  In awarding grants, the provision directs FDA to prioritize the incorporation of digital health technologies and RWE in drug development.
  • Sec. 304: Increasing Use of Real-World Evidence.  This section builds on FDA’s mandate in the Cures Act to establish an RWE Program by requiring (1) FDA to issue guidance on the use of RWE in evaluating the safety and effectiveness of drugs approved pursuant to certain expedited pathways; (2) HHS to identify and implement approaches for using RWE; and (3) HHS to establish a RWE Task Force to coordinate the programs and activities of the Department with regard to the collection and use of RWE.  The RWE Task Force is required to develop and periodically update recommendations on ways to encourage patients to engage in generation of RWE and participate in post-approval clinical trials for collection of RWE.
  • Sec. 402: Strategies to Increase Access to Telehealth Under Medicaid and Children’s Health Insurance Program.  This provision requires HHS to provide guidance to states on strategies for facilitating access to telehealth under the Medicaid and Children’s Health Insurance programs.  This provision also requires studies to be conducted evaluating the impact of telehealth and collaboration among agencies with respect to telehealth services.

Cures 2.0 demonstrates a recognition of the importance of evolving digital health and health data analytics in medical innovation and the delivery of healthcare. Interested stakeholders should consider providing comments to Reps. DeGette and Upton.  Enactment of Cures 2.0, whether as standalone legislation or as part of next year’s FDA medical product user fee reauthorization, would create new opportunities for FDA and HHS to take additional steps to advance digital health policies and initiatives.

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Photo of Mingham Ji Mingham Ji

Mingham Ji is an associate in the firm’s Washington, DC office, where she is a member of the Food and Drug and Anti-Corruption practice groups. Ms. Ji advises food, dietary supplement, pharmaceutical, and biotechnology companies on regulatory and compliance issues.

Photo of Olivia Dworkin Olivia Dworkin

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge…

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge medical technologies and digital health products and services, Olivia regularly helps new and established companies navigate a variety of state and federal regulatory, legislative, and compliance matters throughout the total product lifecycle. She has experience counseling clients on the development, FDA regulatory classification, and commercialization of digital health tools, including clinical decision support software, mobile medical applications, general wellness products, medical device data systems, administrative support software, and products that incorporate artificial intelligence, machine learning, and other emerging technologies.

Olivia also assists clients in advocating for legislative and regulatory policies that will support innovation and the safe deployment of digital health tools, including by drafting comments on proposed legislation, frameworks, whitepapers, and guidance documents. Olivia keeps close to the evolving regulatory landscape and is a frequent contributor to Covington’s Digital Health blog. Her work also has been featured in the Journal of Robotics, Artificial Intelligence & Law, Law360, and the Michigan Journal of Law and Mobility.