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.

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 pharmaceutical, food, consumer brands, digital health, and medical device industries through strategic advice on FDA compliance issues.
Olivia defends her clients against such litigation as well, representing them through various stages of…

Olivia Dworkin minimizes regulatory and litigation risks for clients in the pharmaceutical, food, consumer brands, digital health, and medical device industries through strategic advice on FDA compliance issues.
Olivia defends her clients against such litigation as well, representing them through various stages of complex class actions and product liability matters. She maintains an active pro bono practice that focuses on gender-based violence, sexual harassment, and reproductive rights.

Prior to joining Covington, Olivia was a fellow at the University of Michigan Veterans Legal Clinic, where she gained valuable experience as the lead attorney successfully representing clients at case evaluations, mediations, and motion hearings. At Michigan Law, Olivia served as Online Editor of the Michigan Journal of Gender and Law, president of the Trial Advocacy Society, and president of the Michigan Law Mock Trial Team. She excelled in national mock trial competitions, earning two Medals for Excellence in Advocacy from the American College of Trial Lawyers and being selected as one of the top sixteen advocates in the country for an elite, invitation-only mock trial tournament.