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.