Advancing digital health: FDA innovation during COVID-19

www.nature.com/npjdigitalmed COMMENT OPEN Advancing digital health: FDA innovation during COVID-19 Kushal Kadakia1, Bakul Patel1 and Anand Shah 1✉ Digital health products have played an important role in the COVID-19 response, from supporting the remote monitoring of patients to enabling continuity in data collection for clinical trials. The U.S. Food and Drug Administration (FDA) has issued a number of temporary policies to support digital health innovation during the pandemic, such as guidance documents to expand the use of digital therapeutics for psychiatric disorders and medical devices for remote patient monitoring. In this article, we contextualize these policies to the agency’s existing regulatory framework for digital health, outline key considerations for patients and health care providers, and identify implications for the future of digital health innovation. 1234567890():,; npj Digital Medicine (2020)3:161 ; https://doi.org/10.1038/s41746-020-00371-7 The COVID-19 pandemic has accelerated the transition to digital health in the American health care system. For example, many clinical trial sponsors have adopted telehealth and remote patient monitoring technologies to enable continuity in data collection during the pandemic. Likewise, various mobile medical applications and software functions have been used to support public health surveillance, enable the dissemination of educational materials, and streamline communication for patients and providers. Furthermore, regulatory relief from the Centers for Medicare & Medicaid Services (CMS) has enabled clinicians to shift visits to virtual platforms to reduce infection risk to patients. The Food and Drug Administration (FDA) has issued multiple temporary policies to support the uptake of these tools during the public health emergency1. These actions are an extension of the agency’s longstanding commitment to advancing regulatory science for digital health, which was articulated in 2017 with the Digital Health Innovation Action Plan and solidified with the creation of a Digital Health Center of Excellence, which was launched in 20202,3. In this article, we contextualize FDA policies to support digital health during the COVID-19 pandemic to the agency’s existing risk-based approach to regulation, and preview the implications of these policies for the future of digital health innovation. FDA’S REGULATORY FRAMEWORK FOR DIGITAL HEALTH When Congress provided FDA with the authority to regulate medical devices in 1976, medical technologies were largely analog4. Hardware-based devices differ significantly from software-based devices in terms of their design, development life cycle, and risk-benefit calculus. As innovators began to develop digital tools to reduce care fragmentation, promote personal wellness, and support the diagnosis and treatment of disease, the agency recognized the need to develop a regulatory framework that stays current and is attuned to the unique considerations of digital tools 5. Of note, software functions that do not meet the definition of a medical device in the Federal Food, Drug, and Cosmetic (FD&C) Act are outside of the agency’s device regulatory purview. For example, the FDA does not regulate videoconferencing platforms that are used to enhance communication between patients and providers—such as the virtual modalities used for clinical visits during COVID-19—because they do not meet the device definition. Digital health products that are medical devices, such as mobile medical applications used to diagnose irregularities in cardiac rhythm, are regulated by FDA according to the level of risk posed to consumers. To provide momentum for the digital transformation of American medicine, the FDA issued policy guidance in 2013 and subsequently updated it in 2015 and 20196. Early progress from the FDA’s Digital Health Innovation Action Plan was promising and established risk-based policies explaining FDA’s regulatory approach. For example, the agency has focused its oversight on higher-risk mobile medical applications (e.g., those used to diagnose or treat patients), but not on lower-risk digital health products (e.g., those focused solely on promoting wellness)2. As part of the Digital Health Innovation Action Plan, the FDA is also exploring the creation of a Software Pre-Certification program, which is currently in development for software as a medical device as a pilot7. By developing an oversight process and mechanisms that take into account a developer’s capability, a streamlined review of the product’s analytical and clinical performance, and the products’ real-world performance, the agency believes that a regulatory model as envisioned in the Software Pre-Certification Pilot program can be designed to keep pace with digital health advances and provide a reasonable assurance of safety and effectiveness. DIGITAL HEALTH INNOVATION FOR COVID-19 Several milestones demonstrate how thoughtful regulatory strategies can advance the development of digital health products. For example, the FDA cleared the first-ever digital health therapeutic in 2018, and has cleared several products since then, most recently a game-based therapeutic for attention deficit hyperactivity disorder8,9. Additionally, the agency has continued to iterate on its Software Pre-Certification Pilot program, publishing an update on initial lessons in 202010. However, the onset of the COVID-19 pandemic has dramatically and rapidly increased the value proposition of digital health, with unprecedented adoption and utilization of new software tools and digital platforms by payers and providers to meet patient needs during the public health emergency. The FDA has sought to expand access to clinically-appropriate, low-risk digital health tools during the COVID-19 pandemic by stating its intention not to enforce certain regulatory requirements for some devices. U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. ✉email: 1 Seoul National University Bundang Hospital K. Kadakia et al. 1234567890():,; 2 A clear use case of regulatory flexibility is mental health care. Research indicates the pandemic has taken a toll on the wellbeing of many Americans, with the number of adults reporting symptoms of psychological distress more than tripling in April 2020 compared to April 201811. To address the enhanced mental health burden, the FDA issued guidance to temporarily expand patient access to digital health therapeutics for psychiatric disorders12. Under this policy, FDA stated its intention not to object to the distribution and use of such devices (e.g., computerized behavioral therapy, mobile medical applications for mental health) for the duration of the public health emergency without the submission of a premarket notification under Section 510(k) of the FD&C Act or compliance with other requirements, such as those for Unique Device Identification. Likewise, experts are concerned about the health (...truncated)