The two sessions were moderated by Bakul Patel | Director for the Digital Health Center of Excellence (DHCoE)
On September 22, 2020, the FDA established the Digital Health Center of Excellence (DHCoE) which is a new evolution of the Digital Health Program under the Center for Devices and Radiological Health (CDRH). The DHCoE is intended to serve as a resource for digital health technologies and policy in order to provide technology developers and stakeholders guidance to rapidly deliver high-quality digital health technologies to patients. The ultimate goal is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.
In order to allow digital health device manufacturers, developers, health care providers, researchers, and other stakeholders to learn about the Digital Health Center of Excellence (DHCoE), the FDA hosted two virtual learning sessions in late 2020. The FDA intends to collect feedback from attendees from these sessions and hopes that the DHCoE framework can be further iterated and optimized.
The main aspects that the DHCoE operates on include Policy and Tech Support, Strategic Partnership, Strategic Initiatives, and Policy Development. The main focused areas that the DHCoE have been working on to develop international harmonized regulations are SaMD, SiMD, virtual reality, digital biomarkers, and other AI applications.
The sessions were moderated by Bakul Patel, the director for the DHCoE, and representatives from different disciplines in digital health care, including Center for Devices and Radiological Health, AdvaMed, Rene Quashie, Consumer Technology Association, Digital Therapeutic Alliance, Tour de Heart, Rock Health, University of Rochester Medical Center, American Medical Association, Pharmaceutical Research and Manufacturers Association, Keck School of Medicine of USC, and Yale University-Mayo Clinic CERSI. The panel discussion involved clarifying regulations (e.g. stakeholder education, expected clinical data), building partnerships within the community, amplifying the new technology innovations, exploring the clinical needs and challenges, adapting telemedicine, and addressing the gap between healthcare providers and technology manufacturers.
During the discussion, panelists praised and advocated for international harmonized standards and the frameworks from the FDA. A great example is FDA’s interaction with IMDRF on SaMD standards and the eventual adoption of the framework. The discussion between the panelists and the participants mainly focused on the unmet needs surrounding digital health developments.
One prioritized topic of discussion was the convergence of digital technologies blending with drug development and overall disease management. Panelists and participants encouraged the DHCoE to help clarify the clinical trial requirements for digital-based therapeutics and digital diagnostics, such as types of clinical trials, types of endpoints, control arms, etc. Moreover, both the industry and academia called for clarifications on trial designs between digital health and either traditional devices or traditional medications/therapies. The FDA has recognized this need and agreed that a more definitive regulatory pathway can lead to much more insight on planned activities and precise capital recourses.
Another discussion was regarding how digital health technologies and innovations are going to enable new channels for both healthcare and wellness delivery. In addition, healthcare providers want to know how they will get paid for using these new technologies. For instance, the idea of a parallel regulatory review with CMS reimbursement review can occur, enabling an innovator to make investments in evidence generation that is both clinical in nature for safety and efficacy and economic data as signals to the private payer market that accelerates adoption.
The DHCoE provides service to both internal and external of the FDA. There are three levels of services:
CDRH Specific: lead strategic direction in digital health, build best practices and resources, coordinate policy developments
FDA-Wide: support the agency with training, promote collaboration across FDA, amplify regulatory science research in digital health
External to FDA: provide clarity on regulation, facilitate international and domestic partnerships, comminute between the FDA and external organizations
In order to bring the benefit of digital health to the public efficiently and collaboratively, the DHCoE has developed a roadmap, containing three phases:
Phase I: Communicate
Collect voices and needs from the stakeholders
Update and develop resources for FDA staff
Phase II: Coordinate
Build partnerships for policy, regulatory science, and fellowships
Develop resources and community for stakeholders
Phase III: Amplify
Update and implement a regulatory framework for digital health
Harmonization with international regulators
Overall, the listening sessions are very provocative discussion with policymakers, and it is exciting to see bi-directional communication happening in the future. More information can be found on Webinar – Digital Health Center of Excellence Listening Session #1 – Slides and Webinar – Digital Health Center of Excellence Listening Session #2 – Slides.