The Food and Drug Administration (FDA) Digital Health Center of Excellence (DHCoE) held its first listening session with digital health stakeholders on October 19, 2020. Bakul Patel, Director of the DHCoE, stated that advancements in digital health are moving health care from the clinic to the patient. It is essential that innovators in digital health understand patient behavior and focus on wellness and prevention.

A panel of stakeholders urged regulatory clarity for innovations in digital health and adoption of international standards. In particular, the FDA should ensure consistency of approach across divisions of the agency. The industry needs insight into when FDA clearance is required for digital health tools, and when it is not required, and there should be well-defined regulatory pathways. Speakers noted that developers in consumer technology may not be used to dealing with the FDA and will need education on agency processes.

Speakers noted that both patients and the provider community are consumers of digital health. Patients are interested in how patient-generated data can be utilized in the patient-physician relationship, and how patients will be able to manage their data. Several areas for potential collaboration were identified, including:

  • Artificial intelligence (AI)¬†
  • Clinical decision support¬†
  • Quality standards¬†
  • Streamlining of patient/provider communication utilizing digital health inputs.

Slides from the session are available here.