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FDA Digital Health Center of Excellence

Last month, the U.S. Food and Drug Administration announced the formation of its Digital Health Center of Excellence (DHCoE), a combination of virtual and dedicated resources housed within the Centers for Devices and Radiological Health designed to support developers of digital health products and devices. 

The FDA defines digital health as

"mobile health, health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine" that have the "potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual."

Recognizing that technology is advancing rapidly, and that innovation is promoting interconnectivity between health devices, health care providers, and information systems, the FDA saw a need to reform its own workflows in ways that empower the developers of digital health products with the information needed to balance the risks and rewards of digital health.

The DHCoE is not responsible for reviewing and providing marketing approval for digital health products -- that responsibility remains with the appropriate regulatory group. It does however, aim to align the FDA's goals with regard to digital health and to provide knowledge and expert advice to product developers.

The DHCoE will be focusing on a range of issues initially. By concentrating its efforts on such as the role of artificial intelligence, wearable devices, virtual or augmented reality, digital pathology and others, the DHCoE aims to harmonize the FDA's own efforts and provide enhanced clarity to stakeholders.

By engaging with stakeholders, the DHCoE expects to solicit input ensuring that the voices of developers, patients and others are reflected in its work. Further, the DHCoE will build partnerships with and between stakeholders in order to create a broad community that can encourage interaction and learning. Finally, the DHCoE expects to coordinate with other regulators in order to identify the need for and to facilitate harmonization between regulatory needs and requirements.

The FDA will hold two listening sessions allowing stakeholders and other interested parties to provide input to the development and direction of the DHCoE. The first listening session invited a panel of representatives from the medical device, consumer technology, investor, provider and patient communities to share thoughts and ideas on the goals and outcomes of the DHCoE. 

Panelists applauded the efforts to increase transparency into its regulatory processes and its efforts to coordinate and harmonize efforts across the industry. Stakeholders urged DHCoE to continue forward on its path by developing education aimed at companies that have not historically worked with the FDA and to educate providers and patients alike on the devices that are being used and how they are being used in their own self-management of their health care. 

Acknowledging its limitations, DHCoE recognizes that it must be strategic in how it collaborates and interacts with technology developers. By striving for the best bang for their buck, they want to make sure that it is coordinating with the correct stakeholders. There was acknowledgement that some technology is not regulated by the FDA -- wellness apps for instance, leaving a gap between consumer grade and health grade technology.

Another gap that the group discussed was reimbursement. The FDA recognizes that it does not regulate payer coverage or payment. This potentially leaves a major gap that could negatively impact developers ability to market digital health solutions. If payers are not adequately involved in the policy making process, or if discrepant regulatory requirements are not harmonized, digital health may find it difficult to develop broad payer acceptance. Stakeholders also encouraged a parallel-review like process that would help to remove this barrier.

A second listening session will be held on November 12th to collect additional thoughts and ideas from stakeholders.

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