The FDA has several centers of excellence, and it recently added to the roster of these programs with a new Digital Health Center of Excellence (DHCoE). Despite the energy and fanfare applied to the unveiling, the DHCoE is still a work in progress, although it signals a recognition that existing FDA programs won’t suffice to keep pace with this fast-moving technological space.
The FDA’s Sept. 22 press release characterizes the launch of the center as a critical step in the agency’s commitment to advancing digital health technology, which encompasses several product categories. The list includes wearables, software as a medical device (SaMD), and technologies that are used to study medical products. Commissioner Stephen Hahn said establishment of the DHCoE is “the next stage in applying a comprehensive approach to digital health technology,” although much of the early emphasis will be on technical assistance to both internal and external stakeholders.
Bakul Patel, who has held the directorship of the digital health office at the Center for Devices and Radiological Health (CDHR) for roughly a decade, will serve as the director of the DHCoE. However, the FDA statement makes clear that Patel will have his hands full. Under his leadership, the center will launch an unspecified roster of strategic initiatives, which will include supporting CDRH with its roll-out of the PreCert program for SaMD.
DHCoE Not Involved in Premarket Reviews
The agency posted an FAQ about the DHCoE, which clarifies that the center will not be responsible for premarket reviews, but will assist the CDRH director in establishing priorities for regulatory science research. In addition to assisting in the PreCert program, the DHCoE will work toward harmonization of digital health regulation with other entities, principally the International Medical Device Regulators Forum (IMDRF).
The DHCoE is part of CDRH, but will work across product centers to assist agency-wide efforts, a particularly important consideration given the role digital health will continue to play in areas such as patient medication management. This was the subject of a November 2018 Federal Register notice, and true to form, the agency’s proposal for how such software might be regulated proved controversial, demonstrating once again that regulation of digital health is vastly more complicated than might be readily apparent.
The process of standing up the DHCoE will be anything but simple, as depicted in the FAQ as a three-phase program. Phase I will generally be focused on raising awareness and engaging with stakeholders. Among these activities, slated for autumn 2020, are:
- Conducting listening sessions with stakeholders;
- Commence operationalization of outcome measures for the center; and
- Development of resources for agency staff.
The second phase, which will run through winter 2020-winter 2021, will be dedicated to partnership development, which will require formation of a series of advisory groups. Whether this will include a digital health advisory committee is not explained, but CDRH’s roster of advisory committees would seem to suggest that a digital health advisory committee is a virtual inevitability.
Phase III of the DHCoE program is intended to build and sustain capacity, which includes updates to existing regulatory frameworks and the implementation of novel ones. This section also lists the objective of increasing harmonization with other regulatory entities, although there is also an acknowledgement that the agency will have to hire additional staff with expertise in the field to handle this ambitious agenda.
Another webpage for the DHCoE lists the services the center will offer once it is established, which includes cybersecurity and further development of the discussion paper for artificial intelligence (AI) and machine learning (ML). One of the organizations with which center staff will engage is the AI World Team at Xavier University, a collaborative community for AI. This community includes a number of non-governmental organizations, including the American Medical Association (AMA) and the Association for the Advancement of Medical Instrumentation (AAMI).
The CDRH Network of Experts program will feature a new addition, the Network of Digital Health Experts, which will advise the agency’s staff on technical questions. These range from:
- Artificial Intelligence (AI/ML);
- Sensors, wearables and the medical Internet of Things (IoT);
- Digital Therapeutics (DTx);
- Mobile networks and wireless communication.
This last item is a consideration of some importance as demonstrated by the agency’s March 2020 advisory regarding a vulnerability in connection with Bluetooth components. These components were demonstrated to be susceptible to hackers when in a low-energy state, and the problem affected several manufacturers of medical devices, including pacemakers and insulin pumps.
Experience with COVID May Be Instructive
One of the consequences of the COVID-19 pandemic has been the development of a less straightjacketed regulatory stance by the FDA. An example of this is the updated June 2020 policy providing enforcement discretion for non-invasive patient monitoring devices, which would appear to fall under the definition of digital health. The policy spells out the circumstances in which the agency will allow developers to make limited modifications for indications for use, product claims, and changes to hardware and/or software, but the policy extends to clinical decision support (CDS) software as well.
Whether the agency’s experience with this and other pandemic-driven policies and guidances will lead to a more relaxed general approach to regulation of these products is difficult to anticipate. In any event, the firsthand experience may give FDA staff a greater level of comfort in dealing with digital health policymaking over the next few years, which will explicitly require a greater degree of innovative thinking on the part of the agency.
Some might argue that formation of this Center of Excellence is overdue, a question that may arise when CDRH hosts two listening sessions, which are scheduled for October 19 and November 12, 2020. The news about the DHCoE demonstrates unmistakably that the agency is keen on engaging with those with a stake in this ecosystem. Stakeholders may be frustrated by the seemingly glacial pace of development of digital health policymaking, but the FDA has clearly heard the frustration, and is undoubtedly responding to the best of its ability at a time when its resources are severely crunched.