To better align the FDA with the rapidly changing digital health environment, last year the agency opened the Digital Health Center of Excellence (DHCoE).
link: https://www.fda.gov/medical-devices/digital-health-center-excellence

The launch of the DHCoE further solidifies the agency’s dedication to the advancement of digital health technology, such as mobile health devices, SaMD, wearables that are used as medical devices, and technologies that are now commonly used to study medical products.

The DHCoE serves various stakeholders—including patients, developers, healthcare providers, researchers, industry, payors, other government agencies, international regulatory bodies, and other centers within the FDA—and is tasked with empowering these digital health stakeholders to advance health care by fostering responsible, high-quality digital health innovation.

Digital health tools and technologies fall under the FDA’s definition of devices, which
are instruments used in the “diagnosis, cure, mitigation, treatment, or prevention of disease, or that affect the structure or function of the body.” The FDA has the authority to regulate medical devices, including software that is considered a medical device.

This type of software, termed Software as Medical Device (SaMD), is defined as “software intended to be used for one or more medical purposes without being part of a hardware medical device.” SaMD can be used in a variety of platforms, such as medical devices, general computing platforms, and virtual networks.

A few examples of the many types of SaMD include software that:

  • Helps radiologists and clinicians find and diagnose a cardiovascular condition by analyzing magnetic resonance imaging scans
  • In the form of a mobile app, takes input from a blood glucose meter and a patient food log to provide insulin dosage recommendations for diabetes
  • Analyzes a patient’s medical history and diagnostics data to determine the correct drug to prescribe
  • Performs image processing to detect cancer
  • Regulates an installed medical device, such as a pacemaker.

Examples of technologies that are not considered SaMD, and therefore are not FDA-regulated, include Electronic Health Records (EHRs), software that provides administrative support to health care facilities, and technologies considered low-risk, for example, tools, such as fitness apps, that encourage a healthy lifestyle.

Link to further info
https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

In June 2021, the American College of Surgeons BULLETIN featured an interview with Bakul Patel, director of the DHCoE, who described its role in advancing and realizing the potential of digital health.
link: https://bulletin.facs.org/2021/06/the-digital-transformation-in-health-care-the-fdas-perspective/#FDA_regulation

He was asked how medical societies could collaborate with the FDA—for example, to partner with the FDA as contextual clinical experts to verify SaMD?

Mr Patel replied, “Physicians and medical societies can contribute to the FDA’s review of digital health technologies in several ways. The FDA is actively seeking the specialty society and physician perspective on what tools and information would be most useful in driving improvements and advancements in clinical care and the format in which the information should be expressed. Using AI/ML as an example, understanding where physicians see the benefits of this technology in their practices is crucial to help build trust in the capabilities of the technology, leading to broader use.”

He added, “Feedback about why physicians decide not to use or do not trust some digital health technologies also would be useful as the FDA approves and clears these products. This feedback is crucial when the FDA evaluates the benefits and risks of these nontraditional digital health tools, because they are not as widely accepted and understood by physicians, compared with devices such as implants that have been used for many years. The FDA would use this feedback to continue investigation and research to create more practical and useful digital health tools.”

Finally, Mr. Patel noted, “In addition to using feedback mechanisms to collaborate with the FDA, specialty societies should continue to engage and educate their membership about the roles and responsibilities of the FDA and the DHCoE. Education and engagement with the FDA will help drive a greater understanding of how new digital health tools have the potential to improve many parts of care and improve efficiency and care coordination.”