The FDA has released a range of decisions regarding the agency's role in regulating digital health technologies since Scott Gottlieb, MD, assumed the role of commissioner in May.
Here are three highlights from the FDA's year in digital health.
1. Defining when software is — and is not — a medical device
In December, Dr. Gottlieb released three policy guidelines outlining the agency's approach to digital health oversight, including a long-awaited draft guidance on clinical decision support software.
Under the draft guidance, the FDA would continue to oversee software programs that analyze data to make treatment recommendations or diagnoses. However, software that allows a user to "independently review" the basis for its recommendations — such as CDS that suggests clinicians order particular tests based on existing guidelines — would be excluded from FDA regulation.
Another draft guidance laid out the FDA's determination that many existing digital health technologies — such as mobile health and lifestyle apps — fall outside of the agency's purview, since they "pose a low risk to patients," according to Dr. Gottlieb. The third policy, a final guidance, established risk-based principles for regulators to use when evaluating the performance of Software-as-a-Medical-Device services.
2. Launching the 'pre-cert' pilot program for digital health
At MedCon, a Cincinnati-based medical device conference that took place in May, FDA official Bakul Patel shared plans for the agency's digital health unit. Mr. Patel, associate director for digital health at the FDA's Center for Devices and Radiological Health, said the new unit would consider establishing pre-market approval and clearance pathways for digital health products.
These plans came to fruition in July with the launch of the Pre-Cert for Software Pilot Program, part of the FDA's Digital Health Innovation Action Plan. The pilot aims to streamline approval for digital health technologies by reviewing developers, rather than individual products. Pre-certified developers would collect post-market data on their products, which the FDA would use to confirm product safety.
In September, the FDA released the names of the first nine digital health companies to participate in the pilot program, which included tech giants like Apple and Fitbit.
3. Expanding the agency's digital health team
Following the launch of the agency's digital health unit, FDA officials began seeking team members to offer additional insight into trends like cybersecurity, interoperability and mobile health.
In August, the FDA invited digital health experts to apply for its entrepreneur-in-residence program. Fellows selected for the six-month program, which the FDA established to support its Pre-Cert for Software Pilot Program, work on-site at the agency's Silver Spring, Md.-based campus, analyzing software and developing data collection models, among other tasks.
One month later, the FDA began advertising for an adviser to join its digital health unit. The selected digital health adviser, also advertised on USAJobs.gov as an "interdisciplinary engineer," marked the first in a set of hires the FDA planned to add to its digital health team, an FDA spokesperson confirmed to Becker's Hospital Review via email in September.