FDA Commissioner Scott Gottlieb trumpeted the agency’s “modern and flexible” approach to digital health regulation when speaking at Health Datapalooza last week.  As we have written about here, FDA has announced multiple initiatives over the last several months designed to clarify the regulatory considerations around new and emerging digital health technologies.  Last week’s speech continued this march, including the following highlights:

Digital Health Innovation Action Plan

Commissioner Gottlieb announced a new policy that streamlines the path for digital health products that contain several functions, some of which are subject to FDA medical device regulation, and some of which are not.  The new guidance, available here, attempts to clarify where FDA will and will not be reviewing certain software functions.  As expected, the focus of the agency’s review will be on the safety and effectiveness of higher-risk medical device functions that diagnose or treat patients.

Pre Cert 1.0 Coming by End of 2018

Last September, FDA announced its “Pre-Cert” pilot program, which focuses on the company’s program of design, testing, validation, operation, and maintenance rather than the features of a specific product to determine whether a company can be “pre-certified.”

Last week, Commissioner Gottlieb announced an update – the release of a Working Model of the program.  It is designed to be a first of several iterations, each informed by input from developers, patients, providers, and the public.  Commissioner Gottlieb said that FDA is committed to launching “Pre Cert 1.0” by the end of 2018, with further refinements in 2019.

Artificial Intelligence (AI) Regulatory Framework and Digital Health Incubator

Commissioner Gottlieb described AI as “one of the most promising digital health tools” and advocated employing the Pre-Cert approach to allow companies to make minor changes to their devices without having to make new submissions each time.  Given this potential, Gottlieb announced that FDA is “actively developing a new regulatory framework to promote innovation in this space and support the use of AI-based technologies.”  He stressed that the regulatory structure must be sufficiently flexible to keep pace with the field.

Consistent with the use of AI and machine learning to inform healthcare diagnoses and decisions, Commissioner Gottlieb announced the creation of an internal data science incubator called the Information Exchange and Data Transformation (INFORMED).  The initial focus of the incubator will be, among other things, “the conduct of regulatory science research in areas related to health technology and advanced analytics related to cancer.”  The project will also involve collaborations with Project Data Sphere, the National Cancer Institute, and Harvard University.

Drug Development and Safety Reporting Announcements

Commissioner Gottlieb announced two initiatives relating to drug development and safety.

  • First, in light of the multiple use cases for digital health and prescription drugs, new guidance will be released to address the role of digital health in drug development.  Specifics on timing were not mentioned.
  • Second, a new Premarket Digital Safety Program is underway to enable a unified data standard for meeting electronic reporting requirements under the expedited safety reporting regulations of an Investigational New Drug Application.  The new digital submission process is intended to eventually replace the paper-based system which Commissioner Gottlieb characterized as a “fragmented analog workflow.”

We will continue to follow FDA’s evolution in the regulation of digital health and keep you updated here.