The U.S. FDA has now revealed several companies that it says will help “shape a better and more agile approach” on digital health technologies. The announcement itself was made via the agency’s official website on September 26 and nine different companies will be taking part in an FDA digital health software pre-certification pilot program with the goal of adjusting regulation surrounding digital health technologies. The companies chosen for the Pre-cert pilot program include major players in both the tech and health industries, such as Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool, Verily, Apple, Fitbit, and Samsung.
The goal of the program is to receive input and feedback about how various regulations impact the rapid advancements that can be and are being made in terms of health-related software solutions and technology. More specifically, the FDA is looking to help fix problems with regulation that can arise because of the iterative nature of modern technologies. That should, in turn, allow the FDA to be more comprehensive and effective in its own responsibilities, as it pertains to providing oversight to the industry. As part of the push to accomplish those goals, the companies have agreed to give the FDA access to the various methods and measures they use to create and test those health solutions. That’s in addition to providing information about how post-market data is collected. Taking things further, the companies also needed to agree to allow FDA officials to make on-site visits to inspect the companies’ operations.
The fact that the FDA would want to become more involved in modern technology shouldn’t come as too much of a shock since many in the tech industry have begun finding ways to provide users with pertinent health-related information. Beyond that, the agency is already responsible for providing oversight for any products that emit any kind of electronic radiation, which technically encompasses smartphones and connected wearables. The Pre-cert program won’t be taking place out of the public eye or without external feedback, either. Public updates about the program will be shared through the associated website and at stakeholder meetings. A workshop is also planned for sometime in January 2018. Feedback will also be taken from others in the industry, stakeholders, and the general public.