Several tech giants are about to make a name for themselves in the world of digital health. Apple, Fitbit and Samsung are among nine companies selected for a pilot program designed to streamline the federal process for regulating and approving medical software.
Some of the world’s most valuable technology companies are moving into the regulated medical sector. And now they have found an important ally from within the federal government.
The U.S. Food and Drug Administration this week said that it will work with nine companies — including Alphabet, Apple, Fitbit and Samsung — to make it easier to fast-track medical software that is deemed to be of low risk through the regulatory approval process. The program is known as the “precertification pilot.”
What that means, according to regulatory experts, is that these companies are moving from wellness (fitness, nutrition and so on) and into the medical market. In other words, if the program proves successful, the Fitbit and Apple Watch of the future won’t simply track step counts, but also screen for medical conditions so users can seek medical help before it’s too late.
According to ArsTechnica.com, “The FDA is trying to make it easier for consumers to have access to approved health devices and programs so that each individual can take more responsibility for their own health. Consumers already use wearable devices and health apps to assess general health and specific medical conditions, even though most of these devices do not bear an FDA-approved stamp. The companies participating in this pilot program will help the FDA narrow down “key metrics and performance indicators for precertification” surrounding a company’s digital health software.”
The FDA released a statement that, in part, read the nine companies selected for the program represent “a wide range of companies and technology in the digital health sector, including small startups and large companies, high- and low-risk medical device software products, medical product manufacturers and software developers.” Those companies are:
- Apple, Cupertino, California
- Fitbit, San Francisco, California
- Johnson & Johnson, New Brunswick, New Jersey
- Pear Therapeutics, Boston, Massachusetts
- Phosphorus, New York, New York
- Roche, Basel, Switzerland
- Samsung, Seoul, South Korea
- Tidepool, Palo Alto, California
- Verily, Mountain View, California
The FDA will use to the program to determine if its possible for companies to submit less information to the agency when seeking pre-market approval for a product, or if some products can skip the step all together.
We’d love to hear your thoughts on whether this program, and the companies involved, can revolutionize our approach to digital health. Can these companies more freely develop new software that will detect certain medical conditions? Generating meaningful dialogue around the health stories making headlines is another way we are working toward our long-term goal of one day making Arizona the Healthiest State in the Nation!