Apple, Fitbit, Samsung selected for US digital health programme - Mobile World Live

Apple, Fitbit, Samsung selected for US digital health programme

27 SEP 2017

Apple, Fitbit and Samsung were among nine tech companies tapped to participate in a digital health software certification pilot programme run by the US Food and Drug Administration (FDA).

According to the FDA, the programme is meant to help the agency develop a new approach toward digital health technology by changing the focus of certification to the developer rather than the product. The goal, the FDA said, is to home in on key metrics and indicators the agency could use for precertification and lessen the amount of information which must be submitted to the FDA before a new health product can be marketed to the public.

“We need to modernise our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices,” FDA Commissioner Scott Gottlieb said in a statement.

Additional participants in the programme include Verily Life Sciences, Tidepool, Johnson & Johnson, Roche, Pear Therapeutics and Phosphorus. The FDA reported more than 100 companies applied to take part in the programme, but said the nine were chosen based on criteria including company size, record of quality and excellence, clinical focus and product risk.

Apple, Fitbit and Samsung were all among the top five providers of wearable devices in Q1 2017 according to IDC figures.

Reports indicate Apple is working on a project with Stanford Medicine which will use data from its Watch to help identify irregular heartbeats. Verily Life Sciences announced it is developing a smart contact lens which can track a user’s blood sugar levels. Fitbit, already known for its line of fitness trackers, indicated it’s in clinical trials to validate technology to screen for conditions like Sleep apnea and Atrial Fibrillation.

Participants in the precertification pilot have agreed to share with the FDA the measures they use to develop, test and maintain their software products, as well as how they collect post-market data and provide quality management.

The FDA said it plans to share findings from the first four months of the programme at a workshop in January.


Diana Goovaerts

Diana is Mobile World Live's US Editor, reporting on infrastructure and spectrum rollouts, regulatory issues, and other carrier news from the US market. Diana came to GSMA from her former role as Editor of Wireless Week and CED Magazine, digital-only...

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