Health-focused apps in the US do not need to go through any screening process before being featured on any electronic device. They simply show up as a part of the product or users can download them from the App Store. These apps may experience a drastic change in the near future. According to a report by Tech Radar, the US Food and Drug Administration (FDA) has announced that health-focused apps will now be required to go through its “Pre-Cert for Software” program before anything else. The list of companies whose products will go through this program are Fitbit, Apple, Samsung, Tidepool, Pear Therapeutics, Johnson and Johnson, Phosphorus, Alphabet’s Verily and Roche.

FDA will set the standards

The Tech Radar report suggests that this test is going to help the FDA establish the expected standard that companies in the market need to reach. The app/product manufacturer must be aware of the principles. The FDA has full authority to visit a company’s manufacturing unit to keep a check on the product’s development procedure. There will be a time when FDA no longer feels that intervention is required. But this will only take place after the trust between the company and the FDA has been established. This is the first time that something like this is taking place in the US.

The FDA thinks that chances are high for this program to be a miserable failure. Thus, they are only introducing it in the form of a pilot program.

Regulations have tended to hamper a product’s development procedure in the past. For example, back in 2015 when Apple was testing glucose monitor software, the FDA pointed out certain add-ons. The making of the app almost immediately stopped. Apple CEO, Tim Cook had said at that time that they don’t want their products to go through the FDA process.

Cook felt that it would hold them back from innovating too much. Putting through the FDA procedure would mean that they are willingly signing up for longer cycles of development.

Glucose monitor app

Apple, however, was successful at developing the glucose monitor app. Earlier this year, Tim Cook was spotted wearing a prototype of Apple’s next-generation Watch.

A report by Tech Radar suggests that the device contained the ability to detect glucose in one’s body. According to a report by The Telegraph, such restrictions have been going on in Europe for long. The European government handles most innovations like this. It is possible that the US is essentially following in Europe’s footsteps.
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