February 28, 2024

Interesting story that I read on Ars Technica just now about the precertification of software and personal health technology by the FDA. It looks like the FDA is interested in making sure that software and its underlying systems are good for people and accurate for giving people using the hardware on their wrists and in their pockets.

The FDA has partnered with some of the biggest names in health and technology to modernize consumer health devices and programs. The agency just announced the companies who will be the first to participate in its precertification pilot program under its Digital Health Innovation Action Plan. Apple, Fitbit, Samsung, and Johnson and Johnson are among the nine companies included in the program, meaning they will collaborate with the FDA to create guidelines for other companies to get FDA pre-certification based on their digital health programs.

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.

Why Would Pre-Certifying Apps Help You?

This is an interesting development because even on my own Samsung S8 I have an SPO2 (Blood oxygen)  and heart rate monitor. It would be nice to know that these were accurate from someone independent like the FDA, although from surfing various forums it seems as though the Oxygen monitor is fairly accurate as well as the heart rate sensor.

Personal health technology can take many forms and I am seeing it moving into our lives very quickly.

Apple in it’s last release of the Apple Watch was highlighting that they can see a time in the future that you could allow the health information that the watch gets to be sent to a doctor to help a diagnosis.

Of course the science fiction of this is a few years out but at least keeping track of heart rate all the time as well as steps would help now.

What Is The Future Of Personal Health Technology?

According to Scott Gottlieb from the FDA:

As we launch our Digital Health Innovation Action Plan, I am conscious of the fact that apps and app updates come to market every day. But the most powerful feature of this market may not be one revolutionary app but rather a combination of apps that provides consumers and providers with the information they need. This can help people better manage their chronic diseases, which could result in less trips to the doctor for checkups, or better awareness of illness, like prompts to a parent with a sick child on when they need to see a provider.

So it looks like the FDA is definitely seeing the future coming fast and I have to agree. Over the last few years with my phones, Fitbits, and seeing others with iPhones and Apple Watches, I can say that the health benefits of the devices that we carry all the time are very interesting and useful and they will be even more useful as new sensors and software come over the next few years

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