The head of the FDA’s digital health arm has said that he plans to extend little oversight on new wearable devices like the Apple Watch.
“We are taking a very light touch, an almost hands-off approach,” said Bakul Patel to Bloomberg.
A flurry of questions have begun to bubble over new mobile technologies claiming to have healthcare hooks. While health tracking devices are anything but new, the Apple Watch is expected to bring wrist-worn wearables to the mass market. This has led many to wonder if there should be regulatory oversight.
The questions revolve around what features a device has and what conclusions can be drawn from these features. The Apple Watch, for example, is looking to incorporate a slew of potential health-based features on its device including ways to measure blood pressure, body temperature, glucose levels, hydration, and oxygen level. And devices like these are expected to get only more advanced as time goes on.
Patel says the FDA is looking into is whether a feature on a new product tries to copy what a medical device would do. If the technology is not focusing on diagnosis and treatment, it will likely not be thoroughly examined.
In the past there have been a few brouhahas over tech startups claiming to offer unverified medical services. Most famous was 23andMe, which offered users personalised health reports that were said to provide clues about what future illnesses the users may face. The FDA went after 23andMe last year, telling the startup to stop marketing its testing services.
The FDA considered 23andMe to be exceptionally problematic at the time because it could have been used to help patients and professionals make medical decisions. Wearable devices like the Apple Watch are probably not going to be used for such serious purposes, at least not at first.
All the same, there likely will be a time when the FDA will need to step in. For instance, a wrist-worn device called the Healbe says it can track caloric intake — a claim which led to an onslaught of critical responses. If devices purporting such capabilities become mass marketed, Patel and his team may need add their two cents.
Until then, Patel told Bloomberg that his administration would continue keeping a close eye on devices like the Apple Watch. But they will remain in the backseat when to comes to formal oversight.
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