As Apple, Samsung, and other companies are stepping into the new market of wearable computers packed with sensors, the Food and Drug Administration has decided to take a soft approach to regulating the players of the new market. The move was suggested by earlier reports, but now Bloomberg cites FDA officials giving the green light to heath-focused application developers.
“We are taking a very light touch, an almost hands-off approach,” Patel, the FDA’s associate director for digital health, said in an interview. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”
While the soft approach is good news for developers and manufacturers such as Apple, privacy advocates are closely watching the US Health and Human Services Office of Civil Rights, which is responsible for overseeing the security of patient-health data collected by electronic devices.
As Bakul Patel (the person who oversees the new wave of consumer-focused health products at the Food and Drug Administration) says, the FDA’s guidelines on regulating mobile apps were released in February: Fitness tracking and other wellness-related products (see Apple Watch) are free from any regulation, but technology used for diagnosis, treatment, and prevention will be checked.
“I worry that there are going to be companies that are skirting the rules,” said Malay Gandhi, managing director ofRock Health, a health-focused venture capital firm in San Francisco. “We have to see the enforcement, otherwise it creates a very uneven playing field between companies that are acting ethically and those that aren’t.”
So, if manufacturers market their products as devices assisting doctors in making medical decisions, the FDA will check those products. If you choose Apple’s way, marketing the devices fitness features, the regulator’s guidelines will give you more freedom of movement.
However, the FDA will keep an eye on emerging technologies that aim to diagnose illnesses or even offer recommendations for treatment, says Patel. Apple seems to be in their sight, as Tim Cook said earlier this month that the Apple Watch and HealthKit may be able to help “pinpoint some diseases and cancers in the next several decades”. But that’s the far future.