“With Apple Inc. and fellow Silicon Valley companies edging further into health care, the U.S. agency in charge of oversight says it will give the technology industry leeway to develop new products without aggressive regulation,” Adam Satariano reports for Bloomberg News. “”
“Bakul Patel, who oversees the new wave of consumer-focused health products at the Food and Drug Administration, said most wearable gadgets such as the soon-to-be-released Apple Watch and health-focused applications for smartphones have a way to go before warranting close scrutiny from the agency,” Satariano reports. “‘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.'”
“Patel said Apple and Google Inc. and other corporations should play a role in screening applications to be sure health-software developers aren’t over-promising the benefits of their products,” Satariano reports. “Both companies have visited FDA headquarters in Maryland to discuss their health initiatives, he said.”
Read more in the full article here.
MacDailyNews Take: This sounds good. Let the fitness devices and apps bloom. The ones that need regulation should, of course, receive it. Apple et al. could identify items (apps, new sensors/features) for the FDA to inspect further and they should keep up a continuous dialog with the FDA, although the risk of trade secrets leaking to competitors or even to the press is concerning.