Apple officials said the IT industry may have a "moral obligation" to "do more" with health sensors and other similar devices in a conversation held in December with U.S. Food and Drug Administration officials.
The conversation--which was made public three months after a Freedom of Information Act request to the FDA by Apple Toolbox--focused on the federal agency's mobile medical application guidance, issued last fall. FDA Commissioner Margaret Hamburg, Center for Devices and Radiological Health Director Jeffrey Shuren and Bakul Patel, a senior policy advisor to Shuren, all participated in the discussion.
The Apple contingency, according to a memorandum of the meeting, called the guidance "a step in the right direction," expressing to the FDA that they wanted to ensure the company's goals were in line with the agency's efforts.
Apple, of course, unveiled its HealthKit offering at the company's Worldwide Developers Conference in San Francisco last week. HealthKit aims to serve as a virtual service framework to foster data sharing between patients and medical professionals, third-party devices such as Nike's FuelBand wearables and medical institutions; an initial partnership with the Mayo Clinic was announced.
Much of Apple's conversation with the FDA also focused on how the agency would hypothetically regulate efforts, such as glucometers, which were infamously a part of HealthKit's unveiling, according to a blog post published to Rock Health's website by Integrated Plasmonics Research Director Aaron Rowe. As Rowe pointed out, a slide that appeared toward the end of Apple's presentation displayed incorrect metrics for diabetes management.
Both MobiHealthNews and 9to5Mac speculated that Apple wanted clarification about how such regulation could alter the regulatory status of wearable devices, presumably to use in finalizing designs for its rumored watch offering, predicted by Nikkei Asian Review to hit the market by October.
To learn more:
- here's the memo, courtesy of Apple Toolbox
- check out the Rock Health blog post
- here's the MobiHealthNews post
- read the 9to5Mac post
- here's the Nikkei Asian Review article