FDA regulators finally opened up about last year’s chat with consumer technology giant Apple (NSDQ:AAPL), opening the books on a meeting that spurred a lot of speculation about the company’s healthcare prospects.
According to meeting minutes obtained through a Freedom of Information Act request filed by 9to5Mac.com, Apple spoke with the FDA about its "moral obligation to do more" with its technology, especially given the capability of its smartphones to support sensors that may have implications for how users track and view their health.
"For instance, Apple’s devices have cameras and accelerometers," according to the meeting memorandum provided by the FDA. "There is still an opportunity to innovate, but Apple wants to make sure they are on the side of the FDA."
The meeting also lingered on regulatory oversight of mobile healthcare products, with Apple apparently lauding the FDA for its "fair" and "balanced" approach and FDA appearing to assuage the company’s concerns about oversight of the technology used in new healthcare applications.
Even a glucometer would not need FDA oversight, the agency told Apple, unless the device was explicitly marketed for medical use. The agency may get involved after the fact, however, if it sees the device making its way into medical use regardless of how it’s marketed.
"FDA will regulated [sic] based on the intended use of a device. Using the glucometer example, the glucometer may be unregulated if the intent is for a user to follow their blood sugar for the purposes of better nutrition," according to the meeting memo. "If the glucometer is marketed for diabetics, however, it would more likely be regulated as a medical device. FDA looks at how devices are actually used. If the manufacturer advertises the device for an unapproved use of FDA sees a lot of off-label use that is potentially dangerous, FDA may regulate after the fact."
The December 2013 meeting generated a lot of buzz from tech industry analysts who spotted Apple’s emerging interest in the healthcare space, which has also drawn rival consumer electronics companies such as LG Electronics (KRX:066570) and Samsung (LON:BC94).
Apple has been nabbing up experts from companies in the health, fitness and sensor space, and even took a couple along to the FDA meeting, including former Masimo (NSDQ:MASI) chief medical officer Michael O’Reilly. Apple also recently hired a couple of other medical sensor experts, including Nancy Dougherty, formerly involved with transdermal drug delivery devices and wearable vital signs monitoring, and Ravi Narasimhan, who also worked with personal vital signs monitoring.
The company early this year also landed a patent for a smartphone heart sensor, although that application laid out plans to use the sensor primarily for personalization and authentication.
Months of speculation came to a head last week when Apple finally unveiled its rumored “HealthKit” project and "Health" app, which aims to become a mobile silo for personal health and fitness information, including patient-generated data and information generated through various physician portals.
The secretive company has not yet commented on ongoing rumors that its interest in sensor technology will include a new "iWatch" wearable device, which would further feed data into the Health app. Analysts with RBC Capital said in a note to investors this month that Apple may announce a wearable product in October or November this year, and that such a technology represents a "material opportunity" for the company.
Rival phone-maker Samsung has also been making major moves in digital health with the launch of its wearables platform, including the ‘Simband’ hardware and ‘SAMI’ software, made open to developers. Samsung president and chief strategy officer has called digital health the "single greatest opportunity of our generation," adding that the company is on the lookout for new ways to meld technology and health.
