As Apple, reportedly, goes to market with iWatch, they’re also meeting with the FDA, supporting rumors of iWatch’s advanced medical potential.
Apple’s iWatch, currently the subject of industry rumors and consumer curiosity, is poised to transform the healthcare industry. Pundits have speculated that the iWatch will be able to provide a wide range of medical data for everyone from runners interested in peak performance to emergency room staff who need quick stats to treat patients. From heart rate and hydration statistics to glucose levels for diabetics, the iWatch promises to innovate the industry.
Apple seems to understand very well that their biggest hurdle in getting to market with iWatch’s medical technology could be the United States Food and Drug Administration (FDA). The FDA defines mobile apps/devices as “software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.” (7) Because iWatch medical technology could potentially pose a risk to the people who might use it, the FDA may need to review any iWatch medical applications prior to launch.
It’s likely that Apple has had its eye on this hurdle for a while. In fact, Apple executives have been meeting with FDA officials since shortly after the April 2010 launch of the first iPad.
Apple executives knew there was a huge potential for the iPad in the medical industry. From the moment iPad launched, medical professionals, embraced the iPad, and by July 2010, more than 2,000 medical apps populated Apple’s App Store. (3)
As the potential for the iPad as a player in the medical industry was growing, Apple was cultivating a relationship with the FDA. According to the FDA’s public records, Apple and the FDA have met three times, first on April 8, 2010, to talk about “medical applications” (5) and again on June 11, 2010, on the topic of “medical devices”. (6)
The FDA’s job is to balance public safety with the public interest. After these two meetings, in July 2011, the FDA released its first iteration of definitions and guidelines for Mobile Medical Applications. (8) By September 2011, Apple launched a section called “Apps for Healthcare Professionals” in its App Store (4) with healthcare-themed apps for reference and education as well as more advanced apps including electronic medical records (EMR), patient monitoring, and imaging.
The waiting game
Apple executives were back at the FDA in December of 2013 to discuss “mobile medical applications”, a clear indication that Apple has moved into the health monitoring technology arena enough to know that they need to talk with the FDA at length.
The FDA has been refining its definitions and policies surrounding medical applications and devices. “Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risk if they do not operate correctly,” stated a recent FDA press release, adding, “The FDA’s tailored policy protects patients while encouraging innovation.” (2)
The press release continued:
The FDA is focusing its oversight on mobile medical apps that:
- are intended to be used as an accessory to a regulated medical device – for example, an application that allows a healthcare professional to take a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
- transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.” (2)
Certainly, some of the functionality that iWatch is rumored to aspire to falls under the FDA oversight guidelines for medical mobile devices and apps, subjecting Apple to the same FDA scrutiny as other manufacturers.
How would FDA regulations, review, approvals, and processes impact the release of a medical version of Apple’s iWatch? Take the case of the Smart Body Analyzer, a product by Withings that measures weight, body fat percentage, and heart rate, and syncs with smartphones and iPads. Withings waited for almost three years to get FDA clearance to launch.(1) Apple’s more sophisticated functionality could mean a longer approval time by the FDA, but perhaps by meeting with the FDA in the development stages, Apple will have bought some time as it goes to market.