It’s no secret that Apple is developing an iWatch as part of its healthcare platform. But all sorts of questions abound as to its potential applications. Apple’s splash into the healthcare market last week revealed some details about an app and its cloud-based platform, but not much more than that. In a new development, a Freedom of Information Act request from Apple Toolbox produced highlights of a conversation the U.S. Food and Drug Administration had with Apple executives in December last year.
The result is a summary of highlights from the hour-long meeting. Apple Toolbox published them on its website.
Basically, Apple wants to work with the FDA and avoid having its mobile health tools fall afoul of FDA mobile device regulation. I found this one revealing the FDA’s thinking on senors particularly interesting:
“Under the current regulatory scheme, FDA will review a device based on the manufacturer’s intended use for the device. With regards to sensors, the presence of a particular sensor will not necessarily lend the device to FDA regulation. Instead, FDA would be more likely to regulate the software that puts the sensor to use, if use of the software alters the device’s use to be a medical device.”
Some other notes added more color on the FDA’s approach to mobile health tools as diagnostic devices, particularly for its use of the example of glucose monitoring.
“The current mobile medical app guidance indicates that FDA does not view apps that are purely educational or informational as medical devices. Apps that actively measure something are considered diagnostic. For instance, a glucometer would be considered diagnostic because it measures blood sugar; it would not be considered merely information although it “informs” the user of the blood sugar level. The display screen of the glucometer would not be regulated, as it only receives the data and shows it. The software that does the measuring is the part that is regulated.”
and
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“FDA will regulated 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. 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.”
That last bit — FDA may regulate after the fact — is probably exactly what Apple is trying to avoid. I imagine the people most interested in their blood sugar, aside from diabetes, are people who suspect they may have diabetes (8.1 million, according to American Diabetes Association) or have pre-diabetes (86 million, according to ADA). Considering the estimates for undiagnosed diabetes, and for pre-diabetes that’s a pretty big market segment. And I suppose technically, they don’t qualify as diabetics so much as people interested in nutrition. It would be interesting to see how the FDA deals with those potential nuances.
The meeting highlights corresponded with news about some of Apple’s sensor patents that are expected to form part of HealthKit. Its app, called Health, will collect body metrics including blood pressure, heart rate, and stats on diet and exercise.
