Apple meets FDA regarding Health Based Services: HealthKit Development?
Apple seems to be gearing up for a venture into the health information business as recent reports have suggested that Apple representatives have met with the Food and Drug Administration (FDA) to discuss just that.
Apple first initiated its health services with the announcement of the new app “Health” which monitors heart rate, blood pressure, diet and exercise. To go one up on other health-based apps, Apple also launched a cloud platform called “HealthKit” that is able to store all these health information, even those from third party apps. There is even talk of collaboration with the doctors at Mayo Clinic in uploading patient information to this database, which once again highlights Apple’s intent on committing to the health market.
With the release of health-related software, HealthKit and Apple Health, Apple is largely expected to be working on the hardware as well. All eyes are on the upcoming iWatch, as it has been stated this device will come equipped with an array of biosensors to improve on health-based monitoring. So far, we do not have anything concrete on whether these rumors are true. Recently revealed information has shown that Apple did in fact contact the FDA regarding their stance on wearable devices bearing biosensors.
Documents obtained through the Freedom of Information Act by Apple Toolbox as well as the FDA public calendar did confirm that meetings have taken place between the FDA and the top brass of Apple including Senior Vice President of Operations Jeff Williams and Vice President of Software Technology, Bud Tribble in December last year. The key topic of discussion was the necessity regulation of medical devices and sensors by the FDA.
Summary of the Apple-FDA meeting, December 2013 (via Venture Beat) :
- Apple to FDA: Sensors already exist on medical devices. For instance, Apple’s devices have cameras and accelerometers. There is still an opportunity to innovate, but Apple wants to make sure they are on the side of the FDA.
- FDA to Apple: 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.
A summary of the meeting stated that regulation of the device depended solely on the intended use of the product. The summary went on to use specifically a glucose meter as an example, stating that if it is marketed for users who intend to generally monitor glucose levels, regulation will not be necessary. However, if the device is marketed specifically for diabetics, then it needs to be regulated. Another interesting fact was the mention of the glucose meter, which could potentially be one of the biosensors that would be on Apple’s next wearable.
What we can get from this meeting is that Apple intends to work as closely as possible with the FDA so that it would not have any regulatory issues when their health-based products are put on the market. Also, it tells us that Apple may have long term plans in the health services field with investments such as cloud based information storage and potentially the introduction of more biosensors.