- A three-year trail of emails between Apple and the Food and Drug Administration sheds some light on the tech giant’s future plans in healthcare.
- The emails, obtained by MobiHealthNews from the FDA via a Freedom of Information Act request, include discussions about the 510(k) process, the App Store review process, Research Kit apps, diagnostic apps and keeping Apple apps in unregulated waters, among other things.
- They also hint at three regulated medical products Apple is developing: an app to diagnose Parkinson’s disease and two cardiac devices.
The emails date back to shortly after a 2013 meeting between Apple and the FDA, and show a concerted effort on the part of FDA officials to keep future meetings under the radar. According to MobiHealthNews, meeting names and locations were changed and often omitted from the public calendars of top agency officials, including FDA Commissioner Robert Califf and Jeffrey Shuren, director of the Center for Devices and Radiological Health.
During a January 29, 2014, meeting, Apple briefed the agency on how it vets third-party apps sold in the App Store. The company recently updated its App Store Review Guidelines to make it harder for vendors to market apps that risk causing physical harm — for example, apps that provide inaccurate data or could be used for diagnosing or treating patients.
The emails also show that Bakul Patel, associate center director for digital health at the FDA, invited Apple to participate on a working group on standalone medical software, under the auspices of the International Medical Device Regulators Forum, a group focused on harmonization. The agency sought input from Apple on a new regulatory framework of software as a medical device.
Speculation that Apple is poised for a major thrust into healthcare has been growing with a series of recent high-profile hires and partnerships with large healthcare systems. The company is also collaborating with IMB, Johnson & Johnson and Medtronic on a cognitive computing platform called Watson Health Cloud. In August, Apple confirmed the purchase of digital health record startup Gliimpse.
The emails about cardiac devices could point to a product earlier revealed to be under development. The company has a patent application pending for a new wearable device that can accurately measure electrocardiographic information across different body areas and provide actionable data to doctors.