Does Apple's HealthKit prove FDA guidance is working?

By Anthony Brino
05:08 AM

Skepticism remains over the Food & Drug Administration’s regulation of mobile health. The approach will just slow innovation, as Scott Gottlieb, MD, an American Enterprise Institute analyst and former FDA deputy commissioner, argued recently in the Wall Street Journal.

If Apple’s optimistic plans for the Health Kit mobile suite are any indication, though, the FDA is doing well so far in its risk- and discretion-based regulatory framework, subjecting mobile apps to the same standard as medical devices.

True, from a regulatory or product development standpoint, it may not be as easy for a tech startup to launch a mobile healthcare app as it is to build an app for finding the nearest food truck. But the FDA’s guidance on what it will and will not examine through device classification and premarket clearance processes is looking like it will be able to accommodate Apple’s much-hyped healthcare product, along with many more basic and advanced diagnostic, monitoring and engagement tools to come.

Since releasing the final framework last fall and meeting with Apple executives this past winter, the FDA has been occasionally updating its guidance and adding new examples of app functionality that won’t have to go through premarket approval, which of course can be a lengthy and protracted.

[Related: Top 5 Government Health IT stories of the summer.]

Among a few of the examples added to the list this year are apps that show drug-drug interactions and safety information, and one that should be relevant to Apple’s HealthKit: “Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a healthcare provider, or upload it to an online (cloud) database, personal or electronic health record.”

That’s good news for Apple and its venture with IBM to bring the best of consumer, mobile and enterprise technology to clinicians and health systems — one end goal being a Siri-ready Watson for physicians evaluating complex treatment decisions based on extensive datasets across multiple sources.

Already in the works, not slowed down by FDA regulation, is a mobile ultrasound app that the Cleveland Clinic is piloting, letting patients, such as expecting mothers, take ultrasounds of themselves and then send the images to clinicians for evaluation.

Now, the FDA is trying to give the greater mobile health community more clarity on what will likely not require premarket device submissions, proposing discretionary oversight for consumer-and clinician-facing apps and app devices, covering areas like body thermometers, stethoscopes, audible first aid kits, hearing aids, and fertility diagnostics.

Bradley Merrill Thompson, a lawyer counselling the mHealth Regulatory Coalition, told sister site mHealth News that the proposal is "a huge boost the to mHealth industry.”

All along FDA leaders have said they believe that mobile health apps have “great potential,” and that they want to “encourage innovation by providing clarity and predictability,” applying the most scrutiny only to apps with the most potential for adverse and unintended outcomes.

Meanwhile, Apple is stirring considerable expectations for its newest products, whatever they are: “9.9.2014: We wish we could say more,” the company teased recently, announcing its next event.

Perhaps almost as excited as Apple fans are mobile health proponents, wondering about the potential for Apple’s Health Kit and the innovations it may inspire — and how to make the FDA’s role work in years to come as technology advances.


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