Healthcare Technology Featured Article

August 12, 2014

Apple's HealthKit Readies Appearance Despite Regulatory Hazards

Apple's HealthKit is an exciting proposition for quite a few people, and recently, Apple hit several major healthcare facilities—including the Cleveland Clinic, Mount Sinai and even Johns Hopkins—to talk up just how the service will work and what kind of benefit it will bring when it does arrive. But the talks—joined by Allscripts, who offers up a competing electronic health record (EHR) product to Epic Systems—are said to be only that at this point, and there could be quite a bit of problem awaiting Apple as a mountain of regulatory issues that could well hamper HealthKit before it even gets out of the gate.

Apple's HealthKit offers one major proposition that could impact healthcare as it's commonly viewed today; it seeks to put large amounts of healthcare data into users' hands directly, as well as in health providers' hands. Things like blood pressure and heart rates will go into the mix, and will eventually form a kind of clearinghouse for healthcare data that can be used to make decisions and form plans around improvements in healthcare overall. While this data isn't exactly unknown to users—everything from software applications to medical devices is collecting this data—it isn't being centrally warehoused, and Apple means to provide that warehouse with HealthKit.  That's where the regulators are coming into the picture, and early word says said regulators aren't exactly happy about Apple's plan.

While a host of application and device makers are looking to Apple on this one, it increasingly seems that Apple's HealthKit won't be interfacing readily with the various IT systems that are currently in place. Many of these systems were the systems around which regulations were built, which makes for a distressing prospect: can Apple's plan go through given that Apple seems to be operating off the map, so to speak, when it comes to all the other healthcare systems in place. While Apple seems to be getting a variety of interested partners lining up to join up with Apple's efforts—Cleveland Clinic is actively experimenting with the HealthKit beta version and giving Apple plenty of feedback in response—it still may not be enough to surmount the regulatory hurdles potentially involved with such a setup.

Naturally, Apple has been working with a variety of developers to shore up the security around the collected data, as well as how it's collected, but it's still likely to run afoul of HIPAA standards, particularly if “clinical information” is involved. Data about a run, meanwhile, wouldn't fall under such standards, a point that's leaving some confused. The Office of the National Coordinator for Healthcare IT's former chief privacy officer Joy Pritts elaborated, saying “It is really difficult for consumers to know if their health information is protected by HIPAA because it’s so dependent on the specific facts.”

A regulatory environment where some things are protected and some aren't can be extremely difficult for any company to work with. While Apple, reportedly, is already putting some lawyers and lobbyists to work in Washington to try and make the path a little smoother, it's still a difficult proposition that's going to need a little retooling. Regulatory issues often don't anticipate innovation, which can be a serious problem for innovative companies that want to bring out a new solution to an old problem.

Only time will tell just how well Apple's HealthKit can do in the face of regulatory pushback, but hopefully some accommodation can be reached to allow a valuable new tool to hit the public.

Edited by Alisen Downey

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