WWDC: Apple's HealthKit is certainly going to kick start the market for health-related apps and devices, but you can't yet guarantee these solutions will actually keep you healthy. Here are four reasons why:
The FDA recognizes the need to regulate mobile medical apps, but its current framework is "risk-based," meaning while solutions promising support for specific problems will be regulated, general purpose health-related solutions may not be.
This means consumers will be unable to rely on the solutions presented to them as they will not be able to be certain if the advice their app gives them is based on good science. A consumer choosing a health-related app from any app store on any mobile platform will need to check on what scientific evidence the solution they are looking at is based.
There is also a danger of over-simplification. While apps will offer generic health and advice data, it is unlikely they will be able to deliver customized advice for people who might suffer from other conditions that may require varying health maintenance regimes. Then you hit the hurdles of data protection.
UPDATE: It looks like Apple is working to be in tune with the FDA on what it creates within Healthbook.
There's a dream that patients may one day be able to make their entire medical histories available to the solutions they use, if they choose to do so. That would enable these solutions to develop user-centric health programs that reflect the needs of individual users, and enable these apps to give early warnings of imminent problems.
The barrier to this dream is that patient health records are not available in consistent formats that can be accessed by third-party medical solutions. In the UK, the former CEO of the Institute of Immunology told me patient health records are "a mess."
This is important because until such records are made available in useful formats, patients will not be able to use mobile medical solutions to deliver the depth of personalized health monitoring and advice that could truly make a difference to their lives. This undermines the potential of mHealth.
The need to build solutions based on good science and good information is certainly understood by professionals in the field. Unfortunately, lack of regulation or vetting procedures will open the floodgates for less ethical developers eager to make a few bucks by climbing aboard the mHealth gravy train. I expect we will experience a deluge of second-rate apps based on poor science that may actually cause health problems to users who have not looked into the integrity of the concepts these apps are based on.
These second-rate apps will be a problem for health-conscious consumers, who must spend time figuring out which apps they can trust.
One way in which consumers may be able to sift through these apps will be to check whether the software is HIPAA-compliant. Serious developers will be aware of the impact of HIPAA on their software, and will have worked to achieve compliance. Cowboys are less likely to do so, as it is a complex process those seeking a quick buck will probably avoid.
As health-related solutions evolve, they will inevitably become capable of intelligent diagnosis of conditions, including those users may be unaware of. That's great if it saves lives, but appalling if the concepts used to deliver diagnosis are based on inaccurate science -- creating fear and wasting valuable medical resources.
Apple can easily solve all these problems.
Apple has already invested in a team of highly experienced medical professionals to help it develop HealthKit. The company is also working closely with the FDA. The App Store review team could easily include a team of medical professionals tasked with checking the medical science used in development of every HealthKit-compatible solution, rejecting any which don't make the grade. This seems a logical step, as until quality control is applied to health-related solutions, consumers will be unable to easily tell whether an app or service will truly improve their health. And the mobile healthcare revolution will be over before it begins.
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