|A mHealth app walled garden: |
enter at your own risk?
Naturally, for time-pressed readers who'd rather not read it all, your PHB is happy to provide this ten point summary.
1) There are more than 40,000 of mHealth apps and the industry is still in its infancy.
2) Despite their faddish sexiness, there is very little hard evidence that many of the commercially available apps to lead to measurable improvements in clinical or economic outcomes. However, some of the underlying technology (such as pedometers) does provide a benefit.
3) The Food and Drug Administration (FDA) will assert its regulatory authority if the app "acts" like a "medical device" or as an accessory to a "medical device." Logging data, retrieving content or communicating won't be regulated, but medication dosing guides or the provision of diagnostic information will be.
4) 3) Little is known about the physician prescribing patterns for apps. We also haven't figured out if or how a patient's access to an app should depend on a licensed professional's approval/prescription.
5) There is a possibility that many currently available apps are putting users' privacy at risk.
6) Little is known about apps' compatibility with electronic health records (EHRs). This may be less of an "ecosystem" and more a bunch of isolated "walled gardens."
7) One vulnerability to any app's usefulness is data overload. Hundreds of food entries, for example, may do little to increase user insight about his or her diet.
8) Other than the FDA and its fussing over apps' medical "deviceness", there is no agency or entity that provides certification for apps. Consumers are on their own, based largely on on-line reviews and word of mouth. One organization tried to do it and conspicuously failed.
9) The time is right to create "guidelines" for app developers, such as how to provide useful data summaries as well as visual displays, maximize patient safety, ensure information accuracy and protect consumer privacy.
10) The time is also right for funding agencies to support research on apps, especially for persons with chronic illness.
Naturally, the PHB offers commentary:
It remains to be seen if the FDA can keep up, especially with apps that are in the "grey zone" between offering advice/possibilities vs. diagnosis/treatment. That shortcoming is vulnerable to overlawyering and regulatory overreach. That means prolonged time to market, increased uncertainty, hampered innovation and the threat of retroactive and potentially capricious reviews.
As you are reading this, many apps are undoubtedly being developed by the population health service providers. It may be time for entities like the Population Health Alliance or stakeholder organized medicine organizations to take the lead in establishing app benchmarks, best practices and guidelines. If they don't lead on this, someone will do it to them.
While vendors that offer apps along with their coaching may be inclined to regard them as proprietary and shield them from the scrutiny of peer review research, apps that are proven to improve outcomes will ultimately rise to the top. It's not just the funding agencies but the companies that offer these apps that have a stake in "proving it," while also advancing medical knowledge for the betterment of all of us.
Finally, wouldn't it be neat if there was a generic mHealth app that could be used by medical homes to facilitate nurse-patient coaching, link the patient to the EHR and enhance communication with providers? If there is one that the PHB isn't aware of, it wants to know about it.
Image from Wikipedia