Ben Chodor had the right idea when he initiated Happtique’s certification program. The mobile health industry has produced a lot of apps , but not much in the way of effective independent evaluation. There are plenty of shenanigan apps out there that either don’t do what they say they do or don’t adequately protect users’ data from a hack attack. But in light of Happtique’s move to review its certification program, it seems like a good time to think about what’s missing.
It seems like there needs to be some way to prove that apps actually help people.
When Happtique released its final standards earlier this year, Albert Shar of QERT expressed concern over the lack of standards for efficacy.
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Consumers are the best reviewers when it comes to apps like calorie counters and exercise apps. But if the industry wants to advance them to the point where physicians widely prescribe them , then they need to have the discipline of scientific proof that they help patients and keep their data safe.
Although it’s useful for a healthcare industry in the midst of reform to have tools to reduce costs and improve patient outcomes, those kinds of claims by app developers make some industry insiders’ eyes glaze over.
Bradley Merrill Thompson, a member of Epstein Becker & Green, was the co-chair of the regulatory working group advisory committee for the U.S. Food and Drug Administration’s Safety and Innovation Act over the summer. He said private certification for mobile health apps could spur app developers to produce better, more secure products. As a model, he pointed to Continua Health Alliance, which is developing a certification program for the interoperability of medical devices, including home use medical devices. He said he prefers a private industry solution to government intervention.
“If we could have a really effective certification program, the existence of such a program would reduce the need for FDA to regulate some of these middle risk technologies.”
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He added: “Certification needs to be broad enough in scope to provide real value, and for many apps that boils down to demonstrated efficacy. It’s certainly useful to know that an app works from a software perspective reliably, but it is even more valuable to know that the app can actually improve health.”
Johns Hopkins School of Public Health initiated an interesting program earlier this year. mHealth Evidence catalogs, categorizes and grades mobile health evidence. Its website includes peer-reviewed articles on mhealth activities in developed and developing countries and is curated with sources proactively identified or included based on request.
IMS Health launched App Script at the mHealth Summit and claims that it shows which apps have efficacy data. Its healthcare informatics division produced the report on consumer facing apps this fall. The idea for App Script is that it will serve as a way for physicians to prescribe apps. It generates a score for each app based on ranking criteria including functionality, peer and patient reviews, certifications and its potential to improve outcomes and lower the cost of care. It would be cool if each app showed users what each criteria scored.
People tend to trust their physicians and nurses more than, say, the Internet or insurers or heck, the media. But the only way prescribing apps will become widespread is if these groups believe they are worthwhile.
Happtique made a wise decision when it decided to put the certification program on hold pending a review. Now it has the opportunity to tighten up and bolster its review process.
