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Summary:

Happtique, a New York company building a certification program for mobile health apps, on Wednesday will release its final set of standards for developers.

mobile health
photo: iadams

With an estimated 40,000 mobile health apps (PDF) available for doctors, consumers and others in healthcare, it can be hard to separate quality apps from, well, crap.  A November report from the New England Center for Investigative Reporting highlighted the number of apps that over promise and under deliver. And while more doctors are using apps to monitor patients or check information, there are still valid concerns about reliability, privacy and security.

To help give hospitals and health care providers more clarity around the good, bad and ugly in mobile health apps, New York-based Happtique has been working on a certification program for mobile apps and on Wednesday plans to release its final set of standards.

“One of the things I hear all the time when I’m dealing with providers and institutions is ‘hey, there are so many apps out there, how do we know which ones have just even been looked at by clinicians? … Or within [a category] ‘how do we decide which ones that we’ll use or recommend to patients?’,” said Ben Chodor, CEO of Happtique. “They just need somewhere to turn where at least these apps have been peer-reviewed and scanned so we know that they’re safe.”

In the past year, Happtique has enlisted experts and patient advocates to serve on its standards committee, and it’s met with hospital and medical associations and government agencies to hear their feedback. Last July, it released a draft of its standards to give developers, care providers and other health care professionals the opportunity to comment.

The final standards released Wednesday cover not only technical performance, including operability, privacy and security, but content standards. For example, they encompass issues like the credibility of an app’s information and sources, the fairness of its description and claims, compliance with rules and regulations and advertising disclosures.

Chodor said they’re intended to give health care providers and consumers a Good Housekeeping-like “seal of approval” to look for, as well as provide app developers a set of guidelines to build to and a way to show customers their value.

The Food and Drug Administration is still expected to hand down its own guidelines — and Happtique says its standards will shift to follow federal regulations. But the FDA will only cover some mobile apps, leaving others in a gray area still helped by an industry standard, Chodor said, adding that Happtique could also be a feeder to the FDA.

Still, even though mobile health could certainly be helped by standards, some argue that Happtique’s plan is unfolding a little too early because there aren’t enough good apps worth filtering out. And, in the vast and quickly growing world of mobile health, Happtique will have to establish itself as a trusted, known name. But its pedigree and partnerships will likely serve it well — not only did it grow out of the hospital community (it was incubated in the venture arm of the Greater New York Hospital Association), it’s signed on impressive clients, including Mount Sinai Hospital, Hospital for Special Surgery and St. Lukes Houston.

While Happtique’s final guidelines will be released Wednesday, it won’t start taking submissions from developers until this spring. At that time, app developers interested in certification will pay $2,500 to $3,000 and then it will go to third-party partners for review. The Association of American Medical Colleges and the Commission on Graduates for Foreign Nursing Schools (CGFNS), a credentialing authority for healthcare professionals, will review the content and Intertek will scan for technical performance.

  1. Thanks for sharing this interesting article Ki Mae!

    “when I’m dealing with providers and institutions is ‘hey, there are so many apps out there, how do we know which ones have just even been looked at by clinicians? …”

    I wonder if these providers and institutions encounter similar problems when they are in the market for buying text and reference books? Does the librarian at the Mount Sinai Hospital for example refer to a certification body that tells them what is a good book or not or do they just use their professional expertise, connections and good judgement?

    Clinicians I know here in Europe who use a lot of smartphone apps started out several years ago with the well known brands eg. text & reference book apps that are produced or at least branded by the familiar medical publishers. They then find more in their specialist areas using their indepth knowledge, reading of subject matter publications and personal connections to make judgments. When they find good apps they again use apps to share these with their colleagues (eg. via Doctor community websites like Doctors.net.uk in the UK).

    Is the US market very different from here in Europe? Do Healthcare Professionals in the USA not trusted online sources of medical education, research and communication?

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  2. Is a certification process really required?
    I think that if there’s an actual care element involved with app – where care is being administered or recorded through the app – then it out to undergo FDA device certification.

    Beyond that, it should be up to the company that has developed the app to prove it’s efficacy to hospitals and provider groups. As is true of any business, healthcare or otherwise.

    The only thing Happtique can really offer is determining if the app follows certain security measures but those are somewhat ill defined right now and I think if the company shows they have followed the regulations with good intention, that should suffice.

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