Collaboratively developed guidelines for the privacy, content, security, design and operability of mobile health (mHealth) apps have been released. Compliance with the guidelines can provide a level of assurance that an app delivers value to patients, physicians and other users.

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The guidelines were developed by Xcertia, a nonprofit founded by the AMA and other major health and technology organizations. They address concerns that have hindered the use of mHealth apps. Fears that an app may expose personal health information, that its content is inaccurate or that its functionality is limited have slowed adoption of mHealth digital health tools.

“We hope the publication of these guidelines will encourage others to begin the process of bringing more order to the evaluation and selection of mHealth apps that physicians and consumers will find to be of real value in their health and wellness journeys,” said Michael Hodgkins, MD, Xcertia chair and AMA chief medical information officer.

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For example, on privacy the guidelines cover notice and disclosure and say that mHealth privacy notices should tell users how an app collects, uses and retains their private health data. That notice “should be unbundled from other information notices regarding the application,” the guidelines say. Which types of data the “the app obtains, and how and by whom that information is used” should also get disclosed.

The Xcertia guidelines also say that apps should be “based on one or more credible information sources including, but not limited to: protocols, published guidelines, evidence-based practice and peer-reviewed journals.” An appendix outlines “a selected number of accepted condition-specific guidelines.” App publishers also should document how they ensure the health content is kept up to date.

Meanwhile, an mHealth app with “tools that perform user or patient management functions, including but not limited to mathematical formulae, calculations, data tracking, reminders, timers, measurements or other such functions” should do so “with consistent accuracy and reliability to the degree specified in the app.”

The content guidelines also cover evidence documentation and transparency, as well as publishing outcomes data.

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The AMA’s involvement with Xcertia stems from a policy adopted in 2016 that was recommended in an AMA Council on Medical Service report.

The council found that mHealth “apps vary greatly in their functionality, accuracy, safety and effectiveness,” and that “studies have also raised concerns regarding mHealth app content and accuracy, which can pose threats to the health and safety of patients.”

Initially previewed at the Connected Health Conference in 2018 and then released at the 2019 meeting of the Healthcare Information and Management Systems Society (HIMSS), the draft guidelines were available for a 90-day public comment period that closed in the spring.

HIMSS is one of the AMA’s partners in Xcertia’s effort to collaboratively develop mHealth-industry guidelines. The American Heart Association and digital health nonprofit DHX Group are also partners.

The combined expertise of this diverse membership leverages the insights of clinicians, patients, government agencies and industry experts. It also furthers the AMA commitment to making technology and digital health solutions an asset and not a burden.

Guidance for physicians in this area can be found in the AMA Digital Health Implementation Playbook, which covers key steps, best practices and resources to accelerate the adoption and scale of digital health solutions.  Download the Playbook now.

“Data continues to suggest that consumers and clinicians are skeptical when it comes to mHealth app adoption and use,” an Xcertia blog post says. “But simply publishing guidelines or standards that can be used to evaluate an app is not enough.”

The post outlines Xcertia’s approach to drive adoption. It involves working with app developers, clinicians, consumers and payers to confirm their support for guideline implementation, educating them on the importance of doing so, and then “rolling up the shirt sleeves and making it happen.”

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