Mobile health (mHealth) apps need to be transparent about what information has been used to develop the product and the information the app is based on needs to come from one or more credible sources of information, according to recently released guidelines.

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The guidelines were developed by Xcertia, an independent nonprofit that the AMA and other major health and technology organizations founded. When developers comply with the Xcertia mHealth App Guidelines—which include sections that address privacy, content, security, design and operability—it helps provide a level of assurance that a mHealth app delivers value to patients, physicians and other users.

When it comes to content, the guidelines call for the app to be based on one or more credible sources such as protocols, published guidelines, evidence-based practice or actual studies published in peer-reviewed journals. And that information needs to be clearly communicated and easy to find in the app.

Today, developers often bury information that explains what credible sources they used to develop the app, or they do not even make the information available to the users. The content portion of the Xcertia guidelines aims to change that.

“The content guidelines are not making a judgment on the evidence that is being used. We don’t set the bar and say you need to be relying on a randomized controlled trial,” said Michael Hodgkins, MD, Xcertia chair and AMA chief medical information officer. “There are different levels of evidence, from weak to strong, and developers need to be transparent about what level of evidence supports their claims.”

Among the levels of evidence outlined in the guidelines: systematic review or meta-analysis of randomized controlled trials, quasi-experimental studies, expert medical or academic opinion, and single descriptive or qualitative study represent the spectrum from strong to weak. The guidelines tell developers that “if the level of research is based on expert or academic opinion or no study, the app’s public description should clearly state, ‘The effectiveness of the app has not been studied.”

Dr. Hodgkins noted that evidence can change over time. While an app may start out based on weaker evidence, stronger evidence may emerge later. Developers can update this information in the app as it develops.

“You just need to very clear and transparent about it,” he said. “You can’t bury this information in a dense user agreement. You need to have a separate section where people can see the information, or you need to link to your website where people can see the information.”

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In addition to transparent information and credible sources, the guidelines outline how apps need to address a number of other areas that fall under content.

Current information. The date and sources of the app’s content need to be provided through an “About” section, such as a tab or button. Among other things, the app publisher needs a method to determine whether an app’s content needs updating to stay current.

Information accuracy. The app’s description and content must be truthful and fair, and not misleading.

Accuracy of results. An app that has tools that perform user or patient-management functions, such as mathematical formulas or timers, must be consistently accurate and reliable.

Advertising within the app. Ads need to be clearly identified and comply with regulatory requirements.

Publishing outcomes data. The types of results achieved by the app or study of the app should be transparent and visible to users and health professionals.

Transparency of data. The context of the app and data should be clear to users and health professionals, for example, the app’s public description should accurately state in plain language what individual health data is collected, who it is shared with and what it is used for. It also should also specify which environments its designed for, such as hospital, home, community health center or other setting.

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Xcertia is not an accrediting body, but app developers can seek Xcertia board approval that they are following the established guidelines and can then use the Xcertia name and logo.

The AMA involvement in Xcertia stems from a 2016 policy recommended in an AMA Council on Medical Service report. The Healthcare Information and Management Systems Society, the American Heart Association and the digital health nonprofit DHX Group co-founded the effort to improve trust in, and the value of, mHealth apps.

Members of the Xcertia board are drawn from Accenture, the App Association, Mayo Clinic, Partners Healthcare, IBM Watson Health, the American Telemedicine Association, the University of Illinois at Chicago, and the IQVIA Institute for Human Data Science.

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