Safety, efficacy guidelines in store for mobile health apps

Kevin B. O'Reilly
Editor
AMA Wire
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Some of the U.S. health system’s biggest movers and shakers are starting a nonprofit that will collaborate with mobile health app developers, patient advocates and others to develop best practices aimed at promoting safety and effectiveness. The effort comes on the heels of research showing the nascent field of mHealth has room to improve.

The AMA, American Heart Association (AHA), Healthcare Information and Management Systems Society (HIMSS) and digital health nonprofit DHX Group are the founders of the new guideline-writing organization, dubbed Xcertia. They are asking other organizations representing patients, technology firms and other health care stakeholders to join in guideline development. The new organization will not certify mHealth apps. Rather, Xcertia’s guidance is intended for others to use when developing, evaluating or recommending mHealth apps.

The intent is to influence the mHealth marketplace in a positive direction while enhancing innnovative solutions that lead to better health tools. Leaders of the initiative say their aim is to help mHealth developers create solutions that realize the technology’s promise to achieve  improved health outcomes.

The announcement “represents a significant first step to bringing meaningful clarity and focus to evaluation within the mHealth space,” Eric Peterson, MD, chair of the AHA’s Center for Health Technology and Innovation, said in a statement issued jointly by the four organizations. “The AHA is an evidence-based organization, so we can add an emphasis on evaluation that is critical for the mHealth space to realize its full potential and, truly, deliver better outcomes for patients.”

Leaders of HIMSS, which represents about 64,000 individual members, 640 corporate members and more than 450 nonprofits in the health information technology sector, are also eager to see the mHealth guidelines-setting effort take flight.

“Secure, real-time access to accurate electronic health information gives consumers, patients, and clinicians the knowledge needed to make informed health-related decisions,” HIMSS Executive Vice President Carla Smith said. She added that “with safe, effective and reputable mobile health apps, clinicians, caregivers, consumers and patients can better manage care and maintain their wellness.”

The Xcertia announcement has been met positively by industry.

Goal is mHealth that improves care

The formation of Xcertia comes a month after the AMA adopted a sweeping set of policies designed to help integrate mHealth apps into clinical practice.

“While some mobile apps and devices are subject to FDA regulation, others are not, and do not undergo rigorous evaluation before deployment for general use, which raises quality and patient safety concerns,” said the AMA Council on Medical Service (CMS) report the AMA adopted at its 2016 Interim Meeting in Orlando, Fla.

“Without ensuring that there is strong and sufficient evidence that provides clinical validation to mHealth apps and associated devices, trackers and sensors,” the CMS report added, “physicians will not fully integrate mHealth apps into their practices. More investment is needed in expanding the evidence base necessary to show the accuracy, effectiveness, safety and security of mHealth apps.”

The AMA policy says, among other things, that mHealth apps ought to follow evidence-based practice guidelines, support patient-centered care delivery and care coordination, support data portability, interoperability and security, and protect patients’ health privacy.

“Physicians recognize the tremendous potential in digital health tools and are looking to the AMA to help make sense of mobile health technologies,” said AMA Executive Vice President and CEO James L. Madara, MD. “Our role in helping to form Xcertia underscores the AMA’s ongoing commitment to innovation and collaboration that helps empower patients to assess mobile health apps, and enable physicians to take a lead role in advancing the state of digital health technology.”

In an interview at the Health 2.0 meeting in September, Dr. Madara said the possibility of patients getting hurt by subpar mobile technology is foremost among the AMA’s concerns. He noted a JAMA Internal Medicine evaluation of a blood-pressure app that spent months atop the best-seller charts in the  Apple app store. Researchers concluded in the May 2016 study that the app’s measurements “were highly inaccurate,” wrongly telling nearly 80 percent of patients with hypertensive BP levels that their blood pressure is normal.

“Health care is not a normal market,” Dr. Madara told Health 2.0 co-chair Matthew Holt. “You put a leaky faucet out there, the market is efficient, people stop buying it, no harm no foul except for a minor investment. In health care, it’s different. If something doesn’t work, there is potential patient harm.”

Dr. Madara added that this is a critical period for mHealth given the regulatory framework, a patchwork affair involving the Department Health and Human Services’ Office for Civil Rights, the Food and Drug Administration and the Federal Trade Commission.

“You have two choices: You can self-regulate or let the government do it,” he said. Government agencies “tend to be heavy-handed, they overreach, they’re not nuanced, and it’s one-size-fits-all. If a community shows a responsibility to self-regulate, you can have a different story.”

widely reported study published in the December issue of Health Affairs found that “consumers’ ratings were poor indications of apps’ clinical utility or usability and that most apps did not respond appropriately when a user entered potentially dangerous health information.”

Researchers from Brigham and Women’s Hospital and the University of Michigan, Ann Arbor, evaluated 137 patient-facing apps listed on the Google and Apple app stores and recommended by medical professional society websites, mobile technology or patient advocacy experts. Among other things, researchers concluded that “data privacy and security will continue to be major concerns in the dissemination of mHealth apps.”

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