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Amid a Flood of New mHealth Apps, Xcertia Looks to Set Standards

A group formed a year ago by HIMSS, the AMA and the AHA has unveiled proposed guidelines for mHealth apps, just as a new report finds the number of apps has almost doubled since 2015.

Source: ThinkStock

By Eric Wicklund

- An mHealth app evaluation and certification resource launched roughly a year ago by the American Medical Association, American Heart Association and Healthcare Information and Management Systems Society (HIMSS) is seeking public input on proposed guidelines for app operability, privacy, security and content.

The move is timely: A recent survey indicates mHealth apps have doubled in number in just two years, to the tune of 200 new mobile health apps being launched every day.

Xcertia, founded in December 2016 by the three organizations and the nonprofit DHX Group, has unveiled preliminary guidelines for healthcare providers, mobile health developers and others involved in creating mHealth apps.

“One year since Xcertia announced its formation, the collaboration is releasing initial mobile health apps guidelines as a starting point to build on,” Michael Hodgkins, MD, chairman of the group’s Board of Directors, said in a press release. “Cooperative input on the guidelines from consumers, developers, payers, clinicians, academia and other motivated stakeholders will provide Xcertia with guidance on where it needs to focus its efforts in 2018 to positively impact the trajectory of the mobile health app industry.”

The effort comes as the IQVIA Institute for Human Data Science – formerly the IMS Institute – has released a report pegging the number of mHealth apps now on the market at more than 318,500, almost double the 165,000+ apps counted by the institute in 2015.

The study also finds that the mHealth app market is becoming more specialized, as providers and patients look for specific care management apps instead of general wellness tools. Health condition management apps now comprise 40 percent of the market, up from 27 percent two years ago.

“This rapid app expansion, coupled with more than 340 consumer wearable devices on the market worldwide, provide evidence of Digital Health’s accelerating innovation,” the study notes. “At this time, there is at least one high-quality app for each step of the patient journey.”

Also, the institute counted 571 published studies on app efficiency, and noted that apps targeting five patient populations – diabetes prevention, diabetes care, asthma, cardiac rehabilitation and pulmonary rehab – could save the nation an estimated $7 billion a year in acute care expenses, or about 1.4 percent of the total healthcare costs spent on those populations.

“However, despite progress to date, a number of barriers still exist to widespread adoption by patient care institutions, and only an intermediate level of adoption has yet occurred,” the study concluded, noting that only about 20 percent of the nation’s large health systems have shifted from pilot mHealth programs to full-scale rollouts.  “A variety of industry and policy initiatives have now emerged to address these barriers and accelerate the ongoing adoption of digital health tools by care provider organizations. Within the next 10 years, the use of digital health is likely to be mainstream for most organizations delivering human health.”

That said, those providers are going to need a reliable means of validating mHealth apps. And that’s where groups like Xcertia come in.

“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,” the AMA’s Council on Medical Service said in a report adopted at the 2015 interim meeting. “Without ensuring that there is strong and sufficient evidence that provides clinical validation to mHealth apps and associated devices, trackers and sensors, 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.”

Xcertia’s proposed guidelines target four categories:

  • Operability - for assessing whether a mobile health app installs, loads, and runs in a manner that provides a reasonable user experience;
  • Privacy - for assessing whether a mobile health app protects the user’s information, including Protected Health Information (PHI) in full compliance with all applicable laws, rules and regulations;
  • Security - for assessing if the application is protected from external threats; and
  • Content - for assessing whether the information provided in the mobile health app is current and accurate.

Xcertia is soliciting public comments on its new guidelines through the end of this month. Officials said the guidelines will then be updated annually by workgroups drawn from the groups’ membership. 

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