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Commission Eyes Global Standards for mHealth Devices That Measure BP

The Lancet Commission on Hypertension is calling for an international standard for validating mHealth devices that measure blood pressure, noting that many of the 3,000+ devices on the market aren't properly tested.

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By Eric Wicklund

- More than 30 physicians across the globe are calling for global validation standards for mHealth devices that measure blood pressure, saying consumer-facing digital health devices now on the market may be putting lives at risk.

An abstract published recently in the Journal of Hypertension by the Lancet Commission on Hypertension identified more than 3,000 commercially available connected health devices, many of which haven’t been properly vetted for accuracy based on established scientific standards.

“This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation,” the position statement, authored by 36 researchers, notes. “In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale.”

Launched in 2016, the commission includes representatives from the University of Tennessee Health Science Center, the University of Alabama at Birmingham, the American Heart Association, the Pan-American Health Organization, the American Medical Association, Mount Sinai’s Icahn School of Medicine, the James J. Peters VA Medical Center in New York and the University of Pennsylvania’s Perelman School of Medicine, as well as institutions in Australia, the UK, China, Ireland, South Africa, Denmark, Switzerland, Canada, Brazil, France, Colombia, Italy, South Korea and Greece.

The issue isn’t limited to blood pressure devices, and has long plagued healthcare providers looking to expand telehealth and mHealth services outside the hospital and into remote locations like the patient’s home. In 2017, for instance, a study featured in this journal indicated that in-home BP devices were accurate only 70 percent of the time.

The fast-growing, consumer-facing mHealth market is filled with wearables and other devices that meet commercial standards, but don’t meet clinical guidelines. As a result, healthcare providers won’t trust the data coming from them. And yet those devices often are popular with consumers, and would help providers meet patient engagement and care management goals if they could be validated.

To address that problem, the abstract calls for mandatory independent validation of all BP devices based on the International Organization for Standardization (ISO), which published standards for mHealth-enabled blood pressure monitors in 2016. In addition, the group called for specific standards for new technologies and an online database of validated devices, accessible by both providers and the public.

“Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP,” the abstract concluded.

Here in the US, the AMA has been leading efforts to rein in mHealth devices used for BP monitoring.

Earlier this year, the AMA took a step toward validation of mHealth devices when it unveiled the Self-Measured Blood Pressure Data Model, which aims to “define what data to collect, select how to represent the collected data, and determine how to encode the data for easy transmission, exchange and retrieval.” The model was produced by The Integrated Health Model Initiative (IHMI), launched in 2017 by the AMA.

“For too long, clinicians have struggled to navigate a landscape with oceans of data but puddles of information,” IHMI Chief Medical Information Officer Tom Giannulli, MD, MS, said. “The ability to harness patient-generated health data from a multitude of sources has come of age, and will empower patients and physicians to find and leverage meaningful data to improve health.”

“With the increase in health care consumerism, there is a critical need to enable data models that manage the collection and exchange of health data so patients and clinicians can make sense of it and rely on its clinical validity,” he added.

In 2018, the AMA joined forces with the American College of Cardiology and American Heart Association to develop a list of validated BP monitors. And earlier this year, the AMA and AHA launched Target BP, a national initiative aimed at improving home-based BP monitoring programs.

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