There are solutions to solving the challenges presented by digital health technology, and strategies for improving the effectiveness of such tools, but it will take effort from both vendors and the federal government, according to a commentary in the JAMA Internal Medicine.
Adam J. Schoenfeld, M.D., Neil Jay Sehal, Ph.D., and Andrew Auerbach, M.D., of the University of California, San Francisco, write in the commentary that health app and sensory technology vendors must be clear about use of mobile tools, and delineate the now blurred line between wellness and disease management. At the same time, the U.S. Food and Drug Administration must play a role in app approval and screening.
"The design and results of such tests should be made public to allow consumers to select apps on the basis of accuracy as well as consumer reviews," according to the authors, who also note that the FDA will need funding to increase screening and that the agency should determine risk categories for mHealth devices and apps.
A JAMA report published earlier this month revealed a popular app for monitoring blood pressure is highly inaccurate and provided three-quarters of users with incorrect readings and yet is still likely being used by thousands of consumers.
Schoenfeld, Sehal and Auerbach write that one step could be to create criteria to "distinguish between apps that provide patient education or motivational support, which should not require FDA approval, and those that support medical decision-making."
In addition, they call for greater commitment of partnerships to develop data to support the health impacts of apps and sensors and how the mHealth platforms affect population health.
In late 2015, a former FDA official, in a commentary published at Forbes, expressed a similar opinion, and said the FDA mHealth regulatory approach needs work as it's thwarting innovation.
For more information:
- read the commentary