With the rapid growth of digital health solutions, there is a serious need for an objective, transparent and standards-based framework to evaluate these healthcare products.
That’s the contention of researchers from the Johns Hopkins University schools of medicine, public health and applied physics laboratory, who have developed what they contend is such a framework.
There are more than 3 million mobile health apps out there, with 200 new ones springing up daily,” says Simon Mathews, MD, who led the research team and leads clinical innovation efforts at the Johns Hopkins Armstrong Institute for Patient Safety and Quality. “Patients, providers, payers, industry and regulators all have to navigate the confusion. It’s a challenge to find solutions that provide real value.”
In particular, the Johns Hopkins researchers contend that in the rush to get their digital health products to market many developers pay too little attention to product design, safety testing and clinical—with minimal verification and validation. As a result, no reliable mechanism currently exists to identify validated digital health solutions, they argue.
However, Mathews and his colleagues believe they have come up with a “path to validation” for digital health that they published in the journal npj Digital Medicine.
“We believe an approach that is guided by end-user requirements and formal assessment across technical, clinical, usability and cost domains is one possible solution,” state the authors. “For digital health solutions to have greater impact, quality and value must be easier to distinguish. To that end, we review the existing landscape and gaps, highlight the evolving responses and approaches, and detail one pragmatic framework that addresses the current limitations in the marketplace with a path toward implementation.”
The path they recommend is a “digital health scorecard” covering four domains—technical, clinical, usability and cost—that would provide ratings for solutions by applying rigorous and objective validation of the technology similar to the Underwriters Laboratory and Consumer Reports, nonprofit testing labs that assess products for quality and safety.
“Our proposed digital health scorecard takes a hybrid approach of these models,” observes Mathews. “It defines requirements and standards for digital health products, puts those products through rigorous and objective testing, then offers objective reports of the results.”
To test the first iteration of the digital health scorecard, researchers indicate that they are “pursuing a small-scale pilot study implementing this approach in granular detail, the results of which will be published upon completion.”
Ultimately, they say governmental regulatory bodies—such as the Centers for Medicare and Medicaid Services, Federal Trade Commission and Food and Drug Administration—should “partner with clinical stakeholders to create a standard set of requirements using the categorical concepts proposed here.”
In addition, Mathews and his colleagues contend that a leading health system or hospital could partner “with one or more of the aforementioned regulatory bodies” and lead the development and adoption of the digital health scorecard.
Originally published in Health Data Management by Greg Slabokin on May 22, 2019