mHealth Apps Should Be Reviewed and Certified, Experts Argue

Ken Terry

June 10, 2014

The number of mobile health (mHealth) apps has exploded in recent years, but physicians and consumers have little information regarding their safety, security, and effectiveness. Therefore, the private sector should create independent groups to review and certify mHealth apps, experts argue in a viewpoint article published online March 24 in JAMA.

In September 2013, the US Food and Drug Administration (FDA) issued a final rule indicating that it would regulate only a narrow range of apps, note coauthors Adam C. Powell, PhD, president of Payer+Provider Syndicate in Boston, Massachusetts, and Adam B. Landman, MD, and David W. Bates, MD, from Harvard Medical School in Boston. Only those apps that turn smartphones into regulated medical devices, are accessories to regulated devices, or diagnose or recommend treatments to specific patients will be regulated.

"Although the FDA has focused on safety, it has largely left the review and certification of apps to the marketplace," the authors state.

Current reviews of medical apps, they argue, focus on "personal impressions," rather than evidence-based assessments of clinical performance and data security. For that sort of review, they say, dedicated organizations with the requisite skill sets are needed.

Yet, with more than 40,000 mHealth apps currently on the market, no single organization could review them all in a meaningful way. In fact, even multiple organizations could not do it, Dr. Powell told Medscape Medical News.

Therefore, he and his coauthors suggest that, at least initially, review organizations focus on "the most widely used and clinically useful apps," although they do not specify how such apps would be identified.

In addition, the authors propose that guidelines be created to help developers build high-quality apps and to serve as a basis for reviews. The reviews might cite the published evidence for the efficacy of certain classes of apps, such as exercise apps. They could also rank apps according to their comparative efficacy, if review bodies or developers wanted to invest in clinical trials, Dr. Powell said.

The authors also propose that the review organizations certify that mobile apps are not harmful and do not have security or privacy issues. The certification would be voluntary, but Dr. Powell said many developers would want to obtain certification "to assure consumers of their products' quality."

The federal government might play an important role in this scheme. According to the authors, "The Office of the National Coordinator for Health Information Technology...could help support the development of mHealth app guidelines and eventually commission app certification entities, as it is now doing for electronic health records."

However, Dr. Powell stressed that the government's involvement, beyond possibly choosing certification entities, would be limited to making recommendations, just as the Department of Agriculture publishes its "food pyramid" as a guide to proper nutrition. "We're proposing that a set of best practices be released in a very light-handed fashion so people can gain from that learning."

Financial Support Key Hurdle

A big question about the review and certification organizations is how they would be financially supported. Developers could pay fees to have products certified; a company called Happtique indeed tried that approach, but it has since ended its app curation experiment for reasons that are unclear. Another model is to have users pay for the evaluation of apps. That method has worked well for KLAS Research, which charges hospitals for reports on different kinds of software, but as the authors acknowledge, consumers who pay little or nothing for mHealth apps are unlikely to pay for reviews of them. Dr. Powell also suggested that healthcare payers might want to support these entities.

Research firm IMS Health is trying a slightly different approach. IMS claims to have reviewed the 40,000 mHealth apps, using proprietary criteria it has devised with the help of academic advisors. It is currently trying to sell a program for creating mHealth formularies to healthcare providers and health plans.

Joseph M. Smith, MD, PhD, chief medical and science officer of the West Health Institute, La Jolla, California, which advocates for mobile health in all of its forms, said there is a need for the kind of review and certification bodies the authors propose, but he does not understand the business model for it. "Until the people who buy these things demand such certification, I'm not sure what the value proposition would be."

Dr. Smith also agreed that the government should not set the standards for certifying mHealth apps. "It should instead recognize the standards and incentivize the adoption of those standards," he said.

According to the viewpoint authors, the value of mHealth apps will be limited unless providers can use the data in their EHRs. Therefore, they contend, it will be important to develop and use standardized vocabularies and interfaces for data storage and reporting.

Dr. Smith wholeheartedly agreed, but again, he stressed that the government should not prescribe the standards to be used. "The government can recognize data standards, draw attention to them, and provide some guidance to industry. It doesn't have to be more involved in that."

Dr. Powell has reported receiving personal fees from mHealthCoach and Verbal Applications. One coauthor has reported that he has developed 2 mobile health apps, one of which was funded by the Brigham and Women’s Hospital Health Information Technology Innovation Program, and the other was funded by a Brigham and Women’s Hospital Biomedical Research Institute Translatable Technologies and Care Innovation Grant. One coauthor was supported in part through the Libretto Consortium and has reported receiving personal fees from Medicalis; receiving patent royalties from Medicalis for radiology decision support software; chairing the Food and Drug Administration Safety and Innovation Act workgroup, which has advised the US Food and Drug Administration, Federal Communication Commission, and the Office of the National Coordinator on the regulation of healthcare information technology including mobile technology; and serving as a member of the Health Information Technology Policy Committee. Dr. Smith has disclosed no relevant financial relationships.

JAMA. Published online March 24, 2014. Extract

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