In the run-up to and in the wake of last week's congressional hearings on potential Food and Drug Adminstration regulation of mobile health and medical apps, we have heard numerous alternatives to the existing FDA regulatory framework proposed.
Congress should give the Office of the National Coordinator for Health Information Technology (ONC) the power to regulate not only apps, but also electronic health records, some have suggested. Others would like to see self-policing by the private sector, akin to the initial role of the Certification Commission for Healthcare Information Technology (CCHIT), which started as the EHR vendors' answer to the prospect of regulation. Happtique may seem to be heading down this path, but CEO Benjamin Chodor shot that notion down during the hearings.
A third approach might be along the lines of what CCHIT has become today, a participant in a privately run but federally monitored certification program to test products against government standards.
And then there is the interesting idea proffered by Dr. Thomas Santo on the popular KevinMD blog last week: Get physician organizations involved.
"If you visit the websites of some of the major medical organizations in the country, the American Medical Association, the American College of Physicians, the American Academy of Pediatrics, among many others, not one of them has a link to 'endorsed apps,' 'mobile health' or any other reference to digital health tools," Santo wrote. I don't know who the "many others" are, so I can't check this claim, but the point is taken.
"Without providing some guidance as to what works and doesn't work, physicians miss the opportunity to maximize the benefits of this technology in terms of quality of care, access to care and cost, those things that occupy much of the discussion on health care today," Santo continues.
This I know to be true. Without professional guidance, health and medical apps risk falling into the "for amusement purposes only" category, and if physicians aren't willing to help their patients understand how certain apps fit into the overall picture of health, then we are just building another silo in an oversiloed industry. It is good for patients to be engaged, but professionals still have to help consumers interpret the information digital tools produce or uncover.
"One hurdle to capitalizing on this new wave of patient engagement is the fact that the market is full of products that are unlikely to produce any long-term health benefits, with more beneficial, substantive tools interspersed in between," Santo adds. This is also true.
The Federal Trade Commission has forced at least two acne-related apps of dubious benefit off the market. Threat of legal action over a copyright issue caused another app developer to pull a mobile psychiatric reference guide. Again, though, these appear to be isolated incidents, a combination of a federal agency acting once and the owner of intellectual property engaging in some self-policing.
I like the idea of professional organizations reviewing apps for accuracy and medical usefulness, but I shudder when I think about medical societies "endorsing" products. As I read Santo's commentary, the first thing that came to mind was the endorsement the AMA effectively gave Sunbeam products in 1997 when the two entities inked a marketing deal.
After a public backlash against the AMA's credibility, the medical society terminated the agreement, and ended up paying Sunbeam $9.9 million to settle a lawsuit. Fallout from that incident later led the AMA's chief executive to sue the organization.
Ever since then, the AMA has been rightfully wary of lending its seal of approval to commercial products that were not its own. I hardly think the organization – or any other medical society – would be eager to endorse mobile apps.