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Rob McCray’s Response to “Reining in FDA regulation of mobile health apps” Blog Post

WLSA’s President and CEO Rob McCray commented on Nita Farahany post in the Washington Post blog, “Reinging in FDA regulation of mobile health apps.” Farahany wrote in support of both the House SOFTWARE Act and the Senate PROTECT Act, which aim to have less FDA oversight on mobile medical apps, sparking quite a lively discussion.  To read the post, click here.   See Rob McCrays’ comment below.


Dear Professor Farahany,

Unfortunately, your comment that “There are more than 97,000 health apps listed in Apple’s apps store, and these applications are transforming consumer health” is not supported by any evidence of efficacy. A very small number are associated with evidence of improved health, mostly as part of a study designed for peer review or submission to the FDA. The last new technology to be carved out of FDA oversight was the nutritional supplements industry. More than 20 years later, consumers cannot be certain about the actual contents of most of these products and the weight of scientific evidence is that their effect on health is neutral to negative. As a result, the supplements industry is a $28 Billion industry which is hardly transformative in a $2.7 Trillion health economy.

We need validation of health software to ensure (1) that products operate as described and (2) that they actually deliver health benefits commensurate with their risks. Regulation and the market can deliver this. Given the pace of technology innovation, regulatory processes should be reformed, not eliminated. In the market, we should pay for results not the quantity of procedures in a market where outcomes and charges are transparent. In this way we can have a health care market that benefits from the type of competition that works for the rest of the economy. There will be a need for legislation but first we must define our goals.

That said, I do not believe that we need to regulate the vast majority of the 97,000 apps that fall into the “healthy education” and “healthy entertainment” categories. Positively, these apps represent a growing awareness of the value of consumer engagement and the insufficiency of health care. Some of these apps will become valuable to personal health and health care, few will do significant harm and most will fade away. Hopefully, the app developers will remain involved to help transform personal health and health care.