Dive Brief:
- The FDA weighed in last week with a draft guidance on how it would classify personal health technology with regards to consumer risk, the first step in developing regulations for device-makers.
- The first guidance addressed low-risk general wellness devices, which the FDA would not regulate. It outlined that products in these categories can incorporate audio recordings, exercise equipment, mobile apps, video games and other related products sold by retail establishments. The guidance further divided products in this low-risk class into two categories: those that don't refer to any specific condition like weight, sleep issues or stress management; and those that might help reduce risks associated with chronic conditions and diseases.
- The key difference here is that products that claim to promote or maintain a healthy weight, encourage healthy eating or assist with weight loss would not need to be regulated. However, those devices that claim they can treat or diagnose obesity or eating disorders would be subject to regulation. A second draft guidance further defined a medical device accessory as something that is "intended to support, supplement and/or augment the performance of one or more parent devices."
Dive Insight:
Mention FDA regulation to anyone connected to the mHealth industry, and you'll likely produce at least a shiver or two. That being said, this is not a bad thing, neither for the industry nor for consumers.
For those looking for weight loss solutions alone, the market is still weighed down with pills, oils, tinctures and products that aren't much more than modern snake oil. Even with stringent regulations on the books, both the FDA and FTC are still losing the battle against manufacturers who mislead consumers trying to lead healthier lives. Introducing technology-based products with mobile connectivity opens the door to that side of the industry as well as to those innovators who have made genuine breakthroughs that can enrich consumers' lives.
This initial set of guidance received a tepid response from the industry, like the blog posted by Joel White, executive director of the Health IT Now Coalition, who wrote, "Health IT Now is disappointed to see the release of FDA guidance attempting to define the regulatory parameters for health IT, not because we disagree with the policy, but because it continues FDA's reach into new technologies at the same time Congress is working on changes to the FDA's authority in this area."
This is understandable, given the organization's charter and membership, but still misguided. The only way to protect consumers from less-than-effective devices and simultaneously support the innovations led by legitimate device manufacturers is to reign in those who would seek to cash in on the mHealth wave with devices whose efficacy cannot match their claims.