Bradley Merrill Thompson, a Member of the Firm in the Healthcare and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Medical App Regulations, Device Security Share the Spotlight at mHealth World Congress." The article also appeared in Healthcare IT News and Government Health IT.
Following is an excerpt:
Two issues near and dear to the hearts of mHealth enthusiasts — mobile app regulation and privacy and security — took center stage as the 4th Annual mHealth World Congress opened Wednesday afternoon in Boston. ?...
Taking up the reins for most of the session was Brad Merrill Thompson, JD, general counsel for the mHealth Regulatory Coalition and counsel for the Continua Health Alliance. Thompson, who drafted a response from the coalition to the FDA's guidance document, issued about a year ago, said the FDA is only concerned with a small fraction of mobile medical apps that meet specific uses: They either assist in the development of clinical decisions for health issues, or as accessories that cause an app to be used as a medical device.
Thompson said stakeholders want the FDA to clarify the issue of intended use, which focuses on the difference between wellness and health apps, and much of that discussion focuses on what the developer says the app will do. "It all comes down to how you promote the product," he said.
For instance, he pointed out, the FDA stepped in roughly three years ago when the makers of Cheerios began advertising that the cereal helped reduce cholesterol — thus qualifying it as a new drug. That advertising campaign was quickly shelved.
Thompson said some apps blur the distinction between health and wellness, moving away from language like "improve" and "monitor" to the more risky "diagnose" claim. An in-house study of 100 mobile health apps found on iTunes, he said, found 8 percent that definitely needed regulation and 56 percent that wouldn't need it — but 36 percent fell into an ambiguous area that might require regulation.
"You're drawing connections between leading mHealth products and leading a healthier life ?... and you're got to understand that there are lines that can't be crossed," he said.
Another area of concern, Thompson said, is clinical decision support (CDS) software — what he called "the next wave" in electronic health records. He said most EHRs are generally considered passive collection points, but as they develop tools that allow them to analyze data and draw medical conclusions, the FDA will have to step in and look at them.
