Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in an American Association for the Advancement of Science (AAAS) article titled “Mobile Health App Developers Seek Guidance on Federal Regulations.”
Following is an excerpt:
Thompson said the FDA has started by determining which technologies it will not be regulating. The agency announced in February that it would not regulate the simplest mHealth technology: software that is used primarily to store, transfer, display, or convert data from a medical device, such as a program that stores blood pressure readings for later review. However, Thompson said this guidance conflicts with existing rules and called for the agency to address the discrepancy.
Thompson praised the FDA for its decision earlier this year to step back from the regulation of “wellness” apps, allowing app developers to claim that their product can help patients with a particular disease live a healthy life. For instance, developers of a calorie-tracking app can say it is particularly helpful for people with diabetes.
The FDA will “permit you to make claims of relationships to diseases as long as you don’t claim to cure them or diagnose them,” Thompson noted. “That is very important for the industry.”
The article covers Mr. Thompson’s comments at “Your iPhone Will See You Now: Mobile Health in the 21st Century,” an event hosted by the AAAS on November 19.