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.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.