Bradley Merrill Thompson Quoted in Article, “European Regulation Looms Over Mobile Health”

The Gray Sheet

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "European Regulation Looms Over Mobile Health."

Following is an excerpt:

The mHealth Regulatory Coalition, an industry group that has been active in engaging FDA on evolving mobile health policies, is now extending its efforts to Europe as the European Union and several member countries are planning new regulations in the space. ?...

"While we [were] pushing ahead in the U.S., the member companies were coming to us and saying, 'Well, we've got the same issue outside the U.S. — for example, in the EU. Can you do something to help us'" Thompson said in an interview. "The EU really is going through its own regulatory revolution both in the medical device realm ?... but also more specifically in the area of software.

"So we concluded that there it was an awful lot easier to try and have an impact on those regulatory policies before they were developed, than after they were already set in place," Thompson said. "We felt like the time to do something was now, and we had to organize the stakeholders and have a discussion around that." ?...

In the EU, as in the U.S., Thompson argues that mobile applications designed to impact disease states are more highly regulated than applications promoting wellness. That becomes a problem for mobile health companies. ?...

Thompson said, "In the EU, privacy really seems to be much more concerning than in the U.S. In the U.S., HIPPA is now [a] fairly old regulation; people generally understand what it requires — it's burdensome, but it's fairly mature in the way of requirements. In the EU, I guess we're seeing the number of new privacy requirements, and the trend is to be very draconian, very demanding in terms of the safeguards you have to take in order to protect the privacy of data." He further expressed worries about the unintended consequences of the new privacy law.