Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Who Should Regulate mHealth?"

Following is an excerpt:

Not everyone is eager to see the U.S. Food and Drug Administration issue its final guidance on mobile medical app regulation.

While the mHealth Regulatory Coalition and several mHealth advocates have asked the FDA to release its long-delayed guidance — which has been in the works since the agency issued preliminary guidelines in late 2011 — a coalition of roughly 120 health IT stakeholders has asked the government to put the brakes on the FDA until a much more wide-ranging study of HIT regulations is finished.

In fact, some are wondering if the FDA is the right agency to oversee mHealth regulation.

"The MRC believes the timely release of the final guidance will benefit industry, stimulate investment, help ensure patient safety and is consistent with the views expressed by Congress and the desires of the broader mHealth community," wrote Bradley Merrill Thompson, a Washington DC attorney and coalition member, in the June 21 letter. The guidance, he said, "is needed by industry and will help unlock investment in the mHealth market. Many investors and companies are reluctant to invest significant time and money in mHealth technologies until the regulatory framework is clear."

"(Sebelius') objectives are different from the FDA regulatory framework on mobile medical apps. The secretary is charged with making broad policy recommendations on a comprehensive strategy for all Health IT," the MRC concluded in a position paper that accompanied Thompson's letter. "FDA's guidance, on the other hand, is focused on providing specific details of whether different mobile medical apps will be regulated or not — this is the level of regulatory detail app developers need now."

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.