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 "Congress Must Wait for FDASIA Report."

Following is an excerpt:

At the Nov. 19 hearing, a panel of industry witnesses with similar agendas testified in support of the SOFTWARE Act and urged Congress to pass the proposed legislation, which seeks to limit the FDA's authority to regulate mobile medical apps and other software that function as medical devices. ...

Personally, I would liked to have seen Bradley Merrill Thompson, general counsel for both the Clinical Decision Support Coalition and mHealth Regulatory Coalition, included in the panel of witnesses representing industry. ...

Thompson sent a letter to the committee on behalf of the Clinical Decision Support Coalition asserting that "it seems inconsistent for Congress to move forward with legislation to address the regulation of [clinical decision support software]," when a FDASIA-mandated report to Congress on a risk-based regulatory framework for health IT (including clinical decision support software, which was not addressed by the FDA's final guidance on mobile medical apps) is expected in early 2014.

"We do not understand why Congress, after directing this work to be done, would proceed with the SOFTWARE bill now, before the FDASIA process is complete," he wrote. "We think it is important to first hear what the federal experts on health information technology recommend before proceeding to develop legislation."

Moreover, as Thompson points out, the SOFTWARE Act runs contrary to the recommendations of the FDASIA advisory committee in regulating high-risk clinical decision support apps such as computer-aided diagnosis. "The proposed legislation's category of 'clinical software' casts its net too widely, and therefore removes from FDA regulation some software and hardware that really should not be removed," he wrote to the committee.

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.