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 "Opponents Say PROTECT Act Could Destroy mHealth, Endanger Patients."

Following is an excerpt:

The Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014, introduced earlier this month by Sens. Angus King (I-Maine) and Deb Fischer (R-Nebraska), seeks to clarify the extent to which the U.S. Food and Drug Administration can regulate health IT. ...

But Bradley Merrill Thompson, a Washington, D.C.-based attorney who advises the mHealth Regulatory Coalition, calls the proposed bill a "meat cleaver" that would, if passed into law, do a lot of damage, particularly to clinical decision support apps.

"The PROTECT Act (would declare) all such mobile apps unregulated regardless of risk," he said in an e-mail exchange with mHealth News. "That is a colossally bad idea, both for patients who would be put at risk, but also for (an) industry that would be dragged down by apps that don't work and destroy the credibility for the industry." ...

"What we need is a more refined approach that distinguishes high-risk apps from low-risk and allows the FDA to continue its role with high-risk apps," Thompson said. "No one yet has come up with the right conceptual approach for distinguishing clinical decision support apps based on risk, and in my opinion we ought to continue to work with the experts at the agency to develop that more nuanced parsing. It is not the right time for legislation." ...

"The biggest issue with both the SOFTWARE Act and the PROTECT Act is that it would deregulate certain stand-alone software used for such things as guiding therapeutic decision-making," he said. "For example, under both acts, a radiation dosage calculator would be removed from FDA regulation even though there is considerable risk in using such a program."

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.