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 "Senate Bill Shifts Oversight of Clinical Support Software from FDA to NIST."

Following is an excerpt:

The Senate bill, "Preventing Regulatory Overreach To Enhance Care Technology Act," would divide health information into two categories: clinical and health software. Unlike the SOFTWARE Act introduced by Rep. Marsha Blackburn (R-TN), which creates three general categories of software, the Senate bill specifies that clinical software means clinical decision support software or other software that "captures, analyzes, changes or presents patient or population clinical data or information" and recommends a course of action, but does not make any structure/function changes to the body. Also, unlike the House legislation, the PROTECT Act does not define medical software, but says that neither clinical or health software includes software intended to diagnose patients or that is a component or integral to the function of the device. ?...

Bradley Merrill Thompson, an attorney with Epstein, Becker & Green, added that while the PROTECT Act resolves some of the technical issues in the House bill, the proposal to remove FDA authority over HIT is a bad idea.

"Fundamentally, the Senate legislation would make NIST responsible for technical standards and take FDA completely out of the equation," he said. "That's just a terrible idea. FDA has a lot of experience in this area, they also have statutory authority that would be useful to regulating certain types of high-risk HIT."

He pointed out that NIST was founded as a non-regulatory agency. While NIST could play an important role in developing standards FDA, as a regulatory agency, actually has authority to conduct inspections, take enforcement actions when a company violates a requirement and establish regulations, he said. Further, Thompson took issue with the lawmakers' reference to findings from a federal workgroup tasked with helping FDA, ONC and FCC craft its proposal for an HIT regulatory framework. The bill says the workgroup identified major barriers to effective regulation of mobile health and health software that could not be addressed without changes to existing laws. But Thompson, who was a member of that working group, said the group was referring to the need for more guidance, not recommending statutory change.

"[I]t seems as though industry has its work cut out for itself because this legislation suffers from the same fundamental flaws that the SOFTWARE Act does and people on Capitol Hill do not seem to be listening to any but a few voices," he said.

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.