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 "FDA Loosens Grip in Latest Win for Digital Health Firms." (Read the full version – subscription required.)

Following is an excerpt:

The U.S. Food and Drug Administration on Friday vowed not to regulate a sizable class of hardware and software products that store medical device data, a gesture that experts say will spur innovation at small businesses and potentially undercut congressional efforts to curb the agency's authority over digital technologies.

In draft guidance, the FDA said it won't police so-called medical device data systems, which can collect, store and transfer information about patient health, such as vital signs or other clinical measurements. The exemption will also cover devices that house and communicate images, such as those from an MRI or ultrasound. …

Friday's move is "consistent with the notion that FDA is getting out of the broad health IT management sphere and leaving that to ONC," Thompson said. …

"I really wish they would just bite the bullet and engage in rulemaking," Thompson said. "If they did that, I think it would demonstrate that there's no need for Congress to act."

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.