Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “New AI White Paper,” by Darius Tahir.

Following is an excerpt:

The agency is trying to figure out how to regulate artificial intelligence in medicine. In a new white paper Tuesday, the agency notes that advanced AI might be able to update itself in the future.

While it’s a potentially powerful approach — the agency contemplates software that gradually trains itself to better spot cancerous skin lesions — it’s also a tricky one. Traditionally the agency approves a product and substantial revisions require additional clearance. Software updating itself poses a tricky problem, and the agency is soliciting views about how it should scrutinize such products. (One possibility: The agency is thinking about requiring a “predetermined change control plans,” which specifies how the product might evolve over time.) …

Not everyone was wholly pleased. Epstein Becker Green lawyer Bradley Merrill Thompson generally agreed it was positive that the agency was considering the subject at all. But he worried that the agency was “becoming really good at coming up with ideas and not so good about carrying through with them.”

In particular, he flagged inconsistencies — whether the process would require draft guidance or new legislative authority — in the agency’s materials that suggested its strategy wasn’t entirely clear.

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.