Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in insideBIGDATA, titled “FDA’s Next Frontier: Regulating Machine Learning in Clinical Decision Support Software.”

Following is an excerpt:

Many at FDA are big fans of using machine learning in healthcare. As a research tool, machine learning offers great promise in the discovery of new drugs and other treatments.  But when machine learning algorithms become part of a regulated medical device, the unique nature of that technology creates challenges for the agency.

Machine learning is not a new subject for FDA. For years, the agency has been regulating software that uses machine learning algorithms to analyze medical images such as mammograms for potential areas of concern.  For these products, there is now a relatively well-traveled path to market that includes providing FDA with specific information about the algorithm and its training, information on the features analyzed and the models and classifiers used. Further, in their submissions, developers commonly compare the software results against three human experts to see if there is sufficient agreement.

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.