Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was featured in Insights: HIMSS Europe, in “Regulating CDS and AI: Which Way Forward?” by Tonya Stewart.

Following is an excerpt:

Picking out the right path through the maze that is medical product regulation is no easy task these days. There are no simple signposts to guide the way.

With the advent of clinical decision support (CDS) software and artificial intelligence (AI), we’re cutting through even more unchartered territory. So what is the right path? Is a risk-based approach best? Does a decentralised approach like the European CE mark system work to get innovation to market? How do we regulate an unknown like AI, when we don’t really fully understand how it works ourselves? …

Bradley Merrill Thompson, a medical device attorney with Epstein Becker and Green, joins us from Washington, DC in the US… [to] tell us what’s in store for the regulation of healthcare IT tools into the future. …

Uncertainty over CDS regulation is stopping vital software getting to market …

It’s been six years since the US Food and Drug Administration (FDA) said it would begin developing guidance for clinical decision support, says medical device attorney Bradley Merrill Thompson, chair of the CDS Coalition, a pressure group fighting against over regulation of the clinical decision support market in the US. Now that the guidance is finally here, says Thompson, not only does it fail to consider the next generation of medical software that integrates machine learning and artificial intelligence, but it neglects to give guidance on risk, despite promises that it would, leaving the industry in the dark over how to move forward.

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