Comparing EU and US Approaches to Regulating Clinical Decision Support Software

European Medical Device Technology

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, and Jason Brooke, an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office, cowrote an article titled "Comparing EU and US Approaches to Regulating Clinical Decision Support Software."

Following is an excerpt:

The European Union currently is overhauling its medical device law and medical software regulation and clarifying the scope of the EU medical device law with respect to software used in clinical settings. This paper analyses EU regulation of clinical decision support (CDS) software and is a companion paper to one published on 28 December 2011 on FierceHealthIT. In this paper, we intend to provide the EU perspective on regulation of CDS software.

We have kept the structure identical to facilitate comparing the regulations under both jurisdictions. Since the US regulatory framework in relation to software is more detailed and developed and EU law has a different approach to certain issues, we expect the comparison to be valuable for companies that have an interest in both jurisdictions.