The European Commission Borderline and Classification committee has put out a call for software experts to join a working group on qualification and classification of software. The first meeting will be December 2nd, and will be chaired by Lennart Philipson from the Swedish Medical Products Agency. The Medical Information System report from Sweden has been circulated as a starting point. See the report at the link provided. This, as well as other EU activities related to changes in wording in the device directives related to software and Health Canada’s recent reclassification of patient information systems, indicates increased focus on healthcare information systems and standalone software.