Certification of prescription assistance software (PAS) is optional in France. It helps to improve prescription practices and provides an additional guarantee beyond CE marking. The HAS has published the new procedure for the certification of PASs (known as V2021) and the certification standards for PASs for outpatient medicine and hospital use.
In a bid to simplify matters, this new procedure is linked to the European regulations on CE marking to which PASs are subject. Thus, for software with this marking, the criteria validated when marking was earned will be deemed adequate and will not be re-evaluated at the time of the HAS certification request.
Although it is optional, certification will allow a software product to be put on the market that:

• Is in line with the eHealth technical framework in France (involved in the Convergence tool, the DMP shared medical record, the MSS messaging system, e-prescriptions, etc.);
• And meets the needs of users/prescribers.