Publications
New European regulations on software in the healthcare sector
Our Digital Law and Data Protection Area has prepared an analysis of the new European regulatory framework applicable to healthcare software, marked by regulations such as the Data Act, the Artificial Intelligence Regulation, and the NIS 2 Directive
These provisions strengthen security, data protection, and interoperability, imposing new technical and legal obligations that digital health projects must integrate from the design stage onwards.
The informative note can be found in the related documentation:
