We issue specialist opinions on the applicability of the rules specific to the digital health sector — including the Italian electronic health record (“Fascicolo Sanitario Elettronico”) , telemedicine, compliant digital preservation and online reporting — with a precise indication of the related compliance obligations.
The service is personalised to the Client’s role and the features of the project and draws on an integrated legal and technical/IT team. Among other things, our opinions address the interoperability and feeding of the Fascicolo Sanitario Elettronico, the requirements for compliant preservation and digital reporting, the obligations on signatures and time stamping and the implications for the protection of health data.
We aim to offer an operational reading of the regulatory framework, translating legal requirements into concrete, immediately usable guidance.