Health information and health insurance systems and their computerised services, which are accessible both to professionals working in the health system for the purposes of prevention, diagnosis, care and social and medico-social monitoring, and to private users of these tools
Draft Order on the electronic identification of users of digital health services and amending the Social Security Code
Only the provisions of Articles 1 and 3 of the draft Order are subject to the obligation to notify the European Commission. Article 2 is excluded from the scope because it falls within the exception provided for in Article 1 of Directive (EU) 2015/1535, which specifies for the definition of ‘technical regulation’ that ‘technical specifications or other requirements or rules on services linked to national social security systems are not included. ’
Articles 1 and 3 of the draft Order create, in the Public Health Code, the body of legislative-level rules applicable to digital health services with regard to the electronic identification of their users, whether the latter are users of the health system or professionals working in the health system.
In particular, these rules require the following from the digital health service:
- the appropriate assurance level of the electronic identification means used, within the meaning of the provisions of Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market, which may potentially be supplemented by minimum requirements allowing users to obtain, manage and authenticate electronic identification means;
- if applicable, the electronic identification means requested, it being understood that the public authorities provide identities or identity federation services that may be recommended or imposed on certain services, either exclusively or not.
The Order refers to several implementing provisions at regulatory level, which will be reported to the European Commission on the basis of Directive (EU) 2015/1535. These provisions will specify:
- the required level for the electronic identification means used to identify professionals and individuals, depending on the digital health services concerned;
- the procedures for compulsory prior enrolment in a national directory of professionals (both natural persons and legal persons) involved in the health system;
- the characteristics and conditions for issuing electronic identification means to professionals.