For the primary use of health data, this draft regulation applies to all digital services using personal health data, in the health and social care sectors. It provides for:

• In interoperability matters, specifying and making mandatory a syntactic, semantic health data exchange format;
• In security matters, specifying and making mandatory requirements concerning the confidentiality, integrity, security, and protection of electronic health data, as well as specifications for the management and use of electronic identification;
• In compliance matters, designating a Digital Health Authority for each Member State responsible for certifying the compliance of digital health services with the interoperability and security specifications defined at European level.

The draft EHDS regulation makes participation in the MyHealth@EU common infrastructure mandatory in order to supply and receive health data for the purposes of the care pathway, with priority given to Patient Summaries (the European equivalent of synthèses médicales), electronic prescribing and dispensing, hospital discharge letters, medical images and medical imaging reports, and lab test results.

As part of the MyHealth@EU programme, the Agence du Numérique en Santé (ANS) is the national contact for e-health and is working on the development of European use cases.

To this end, the ANS is implementing the Sesali.fr service, which currently enables healthcare professionals to connect and consult the medical summary of a patient from another European Union country. In addition, the ANS is providing an API enabling Sesali to be incorporated into healthcare software to access European patient data.

This section contains a number of provisions concerning EHR systems, including compliance criteria (data involved, semantic coding methods and technical specifications, data confidentiality, integrity, and security requirements, data quality and completeness, contents of the technical documentation and fact sheet), conditional marketing (or entry into service) (fact sheet, technical documentation, EU declaration of conformity, CE marking) and compliance obligations (corrective measures, disclosure, cooperation with market surveillance authorities).

The EHDS regulation provides for the establishment of a market surveillance authority responsible for monitoring the compliance of economic operators (manufacturers, agents, importers, distributors) of EHR systems with the regulation.

The draft regulation establishes a governance framework designed to simplify and harmonise access conditions. This governance framework provides for:

• Rules and a procedure for accessing data that impose deadlines for authorisation and making data available
• The establishment of national data access bodies to make it easy to consult the conditions under which electronic health data is made available for secondary use, with a certain amount of disclosure involved;
• Defining the roles and responsibilities of the players involved;
• Setting up a common decentralised HealthData@EU infrastructure for making data available and usable.

The draft EHDS regulation makes participation in the HealthData@EU infrastructure compulsory. The Health Data Hub (HDH) is coordinating a consortium of 16 partners to create a HealthData@EU pilot. This 2-year project, funded by the European Commission, aims to:

Develop and deploy a network of core services and platforms (nodes) to connect participating countries via their national checkpoints (HDABs, Health Data Access Bodies), as well as certain European bodies such as the ECDC (European Centre for Disease Prevention and Control) and the EMA (European Medicines Agency);
Assess the feasibility and capability of Member States to deploy such infrastructure EU-wide.