Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS Article 24. Supplementary cross-border digital health services and infrastructures
- 1.Member States may provide through MyHealth@EU supplementary services that facilitate telemedicine, mobile health, access by natural persons to existing translations of their health data, exchange or verification of health-related certificates, including vaccination card services supporting public health and public health monitoring or digital health systems, services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and high-quality healthcare. The Commission shall, by means of implementing acts, set out the technical aspects of such supplementary services. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
- 2.The Commission and Member States may facilitate the exchange of personal electronic health data with other infrastructures, such as the Clinical Patient Management System or other services or infrastructures in the health, care or social security fields which may become authorised participants in MyHealth@EU. The Commission shall, by means of implementing acts, set out the technical aspects of such exchanges. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2). The connection and disconnection of another infrastructure to or from the central platform for digital health shall be subject to a decision of the Commission adopted by means of an implementing act, based on the result of compliance checks of the technical aspects of exchanges as referred to in the first subparagraph of this paragraph. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 98(2).
- 3.A national contact point for digital health of a third country or a system established at international level by an international organisation may become an authorised participant in MyHealth@EU, provided that it fulfils the requirements of MyHealth@EU for the purposes of the personal electronic health data exchange as referred to in Article 23, that the transfer stemming from the connection to MyHealth@EU complies with the rules in Chapter V of Regulation (EU) 2016/679, and that the requirements concerning legal, organisational, operational, semantic, technical and cybersecurity measures are equivalent to those applicable to Member States in the operation of MyHealth@EU services. Those requirements shall be verified by the Commission through compliance checks. Based on the outcome of the compliance checks referred to in the first subparagraph of this paragraph, the Commission may, by means of implementing acts, decide to connect or disconnect the national contact point for digital health of the third country or the system established at international level by an international organisation, as applicable, to or from MyHealth@EU. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2). The Commission shall establish and maintain a list of national contact points for digital health of third countries or of systems established at international level by international organisations which are connected to MyHealth@EU pursuant to this paragraph and shall make that list publicly available.
Relevant Recitals for this Article
Telemedicine is becoming an increasingly important tool that can provide patients with access to care and tackle inequities. It has the potential to reduce health inequalities and reinforce the free movement of Union citizens across borders. Digital and other technological tools can facilitate the provision of care in remote regions. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision. Under Article 168 of the Treaty on the Functioning of the European Union (TFEU), Member States are responsible for their health policy, in particular for the organisation and delivery of health services and medical care, including the regulation of activities such as online pharmacies, telemedicine and other services that they provide and provide reimbursement for, in line with their national legislation. Different healthcare policies should not, however, constitute barriers to the free movement of electronic health data in the context of cross-border healthcare, for example telemedicine and online pharmacy services.
In addition to services in MyHealth@EU for the exchange of personal electronic health data based on the European electronic health record exchange format, other services or supplementary infrastructures could be needed, for example in cases of public health emergencies or where the architecture of MyHealth@EU is not suitable for the implementation of some use cases. Examples of such use cases include support for vaccination card functionalities, including the exchange of information on vaccination plans, or verification of vaccination certificates or other health-related certificates. Such additional use cases would also be important for introducing additional functionality for handling public health crises, such as support for contact tracing for the purposes of containing infectious diseases. MyHealth@EU should support exchanges of personal electronic health data with national contact points for digital health of relevant third countries and systems established at international level by international organisations in order to contribute to the continuity of healthcare. This is particularly relevant for individuals travelling to and from neighbouring third countries, candidate countries, and the associated overseas countries and territories. The connection of such national contact points for digital health of third countries to MyHealth@EU and the interoperability with digital systems established at international level by international organisations should be subject to a check ensuring the compliance of those contact points and digital systems with the technical specifications, data protection rules and other requirements of MyHealth@EU. In addition, given that the connection to MyHealth@EU will entail transfers of personal electronic health data to third countries, such as sharing a patient summary when the patient seeks care in that third country, relevant transfer instruments under Chapter V of Regulation (EU) 2016/679 should be put in place. The Commission should be empowered to adopt implementing acts to facilitate the connection of such national contact points for digital health of third countries and systems established at international level by international organisations to MyHealth@EU. When preparing those implementing acts, the Commission should take into account Member States’ national security interests.