Article 19
Digital health authorities
In short: Each Member State shall designate one or more digital health authorities responsible for the implementation and enforcement of the EHDS primary use requirements at national level.
- Each Member State shall designate one or more digital health authorities responsible for the implementation and enforcement of
this Chapter [on primary use] at national level. The Member States shall inform the Commission of the identity of the digital health authorities by 26 March 2027.
Where a Member State designates more than one digital health authority or where the digital health authority consists of multiple organisations,
the Member State concerned shall communicate to the Commission a description of the distribution of tasks between those various authorities or
organisations. Where a Member State designates several digital health authorities, it shall designate one digital health authority to act as coordinator.
The Commission shall make that information publicly available.
- Each digital health authority shall be entrusted with the following tasks and powers:
- (a) ensuring the implementation of the rights and obligations provided for in this Chapter and
Chapter III by adopting necessary national, regional or local technical solutions and by establishing
relevant rules and mechanisms;
- (b) ensuring that complete and up-to-date information about the implementation of rights and obligations provided for
in this Chapter and
Chapter III is made readily available to natural persons, health professionals and healthcare providers;
- (c) in the implementation of technical solutions referred to in point (a) of this paragraph, ensuring that such technical solutions comply
with this Chapter,
Chapter III and Annex II;
- (d) contributing at Union level to the development of technical solutions enabling natural persons and health professionals to exercise their
rights and comply with their obligations set out in this Chapter;
- (e) facilitating persons with disabilities to exercise their rights under this Chapter
in accordance with Directive (EU) 2019/882 of the
European Parliament and of the Council (31);
- (f) supervising the national contact points for digital health and cooperating with other digital health authorities and the Commission on
further development of MyHealth@EU;
- (g) ensuring the implementation at national level of the European electronic health record exchange format, in cooperation with national
authorities and stakeholders;
- (h) contributing at Union level to the development of the European electronic health record exchange format, to the elaboration of common
specifications, in accordance with Article 36,
which address quality, interoperability, security, safety, ease of use, accessibility,
non-discrimination or fundamental right concerns, and to the elaboration of the specifications of the EU database for registration of
EHR systems and wellness applications referred to in Article 49;
- (i) where applicable, performing market surveillance activities in accordance with Article 43,
while ensuring that any conflicts of
interest are avoided;
- (j) building national capacity for implementing requirements concerning interoperability and security of electronic health data for
primary use and participating in information exchanges and capacity building activities at Union level;
- (k) cooperating with market surveillance authorities, participating in the activities related to handling of risks posed by
EHR systems and of serious incidents and supervising the implementation of corrective action in accordance with Article 44;
- (l) cooperating with other relevant entities and bodies at local, regional, national or Union level, to ensure interoperability,
portability and security of electronic health data;
- (m) cooperating with supervisory authorities in accordance with Regulations (EU) No 910/2014 and (EU) 2016/679 and
Directive (EU) 2022/2555 of the European Parliament and of the Council (32) and with other relevant authorities, including
those competent for cybersecurity and electronic identification.
- Each Member State shall ensure that each digital health authority is provided with the human, technical and financial resources,
premises and infrastructure necessary for the effective performance of its tasks and exercise of its powers.
- In the performance of its tasks, each digital health authority shall avoid any conflicts of interest. Each member of staff of the
digital health authority shall act in the public interest and in an independent manner.
- In the performance of their tasks, the relevant digital health authorities shall actively cooperate and consult with relevant
stakeholders' representatives, including patients' representatives, healthcare providers and health professionals' representatives,
including health professional associations, as well as consumer organisations and industry associations.
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