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 84. Digital health literacy and digital health access
- 1.Member States shall promote and support digital health literacy and the development of relevant competences and skills for patients. The Commission shall support Member States in this regard. Awareness-raising campaigns or programmes shall aim, in particular, to inform patients and the public at large about primary use and secondary use in the framework of the EHDS, including the rights arising from it, as well as the advantages, risks and potential gains for science and society of primary use and secondary use.
- 2.The awareness-raising campaigns and programmes referred to in paragraph 1 shall be tailored to the needs of specific groups and shall be developed, reviewed and, where necessary, updated.
- 3.Member States shall promote access to the infrastructure necessary for the effective management of natural persons’ electronic health data, both for primary use and secondary use.
Relevant Recitals for this Article
Improving digital health literacy for both natural persons and health professionals is essential to trust and safety and appropriate use of health data and thus is essential to achieving a successful implementation of this Regulation. Health professionals are faced with profound changes in the context of digitalisation and will be offered further digital tools as part of the implementation of the EHDS. Consequently, health professionals need to develop their digital health literacy and digital skills and Member States should provide access for health professionals to digital literacy courses so that they can prepare to work with EHR systems. Such courses should allow health professionals and IT operators to receive sufficient training in working with new digital infrastructures to ensure cybersecurity and ethical management of health data. The training courses should be developed and reviewed, and kept up to date, on a regular basis in consultation and cooperation with relevant experts. Improving digital health literacy is fundamental in order to empower natural persons to have true control over their health data, actively manage their health and care, and understand the implications of the management of such data for both primary use and secondary use. Different demographic groups have varying degrees of digital literacy, which can affect natural persons’ ability to exercise their rights to control their electronic health data. Member States, including regional and local authorities, should therefore support digital health literacy and public awareness, while ensuring that the implementation of this Regulation contributes to reducing inequalities and does not discriminate against people lacking digital skills. Particular attention should be given to persons with disabilities and vulnerable groups including migrants and the elderly. Member States should create targeted national digital literacy programmes, including programmes to maximise social inclusion and to ensure all natural persons can effectively exercise their rights under this Regulation. Member States should also provide patient-centric guidance to natural persons in relation to the use of electronic health records and primary use of their personal electronic health data. Guidance should be tailored to the patient’s level of digital health literacy, with specific attention to be given to the needs of vulnerable groups.