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 102. Evaluation, review and progress report
- 1.By 26 March 2033, the Commission shall carry out a targeted evaluation of this Regulation, and submit a report on its main findings to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. That evaluation shall cover the following:
- (a)the possibilities of further extending interoperability between EHR systems and electronic health data access services other than those established by the Member States;
- (b)the need to update the data categories referred to in Article 51 and the purposes listed in Article 53(1);
- (c)the implementation and use by natural persons of the mechanisms to opt out from secondary use referred to in Article 71, in particular on the impact of those mechanisms on public health, scientific research and fundamental rights;
- (d)the use and implementation of any stricter measures introduced pursuant to Article 51(4);
- (e)the exercise and implementation of the right referred to in Article 8;
- (f)an assessment of the certification framework for EHR systems established in Chapter III and the need to introduce further tools regarding conformity assessment;
- (g)an assessment of the functioning of the internal market for EHR systems;
- (h)an assessment of the costs and benefits of the implementation of the provisions for secondary use laid down in Chapter IV;
- (i)the application of fees as referred to in Article 62.
- 2.By 26 March 2035, the Commission shall carry out an overall evaluation of this Regulation, and submit a report on its main findings to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment or other appropriate measures. That evaluation shall include an assessment of the efficiency and functioning of the systems providing for access to electronic health data for further processing, carried out on the basis of Union or national law referred to in Article 1(7), with regard to their impact on the implementation of this Regulation.
- 3.Member States shall provide the Commission with the information necessary for the preparation of the reports referred to in paragraphs 1 and 2 and the Commission shall take that information duly into account in those reports.
- 4.Every year following 25 March 2025 until the end of the year in which all provisions of this Regulation apply as provided for in Article 105, the Commission shall submit a progress report to the Council on the preparations for the full implementation of this Regulation. That progress report shall contain information about the degree of progress and the readiness of the Member States in relation to the implementation of this Regulation, including an assessment of the feasibility of reaching the timeframes laid down in Article 105, and may also contain recommendations for Member States to improve preparedness for the application of this Regulation.
Relevant Recitals for this Article
Implementing the EHDS will require significant development work across Member States and central services. To track the progress made in that regard, the Commission should, until the full application of this Regulation, report annually on that progress, taking into account information provided by the Member States. Those reports could include recommendations for remedial measures, as well as an assessment of the progress made.
In order to assess whether this Regulation reaches its objectives effectively and efficiently, is coherent and still relevant and provides added value at Union level, the Commission should carry out an evaluation of this Regulation. The Commission should carry out a targeted evaluation of this Regulation within eight years of its entry into force, and an overall evaluation within 10 years of its entry into force. The Commission should submit reports on its main findings following each evaluation to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions.