Implementing and delegated acts
What the Regulation tasks the Commission with adopting by implementing or delegated acts, and where each one stands. Nine have a deadline: 26 March 2027.
Status checked on 25 October 2026. The list of empowerments comes from the Official Journal text, and a test checks that none is missing. Statuses were checked against Have your say, the comitology register and the Official Journal. Anything with none is listed as «no public trace».
- 4 Adopted
- 1 Draft open for feedback
- 1 Draft, feedback closed
- 7 In preparation
- 18 No public trace
| Legal basis | Subject | Deadline | Status | Act and dates | Evidence |
|---|---|---|---|---|---|
| 4(4) | Interoperability specifications for cross-border proxy services implementing act · mandatory | — | No public trace | 1 | |
| 13(4) | Data quality requirements for registering health data in EHR systems implementing act · mandatory | 26 March 2027 | In preparation | 1 2 | |
| 14(1) | Cross-border specifications for additional national data categories implementing act · optional | — | No public trace | ||
| 14(2) | Amending Annex I priority category characteristics delegated act · optional | — | No public trace | ||
| 15(1) | EEHRxF technical specifications for the priority categories implementing act · mandatory | 26 March 2027 | In preparation | call for evidence: 30 March 2026; planned adoption: Q4 2026 | 1 2 3 4 |
| 15(2) | Regular EEHRxF updates for coding systems and nomenclatures implementing act · mandatory | — | No public trace | ||
| 15(3) | Extending EEHRxF to additional data categories implementing act · optional | — | No public trace | ||
| 16(2) | Cross-border identification and authentication of patients and professionals implementing act · mandatory | — | Adopted | Implementing Regulation (EU) 2026/2099 feedback: 9 April 2026 – 7 May 2026; committee vote: 23–24 June 2026; adopted: 21 September 2026; published in the OJ: 22 September 2026 | 1 2 3 4 |
| 17 | Technical implementation of natural persons' primary-use rights implementing act · mandatory | — | No public trace | ||
| 23(4) + 23(8) | MyHealth@EU: technical development, security and the Commission as processor implementing act · mandatory | 26 March 2027 | Adopted | Implementing Regulation (EU) 2026/2083 feedback: 9 April 2026 – 7 May 2026; committee vote: 23–24 June 2026; adopted: 18 September 2026; published in the OJ: 21 September 2026 | 1 2 3 4 |
| 24(1) | Technical aspects of supplementary MyHealth@EU services implementing act · mandatory | — | No public trace | 1 | |
| 24(2) | Exchanges with other infrastructures and their connection decisions implementing act · mandatory | — | No public trace | ||
| 24(3) | Connecting third-country or international contact points to MyHealth@EU implementing act · optional | — | No public trace | ||
| 36(1) | Common specifications for harmonised EHR system components implementing act · mandatory | 26 March 2027 | In preparation | call for evidence: 30 June 2026; planned adoption: Q4 2026 | 1 2 3 4 |
| 40(4) | Common specifications for the European digital testing environment implementing act · mandatory | — | In preparation | call for evidence: 30 March 2026; planned adoption: Q1 2027 | 1 2 3 |
| 47(3) | Format and content of the wellness application label implementing act · mandatory | — | No public trace | ||
| 49(4) | Data manufacturers must enter in the EU EHR/wellness database delegated act · optional | — | In preparation | 1 2 | |
| 62(6) | Principles for HDAB fee policies and fee structures implementing act · mandatory | — | No public trace | ||
| 63(7) + 75(12) | HealthData@EU: requirements, architecture and compliance IT tool implementing act · mandatory In DataSpaceHealth: Applies to the connection to HealthData@EU, which the portal only rehearses in an unofficial test environment. | 26 March 2027 | Draft, feedback closed | Draft implementing regulation Ares(2026)8339104 feedback: 1 September 2026 – 29 September 2026; planned adoption: Q4 2026 | 1 2 3 4 |
| 68(14) | Logo acknowledging the contribution of the EHDS implementing act · optional | — | No public trace | ||
| 70 | Templates: access application, data permit, health data request implementing act · mandatory In DataSpaceHealth: Once adopted, the portal's application form and permit will have to follow these templates. | 26 March 2027 | Draft open for feedback | Draft implementing regulation Ares(2026)9764418 feedback from: 16 October 2026; feedback until: 13 November 2026; planned adoption: Q4 2026 | 1 2 3 4 |
| 73(5) | Requirements for secure processing environments implementing act · mandatory In DataSpaceHealth: Applies to the portal's secure processing environment (Databricks). | 26 March 2027 | In preparation | call for evidence: 9 March 2026; planned adoption: Q1 2027 | 1 2 3 |
| 74(3) | Template for controller-processor agreements in secondary use implementing act · optional | — | No public trace | ||
| 75(5) | Recognising third-country/international contact points for HealthData@EU implementing act · optional | — | No public trace | 1 | |
| 75(13) | Decisions connecting individual authorised participants to HealthData@EU implementing act · optional | — | No public trace | 1 | |
| 77(4) | Minimum metadata elements for dataset descriptions implementing act · mandatory In DataSpaceHealth: The console checks each dataset description against its 27 minimum elements when validating it and asks for the missing ones. Descriptions already published have not been redone. | 26 March 2027 | Adopted | Implementing Regulation (EU) 2026/2098 feedback: 14 April 2026 – 12 May 2026; committee vote: 23–24 June 2026; adopted: 18 September 2026; published in the OJ: 21 September 2026 | 1 2 3 4 |
| 78(5) | Amending the elements of the data quality and utility label delegated act · optional | — | No public trace | 1 | |
| 78(6) | Visual characteristics and technical specifications of the quality label implementing act · mandatory In DataSpaceHealth: Applies to the quality and utility label the catalogue shows. | 26 March 2027 | In preparation | call for evidence: 27 July 2026; planned adoption: Q1 2027 | 1 2 3 |
| 80 | Minimum specifications for high-impact datasets implementing act · optional | — | No public trace | ||
| 91(2) | Recognising a third country's reciprocal access implementing act · optional | — | No public trace | ||
| 92(11) | Establishment and operation of the EHDS Board implementing act · mandatory | — | Adopted | Implementing Regulation (EU) 2026/771 feedback: 9 December 2025 – 6 January 2026; committee vote: 26 February 2026; adopted: 7 April 2026; published in the OJ: 8 April 2026 | 1 2 3 4 |