What does EU · Health Data Space (Reg 2025/327) cover?

Electronic-health-data access logging. It applies to: EHR systems & health-data holders (EU).

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EU · Health Data Space (Reg 2025/327)

Electronic-health-data access logging.

Instrument: Regulation, legally binding in the EUApplies to: EHR systems & health-data holders (EU). Built · applies 26 Mar 2027

What the signed record shows

Access-event logs (who/when/what), accessor identity, and patient access-restriction signals.

The proof is a signed, tamper-evident record. Anyone can check it, without an account, and nothing has to leave the building to make it. Evidence, not a promise.

Citation: EHDS Art 9; Annex II §3; Arts 8/13

In the same family

FDA · 21 CFR Part 11Electronic records & signatures EU GMP · Annex 11Computerised-systems integrity FDA-EMA · Good AI Practice (Jan 2026)Data governance, performance, life-cycle management

What to do about it

Keep the evidence this asks for, as the work happens.

A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer™. It runs inside your own environment and nothing has to leave it.

Life sciences: how the control works Or verify a real record →

Part of the Regulayer™ proof catalogue: 156 laws and standards, one sealed engine. This page is a product description, not legal advice.

What the statute requires, section by section

Regulation (EU) 2025/327 on the European Health Data Space (EHDS). Provisions addressed:

Art. 9: Right to obtain information on accessing data: patients can obtain information (incl. automatic notifications) on any access to their electronic health data; the access-log information is retained at least 3 years and includes who accessed, date/time, and which data.
Annex II Section 3: Requirements for security and logging: the European logging software component records, on every access event, (a) identity of the accessor, (b) identity of the data subject, (c) categories of data accessed, (d) time and date, (e) origin(s) of data; with tools to review/analyse the logs.
Art. 13: Registration of personal electronic health data; Art. 8, right to restrict access. Entry into force 26 March 2025; general application 26 March 2027 (phased).

Taken from the Regulayer™ entry for this instrument, which is built against the primary text.

This is the duty on the business. For what a lawyer in Europe must disclose about using AI in a filing, see Europe: the EU AI Act, the CCBE guides, and what Germany tells its lawyers.