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

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

What does the Regulayer pack for EU · Health Data Space (Reg 2025/327) prove?

Access-event logs (who/when/what), accessor identity, and patient access-restriction signals. The record is signed and tamper-evident, and anyone can verify it free, without an account.

Regulayer / The 114 laws / Pharma & life sciences

EU · Health Data Space (Reg 2025/327)

Electronic-health-data access logging.

Applies 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, free, 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

Seven days free, then $349 a month.

A signed record of which AI you used and what you checked, sealed to the exact file you deliver, made on your own machine and checkable free by anyone you send it to.

Start the free week Or verify a real record, free →

Part of the Regulayer proof catalogue: 114 laws and standards, one sealed engine. This page is a product description, not legal advice.