- Regulation (EU) 2025/327 on the European Health Data Space applies from March 26, 2027.
- Secondary use of health data starts on March 26, 2029, except for several categories deferred to 2031.
- Data from clinical trials, clinical investigations and performance studies only enter secondary use on March 26, 2031.
- A data holder has three months at most to answer a request (Regulation (EU) 2025/327, 2025).
- Microenterprises and individual researchers are exempt, unless national law decides otherwise.
Regulation (EU) 2025/327 on the European Health Data Space, the EHDS, was published in the Official Journal on March 5, 2025 and applies from March 26, 2027. For a team running clinical trials, the date that matters comes later: clinical trial data only enter the secondary use regime on March 26, 2031. Between those two dates, the regulation applies in blocks, each with its own timeline. Academic and hospital sponsors will be health data holders under the regulation. They have four and a half years to prepare datasets that a public body can ask them to hand over within three months.
What does the EHDS change for a clinical trial?
The EHDS does not change how you run a trial. Regulation (EU) 2025/327 organizes two uses of electronic health data: patients' and health professionals' access to health data, called primary use, and its reuse for research, innovation or policymaking, called secondary use. An ongoing trial remains governed by Regulation (EU) No 536/2014, the GDPR and, in France, the CNIL reference methodologies.
Article 1 of the regulation says so: it applies without prejudice to Regulation 536/2014 and the GDPR. Trial authorization, the ethics committee opinion, participant information and the legal basis for processing stay as they are.
What changes is what comes after. Once the trial ends, its data become a category the sponsor must make available when a public body requests it, for purposes the regulation lists. The sponsor becomes a “health data holder” under Article 2, which covers anyone “performing research in relation to the healthcare or care sectors”.
When does the EHDS apply?
The EHDS applies in three stages. The regulation applies on March 26, 2027, secondary use on March 26, 2029, and five data categories, including clinical trial data, on March 26, 2031. Primary use follows its own timeline, in 2029 and then 2031, depending on the data category.
Article 105 of Regulation (EU) 2025/327 sets these deadlines. The table below lists the ones that matter to a clinical research team.
| Date | What applies | Article |
|---|---|---|
| March 26, 2027 | General application of the regulation; each Member State communicates its national contact point for secondary use | Art. 105; Art. 75(1) |
| March 26, 2029 | Primary use: patient summaries, electronic prescriptions and dispensations | Art. 105; Art. 14(1)(a) to (c) |
| March 26, 2029 | Secondary use (Chapter IV): data from EHRs, registries, medical devices and biobanks | Art. 105; Art. 51 |
| March 26, 2031 | Primary use: medical imaging, test results, discharge reports | Art. 105; Art. 14(1)(d) to (f) |
| March 26, 2031 | Secondary use of data from clinical trials, clinical investigations and performance studies | Art. 105; Art. 51(1)(m) |
| March 26, 2031 | Secondary use of data from research cohorts, questionnaires and surveys, after the first publication of the results | Art. 105; Art. 51(1)(p) |
The same deferral to 2031 covers genetic and genomic data, other omic data, and data on factors impacting health (Article 51(1), points (b), (f) and (g)).
Why must clinical trial data wait until 2031?
Article 105 of Regulation (EU) 2025/327 defers five of the seventeen categories in Article 51 to March 26, 2031, clinical trial data among them, and the operative text gives no reason for that choice. For a sponsor, the effect is concrete: two more years than registries or EHRs to prepare reusable trial data.
Point (m) of Article 51 is broad. It covers data “from clinical trials, clinical studies, clinical investigations and performance studies” subject to four texts: Regulation 536/2014 for medicinal products, Regulation (EU) 2024/1938 for substances of human origin, the MDR for medical devices and the IVDR for in vitro diagnostic medical devices. A device manufacturer running a clinical investigation falls within scope in the same way as a drug trial sponsor.
Article 51 makes no distinction based on when the data were collected. A trial that starts in 2027 and ends in 2030 will produce data that fall under the regime from 2031. The structuring decisions therefore belong to eCRF design, not to the day a request arrives.
Who must make trial data available?
Any health data holder under Article 2 of the regulation, which includes public and private sponsors conducting health research. Article 50 exempts two categories: natural persons, including individual researchers, and microenterprises. Each Member State can lift these exemptions in its national law.
Under Commission Recommendation 2003/361/EC, a microenterprise employs fewer than 10 people and has an annual turnover or balance sheet total of no more than 2 million euros. Two cases show where the line falls.
An eight-person startup running a clinical investigation on its device remains exempt, unless the Member State where it is established decides otherwise. Member States must notify that choice to the Commission by March 26, 2029 (Article 50(4)).
A university hospital sponsoring an academic trial is not exempt. It is a data holder as soon as it processes health data for research, and its trial data will enter the regime in 2031.
What will a sponsor have to do from 2031?
A sponsor acting as a data holder will have to deliver its data to the health data access body in its country, on request, within three months at most, a period the body can extend by another three months. It will also have to describe its datasets in the national dataset catalogue and check that description at least once a year.
Article 60 sets these duties. The request always comes through the public body: a user obtains a data permit (Article 68) or has a health data request approved (Article 69), and the body then contacts the data holder. The sponsor never deals directly with the researcher or company that reuses its data.
Three rules frame this reuse:
- Limited purposes. Article 53 lists the permitted uses, including scientific research that contributes to public health, health technology assessment, and the development and training of algorithms for medical devices and AI systems.
- Anonymization by default. The access body provides anonymized data when the purpose allows it, and pseudonymized data only if the user shows that anonymized data cannot serve the purpose (Article 66).
- A right to opt out. Anyone can opt out of the secondary use of their data at any time, without giving a reason (Article 71). The opt-out is reversible and does not affect permits granted before it was exercised.
Data protected by trade secrets or intellectual property rights remain in scope, with protective measures that the access body puts in place (Article 52).
What the EHDS has not settled yet
Several points will stay open until the implementing acts provided for in the regulation are published. The formats for dataset descriptions and the data quality and utility label (Articles 77 and 78) are not yet set. Each Member State designates its health data access bodies and must give the Commission the details of its national contact point by March 26, 2027 (Article 75).
For a sponsor, this means no specific technical obligation applies today. The decisions that cost the most to reverse later, however, are made now: variable names, data dictionaries, documentation of derivations and export format. A trial designed in 2027 with study-specific variable names and no documented dictionary will take a long time to describe in a catalogue in 2031.
How Datacapt prepares your data for reuse
In Datacapt, eCRF items carry their CDASH names from the study build, and your team exports the study in CDISC ODM format. The platform provides an item dictionary, and the dataset downloads as CSV, XLSX, PDF or SAS. Every change to a data point is recorded in a time-stamped audit trail, and the data are hosted in France by an HDS-certified partner.
These choices do not make a study “EHDS compliant”: the EHDS has not yet published any technical requirement. They keep the description of your datasets from turning into a retroactive documentation project when the first request arrives.
Academic and hospital research teams will find on our dedicated page how Datacapt supports investigator-initiated studies. For data retention after the trial, our article on archiving and confidentiality in clinical trials covers retention periods and responsibilities.
Frequently asked questions about the EHDS
[[faq]]
Sources
- European Parliament and Council, Regulation (EU) 2025/327 of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847, EUR-Lex, 2025
- European Commission, Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (2003/361/EC), EUR-Lex, 2003
Does the EHDS apply to clinical trials from 2027?
No. Regulation (EU) 2025/327 applies from March 26, 2027, but data from clinical trials, clinical investigations and performance studies only enter secondary use on March 26, 2031, under Article 105. Running a trial remains governed by Regulation 536/2014, the MDR, the IVDR and the GDPR.
Is an academic sponsor a data holder under the EHDS?
Yes. Article 2 of Regulation (EU) 2025/327 includes among health data holders anyone performing research in relation to the healthcare sector. A university hospital or research institute that sponsors trials falls within scope. Only individual researchers and microenterprises are exempt, unless national law decides otherwise.
How long does a data holder have to deliver data to the access body?
Article 60 of Regulation (EU) 2025/327 sets a reasonable time limit of no more than three months from the request of the health data access body. That body can extend the period by up to three months in justified cases. The request always follows a data permit or an approved health data request.
Can a participant refuse the reuse of their trial data?
Yes. Article 71 of Regulation (EU) 2025/327 gives every person the right to opt out, at any time and without giving a reason, of the processing of their health data for secondary use. The opt-out is reversible. Each Member State must provide an accessible and easy-to-understand opt-out mechanism.
With over 10 years of experience working in CROs, Khalil brings deep expertise in clinical trials and a clear understanding of the daily challenges faced by research professionals. His insights are grounded in real-world operations, making his perspective both practical and strategic.
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