White paper
Health data holder
The European Health Data Space gives research hospitals a defined role in the secondary use of health data. The duties are fixed in law. The work of meeting them takes longer to build than the time left.
Daren Wilson
What research hospitals need to know.
Briefings, white papers, and guides on the rules and data behind hospital research, with every fact sourced.
3 results
Newest first
Guide
EHDS readiness for research hospitals
From March 2029, the European Health Data Space makes hospitals health data holders. They must describe their datasets, keep those descriptions current, and supply requested data to a health data access body within three months. Clinical trial, genomic, and cohort data follow in March 2031. Readiness means one governed, well-described record, in place before the requests arrive.
Daren Wilson
Article
The research operating system: why Europe's hospitals need one, and why now
Hospitals run two operations: care and research. Care is gaining its own operating systems. Research still runs on whatever each sponsor sends, while Europe loses trial share, shortens authorisation, and gives hospitals data-holder duties from 2029. Hospitals should own the operating layer of their research. Six requirements define that layer.
Daren Wilson
Questions
- Is our hospital a health data holder under the EHDS?EHDS readiness for research hospitals
- When do the duties start?EHDS readiness for research hospitals
- Does the patient data leave the hospital?EHDS readiness for research hospitals
- Can a hospital charge for making data available?EHDS readiness for research hospitals
- Is site activation really slower than authorisation?The clock has moved to the hospital
- What does ACT EU measure?The clock has moved to the hospital
Search the glossary
- ACT EU
Accelerating Clinical Trials in the EU, the joint initiative of the European Commission, national medicines agencies, and the European Medicines Agency to make the EU more attractive for clinical research. It sets and tracks 2030 targets.
- ALCOA+
The data integrity principles regulators expect of trial records: attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available.
- Anonymisation
Processing that makes it no longer possible to identify the person a record describes, by any means reasonably likely to be used. Anonymised data falls outside the GDPR.
- Audit trail
A secure, computer-generated, time-stamped record of who created, changed, or deleted an electronic record, when, and why. Inspectors rely on it to reconstruct what happened in a trial.
- Biobank
A collection of human biological samples, such as blood or tissue, stored with linked data and consent records so the samples can be used in future research.
- Case report form (CRF)
The document, paper or electronic, in which a site records the data a trial protocol requires for each participant. An electronic version is an eCRF.