ArticleNPJ digital medicine2026
Guideline for secondary use of health records within Norwegian and EU regulatory frameworks.
Article in NPJ digital medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- FAIR by design (TRACE): A Trusted Research Access & Collaboration Environment.BMC medical informatics and decision making · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Secondary use of health records is vital for research, quality improvement, innovation, but it must comply with complex legal, ethical, and security requirements. In Norway and the European Economic Area (EEA), this involves navigating national health legislation alongside the European Union (EU) regulations. For secondary use in Norway, we identified sixteen regulatory documents, notably the European Health Data Space (EHDS) regulation. We synthesized these documents into a nine-step guideline with checklists to operationalize secondary use as a structured workflow, encompassing Secure Processing Environments (SPE), security controls, lawful consent, ethical review, contractual, technical safeguards, and auditability. Additionally, we provide recommendations for applying the guideline in other EEA countries. The guideline reflects on the phased application of the EHDS, SPE requirements, and the Artificial Intelligence (AI) act. As a practice-oriented synthesis, it offers a practical starting point for navigating lawful secondary use of health records.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.