| Title: |
Balancing clinical relevance, legal boundaries, and technological solutions : a case-based analysis of secondary use of electronic health records in Sweden |
| Authors: |
Dóczi, Zoltán; Valachis, Antonis |
| Publisher Information: |
Örebro universitet, Institutionen för beteende-, social- och rättsvetenskap Örebro universitet, Institutionen för medicinska vetenskaper Region Örebro län Örebro University Hospital, Region Örebro County, Örebro, Sweden Department of Oncology 2026 |
| Document Type: |
Electronic Resource |
| Abstract: |
Background: The secondary use of electronic health records (EHRs) poses legal challenges, particularly when the responsibility for managing EHRs lies with local or regional authorities. This article presents a case-based analysis of the secondary use of EHR data in contexts where data privacy responsibilities are managed regionally in Sweden. Methods and results: Using two distinct purposes for the secondary use of the digital tool Patient Overview Breast Cancer: (i) assessing the uptake of new treatment strategies in a real-world setting for quality assurance, and (ii) evaluating the effectiveness of these strategies in specific patient subgroups with limited evidence for research purposes, the study explored the distinctions between research and quality assurance, the legal implications of each framework, and the potential role of federated learning as a privacy-preserving technological solution. Conclusions: Federated learning offers a promising approach to overcome legal and organizational barriers to secondary use of regional EHRs in Sweden, enabling scalable, clinically meaningful insights for cancer care. However, its effective implementation requires a unified national framework that balances personal integrity with patient safety, supported by regulatory sandboxes. |
| Index Terms: |
health law; secondary use of data; electronic health records; quality assurance; research; federated learning; Law; Juridik; Cancer and Oncology; Cancer och onkologi; Article in journal; info:eu-repo/semantics/article; text |
| DOI: |
10.1016.j.esmorw.2025.100661 |
| URL: |
http://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-125914; ESMO Real World Data and Digital Oncology, 2026, 11 |
| Availability: |
Open access content. Open access content; info:eu-repo/semantics/restrictedAccess |
| Note: |
English |
| Other Numbers: |
UPE oai:DiVA.org:oru-125914; 0009-0008-4039-2746; 0000-0001-6059-0194; doi:10.1016/j.esmorw.2025.100661; ISI:001642960100001; 1582083000 |
| Contributing Source: |
UPPSALA UNIV LIBR; From OAIster®, provided by the OCLC Cooperative. |
| Accession Number: |
edsoai.on1582083000 |
| Database: |
OAIster |