From Broad Consent to Patient Engagement: A Framework for Consent Management and Study Oversight

Research output: Contribution to book/Conference proceedings/Anthology/ReportConference contributionContributedpeer-review

Contributors

Abstract

INTRODUCTION: The German Medical Informatics Initiative (MII) promotes the use of routine clinical data for research, supported by the broad consent framework to ensure patient engagement. This work proposes a data management process and reference infrastructure to improve transparency by enabling patients to track their consent history and data use in research.

METHODS: We analyzed the data provision process at the University Hospital Dresden (UKD) to identify roles and data flows relevant to secondary data use under broad consent. Established MII tools in use at UKD were evaluated for their suitability in enabling secure data access.

RESULTS: We developed a structured data access process and implemented a reference infrastructure that lays the groundwork for a potential patient-facing application providing secure access to consent and study details.

CONCLUSION: The reference infrastructure demonstrates how existing MII tools can be repurposed to offer patient-centric transparency in secondary data use. Future work will address scalability, access control, and ethical considerations, such as patient expectations and the clarity of information.

Details

Original languageEnglish
Title of host publicationGerman Medical Data Sciences 2025: GMDS Illuminates Health
EditorsRainer Rohrig, Thomas Ganslandt, Klaus Jung, Ann-Kristin Kock-Schoppenhauer, Ann-Kristin Kock-Schoppenhauer, Jochem Konig, Ulrich Sax, Martin Sedlmayr, Cord Spreckelsen, Antonia Zapf
Pages265-273
Number of pages9
ISBN (electronic)978-1-64368-615-8
Publication statusPublished - 3 Sept 2025
Peer-reviewedYes

Publication series

SeriesStudies in health technology and informatics
Volume331
ISSN0926-9630

External IDs

Scopus 105015127167
ORCID /0000-0002-1887-4772/work/196688954
ORCID /0000-0003-0154-2867/work/196689296
ORCID /0000-0002-9888-8460/work/196691454

Keywords

Keywords

  • Germany, Humans, Informed Consent, Patient Participation/methods, Health Information Exchange, Medical Informatics Applications, Patient Access to Records, Broad Consent