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Digitalizing informed consent in healthcare: a scoping review
Mascha Goldschmitt1, Patricia Gleim2, Sekina Mandelartz3
1Department of Work, Organizational, and Business Psychology, Johannes Gutenberg University Mainz, Wallstr. 3, Mainz, 55122, Germany. goldschmitt@uni-mainz.de.
BMC Health Services Research
|July 3, 2025
Summary
Digitalizing medical consent improves patient understanding but has mixed results on satisfaction. AI in consent is emerging, requiring more research for safe implementation without medical oversight.
Area of Science:
- Digital Health
- Medical Informatics
- Health Services Research
Background:
- Traditional paper-based informed consent presents challenges in comprehensibility and customization.
- Digitalization, particularly with AI, offers potential solutions to improve the consent process.
- The study acknowledges its initial preregistration as a systematic review with PROSPERO (CRD42023397681).
Purpose of the Study:
- To explore the digitalization of the medical consent process.
- To identify technologies used, their roles, evaluation outcomes, and implementation success factors.
Main Methods:
- A scoping review following Joanna Briggs Institute (JBI) guidelines.
- Searched databases (Web of Science, EBSCOHost, PubMed, PubPsych) for articles from January 2012 to June 2024.
- Screened 4287 records, including 27 studies in the final analysis.
Main Results:
- Digital consent enhances patient understanding of procedures, risks, benefits, and alternatives.
- Evidence on patient satisfaction, convenience, and stress is mixed.
- Healthcare professionals may experience time savings, but AI technologies require medical oversight.
Conclusions:
- The digitalization of patient consent is in its early stages, with limited evaluation of interactive and AI technologies.
- Significant potential exists to optimize consent for patients and healthcare professionals.
- Further methodologically sound studies are needed to validate findings and guide future implementation.
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