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Related Experiment Video

Updated: Jan 8, 2026

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Digitalizing Risk Minimization Measures in EU: Explorative Co-design Workshops with Expert Stakeholders.

Mathias Møllebæk1, Amalie Christine Bagger1, Kirstine Lund Hansen1

  • 1Copenhagen Centre for Regulatory Science, Department of Pharmacy, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark.

Therapeutic Innovation & Regulatory Science
|December 17, 2025
PubMed
Summary

Digitalizing medicines safety information in the EU offers personalized interventions but requires addressing implementation, workload, and ethical challenges. Future strategies must consider digital access and diverse information ecosystems for effective risk minimization.

Keywords:
Digital healthDigitalizationDrug regulationDrug safetyDrug safety communicationRisk minimization

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Digital Health Technologies
  • Health Policy and Regulation

Background:

  • Traditional medicines safety measures like package leaflets are evolving with digital technologies.
  • Limited strategic discussion exists on digitalizing additional risk minimization measures.
  • Digital tools are crucial for accessing medicines information for patients and healthcare professionals.

Purpose of the Study:

  • To gather expert stakeholder visions for digital risk minimization in the EU.
  • To explore policy and healthcare implications of future digital risk minimization technologies.

Main Methods:

  • Co-design workshops involving diverse stakeholders (clinicians, regulators, industry, IT, legal experts) across three EU member states.
  • Thematic analysis of workshop transcripts and visual products through two coding cycles.

Main Results:

  • Digitalization transforms roles, responsibilities, and collaborations for effective and sustainable digital solutions.
  • Implementation pathways must adapt to diverse EU information ecosystems and digital access by patients and professionals.
  • Remote monitoring may empower patients as data subjects, introducing new ethical and legal considerations.

Conclusions:

  • Digital risk minimization in the EU presents opportunities for timely, personalized interventions.
  • Implementation complexity, healthcare professional workload, and patient ethics are key challenges.
  • Focused policy deliberation and research in digital health are warranted.