WP 7
ELSI

Prof. Dr. Reiner Anselm

Lehrstuhl für Systematische Theologie und Ethik

Prof. i.R. Dr. Ulrich M. Gassner

Ehem. Professur für Öffentliches Recht, Universität Augsburg

Work Package 7: ELSI – Ethical, Legal and Social Implications

The implementation of P4 medicine requires clear ethical and legal guidelines. WP7 supports DigiMed Bayern by conducting a comprehensive analysis and shaping these framework conditions to ensure data protection, patient rights, and social responsibility.

Key Topics:

  • Ethics & Society:
    Further development of classical medical ethics principles (autonomy, non-maleficence, beneficence, justice) for big data approaches and personalized medicine. Discussion of concepts such as data sovereignty and data solidarity.
  • Legal Analysis:
    Ensuring compliance with the GDPR, GenDG, BGB, and other standards. Clarifying issues regarding consent, data protection, data linkage, and liability.
  • Participation & Transparency:
    Promoting public dialogue, workshops, and publications on the ethical and legal challenges of P4 medicine.

Added Value:
WP7 lays the foundation for the responsible, legally compliant, and socially acceptable use of health data – fostering trust and sustainability in digital medicine.

Results Work Package 7

ELSI: Ethics, Legal, and Social Sciences in Digital Medicine

Overview

Work Package 7 addresses the ethical, legal, and social implications (ELSI) of digitalization and personalization in medicine. The goal is to establish the framework for responsible research and use of health data and to promote societal acceptance.

Key Findings

  • Ethics (WP7.1):
    • Development of new ethical principles for decision-making by patients and researchers in P4 medicine.
    • Metaethical grounding of the approach: From individual to collective responsibility, particularly in the handling of big data and data solidarity.
    • No obligation to participate in research, but clear ethical responsibility in the handling of health data.
    • Communication via collectives: Transformation of social groups through digitalized medicine, e.g., in the context of the COVID-19 crisis.
    • Anthropological foundations: New connections between biology, mind, and social reason.
  • Social science companion study to the VRONI study:
    • Conducting interviews and surveys with parents, pediatricians, and pediatric cardiologists.
    • Analysis of the reasons for accepting or rejecting FH screening in children.
    • Key finding: Parents’ trust in their doctor is crucial for participation in the screening.
    • Recommendations for clinical practice: Ensuring financial reimbursement for consultations, flexible scheduling of screening appointments, and establishing regional cooperation centers to support families affected by FH.
  • Legal (AP7.2):
    • Ensuring legal compliance when working with sensitive health data, including genetic data from children.
    • Proactive coordination with the Bavarian State Commissioner for Data Protection (BayLfD): Drafting and coordination of over 130 documents relevant to data protection law.
    • Groundbreaking decisions regarding central data storage in the DigiMed Secure Cloud and anonymization in the HerzFit app.
    • No legal incidents during the project period – DigiMed is considered a pioneer in data protection-compliant research in Germany.

Sustainability and Outlook

  • Further development of ELSI research beyond DigiMed, e.g., through handbook projects and grant applications to the Volkswagen Foundation and the DFG.
  • Application of ethical considerations in new research projects and data repositories.
  • Need for context-sensitive approaches to prevention measures and follow-up studies on how families with a positive FH diagnosis cope with their diagnosis.
  • The DigiMed Secure Cloud and the legal standards developed serve as a model for future projects and collaborations.
Conclusion for Work Package 7

Work Package 7 has established the ethical, legal, and social foundations for the responsible use of health data in digital medicine. The results enhance public acceptance, ensure legal compliance, and provide practical recommendations for implementing preventive and research measures.