Individualised Health Care: Ethical, Economic and Legal Implications for the German Health Care System | Max-Planck-Institut für Sozialrecht und Sozialpolitik - MPISOC

Research Projects

Health Law

Individualised Health Care: Ethical, Economic and Legal Implications for the German Health Care System


Project description

The main focus of the joint project „Individualized Health Care“, which has now been concluded, is the integration of individualized medicine into the German health care system. Individualized medicine is understood to be a medical concept which serves to identify individual – especially biological – factors which could help predict a patient’s probability of developing a disease as well as the effectiveness of certain treatment processes. The joint project’s goal was to evaluate the ethical, economical and legal implications of such an individualized medical approach in order to prevent and treat diseases. It aimed to work out perspectives for an ethically justified, economically rationalized and legally appropriate development and application of these treatments.

In the course of this research project the Department for Social Law focused on how measures of individualized medicine could be integrated into the benefits catalogue of Germany’s statutory health insurance system. Scientists also conducted research into the possible implications for patients‘ personal rights. With regards to the resulting discussion on the necessity of legal protection concerning genetic health records, the USA’s legal situation, where gene-based individualized medicine is already more common, was incorporated. Furthermore, researchers at the Institute for Ethics and History of Medicine at the LMU Munich looked into the ethical issues of individualized healthcare in more detail, whereas questions regarding economical aspects were answered by scientists at the Helmholtz Zentrum Munich, the German research institute for Health and Environment. The three-year project was funded by the Federal Ministry for Education and Research within the context of its research focus ELSA (ethical, legal and social aspects of modern life sciences and biotechnology).

Photo: MPI for Informatics - Bock

Key results

  • Individualized health services can be fitted into the already existing performance categories of the SGB V. However, the precise classification depends on the customization of the particular benefits.
  • In refunding individual health benefits, possible obstacles arise, for example with regard to the necessary benefit documentation or drug-test-combinations concerning social and legal quality control.
  • As these individualized treatment methods also establish the use of genetic health data within the medical sector in general, a comprehensive protection of the right to informational autonomy is needed.
Contact Person(s)

Prof. Dr. Ulrich Becker, LL.M. (EHI)

Presentations and Contributions
Dr. Simone von Hardenberg
Individualisierte Medizin aus rechtlicher Sicht: Sind meine genetischen Gesundheitsdaten ausreichend geschützt?
Dr. Simone von Hardenberg
Individualisierte Medizin für Patienten der GKV: Möglichkeiten und Grenzen aus rechtlicher Sicht
Dr. Simone von Hardenberg
Individualisierte Medizin als Leistung der GKV?
Dr. Simone von Hardenberg
Individualisierte Medizin und genetische Gesundheitsinformationen, Chancen und Risiken aus rechtlicher Sicht

Becker, Ulrich; Hardenberg, Simone von:
Companion Diagnostics in der GKV, Hürden und Perspektiven für ihren Zugang, in: Medizinrecht, 34 (2016) 2, p. 104-109.

Hardenberg, Simone von:
Individualisierte Medizin in den USA – Zum dortigen Schutz genetischer Gesundheitsdaten, in: Datenschutz und Datensicherheit, 38 (2014) 9, p. 619-622.

Hardenberg, Simone von:
Zur Nutzung genetischer Gesundheitsdaten in der Individualisierten Medizin, in: Zeitschrift für Datenschutz, 4 (2014) 3, p. 115-118.

Hardenberg, Simone von; Wilman, Nikola:
Individualisierte Medizin als Exklusiv-Medizin?, in: MedR (Medizinrecht), (2013) 2, p. 77-81.

Hardenberg, Simone von:
Zur Integration individualisierter Arzneimitteltherapien in den Leistungskatalog der Gesetzlichen Krankenversicherung, in: Der Gynäkologe, 46 (2013) 9, p. 675 ff..