Innovative In-Vitro Diagnostics within the Health Care System | Max-Planck-Institut für Sozialrecht und Sozialpolitik - MPISOC

Research Projects

Health Law

Innovative In-Vitro Diagnostics within the Health Care System


Project description

Molecular diagnostics in the form of in vitro diagnostics is becoming ever more significant. This means, in particular, diagnostic laboratory tests that serve to yield molecular biological and genetic information on a patient. Such information is used to customize medical treatment to the individual needs of a patient and to thus achieve better treatment results than by way of standard therapies.

In a public health system, on the one hand, patients should have access to such innovative health care services as quickly as possible. On the other hand, access to these services must be sufficiently monitored and financially feasible. Accordingly, various – and often conflicting – interests need to be reconciled. This in turn requires an appropriate regulatory legal framework, which, in fact, the German statutory health insurance system currently does not have as regards in vitro diagnostics.

The aim of the project is to elaborate, in terms of legal policy, a proposal for improvement that balances any conflicting interests in an adequate way and allows for the integration of novel diagnostic services into the catalogue of services offered by the statutory health insurance. For this purpose, the legal systems of selected countries will be compared and the various solutions obtained will be analysed with a view to whether and how this proposed balance in the field of innovative in vitro diagnostics is realized. The findings obtained shall help improve the legal framework conditions that are crucial for the integration of medical research into health care.

This research project is supported by the Fritz Thyssen Foundation (Fritz Thyssen Stiftung für Wissenschaftsförderung).

Objectives of the study

  • Improve access to medical innovations
  • Introduce “individualized” medicine to the statutory health insurance system
  • Proposal for a regulation based on a legal comparison concerning in vitro diagnostics
Contact Person(s)

Ulrich Becker


Fritz Thyssen Stiftung für Wissenschaftsförderung

Presentations and Contributions
Prof. Dr. Ulrich Becker, LL.M. (EHI), Dr. Simone von Hardenberg
Personalisierte Medizin für Kassenpatienten?
Prof. Dr. Ulrich Becker, LL.M. (EHI), Dr. Simone von Hardenberg
Medizinische Innovationen als Aufgabe des Sozialrechts am Beispiel der Companion Diagnostics in der GKV

von Hardenberg, Simone/Schneider, Susanne/Wien, Philipp:
Innovative Labordiagnostik in der GKV: Sozialrechtliche Qualitätssicherung am Beispiel der Liquid Biopsy, in: Zeitschrift für das gesamte Medizinprodukterecht (MPR), 17 (2018) 4, p. 120-127.

von Hardenberg, Simone/Wien, Philipp:
Companion Diagnostics: Sozialrechtlicher Reformdruck vor dem Hintergrund aktueller medizinischer Entwicklungen, in: Gesundheit und Pflege, 7 (2017) 1, p. 9-15.