Legal opinion for the Federal Ministry of Health: Proposed solutions for a new health research data protection law at federal and state level

The legal framework currently in place in the Federal Republic of Germany for the processing of personal data for research purposes is characterized by a network of standards comprising the DS-GVO, the Federal Data Protection Act, the State Data Protection Acts and the State Hospital Acts with independent regulations on research with patient data. In the normal case of a research association with hospitals under different sponsorship across state borders, the legislative patchwork leads to a variety of regulations that is difficult to overlook. This results in considerable legal uncertainties and disadvantages for the attractiveness of Germany as a research location.

Against the background of this problem, the following legal opinion from Dierks+Company discusses potential options for action to simplify the use of health data for research purposes, some of which have already been implemented with the recent law on the protection of the population (“Bevölkerungsschutzgesetz”).

You can read more about the legal opinion in German on our Publications page.

The legal opinion was prepared by Prof. Dr. Dr. Christian Dierks, with the collaboration of Dr. Philipp Kircher, Charlotte Husemann, Dr. Karsten Engelke, Julia Pirk and Dr. Martin Haase, and is publicly available on the official website of the Federal Ministry of Health.

This volume offers an overview of the current legal framework to researchers and all other interested parties who wish to use social and health data. The work also enables the healthcare industry and government institutions to develop solutions and products that improve the quality of care. Thus, this publication gives actors in the health care system an important orientation for the legally compliant use of social and health data. In the first part, the social-legal framework for the use of social data for research is presented. The second part provides an overview of the handling of research data after application of the DSGVO (General Data Protection Regulation) and corresponding national adaptations of the legal framework.

You can read more about the book in German on our Publications page.

The book is available for purchase here.