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.

Localization systems, emergency call or fall detection systems, but also shutdown systems for household appliances or digital aids to remind people to take food and drink are Ambient Assisted Living technologies. Ambient Assisted Living technologies, in short AAL, have a nursing benefit by enabling people in need of care to lead independent lives and at the same time relieving the burden on nursing staff.

The expert report shows how the legal regulations in the German Social Security Code (SGB V and XI) can be adapted to integrate digital assistance systems as care aids into standard care.

During the last few weeks, the report got very popular in online media (and also in offline media).

Here are some of them:

The report was prepared by Christian DierksSebastian Retter, and Julia Pirk, on behalf of the Federation of German Consumer Organisations.

It is available to read and download here (German).