Healthcare Regulation & Management

The marketing of a medical device or the approval of a medicinal product requires compliance with the highest standards of quality, safety and efficacy as well as a favorable risk-benefit profile. Compliance with these requirements is regulated by law. With the development of new technologies, such as the use of artificial intelligence in software products, the use of real-world data or personalized medicine, the legal regulations as well as the assessment methods must be constantly adapted.

In the project of the Innovative Medicines Initiative "Screen4Care", Dr. Rachel Cassidy, Sandra Gillner and Prof. Dr. Rudolf Blankart are dealing with the regulatory requirements of new screening technologies.

In modern healthcare systems, the costs of medical services are reimbursed via a health insurance fund or a national health service. The prices for healthcare services are usually negotiated at institutional level or regulated by law. Increasingly, processes based on scientific evidence are being used to systematically evaluate healthcare technologies and applications in comparison with treatment alternatives.

In the "Screen4Care" project, Sandra Gillner and Dr. Rachel Cassidy are looking at the challenges of evaluating and reimbursing innovative screening technologies.

The international comparison of healthcare systems is very complex and must be viewed in a differentiated way. While one healthcare system can ensure optimal outpatient care, another system provides optimal tertiary care or is particularly efficient in the care of chronic diseases. International comparisons, or the analysis of international variation, make it possible to draw conclusions in order to continuously improve one's own healthcare system. However, such comparisons are complex due to the heterogeneity of the population, the institutional framework, the historically evolved structures and the data protection requirements.

In projects such as "ICCONIC", Lize Duminy and Jean Pierre Uwitonze are developing innovative methods to make data comparable across national borders and to draw conclusions.

The transfer of scientific findings into political decisions is often a lengthy process. Prof. Dr. Rudolf Blankart informs parliamentarians and the administration about the current state of science and possible regulatory solutions as part of his expert work, particularly in the area of creating a legal framework to make the healthcare system more efficient or to prevent market failures in the development of new antibiotics. The Chair of Regulatory Affairs achieves this in particular by maintaining trans- and interdisciplinary networks.

Authorization Regulation of Health Technologies
In the "Smaragd" project, Oliver Lammer and Prof. Dr. Rudolf Blankart dealt with the regulatory challenges of using natural language processing in medical devices.
In the "Marano" project, Kosta Shartov dealt with the challenges of the new Medical Device Regulation for companies.

Remuneration Regulation of Healthcare Technologies
In the "COMED" project funded by the European Commission, the Chair of Regulatory Affairs (Prof. Dr. Rudolf Blankart) dealt with the development of new methods for evaluating health technologies and the development of procedures that make the evaluation process more efficient.

Comparative Health Systems Research
As part of the National Research Programme 74, Lize Duminy and Jean Pierre Uwitonze developed innovative methods to make data on international comparisons of healthcare systems comparable across national borders and to draw conclusions.