Rechtsrahmen des Neugeborenen-Screenings – vom etablierten Verfahren zur Genomanalyse

The human genome contains highly sensitive personal information. The introduction of genome analysis as part of newborn screening has the potential to improve healthcare at a very early stage of life, but at the same time it involves considerable risks that require legal clarification. Against this background, this paper examines the current legal situation regarding the introduction of genomic newborn screening and compares the legal framework in Germany and France. The focus is on the legal framework for conducting the test, the detectable genetic characteristics, and data protection issues, particularly with regard to the processing of genetic data for research purposes. Finally, possible amendments to the current law are discussed.