Health data protection law is not an independent field of law, but rather data protection law in a particularly sensitive environment. Injuries are not only a direct threat to the physical and psychological integrity of those affected, but are also a matter of criminal law in many cases. In the future, infringements against data protection law will be severely punished.
Digital health
Import
Implementation MDR, IVDR
Distribution
CE mark
Medical device legislation is defined at European level within the framework of directives and regulations which are to be observed in full in the near future, and at national level within the framework of the Medical Devices Act as well as various more specific ordinances.