DZL joins other organizations in supporting TMF comment on EU Draft Data Protection Regulations
Security of private data is of growing importance. Therefore, the European Union (EU) initiated an update of the current legal framework, the EU Data Protection Directive of 1995. The draft of these new “General Data Protections Regulations” (GDPR) was issued last October and has now been commented upon by the TMF (Technologie- und Methodenplattform für die vernetzte medizinische Forschung). The German Center for Lung Research and several other prominent German research institutions co-signed the TMF commentary.
The signatories agree with the need for protection of data related to private persons. In biomedical research data protection is especially important with regard to patients and test persons. Responsible and ethical handling of personal data and biomaterials ensures trust of people in medical research and increases willingness to take part in clinical studies. However, the signatories also agree that it is important that regulations and procedures do not unintentionally hamper biomedical research progress. New regulations must balance the needs of personal data protection with citizens’ demands and expectations for medical progress. There are some critical aspects in the European Union draft which could interfere with research developments in Germany and the EU in general, should these regulations be adopted in their current form. For example, the EU proposals regarding use of ‘historical biomaterials’ and with ‘broad consent’ procedures are particularly problematic.