A further important step for the HiGHmed data protection concept

Under the direction of Prof. Ulrich Sax (University Medicine Göttingen) and Hauke Hund (Heilbronn University of Applied Sciences), further developments of the HiGHmed data protection concept were positively rated by the data protection group of the TMF on 20th of November 2020. The detailed concept takes into account the site-specific regulations of the data integration centers and the requirements from the respective use cases. New in the data protection concept: the “Five Safes Framework” system, which describes five types of data provision: safe projects, safe people, safe data, safe setting and safe outputs.

„Safe Projects“ focuses on the trustworthiness of the data users and the ethical and legal appropriateness of the evaluations carried out. „Safe People“ refers to the need to train employees. Contents would be e.g. data protection or Good Clinical Practice (GCP).

The remaining three axes are particularly relevant for an evaluation of provisioning procedures: „Safe Data" clarifies that only protected data should be processed (important measures: pseudonymization, anonymization). "Safe Setting" points out that only safe environments should be used for processing (important procedures: virtual data access, distributed analyses). „Safe Outputs" means that only safe evaluation results may be published (important measures: aggregation). The implementation of appropriate protective measures has potential effects on the scalability, flexibility and generality of a delivery method, which can affect its "usefulness" and have various delivery methods discussed in the context of the MII and HiGHmed.

The further developments of the data protection concept are also a great success for HiGHmed, for which the patient's privacy and the right to self-determination have the highest priority.