Researchers are aware of a consent’s importance, because informed consents are THE basis for study participation in research projects, if not otherwise regulated by law. Any incorrectly filled-in consent is invalid and inevitably leads to the participant’s exclusion from the study and loss of data for the research. The article highlights paper-based consent forms, [...]
For our users, who carefully read our News and Release-Notes, it is certainly not a technical novelty that our consent management gICS already supports the HL7 Germany FHIR Standard for Consent Management since 2021. Together with the colleagues from Erlangen, Munich and Heilbronn, a n article was published, which highlights backgrounds in relation to [...]
At the end of the year, another publication from the Trusted Third Party Greifswald was published. As part of the DFG-funded project 3LGM2IHE, requirements for record linkage, pseudonymization and the management of consents were extracted from the TMF Data Protection Guidlines (TMF Datenschutzleitfaden). These requirements were compared with the software solutions E-PIX, gPAS and [...]
We just finished our session on "Patient consent management in medical research with FHIR" at this year's FHIR DevDays 2022 in Cleveland, Ohio. The aim was to present the results of the HL7 Germany working group "Consent Management" and to make them known internationally. Of course, reference was also made to current activities of [...]
Next week, the HL7 FHIR DevDays will take place in Cleveland, Ohio, as a hybrid event. The German HL7 FHIR Working Group "Consent Management" will present the freshly balloted FHIR Consent Profiles in the slot "Patient Consent Management in medical research with FHIR". These concepts form the basis for current activities of the Medical [...]
In order to answer legal and practice-relevant questions conclusively with regard to applicable legislation, the University Medicine Greifswald commissioned a legal opinion from Dierks+Company using comprehensive and concrete questions related to the GDPR and national legislation. In order to provide maximum support for national and international cooperation projects, it has been written in English [...]
The many years of experience gathered by the German Centre for Cardiovascular Research (DZHK) with regards to data protection compliant acquisition of clinical data, diagnostic images and samples are now also being used for the German Covid-19 research. The DZHK provides its research platform for the National Pandemic Cohort Network (NAPKON) until spring 2021. [...]