The international data governance landscape.

"data sharing 118 the rda has released a large number of deliverables through this mechanism including academic publications surveys recommendations and policies for the conduct of research and software tools119"

"G. Mandatory Disclosure Requirements The third category of laws relevant to data governance is access to information laws, and other legislatively enshrined requirements to disclose data. Such laws include public-sector ‘access to information’ legislation, which requires government agencies to make the information they hold available to the public in anonymized format on request. Other examples thereof include the disclosure requirements imposed by medicines agencies (eg the European Medicines Agency and Health Canada), which require the public disclosure of clinical trial results relating to drugs and medical devices.46 Both access to information laws and clinical trial disclosure requirements generally necessitate the public disclosure of data, but mandate that personal data are not to be disclosed. Access to information legislation often provides a number of further justifications for the non-disclosure of data, including commercial interests, State interests, or the prohibitive impracticability of accessing and disclosing the desired data. If data cannot be disclosed for reasons of confidentiality or privacy, both clinical trial disclosure policies and access to information legislation generally require the data to be de-identified and disclosed in an anonymized format.47 CONFLICT OF INTEREST AB and BMK have no conflict of interest to declare. FMG is a member of the European Group on Ethics in Science and New Technologies. This paper is written in a purely private capacity and the views expressed here cannot be attributed to anyone other than the authors."

"FMG is funded by the German Federal Ministry of Education and Research, Project TrustDNA (Grant Number: 16DTM108A) FMG is funded by the German Federal Ministry of Education and Research, Project TrustDNA (Grant Number: 16DTM108A)"