BY-COVID Milestone 2.2 Mechanism for data access and use of routine real-world data

As referred in BY-COVID Work Package (WP) description, WP2 brings together data resources and catalogues across domains, captures data governance and access procedures. It aims at aligning metadata descriptions and other relevant semantic information first within domains (e.g., biomolecular and imaging, clinical and health, survey, etc.) and at a second stage (in alignment with WP3 developments) expose a reference catalogue with harmonised metadata descriptions across domains. 

Deliverable (D) 2.2, part of BY-COVID WP2, will develop a common sense of the preferred mechanisms already available for accessing real-world data and transfer it across research domains and jurisdictions, describing technical, legal and organisational barriers across data sources and identified solutions for real-world data access including the procedures to manage users permissions for controlled access data. 

This milestone, which focuses on patient clinical and health data, starts paving the way of this Deliverable (D) 2.2 providing insight on issues affecting access and use of sensitive real-world data. In this milestone we do refer to routine health data reuse not to the reuse of data primarily collected for research purposes.  

The milestone starts with a definition of key concepts, shedding light on the legal bases for access and reuse when the purpose is research, and provides a template for the description and assessment of RWD access and use policies and procedures using, as examples, three real-world data initiatives collected in milestone 2.1.