The BioChain has published a new policy white paper proposing that Europe make a clearer distinction between data governance and evidence governance.
What happens after data becomes evidence
From Data Governance to Evidence Governance: Building Verifiable Evidence Chains for European Life Sciences examines what happens after governed data are transformed into scientific, analytical or regulatory evidence.
European policy has made substantial progress in governing how data can be accessed, protected, reused and shared. The European Health Data Space, European research infrastructures, regulatory data networks and increasingly distributed analytical environments are creating new opportunities to use data across organisations and national borders.
The white paper asks what happens to governance once those data become a consequential claim. A secure environment can determine who was permitted to access a dataset. A data-quality framework can assess whether a source is suitable for a particular purpose. An interoperable model can allow analysis across distributed datasets. Those controls are fundamental, but they do not by themselves answer every later question about precisely which source artefacts, transformations, software versions, analytical decisions and derived results produced a particular conclusion.
A verifiable evidence chain
The paper proposes the term evidence governance for this additional layer and introduces the concept of a verifiable evidence chain: a persistent and machine-readable relationship between source data, transformations, analytical processes, derived artefacts, interpretations and consequential decisions.
Its recommendations include development of a European minimum evidence record; better portability of evidence lineage across organisational boundaries; treatment of material software, model and reference-data versions as evidential properties; privacy-preserving verification; and carefully selected European pilots in genomics, distributed real-world evidence and cross-border outbreak investigation.
Importantly, the paper does not advocate a new central European database and does not prescribe blockchain or any other single architecture. The argument is deliberately technology-neutral: Europe should first define which evidential relationships need to survive and then determine the most appropriate mechanisms for preserving them.
Part of the Evidence Governance Series
The paper forms part of The BioChain Evidence Governance Series and is intended to contribute to discussion among European institutions, regulatory agencies, research infrastructures and organisations working with increasingly distributed scientific evidence.
Questions & Answers
What distinction does the paper propose?
A clearer separation between data governance (who may access, protect, reuse and share data) and evidence governance (what must persist once data become a scientific or regulatory claim).
What is a “verifiable evidence chain”?
A persistent, machine-readable relationship between source data, transformations, analytical processes, derived artefacts, interpretations and consequential decisions.
Does the paper prescribe a specific technology, like blockchain?
No. It is deliberately technology-neutral, arguing Europe should first define which evidential relationships need to survive before choosing a mechanism to preserve them.
Who is the paper aimed at?
European institutions, regulatory agencies, research infrastructures and organisations working with increasingly distributed scientific evidence.