Sociotechnical Challenges of Real-World Evidence

Even the most advanced algorithms cannot succeed without the right human, legal, and organizational structures. In this theme, we examine the sociotechnical foundations required to make real-world evidence generation responsible and sustainable.

We study governance frameworks, ethical and legal considerations, stakeholder alignment, and the social dynamics that determine whether data sharing initiatives thrive or fail. This work has positioned our group as a connector between patients, clinicians, policy makers, industry, and data scientists.

Our sociotechnical expertise has been shaped by large global initiatives such as the MS Data Alliance and the COVID-19 in MS Data Sharing Initiative, where shared governance and trust-building played key roles. Through OHDSI Belgium and MS-Observe, we continue to support national and international efforts to create responsible, transparent data ecosystems.

Key focus areas

• Data governance and stewardship

• Ethical and legal frameworks for data use

• Trust-building across stakeholders

• Socio-organizational analysis of data ecosystems

• Multistakeholder collaboration and co-creation
  
  

Highlighted initiatives

• MS Data Alliance (2018–2024)

• COVID-19 in MS Global Data Sharing Initiative

• OHDSI Belgium – National Node

• MS-Observe – Belgium-wide real-world evidence study
  
  

Outputs

• Governance models and ethical frameworks

• Multilingual policy guidance

• Stakeholder engagement methods

• Training and implementation workshops