Precision medicine is widely described as a key driver of more effective, personalised and data-driven healthcare. At the same time, its practical implementation increasingly challenges established models for regulation, governance and responsibility. This report analyses precision medicine not primarily as a technological development, but as a gov ernance challenge emerging at the intersection of research, clinical practice and industrial development.

Focusing in particular on multi-omics- and AI-based applications, the report shows how responsibility, risk and decision-making are shaped through early and often informal choices made before solutions become clearly defined products or established clinical methods. These choices frequently take place in organisational and institutional “in-between spaces”, where existing governance frameworks provide limited guidance and where responsibility tends to become fragmented rather than collectively assumed.

Drawing on a policy lab approach and interviews with actors from academia, healthcare and industry, the analysis highlights how juridical interpretations often come to substitute for governance when decision mandates are unclear, and how pragmatic solutions such as in-house development emerge in response to unmet clinical needs. While legally permissible, such practices shift regulatory and long-term responsibility to healthcare organisations, often without these implications being made explicit.

Rather than proposing specific regulatory reforms, the report argues for a shift in perspective towards governance as an ongoing process. It emphasises the need for structues, methods and working practices that support shared responsibility, joint risk assessment and explicit decision-making across organisational boundaries. The “Vägvisaren” (Annex A) developed within the project is presented as one such methodological support, designed to make responsibility and consequences visible in the early stages where future pathways are shaped.