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Short abstract

Efforts to embed ethics in health data governance led to the development of standardized tools for ethical assessment. We examine how these tools promise consistency and scalability, but also reshape ethical practice, shifting responsibility, privileging certain expertise, and quantifying values.

Long abstract

This contribution examines increasing efforts to “embed” ethics by integrating standardized tools and frameworks into ethical assessment procedures that intend to make such programs more “actionable” or “operationalizable” in everyday governance. We examine such efforts in the context of emerging infrastructures for secondary use of health data, such as the European Health Data Space (EHDS), which require an increasing number of legal and ethical review of data access requests.

Building on our recent scoping review of tools designed to operationalize ethical evaluation of data access (Jacquemin et al. submitted 2026), we analyze how ethical principles are translated into structured questionnaires, scoring systems, risk matrices, and decision aids. We critically examine these instruments’ promises of consistency, transparency, and scalability, and we pay particular attention to narratives of scale and “automation” of ethical review by embedding normative judgments into algorithms and workflows.

Relating the ethics tool literature with our current work in a European consortium on health data sharing, we evaluate how these tools reshape how ethics is practiced: often shifting responsibility toward data applicants; privileging certain forms of expertise and participation; and making some values more readily measurable, and thus actionable, than others. Tools also often structure ethical reflection without resolving normative trade-offs, leaving final decisions to ethics committees. We are specifically interested in the mobilization of quantification necessary to scale ethical assessment and reflect on the way that discourses on scale in ethics assessment bear upon important calls for embedding “situated ethics,” “ethics as process,” or “ethics in practice”.