The ELSA Way is a public website where researchers, developers, healthcare professionals, patients and community members can find, and add to, practical guidance on developing AI for healthcare responsibly. It follows the AI lifecycle from design and data collection to deployment and monitoring, and at each step it asks what that step means for patients, staff and the law.
What ELSA means¶
ELSA stands for the ethical, legal and societal aspects of AI. The ELSA AI Lab Northern Netherlands (ELSA-NN) builds knowledge about responsible AI in healthcare and helps put it into practice. In a project, those aspects turn into questions like these:
| Aspect | Questions to ask |
|---|---|
| Ethical | Does the system respect patients’ autonomy and dignity? Which harms could it cause, and how will you prevent or limit them? |
| Legal | Does it comply with the GDPR European Parliament and Council (2016), the EU AI Act European Parliament and Council (2024), the MDR or IVDR European Parliament and Council (2017)European Parliament and Council (2017) and Dutch law such as the WGBO (the Dutch law on the treatment agreement between patient and care provider)? Who is liable when it goes wrong? |
| Societal | Does it widen or narrow differences in health between groups? How does it change clinicians’ work? What is its environmental footprint? Can everyone who needs it use it, whatever their digital skills, disability or language? |
What it does not do¶
The ELSA Way does not certify AI systems, and it does not replace legal advice for your specific case. Use it as a working reference during your project, from the first idea onwards, rather than as a list to tick off at the end.
How it is built¶
The content comes from:
research with AI developers and healthcare professionals (surveys, interviews, co-creation workshops);
peer-reviewed publications, turned into practical guidance;
open collaboration on GitHub;
engagement with patients and communities;
exchange with other ELSA labs in the Netherlands and beyond.
We also borrow tools from other fields when they transfer well. The ELSA Scan Hilten et al. (2025), for example, is a 25-question assessment of ELSA issues that Wageningen University & Research developed for AI in agri-food. Many of its questions are just as relevant to a hospital.
- European Parliament and Council. (2016). Regulation (EU) 2016/679 – General Data Protection Regulation. Official Journal of the European Union.
- European Parliament and Council. (2024). Regulation (EU) 2024/1689 of the European Parliament and of the Council on artificial intelligence. Official Journal of the European Union.
- European Parliament and Council. (2017). Regulation (EU) 2017/745 on medical devices (MDR) [Techreport]. Official Journal of the European Union.
- European Parliament and Council. (2017). Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) [Techreport]. Official Journal of the European Union.
- van Hilten, M., Ryan, M., Blok, V., & de Roo, N. (2025). Ethical, Legal and Social Aspects (ELSA) for AI: An assessment tool for Agri-food. Smart Agricultural Technology, 10, 100710. 10.1016/j.atech.2024.100710