EESC demands that AI and Big Data be used ethically and inclusively in rare disease care

The EESC has called for urgent action to ensure that artificial intelligence (AI) and Big Data are used ethically and inclusively in rare disease diagnosis and treatment. At its September 2025 plenary, the Committee adopted an opinion highlighting the need for digital innovation to improve patient outcomes while safeguarding rights and transparency.

With over 7 000 rare diseases affecting 300 million people globally, including 30 million in the EU, AI-driven tools can accelerate diagnosis and enable personalised treatments. However, the EESC warns that these advances must be balanced with robust ethical and legal safeguards. The Committee urges all EU Member States to digitise health data, adopt high-quality registration standards, and ensure that AI healthcare models only access anonymised, encrypted patient data.

Persistent gender and ethnic disparities in rare disease diagnosis must be addressed. The EESC calls for gender-diverse training data, bias audits, and targeted funding to increase female participation in AI healthcare. Patients should have control over their health data, with ongoing consent and transparency about data use.

To prevent market dominance, the EU should support start-ups and SMEs developing AI for rare disease diagnostics. Public-private partnerships and fair data access are vital to keep innovations affordable and accessible. The EESC demands EU-wide ethical guidelines, physician oversight, and professional training to empower healthcare workers and patients. (lm)