EB158 - EU statement - Item 15 - Harmonization of regulatory approaches, governance and standards for data, digital health and artificial intelligence in the health sector
WHO
158th session of the Executive Board
Item 15 – Harmonization of regulatory approaches, governance and standards for data, digital health and artificial intelligence in the health sector
EU Statement
Chair,
I have the honour of speaking on behalf of the European Union and its 27 Member States.
The candidate countries North Macedonia, Montenegro, Serbia, Albania, Ukraine, Republic of Moldova[1] and Georgia, the EFTA country Norway, member of the European Economic Area, as well as Armenia align themselves with this statement.
The European Union attaches great importance to digital technology and systems for health, including tools like artificial intelligence as driver of stronger, more inclusive health systems. We are committed to building equitable, transparent, explainable, well-regulated and person-centered digital health systems that improve access, quality and safety of care for all, while preserving human rights, with particular attention to the protection and security of health data.
We agree that the next Global Strategy on Digital Health should address the inequitable and uneven progress in digital health and the use of AI in healthcare, including fragmented, fragile and parallel systems, limited interoperability and insufficient capacity across countries and regions.
In response to the questions in EB158/19, the EU sees health data and health information systems as the essential foundation to enable AI build upon reliable, representative, interoperable and trustworthy data, with strong and ethical governance embedded into health systems. Building trust among patients and healthcare professionals is crucial for progress in AI application in healthcare. We therefore support a stronger focus on “digital foundations”, anchored in the WHO–ITU National eHealth Strategy Toolkit building blocks—leadership and governance; strategy and investment; legislation, policy and compliance; workforce; infrastructure; standards and interoperability; and services and applications. We encourage the WHO to take a more active role in leading harmonization efforts with other international standards organizations such as SNOMED International to accelerate standards development that enhance patient safety, AI readiness and health systems sustainability.
On AI, we support efforts to advance sound governance practices, benchmarking and risk management, and we welcome WHO’s work with ITU and WIPO on performance and quality benchmarking, transparency and validation to ensure safety, accountability and quality. Frameworks for assessing AI algorithms should be established. These efforts should be grounded in WHO’s ethical principles for AI for health, which safeguard the autonomy, well-being, safety of patients and healthcare professionals, and to ensure that health systems operate with transparency, accountability, inclusiveness and equity, and sustainability. In this spirit, we also follow closely different regional initiatives such as the GDO on AI in Health that will be considered at our regional committee.
Finally, on partnerships and development approaches, we encourage an integrated health-systems approach to digital investments to improve sustainability and avoid duplication, building on existing initiatives such as the Global Initiative on Digital Health, the Global Initiative on AI for Health, and global digital public infrastructure including the Global Digital Health Certification Network.
Thank you.
[1] North Macedonia, Montenegro, Serbia, and Albania continue to be part of the Stabilisation and Association Process.