Technical and scientific support for Health AI providers and notified bodies
TEF-Health. AI Alignment, Safety and Trust in Europe
European Testing and Experimentation Facilities (TEFs) help providers of AI technologies for the healthcare sector to bring their solutions to market faster py providing testing and validation services.
AI-Act – the worldwide first regional regulation enforcing trustworthy AI foresees Testing and Experimentation Facilities (TEFs) as an implementation instrument.
The EU AI-Act is the first regulation worldwide that controls and guides trustworthy AI.
It provides detailed instructions how trustworthy AI is implemented and enforced in the European Union. The AI-Act foresees different instruments, one of which are sectorial AI Testing and Experimentation Facilities (TEFs). The purpose of TEFs is to “contribute to the implementation of this Regulation. Within their respective mission and fields of competence, they may provide in particular technical and scientific support to providers and notified bodies.” (AI-Act, Article 74) Additionally, access to TEFs shall be facilitated “to bodies, groups or laboratories established or accredited pursuant to any relevant Union harmonization legislation and which fulfil tasks in the context of conformity assessment of products or devices covered by that Union harmonization legislation.” (AI-Act, Article 75)
Four sectorial TEFs have been established under the Digital Europe program – one of which is TEF-Health.
To date, four TEFs have been founded in the sectors Healthcare (TEF-Health), Smart Cities (Citcom.ai), Agriculture (Agrifood-TEF) and Manufacturing (AI-Matters). The four TEFs work closely together under the label xTEF and use synergies. Formally this collaboration is supported by a Coordinate Support Action (CSA). TEF-Health comprises nine participating member states (Germany/lead, Belgium, Czech Republic, Finland, France, Italy, Portugal, Slowakia, Sweden) and 52 participating public and private entities including notified certifiers, standardization authorities, University Hospitals, and Research Organizations.
TEFs are funded by the European Commission (EC) and members states and will provide continuous access to testing infrastructure.
TEF-Health is funded with € 60 Million from January 2023 to December 2027 – where €30 Million are provided by the EC and €30 Million by member states and participating organizations. TEFs are part of the implementation instruments outlined in the AI-Act and as such will continue to exist beyond the 5 years of initial funding.
