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Quality AssuranceOngoing

TEF-Health

Testing and Experimentation Facility for Health AI and Robotics

Background / Rationale

Technological advances in the field of artificial intelligence (AI) offer new opportunities to support decision making in healthcare. Yet, new medical devices must first prove their safety and usefulness before they can be adopted in clinical practice. Concerningly, there is a lack of standardized procedures and testing infrastructure for developing, testing and certifying new medical AI products.

The EU project TEF-Health addresses this gap by establishing a European reference testing and experimentation facility (TEF) to ensure that the digital transformation of our healthcare system occurs safely and for the benefit of all. In this project, 50+ interdisciplinary partners from Europe work together to develop new regulatory testing procedures for this technology. These activities include for instance developing standardized testing protocols and certifications and a testing facility to test new tools in real or realistic environments. The newly created evaluation resources and infrastructure will be made available to industry in the future in the form of fee-based services.

In the project team Responsible Algorithms at the BIH QUEST Center, we contribute to the TEF-Health project by developing services to implement ethical requirements for developing trustworthy medical AI tools. In particular, we aim to develop standardized procedures to fulfil the ethical requirements of transparency and robustness, which will be offered as services to companies. 

More information about the TEF-Health project can be found here and here.

Objectives

The TEF-Health objectives include:

  • Carrying out tests and experiments of AI solutions in real or realistic environments
  • Implementing evaluation activities to facilitate market access for trustworthy intelligent technologies considering regulatory requirements (certification, standardization, code of conduct), and ensuring easy access to these resources (link with digital innovation hubs)

The QUEST Center objectives for TEF-Health include:

  • Offering services to companies to fulfil the trustworthy AI requirement of transparency by reporting. In particular, we aim to support companies to report comprehensive information to medical end-users and the public to demonstrate how ethical requirements such as robustness, non-discrimination and fairness are implemented and monitored for medical AI products.
  • Developing standardized procedures to assess ethical requirements. The goal is that these procedures can be adopted by auditors who assess the safety and quality of medical AI tools.

Methodology

The methodology to enhance transparency about medical AI tools is based on a reporting survey with semi-open questions on the intended use, development, ethical considerations, validation and caveats for deployment. This survey can be implemented as a service, where companies report about their medical AI products and auditors will subsequently assess the reported information on whether they fulfill ethical requirements regarding transparency robustness, fairness, etc. A prototype for this service has been previously piloted with three companies. The results of this are reported here.

Expected Results / Implications / Perspectives

The created TEF-Health evaluation resources will be made available to industry in the form of services.

Funder and Cooperation Partner

The TEF-Health project is funded by the European Commission under its Digital Europe program, and by national funding agencies.

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