AI assessment tools for decision-making on telemedicine: liability in case of mistakes

Abstract

The implementation of artificial intelligence as a medical decision support tool for triage, such as the SmED system in Germany, raises its potential application as a medical decision support for the use of telemedicine. The use of this self-learning artificial intelligence system (machine learning) raises the question of who is liable for damages in the event of an erroneous prediction by the system. This paper explores the answer to this question in line with the proposed new regulatory framework for AI in the European Union: the Proposal for a Directive of the European Parliament and of the Council on adapting non-contractual civil liability rules to artificial intelligence [AI Liability Directive-COM (2022) 496 final] and the Proposal for a Directive on liability for defective products [COM (2022) 493 final].