Ethical, legal and social aspects are gaining increasingly more attention in the development and during the initial clinical application of medical devices. The introduction of elements of artificial intelligence (AI) and systems which are using AI makes this already complex topic even more challenging. The introduction of so-called dynamic AI or dynamic machine learning (ML) algorithms in this respect represents a turning point. Unlike conventional medical devices, the development of systems using dynamic AI is not yet complete at the beginning of the clinical application. The aim of a dynamic AI system is to continuously improve through practical use and by the processing of usage data. This continuous evolution, along with the lack of transparency regarding internal work processes, could make it difficult to understand the underlying rationale for the assessments made by the algorithms. This aspect affects the acceptance of the technology both by clinicians and patients and furthermore questions the autonomy of patients and clinicians in the course of the treatment process. A way out of this ethical and regulatory dilemma must urgently be found and will require extreme efforts from all stakeholders. At present, no consensual solution is apparent. What is quite certain, however, is that users, i.e. in concrete terms surgeons, must play a much more active role than they have done in the past when dealing with AI-based medical devices and should prepare themselves to actively accompany the software life cycle of AI technologies.      «

Ethical, legal and social aspects are gaining increasingly more attention in the development and during the initial clinical application of medical devices. The introduction of elements of artificial intelligence (AI) and systems which are using AI makes this already complex topic even more challenging. The introduction of so-called dynamic AI or dynamic machine learning (ML) algorithms in this respect represents a turning point. Unlike conventional medical devices, the development of systems us...     »