Ethical use of artificial intelligence to prevent sudden cardiac death: an interview study of patient perspectives.

Background: The emergence of artificial intelligence (AI) in medicine has prompted the development of numerous ethical guidelines, while the involvement of patients in the creation of these documents lags behind. As part of the European PROFID project we explore patient perspectives on the ethical implications of AI in care for patients at increased risk of sudden cardiac death (SCD).

Aim: Explore perspectives of patients on the ethical use of AI, particularly in clinical decision-making regarding the implantation of an implantable cardioverter-defibrillator (ICD).

Ethical issues in two parallel trials of personalised criteria for implantation of implantable cardioverter defibrillators for primary prevention: the PROFID project-a position paper.

Aim: To discuss ethical issues related to a complex study (PROFID) involving the development of a new, partly artificial intelligence-based, prediction model to enable personalised decision-making about the implantation of an implantable cardioverter defibrillator (ICD) in postmyocardial infarction patients, and a parallel non-inferiority and superiority trial to test decision-making informed by that model.

Method: The position expressed in this paper is based on an analysis of the PROFID trials using concepts from high-profile publications in the ethical literature.

Results: We identify ethical issues related to the testing of the model in the treatment setting, and to both the superiority and the non-inferiority trial.