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Artificial intelligence (AI) software that analyzes medical images is becoming increasingly prevalent. Unlike earlier generations of AI software, which relied on expert knowledge to identify imaging features, machine learning approaches automatically learn to recognize these features. However, the promise of accurate personalized medicine can only be fulfilled with access to large quantities of medical data from patients. This data could be used for purposes such as predicting disease, diagnosis, treatment optimization, and prognostication. Radiology is positioned to lead development and implementation of AI algorithms and to manage the associated ethical and legal challenges. This white paper from the Canadian Association of Radiologists provides a framework for study of the legal and ethical issues related to AI in medical imaging, related to patient data (privacy, confidentiality, ownership, and sharing); algorithms (levels of autonomy, liability, and jurisprudence); practice (best practices and current legal framework); and finally, opportunities in AI from the perspective of a universal health care system. [ABSTRACT FROM AUTHOR]

Along with potential benefits to healthcare delivery, machine learning healthcare applications (ML-HCAs) raise a number of ethical concerns. Ethical evaluations of ML-HCAs will need to structure the overall problem of evaluating these technologies, especially for a diverse group of stakeholders. This paper outlines a systematic approach to identifying ML-HCA ethical concerns, starting with a conceptual model of the pipeline of the conception, development, implementation of ML-HCAs, and the parallel pipeline of evaluation and oversight tasks at each stage. Over this model, we layer key questions that raise value-based issues, along with ethical considerations identified in large part by a literature review, but also identifying some ethical considerations that have yet to receive attention. This pipeline model framework will be useful for systematic ethical appraisals of ML-HCA from development through implementation, and for interdisciplinary collaboration of diverse stakeholders that will be required to understand and subsequently manage the ethical implications of ML-HCAs. [ABSTRACT FROM AUTHOR]