Abstract
Artificial intelligence (AI) and its machine learning (ML) algorithms are offering new promise for personalized biomedicine and more cost-effective healthcare with impressive technical capability to mimic human cognitive capabilities. However, widespread application of this promising technology has been limited in the medical domain and expectations have been tampered by ethical challenges and concerns regarding patient privacy, legal responsibility, trustworthiness, and fairness. To balance technical innovation with ethical applications of AI/ML, developers must demonstrate the AI functions as intended and adopt strategies to minimize the risks for failure or bias. This review describes the new ethical challenges created by AI/ML for clinical care and identifies specific considerations for its practice in medicine. We provide an overview of regulatory and legal issues applicable in Europe and the United States, a description of technical aspects to consider, and present recommendations for trustworthy AI/ML that promote transparency, minimize risks of bias or error, and protect the patient well-being.