Unfortunately, there is currently limited high-quality evidence of this type available for many medical AI systems. For the tool to be accepted, trials need to be designed to show that it provides a benefit to the patient, the patient’s family, the health professionals using the tool, the health care system at large, or some combination of these potential beneficiaries. For a given AI tool to be used, evidence that it will perform in a safe and effective manner must be demonstrated using randomized controlled trials designed to test the tool against an established standard. What is missing? In addition to needed technical advances, AI must meet the same bar for clinical evidence that is expected from other clinical interventions. ![]() Although many such devices have met regulatory standards, the uptake in the medical community has failed to meet expectations. ![]() There are FDA-approved devices that use AI to read a broad range of imaging modalities, programs that provide diagnostic assistance, and software that helps outline possible treatments and provide prognostic data for clinicians. The past decade has seen a resurgence of artificial intelligence (AI) in medicine enabled by new advancements in machine learning, from deep learning systems for computer vision to the latest conversational agents based on large language models. In addition to original research, NEJM AI will provide reviews, policy perspectives, and accessible educational material targeted at practicing physicians and clinician leaders interested in applying AI, computer scientists seeking to translate algorithmic advances to clinical practice, and policy makers and regulators. ![]() NEJM Group, the publisher of the New England Journal of Medicine, is planning a new journal, NEJM AI, to identify and evaluate state-of-the-art applications of artificial intelligence to clinical medicine.
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