Intervention design for artificial intelligence-enabled macular service implementation: a primary qualitative study.

Background: Neovascular age-related macular degeneration (nAMD) is one of the largest single-disease contributors to hospital outpatient appointments. Challenges in finding the clinical capacity to meet this demand can lead to sight-threatening delays in the macular services that provide treatment. Clinical artificial intelligence (AI) technologies pose one opportunity to rebalance demand and capacity in macular services.

Clinical Evaluation of Artificial Intelligence-Enabled Interventions.

Artificial intelligence (AI) health technologies are increasingly available for use in real-world care. This emerging opportunity is accompanied by a need for decision makers and practitioners across healthcare systems to evaluate the safety and effectiveness of these interventions against the needs of their own setting. To meet this need, high-quality evidence regarding AI-enabled interventions must be made available, and decision makers in varying roles and settings must be empowered to evaluate that evidence within the context in which they work.

AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

Background: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals.