Objectives: This paper draws attention to: i) key considerations for evaluating artificial intelligence (AI) enabled clinical decision support; and ii) challenges and practical implications of AI design, development, selection, use, and ongoing surveillance. Method: A narrative review of existing research and evaluation approaches along with expert perspectives drawn from the International Medical Informatics Association (IMIA) Working Group on Technology Assessment and Quality Development in Health Informatics and the European Federation for Medical Informatics (EFMI) Working Group for Assessment of Health Information Systems. Results: There is a rich history and tradition of evaluating AI in healthcare. While evaluators can learn from past efforts, and build on best practice evaluation frameworks and methodologies, questions remain about how to evaluate the safety and effectiveness of AI that dynamically harness vast amounts of genomic, biomarker, phenotype, electronic record, and care delivery data from across health systems. This paper first provides a historical perspective about the evaluation of AI in healthcare. It then examines key challenges of evaluating AI-enabled clinical decision support during design, development, selection, use, and ongoing surveillance. Practical aspects of evaluating AI in healthcare, including approaches to evaluation and indicators to monitor AI are also discussed. Conclusion: Commitment to rigorous initial and ongoing evaluation will be critical to ensuring the safe and effective integration of AI in complex sociotechnical settings. Specific enhancements that are required for the new generation of AI-enabled clinical decision support will emerge through practical application.

Objective: To summarize the research literature about safety concerns with consumer-facing health apps and their consequences.Materials and Methods: We searched bibliographic databases including PubMed, Web of Science, Scopus, and Cochrane libraries from January 2013 to May 2019 for articles about health apps. Descriptive information about safety concerns and consequences were extracted and classified into natural categories. The review was conducted in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) statement.Results: Of the 74 studies identified, the majority were reviews of a single or a group of similar apps (n = 66, 89%), nearly half related to disease management (n = 34, 46%). A total of 80 safety concerns were identified, 67 related to the quality of information presented including incorrect or incomplete information, variation in content, and incorrect or inappropriate response to consumer needs. The remaining 13 related to app functionality including gaps in features, lack of validation for user input, delayed processing, failure to respond to health dangers, and faulty alarms. Of the 52 reports of actual or potential consequences, 5 had potential for patient harm. We also identified 66 reports about gaps in app development, including the lack of expert involvement, poor evidence base, and poor validation.Conclusions: Safety of apps is an emerging public health issue. The available evidence shows that apps pose clinical risks to consumers. Involvement of consumers, regulators, and healthcare professionals in development and testing can improve quality. Additionally, mandatory reporting of safety concerns is needed to improve outcomes.

We identify and describe nine key, short-term, challenges to help healthcare organizations, health information technology developers, researchers, policymakers, and funders focus their efforts on health information technology–related patient safety. Categorized according to the stage of the health information technology lifecycle where they appear, these challenges relate to (1) developing models, methods, and tools to enable risk assessment; (2) developing standard user interface design features and functions; (3) ensuring the safety of software in an interfaced, network-enabled clinical environment; (4) implementing a method for unambiguous patient identification (1–4 Design and Development stage); (5) developing and implementing decision support which improves safety; (6) identifying practices to safely manage information technology system transitions (5 and 6 Implementation and Use stage); (7) developing real-time methods to enable automated surveillance and monitoring of system performance and safety; (8) establishing the cultural and legal framework/safe harbor to allow sharing information about hazards and adverse events; and (9) developing models and methods for consumers/patients to improve health information technology safety (7–9 Monitoring, Evaluation, and Optimization stage). These challenges represent key “to-do’s” that must be completed before we can expect to have safe, reliable, and efficient health information technology–based systems required to care for patients.

Clinical decision support (CDS) in e-prescribing can improve safety by alerting potential errors, but introduces new sources of risk. Automation bias (AB) occurs when users over-rely on CDS, reducing vigilance in information seeking and processing. Evidence of AB has been found in other clinical tasks, but has not yet been tested with e-prescribing. This study tests for the presence of AB in e-prescribing and the impact of task complexity and interruptions on AB. One hundred and twenty students in the final two years of a medical degree prescribed medicines for nine clinical scenarios using a simulated e-prescribing system. Quality of CDS (correct, incorrect and no CDS) and task complexity (low, low + interruption and high) were varied between conditions. Omission errors (failure to detect prescribing errors) and commission errors (acceptance of false positive alerts) were measured. Compared to scenarios with no CDS, correct CDS reduced omission errors by 38.3% (p < .0001, n = 120), 46.6% (p < .0001, n = 70), and 39.2% (p < .0001, n = 120) for low, low + interrupt and high complexity scenarios respectively. Incorrect CDS increased omission errors by 33.3% (p < .0001, n = 120), 24.5% (p < .009, n = 82), and 26.7% (p < .0001, n = 120). Participants made commission errors, 65.8% (p < .0001, n = 120), 53.5% (p < .0001, n = 82), and 51.7% (p < .0001, n = 120). Task complexity and interruptions had no impact on AB. This study found evidence of AB omission and commission errors in e-prescribing. Verification of CDS alerts is key to avoiding AB errors. However, interventions focused on this have had limited success to date. Clinicians should remain vigilant to the risks of CDS failures and verify CDS.

Objective: Many research fields, including psychology and basic medical sciences, struggle with poor reproducibility of reported studies. Biomedical and health informatics is unlikely to be immune to these challenges. This paper explores replication in informatics and the unique challenges the discipline faces.Methods: Narrative review of recent literature on research replication challenges.Results: While there is growing interest in re-analysis of existing data, experimental replication studies appear uncommon in informatics. Context effects are a particular challenge as they make ensuring replication fidelity difficult, and the same intervention will never quite reproduce the same result in different settings. Replication studies take many forms, trading-off testing validity of past findings against testing generalizability. Exact and partial replication designs emphasize testing validity while quasi and conceptual studies test generalizability of an underlying model or hypothesis with different methods or in a different setting.Conclusions: The cost of poor replication is a weakening in the quality of published research and the evidence-based foundation of health informatics. The benefits of replication include increased rigor in research, and the development of evaluation methods that distinguish the impact of context and the nonreproducibility of research. Taking replication seriously is essential if biomedical and health informatics is to be an evidence-based discipline.