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Importance: Given the importance of rigorous development and evaluation standards needed of artificial intelligence (AI) models used in health care, nationwide accepted procedures to provide assurance that the use of AI is fair, appropriate, valid, effective, and safe are urgently needed. Observations: While there are several efforts to develop standards and best practices to evaluate AI, there is a gap between having such guidance and the application of such guidance to both existing and new AI models being developed. As of now, there is no publicly available, nationwide mechanism that enables objective evaluation and ongoing assessment of the consequences of using health AI models in clinical care settings. Conclusion and Relevance: The need to create a public-private partnership to support a nationwide health AI assurance labs network is outlined here. In this network, community best practices could be applied for testing health AI models to produce reports on their performance that can be widely shared for managing the lifecycle of AI models over time and across populations and sites where these models are deployed. This article outlines the need for a nationwide public-private network of assurance laboratories that would aid in the evaluation and development of artificial intelligence (AI) in health care. [ABSTRACT FROM AUTHOR]

Importance: There is increased interest in and potential benefits from using large language models (LLMs) in medicine. However, by simply wondering how the LLMs and the applications powered by them will reshape medicine instead of getting actively involved, the agency in shaping how these tools can be used in medicine is lost. Observations: Applications powered by LLMs are increasingly used to perform medical tasks without the underlying language model being trained on medical records and without verifying their purported benefit in performing those tasks. Conclusions and Relevance: The creation and use of LLMs in medicine need to be actively shaped by provisioning relevant training data, specifying the desired benefits, and evaluating the benefits via testing in real-world deployments. This special communication discusses whether large language models (LLMs) are being trained with the right kind of self-supervision and if the purported value propositions of using LLMs in medicine are being verified. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses a recent executive order by US President Joe Biden about the development and implementation of AI, including the role of government vs the private sector and how the order may affect health care. [ABSTRACT FROM AUTHOR]

Background: Patients with serious illness benefit from conversations to share prognosis and explore goals and values. To address this, we implemented Ariadne Labs' Serious Illness Care Program (SICP) at Stanford Health Care. Objective: Improve quantity, timing, and quality of serious illness conversations. Methods: Initial implementation followed Ariadne Labs' SICP framework. We later incorporated a team-based approach that included nonphysician care team members. Outcomes included number of patients with documented conversations according to clinician role and practice location. Machine learning algorithms were used in some settings to identify eligible patients. Results: Ambulatory oncology and hospital medicine were our largest implementation sites, engaging 4707 and 642 unique patients in conversations, respectively. Clinicians across eight disciplines engaged in these conversations. Identified barriers that included leadership engagement, complex workflows, and patient identification. Conclusion: Several factors contributed to successful SICP implementation across clinical sites: innovative clinical workflows, machine learning based predictive algorithms, and nonphysician care team member engagement. [ABSTRACT FROM AUTHOR]

Introduction: Pharmacovigilance programs protect patient health and safety by identifying adverse event signals through postmarketing surveillance of claims data and spontaneous reports. Electronic health records (EHRs) provide new opportunities to address limitations of traditional approaches and promote discovery-oriented pharmacovigilance. Methods: To evaluate the current state of EHR-based medication safety signal identification, we conducted a scoping literature review of studies aimed at identifying safety signals from routinely collected patient-level EHR data. We extracted information on study design, EHR data elements utilized, analytic methods employed, drugs and outcomes evaluated, and key statistical and data analysis choices. Results: We identified 81 eligible studies. Disproportionality methods were the predominant analytic approach, followed by data mining and regression. Variability in study design makes direct comparisons difficult. Studies varied widely in terms of data, confounding adjustment, and statistical considerations. Conclusion: Despite broad interest in utilizing EHRs for safety signal identification, current efforts fail to leverage the full breadth and depth of available data or to rigorously control for confounding. The development of best practices and application of common data models would promote the expansion of EHR-based pharmacovigilance. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To evaluate whether one summary metric of calculator performance sufficiently conveys equity across different demographic subgroups, as well as to evaluate how calculator predictive performance affects downstream health outcomes. STUDY DESIGN: We evaluate 3 commonly used clinical calculators--Model for End-Stage Liver Disease (MELD), CHA2DS2-VASc, and simplified Pulmonary Embolism Severity Index (sPESI)--on the cohort extracted from the Stanford Medicine Research Data Repository, following the cohort selection process as described in respective calculator derivation papers. METHODS: We quantified the predictive performance of the 3 clinical calculators across sex and race. Then, using the clinical guidelines that guide care based on these calculators' output, we quantified potential disparities in subsequent health outcomes. RESULTS: Across the examined subgroups, the MELD calculator exhibited worse performance for female and White populations, CHA2DS2-VASc calculator for the male population, and sPESI for the Black population. The extent to which such performance differences translated into differential health outcomes depended on the distribution of the calculators' scores around the thresholds used to trigger a care action via the corresponding guidelines. In particular, under the old guideline for CHA2DS2-VASc, among those who would not have been offered anticoagulant therapy, the Hispanic subgroup exhibited the highest rate of stroke. CONCLUSIONS: Clinical calculators, even when they do not include variables such as sex and race as inputs, can have very different care consequences across those subgroups. These differences in health care outcomes across subgroups can be explained by examining the distribution of scores and their calibration around the thresholds encoded in the accompanying care guidelines. [ABSTRACT FROM AUTHOR]

Predictive models for clinical outcomes that are accurate on average in a patient population may underperform drastically for some subpopulations, potentially introducing or reinforcing inequities in care access and quality. Model training approaches that aim to maximize worst-case model performance across subpopulations, such as distributionally robust optimization (DRO), attempt to address this problem without introducing additional harms. We conduct a large-scale empirical study of DRO and several variations of standard learning procedures to identify approaches for model development and selection that consistently improve disaggregated and worst-case performance over subpopulations compared to standard approaches for learning predictive models from electronic health records data. In the course of our evaluation, we introduce an extension to DRO approaches that allows for specification of the metric used to assess worst-case performance. We conduct the analysis for models that predict in-hospital mortality, prolonged length of stay, and 30-day readmission for inpatient admissions, and predict in-hospital mortality using intensive care data. We find that, with relatively few exceptions, no approach performs better, for each patient subpopulation examined, than standard learning procedures using the entire training dataset. These results imply that when it is of interest to improve model performance for patient subpopulations beyond what can be achieved with standard practices, it may be necessary to do so via data collection techniques that increase the effective sample size or reduce the level of noise in the prediction problem. [ABSTRACT FROM AUTHOR]