One of the key challenges in successful deployment and meaningful adoption of AI in healthcare is health system-level governance of AI applications. Such governance is critical not only for patient safety and accountability by a health system, but to foster clinician trust to improve adoption and facilitate meaningful health outcomes. In this case study, we describe the development of such a governance structure at University of Wisconsin Health (UWH) that provides oversight of AI applications from assessment of validity and user acceptability through safe deployment with continuous monitoring for effectiveness. Our structure leverages a multi-disciplinary steering committee along with project specific sub-committees. Members of the committee formulate a multi-stakeholder perspective spanning informatics, data science, clinical operations, ethics, and equity. Our structure includes guiding principles that provide tangible parameters for endorsement of both initial deployment and ongoing usage of AI applications. The committee is tasked with ensuring principles of interpretability, accuracy, and fairness across all applications. To operationalize these principles, we provide a value stream to apply the principles of AI governance at different stages of clinical implementation. This structure has enabled effective clinical adoption of AI applications. Effective governance has provided several outcomes: (1) a clear and institutional structure for oversight and endorsement; (2) a path towards successful deployment that encompasses technologic, clinical, and operational, considerations; (3) a process for ongoing monitoring to ensure the solution remains acceptable as clinical practice and disease prevalence evolve; (4) incorporation of guidelines for the ethical and equitable use of AI applications.
Background The clinical narrative in electronic health records (EHRs) carries valuable information for predictive analytics; however, its free-text form is difficult to mine and analyze for clinical decision support (CDS). Large-scale clinical natural language processing (NLP) pipelines have focused on data warehouse applications for retrospective research efforts. There remains a paucity of evidence for implementing NLP pipelines at the bedside for health care delivery. Objective We aimed to detail a hospital-wide, operational pipeline to implement a real-time NLP-driven CDS tool and describe a protocol for an implementation framework with a user-centered design of the CDS tool. Methods The pipeline integrated a previously trained open-source convolutional neural network model for screening opioid misuse that leveraged EHR notes mapped to standardized medical vocabularies in the Unified Medical Language System. A sample of 100 adult encounters were reviewed by a physician informaticist for silent testing of the deep learning algorithm before deployment. An end user interview survey was developed to examine the user acceptability of a best practice alert (BPA) to provide the screening results with recommendations. The planned implementation also included a human-centered design with user feedback on the BPA, an implementation framework with cost-effectiveness, and a noninferiority patient outcome analysis plan. Results The pipeline was a reproducible workflow with a shared pseudocode for a cloud service to ingest, process, and store clinical notes as Health Level 7 messages from a major EHR vendor in an elastic cloud computing environment. Feature engineering of the notes used an open-source NLP engine, and the features were fed into the deep learning algorithm, with the results returned as a BPA in the EHR. On-site silent testing of the deep learning algorithm demonstrated a sensitivity of 93% (95% CI 66%-99%) and specificity of 92% (95% CI 84%-96%), similar to published validation studies. Before deployment, approvals were received across hospital committees for inpatient operations. Five interviews were conducted; they informed the development of an educational flyer and further modified the BPA to exclude certain patients and allow the refusal of recommendations. The longest delay in pipeline development was because of cybersecurity approvals, especially because of the exchange of protected health information between the Microsoft (Microsoft Corp) and Epic (Epic Systems Corp) cloud vendors. In silent testing, the resultant pipeline provided a BPA to the bedside within minutes of a provider entering a note in the EHR. Conclusions The components of the real-time NLP pipeline were detailed with open-source tools and pseudocode for other health systems to benchmark. The deployment of medical artificial intelligence systems in routine clinical care presents an important yet unfulfilled opportunity, and our protocol aimed to close the gap in the implementation of artificial intelligence–driven CDS. Trial Registration ClinicalTrials.gov NCT05745480; https://www.clinicaltrials.gov/ct2/show/NCT05745480
Predictive models are increasingly being developed and implemented to improve patient care across a variety of clinical scenarios. While a body of literature exists on the development of models using existing data, less focus has been placed on practical operationalization of these models for deployment in real-time production environments. This case-study describes challenges and barriers identified and overcome in such an operationalization for a model aimed at predicting risk of outpatient falls after Emergency Department (ED) visits among older adults. Based on our experience, we provide general principles for translating an EHR-based predictive model from research and reporting environments into real-time operation.
The clinical narrative in the electronic health record (EHR) carries valuable information for predictive analytics, but its free-text form is difficult to mine and analyze for clinical decision support (CDS). Large-scale clinical natural language processing (NLP) pipelines have focused on data warehouse applications for retrospective research efforts. There remains a paucity of evidence for implementing open-source NLP engines to provide interoperable and standardized CDS at the bedside. This clinical protocol describes a reproducible workflow for a cloud service to ingest, process, and store clinical notes as Health Level 7 messages from a major EHR vendor in an elastic cloud computing environment. We apply the NLP CDS infrastructure to a use-case for hospital-wide opioid misuse screening using an open-source deep learning model that leverages clinical notes mapped to standardized medical vocabularies. The resultant NLP and deep learning pipeline can process clinical notes and provide decision support to the bedside within minutes of a provider entering a note into the EHR for all hospitalized patients. The protocol includes a human-centered design and an implementation framework with a cost-effectiveness and patient outcomes analysis plan.
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