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The Food & Drug Administration (FDA) is considering the permanent exemption of premarket notification requirements for several Class I and II medical device products, including several artificial Intelligence (AI)-driven devices. The exemption is based on the need to rapidly more quickly disseminate devices to the public, estimated cost-savings, a lack of documented adverse events reported to the FDA's database. However, this ignores emerging issues related to AI-based devices, including utility [...]

To develop a computer model to predict patients with nonalcoholic steatohepatitis (NASH) using machine learning (ML).

The COVID-19 pandemic swept across the world rapidly, infecting millions of people. An efficient tool that can accurately recognize important clinical concepts of COVID-19 from free text in electronic health records (EHRs) will be valuable to accelerate COVID-19 clinical research. To this end, this study aims at adapting the existing CLAMP natural language processing tool to quickly build COVID-19 SignSym, which can extract COVID-19 signs/symptoms and their 8 attributes (body [...]

Precision medicine can revolutionize health care by tailoring treatments to individual patient needs. Advancing precision medicine requires evidence development through research that combines needed data, including clinical data, at an unprecedented scale. Widespread adoption of health information technology (IT) has made digital clinical data broadly available. These data and information systems must evolve to support precision medicine research and delivery. Specifically, relevant health IT data, infrastructure, clinical integration, and policy [...]

The Office of National Coordinator for Health Information Technology final rule implementing the interoperability and information blocking provisions of the 21st Century Cures Act requires support for two SMART (Substitutable Medical Applications, Reusable Technologies) application programming interfaces (APIs) and instantiates Health Level Seven International (HL7) Fast Healthcare Interoperability Resources (FHIR) as a lingua franca for health data. We sought to assess the current state and near-term plans for the SMART/HL7 [...]

We aimed to develop a model for accurate prediction of general care inpatient deterioration.

There are signals of clinicians' expert and knowledge-driven behaviors within clinical information systems (CIS) that can be exploited to support clinical prediction. Describe development of the Healthcare Process Modeling Framework to Phenotype Clinician Behaviors for Exploiting the Signal Gain of Clinical Expertise (HPM-ExpertSignals).