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WEBSentinel Operations Center (SOC) These centers collaborate to advance regulatory science using the Sentinel System. However, each center operates independently and has a dedicated leadership team and staff. The three centers each carry out projects associated with their strategic objectives. The U.S. FDA leads the Sentinel Initiative. The main

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URL: https://www.sentinelinitiative.org/

A COVID‐19‐Ready Public Health Surveillance

WEBOver more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID‐19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System …

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Health Outcomes of Interest Sentinel Initiative

WEBThis webpage provides access to Sentinel Health Outcome of Interest (HOI) activities that have been conducted by the FDA. The search below can be used to find more information about each study type or health outcome. Code lists (such as ICD-9-CM codes, ICD-10 codes, procedure codes, etc.), algorithm criteria, and literature reviews for these

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Horizon Scan of Electronic Health Record Databases

WEBTo address the Real-World Evidence (RWE) Data Enterprise mandate, the FDA has tasked the Sentinel Innovation Center (IC) and Sentinel Operations Center (SOC) with establishing a query-ready, quality-checked distributed data network containing electronic health records (EHRs) for at least 10 million lives with reusable analysis tools.

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Sentinel Common Data Model Sentinel Initiative

WEBThe Sentinel Operations Center (SOC) coordinates the network of Sentinel Data Partners and leads development of the Sentinel Common Data Model (SCDM), a standard data structure that allows Data Partners to quickly execute distributed programs against local data. The SOC manages creation of the Sentinel Distributed Database …

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Making Medicaid Data More Accessible Through

WEBThis is a joint agency project involving the Food and Drug Administration (FDA) and National Institutes of Health/ National Library of Medicine (NIH/NLM) that addresses the Patient-Centered Outcomes Research (PCOR) priority to expand data capacity or data infrastructure for conducting research that informs decisions about the …

Category:  Food,  Medicine Go Health

FDA Sentinel System's Coronavirus (COVID-19) Activities

WEBFDA’s Sentinel System is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic, ranging from monitoring the use of drugs, describing the course of illness among hospitalized patients, and evaluating the treatment impact of therapies actively being used under real-world conditions. …

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How Sentinel Gets Its Data Sentinel Initiative

WEBThe Sentinel System is comprised of health care organizations, known as Data Partners, that have medical billing information and electronic health records. This data is collected routinely with every healthcare encounter and is used to answer FDA’s medical product safety questions. Each Data Partner keeps their own data and controls who can

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Broadening the Reach of the FDA Sentinel System: A Roadmap for

WEBThe Sentinel System is a major component of the United States Food and Drug Administration’s (FDA) approach to active medical product safety surveillance.

Category:  Food,  Medical Go Health

Health Outcome Algorithm Inventory Sentinel Initiative

WEBThis file contains a summary of literature reviews conducted in 2012-2013 by the Mini-Sentinel Applied Surveillance Core on International Classification of Diseases, Ninth Revision (ICD-9) algorithms to identify health outcomes of interest in administrative data, focusing on algorithms that have undergone validation through medical records …

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Inclusion of Semi-Structured and Unstructured Electronic Health …

WEBThe MOSAIC-NLP (Multi-source Observational Safety study for Advanced Information Classification using NLP) project intends to build and utilize semi-automated methods and tools, including natural language processing (NLP), to enable outcome identification, confounder feature extraction, and longitudinal contextualization of …

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Who Is Involved Sentinel Initiative

WEBGerald J. Dal Pan, MD, MHS. Director, CDER Office of Surveillance and Epidemiology. Robert Ball, MD, MPH. Deputy Director, CDER Office of Surveillance and Epidemiology. Patricia (“Trish”) Bright, PhD, MSPH. Associate Director for Sentinel, CDER Office of Surveillance and Epidemiology. Additional members of the FDA Sentinel Core Team:

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Sentinel Innovation Center (IC) Sentinel Initiative

WEBThe Sentinel Innovation Center is a test bed to identify, develop, and evaluate innovative methods to study drug safety and effectiveness using real-world data. The IC was created in response to FDA’s Medical Data Enterprise Initiative to build a new system containing electronic health records from 10 million lives and the Sentinel Five-Year

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Empirical Application of the Sentinel Electronic Health Record (EHR

WEBHealth insurance claims data currently form the backbone of the Sentinel Distributed Database (SDD), owing to their complete capture of outpatient pharmacy dispensing records, medical encounters, and hospitalizations during well-defined periods of health plan enrollment.

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Sentinel Innovation Center Master Plan

WEBMaster Plan framework and roadmap. Below we present the Master Plan framework (Figure 1), which involves four key strategic priorities: (1) data infrastructure; (2) feature engineering; (3) causal inference; and (4) detection analytics. Each strategic priority has a set of goals for achieving the Innovation Center vision.

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Claims and EHR Data

WEBSentinel’s Use of Healthcare Claims and EHR-based Data Sources. One of the main focuses of the Sentinel System’s Five-Year strategy (2019-2023) is to incorporate the use of electronic health record (EHR) data, supplemented with claims data, to support public health surveillance. The strategy also aims to incorporate emerging data science

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Creating a Sentinel Linked Electronic Health Record (EHR)-claims

WEBThe Innovation Center (IC) will build a development network of commercial Data Partners – Mass General Brigham, Kaiser Permanente Washington Health Research Institute, Duke Clinical Research Institute, and Vanderbilt University Medical Center – to enable ready access to linked Electronic Health Record (EHR) - claims data, including …

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Assessment of the Natural History of Coagulopathy in COVID-19

WEBThe purpose of this project is to describe the natural history of coagulopathy among COVID-19 patients. Activities include development of a study synopsis to assess the risks of arterial and venous thromboembolic events, and related death, among COVID-19 patients, assessment of feasibility, and implementation of the study synopsis within …

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Toolkit for Assessing and Mitigating Risk of Re-identification …

WEBAssessing and Mitigating Re-Identification Risk 2 reduces risk without compromising scientific or public health value depends on the specifics of each data sharing scenario.

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