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Making Medicaid Data More Accessible Through Common Data Models and FHIR APIs
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Resource Development
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ASPE, FDA
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NLM
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This project aims to develop and publish open source code to format T-MSIS Research Identifiable File (RIFs) to the OMOP CDM in conjunction with the FDA’s formatting to the Sentinel CDM. Data quality will be characterized using a harmonized Data Quality Assessment Framework for electronic healthcare data that was developed in a previously funded OS-PCORTF project. Lastly, the project will assess the feasibility of using FHIR to link EHRs to T-MSIS claims data.
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Mapping of the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) and International Classification of Disease (ICD) Clinical Terminology
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Resource Development
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CDC, IOS
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NLM
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The US Department of Health and Human Services (HHS) has set a goal for the nationwide implementation of an interoperable health information technology infrastructure to improve the quality and efficiency of healthcare. Achieving this goal will require that key clinical data elements are captured or recorded in detailed, standardized form (using standard vocabularies, codes, and formats) as close to their original sources (patients, healthcare providers, laboratories, diagnostic devices, etc.) as possible. If these standardized clinical data can also be used to generate HIPAA- compliant billing transactions automatically, this will provide another incentive for adoption of clinical data standards. For the automated generation of bills from clinical data to become a reality, robust mappings from standard clinical terminologies to the HIPAA code sets must be created. To support the transition to ICD-10-CM in 2015, a map from SNOMED CT to ICD-10-CM is being created.
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Materials Genome Initiative (MGI)
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIBIB
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The Office of Science and Technology Policy(OSTP) chartered this committee to create a new era of policy, resources, and infrastructure that support U.S. institutions in the effort to discover, manufacture, and deploy advanced materials twice as fast, at a fraction of the cost. Led by the National Institute of Standards and Technology(NIST), the National Science Foundation (NSF), and the Department of Defense (DoD) as co-leads it also includes the Food and Drug Administration (FDA), the National Aeronautics and Space Administration (NASA), and the Department of Energy (DoE). 2020 meeting was canceled due to the COVID-19 pandemic. MGI released a strategic plan in 2021.
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Maternal Health Working Group
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Committee, Work group, Advisory group, or Task Force
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ACF, ACL, AHRQ, CDC, CMS, FDA, HRSA, IHS, OS, SAMHSA
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NICHD, NHLBI, NIMHD, OD/DPCPSI/ORWH
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This internal Department of Health and Human Services (HHS) group was formed in June 2019, with the goal of developing a trans-HHS Action Plan aimed at making the U.S. the safest place in the world to give birth.
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Medical Expenditure Panel Survey (MEPS): Experiences with Cancer Survivorship Supplement (MEPS CSAQ)
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC
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NCI, OD/DPCPSI/OBSSR
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The National Cancer Institute (NCI) has collaborated with CDC, AHRQ, and other organizations to provide supplemental funding for the Medical Expenditure Panel Survey (MEPS) to improve the quality of data for estimating the cancer survivorship burden in the United States. Using responses to the National Health Interview Survey (NHIS) question about ever receiving a cancer diagnoses, households with cancer survivors were oversampled for selection in this MEPS supplement. ;The increased sample of cancer survivors will improve national estimates of the burden of cancer. Additionally, this collaborative group developed a targeted questionnaire and associated database to further understand the burden of cancer, its treatment and impact on access to health care, the ability to work and participate in usual activities, health insurance, and quality of care.
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Memorandum of Understanding (MOU) between the FDA Center for Devices and Radiological Health and NIH/NINDS
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Other
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FDA
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NINDS
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This MOU provides a mechanism for addressing cross-cutting issues related to the development of devices for neurological disorders, from bench science to clinical studies and the Food and Drug Administration (FDA) approval.
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Memorandum of Understanding (MOU) between the FDA/Center for Biologics Evaluation and Research (FDA/CBER) and NIH/NINDS
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Other
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FDA
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NINDS
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This Memorandum of Understanding (MOU) provides a mechanism for addressing cross-cutting issues related to therapy development for neurological disorders, from bench science to clinical trials and the Food and Drug Administration (FDA) approval and licensure.
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Microphysiological Systems for Drug Efficacy and Toxicity Testing (Tissue Chip for Drug Screening)
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Research Initiative
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FDA, ASPR
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NCATS, NCI, NEI, NHLBI, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCR, NIDDK, NIEHS, NIGMS, NINDS, NINR, OD/DPCPSI/ORWH, OD/DPCPSI/OSC
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The Microphysiological systems initiative aims to develop 3-D human tissue chips that accurately model the structure and function of human organs, such as the lung, liver, and heart. Researchers are currently using these models to predict whether a candidate drug, vaccine, or biologic agent is safe or toxic in humans in a faster and more cost-effective way than current methods. More than 30 percent of promising medications have failed in human clinical trials because they are determined to be toxic despite promising pre-clinical studies in animal models. These organs-on-chips will also enable scientists to predict more accurately how effective a therapeutic candidate would be in clinical studies. To help streamline the therapeutic development pipeline, NIH, in collaboration with the US Food and Drug Administration (FDA) and the Innovation and Quality (IQ) Consortium of pharmaceutical companies, is leading this initiative to improve the process for predicting whether drugs will be safe and effective in humans. In an effort to overcome some clinical trial challenges, Clinical Trials on a Chip is supporting the development of tissue chips to inform clinical trial design for both common and rare diseases support the planning and execution of clinical trials; assist in patient stratification; help identify reliable clinical trial endpoints; and ultimately develop tools for more informative and efficient clinical trials for both common and rare diseases. Another program, the Tissue Chips in Space initiative, is creating tissue- and organ-on-chip platforms that can be sent to the ISS National Lab so that scientists can better understand the role of microgravity on human health and diseases and translate those findings to improve human health on Earth.
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Mind Your Risks
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Public Education Campaign
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CDC, CMS
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NINDS
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The Mind Your Risks campaign is designed to create awareness and action about the fact that risk factors for stroke, particularly hypertension, may be linked to cognitive impairment and dementia.
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Monthly Zika Vaccine Development Meeting
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Resource Development
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BARDA, FDA
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NIAID
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This working group is collaborating on development of assays and animal models for zika vaccines. Collaboration includes exchange of study data, study reports, and regulatory strategy for assay and model development and development of a regulatory package to support licensure of products through alternative pathways.
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