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Clinical Vocabulary and Standards Development for Meaningful Use of Electronic Medical Records
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, CMS, OS
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NLM
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NLM is collaborating with OS and HHS Office of the National Coordinator for Health Information Technology (ONC) on developing and disseminating regulatory language related to health information technology, meaningful use, and standards and certification criteria related to electronic health records and messaging. The collaboration includes serving as members of the Content Standards Workgroup, and Semantic Standards Workgroup of the Health IT (HIT) Standards Committee. The HIT Standards Committee is a Federal advisory committee that was created by the Health Information Technology for Economic and Clinical Health (HITECH) Act to provide input to HHS on the policies and technologies needed to improve health and care.
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ClinicalTrials.gov
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Resource Development
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FDA
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NLM, CC, NCATS, NCCIH, NCI, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, OD/OER, OD/OSP
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ClinicalTrials.gov is an NLM-operated database containing summary protocol and results information from publicly and privately funded clinical research. As of December 2016, the database included summary protocol information on more than 230,000 clinical studies conducted in over 195 countries, with nearly 24,000 records displaying summary results. NLM originally collaborated with FDA on implementing Section 113 of the Food and Drug Administration Modernization Act of 1997. It subsequently collaborated with FDA and NIH OD to implement the statutory requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 through rulemaking. The final rule (42 CFR Part 11) was issued in September 2016. NLM is currently collaborating with FDA and other parts of NIH to implement the regulatory requirements of 42 CFR Part 11.
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CMS End-stage Renal Disease (ESRD) Affinity Group
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Committee, Work group, Advisory group, or Task Force
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CMS
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NIDDK
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CMS has established a number of affinity groups to focus groups of individuals interested in and working on particular topics -- in this case, end-stage renal disease (ESRD). NIDDK Program staff have participated in meetings, bringing domain expertise and perspectives on current research findings.
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CMS-FDA-NIH Trilateral Council
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA
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OD/OSP, NIA, OD/OER
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The CMS-FDA-NIH Trilateral Council provides a forum for agency leaders to discuss policy issues, programs, and research initiatives of mutual interest and determines appropriate interfaces and collaborations that may inform NIH-funded research, FDA guidance and regulations, and CMS policies and programs. The Council formed in April 2016 and meets at the request of the Chairs: the NIH Director, FDA Commissioner, and CMS Administrator.
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CMS-NIH Senior Leadership Council
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Committee, Work group, Advisory group, or Task Force
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CMS
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OD/OSP, NIA, OD/OER
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The CMS-NIH Senior Leadership Council provides a forum for agency leaders to discuss policy issues, programs, and research initiatives of mutual interest and determines appropriate interfaces and collaborations that may inform NIH-funded research and CMS policies and programs. The Leadership Council is co-chaired by the NIH Director and CMS Administrator and meets at the request of the Chairs.
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CMS/CDC/FDA/NIH Opioid Abuse Collaboration
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Committee, Work group, Advisory group, or Task Force
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CDC, CMS, FDA
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NIA, NIDA, NINDS
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The purpose of this collaboration is to discuss agency activities surrounding the HHS Secretary’s opioid abuse initiatives.
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Collaboration With Indian Health Service Institutional Review Board (IRB) In Training IRB Interns From Native Communities
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Committee, Work group, Advisory group, or Task Force
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IHS
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CC, NHGRI
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The Clinical Center’s Department of Bioethics, in collaboration with NHGRI, piloted an Institutional Review Board (IRB) internship program for Native Americans.
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Collaborative Islet Transplant Registry Ad Hoc Scientific Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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FDA, HRSA
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NIAID
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This Advisory Committee provides scientific direction to the Collaborative Islet Transplant Registry on an ad hoc basis.
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Collaborative Use Repurposing Engine (CURE)
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Research Initiative
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FDA
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NCATS
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CURE is a new tool designed to centrally capture and organize real-world information about how healthcare practitioners use existing drugs in novel ways to treat patients with neglected tropical diseases (NTDs), emerging infections, and drug-resistant infections when treatment options are limited or inadequate. It is currently publicly available in “beta” as an open-access website that enables healthcare practitioners throughout the world to contribute to the database by using a simple online form, a smartphone or other mobile device. In addition to submitting their own case reports, practitioners are also able to query and retrieve information from the database.
Neglected Tropical Diseases (NTDs) are a group of parasitic and bacterial diseases that cause substantial illness for more than one billion people globally. Patients with NTDs, emerging or drug-resistant infections may lack adequate treatment options due to the limited number of drugs approved for these conditions. Out of necessity, healthcare practitioners try to use existing drugs in novel ways to treat these patients. At present, much of this clinical experience, regardless of whether the patient outcomes are positive or negative, is never reported or shared, and the knowledge is therefore lost.
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Combating Antibiotic Resistant Bateria (CARB)
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Resource Development
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CDC, FDA
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NLM, NHGRI, NIAID
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The National Action Plan for Combating Antibiotic-resistant Bacteria is a multi-agency initiative to deal with the threat of increasing antibiotic resistance. NCBI has a part in Sub-Objective 2.1.4: Develop and maintain a national sequence database of resistant bacteria.
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