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6 Results by "Josh Rising"

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Date	Summary	Content Type
Jun 22, 2012	Improving Medical Device Safety Through Better Surveillance In 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative, a national electronic system designed to “track the safety of drugs, biologics, and medical devices once they reach the market.” By proactively monitoring data from electronic health records and other sources rather than relying on spontaneous reporting from manufacturers and health care providers, the Sentinel system can more quickly identify safety issues. More info	Issue Brief
Jun 22, 2012	Facilitating Medical Device Innovation: De Novo Reform The de novo process as it exists now is not achieving its purpose of streamlining the path to move new devices onto the marketplace and has instead added unnecessary and time-consuming requirements. More info	Issue Brief
Nov 8, 2012	Pew Comments to the FDA Regarding the Unique Device Identification System Pew’s Medical Device Initiative, along with the American Heart Association and Trust for America’s Health, submitted comments to the U.S. Food and Drug Administration (FDA) regarding its proposed rule for a unique device identification (UDI) system for medical devices. Once implemented by the FDA and utilized by healthcare providers, the UDI system will be the cornerstone for significant improvements in postmarketing surveillance of medical devices. More info	Issue Brief
Jan 15, 2013	Comments on Stage 3 of the the Meaningful Use of Health Information Technology In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology and The Pew Charitable Trusts urge the ONC to incorporate medical device identifiers developed under the FDA’s unique device identification (UDI) system into both electronic health record (EHR) certification criteria and Stage 3 meaningful use (MU) objectives. More info	Issue Brief
Feb 5, 2013	Comments on the Health Information Technology Patient Safety Action and Surveillance Plan In comments to the Office of the National Coordinator for Health Information Technology (ONC), the American College of Cardiology, Consumers Union, the National Women's Health Network, the National Research Center for Women and Families, the Trust for America's Health, and The Pew Charitable Trusts urge the ONC to promote adoption of the unique device identification (UDI) system for medical devices to improve the safety of medical care. More info	Issue Brief
Apr 4, 2013	Pew Comments on Draft Recommendations for Meaningful Use, Stage 3 The Pew Charitable Trusts submitted comments on preliminary recommendations regarding Stage 3 meaningful use objectives and standards for electronic health records (EHRs) to the Office of the National Coordinator for Health Information Technology. These comments follow remarks at recent meetings of the Health Information Technology (HIT) Policy Committee and HIT Standards Committee. More info	Issue Brief