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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software
This guidance provides clarity on the scope of FDA's oversight of clinical decision support software intended for health care professionals, patients, or caregivers.
https://en.wikipedia.org/wiki/Clinical_decision_support_system
A clinical decision support system (CDSS) is a health information technology system that is designed to provide physicians and other health professionals with clinical decision support (CDS), that is, assistance with clinical decision-making tasks. A working definition has been proposed by Robert Hayward of the Centre for Health Evidence ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-and-patient-decision-support-software
Provides clarity on the scope of FDA's regulatory oversight of clinical decision support software intended for healthcare professionals, and more.
https://www.acr.org/Clinical-Resources/Clinical-Decision-Support
The Protecting Access to Medicare Act (PAMA) now requires referring providers to consult appropriate use criteria (AUC) via a CMS-qualified clinical decision support mechanism (qCDSM) prior to ordering CT, MR, Nuclear Medicine and PET exams for Medicare patients. 2020 is a one-year “Educational ...
https://egems.academyhealth.org/article/10.5334/egems.244/
Introduction. Reducing misdiagnosis and costly “diagnostic odysseys” by using diagnostic decision support software (DDSS) has been a key goal from the outset of medical informatics [1, 2].However it has long been appreciated that standalone systems that are not integrated into the clinical workflow are a barrier to adoption, particularly for tools that require significant data entry [].Cited by: 2
https://www.darkdaily.com/new-fda-regulations-of-clinical-decision-support-digital-health-applications-and-medical-software-has-consequences-for-medical-laboratories/
Apr 06, 2018 · FDA Softens Stance on Clinical-decision Support Software. Clinical and Patient Decision Support Software. FDA Issues New Guidance for Clinical and Patient Decision Support Software. Statement from FDA Commissioner Scott Gottlieb, M.D., on Advancing New Digital Health Policies to Encourage Innovation, Bring Efficiency and Modernization to Regulation
https://www.healthit.gov/topic/safety/clinical-decision-support
Clinical decision support (CDS) can significantly impact improvements in quality, safety, efficiency, and effectiveness of health care. The Office of the National Coordinator for Health IT (ONC) supports efforts to develop, adopt, implement, and evaluate the use of CDS to improve health care decision making.
https://www.itnonline.com/article/intro-clinical-decision-support-radiology
Mar 19, 2013 · In radiology, the main use of clinical decision support is to quickly determine what type of imaging exam or diagnostic testing is needed for a patient with specific symptoms. The software is based on AUC set by various medical societies, including the American College of Radiology (ACR).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2150633/
Clinical decision support systems can improve medical diagnosis and reduce diagnostic errors. Older systems, however, were cumbersome to use and had limited success in identifying the correct diagnosis in complicated cases.To measure the sensitivity and ...Cited by: 110
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4381462/
Mar 26, 2015 · EHRs have laid the foundation for clinical decision support systems. The lack of clear evidence for positive effects of EHR use on clinical outcomes suggests that EHR adoption is only a first step toward improving patient healthcare through informatics.Cited by: 165
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