CAHIMS 4.3 Questions And Answers All Verified Solution Update

CAHIMS 4.3 Questions And Answers All Verified Solution Update Which of the following is an example of "competent human intervention" as described in the 1989 FDA policy? a. A nurse stopping a patient from taking the wrong drug b. A physician deciding not to follow the advice of a clinical decision support system c. A chairperson of an FDA panel helping the panel to reach consensus on approving a piece of clinical software d. A health IT professional assuring that an electronic medical record is configured properly - ANSWER-B Which organization was already an EHR certification organization prior to the establishment of the current ONC Authorized Testing and Certification Bodies? a. Drummond b. CDRH c. CCHIT d. FDA - ANSWER-C What was one of the recommendations from the 1996 FDA workshop on regulating clinical software? a. Software quality audits b. Competent human intervention as a guiding principle c. FDA regulation of EHRs d. Establishment of a certification process for EHRs - ANSWER-A HITECH mandates certification of EHRs to assure that a. unsafe EHRs are not permitted. b. EHRs include functionality for meaningful use. c. good manufacturing practices are followed by EHR vendors. d. EHRs are implemented properly. - ANSWER-B FDA regulation of EHRs is UNLIKELY to reduce errors due to a. faulty hardware. b. faulty software. c. design flaws. d. implementation flaws. - ANSWER-D Which of the following explains why FDA or CDRH pre-market and post-market reviews are difficult to perform on EHR software programs? a. The standard for "meaningful use" continues to change. b. Problems caused by related sources and configuration designs are not easily tested. c. Congressional debates concerning jurisdiction delays the reviewing process. d. Testing the software does not ensure proper use of the software. - ANSWER-B Which of the following publications served as a catalyst for valuing HIT in relation to patient safety? a. Ross Koppel's study in JAMA b. Dual review reports in the Annals of Internal Medicine and JAMIA in the late 90's c. Institute of Medicine report, "To Err is Human" d. Leapfrog's "Development of a Consumer Communications Toolkit" - ANSWER-C Which was not a reaction by the Office of the National Coordinator to the anticipated use of EHRs?...