CAHIMS 4.3 Questions and Correct Answers
1. 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 config-
ured properly ANSWER B
2. 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
3. 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
4. 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
5. FDA regulation of EHRs is UNLIKELY to reduce errors due to
a. faulty hardware.
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, CAHIMS 4.3 Questions and Correct Answers
b. faulty software.
c. design flaws.
d. implementation flaws. ANSWER D
6. Which of the following explains why FDA or CDRH pre-market and post-mar-
ket 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
7. 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
8. Which was not a reaction by the Office of the National Coordinator to the
anticipated use of EHRs?
a. Collaboration with NIST to develop EHR usability measures
b. Overseeing the establishment of Authorized Testing and Certification Bod-
ies
c. Initiating a panel discussion by the Institute of Medicine on HIT and safety
d. Recommending stricter regulations by the FDA on EHR design and imple-
mentation ANSWER D
9. According to the lecture, which is a possible drawback to EHR regulation?
a. Decrease in innovative designs
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1. 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 config-
ured properly ANSWER B
2. 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
3. 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
4. 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
5. FDA regulation of EHRs is UNLIKELY to reduce errors due to
a. faulty hardware.
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, CAHIMS 4.3 Questions and Correct Answers
b. faulty software.
c. design flaws.
d. implementation flaws. ANSWER D
6. Which of the following explains why FDA or CDRH pre-market and post-mar-
ket 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
7. 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
8. Which was not a reaction by the Office of the National Coordinator to the
anticipated use of EHRs?
a. Collaboration with NIST to develop EHR usability measures
b. Overseeing the establishment of Authorized Testing and Certification Bod-
ies
c. Initiating a panel discussion by the Institute of Medicine on HIT and safety
d. Recommending stricter regulations by the FDA on EHR design and imple-
mentation ANSWER D
9. According to the lecture, which is a possible drawback to EHR regulation?
a. Decrease in innovative designs
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