Question

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 1

An example of 'competent human intervention' as per the 1989 FDA policy is a physician who decides not to follow a clinical decision support system, as it illustrates a healthcare professional's active decision-making role based on expert judgment in a clinical setting. Option b.

Step-by-step explanation:

The 1989 FDA policy about competent human intervention is illustrated through various practices in medical and healthcare settings.

Competent human intervention implies that a trained professional actively makes decisions or takes action based on their knowledge, skills, and judgment within the healthcare context, thereby intervening in a process that might otherwise be automated or guided by technology or protocols.

The correct choice that represents an example of competent human intervention, according to this policy, is:
b. A physician deciding not to follow the advice of a clinical decision support system

This reflects a situation where a healthcare professional, based on their experience and expertise, exercises their judgment to override or modify the recommendations of a technology-based tool (such as software or a protocol).

This demonstrates the importance of human factors and the role of the professional's discretion in clinical decision-making processes.

So Option b is correct answer.