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Fp55 replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices 6 years, 11 months ago
One risk-benefit factor to consider is how false-positive or false-negative results would affect the patient. In the case of a diagnostic device that produces a false-positive result, the patient would be incorrectly diagnosed with a disease. The patient would then be subject to all of the risks associated with the treatment while receiving none of the benefits. In addition, a healthy patient might actually have an increased risk depending on the nature of treatment. A false-negative result would meant that the patient would miss out on the possible benefits of treatment. Each of these risks carry varying severities therefore a proper analysis would incorporate the level of harm and the possibility of it occurring.