Table 9 Illustrative examples of consequences where V3 evaluation does not occur.
Illustrative examples | Consequences |
|---|---|
Cuffless blood pressure measurement | If the software for blood pressure estimation through a cuffless wearable was not carefully verified and validated, inaccurate blood pressure estimations used in clinical decisions may result in misdiagnosis and improper treatment that can result in patient harm. |
Heart rate monitoring | Inaccurate heart rate monitoring could lead to improper conclusions about a patient’s risk for life-threatening cardiac events. Either over- or under-treatment in this scenario would likely result in patient harm and misallocation of health resources60. |
Tapping on a smartphone to measure dementia | A BioMeT designed to detect dementia based on tapping patterns on a smartphone can diagnoses dementia in a healthy person if an older smartphone is used with a newer operating system because the delays and irregular tapping patterns are observed and misinterpreted by the BioMeT61. In this case, a carefully constructed verification process would have included testing the software in most, if not all, existing operating environment, so that the software specifications are met or the software usage is discouraged under certain conditions, and misdiagnosis owing to similar hardware system failures may be avoided. This example was witnessed firsthand by a member of our team. |
