SensNews Sept 2020

Sensor100 September 2020 16 AppleWatch's abnormal pulse feature driving many unnecessary healthcare vis- its Mayo Clinic researchers say It takes roughly seven patients presenting after an abnormal pulse alert to establish one clinically actionable cardiovascular diagnosis. A new review of AppleWatch-related presentations sug- gests that the device's abnormal pulse detection feature may be fueling unnecessary healthcare utilization. "The observation that new clinically actionable cardiovascu- lar diagnoses of interest were diagnosed in only 11.4% of pa- tients following medical evaluation as directed by the treat- ing provider suggests a high false positive rate as a screening tool for undiagnosed cardiovascular disease," Mayo Clinic researchers wrote in the Journal of the American Medical Informatics Association. "False positive screening results have the potential to lead to excessive healthcare resource utilization and anxiety among the 'worried well.'” The retrospective look at clinical documentations also suggests that a sizable portion of those presenting used the AppleWatch's feature "in a manner inconsistent with FDA guidance." The abnormal pulse detection feature is accessible across all genera- tions of AppleWatch devices, and is not to be confused with the ECG atrial fibrillation tool introduced with the Series 4 AppleWatch. These findings raise issues surrounding digital health. A diagnostic test reporting 6 false negatives for every one positive would not be acceptable under any circum- stances, so why is this one on the market? It is likely that the "worried well" will be major users of this technology, but that is not a justification fro selling a misleading product. Reported by MobileHealthNews 28 September