Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in CNBC, in “Why the Apple Watch Won’t Replace Your Doctor Anytime Soon,” by Christina Farr.
Following is an excerpt:
Apple is moving ahead with a plan to screen for disease with its Apple Watch, starting with a clinical study. …
“A heart rate sensor would have a very difficult time demonstrating the level of reliability and accuracy necessary for a diagnostic claim,” said Bradley Merrill Thompson, an FDA expert with the law firm Epstein Becker & Green.
Either way, as Thompson points out, Apple will face some kind of regulatory process if it turns the study into a product.
That would be unprecedented territory for Apple, which would need to think about a lot more than designing elegant products.
“Software has to go beyond just reliability to showing that the software encounter actually leads to appropriate care for the patient,” he said.