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 Becker’s Health IT & CIO Review, in “Analysis: 2 Barriers to Apple’s Smartwatch, Arrhythmia Detection Project,” by Jessica Kim Cohen.
Following is an excerpt:
Apple CEO Tim Cook confirmed reports the company has been working with researchers at Stanford (Calif.) University to equip the Apple Watch with a heart rate sensor to detect abnormal heart beats, like arrhythmias, Sept. 12.
However, physicians and regulatory experts claim it’s unlikely the tech giant will roll out a diagnostic tool to the general population, according to an analysis by CNBC digital health reporter Christina Farr.
Here are two barriers the sources laid out. …
Regulatory hurdles. Should Apple choose to target at-risk groups for the Apple Watch project, it might have to address regulatory concerns from the U.S. Food and Drug Administration. While FDA approval isn’t necessary to create general screening tools for disease, there are several regulatory benchmarks to meet for a product to become a diagnostic tool.
“A heart rate sensor would have a very difficult time demonstrating the level of reliability and accuracy necessary for a diagnostic claim,” Bradley Merrill Thompson, an FDA expert with the New York City-based law firm Epstein Becker & Green, told Ms. Farr.
