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 POLITICO Morning eHealth, in “Apple Watch to Act as Heart Monitor,” by Darius Tahir and Arthur Allen.
Following is an excerpt:
Apple Watch Acts as Heart Monitor: Apple’s next version of its Apple Watch will include software that will look for abnormal health rhythms, as the tech giant studies the technology’s effectiveness with Stanford and the FDA, the company announced at its product launch event Tuesday. Consumer tech companies haven’t, by and large, made such a definitive move into clinical care — as opposed to wellness or fitness or serving as a platform for other companies’ health care plays. At this point, it’s an open question as to how much the move actually matters. …
FDA implications: We also reached out to digital health expert Bradley Merrill Thompson, a lawyer with Epstein, Becker & Green. He expects the algorithm – not the Watch itself – to be a class II, or medium-risk, device.