The paper, written by four professors affiliated with Cambridge, Mass.-based Harvard University, outlines the potential problems associated with remote monitoring technology, including inadequate data protection and the fact that many of these tools are not considered medical devices and are thus not subject to FDA regulation.
“We want patients to know these technologies have been authorized for emergencies only on the limited criteria that they may be effective,” Sara Gerke, one of the paper’s authors, told STAT. “That doesn’t mean the products are safe and effective.”
The paper’s conclusion states that remote monitoring technology developers should be guided by the motto “ethics by design, even in a pandemic.”
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