Kyle Faget Discusses FDA’s Growing Scrutiny of Digital Health and Patient Monitoring Tools

Foley & Lardner LLP Partner Kyle Faget is quoted in the STAT+ article, “FDA’s letter to medical device maker iRhythm is a warning for the industry,” discussing a letter recently issued by the U.S. Food and Drug Administration (FDA) to a heart monitoring company and the consequences it may foreshadow for the expanding intersection of health care and technology.

The letter highlights the FDA’s growing scrutiny of digital health and patient monitoring tools. While the agency regularly issues warning letters to enforce patient safety, regulatory action in the digital health space is a relatively new development.

“The warning letter is a clear message to industry that FDA will enforce against manufacturers when changes are made to software that could impact safety and efficacy of the device,” said Faget, who is the co-chair of Foley’s Health Care Practice Group.