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WiFi, Bluetooth OK’d for Breathing, Heart Monitors During Virus

June 5, 2020, 9:22 PM

Medical device makers have more leeway to tweak non-invasive tools like breathing or heart monitors so doctors can keep better tabs on patients without unnecessary office visits during the pandemic.

The Food and Drug Administration gave doctors more resources to check in on their patients without having to see them face to face and risk exposing them to Covid-19 during routine visits, the agency said Friday.

There are roughly 20 types of devices that can be outfitted with additional monitoring capabilities to send doctors information about their patients’ health as part of the policy change. That includes some devices that monitor breathing, temperature, heart rate, and oxygen levels. This change updates the FDA’s previous March policy about device tweaks during the pandemic and expands the list of devices eligible for changes.

Device makers don’t have to send notifications to the FDA before selling these products with these changes, which could include adding WiFi or Bluetooth capabilities to send data to the patient’s doctor. The agency warned companies making those types of modifications must be wary of cybersecurity issues and guided companies to its cybersecurity policies.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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