Digital Health Solutions Authorized During Coronavirus Outbreak

FDA authorizes telepharmacy and telehealth apps and digital devices

computer, smart phone and stethoscope

As part of the government’s ongoing efforts to address the SARS-CoV-2 coronavirus outbreak, the U.S. Food and Drug Administration issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices, to expand their use.

Announced on March 20, 2020, the FDA says this new policy should enable healthcare providers to use digital applications and devices to remotely monitor COVID-19 disease patients. 

The devices include those that measure body temperature, respiratory rate, heart rate, and blood pressure.

“Allowing these devices to be used remotely can help healthcare providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., in a related press release.

These non-invasive monitoring devices have the potential to be connected to a wireless network through Bluetooth, Wi-Fi, or cellular connection to transmit a patient’s measurements directly to their health care provider or other monitoring entity. 

Some of these devices also have the potential to apply algorithms to transform a patient’s physiological parameters into a novel index or alarm that may aid a healthcare professional in the diagnosis of a particular condition or disease state/severity

“This policy reflects the FDA’s commitment to ease burdens on healthcare providers and facilities as they face this public health emergency.” 

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“Such devices include technologies capable of enabling remote interactions to provide crucial information to be used as an adjunctive when health care providers diagnose or treat COVID-19 or co-existing conditions.” 

“During this public health emergency, it is imperative that the FDA provide regulatory relief and adapt as the situation warrants to act upon measures to save lives.”

“This new policy applies to certain modifications to the indications, claims, functionality, or hardware or software of FDA-cleared non-invasive remote monitoring devices used to support patient monitoring.”

Furthermore, this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19, declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.

The FDA is an agency within the U.S. Department of HHS, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

FDA policy news published by Precision Vaccinations.