COVID-19: Providers, clinical trial investigators gain clarity around remote monitoring

Erin McCallister Senior Manager, Health Research Institute, PwC US March 27, 2020

Amid a flurry of guidance issued by the FDA in response to the COVID-19 pandemic was a document that loosens agency requirements for remote monitoring technologies that could be used by healthcare providers, patients and clinical trial investigators as in-person visits have been halted because of the outbreak.

The tools could also enable remote monitoring of COVID-19-positive patients with mild disease or patients at risk of severe disease if they become infected.

On Sunday, the FDA issued a final guidance on the use of noninvasive remote monitoring devices to support patient monitoring during the COVID-19 pandemic. The outbreak has caused many hospitals and research centers to cancel routine, in-person visits, including those for clinical trials.

The guidance is intended to allow physicians and healthcare providers to monitor patients while avoiding potential exposure to the virus from an office visit.

The devices listed in the guidance are mainly focused on those that monitor basic vital signs and include electronic thermometers, electrocardiographs, cardiac monitors, electrocardiograph software for over-the-counter use, pulse oximeters, noninvasive blood pressure, respiratory rate monitors and electronic stethoscopes.

The guidance does not apply to devices that would determine whether patients need immediate clinical intervention, or devices solely or primarily relied on by health professionals or patients to make diagnosis or treatment decisions related to COVID-19 or coexisting conditions.

In the guidance, the FDA states that it will not object to “limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared non-invasive remote monitoring devices that are used to support patient monitoring … during the declared public health emergency … without prior submission of a premarket notification.”

The types of modifications FDA will allow include monitoring of patients with COVID-19 or comorbidities such as hypertension or heart failure; remote devices previously approved for use only in hospitals or other healthcare facilities; and changes to the hardware or software that allow for increased remote monitoring capability.

HRI impact analysis

Hospitals and research facilities across the US, including those in some of the hardest-hit areas, have placed restrictions on inpatient visits. The new guidance is likely to increase the use of digital tools as companies scramble to move to telehealth.

An analysis by HRI found that nearly half of clinical trials being run in the US are at hospitals or institutions in cities and states with the greatest number of COVID-19 patients. The FDA has also issued a guidance that recommended companies move to remote monitoring tools as one means to deal with potential delays or challenges in obtaining patient data.

The demand for telehealth is also increasing as patient visits at hospitals are curtailed . A policy by CMS earlier this month expanded the coverage of telehealth for Medicare beneficiaries, pushing some of the most frail and at-risk patients to a digital platform. These patients and their doctors are likely benefactors from the availability of more remote monitoring tools.

American consumers have told HRI since 2013 that they’re eager to embrace more convenient, digitally enabled care, and more consumers are inching toward DIY healthcare via remote monitoring tools and other digital health apps.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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