The effects of COVID-19 have been widespread across different parts of the medical device world, but the Digital Health sector has seen the most growth because of the pandemic. The scope of digital health includes mobile health, health information technology, wearable devices, and telehealth/telemedicine. As the world looks for ways to migrate normal life to “social-distance” life, Digital Health provides the ability for healthcare providers and patients to connect quickly, effectively, and remotely...

1. Digital Health in the Age of COVID-19
By: Madison Wheeler
The effects ofCOVID-19havebeenwidespread across different parts of themedicaldevice
world, but the Digital Health sector has seen the most growth because of the pandemic. The scope
of digital health includes mobile health, health information technology, wearable devices, and
telehealth/telemedicine. As the world looks for ways to migrate normal life to “social-distance”
life, Digital Health provides the ability for healthcare providers and patients to connect quickly,
effectively, and remotely.
The FDA’s Center for Devices and Radiological Health (CDRH) has had a long-standing
Digital Health program with the goal of protecting and promoting public health while also
providing regulatory clarity on the subject. With the onset of the COVID-19 pandemic and the
increased demand for digital health, the FDA has clarified its risk-based approach to how digital
health products are regulated; in doing so, the Agency has identified different products and
software functions that may be useful in the response to COVID-19 and how they intend to
regulate them. The FDA first identified products and software functions that are not regulated as
medical devices because they do not function to diagnose or treat COVID-19 or any other
disease/condition. For example, software that provides health care providers or patients with
educational or common reference information about COVID-19 will not be regulated as a medical
device. Additionally, the FDA will not regulate software for videoconferencing with health care
providers as the software itself is not a medical device, but simply a portal to facilitate
communication.1
The FDA has also identified lower-risk device software functions which it does not intend
to enforce requirements on during the public health emergency. Like other Coronavirus-related
guidelines and policies provided by the FDA, this regulatory flexibility is intended to provide
expanded accessto healthcareduring thepublic health emergency. Theselow-riskdevicesinclude
software functions that use patient characteristics (age, sex, risk factors) to provide patient-
specific screening and recommendations, software that guides users through a questionnaire of
signs and symptoms to provide recommendations on health care facilities, and applications that
enable someone to create or send an alert to first responders.2
For higher-risk digital health devices, or devices otherwise not covered in the categories
above, the FDA recommends utilizing the Emergency Use Authorization pathway. If you have a
software or application that can be used in response to COVID-19 but are unsure how to navigate
the current regulatory landscape, EMMA International is ready to get you started. Give us a call
at 248-987-4497 or email info@emmainternational.com to see how we can help.
1 FDA (March 2020) Digital Health Policiesand Public Health Solutionsfor COVID-19 retrieved on 05/11/2020 from:
https://www.fda.gov/medical-devices/digital-health/digital-health-policies-and-public-health-solutions-covid-19
2 FDA (September 2019) Policy for Device Software Functions and MobileMedical Applicationsretrieved on
05/11/2020 from: https://www.fda.gov/media/80958/download