18 October 2021: Editorial
Editorial: Global Initiatives Support the Use and Regulation of Digital Health Technology During the COVID-19 PandemicDinah V. Parums *
Med Sci Monit 2021; 27:e935123
ABSTRACT: The development and use of digital health technology have increased during the global COVID-19 pandemic. Artificial intelligence (AI)-powered digital tools have been increasingly used to diagnose and screen for SARS-CoV-2 infection. Digital technology, in the form of mobile phone applications (apps), has been adopted by several countries to track infected individuals as infection prevention and surveillance measures. Global best practice guidelines, technology approvals, and patient care models have only recently begun to catch up with the developments in digital technology. In 2021, the WHO published a global strategy on digital health (eHealth) and mobile health (mHealth) for 2020 to 2025. The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) now evaluates software as a medical device (SaMD) and software that is in a medical device (SiMD) through the International Medical Device Regulators Forum (IMDRF). This Editorial aims to discuss how the COVID-19 pandemic has driven global initiatives to support the use and regulation of digital health technology and the requirements for digital health evidence frameworks and new approaches to regulatory approvals.
Keywords: Editorial, digital technology, COVID-19, Digital Health, SARS-CoV-2, regulation, eHealth, pandemic
The COVID-19 pandemic has driven global initiatives to support the use and development of digital health technology. Because the pandemic is ongoing, the value of digital health technology to the pandemic response has yet to be determined. However, the COVID-19 pandemic has also driven digital health evidence frameworks and new approaches to regulatory approvals.
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