Lexology July 28, 2020
With the coronavirus (COVID-19) pandemic showing no signs of abating, many digital health developers have refocused their technical expertise to develop products for use in the pandemic, including software apps for COVID-19 screening and risk assessments, digital therapeutics, and remote patient monitoring systems. The Food and Drug Administration (FDA) also has focused on the use of digital health technologies to address pandemic-related issues by issuing several new guidance documents on various types of digital health devices. In addition, FDA has approved multiple Emergency Use Authorizations (EUAs) for software intended for use in screening COVID-19 patients, remote monitoring systems, and wearable device technologies.
Companies developing digital health technologies for use in the COVID-19 pandemic should be mindful of FDA’s quickly evolving...
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