A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

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With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and treatment developers alike. About one in two healthcare consumers surveyed say they have postponed or canceled healthcare services since the beginning of the pandemic. Race, gender, and socioeconomic disparities have increased as well.

These trends have impacted clinical investigations, making data collection more challenging. It can be challenging for patients in remote locations to access clinical investigations and for sponsors to collect data from remote locations. Enter digital health technologies, or “DHTs,” which can facilitate clinical investigations being conducted to evaluate medical products. The last few years have seen great strides in technologies that can be used to remotely collect and analyze data from a broad array of trial participants.

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