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Food and Drug Administration (FDA) › Digital Health › Data Collection

Foley & Lardner LLP

Decentralized Clinical Trials: Sponsor Responsibilities

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In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Jones Day

Vital Signs Digital Health Law Update | Spring 2023

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Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more

MoFo Life Sciences

FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

MoFo Life Sciences on

In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

King & Spalding

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...more

Foley & Lardner LLP

FDA Addresses the Role of Digital Health Technology in Clinical Trials

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The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. DHT can take the form of hardware and...more

Sheppard Mullin Richter & Hampton LLP

FDA Releases Guidance for Digital Health Tech Used in Clinical Investigations

Sheppard Mullin Richter & Hampton LLP on

n December 22, 2021, the Food and Drug Administration (FDA) issued a draft guidance for sponsors, investigators, and other interested parties on using digital health technologies (DHT) to acquire data remotely from...more

Cooley LLP

Alert: FDA Finalizes Guidance on Devices that Store and Transfer Data

Cooley LLP on

The Food and Drug Administration (FDA) on February 6th, finalized guidance on certain medical devices that store and transfer data, opting for a very light regulatory touch. In its guidance, the FDA states that it doesn't...more

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