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FDA to modernize digital health software regulatory framework

Tuesday, October 10, 2017

The FDA has named nine companies selected to participate in a first-of-its-kind pilot program designed to revolutionize digital health regulation in the U.S. The importance of this pilot program is vast and the driving force behind why the FDA is launching it. According to the FDA, “The FDA’s Pre-Cert Pilot Program is intended to inform a tailored approach to digital health technology by looking at the software developer or digital health technology developer, rather than primarily the product.”

Vivli announces new data sharing platform for clinical trials research

The Laura and John Arnold Foundation has recently donated $2 million in funds to Vivli, a Massachusetts nonprofit, for establishing a unique data sharing platform for use in clinical trials.
“This financial support allows us to quickly move to launch the platform in 2018,” said Dr. Ida Sim, Vivli co-founder and technical lead. “Vivli’s technology and coordinated policies and processes will lead to new scientific discoveries from integrating existing datasets.”


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