(and not the walled garden of AOL) When I was the Chief Science Officer at the HHS Office of the National Coordinator for Health IT (ONC), I can’t tell you the number of times that a company would come into my office with the solution to interoperability, or information exchange…

This is the fourth in a four part series on the NIH genomic data sharing policy RFI, looking at consent for genomic data sharing and linking. Framework for consent We can look at genomic data sharing, linking, and consent in three different situations: Data collected, submitted to repositories (or linked) in which all…

This is the third in a four part series, describing some of the key aspects of the NIH RFI on genomic data sharing. Questions/answers regarding the NIH RFI on genomic data sharing The NIH genomic sharing policy RFI includes a number of requests regarding de-identification, consent, linking and sharing data, harmonizing the policies with data management requirements, and how…

The NIH has taken a good step forward in revisiting (and potentially updating) the NIH genomic data sharing policy. In this the second of four blogs, I’d like to provide the historical background of genomic data sharing policy, and why this particularly update is important. Has genomic information always been considered personally identifiable? Remarkable, the recognition that genomic…

This is the first in a four part series on the NIH genomic data sharing RFI, focused on privacy, data sharing, linking, and consent. It is encouraging to see a comprehensive update to the NIH data sharing policies for genomic data. Genomic data is critical to the advancement of science…

Last week Datavant submitted comments on the recently issued FDA’s guidance that helped to clarify how real world data could be made “fit for purpose” in regulatory decision-making. In our response, we celebrated and applauded the FDA for advancing the use of real world data while highlighting a critical gap…