Elizabeth Guo

Elizabeth Guo received her law degree from Harvard Law School and her M.P.H. from the Harvard School of Public Health in 2016.

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Pharmaceutical Digital Health Innovators Take Note: FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs

By Elizabeth Guo and Wade Ackerman on Posted in Health Data, Medical Apps, Medical Devices and FDA
On November 16, 2017, the Food and Drug Administration (“FDA” or the “Agency”) will hold a public hearing on a proposed approach for sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device. FDA will accept comments to the docket until January … Continue Reading

Three Questions You Need to Ask When Negotiating Digital Health Deals

By Elizabeth Guo on Posted in Health Data, Transactions
According to a distinguished panel of lawyers from MSD and Covington & Burling, companies involved in Digital Health deals need to ask themselves the following questions: What data is required to develop and deliver the Digital Health solution, and does your company have sufficient expertise in-house to analyze the data? What happens if your technology … Continue Reading

FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan

By Elizabeth Guo, Wade Ackerman and Christina Kuhn on Posted in Health Data, Medical Apps, Medical Devices and FDA
On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month. The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes … Continue Reading
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