Vanessa K. Burrows
Subscribe to Vanessa K. Burrows's PostsVanessa K. Burrows counsels clients on health care law and regulatory issues, with an emphasis on drug, medical device, food, beverage, and pharmacy law. Her broad-based experience also includes the Health Insurance Portability and Accountability Act (HIPAA) compliance, health privacy and security, alcohol beverages and public health. She advises health care entities and their contractors on compliance, regulatory, data sharing, licensing, and enforcement matters. She also counsels clients on compliance with Food and Drug Administration (FDA) regulations and guidance. Read Vanessa Burrows' full bio.
Order now: The Law of Digital Health Book
By Vanessa K. Burrows, McDermott Will & Emery, Amanda Enyeart, Anisa Mohanty, Amy C. Pimentel, Bernadette M. Broccolo, Dale C. Van Demark, Jiayan Chen, Lisa Mazur, Marshall E. Jackson, Jr., Michael W. Ryan, Ryan S. Higgins and Scott Weinstein on Mar 20, 2018
Posted In Big Data, Cloud, Consumer Protection, Data Privacy, General Interest, Telehealth
Designed to provide business leaders and their key advisors with the knowledge and insight they need to grow and sustain successful digital health initiatives, we are pleased to present The Law of Digital Health, a new book edited and authored by McDermott’s team of distinguished digital health lawyers, and published by AHLA. Visit www.mwe.com/lawofdigitalhealth to order this...
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Government Issues New Tool to Help Mobile App Developers Identify Applicable Federal Laws
By Jennifer S. Geetter, Michael W. Ryan, Vanessa K. Burrows and Vernessa T. Pollard on Apr 20, 2016
Posted In Consumer Protection, Data Privacy, General Interest, Mobile Apps
This week, the Federal Trade Commission (FTC or Commission) released an interactive tool (entitled the “Mobile Health Apps Interactive Tool”) that is intended to help developers identify the federal law(s) that apply to apps that collect, create and share consumer information, including health information. The interactive series of questions and answers augments and cross-references existing...
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FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness
By Jennifer S. Geetter, Michael W. Ryan and Vanessa K. Burrows on Feb 17, 2016
Posted In Big Data, General Interest
At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel infrastructure to conduct post-market effectiveness studies. Sentinel is an electronic surveillance system that aggregates data from electronic medical records, claims and...
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FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices
By Daniel F. Gottlieb, Jennifer S. Geetter, Michael W. Ryan and Vanessa K. Burrows on Jan 29, 2016
Posted In Cybersecurity, Data Privacy, Mobile Apps
On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for managing postmarket cybersecurity vulnerabilities in medical devices that contain software or programmable logic and software that is a medical device, including networked medical devices. The...
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