Q&A roundtable discussions are conducted by members of the community to provide opportunities for a small group discussion with subject matter experts.

There are 8 seats at the table for the 90-minute discussion.

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Join Bill Waller as he discusses issues surrounding health care IT and privacy, and their intersection with FDA law. This discussion will highlight healthcare IT, connected devices, medical monitoring and steps to take to avoid having your product or technology considered a device that is regulated by FDA law. Bill has advised a variety of Fortune 500 companies, medtech startups, and everything in between on these issues, providing training to scientists, sales teams and executives.

Bio:

Bill Waller is a senior medical product executive, compliance, privacy and FDA regulatory attorney with over twenty years’ success in developing and leading regulatory, compliance, privacy and legal teams. Bill is a practical, skilled and sought after outside counsel and contract general counsel, serving multiple clients in the life sciences. Bill’s start up focus is on Optimize Health and Toi Labs, two start ups in the remote monitoring space with FDA devices and other tech, and Pillsy, the Amazon category leader for smart pill bottles. As CEO, Bill this year sold start-up medical technology company, Monitor Mask, Inc., to Salter Labs, Inc. Recently, Bill served for six years as Varian Medical System’s Lead Counsel for the Seattle site (and subsidiary Calypso Medical) and Head of Global Regulatory Law. Before Varian, Bill was VP of Compliance and Chief Privacy Officer for Seattle-based biotech Dendreon, and prior to that, VP of Compliance for the vaccines and device division of Novartis. Bill is the former leader of a NW med tech angel group and is active in the med tech start up ecosystem. Bill’s current legal clients include Kite Pharma, Gilead, various radiotherapy companies and a leading Seattle biotech research institute.

Earier in his career, he served in senior health care roles in the federal government and with leading FDA law firms, including Covington & Venable, where he advised about advertising, privacy, compliance, approvals and regulatory matters. His government service includes serving as Majority Counsel for the US House of Representatives Oversight Subcommittee with jurisdiction over FDA, which led efforts in the first successful use of the Congressional Review Act repealing federal regulations. Bill is a corporate advisor to a few medical technology startups involved in medical scans, pharmacy and privacy. He received a JD with honors from Harvard Law School, and a BA with highest honors from Colgate University. He is an Eagle Scout and former ethics instructor with the Boy Scouts of America. Bill lives in the Seattle area with his wife and, during college breaks, his two children.