ANDY VAN HAUTE is an associate in Sidley’s Washington, D.C. office who counsels life sciences companies on a wide range of FDA and healthcare regulatory issues. As part of Sidley’s Healthcare group, Andy advises pharmaceutical and medical device manufacturers, clinical laboratories, and other healthcare entities on a broad range of regulatory issues, including compliance with the Federal Anti-Kickback Statute and other fraud and abuse laws; healthcare compliance programs; federal healthcare program reimbursement; clinical lab requirements under CLIA; and Sunshine Act compliance. Andy is experienced in assisting life sciences companies in the creation and implementation of compliance programs to address these issues, as well as in conducting internal reviews to measure those programs’ effectiveness.
As a member of Sidley’s Food, Drug, and Medical Device Regulatory group, Andy’s practice is focused on medical device, digital health, and in vitro diagnostic companies. He is experienced in advising innovative product developers and manufacturers on key threshold FDA regulatory questions, as well as in advising established life sciences companies on issues such as clinical trials regulation, product approvals and clearances, advertising and promotional claims and adverse event reporting obligations.
Andy has spoken at a variety of national and local conferences to physician groups and others on issues of importance to the life sciences industry. He is a frequent guest lecturer at George Washington University’s Healthcare Corporate Compliance Certificate Program and has also been a guest lecturer at Northwestern University’s multidisciplinary NUVention program.
Prior to joining Sidley, Andy had a particular focus on the medical device industry, having served as associate general counsel for AdvaMed, the leading global trade association for medical technology companies. In this position Andy developed legal and compliance policy positions on behalf of the industry and worked closely with industry leaders to advance the Association’s priorities. Andy played a key role in the 2008 development of AdvaMed’s revised Code of Ethics on Interactions with Health Care Professionals, as well as in the development subsequent best practices guidance for companies on implementing the Code. He also worked closely in the areas of device promotion, Physician-Owned Distributors (PODs), Physician Payment Sunshine, OIG exclusion policy and the creation and harmonization of ethical standards for industry in markets around the world. While at AdvaMed, Andy also advised the Association and its staff on a broad scope of internal legal issues.
Admissions & Certifications
- District of Columbia
- New York
- Catholic University of America - Columbus School of Law, J.D., 2007 (cum laude, Editor, Catholic University Law Review)
- University of Notre Dame, B.B.A., 2003