Vanessa K. Burrows counsels health care and regulated products clients on regulatory, transactional, and compliance matters, with a particular focus on drug, medical device, food, beverage, cannabis and pharmacy laws. Her broad-based experience includes 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, change of control, license, supplier, quality, product trial, and enforcement matters. She also counsels clients on compliance with Food and Drug Administration (FDA) regulatory matters, guidance, and inspections, as well as federal Open Payments regulations and state sunshine or transparency laws.
Additionally, Vanessa has evaluated a variety of cannabis-related matters for clients, including federal research laws, use of cannabis by health care facility patients, and conflicts between federal and state laws on hemp and cannabidiol.
Previously, Vanessa served as the HIPAA privacy officer for the City of Chicago and as an attorney for the Chicago Department of Public Health. In that capacity, she advised the city’s covered entities and business associates. She also provided guidance to the department’s executive team on emergency preparedness authorities and public health laws on communicable diseases, HIV/AIDS/STIs, scope of practice, mental health, tobacco, and quarantine and isolation.
Earlier, Vanessa worked on Capitol Hill as a legislative attorney for the Congressional Research Service in Washington, DC, where she advised members of Congress and their staff in the areas of health law, administrative law and constitutional law. She addressed specific legal issues in legislation including the Patient Protection and Affordable Care Act (ACA), the Food and Drug Administration Safety and Innovation Act (FDASIA), the Family Smoking Prevention and Tobacco Control Act (TCA) and the Food and Drug Administration Amendments Act (FDAAA).
In law school Vanessa was the senior articles editor of the Administrative Law Review.
Advised medical device manufacturers on FDA Form 483s, warning letters, import alerts and detentions, state scope of practice laws, prescription and licensing requirements, clinical trial regulations, promotion of investigational devices and communications guidelines when discussing marketed products
Provided guidance on HIPAA/HITECH regulations and guidance documents related to workforce members, business associates, training, state laws regarding minors, tissue banks, data use agreements, data security and ransomware
Counseled pharmaceutical manufacturers on off-label promotion, gift and entertainment policies, drug shortages, and co-pay programs
Advised multinational technology company and applicable manufacturers on reporting, dispute resolution, and penalties under the Open Payments provisions of the Patient Protection and Affordable Care Act and implementing CMS regulations
Represented a registered 503B outsourcing facility in connection with an FDA inspection of its manufacturing facilities
Provided due diligence reviews for pharmaceutical, medical device and health information technology (HIT) mergers and acquisitions
Managed HIPAA breaches, investigations and responses, from discovery to notification of individuals, Department of Human and Health Services (HHS) and the media
Assessed compliance with HIPAA/Health Information Technology for Economic and Clinical Health Act (HITECH) privacy, security and breach rules, and performed risk assessments
Drafted upstream and downstream business associate agreements, privacy policies and data use agreements
Evaluated the acceptability under FDA standards of adding numerous flavoring ingredients to beer
Counseled clients on compliance with Anti-Kickback laws