Vanessa K. Burrows Email & Phone Number

Washington, Dc, Us

New York, Ny, Us

New York, Ny, Us

Vanessa advises pharmaceutical and medical device manufacturers, healthcare and technology companies, and healthcare providers in connection with M&A, IPOs and other capital-raising transactions, and regulatory and compliance matters.Speaking Engagements:• Food & Drug Law Institute, Recent Rulings on Mifepristone Access (May 2023); Introduction to Drug Law and Regulation (April 2023, April 2022); Law Over Lunch: Biden Administration Priorities for FDA and the COVID-19 Pandemic (Feb. 2021)• American Health Law Association, Telemedicine Webinar Series (April 2023); Will HIPAA Compliance Issues Stop Your Deal? (October 2022); Specialty Drugs: FDA Approval, Medicare Coverage, and the Controversy over Aduhelm (March 2022)• National HIPAA Summit, Assessing HIPAA Compliance in M&A (March 2023)• PLI, Hot Topics in Health Care Law (Dec. 2022)• Hispanic National Bar Association conference, Prescription Drug Pricing (Sept. 2022)• U.S. Army Medical Materiel Development Activity (USAMMDA) and Food & Drug Law Institute, FDA's COVID-19 Activities (June 2022)• Seton Hall Law School Legislative Journal Symposium (Feb. 2022)• TechGC, Briefing on the CARES Act and the FFCRA (March 2020)• Hot Topics for In-House Counsel at Health Care Institutions, a roundtable co-sponsored by AHLA, the American Society for Health Care Risk Management, and the University of Maryland School of Law (Oct. 2019)CLE Presentations:• Artificial Intelligence in Healthcare (June 2023)• Drug Approval: Overview, Breakthrough Therapies, and Developments in Drug Pricing (2022)• Healthcare Legislative and Regulatory Updates (2022)• Vaccine Regulation and Distribution (2021)• Hot Topics and Trends in Healthcare: Regulatory and Intellectual Property (2021) • Medicare for All: Proposals to Remake the Current Federal Healthcare Program (June 2019)• Thinking About Cyber Risk and Privacy (Sept. 2019)• Cannabis Transactions: Considerations for U.S. Financial Institutions (Nov. 2019)

20+ Locations, Worldwide, Us

• Advised medical device and pharmaceutical manufacturers, private equity firms, and lenders on healthcare and FDA regulatory matters• Advised clients on HIPAA/HITECH regulations and guidance related to workforce members, business associates, training, explanation of benefits, state laws regarding minors, data security provisions, data use agreements, tissue banks, and compliance matters• Advised pharmaceutical manufacturer on off-label promotion, gift and entertainment policies, drug shortages, co-pay programs, potential acquisitions, and the False Claims Act • 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• Advised biopharmaceutical company on Medicaid, Public Health Service, TRICARE, VA, and state policies and procedures• Advised alcohol beverage manufacturers and companies on regulatory status of a new product, federal and state regulations, responses to regulators, sales agreements, labeling issues, Foreign Supplier Verification Program, and compliance issues• Represented 503B outsourcing facility in connection with FDA inspection and FDA Form 483• Provided due diligence reviews for pharmaceutical, medical device, hospital, clinical research organization, and health IT mergers and acquisitions• Assisted a flavor supplier in its assessment of the implications of a possible violation of FDA regulationsSpeaking Engagements:• MWE Webinar – The State of the Cannabis and Hemp Industries (April 2019)• American Health Lawyers Association, Academic Medical Centers and Teaching Hospitals Institute - Marijuana: An Overview of Select Legal Issues (Jan. 2019)• Food and Drug Law Institute, Annual Conference, Table Leader (May 2017)• MWE Employee Benefits Innovators Roundtable: Should Your Plan Cover All Drugs? (May 2017)

Akron, Ohio, Us

Speaking Engagements:• Roetzel's Executive & Corporate Counsel Forum - HIPAA: Surviving a Breach (Nov. 2014)• GeriMed Annual Conference - HIPAA Breaches, Audits, and Current Legal Issues (Oct. 2014)• Public Health Law Conference - Big Data, Law, and the Public’s Health (Oct. 2014)• Public Health Law Conference - Data, Health Information, and Local Public Health (Oct. 2014)Representative matters:• Counseled global technology corporation on Safe Harbor self-certification application, process, and assessment• Advised buyers in purchases of home health agency and pharmacy asset purchase involving customer health records• Represented pharmacies in license denials• Assessed compliance with HIPAA/HITECH privacy, security, and breach rules • Performed risk assessments for health care providers and health plans that experienced a HIPAA breach or an unauthorized acquisition or disclosure of protected health information• Managed HIPAA breaches, investigations, and responses from discovery to notification of individuals, HHS, and the media• Drafted upstream and downstream Business Associate Agreements• Created privacy policies and data use agreements• Reviewed advertisements for medical device manufacturer and pharmacy for compliance with FDA requirements• Counseled clients on compliance with anti-kickback laws and application of HHS OIG opinions

As the attorney and HIPAA Privacy Officer for the Chicago Department of Public Health, I provided decision support and informed guidance on legal, compliance, and information technology issues. I diligently assessed risks and the potential for liability for the department, which provides health care services through city clinics.• Implemented HIPAA, HITECH, and federal and state laws and regulations on health and privacy through policies, business associate agreements, billing and medical record systems, and employee manuals and trainings• Developed and negotiated data privacy and security provisions in city contracts• Created data use agreements and business associate agreements• Reviewed contracts, requests for proposals, and intergovernmental agreements • Advised the department on operations, programs, laws, regulations, and policies• Served as a member of the department’s Institutional Review Board• Drafted ordinances, wrote talking points, answered subpoenas, and evaluated proposed legislation and rulesSpeaking Engagements: • Public Health Law and Science: A Seminar for Illinois Judges – Privacy and Confidentiality Issues Related to Public Health and Judicial Proceedings (Nov. 2013)• Preparedness Summit, Atlanta, GA – Hot Legal Topics in Preparedness (Apr. 2014)• National Association of County and City Health Officials Annual Meeting - Public Health Law 101 for Health Officials (July 2014)

• Provide nonpartisan legal analysis to Members of Congress and congressional staff in the areas of food and drug law, health law, administrative law, inspectors general, executive orders, and presidential pardons• Review draft and pending legislation and offer legislative options for addressing legal and policy issues• Prepare background memoranda and potential questions for congressional staff in advance of hearings• Conduct briefings, continuing legal education lectures, and graduate legislative institutes• Testified before the U.S. House of Representatives Subcommittee on Government Management, Organization, and Procurement on March 25, 2009, regarding differences between presidentially-appointed inspectors general and designated federal entity inspectors general• Testified before the U.S. House of Representatives Subcommittee on Government Management, Organization, and Procurement on June 20, 2007, regarding removal of federal inspectors general

Us

Washington, Dc, Us

Juris Doctor

Master Of Arts, Irish Studies

Bachelor Of Arts, Political Science, History, Spanish, Humanities

Education record