
Billee Lightvoet Ward co-chairs Dickinson Wright's Academic Institutions and Life Sciences group. She has been a practicing health care attorney since 2002, and represents hospitals and other healthcare institutions, physicians and physician practices, medical device and pharmaceutical manufacturers, and healthcare vendors in an array of regulatory, compliance, contract and transactional matters. She provides counsel to clients ranging from individual physicians and start-up companies at the local level, to hospitals and large health systems, and pharmaceutical and medical device companies operating on an international scale.
Billee has extensive experience handling commercial arrangements and complex contracting matters, and has represented healthcare clients in a variety of business transactions including mergers and acquisitions, joint ventures, affiliations, co-management arrangements, and other strategic transactions. She has specialized experience advising life sciences companies, health care providers, and institutional review boards concerning regulatory and contract issues associated with clinical investigations and human subjects protections. She counsels product manufacturers and other companies on FDA requirements and other regulatory and practical considerations concerning product classification, premarket strategy, advertising and promotion, and other product development and commercialization matters.
Education & Credentials
Education
Universidad de Extremadura, Caceres, Spain
1993Kalamazoo College
B.A., 1994DePaul University College of Law
J.D., 1997Bar Admission
Acknowledgements
- Grand Rapids Magazine
- "Top Lawyers," Health Care Law, 2020
- Best Lawyers in America®
- Healthcare, 2021-2024
- Crain's Detroit Business
- "Notable Women in Law," 2019
- Michigan Super Lawyers®
- "Rising Star," Healthcare 2011
- National Collegiate Athletic Association
- Division III All-American,1994
Prominent Assignments
Counsel to international cosmetics brand in FDA regulatory compliance
Counsel to personal protective equipment importer on COVID-related FDA compliance
Counsel to COVID-related product developer on FDA labeling and compliance
Counsel to COVID diagnostic test developer on Emergency Use Authorization and 510(k) submission process
Counsel to start-up and established cannabis product developers in FDA and state regulatory compliance
Counsel to physician practice in sale of assets to national health system
Clinical research contract and regulatory counsel to cardiac device company engaged in national, multi-site clinical research trial
Clinical research contract and regulatory counsel to international pharmaceutical company conducting multi-site clinical research trial
Clinical research contract and regulatory counsel to publicly-traded medical technology company conducting multi-site clinical research trial
Counsel to start-up medical device manufacturer in product classification and pre-market strategy
Regularly counsel physician practices and hospitals in professional service arrangements, medical directorships and employment agreements
Regularly counsel covered entities and business associates in health information privacy and breach risk assessments and reporting
Provide counsel to healthcare providers and suppliers in federal and state fraud and abuse matters
Counsel to hospital and health system in clinical research contracting matters and Institutional Review Board operations
Counsel to medical device manufacturer in Open Payments (“Sunshine”) Act reporting
Regularly advise on compliance with the federal Stark Law and Anti-Kickback Statute and corresponding state fraud and abuse laws
Professional Involvement
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American Health Lawyers Association
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State Bar of Michigan – Health Care Law Section
Community Involvement
- Current Member, Board of Directors, Community Healing Centers
- Current Member, Covenant Medical Center Institutional Review Board
- Adjunct Professor, Western Michigan University Homer Stryker, M.D. School of Medicine
- Co-Chair of Player Services, USTA Boys 18s and 16s National Championships
- Past Member, Board of Directors, Big Brothers Big Sisters – A Community of Caring
- Past Member, Board of Directors, Kalamazoo Institute of Arts
- Past Member, Community Research Institutional Review Board
Publications/Presentations
- Author, "Keep the End in Sight: Expiration of the COVID-19 Declared Emergencies," Healthcare Michigan, March 2023
- Presenter, "Wait, Wait...Don't Sell Me! FDA and Other Pre-Market Considerations for Commercial Products," Dickinson Wright Annual Health Law Summit, November 2021
- Co-Author, "Wait, Wait...Don't Sell Me! FDA and Other Pre-Market Considerations for Commercial Products," Dickinson Wright Health Law Blog, November 2021
- Author, “Legal Leanings: FDA Authorization of COVID Vaccines- What Does it Mean?,“ Healthcare Michigan, March 2021
- Author, “FDA Takes Steps to Address Critical Shortage of Personal Protective Equipment”, Dickinson Wright Client Alert, March 2020
- Author, “Keeping Pace in Clinical Research: The Common Rule Picks Up Speed,” Healthcare Michigan, July 2017
- "Physician Peer Review: Ensuring Immunity, Confidentiality and Compliance," (Co-Presenter) Strafford Webinar, June 17, 2015
- "Are You HIPAA-notized Yet?," (Presenter) Dickinson Wright Healthcare Seminar, Detroit & Grand Rapids, Michigan, September 2014
- "E-Discovery – Strategies and Ethical Considerations for Protecting Privileged and Patient Health Information," (Co- Presenter) ICLE's 20th Annual Health Law Institute, Plymouth, Michigan, March 6-7, 2014
- "Is Your Information Protected? Compliance & Regulations for Sensitive Data," Webinar, Crain's Detroit Business, October 2, 2012
- "Health Reform Amendment Raises Ambiguities for Stark Law Compliance," (Co-author), MD News West Michigan, May/June 2010
- "Is Your Data Safe?," (Panelist), Data Privacy and Security Briefing, Applied Security US Incorporated, Grand Rapids, Michigan, August 25, 2009
- "FTC Red Flags Rule: Are You in Compliance?," MD News West Michigan, May/June 2009
- "Institutional Review Boards: Bureaucratic Roadblock or Knowledgeable Resource," MD News West Michigan, January/February 2009