Sheva can help you find innovative solutions to complex regulatory problems.
With more than 30 years of experience advising health care and life sciences companies, Sheva brings tremendous experience and knowledge to advising on complex regulatory issues faced by her clients, and provides deep subject matter knowledge and experience for complex transactions, investigations and litigation.
Known as a thought leader in the health care and life sciences industries, Sheva is deeply committed to providing timely, comprehensive advice to her clients. She counsels health care, managed care, medical device, pharmaceutical, life sciences and PBM clients on regulatory matters, including fraud and abuse, compliance and reimbursement, and helps her clients bring innovative offerings to market.
Sheva served Medtronic, a global leader in medical technology, as principal senior legal counsel for health care-related regulatory and compliance issues.
She advises device, pharmaceutical, PBM and managed care companies and providers, on complex regulatory compliance, fraud and abuse, and other matters.
Sheva represents clients in resolving matters with CMS, FDA and various state agencies, conducts internal investigations and helps establish and implement compliance programs.
A frequent teacher, speaker and writer on topics related to health law and health policy, Sheva has been a member of the Minneapolis Children's Hospital Bioethics Committee, and the University of Minnesota Advisory Board for the Joint Degree in Law, Science & Technology, and has been an adjunct professor at both William Mitchell College of Law and Hamline University School of Law. She teaches health care regulation at both the University of Minnesota and Northwestern University School of Law.
Sheva was named a 2003 AdvaMed Achiever for her role in drafting the AdvaMed Code of Ethics. Sheva is chair of the firm's Life Sciences and Health Law Industry group.
News & Insights
- In the News04.01.2021
- In the News01.06.2021
- Press Release12.15.2017
- Press Release07.31.2017
"Health Apps and the FTC’s Health Breach Notification Rule," mylawCLE, January 2022
"Buyer Beware: Strategic, Regulatory Due Diligence for Buyers (& Sellers)," Stinson's Life Sciences Law Update, May 2021
Co-Presented, "Intersection between HIPAA & Privacy Laws," Stinson's Life Sciences Law Update, May 2021
"Exploring Value-Based Arrangements and a Discussion of FCA Post-Allina," Recent Developments in Health Care and Life Sciences Law Seminar, Stinson, 2019
Co-presenter, "FDA Digital Health Updates," The Digital Health Business Series, Stinson Leonard Street, 2018
"Spotlight on Mergers & Acquisitions - Onboarding New Employees; Auditing the New Data and Determining Reporting Obligations," ACI's 7th Advanced Forum, Chicago, 2015
Co-presenter, MSBA FDA Forum, 2015
"New Healthcare Boilerplate in Med Device/Pharma Contracting," Minnesota CLE Health Law Institute, Minneapolis, 2015
"New FDA Guidance on Low Risk and General Wellness Products," MobCon Digital Health, Minneapolis, 2015
"Sunshine Act, Open Payments, and Aggregate Spent Compliance," ACI Conference New York, 2014
"Advisors to Physicians and Daily Dilemma of Promotion Practices," Health Law Institute Sunshine, 2014
"The Challenges of Creating Effective Content Strategies in an Increasingly Regulated Healthcare Space," American Marketing Association, Minneapolis, 2014
Sunshine Act Compliance & Aggregate Spend Reporting "The Dispute Resolution Process: Managing Alleged Inaccuracies with Reported Spend and Preserving Strong CP Relationships", ACI Conference, New York, 2013
"Reducing Legal Risks in the Sales and Marketing of Medical Devices," 13th National Summit, Chicago, 2013
"A Proactive and Targeted Approach to Billing Audits," Compliance Today, January 2021
Professional & Civic Activities
Professional & Civic Activities
Kaleido Health Solutions, Director & Chair of the Compliance Committee
American Health Lawyers Association
Minnesota State Bar Association
Practices & Industries
- U.S. District Court for the District of Minnesota
Northwestern University School of Law, J.D., cum laude, 1984
- Order of the Coif
George Washington University, B.A., Political Science, with distinction, 1980