Amy S. Leopard is a partner in Walter & Haverfield's Technology, Bioscience and Healthcare Industry group and a member of our Management Committee.  As a former executive, Amy is a valued business advisor in corporate and transactional matters involving health care and intellectual property.  She has in-depth knowledge from over twenty years in the health care industry as vice president in both academic medical center and community hospital settings and an internship in the U.S. Department of Justice Antitrust Division.

Areas Of Emphasis

As the Director of Health Care Regulatory Compliance, Amy spearheads our compliance practice.   Amy focuses on advising clients on complex health care industry strategic, reimbursement and transactional matters.  Amy handles a variety of transactional issues including structuring strategic alliances and restructuring ventures and advising enterprises on corporate compliance.  She provides trusted counsel to health care providers, entrepreneurs, and service providers on licensing, payment, privacy and technology issues, structuring business transactions and negotiating licenses, supplier contracts, distribution agreements, leases, group purchasing and other commercial contract negotiations. 

Amy has a special interest in technology development and licensing and privacy and security issues.  Amy leads the AHLA Telemedicine group for Health Information Technology. She was recently appointed to the Certification Commission for Health Information Technology (CCHIT) Network Certification Group to develop standards for health information exchanges.  She is a frequent speaker and writer to industry executives, lawyers and medical associations on healthcare and information technology issues, both locally and nationally.  She also teaches advanced courses in the law of health care organizations and transactions as an Adjunct Professor at the Case Western Reserve Law School, where she was editor-in-chief of Health Matrix: Journal of Law-Medicine and worked on NIH grant projects.  Amy has been selected by her peers for inclusion in the Best Lawyers in America. 

Her experience includes:

• Counseling physicians, ancillary service providers, entrepreneurs and facilities on state and federal licensing, payment, privacy and technology issues
  
• Drafting and negotiating pharma and device supplier contracts, distribution agreements, software licensing technology, leasing, group purchasing and other commercial contract negotiations.
  
• Analyzing legal and regulatory issues associated with uses and disclosures of health information
  
• Structuring strategic alliances and business transactions to avoid fraud and abuse and self-referral landmines
  
• Developing corporate compliance plans for billing, HIPPA privacy and security, antitrust and regulatory requirements
  
• Defending clients in OIG and FDA investigations, both civil and criminal
  
• Representing providers in numerous Medicare coverage and payment appeals before hearing officers and administrative law judges

Professional & Community Associations

• American Bar Association - Health Care and Intellectual Property Sections
  
  
• American Health Lawyers Association – Health IT Practice Group, Leader, Telemedicine Affinity Group, RHIO and EHR Toolkit, Speaker
  
  
• Cleveland Bar Association - Secretary and Executive Council, Women in the Law Section and Former member Health Law Council, 1999 - 2003
  
  
• Alcohol and Drug Addiction Services Board of Cuyahoga County - Trustee, Executive Committee, Vice Chair, Operations Committee
  
  
• Village Foundation
  
  
• Case Western Reserve University Law-Medicine Center - Professional Advisory Committee
  
  
• Ohio Health Information Security and Privacy Collaboration (HISPC) Legal Working Group
  
  
• WEDI-SNIP Provider Education Sub Workgroup on HIPAA
  
  
• West Virginia Bar Association

Awards & Recognition

• Amy was recently named to the “Network Certification Work Group” formed by the Certification Commission for Health Information Technology (CCHIT), an independent, non-profit, federally-recognized certification body that seeks to develop standards for health information exchanges.
  
  
• AV rated by Martindale-Hubbell
  
  
• Listed in "Best Lawyers in America " . Health Care Law, 2006 through 2008
  
  
• Chair, Health Care Law Committee, Ohio State Bar Association 2002-2004
  
  
• Ohio State Bar Foundation - Fellow, Class of 2003

Recent Presentations  

• “Electronic Health Records and Technology Issues,” Academy of Medicine of Cleveland and Northern Ohio (AMCNO), April 2 & April 9, 2008.
  
  
•  “Hospital/Physician Alignment Trends and Strategies,” Ohio Hospital Association 2007 Fall Conference and Annual Meeting, September 28, 2007
  
  
• National Employee Benefits Web Summit, "Tools and Technology Track: What Electronic Health Records (EHRs) Mean to Employers", June 20, 2007
  
  
• “Healthcare and Information Technology: Policy, Legal and Strategic Issues in Northeast Ohio,” Cleveland Bar Association, Health Law Institute, May 4, 2007
  
  
• “Compliance Update,"  Cleveland Clinic Health System, Physician Organization Board meeting, May 3, 2007
  
  
• “Competitive Bidding,"  Medtrade Spring, Las Vegas, NV April 26, 2007 (with Bob Crump)
  
  
• “Privacy and Legal Issues, Update on Health IT Laws and Regulations,” Academy of Medicine of Cleveland and Northern Ohio, March 9, 2007
  
  
• “Intellectual Property Primer for Physicians,” 47th Annual Meeting of American College of Legal Medicine, Orlando, March 4, 2007
  
  
• “Data Issues in Health Information Exchange,” Lexwork teleconference, February 6, 2007
  
  
• “The Entrepreneurial MD: Healthcare and Intellectual Property Considerations for Physician Entrepreneurs,” Oakstone Medical Publishing teleconference, December 6, 2006
  

• “HIPAA Medical Privacy and Security: An In-Depth Exploration of Internal Enforcement,” American Health Lawyers Association teleconference, May 18, 2006

• “Effective Assistance of Counsel: What Criminal & Health Care Lawyers Need to Know,” Cleveland Bar Association, April 6, 2006

• “Regulatory Issues in Distribution Agreements,” Medtrade Fall 2005 Meeting, Atlanta

• “Physician Contracting: Legal and Regulatory Issues,” American College of Legal Medicine 2005 Annual Meeting, San Diego

• “The HIPAA Privacy Rule,” Cuyahoga County Bar Association, 2005

• “Recruiting, Retaining, and Compensating Physicians and Executives:  Trends, Legal Issues and Strategies,” AHLA 2004 Annual Meeting, New York City

• “HIPAA in a Nutshell:  The Security Rule,” National Business Institute, 2004

• “Managing Conflicts of Interest between Physicians and Industry,” Cleveland Clinic Health System, Fairview Hospital Surgery, 2002

•  “Medicare Appeals,” AHLA 2002 Physician Organizations Law Institute, New Orleans

Recent Publications 

• “Personal Health Records:  Legal, Business and Contractual Issues for Employers” (AHLA HMOs and Health Plans newsletter), Spring/Summer 2007
  
  
• “Technology Donations to Physicians:  New Health IT Rules in Play,” (Northern Ohio Physician, November/December, 2006)
  

• Coauthored three chapters on Healthcare Compliance Guidance for Matthew Bender Health Care Compliance Manual, 2001 and 2004
  

• “Stark II Rules Break Out of the Gate,” Cleveland Physician, July, 2004 and  “Final Stark II Rules: New Opportunities and Challenges,” Cleveland Physician, July, 2001

• “The Medicare Modernization Act of 2003,” authored sections on Medicare regulatory reforms, audits, appeals and coverage determinations for AHLA Member Briefing, 2004

•  “New Exceptions for Academic Medical Centers Under the Final Stark II Rules,” AHLA Physician Organizations, Spring 2001

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