501 Boylston Street, 10th Floor

Boston, MA 02116



Amy Lewis

Amy Lewis outsourced business lawyer

Senior Counsel
Email: amy@outsidegc.com

With over twenty years’ experience in life sciences and health care, Amy brings extensive knowledge spanning all facets of the industry including pharmaceuticals, medical device, hospitals and health systems, physician practices, clinical research, privacy, compliance, and academia.

Amy has held positions in a variety of settings including large law firms, startups, Fortune 500 companies and a major public university. These include University of South Florida (USF) Health (including the medical, nursing, physical therapy, and pharmacy schools as well as residency and fellowship programs and the USF Physicians Group), TAP Pharmaceuticals (a former joint venture of Abbott and Takeda), and Buchanan Ingersoll PC (now Buchanan, Ingersoll, and Rooney).

As a strategic business partner, Amy offers strong regulatory and commercial experience. Amy collaborates with her clients in her areas of focus including the following:

  • FDA and FTC regulatory compliance-including advertising and promotion
  • Health care fraud and abuse
  • Clinical research/clinical trials
  • Privacy and HIPAA
  • Ethics and Compliance
  • Contracts, including numerous types of physician agreements, vendor agreements and clinical research agreements
  • Policies, handbooks, and training
  • Disciplinary matters
  • Graduate Medical Education
  • Pharmaceuticals and Medical Device, including:
    • PhRMA , Sunshine and AdvaMed compliance, AdProm review, R&D, Medical Affairs, Public Affairs, Quality, Compliance, Regulatory, Sales and Marketing, Educational and Scientific Activities, relationships with health care providers, payors, distributors and manufacturers.

She has overseen the successful FDA audit and follow-up for a startup medical device company, as well as managing the legal ethics and compliance obligations for a pharmaceutical company subject to a US Department of Justice Corporate Integrity Agreement.

In addition, as an adoptive parent of three daughters from China, Amy spent five years working in the field of international adoption, counseling adoptive families and service providers in the COA accreditation process, domestic finalization of international adoptions, Hague Convention on International Adoption, and regulatory compliance with USCIS and US Department of State immigration requirements.

She began her legal career with Buchanan Ingersoll PC (now Buchanan, Ingersoll, and Rooney) as a Health Care Associate representing hospitals, skilled nursing facilities and physician practices in all facets of their businesses and as part of the health care mergers and acquisitions team.

Amy is a member of the state bars of Florida and Illinois

Amy graduated with honors from Stetson University College of Law while working as a Licensed Clinical Social Worker at Tampa General Hospital. She holds both a Bachelor’s and Master’s degree from the University of Michigan.

Amy enjoys good food (cooking as well as eating), great travel (including an annual multi-generational trip with her mother and daughters) and boating, fishing, paddle boarding and enjoying her life in Florida with her family.