Heather Potter, J.D., CIPP/E, Associate Attorney

hpotter@gardner.law
+1 (651) 430-2729  office
+1 (920) 723-9986  mobile

Heather Potter focuses on helping clients mitigate legal risks associated with manufacturer commercial functions, implementing compliance and privacy programs, and preparing legal opinions on various topics.  Prior to practicing at Gardner Law, she worked in Regulatory Affairs at Medtronic, Inc.  Heather is an Adjunct Professor at Mitchell Hamline School of Law where she teaches Health Law and Drug and Device law. She is also a council member on the Minnesota State Bar Association – Food, Drug, and Device section.

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CLIENT AD/PROMO REVIEW BOARDS

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COUNTRIES VISITED

As a recipient of an implantable device, and with a spouse who relies on the use of a biologic drug, my role as a counselor and educator is founded on a patient perspective. Working with clients in the medical technology industry allows me to use this perspective to provide effective counsel to clients with a shared goal of helping patients live better lives.
– Heather Potter, J.D., CIPP/E

Practice areas:

  • Advertising and promotional review
  • Privacy (HIPAA, HITECH, GDPR*, CCPA*, et al.)
  • Business interactions with health care professionals
  • Design and implementation of compliance and privacy programs
  • Regulatory assessments, opinions and submissions
  • Transparency reporting

*Ms. Potter is not licensed to provide legal advice on Californian or European law.

Prior to joining Gardner Law, Heather worked in Regulatory Affairs at Medtronic, Inc.

She also interned at Ecolab, CryoLife, and Universal Hospital Services where her work focused on compliance, regulatory, and legal matters.

  • Heather teaches Drug and Device law as well as an Undergraduate Health Law as an Adjunct Professor at Mitchell Hamline School of Law.
  • She serves on the Minnesota State Bar Association Food, Drug, and Device Section Council.

  • Heather has spoken at CLE events regarding recent updates in FDA enforcement action, social media use, privacy law updates, and other topics.
  • She has co-published an article in the Journal of Clinical Ethics.  (Thaddeus M. Pope & Heather M. Bughman, Legal Briefing:  Coerced Treatment and Involuntary Confinement for Contagious Disease, 26 J. CLIN. ETHICS 73-83 (Spring 2015)).

  • Juris Doctor: Mitchell Hamline School of Law (St. Paul, Minnesota), Cum Laude and Health Law Institute Honors. (Health Law Certificate and a Health Care Compliance Certificate).
  • Bachelor of Science—Corporate and Health Communications: University of Wisconsin-Whitewater (Whitewater, Wisconsin).

  • Minnesota State Bar Association

  • Minnesota
  • As a Certified Information Privacy Professional/Europe (CIPP/E), Heather is able to provide comprehensive GDPR knowledge, perspective and understanding to help clients ensure compliance and data protection success in Europe

Heather counsels pharmaceutical and medical technology companies of all sizes on various matters including:

  • Acting as the “Legal” function in the Clinical/Medical, Legal, and Regulatory review process for medical device, pharmaceutical, and combination product manufacturers.
  • Designing and developing privacy programs.
  • Performing privacy audits.
  • Performing compliance training for sales forces, management teams, and physician consultants of pharmaceutical and medical device companies of all sizes.
  • Drafting and implementing custom compliance policies for pharmaceutical and medical device manufacturers.
  • Walking pharmaceutical, medical device, and diagnostic manufacturers (domestic and foreign) through the Open Payments (Physician Payments Sunshine Act) reporting process from tracking and compiling to reporting out.
  • Drafting regulatory assessments regarding the compliance of promotional programs with FDA and FTC regulations, the Anti-Kickback Statute, False Claims Act, Stark Law, Sunshine Act, HIPAA, the Foreign Corrupt Practices Act, and other laws.
  • Reviewing and drafting various agreements for regulatory compliance.
  • Evaluating grants by serving as outside counsel for a Grants and Contributions Committee for various manufacturers.
  • Establishing lawful Medical or Clinical Affairs-directed off-label dissemination policies and procedures for pharmaceutical and medical device manufacturers.
  • Evaluating reimbursement tools and messaging for various manufacturers.
  • Performing annual FDA-directed “Expert Reviews” for dietary supplement manufacturers as required by respective Consent Decrees.
  • Drafting regulatory assessments for HCT/P manufacturers to determine whether their products are exempt from premarket review.
  • Supporting device manufacturers with pre- and post- market regulatory requirements, including pre-submissions, 510(k) submissions, CE Mark renewals, 30-day notices, change control, audit (ISO 13485 and MDSAP) CAPA support, and QMS audit and remediation.