Healthcare Attorney  ·  AI Governance Professional

Eleni Katsoulis

JD  ·  AIGP

Solutions-oriented attorney with 15+ years translating legal and regulatory complexity into clear, actionable strategy — and a pioneering voice in AI governance for the healthcare industry.

15+ Years Experience
78% AI Adoption Lift
450+ Pro Bono Families
Eleni Katsoulis, JD, AIGP

Strategic. Approachable.
Forward-Thinking.

With over 15 years at the intersection of law, regulation, and strategy, I’ve built a career on a simple premise: the most complex problems require the clearest paths forward. My practice spans pharmaceutical regulatory affairs, high-stakes litigation, and AI governance, but my true value lies in bridging the gap between scientists, executives, and regulators to turn legal hurdles into strategic advantages.

I thrive in the “unprecedented.” From defending organizations before federal agencies to guiding novel product launches, I don’t just offer legal advice; I help leaders make better decisions under pressure.

A pioneer in the emerging legal tech landscape, I hold the AIGP (Certified AI Governance Professional) designation and specialize in building responsible AI frameworks that empower innovation. I have designed enterprise-wide AI risk frameworks and led upskilling programs that drove a 78% increase in AI adoption, ensuring organizations can scale responsibly in highly regulated spaces.

I believe that legal expertise should be matched by social responsibility. As a founding director of the Hel.LAS Legal Clinic, the first pro bono clinic of its kind in North America, I’ve turned my passion for advocacy into a platform that has served nearly 500 families. For me, the law is most powerful when it is used to solve problems, whether for a global corporation or a single family in need.

Areas of Expertise

Pharmaceutical Regulatory & Compliance

FDA promotional and labeling review, regulatory strategy, and lifecycle compliance for drug and biologic products.

AI Governance & Strategy

Enterprise AI risk frameworks, upskilling programs, and responsible deployment of AI tools in regulated industries.

Healthcare Litigation & Investigations

Complex litigation management, internal investigations, and government agency defense across state and federal venues.

Medical Affairs & HEOR

Legal support for medical affairs, health economics, and outcomes research within large health systems and pharma.

Healthcare System Counsel

Enterprise-wide risk strategy, policy development, and cross-functional collaboration for complex health organizations.

Social Media & Brand Integrity

Legal risk analysis of emerging platforms, influencer compliance, and brand protection in the digital landscape.

AI

A Pioneer in Legal AI Strategy

I hold the Certified AI Governance Professional (AIGP) designation from the IAPP. As an early adopter of this credential, I utilized it to formalize the work I was already leading: building enterprise AI risk frameworks, advising on responsible tool deployment, and upskilling legal teams to engage with AI with confidence rather than fear.

I speak frequently before business and legal audiences on these topics. Most recently, I presented at the ACI AI Conference on Building Cohesive AI Governance, where I contributed expertise on legal, compliance, and technology considerations for FDA and EU regulatory readiness.

I do not just advise on AI. I have supported the development of dozens of AI tools, built the playbooks, led the training programs, and sat in the rooms where the hard calls get made.

78% AI Adoption Lift
Dozens AI Tools Supported
#1 AIGP Certified

Certification

Certified AI Governance Professional (AIGP)

International Association of Privacy Professionals (IAPP) — Issued January 2026. One of the first attorneys in the country to earn this designation.

Speaking

ACI Conference: Building Cohesive AI Governance

Featured speaker contributing expertise in legal, compliance, and technology for FDA and EU regulatory readiness — February 2025.

Enterprise Initiative

AI Risk Assessment Playbook for Brand Legal

Developed a first-of-its-kind AI risk assessment playbook and led an enterprise-wide upskilling program that achieved a 78% increase in team AI adoption.

Tool Deployment

AI Tool Advisory & Governance

Assisted in building out dozens of AI tools across complex regulated environments, advising on design, deployment, and risk governance to establish scalable organizational standards.

Awards & Honors

2026

LCLD Leadership Fellows Program

Selected for the 2026 cohort of the Leadership Council on Legal Diversity Fellows Program.

2025

St. Dionysios Areopagites Distinguished Service Award

Hellenic Bar Association — for extraordinary legal service and dedication to expanding access to justice.

Read More ↗
2025

Presidential Award Nominee & Therapeutic Business Unit Award

First-in-class product launch recognition.

2023

HBA Foundation Rising Star Award

Hellenic Bar Association Foundation — in recognition of outstanding legal service and community leadership.

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2023

Chicago Lawyer Forty Under 40

Law Bulletin Media — named one of the 40 Illinois Attorneys to Watch.

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2022

Hellenic Bar Association President

Youngest president in the organization’s history. Raised $60,000+ in scholarships and led a mentorship program for young attorneys.

Peer Recognition

What Colleagues Say

“Eleni is hard-working, energetic and compassionate. She works well with plaintiffs’ counsel and patients to ensure the most equitable result. Unwaveringly professional and thoughtful, while at all times maintaining her upbeat personality and generosity.”

Elizabeth BruerAttorney, Swanson, Martin & Bell

“Eleni has an exceptional ability to analyze complex cases and confidently make a determination as to whether the matter should proceed to resolution or whether the remedies of the judicial process should be sought.”

Georgia DemerosAttorney, Thompson Coburn LLP

“Eleni has had the courage to take on a wide array of pro bono cases. She was instrumental in assisting a family to obtain the necessary visas to travel from Greece to Chicago so that their critically ill son could receive essential medical care that saved his life.”

Eleni KouimelisAttorney, Winston & Strawn LLP

As quoted in Chicago Lawyer & Chicago Daily Law Bulletin, 40 Under Forty 2023 ↗

Insights & Analysis

View All Posts
AI Governance

Building a Legal AI Risk Playbook That Actually Gets Used

Lessons from leading an enterprise-wide AI upskilling initiative — and why adoption, not awareness, is the metric that matters most.

March 2025Read More →
Pharma Regulatory

Navigating Novel Product Launches: When Creative Legal Thinking Makes the Difference

How creative legal thinking and deep cross-functional collaboration can unlock seemingly impossible product launches in a heavily regulated environment.

January 2026Read More →
Healthcare Compliance

Social Media, Pharma, and the Emerging Platform Problem

Why legal teams can’t afford to treat TikTok, Threads, and LinkedIn the same way — and how to build a framework that keeps up.

November 2025Read More →

Ready to Talk?

If you’re navigating a complex legal matter, building an AI governance strategy, or looking for a speaker who has actually done this work, let’s talk.

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