Yoon advises medical device, digital health, and other healthcare technology companies on complex commercial transactions, regulatory and compliance matters, and legal issues arising as they develop and commercialize products, enter new markets, and grow. With more than 25 years of experience—including over a decade as General Counsel to global medical device and healthcare technology companies—she brings an in-house perspective and a practical understanding of the interconnected regulatory, commercial, compliance, data, and operational considerations that shape business decisions.

Commercial Transactions

Yoon structures and negotiates transactions supporting product development, commercialization, and growth, including IP licensing and joint development arrangements; data and research collaborations; OEM, manufacturing, and supply arrangements; MSAs and SaaS agreements with health systems, IDNs, GPOs, and other healthcare organizations; DME distribution agreements; and other commercial relationships.

Healthcare Compliance

Yoon counsels medical device, digital health, and consumer health companies on commercial practices involving healthcare professionals, institutions, and patients, including pricing and discounts; product evaluations and demonstrations; free goods and services; healthcare professional engagements; grants and sponsorships; training; and patient-support programs. She helps clients navigate the federal Anti-Kickback Statute, the beneficiary-inducement provisions of the Civil Monetary Penalties Law, the False Claims Act, healthcare transparency requirements, and related federal and state healthcare fraud and abuse laws.

Privacy, Cybersecurity & AI Governance

Yoon helps medical device and health technology companies collect, use, share, and protect health and other sensitive information to support product development, commercialization, operations, analytics, research, and other business objectives. She advises on HIPAA and HITECH, including covered-entity and business-associate requirements, permitted uses and disclosures, de-identification, and HIPAA Security Rule compliance; GDPR, including lawful bases for processing, special-category health data, data-subject rights, processor arrangements, and cross-border data transfers; state consumer health privacy laws; and FTC requirements governing consumer health data. Her work includes privacy and cybersecurity governance and risk management, data-use and sharing arrangements, business associate agreements, and vendor, technology, and other commercial contracts.

Yoon also advises companies that develop, deploy, procure, or provide AI-enabled healthcare products and services. She counsels clients on applicable legal requirements and practical AI governance addressing data use, risk assessment, validation, human oversight, transparency, documentation, and ongoing monitoring. She drafts and negotiates AI terms for customers and vendors, helping customers protect data, intellectual property, confidentiality, and rights in AI inputs and outputs, while helping vendors allocate risk appropriately and preserve the flexibility needed to operate and improve their businesses.

FDA Regulatory Strategy

Yoon advises medical device and health technology companies on FDA regulatory strategy and product communications. She helps clients determine whether products and software functions are regulated as medical devices, fall within statutory exclusions, or are subject to FDA enforcement-discretion policies. She evaluates intended use, functionality, users, clinical context, data inputs and outputs, labeling, and promotional claims, and assesses how new or modified features, including AI-enabled functionality, may affect regulatory status, classification, premarket pathways, and post-market obligations. She also counsels clients on claims, promotional materials, sales practices, and other product communications to align with applicable FDA labeling and promotional requirements and the product’s legally marketed use, as well as FTC advertising and claim-substantiation requirements.

Selected Experience

• Served for more than a decade as General Counsel of global medical device and healthcare technology companies and held executive roles as Chief Compliance Officer and Chief Administrative Officer. Advised boards and senior leaders and worked with product, commercial, regulatory, quality, and operations teams on commercialization, complex transactions, healthcare compliance, privacy and cybersecurity, corporate governance, and enterprise risk.

• Advised an AI-enabled point-of-care ultrasound company through product development, launch, commercialization, and rapid growth, including AI and data governance, technology development and licensing, manufacturing and supply, health system and channel relationships, and academic research collaborations. 

• Advised medical device businesses spanning capital equipment, durable medical equipment, AI-enabled diagnostic technology, industrial oxygen-generation systems, and direct-to-consumer products, addressing the distinct regulatory, reimbursement, commercial, customer, and operational considerations of each business model. 

• Structured and negotiated equipment sale and SaaS agreements with health systems, IDNs, and GPOs, as well as global manufacturing and supply arrangements, distribution and reseller agreements, licensing and joint development arrangements, and other commercial collaborations. 

• Advised an engineered-to-order industrial oxygen-generation business on global equipment and supply transactions, including EPC-style projects, risk allocation, and technical and commercial disputes. 

• Developed compliance strategies addressing healthcare fraud and abuse, corporate compliance, anti-corruption, trade, and export requirements, privacy, cybersecurity, third-party risk, and other legal and regulatory requirements affecting global medical device and health tech operations. 

• Advised senior leadership on privacy and information-security governance and directed the legal response to a significant cybersecurity incident, coordinating legal, technical, operational, and business considerations. 

• Led legal work on a $170 million acquisition, including due diligence, negotiation, and post-acquisition integration. 

• Led legal work on more than $160 million in equity and debt financings for a private-equity-backed healthcare technology company and advised on investor relations and corporate governance. 

Earlier in her career, Yoon practiced corporate law at Proskauer Rose in New York and at Milbank and Allen & Overy in Hong Kong, working on cross-border M&A, private equity, financings, distressed debt, and capital markets transactions for Fortune Global 500 and Fortune 500 companies. 

CREDNTIALS

Education. 

• Brooklyn Law School, J.D. — Dean’s Merit Scholar; Journal of Law & Policy; CALI Excellence for the Future Award; Fellowship, Center for the Study of International Business Law. 

• Barnard College, Columbia University, B.A. 

Admissions.

• Georgia

• New York

• Washington

• Oregon

Certifications

• Artificial Intelligence Governance Professional (AIGP), International Association of Privacy Professionals

• Certified CSF Practitioner (CCSFP), HITRUST

Prior Positions.

• CAIRE Inc., General Counsel & Chief Compliance Officer; Chief Administrative Officer

• EchoNous, Inc., General Counsel & Corporate Secretary

• Catalyst Law, Founder

• Rose Law Firm, Of Counsel

• Solomon International, Founder

• IQPC, General Counsel

• Allen & Overy LLP (HK), Associate, Corporate

• Milbank, Tweed, Hadley & McCloy LLP (HK), Associate, Global Corporate Finance

• Proskauer Rose LLP (NY), Associate, Corporate

COMMUNITY

• Volunteer, Court Appointed Special Advocates for Children 

• Member, Zen Hospice Project