Josh Arkulary
Associate Attorney
O: 651.430.7150
M: 651.364.6377
Josh Arkulary counsels FDA-regulated companies, healthcare organizations, and digital health companies on privacy, data protection, and regulatory compliance matters. With more than a decade of experience advising on HIPAA, FDA, and global privacy requirements, he offers practical guidance grounded in both in-house and operational experience.
Before joining Gardner Law, he served as an attorney consultant at Regeneron Pharmaceuticals, where he supported global clinical research activities across more than 30 countries. His earlier roles within hospital systems and research foundations involved direct engagement with investigators, clinical operations teams, and compliance personnel, giving him firsthand insight into how regulatory obligations function in practice.
Josh assists clients in designing and operationalizing privacy, AI, and data governance programs that harmonize HIPAA, FDA, state privacy and AI laws, and global data protection frameworks with business and research objectives. His work spans drafting privacy policies, reviewing and negotiating a variety of commercial and research agreements, conducting gap assessments, and advising on program improvements to support digital health and data‑driven operations.
Clients also regularly involve Josh in matters related to navigating the regulatory and legal requirements involved in conducting clinical trials, including consent forms, clinical trial agreements, ethics committee reviews, audit readiness, and documentation practices.
Josh has a particular interest in the intersection of privacy, emerging technologies, and healthcare, including the regulatory implications of artificial intelligence and cybersecurity. He brings a measured, experience-based perspective that reflects both regulatory expectations and the day-to-day realities of regulated organizations.
Focus Areas
- Privacy, data protection, and AI governance for life sciences and healthcare companies
- HIPAA, state-specific privacy laws, and global data protection frameworks, including GDPR
- FDA regulatory compliance related to clinical research and regulated products
- Structuring data protection obligations in commercial, technology, and clinical contracts
- Data collection and tracking privacy issues affecting digital health tools and websites
Representative Experience
- Advising pharmaceutical, medical device, and healthcare companies on federal, state-specific, and global privacy compliance obligations
- Drafting and negotiating business associate agreements, data processing agreements, standard contractual clauses, and multifaceted data governance provisions
- Providing strategic advice on web and mobile privacy obligations, covering tracking tools, consent mechanisms, and enforcement risk
- Supporting privacy and regulatory considerations throughout the clinical trial lifecycle, including drafting and negotiating clinical trial agreement and consent forms
- Responding to regulatory authority and ethics committee inquiries related to data protection and clinical research
Differentiators
- More than ten years of experience working inside FDA regulated research and healthcare environments
- Prior in-house role supporting global clinical research operations across more than 30 countries
- Deep familiarity with how regulatory requirements affects real world clinical and operational decision making
- Experience serving as a final escalation point for high risk regulatory and privacy issues
Thought Leadership, Teaching, & Ventures
- Former Adjunct Professor of Law, Mitchell Hamline College of Law
Education
- J.D., Law, William Mitchell College of Law
- B.A., Sociology, Northern State University
Admissions & Affiliations
- Minnesota State Bar
- Colorado State Bar
- International Association of Privacy Professionals
Personal
Josh’s interest in law began in a college mock trial course, where he later captained his university team. Outside of work, he enjoys staying active, coaching youth sports, and spending time with his wife and two young sons. He remains an ever-hopeful Minnesota sports fan.