Nicholas J. Diamond
Nicholas “Nick” Diamond is a regulatory lawyer with extensive, international experience counseling clients across the health sector, including life sciences companies, medical device companies, technology companies, retail pharmacies, medical distributors, industry trade organizations, and nonprofits. He maintains a global practice focused on regulatory, public policy, and ethics issues impacting the U.S., the Asia-Pacific region (APAC), Latin America, the European Union (EU), and the Middle East.
Clients value Nick’s comprehensive, business-focused approach to identifying and responding to regulatory risks and opportunities around the world.
Nick provides strategic counsel to life sciences companies throughout the product life cycle in the U.S. and internationally. He has experience in regulatory compliance, market access, and reimbursement matters across therapeutic areas and in public and private healthcare payment systems. He has supported clients in navigating pre-approval regulatory activities, preparing for and executing product launches in multiple markets, and counseling cross-functional teams on regulatory issues impacting access post-launch. Clients particularly seek his guidance on novel issues for pipeline products and value his long-term strategic approach to market shaping.
Nick is internationally recognized for his experience in vaccine law and public policy. He has extensive experience counseling vaccine manufacturers in the U.S., APAC, Latin America, and the EU on regulatory, public policy, government procurement and financing, liability and compensation, intellectual property, and international trade matters. He has counseled several vaccine manufacturers on highly significant product launches in recent years. He has also counseled other entities, such as healthcare payers and providers, including retail pharmacies, on vaccine-related matters involving coverage and reimbursement, contracting, scope of practice, liability, and public health emergency measures.
Nick’s experience in digital health regulatory matters spans various technologies and platforms, including telemedicine, remote patient monitoring, clinical decision support, and software-as-a-medical-device (SaMD). He has advised on U.S. federal and international matters relating to regulatory submissions, compliance, enforcement, and reimbursement. He has experience counseling medical device and technology companies on software products that are regulated as devices by the U.S. Food and Drug Administration (FDA) or equivalent regulators in other countries. In this regard, he has particular experience with artificial intelligence (AI)-enabled products, such as AI-enabled SaMD. He has also counseled biopharmaceutical and medical device companies on the use of real-world data for both regulatory approval and reimbursement determinations, as well as the use of digital health technologies in the clinical trials process, including for decentralized clinical trials.
Nick also handles corporate governance and compliance matters relating to both bioethics and human rights. He has unique experience counseling life sciences and technology companies on the development of their bioethics programs, with specific experience on issues ranging from AI to gene therapy. He is internationally recognized for his thought leadership on business and human rights issues in the context of national and international laws, international trade and investment agreements, and major international guidelines, such as the U.N. Guiding Principles on Business and Human Rights. In fact, global organizations have sought Nick’s counsel on supply chain-related human rights compliance matters, including modern slavery, under multiple evolving legal regimes.
Outside of his global healthcare regulatory practice, Nick serves as an adjunct professor of law at the Georgetown University Law Center and the University of Houston Law Center, among other academic affiliations. He is widely published internationally on issues spanning global health law, bioethics, business and human rights, public international law, and international investment law. His writing has been published in law reviews, peer-reviewed journals, and major media outlets, as well as discussed or featured in major media outlets, including The Washington Post, Slate, and Forbes. Nick has given invited talks in various academic and industry fora, and has frequently appeared as a commentator on national news networks, such as Bloomberg and MSNBC.
Nick joined Jackson Walker from a global law firm where he concentrated on regulatory matters and served as a senior leader in the firm’s global advisory affiliate. His diverse prior experience includes roles advising the U.S. Department of Health and Human Services on regulatory matters during implementation of landmark healthcare reform legislation.
A.B., Georgetown University
J.D., Charleston School of Law
M.B.E., Perelman School of Medicine at the University of Pennsylvania
LL.M., Georgetown University Law Center, with honors
Global Life Sciences
- Advised large global pharmaceutical industry organization on vaccine-focused public policy issues spanning regulatory harmonization, international trade and intellectual property, and supply chain and distribution issues
- Led and advised coalition of six global vaccine manufacturers in Asia-Pacific and Latin America focused on public policy, regulatory, and market access issues
- Advised large global biopharmaceutical company on international trade and intellectual property issues impacting product and supply chain priorities across the enterprise
- Drafted comment letter on high priority domestic manufacturing and supply chain proposed regulation for a large global biopharmaceutical company
- Advised two large global biopharmaceutical companies on public policy and regulatory issues in Asia-Pacific and Latin America to support access priorities for cervical cancer-focused product portfolios
- Advised seven large global biopharmaceutical companies on market access issues in Asia-Pacific and Latin America for rare disease-focused product portfolios
- Advised coalition of global biopharmaceutical companies on COVID-19 vaccine regulatory issues in Latin America, including market access, public procurement, and liability issues
- Advised global biopharmaceutical company on regulatory and market access developments in multiple global markets for its gene therapy product portfolio
- Advised global vaccine manufacturer on regulatory and market access issues relating to a novel combination vaccine product for the US market
- Advised global vaccine manufacturer on US federal and state regulatory and market access considerations for development of novel delivery mechanisms for vaccines
- Advised global vaccine manufacturer on pharmacy scope of practice regulation in the US and 4 global markets
- Advised global vaccine manufacturer on US state vaccination requirements impacting a late-stage pipeline vaccine candidate
- Advised global vaccine manufacturer on US market access issues relating to Medicare coverage of vaccines
- Advised several large global biopharmaceutical companies on US market access in Medicare Part D
- Advised several large global biopharmaceutical companies on pricing and reimbursement issues for pipeline assets
- Advised large global biopharmaceutical company on product risks associated with health technology assessment developments in Asia and Latin America
MedTech & Digital
- Designed, launched, led, and advised a global coalition of five large medical device and technology companies focused on medical device, software, and artificial intelligence regulatory issues in Asia-Pacific, EU/UK, and US/Canada
- Advised large medical device industry organization in Asia-Pacific on remote care management public policy and regulatory engagement with governments and partners
- Advised multiple digital health companies on US federal and state telemedicine and remote care management regulatory issues relating to reimbursement across all payer types, consent requirements, online prescribing, and licensure
- Advised digital health company on software as a medical device and clinical decision support regulatory issues impacting new product development
- Advised digital health company on potential FDA regulatory enforcement risks relating to new product development
- Advised large health insurance company on advocacy opportunities with the US government relating to the regulation of artificial intelligence-enabled products
- Advised US digital health company on market readiness for ex-US strategic expansion in Canada, UK, and Australia
- Advised large, diversified retail company on US federal and state health policy issues relating to telehealth and remote care management regulations
- Advised innovation hub / incubator on software as a medical device and clinical decision support regulatory issues impacting new product development and deployment in clinical settings
- Advised global biopharmaceutical company on bioethics issues relating to gene therapy, stem cells, and artificial intelligence
- Advised large global technology company on the development of ethical decision-making policies for software engineers in its health product portfolio
- Advised large global technology company on the development of ethical decision-making policies for senior leaders in its health product portfolio
- Advised large global technology company on the development of internal guidance on ethical considerations for product commercialization in its health product portfolio
- Advised large global environmental organization on business and human rights issues impacting supply chain risks
- Advised large medical distributor on pharmacy direct and indirect reimbursement issues, including new regulatory developments and case law impacting operations
- Advised large medical distributor on COVID-19 vaccine purchase and distribution issues impacting C-suite priorities
Speeches & Presentations
- Speaker, “Accelerating vaccine development timelines with experience, expertise and automation,” Bioanalysis Zone Webinar (September 2022)
- Speaker, “The Bright Future of Vaccine Development,” National Vaccine Law Conference (September 2022)
- Speaker, “International Vaccine Law,” National Vaccine Law Conference (September 2022)
- Moderator, “Vaccine Innovation and the Future of Life-Course Immunization,” BIO International Convention (June 2022)
- Presenter, “FDA Enforcement and Regulatory Trends: What’s Ahead in 2022?,” Crowell & Moring Webinar (May 2022)
- “Global Vaccine Policy During the COVID-19 Pandemic,” University of Houston Law Center Health Law & Policy Institute 2021-22 Speaker Series (November 2021)
- Session Chair, “Key Considerations in Utilizing Real World Evidence for Regulatory Decisions,” DIADIA-CoRE Singapore Annual Meeting 2021 Panel Discussion (July 2021)
- Podcast Speaker, “The Pandemic Economy,” The Untold Stories of American Healthcare by the Nashville Healthcare Council (May 2021)
- Presenter, “FDA and the Response to COVID: Lessons Learned, and Where the Agency Goes From Here,” Healthcare Ounce of Prevention Seminar (HOOPS) 2021: Health Care in the Biden Era (February 2021)
- Presenter, “Telehealth and Remote Monitoring: Requirements, Reimbursement, FDA Oversight, and Risks,” Healthcare Ounce of Prevention Seminar (HOOPS) 2021: Health Care in the Biden Era (February 2021)
- Speaker, “Looming Challenges of COVID-19 Immunization: Progress and Gaps,” Network for Excellence in Health Innovation (NEHI) Looming Challenges of COVID-19 Immunization Summit Series (November 2020)
- Co-Author, Güriş Construction & Engineering, Inc. v. Syrian Arab Republic (Int’l Comm. Arb.) (with Kabir A.N. Duggal), International Legal Materials (June 2022)
- Author, “FDA Finalizes Guidance on Combination Products,” Crowell & Moring’s Health Law Blog (February 2022)
- Co-Author, “2021 in Review: Continued Movement at the Intersection of International Arbitration and Human Rights,” Kluwer Arbitration Blog (January 2022)
- Co-Author, “Regime Interaction in Investment Arbitration: Crowded Streets; Are Human Rights Law and International Investment Law Good Neighbors?” Kluwer Arbitration Blog (January 2022)
- Author, “The State of FDA Regulation of Software as a Medical Device,” Law360 (January 2022)
- Co-Author, “Biopharma And Medical Device Trends Investors Should Watch In 2022,” MedTech Intelligence (November 2021)
- Author, “Inter-regime conversations: What barriers persist for individuals in international law?” Leiden Journal of International Law (October 2021)
- Co-Author, “Advancing Health Innovation in 2022: Where Should We Focus?” PharmExec.com (August 2021)
- Co-Author, “Model Investment Agreements and Human Rights: What Can We Learn from Recent Efforts?” Columbia Journal of Transnational Law (August 2021)
- Author, “Adapting Human Rights Due Diligence For Renewable Energy—Key Points,” Bloomberg Law (July 2021)
- Co-Author, “Procedural versus Substantive Reforms: Is the Work of UNCITRAL WGIII Worth the Wait?” Kluwer Arbitration Blog (June 2021)
- Co-Author, “Is Your Data Supply Chain Ethical? Don’t Restrict Due Diligence to Physical Operations.” Corporate Compliance Insights (June 15, 2021)
- Co-Author, “Vaccine Passport Success Rests on True Privacy, Equity, Security,” Bloomberg Law (May 2021)
- Co-Author, “Adding New Ingredients to an Old Recipe: Do ISDS Reforms and New Investment Treaties Support Human Rights?” Case Western Reserve Journal of International Law, Vol.53, Iss.1 (April 2021)
- Author, “The Impossibility of Noncontribution,” 61 VA. J. INT’L. L. ONLINE 175 (2021)
- Co-Author, “Human Rights and Investor–State Dispute Settlement Reform: Fitting a Square Peg into a Round Hole?” Journal of International Dispute Settlement (March 12, 2021)
- Author, “Developments in Investment and Human Rights in 2019,” Yearbook on International Investment Law & Policy 2020 (Lisa E. Sachs et al. eds., 2021)
- Co-Author, “2020 in Review: The Pandemic, Investment Treaty Arbitration, and Human Rights,” Kluwer Arbitration Blog (January 2021)
- Author “The Final Say on Australia’s Plain Packaging Law at the WTO,” O’Neill Institute for National & Global Health Law (August 2020)
- Co-Author, “ISDS Reform and Advancing All “Generations” of Human Rights,” Kluwer Arbitration Blog (June 2020)
- Author, “Necessity in the Time of Pandemics,” Georgetown Journal of International Law Blog (May 2020)
- Author, “Pandemics, Emergency Measures, and ISDS,” Kluwer Arbitration Blog (April 2020)
- Author, “2019 in Review: International Investment Agreements and Human Rights,” Kluwer Arbitration Blog (February 2020)
- Georgetown University Law Center, Adjunct Professor of Law
- University of Houston Law Center (UHLC), Adjunct Professor of Law
- UHLC Health Law & Policy Institute, Advisory Board Member
- Baylor College of Medicine’s Center for Medical Ethics and Health Policy, Health Policy Scholar
- University of Pennsylvania Center for Global Health, Associate Scholar
- Wolters Kluwer’s Kluwer Arbitration Blog, Assistant Editor
- Oxford University Press’ Investment Claims, Contributor
- Brill Research Perspectives in International Investment Law and Arbitration, Associate Editor
September 15, 2022Speaking Engagements
Nick Diamond presented two sessions at the National Vaccine Law Conference held at George Mason University’s Antonin Scalia Law School. The first session, “International Vaccine Law,” covered international structures for the development, regulation, and distribution of vaccines. The second session, “The Bright Future of Vaccine Development,” discusses regulatory issues for the collective pipeline.
September 9, 2022Insights
Supply Chain Due Diligence Requirements for Certain Companies Doing Business in Germany Soon to Go Into Effect
By Nicholas J. Diamond & Manny Schoenhuber | On January 1, 2023, the so-called Supply Chain Due Diligence Act (Lieferkettensorgfaltspflichtengesetz) (the “Act”) will go into effect in Germany. Many companies doing business in Germany will need to ready their compliance operations in the coming months. The Act is also part of a broader trend in the European Union (EU) towards establishing mandatory human rights and environmental due diligence requirements, particularly for supply chain operations.
August 18, 2022Podcasts
~11.5 minutes | Featuring Nick Diamond & Ashley Withers
With the Inflation Reduction Act of 2022 now signed into law, there are a number of changes to federal tax and healthcare laws. Nick Diamond and Ashley Withers join Jackson Walker’s Fast Takes podcast for a brief overview of key changes to taxes and healthcare under the new law.
August 18, 2022Insights
By Nicholas J. Diamond
The Inflation Reduction Act of 2022 has been signed into law. This article explores key healthcare provisions in the IRA, including prescription drug pricing, inflationary rebates, Medicare Part D benefit resign provisions, and vaccine coverage.
August 8, 2022Insights
By Nicholas J. Diamond
The Department of Health and Human Services issued a new proposed rule on Section 1557 of the Affordable Care Act (ACA) that will impact digital health, including the proposed extension of Section 1557 to “clinical algorithms” and telehealth services.
July 27, 2022Insights
By Nicholas J. Diamond
The U.S. Food and Drug Administration has indicated in its draft guidance that it intends to continue to use remote tools to support oversight activities, including a hybrid approach for inspections that combines both onsite and remote modalities, beyond the COVID-19 pandemic.
July 18, 2022Attorney News
Jackson Walker is pleased to announce that Nicholas J. Diamond has joined as a partner in the Healthcare practice based in Houston. With extensive, international experience handling regulatory, public policy, and ethics issues in the U.S. and abroad, Nick counsels clients across the health sector.
- “Why Wind And Solar Companies Need To Address Human Rights,” Energy Monitor (February 2022)
- “With FDA Approval Of First COVID-19 Vaccine, Let The Mandates Begin: US Military, Disney World, CVS Health And More,” USA Today (August 2021)
- “Speed Bumps Ahead For IP Waiver But Will It Nudge Voluntary Licensing?“ Scrip Intelligence/Pink Sheet (May 2021)
- “Vaccine Passport Plans Can’t Ignore Web Of Privacy Laws,” Law360 (April 2021)
- Guest on Bloomberg TV’s Bloomberg Markets (April 13, 2020)
- Guest on Bloomberg TV’s Balance of Power with David Westin (04/13/2020) (April 2020)
- “COVID-19 Legal Issues,” Bloomberg Law with June Grasso (March 17, 2020)
- “Legal Issues Around the COVID-19 Pandemic,” Bloomberg Law with June Grasso (March 10, 2020)
- Guest on Bloomberg TV’s Balance of Power with David Westin (03/05/2020) (see 35:48) (March 2020)
- Guest on MSNBC’s NewsNation with Tamron Hall, “Punishment for Non-Vaxxers?” (2014)