Data, Data Analytics, and AI: Licensing, Litigation, and Regulation

Overview

Data Licensing, Monetization, and AI: Deep Industry Experience from Deal to Dispute

Data is no longer ancillary to business—it is the product, the infrastructure, and the competitive edge. Blank Rome has been advising clients at the forefront of data licensing and monetization for more than two decades, long before “data-as-a-product” and “AI-ready datasets” were market vernacular. We combine top-tier transactional, regulatory, and litigation capabilities to help enterprises, platforms, and innovators transform data into durable value—securely, strategically, and legally. From structuring complex data supply chains and negotiating strategic licensing arrangements, to litigating high-stakes disputes over use rights and trade secrets, we deliver practical, market-informed solutions grounded in deep industry knowledge.

Our team works across sectors where data is mission-critical, including healthcare and life sciences, government contracting, financial services, real estate, hospitality, and technology. We draw on cross-disciplinary strength spanning intellectual property (“IP”), cybersecurity and privacy, business litigation, corporate transactions, insurance recovery, and public policy. We understand how deals are built, how rights are enforced, where disputes arise, and how to align data strategy with fast-evolving artificial intelligence (“AI”), privacy, and consumer protection laws in the United States and globally.

What distinguishes our practice is a singular focus on data as a business asset—not just a compliance obligation. We help clients design forward-looking data and AI strategies that are commercially savvy, regulator-ready, and defensible in court.

We bring uncommon depth to the data and AI marketplace: decades of experience with data commercialization; a proven track record in high-stakes disputes; practical, regulator-aware guidance; and a market lens that recognizes how counterparties, platforms, and regulators think. Whether you are building an AI product, scaling a data marketplace, negotiating mission-critical licenses, or defending your rights in court, we help you capture opportunity while managing risk—confidently and at speed.

Some specific ways our team can assist clients include: 

Data as a Business Asset

We guide clients through the full lifecycle of data commercialization and AI enablement—sourcing, rights management, licensing, enrichment, protection, and monetization. Our lawyers have negotiated tens of thousands of agreements involving the collection, use, sharing, and storage of data, including high-value arrangements supporting model training, deployment, analytics, and productization. For organizations seeking to unlock underutilized datasets, we audit existing rights and restrictions, build pragmatic risk matrices, and structure programs that accelerate monetization while safeguarding IP, privacy, and contractual obligations.

We regularly prepare and negotiate complex data licenses for clearinghouses, data marketplaces, health information networks, and industry consortia, and we represent both suppliers and downstream users in pharma, device, FinTech, AdTech, and platform ecosystems. Our market fluency allows us to benchmark terms, anticipate counterpart positions, and negotiate outcomes that protect long-term value.

Typical engagements include:

  • Designing in-bound and out-bound agreements and governance playbooks that operationalize compliant data collection, use, disclosure, and retention aligned to business goals and applicable law.
  • Structuring and negotiating data licenses and content supply agreements for AI training, fine-tuning, grounding, and evaluation, including provenance, attribution, and license scope; restrictions on use in generative systems; derivative works and model output rights; and rights remediation frameworks.
  • Establishing de-identification, pseudonymization, and data minimization programs; advising on linked and longitudinal “real-world data” use; and validating claims surrounding anonymization and re-identification risk.
  • Advising on vendor diligence and risk allocation for cloud, software-as-a-service, and model-as-a-service arrangements, including audit rights and security obligations.
  • Counseling on web scraping, terms-of-use enforcement, and anti-scraping strategies; negotiating access to platform data and API ecosystems; and addressing Computer Fraud and Abuse Act and contract risk in data acquisition strategies.
  • Developing monitoring frameworks for AI model governance, bias and explainability considerations, IP and confidentiality safeguards, and incident escalation pathways when models or datasets are compromised.
  • Building cross-border data transfer strategies and contractual mechanisms, including for multinational data supply chains and AI development workflows.
  • Advising healthcare and life sciences stakeholders in connection with complex regulatory and implementation challenges arising from the use of health data and biological specimens, including the development of registries and related processes, policies, and data and specimen sharing agreements.
Litigation

Our team has successfully litigated multiple high-profile data-related disputes for market-leading participants to verdict, including cases involving contractual, statutory, and common law use rights; trade secrets; information blocking; and conflicts arising from data exchanged through health information networks. Our deep litigation bench integrates technical fluency with real-world trial experience, allowing us to translate complex data and model issues into compelling narratives for courts and arbitrators while preserving business continuity and reputational trust.

Our team has successfully guided clients through a number of complex litigation matters, including:

  • Represented a client in defense against a $1.5 billion case in which plaintiff data supplier alleged that our client breached a data supply contract, misappropriated trade secrets, and engaged in unfair competition. After a two-week evidentiary hearing in front of a three-arbitrator panel, obtained a complete defense verdict against all claims. Also obtained an injunction requiring the data supplier to continue to deliver data through the end of the contract period.
  • Represented a client in defending against a $500 million breach of contract, misappropriation of trade secrets claims, and unfair competition claim. After a three-week trial in the Federal District Court of Massachusetts, obtained a unanimous jury verdict denying the trade secrets claim and awarding plaintiff only one dollar on account of its breach of contract action.
  • Counsel to a startup in the first ever Carequality dispute against the largest electronic healthcare records company in the world. Verdict pending.
  • Secured multiple temporary restraining orders in Delaware Chancery Court preventing a data supplier from terminating its relationship with a data analytics company and requiring the data supplier to continue delivering data. 
Regulatory and Governance

We help clients anticipate and meet the demands of rapidly evolving privacy, security, and AI regulatory frameworks. Our attorneys align governance with growth objectives, enabling responsible AI and data use without throttling innovation. We advise on U.S. federal and state privacy laws; sectoral rules impacting health data, financial data, and children’s data; genomics; biometric and advertising laws; platform and consumer protection rules; and international regimes governing cross-border data transfers and AI systems. We counsel clients on the information blocking rules and the requirements of the Trusted Exchange Framework and Common Agreement and other health information exchanges. We also assist with incident response, investigations, remediation, and regulator engagement with agencies including the Federal Trade Commission, Food and Drug Administration, Health and Human Services Office for Civil Rights, the Securities and Exchange Commission, and state attorneys general. 

Instead of lengthy citations, we distill what matters: how laws such as the Health Insurance Portability and Accountability Act and Health Information Technology for Economic and Clinical Health Act, Gramm–Leach–Bliley Act, the California Consumer Privacy Act / California Privacy Rights Act and other state privacy laws, Biometric Information Privacy Act, Children's Online Privacy Protection Act, Telephone Consumer Protection Act, Controlling the Assault of Non-Solicited Pornography and Marketing Act, Fair Credit Reporting Act / Fair and Accurate Credit Transactions Act, Family Educational Rights and Privacy Act, the Electronic Communications Privacy Act / Stored Communications Act, and comparable international frameworks apply to your data, your models, and your go-to-market plan. We translate obligations into operational steps, consent forms, contracts, and controls that withstand scrutiny from customers, partners, auditors, and regulators.

Diligence for Investments and Transactions

We regularly support private equity sponsors, strategic investors, and acquirers in the data, analytics, and AI ecosystem. Our cross-disciplinary diligence integrates IP, privacy, data rights, cybersecurity, regulatory posture, and litigation exposure to evaluate current products, pipeline initiatives, and new lines of business. We identify material contracts and hidden encumbrances on data assets, assess de-identification claims and consent architecture, and map third-party rights that can impede monetization. We also prepare companies for sale by strengthening governance, remediation plans, and disclosures so that data and AI issues do not erode valuation or delay closing.

AI for Vendors and Clients

For data and AI vendors, we craft licensing and platform strategies that preserve asset value while enabling scale, including tiered rights models, guardrails around training and fine-tuning, output-use provisions, model evaluation rights, and responsible deployment commitments. For enterprises procuring AI capabilities, we build risk-balanced agreements addressing data contributions, model performance, IP ownership and indemnities, hallucination and defamation risk, and security and resilience requirements. Our experience extends to marketing claims and fair use considerations, content ingestion pipelines, and remedies for noncompliance, infringement, or model drift.

What Sets Us Apart

  • 2025 Best Lawyers® “Best Law Firms” (Woodward/White, Inc.) nationally ranks Blank Rome for:
    • Litigation – Intellectual Property
    • Litigation – Patent
    • Patent Law
  • We leverage relationships within the life sciences and financial industries, as well as the government, to facilitate key introductions that create business opportunities and solve problems.
  • Our life sciences industry team is bolstered by a deep bench of recognized intellectual property leaders with significant experience in acquiring, defending, enforcing, and invalidating medical device and pharmaceutical patents.
  • We have achieved numerous wins in high-profile life science disputes and have extensive trial and appellate experience in federal and state courts across the country.
  • We advise on compliance strategies with respect to global data protection laws and the processing of human biological samples, including transparency initiatives in clinical research.

Experience

  • Prepared full suite of agreements to enable start-to-finish business process for collection, use, and commercialization of de-identified data, including data supply agreements, client-side data license agreements, related software and services agreements, third party access agreements, and data use agreements.
  • Structured and negotiated enterprise data supply and licensing programs for healthcare, life sciences, FinTech, and platform clients, aligning use rights with AI training and deployment objectives while preserving asset value and meeting privacy and security obligations.
  • Audited thousands of customer software license agreements to build pragmatic risk matrices and structured guidelines to enable monetization of data in a manner that is compliant with contractual use rights.
  • Advised on de-identification certifications and pseudonymization methodologies, including linkage of longitudinal “real‑world data” to support evidence generation and product development.