Health Care and Artificial Intelligence

Health care organizations are moving fast to adopt artificial intelligence, automation, and next-generation emerging technologies. Yet the evolving legal and regulatory landscape grows more complex every day, making it difficult to harness responsible and compliant adoption.

Developing or deploying AI responsibly requires advisors with a deep understanding of a complex web of regulatory, technical, and practical considerations. We provide concise, relatable advice to help clients effectively and responsibly harness AI tools to meet strategic and operational objectives, compliance needs, and customer/market demands.

Guiding Clients Through the Health Care AI Landscape

Our team understands the unique technology objectives of our health care clients: integration, access, reliability/accuracy, speed, security, and compliance. We advise academic medical centers, hospitals and health systems, life science and medical device companies, and other health care and technology providers as they pursue these objectives through the development, deployment, integration, and use of AI tools in critical clinical, operational, financial, administrative, and other environments and workflows.

AI Vendor Arrangements & Contracting

AI solutions often involve intricate vendor relationships where there is a reliance on substantial performance, data sharing/use, intellectual property, regulatory, and risk allocation considerations.

We support clients by:

Structuring and negotiating AI-vendor contracts to mitigate or allocate AI-related risks

• Incorporating transparency about proposed vendor use of client/patient data, model updates, and algorithmic decision-making
• Advising on contractual impacts and options to protect client IP, client and patient data, and other assets and sensitive information
• Evaluating statutory and regulatory compliance, general business risk allocation, performance guarantees, and model training provisions
• Addressing third-party liability concerns related to automated or semi-automated clinical support tools

We help clients build durable, trustworthy partnerships with AI vendors while protecting their legal, regulatory, operational, financial, and reputational interests.

Data Privacy, Security & Responsible Use

AI in health care depends on the compliant and responsible sharing, use, and processing of client, patient, and other protected health information and sensitive data.

We help clients navigate:

• Compliance with international, US federal, and state laws and regulations applicable to data use in the context of AI. These include cybersecurity, data privacy, and AI-specific requirements plus general laws that may be applicable to AI-specific use cases
• Data minimization, de-identification/anonymization, and secure processing strategies
• Issues related to cross-border data transfers, data storage and processing, and vendor-hosted environments
• Data breaches and other security or privacy incidents

We work with clients to design compliance-forward AI programs that protect patient trust and client reputations and withstand regulatory scrutiny.

AI Governance & Risk Management

Effective AI adoption requires more than technology — it requires governance. We help organizations build internal frameworks that support safe, ethical, and compliant AI adoption, use oversight, and implementation.

Including:

• Establishment of AI oversight committees
• Development and implementation of policies, procedures and processes for:
• Review and approval of proposed AI systems and use cases
• Development of risk registries, vendor diligence, and other compliance mechanisms
• Technical model validation, monitoring, and documentation
• Mitigation and safeguards for AI-related risks (e.g., cyber, privacy, IP, accuracy, bias/discrimination, etc.)
• Incident response planning for AI-related errors or system failures

Our team helps clients to develop and operationalize governance over infrastructure and to oversee AI reliability, transparency, and alignment with organizational objectives.

Navigating State & Federal AI Regulations

The legal landscape for AI is evolving rapidly. We help clients navigate this matrix of laws by advising on compliance with:

• Federal law, rules, and agency guidance from HHS, FDA, FTC, OCR, and others
• State level laws, rules and agency guidance regarding AI and automated decision making technologies (ADMT), privacy, security, transparency, risk assessment, and other AI-related issues
• Emerging federal legislation, executive orders, policy, and other directives on artificial intelligence
• Regulatory pathways for AI-enabled medical devices and clinical decision support tools

We translate complex regulatory frameworks into practical, actional guidance tailored to each client’s technology, business objectives, and risk profile.