Jiayan’s subject matter and industry insights come from advising a broad range of clients, including AI and other healthcare technology companies; data companies; hospitals and health systems; academic medical centers; genetics companies; digital health companies; PSOs; drug, device, and biotech companies; private equity funds; and platform companies.

Jiayan regularly counsels clients on data privacy requirements under US federal and state privacy law, including the Health Insurance Portability and Accountability Act (HIPAA) and various state genetic, health information, and consumer privacy laws. She works with clients on mapping and implementing data use and sharing strategies with appropriate data governance and programmatic safeguards. Well before the proliferation of generative AI, Jiayan was working with AI developers and deployers on compliance with privacy and research laws, efforts to leverage data to train and validate AI tools, and transactions involving the licensing of AI tools and AI-enabled platforms. These days, Jiayan also guides clients in developing AI governance and advises on proposed regulatory and legislative changes impacting AI.

Jiayan represents clients on a wide array of matters related to biomedical research, including negotiating the full range of agreements impacting research, building research compliance infrastructure, preparing protocols and informed consent and authorizations, and conducting transactions involving research site networks, providers of research solutions and other stakeholders in the biomedical research space. Jiayan’s regulatory practice includes counseling clients on state and federal “sunshine” and gift ban laws. She analyzes proposed arrangements and corporate organizational structures to identify and inform reporting obligations, and helps clients develop compliance mechanisms for managing their reporting obligations.

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• Counseled healthcare technology companies and other digital health companies on myriad privacy and healthcare regulatory issues related to the generation of real-world data and real-world evidence solutions and the development of cutting-edge health information technology platforms.
• Developed AI governance policies, position papers, procurement checklists, and other tools to support the development, testing, deployment, procurement, or commercialization of trustworthy AI.
• Served as regulatory counsel on investments and acquisitions by private equity funds in the pharmaceutical and medtech services sector and digital health sector, including transactions involving research sites, health information technology companies, data companies, and providers of software and other solutions to support research.
• Developed and reviewed research protocols, informed consent and HIPAA authorization forms, and institutional review board submissions.
• Worked with digital health companies to implement innovative programs powered by analytics and data to improve patient outcomes and achieve cost savings for payors and employers.
• Advised health care providers, digital health companies, and technology companies as they designed, negotiated, and implemented complex strategic collaborations.
• Assessed and managed risks related to data and biospecimen use based on evolving legal, ethical and industry dynamics.
• Advised PSOs in connection with listing applications, responses to inquiries by the Agency for Healthcare Research and Quality, developing compliance infrastructure, negotiating participation agreements, and advising on approaches for compliant sharing of patient safety work product.
• Advised manufacturers on applicability of and obligations under the Sunshine Act, state transparency and gift ban laws, and negotiated contractual obligations related to reporting.

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