Overview
Jiayan Chen counsels clients on a range of regulatory, transactional, and strategic issues that arise in the context of efforts to leverage data, bioassets, and technology to drive innovation and quality in healthcare. Jiayan has particular experience with complex, cutting-edge “Big Data” transactions and initiatives designed to advance precision medicine and the use of real-world data.
Jiayan counsels a broad array of clients, including healthcare technology companies, data companies, health systems, academic medical centers, professional associations, and life sciences companies on matters including the following:
- Data privacy and data protection requirements under US federal and state law, including the Health Insurance Portability and Accountability Act (HIPAA), and the General Data Protection Regulation (GDPR)
- Development of data strategies and data governance infrastructure
- Licensing of data, analytical tools, and other health IT products and solutions
- Digital health software hosting, maintenance, and service agreements
- Development of biorepositories and data registries for myriad research, quality, and value-based initiatives
- Research compliance and program development, including institutional and IRB compliance with the Common Rule, HIPAA Privacy Rule, and FDA Good Clinical Practices
- Evolving FDA requirements and standards regarding the collection and use of real-world data and real-world evidence
- Development of research collaborations, networks, and affiliations
- Development of research protocols and IRB submissions
In addition, Jiayan’s practice includes counseling clients on state and federal “Sunshine” and gift ban laws by analyzing proposed arrangements, determining compliance obligations, and evaluating proposed corporate organizational structures in view of managing potential reporting obligations.
Results
- Drafted and negotiated a complex data services and licensing agreement to leverage genomic and phenotypic real-world data to support a range of secondary uses
- Advise health information technology company on myriad privacy, data strategy, licensing, and vendor and customer contracting matters relating to implementation of platform designed to improve patient outcomes
- Served as counsel to a health system, from conception of concept, in designing and implementing a research consortium focused on collaborations designed to advance biomedical discoveries in personalized medicine, including a research study to facilitate molecularly targeted and rapid clinical trial accrual
- Counseled a client in developing a cutting-edge data and technology platform to support provider quality improvement efforts and enable secondary research applications, including advising on regulatory issues, drafting IRB submission materials and foundational agreements, and supporting vendor selection and negotiation
- Served as regulatory counsel on the acquisition of a global clinical research organization, with a focus on research, data privacy, FDA compliance and enforcement issues
- Advised an oncology quality improvement and quality assurance program on day-to-day programmatic and data privacy and security issues
- Counseled a national nonprofit organization in drafting and negotiating template and customized research grant agreements
- Counseled a health system client in connection with a complex biobanking collaboration, including drafting and negotiating the biorepository and material transfer agreement, underlying protocols and consent forms, and advising on complex research design and financial remuneration considerations
Community
- American Health Lawyers Association, Vice Chair of Membership, Tech Licensing and Intellectual Property Affinity Group
- District of Columbia Bar Association, Health Law Section, Member
Credentials
Education
University of Michigan Law School, JD, 2009
University of Michigan, BA, with distinction, 2006
Admissions
District of Columbia
Illinois
