Overview
Jiayan Chen is deeply experienced in the regulatory, transactional and strategic issues that arise when leveraging health information, biospecimens and technology to drive healthcare innovation and quality. She guides stakeholders on privacy compliance and research compliance and in the context of strategic initiatives and collaborations as they seek to harness the power of data, machine learning, DNA sequencing and technologies to develop and deploy new products and solutions and address challenges in healthcare delivery and payment.
Her extensive work with complex and cutting-edge Big Data transactions and initiatives, real-world data and evidence generation, and data and health information technology transactions, and experience in data protection, genomic privacy, and research compliance make her extremely sought after in the industry. Jiayan advises a broad range of clients, including healthcare and life sciences companies, academic medical centers, genetics companies, digital health companies, data companies and healthcare technology companies, on a wide range of issues that arise at the intersection of health data, biospecimens, and technology.
She counsels clients on data privacy requirements under US federal and state law, including the Health Insurance Portability and Accountability Act (HIPAA), and various state genetic and other health information privacy laws, and the General Data Protection Regulation (GDPR). Jiayan provides guidance on research compliance and development, including preparation of protocols and informed consent and authorizations, as well as institutional, sponsor, and IRB compliance with the Common Rule and FDA Good Clinical Practices. She also works with clients on mapping and implementing data use and sharing strategies with the appropriate data governance and programmatic safeguards.
In addition, Jiayan’s practice includes counseling life sciences companies and healthcare providers on state and federal “Sunshine” and gift ban laws. In this regard, she analyzes proposed arrangements and corporate organizational structures for purposes of identifying and informing reporting obligations, and helps clients develop compliance mechanisms for managing their reporting obligations.
Results
- Counseled clients including healthcare providers, academic medical centers, professional associations, and digital health companies to identify and implement opportunities for leveraging data, biospecimens, or health information technology individually or in combination in furtherance of precision medicine, research, or quality initiatives.
- Advised clients including genetics companies, healthcare providers, academic medical centers, life sciences companies, and digital health companies on matters involving compliance with privacy and human subject protection requirements.
- Drafted and negotiated numerous data licensing, data collaboration, health information technology licensing and services, clinical trial, and research collaboration agreements.
- Counseled healthcare technology companies and other digital health companies on myriad privacy and healthcare regulatory issues relating to the generation of real-world data and real-world evidence solutions and the development of cutting-edge health information technology platforms.
- 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 relating to data and biospecimen use based on evolving legal, ethical and industry dynamics.
Community
- American Health Lawyers Association, Tech Licensing and Intellectual Property Affinity Group, membership vice chair
- 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
