Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Healthcare

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.