Jiayan Chen counsels clients on a range of regulatory and strategic issues that arise in the context of biomedical innovation and data sharing initiatives. She also has extensive experience advising life sciences companies and their collaborators on state and federal “Sunshine” and gift ban requirements.
In her regulatory practice, Jiayan advises clients on regulatory and strategic considerations attendant to the development of research collaborations, data sharing initiatives, quality improvement endeavors, and biospecimen and data repositories, including in the context of personalized medicine and secondary use. In this regard, she has experience counseling a broad array of clients, including health systems, information technology companies, professional associations and biotechnology companies. Jiayan regularly assists clients in navigating requirements under the Health Insurance Portability and Accountability Act (HIPAA), the Common Rule, state research and privacy laws, and Food and Drug Administration (FDA) requirements relating to clinical investigations and human subject protections. She has extensive experience designing and implementing complex data sharing strategies, quality improvement initiatives, and research collaborations including in the preparation of protocols, project proposals and other institutional review board (IRB) submissions, as well as in drafting and negotiating complex affiliation, collaboration and research agreements.
Jiayan’s practice also 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.
While in law school, Jiayan was the articles selection coordinator for the Michigan Journal of Gender & Law.