Jiayan Chen is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office. She focuses her practice on counseling clients on a range of regulatory issues, including compliance and strategic considerations for data sharing and research initiatives, as well as on transactions relating to pharmaceutical and medical device companies.
Jiayan’s regulatory practice includes advising clients on research compliance and data privacy and security laws, including the Common Rule, FDA good clinical practices, HIPAA, the Privacy Act of 1974, as well as similar state laws and regulations. In that regard, Jiayan helps clients assess the range of legal, regulatory, and other strategic considerations attendant to the development of data sharing platforms and to data and biospecimen collection and repositories, including in the context of personalized medicine and future, unspecified use. She also has experience preparing data privacy policies and programs and counseling clients on other various legal and compliance issues arising from the use and disclosure of protected health information. Additionally, Jiayan’s work for life sciences clients includes advising on compliance with, and implementation of, the “Sunshine” provisions of the Patient Protection and Affordable Care Act.
More Legal and Business Bylines From Jiayan Chen
- FDA Issues Real-World Evidence Framework for Drugs and Biologics - (Posted On Wednesday, December 12, 2018)
- Recycle, Recycle, Recycle: Key Considerations for Research, Medical Education, and Other Secondary Uses of Data - (Posted On Wednesday, June 06, 2018)
- On the Digital Health Frontier: Developments Driving Industry Change in 2018 - (Posted On Thursday, January 25, 2018)
- Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018 - (Posted On Tuesday, January 09, 2018)
- HHS Finalizes Toned-Down Version of Common Rule Overhaul - (Posted On Tuesday, February 07, 2017)
- HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections - (Posted On Tuesday, September 08, 2015)
- CMS Releases Broad Data on Prescribing Patterns of Physicians and Providers Under Medicare Part D - (Posted On Thursday, May 21, 2015)
- CMS Finalizes Proposal to Remove Continuing Medical Education Exclusion from Sunshine Act Regulations - (Posted On Wednesday, November 12, 2014)
- CMS Proposes Removing CME Exclusion from Sunshine Act Regulations, Citing Redundancy with Indirect Payment Exclusion - (Posted On Thursday, August 07, 2014)
- FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms - (Posted On Tuesday, July 22, 2014)