Jiayan Chen
Subscribe to Jiayan Chen's PostsJiayan 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. Read Jiayan Chen's full bio.
Texas AG’s Landmark AI Settlement: A Wake-Up Call for Health Tech & AI Companies
By Jiayan Chen, Dale C. Van Demark, Jennifer S. Geetter, Shawn C. Helms and Grayson I. Dimick on Oct 3, 2024
Posted In Digital Health, Employee Benefits, Health and Welfare Plans
Healthcare providers, payors, and other healthcare organizations should be aware of a recently announced, “first-of-its-kind” settlement between the Texas attorney general and a healthcare generative artificial intelligence (AI) company resolving allegations that the company made a series of false and misleading statements about the accuracy and safety of its AI products. The settlement highlights the...
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FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance
By James Ravitz, Jennifer S. Geetter, Jiayan Chen, Paul Gadiock, Jeff Weinstein, Marissa Hill Daley, Nathan Gray and Karis Jackson on Aug 20, 2024
Posted In Employee Benefits, Health and Welfare Plans
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance provides valuable information about what steps the FDA will expect sponsors to take to promote adequate representation across demographic characteristics in...
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FDA Establishes CDER Center for Drug Innovation (C3TI)
By James Ravitz, Paul Gadiock, Jiayan Chen, Marissa Hill Daley, Nathan Gray and Karis Jackson on May 29, 2024
Posted In Employee Benefits, Health and Welfare Plans
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support hub for innovative approaches to clinical trials designed to improve the quality and efficiency of drug development and regulatory...
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OCR Issues Proposed Rule to Modify HIPAA Privacy Rule to Include Explicit Protections for Reproductive Healthcare
By Stacey Callaghan, Jiayan Chen, Caroline Reignley, Scott Weinstein and Dexter Golinghorst on Apr 20, 2023
Posted In Digital Health, Employee Benefits, Health and Welfare Plans
On April 12, 2023, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking detailing its proposal to modify the HIPAA Privacy Rule (Proposed Rule). The Proposed Rule comes as a part of the Biden administration’s response to the US Supreme Court’s ruling in Dobbs v. Jackson Women’s...
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Artificial Intelligence Myth Versus Reality: Where Do Healthcare Experts Think We Stand?
By Dale C. Van Demark and Jiayan Chen on Nov 12, 2021
Posted In Digital Health, Employee Benefits, Health and Welfare Plans
As the healthcare industry evaluates how to pay for artificial intelligence (AI) solutions, industry experts say data and real-world evidence are essential for reaching any payment decisions. In this Forbes article, McDermott Partners Dale C. Van Demark and Jiayan Chen provide insight into some of the regulatory challenges AI presents. “For AI to be paid...
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Protecting the Telehealth Consumer: FTC and State-Based Considerations
By Jiayan Chen on Sep 21, 2021
Posted In Digital Health, Employee Benefits, Health and Welfare Plans, Privacy and Data Security
Telemedicine in the United States is facing an important crossroads. While telehealth services have demonstrated their value as an integral part of care delivery, federal and state waivers instituted during the COVID-19 pandemic are likely to expire soon. As lawmakers and agency officials consider updated or expanded digital health rules, regulators are expected to intensify...
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Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018
By Jiayan Chen, Lisa Schmitz Mazur, Michael Ryan, Ryan Marcus, Scott Weinstein, Sarah T. Hogan, Vernessa T. Pollard, McDermott Will & Emery, Bernadette M. Broccolo, Dale C. Van Demark and Jennifer S. Geetter on Feb 8, 2018
Posted In Health and Welfare Plans, Privacy and Data Security
Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing...
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