Research or Quality Improvement? That is the Question

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Health care reform and market shifts have given rise to a growing emphasis on value-based payment and on initiatives to enhance patient safety and the quality and effectiveness of health care and therapies.  As a result, and propelled by rapidly advancing and increasingly accessible technology, health care providers and their collaborators are exploring ways to leverage their data stores to develop new ways to improve the quality of care, manage their operations, and discover innovations to cure disease and provide better treatment to their patients.

The lines that distinguish these various activities, however, are not always intuitive and often blurred.  Health care stakeholders must grapple with applying complicated and, at times, conflicting regulatory standards.  These ambiguities can lead to misinterpretations that cause stakeholders to subject legitimate quality assurance and quality improvement projects to costly and burdensome IRB oversight.

Properly designating these activities under the applicable regulatory framework is critical not only for compliance purposes but also in light of increasing scrutiny by the public and consumer advocates into what some perceive as growing vulnerabilities in, and threats to, personal privacy.  For providers, their collaborators, and other stakeholders, it is in their advantage to adopt a methodical, considered approach in analyzing proposed uses of health information to maintain maximum operational flexibility and a strong compliance framework.  Data repositories that are created and deployed for these activities typically increase in utility when they are longitudinal and expansive, and are often the product of a collaboration among multiple health care institutions and practices.  The potential for complex arrangements among multiple actors underscores the need to develop an upfront assessment and compliance strategy that anticipates future downstream needs.

Educational Objectives:
• Understand the applicable regulatory framework for activities frequently performed as research or “health care operations” by health care providers and their business associates
• Contextualize the issue with real-life examples
• Grasp nuances that distinguish research from common health care operations activities
• Learn of common mistakes and misperceptions
• Consider practical solutions and tools

Who would benefit most from attending this program?
Health care providers (from small physician practices to large health systems) and practitioners; in-house counsel to health care providers; payors; health IT leaders; coalitions and professional trade organizations in the health care industry that have or are considering collaborating with providers to create health information databases; medical researchers.



Jiayan is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office.  She works regularly with clients on compliance and strategic considerations related to developing data and bioasset repositories and research initiatives, including in the context of personalized medicine.  In that regard, Jiayan has helped clients develop innovative and practical bioasset sharing solutions that extend to multiple institutions and entities.  Her practice also includes counseling clients on data privacy and security laws and on compliance with state and federal “Sunshine” requirements.

Degree: JD, University of Michigan Law School
Admitted to practice in Illinois and District of Columbia


Jennifer is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office.  Jennifer is a frequent speaker and author on areas within her practice, including life sciences and biomedical innovation, financial relationships and aggregate spend, data sharing strategies and data privacy and security.  Jennifer works regularly with global clients on developing and implementing data sharing strategies and platforms to achieve business objectives, particularly in connection with biomedical innovation, health care reform, electronic health record implementation, and quality assurance requirements.  She actively advises clients on data sharing architecture, data and biospecimen collection and repositories, data sharing collaborations and partnerships, the creation of health information exchanges, data license and health information technology agreements, and other strategic health information and health information technology transactions.  Jennifer also advises companies on global privacy and data security laws. 

Degree: JD, Harvard Law School
Admitted to practice in Massachusetts, New York, and District of Columbia