September 22, 2021

Volume XI, Number 265

Advertisement

September 22, 2021

Subscribe to Latest Legal News and Analysis

September 21, 2021

Subscribe to Latest Legal News and Analysis

September 20, 2021

Subscribe to Latest Legal News and Analysis
Advertisement

When Regulatory Review Is Necessary: Clinical Research vs. Quality Initiatives [PODCAST]

In this week’s episode, Richard Church interviews Rebecca Schaefer about the intersection and blurred line between clinical research and quality initiatives. The presenters discuss what factors to consider when defining research, the regulatory requirements for research, and HIPAA exemptions to the Common Rule. 

Copyright 2021 K & L GatesNational Law Review, Volume XI, Number 197
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

Richard P. Church, KL Gates, abuse compliance lawyer, Healthcare self disclosures attorney
Partner

Richard Church is a co-leader of the firm’s national health care practice group. He focuses his practice on health law regulatory issues and health care joint ventures, clinical integration and mergers and acquisitions. Richard handles complex 340B structuring, enrollment and compliance matters, Medicare and Medicaid enrollment and reimbursement issues, and health care operational matters. He also handles complex affiliations and transactions between health care providers, including legal compliance, change of ownership filings, and development of post-transaction...

919-466-1187
 Rebecca M. Schaefer healthcare & Transactional Attorney K & L Gates Law Firm North Carolina
Partner

Rebecca Schaefer is a partner at the firm’s Research Triangle Park office. She is a member of the health care practice group, focusing her practice on healthcare regulatory and transactional matters. Ms. Schaefer has specialized knowledge of issues affecting academic medical centers, including those related to faculty practices, clinical research, mission support, governance and privacy. She provides counseling to health systems, physician practice groups and in-house pharmacies related to strategic affiliations, joint ventures, and compliance matters.  

Prior to...

919.466.1111
Advertisement
Advertisement
Advertisement