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 joining the firm, Ms. Schaefer served as an associate university counsel at The University of North Carolina at Chapel Hill, where she was the senior health care attorney for the UNC School of Medicine, UNC Faculty Physicians, and other health affairs schools. In this capacity, Ms. Schaefer advised campus and school-based leadership on myriad regulatory, transactional, institutional policy, and governance matters. Ms. Schaefer has counseled clients in the areas of fraud and abuse, privacy, human subjects research, and life sciences regulation. Her transactional experience includes joint ventures and physician practice acquisitions, as well as professional service, academic affiliation, timeshare, and data use agreements. Ms. Schaefer has drafted and counseled on faculty physician employment matters, including physician compensation plans, employment agreements, and restrictive covenants. Overall, her work for the university applied health care regulatory and transactional expertise to structure and facilitate various opportunities that furthered the patient care, clinical research, and medical education missions of the institution. Prior to UNC-Chapel Hill, Ms. Schaefer was in private practice with a large firm in Washington, D.C. representing clients from various sectors of the health care industry – including hospitals, medical management companies, physician groups, pharmaceutical and medical device companies, patient advocacy groups, and trade associations – on matters such as clinical trial agreements, regulatory compliance counseling, health care transactional due diligence, and the research, analysis, and compilation of legal and policy positions to comment on various agencies’ rulemaking on behalf of clients
More Legal and Business Bylines From Rebecca M. Schaefer
- Ensuring Continuity of Care Following a Cyberattack: ARPA-H Launches Project to Enhance Cybersecurity Tools for Health Care Organizations [Podcast] - (Posted On Wednesday, September 13, 2023)
- Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical Trials - (Posted On Sunday, June 04, 2023)
- Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight [PODCAST] - (Posted On Monday, September 26, 2022)
- All Federal Research Agencies to Update Public Access Policies - (Posted On Wednesday, August 31, 2022)
- Cybersecurity & HIPAA: NIST’s Practical Guidance Updates for Covered Entities and Business Associates [PODCAST] - (Posted On Monday, August 29, 2022)
- Regulatory, Contractual, and Governance Considerations for Data Transactions [PODCAST] - (Posted On Tuesday, May 10, 2022)
- FTC Reminds Vendors of Personal Health Records of Breach Rule Obligations [PODCAST] - (Posted On Thursday, October 07, 2021)
- Congressional and Enforcement Priorities Related to Higher Education Issues - (Posted On Monday, September 13, 2021)
- When Regulatory Review Is Necessary: Clinical Research vs. Quality Initiatives [PODCAST] - (Posted On Friday, July 16, 2021)
- More than Innovation and Competition: The Latest Proposed Monitoring and Enforcement Mechanisms Targeting Foreign Influence in U.S. Research - (Posted On Thursday, July 01, 2021)