Rebecca Schaefer is a partner in the firm’s Healthcare and FDA practice group, focusing her practice on healthcare and research regulatory and transactional matters. Rebecca has specific knowledge of issues affecting academic medical centers, including those related to faculty practices, clinical research, mission support, governance and privacy. She provides counseling to universities, health systems, physician practice groups and clinical research institutes and consortia related to strategic affiliations, joint ventures, big data initiatives and compliance matters. Areas of regulatory experience include the Stark Law, Anti-Kickback Statute, Civil Monetary Penalties Law, HIPAA and state privacy statutes, Common Rule and FDA regulations governing human subjects research, NIH grant rules and disclosure requirements, conflict of interest, research misconduct and medical school accreditation, among other areas.
Prior to joining the firm, Rebecca served as an associate university counsel at The University of North Carolina at Chapel Hill, where she was the senior healthcare lawyer for the UNC School of Medicine, UNC Faculty Physicians, and other health affairs schools. In this capacity, Rebecca advised campus and school-based leadership on myriad regulatory, transactional, institutional policy, and governance matters. Rebecca 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 agreements, academic affiliation, and data use agreements. Rebecca 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 healthcare regulatory and transactional experience 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, Rebecca was in private practice with a large firm in Washington, D.C. representing clients from various sectors of the healthcare 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, healthcare transactional due diligence, and the research, analysis, and compilation of legal and policy positions to comment on various agencies’ rulemaking on behalf of clients.
- American Health Lawyers Association
- Presenter, Health Law Institute, “A Look Back at 2023: Research Year-in-Review,” Pennsylvania Bar Institute, 12 March 2024
- Presenter, “Healthcare Transactions: Structuring Considerations and Key Regulatory Issues,” K&L Gates Under the Wire, 1 February 2024
- Presenter, AHLA Annual Meeting, “Health Care Data Transactions: Navigating the Regulatory and Valuation Challenges,” American Health Law Association, 27 June 2023
- Presenter, AHLA Annual Meeting, “Where Quality Meets Research: Emerging Strategies, Opportunities, and Risks of Integrated Clinical Records,” American Health Law Association, 28 June 2021
- Presenter, “Case Studies in Faculty Consulting-Legal Issues and Policy Choices,” AHLA Academic Medical Centers and Teaching Hospitals Institute, January 2020
- “Legal trends health care investors should know: Q&A with K&L Gates partners Christopher Nasson, Wells Beckett and Rebecca Schaefer," Boston Business Journal, 1 October 2024
- Top Ten 2023: Research Related Developments to Watch, AHLA’s Speaking of Health Law podcast, 10 March 2023
- "Top Ten Issues in Health Law 2023," American Health Law Association, 1 January 2023
- "Antitrust Enforcement of No-Poach Agreements in Health Care and Unique Considerations for AMCs," American Health Law Association, 18 August 2022
- “Navigating the Regulatory and Valuation Challenges in Health Care Data Transactions,” American Health Law Association, 1 April 2022
- "Clinical Research in a Post-Pandemic World," American Health Law Association, 22 November 2021
- "STRATEGIC PERSPECTIVES: Case study in models for academic health systems structuring venture capital investments: Henry Ford Health System," Health Law Daily, 10 September 2021
- “CMS Issues Final Rule to Implement SUPPORT Act Coverage and Reimbursement of Opioid Treatment,” AHLA Weekly, 14 February 2020
- “Lurking Legal Issues for AMCs in Faculty-Led Consulting for Industry via Institutional Contracts,” American Health Lawyers Association, May 2019
- “Hospitals’ Role in Combatting the Opioid Crisis,” Healthcare Business Today, 2 April 2019
