Rebecca M. Schaefer

Conducted health care regulatory due diligence and identified required regulatory consents and approvals in connection with private equity and other investments in health care companies

Advised on AMC-specific considerations related to mission support and institutional funds flow between the hospital and faculty practice components of an academic medical center

Drafted, revised and negotiated a variety of agreements between clinical trial sponsors, clinical research organizations (CROs), principal investigators and other third parties to govern the conduct of numerous clinical trials

Drafted a suite of inter-related agreements in furtherance of establishing a clinical trials research network within a health system

Advised on the organization of a HIPAA hybrid entity and privacy considerations related to clinical research. Advised on breach analysis and providing notice of unauthorized uses and disclosures of protected health information. Drafted and negotiated business associate agreements and other HIPAA required documents

Represented faculty practices in the negotiation of joint venture, management services, professional services, space lease, and other agreements

Advised on faculty physician employment and compensation agreements, including related Stark Law considerations

Developed positions with relevant University and School of Medicine leadership across a range of integration considerations and drafted components of the Academic Affiliation Agreement in connection with the formerly proposed partnership between UNC Health Care and Atrium Health. Advised on various other academic affiliations

Counseled academic medical center on privacy and human subjects research regulations pertinent to a precision medicine artificial intelligence start up

Drafted policies for a physician practice related to compliance with federal and state controlled substances regulations

Advised health system on Stark compliance related to physician non-monetary compensation

Counseled an academic medical center on privacy and consent considerations with respect to a biobank repository

Represented multiple health systems in the acquisition of community hospitals, including conducting due diligence, crafting definitive transaction agreements and advising on integration and operational considerations

Prepared draft legislation on behalf of mental and behavioral health services organization to facilitate organizational changes in anticipation of Medicaid reform

Assisted a newly established health care facility in the development of an active clinical research program, including developing policies necessary for receipt of federal grants and proper administration of clinical trial billing, and negotiated multiple clinical trial agreements

Counseled health care start-ups on entity formation, corporate practice of medicine, licensure, enrollment, reimbursement and contracting considerations.