Rebecca M. Schaefer

Represented BJC HealthCare in its affiliation by member substitution with Saint Luke’s Health System, resulting in a combined system with US$10 billion in revenues

Represented an Indiana-based health system in multiple community hospital acquisitions

Served as lead counsel to a major AMC in structuring and negotiating the formation of a genomic data consortium with eight Fortune Global 500 pharmaceutical companies. The transaction involved a collaboration with a sequencing company to whole genome sequence the AMC’s biobank and pairing the genomic data with de-identified medical record data to enable life science research and development. Support included structuring a unique consortium model; regulatory counseling on HIPAA, GDPR, Common Rule, NIH Certificates of Confidentiality, Anti-Kickback Statute, export control, and other legal considerations; negotiating intellectual property, data access, and licensing terms; and advising on IT security requirements, valuation, tax, and complex commercial contracting issues

Represented a community-based nonprofit health system in the establishment and accreditation of a de novo school of medicine in partnership with a university, including navigating licensure and governance considerations

Served as lead regulatory counsel for the diligence team advising a multistate investor-owned hospital system in its acquisition of a national post-acute care provider valued at over US$1 billion

Represented an academic health system in the design and renegotiation of its affiliation agreement with its primary university school of medicine affiliate, including advising on AMC-specific considerations related to mission support and redesign of funds flow

Represented a university in negotiating a settlement related to its affiliation agreement with a health system and the ongoing support of the faculty practice and school of medicine

Represented an academic health system in the transition of its air ambulance life flight program from an external provider to internal operations, and coordinated review and negotiation of aircraft purchases and related financing, aviation services provider operating agreement, and licensure and enrollment work streams

Advised a children’s hospital on the establishment of a biorepository and use of resources from existing biobanks in industry collaborations. Additionally, counseled on regulatory and legal considerations with proposals to leverage residual biospecimens leftover from routine clinical care in commercial research partnerships with life science companies

Represented an academic health system in a precision medicine initiative that involved an arrangement with a spin-off of their GPO—a precision medicine AI startup—creating a federated model data lake with other participating systems in which digital health technology companies could iteratively train their algorithms. Issues considered and navigated included HIPAA, human research subject protections, intellectual property, commercial terms, and fraud and abuse considerations

Advised an academic health system on the Stark Law and Anti-Kickback-related considerations associated with, and assisted in structuring, a novel model for expanding the system’s community physician practice and physician network

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 an institution on the organization of a HIPAA hybrid entity and privacy considerations related to clinical research, as well as the intersection of the hybrid entity with the HIPAA-affiliated covered entity of the institution’s health system partner

Selected as legal counsel for an ARPA-H funded grant to assist a healthcare technology company in establishing a national data exchange by which hospitals will license de-identified digital images and surgical videos to approved requestors in furtherance of developing medical technologies, including AI technologies

Represented a hospital system in a data licensing transaction with a digital health company facilitating broadscale, algorithm-based de-identification of EHR data for subsequent use in life science research applications, including drug target discovery and clinical trial matching. Project also involved advising on consent and privacy issues related to large-scale digitization of existing pathology slides and a collaborative master research agreement among the academic health system partners participating with the digital health company

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

Provided research security training to the leadership team of an academic health system’s research institutes to address requirements related to foreign influence, NSPM-33, CHIPS and Science Act, and NDAA-233

Assisted NIH-funded cooperative groups in updating their conflict of interest (COI) policies and disclosure forms to address research security-related requirements

Assisted an academic health system in conducting a clinical trial billing audit, including supporting the development of billing coverage analyses (BCAs) to understand whether protocol-related charges were appropriately billed to study sponsor or payor

Supported a number of high-profile research misconduct investigations, guiding internal investigatory processes, representing institutions in related disclosures and refunds to grant-making agencies, and through disciplinary proceedings of faculty under the relevant tenure code

Advised a multistate nonprofit health system on the revision of its financial assistance policies and charity care practices in compliance with 501(r) and state charity care laws in the various jurisdictions in which the system operates, including representing the system in responding to 501(r)-related IRS audits

Assisted a health system in reviewing Stark compliance related to physician compensation arrangements, including investigation, preparation, and filing of several Self-Referral Disclosure Protocols (SRDPs) with CMS

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

Assisted a newly established healthcare 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 healthcare startups on entity formation, corporate practice of medicine, licensure, enrollment, reimbursement, and contracting considerations