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Epstein Becker Green has significant experience representing academic medical centers (AMCs) in a wide variety of regulatory, operational and strategic business issues. We have helped AMCs structure and implement effective relationships between and among the hospital(s), faculty practice and medical school. We also have experience advising academic institutions on compliance issues, responding to government investigations and litigation involving biomedical and human subject research.
Drawing on our vast knowledge in a range of legal subjects, Epstein Becker Green provides complete legal support for AMCs, including:
- Biomedical and human subject research compliance issues
- Structuring relationships with sponsors and trial management organizations
- Advice in connection with sponsored research agreements, grant administration and IRB activities
- Resolving financial conflicts of interest
- Appropriate designs for selection and incentivization of research subjects
- Protecting confidentiality and privacy
- Protecting intellectual property
- Medicare coverage and reimbursement compliance
- Responding to government audits, investigations, and reporting requirements
- Development of institution-wide research policies and procedures
- Labor and employment issues
- HIPAA compliance
- Structuring and negotiating appropriate compensation arrangements with faculty physicians and researchers
- Establishing and implementing corporate compliance programs
- Addressing medical staff matters, including fair hearing requirements and designing state-of-the-art medical staff bylaws
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