Amanda Abbott, General Attorney in San Francisco, California

Amanda Abbott is a San Diego attorney specializing in healthcare and life sciences. Amanda draws upon her prior experiences as in-house corporate counsel, litigator, and neonatal intensive care nurse to provide uniquely pragmatic yet comprehensive legal services and strategic guidance to clients.

Amanda excels at structuring transactions that establish symbiotic clinical, business and research relationships for healthcare providers and biotech companies. She routinely advises clients regarding development and structuring of life sciences industry relationships with health care providers and nonprofit entities. Working with both start-ups and decades-old institutions, Amanda is a creative and efficient resource to her clients.

As Partner at Athene Law, Amanda brings to every transactional matter a deep knowledge of health information and data privacy and security, nonprofit tax-exempt transactions, healthcare reimbursement, clinical trials, fraud and abuse (false claims, anti-kickback, Stark, intellectual property and technology licensing, integrated delivery networks, managed care, and government regulatory mechanisms.

Amanda’s experience includes nearly a decade as in-house corporate counsel to a large health care system where she primarily handled healthcare and life sciences business transactions, clinical services and operations transactions, regulatory compliance guidance, reimbursement litigation oversight, and strategic advising.

Before working as in-house counsel, Amanda was a healthcare attorney with the litigation, transactional, and regulatory compliance groups at a national health care law firm. She began her career as a clinical care provider at the University of California, San Francisco Medical Center.

Education

Amanda earned her B.S.N. from the University of Pennsylvania in 1998, graduating with honors. She was the 1998 recipient of the Penn School of Nursing Award of Special Recognition for her contributions to biomedical research, volunteer work, and campus leadership.

Amanda received her J.D. from the University of California at Davis, King Hall School of Law in 2003. At UC Davis, she received a Witkin Award in Health Law, served on the Moot Court Board and competition team, was inducted into Sacramento’s Schwartz Inn of Court, and served as Judicial Extern for the Honorable Frank C. Damrell, Jr., of the U.S. District Court for the Eastern District.

Representative Matters

• Represented life sciences start-ups in business transactions and policy development essential to becoming fully operational post-formation

• Drafted documents and provided advice to a laboratory regarding Medicaid-funded genetic testing

• Developed and drafted research collaboration agreements for genetic research with hospitals around the United States

• Drafted and negotiated pilot project agreements, strategic partnerships, confidentiality agreements, material transfer agreements, co-development agreements, consulting agreements, multi-party consortium formations and agreements, research collaborations, clinical trial agreements, beta agreements

• Conducted employee and executive training on privacy of information, conflicts of interest in government-funded research and in nonprofit transactions, private use and private benefit, and other nonprofit corporation legal issues

• Negotiated hardware, lab instruments, and consumables purchase and licensing agreements for clinical and research laboratories

• Advised life sciences technology company on copyright, trademark, branding and press releases

• Drafted successful integrated delivery network documents including provider and management contracts, advised a nonprofit network with dozens of locations

• Extensive experience with drafting, analysis and compliance related to information privacy and security, e.g. HIPAA, California information privacy laws, COMIA (Confidentiality of Medical Information Act et al), GDPR (General Data Protection Regulation), CCPA (California Consumer Privacy Act), including Notices of Privacy Practices, privacy breach analysis, working collaboratively with technical experts and consultants to achieve compliant system procedures and protections

• Assisted health care providers in mitigation and response to large data breaches including those with individual, federal, and state agency reporting obligations

• Drafted and provided legal analysis on data sharing and data transfer arrangements, material transfer agreements with complex data sharing elements and multiple funding sources

• Drafted and negotiated service agreements, collaborative development, and data sharing agreements with international corporations including health care providers, technology companies, nonprofit entities, and laboratories

• Provided legal services for hospital revenue cycle and billing compliance departments, overseeing underpayment litigation, drafting and advising on hospital fair pricing, debt collection, and self-pay financial assistance program policies

• Drafted and negotiated research collaboration agreements and clinical trial agreements for nonprofit research center; experienced in clinical research transactions and compliance

• Represented a CLIA laboratory in the acquisition of a biorepository and wet laboratory, drafted and negotiated transactional documents, and advised on key aspects of operational transition and compliance

• Extensively experienced in representing health care providers in public agency (county, state, local health district, school district) contracting for health care services including behavioral and mental health Drafted and negotiated research services and laboratory services agreements; among others, WGS, WES, NGS, and focused disease panels

• Drafted and negotiated HPO (human phenotype ontology) database software and other bioinformatics pipeline technology services agreements (hosted software and SAAS licenses), data use agreements, data transfer agreements

Areas of Expertise

• Shared space and services arrangements

• Provider based status compliance

• Telemedicine and telehealth policies and agreements

• Precision medicine programs

• Stark, Anti-Kickback Statute, False Claims Act compliance

• EHR (electronic health records) licensing

• Supply chain and GPO (group purchasing organization) purchasing

• Patient and provider e-portal terms and conditions development

• Management and technology services agreements

• Data transfer, ownership, licensing and protection

• Professional and administrative services agreements

• Nonprofit corporate governance

• EMTALA (Emergency Medical Treatment and Active Labor Act); transfer agreements

• CLIA (Clinical Laboratory Improvement Amendments)

• Formation of and participation in integrated delivery systems

• Ambulance, air ambulance, medical transport contracting

• CCS (California Children’s Services) contracting (services, pilot programs, regional collaboration agreements)

• Provider reimbursement

• Federal and state health care program enrollment and conditions of payment and CoPs (conditions of participation)

• Billing compliance and repayments

• IRB, Privacy Boards, research compliance

• Working with various provider types in particular: laboratories, co-located hospitals, satellite facilities, primary care clinics, IPAs (independent physician association), FQHCs (Federally Qualified Health Center), PPOs (Preferred Provider Organization), urgent care centers, ancillary health care provider professional corporations, and physician/medical groups.

Professional Affiliations

• American Health Lawyers Association

• Association of Corporate Counsel

• California Society for Healthcare Attorneys

• Lawyers Club of San Diego

• San Diego County Bar Association (Law & Medicine Section Vice Chair 2020)

• Sharp Healthcare Bioethics Committee

• Women in Bio, SoCal Chapter