- Life Sciences
Amanda Abbott is a San Diego attorney specializing in healthcare and life sciences. Amanda draws upon her prior experiences as a nurse, litigator, and in-house corporate counsel to provide uniquely pragmatic yet comprehensive legal services and strategic guidance to clients.
Amanda excels at structuring transactions that establish symbiotic business and research relationships for healthcare providers and biotech companies. Her approach successfully facilitates new technology development and integration into clinical care. By advising both start-ups and decades-old institutions, Amanda is a creative and efficient resource to her clients.
For many years, Amanda served as a key advisor in the establishment and growth of research and clinical operations at a life sciences start up, supporting the clinical research efforts and clinical genetic testing laboratory services operations that yielded rapid growth and recognition for the company as a leader in translational medicine research and implementation.
As a partner at Vanst, Amanda applies her understanding of healthcare issues to enable bench-to-bedside relationships that are vital to innovation in healthcare. She 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 including most notably as a neonatal intensive care unit nurse at the University of California, San Francisco Medical Center.
Amanda is an alumnus of the University of California, Davis, King Hall School of Law, and the University of Pennsylvania.
Representative Matters and Transactions
- Drafted documents and provided advice to a laboratory regarding Medicaid-funded genetic testing
- Developed and drafted research collaboration agreements for genetic research with children’s hospitals around the United States
- Represented a life sciences start up in all business transactions and policy development essential to becoming fully operational post-formation
- 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
- 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
- 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
- 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
- Drafted and negotiated hundreds of HIPAA Business Associate Agreements and Data Use Agreements
- Developed HIPAA-compliant policies and procedures for health care providers of all sizes from solo practitioners in alternative medicine fields to health systems
- Assisted health care providers in mitigation and response to large data breaches including those with individual, federal, and state agency reporting obligations
- Experienced advisor of a covered entity privacy board and for covered entity research administration activities including IRB (Institutional Review Board) and protocol compliance
- 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, in South Korea, Belgium, United Kingdom, China, Israel, and Australia
- 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
- Represented a general acute care hospital in a multi-year deal to manage the Medi-Cal managed care business of multiple regional specialty hospitals, drafted and negotiated related agreements
- 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 from a university, 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
- Developed an intellectual property program for a nonprofit entity, trained employees and executives on policy implementation
- Achieved resolution of novel and complex legal issues that affect health care and life sciences companies’ day to day operations in emerging fields
- Successfully partnered with executives, consultants, and client staff to understand the business and provide thought leadership on creative operational strategies that allowed acceleration of company goals along with risk mitigation
- Routinely advise clients regarding development and structuring of life sciences industry relationships with health care providers and nonprofit entities
- Provided robust yet practical transactional and regulatory compliance guidance to various health care provider types such as: physician/medical group, laboratory, co-located hospital, satellite facility, primary care IPA (independent physician association), FQHC (Federally Qualified Health Center), PPO (Preferred Provider Organization), SNF (Skilled Nursing Facility), urgent care center, ambulatory surgery center, hospice and home care, and ancillary health care provider professional corporations
- Experienced in:
- Providing legal advice and handling day-to-day and as well as transformative business transactions
- Shared space and services arrangements
- Provider based status compliance
- Telemedicine and telehealth policies and agreements
- Precision medicine programs
- Legal issues in shifting payment paradigms
- 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
- Intellectual property and data ownership, licensing and protection
- Professional and administrative services agreements
- Nonprofit corporate governance
- EMTALA (Emergency Medical Treatment and Active Labor Act); transfer agreements
- Sunshine Act compliance
- 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)
- Commercial payer contracting
- Provider reimbursement
- 340B drug pricing program
- Federal and state health care program enrollment and conditions of payment and CoPs (conditions of participation)
- Billing compliance and repayments
- Women in Bio, SoCal chapter
- American Health Lawyers Association
- Lawyers Club of San Diego
- California Society for Healthcare Attorneys
- San Diego County Bar Association (Law & Medicine Committee)
- Association of Corporate Counsel (2011-2019)
- American Association of Nurse Attorneys (2003-2013)
- Sharp Healthcare Bioethics Committee (2006-2011)
- “HIPAA Updates,” San Diego County Bar Association, September 28, 2011
- “HIPAA Update: New Compliance Requirements for Business Associates,” San Diego Legal Secretaries’ Association, June 28, 2010
- “How the Federal Stimulus Package Affects the Health Care Industry,” San Diego County Bar Association, June 11, 2009
- “Resident Abuse & Reporting,” Council for Long Term Care Nurses of California Annual Seminar, October 19, 2006
- Why Your Start-Up Will Benefit from Outside General Counsel Services
- 5 Ways Clinical Researchers Can Avoid Being HIPAA Business Associates
- Legal Review Can Help Your Research Protocol Stay on Track
- “Extending HIPAA’s Reach to Subcontractors May Impact California Litigation Practices,” Vol. 29 California Health Law News (Summer 2011).
- Patric Hooper & Amanda Abbott, Health Care Fraud and Abuse: Practical Perspectives, Ch. 4: Practical Considerations for Defending Health Care Fraud and Abuse Cases (L. Baumann ed., 2d ed. 2007 & Supps. 2008 & 2009).
- “New End of Life Care Requirements for Hospitals,” Vol. 11 Health Law Perspectives No. 4 (April 2009).
- “Special Report: HR 1- The American Recovery Reinvestment Act” (Contributing Writer), Health Law Perspectives (March 2009).
- “Employing or Contracting With an Excluded Individual Risky for Providers,” Vol. 8 Health Law Perspectives No. 9 (Dec. 2006)