As Chair of the firm's Health Care & Life Sciences Group, Andrew provides regulatory and compliance advice to a broad range of clients in the health care and life sciences industries, including hospitals, academic medical centers, and related providers as well as pharmaceutical, medical device, and biotechnology companies.
While Andrew's practice is broad and encompasses many different legal areas within the health care and life sciences space, Andrew has particular experience with respect to the following types of matters: hospital and payer affiliations, including negotiations of affiliation agreements, revisions to governance documents, regulatory approvals, and diligence matters; the formation and operation of accountable care organizations (ACOs), physician-hospital organizations (PHOs), independent practice associations (IPAs), and related multi-provider networks; compliance with the federal anti-kickback statute, Stark law, and other fraud and abuse laws such as in the context of product discount arrangements, relationships with physicians, and health care transactions; the European Union General Data Protection Regulation (GDPR) and HIPAA, HITECH, and state privacy laws including the development of comprehensive privacy and security policies and related guidance documents; and the conduct of human subjects research and related issues, both domestically and internationally.
Andrew has gained a strong understanding of the operational aspects and business of pharmaceutical and device companies through prior on-site placements at three different companies. In these positions, Andrew advised clients on various legal issues including fraud and abuse laws, clinical trials and related issues (e.g., privacy, subject recruitment, site contracting, informed consent forms, and FDA requirements for INDs), market research, promotional review activities, patient assistance programs, group purchasing organization and customer contracts, discount and pricing arrangements, sales representative contracts, and state manufacturer conduct and disclosure laws including on FDA regulations and other requirements related to these activities.
In order to prepare for advising clients on the complex ethical issues involved with human subjects research, Andrew earned a Master of Bioethics from the University of Pennsylvania Center for Bioethics while he was in law school.
Academic & Clinical Research | Biopharma & Medical Device | Government Enforcement & Compliance | Health Care | Health Care & Life Sciences | Payments & Reimbursement | Privacy & Security | Strategic Counseling & Transactions
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