European Union GDPR—Institution
Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies.
Conflicts of Interest
Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.
Multi-Site Global Research
Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent government review of NIH funding activities.
Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.
Presented to senior executives and other management of a start-up pharmaceutical company on complying with the FDA advertising and promotion requirements pre- and post-launch.
Served as on-site, long-term legal counsel for various clients, including pharmaceutical and device companies during times of staffing shortage at the clients.
Informed Consent Form Templates
Developed 23 different types of global research informed consent templates for a major pharmaceutical company along with detailed negotiation guidelines for compliance with applicable laws and best practices.
European Union GDPR—Pharmaceutical Company
Advised pharmaceutical company on all aspects of compliance with the GDPR, including gap analysis, policy and procedure development, and vendor and other third party contract revisions.
Obtained a jury verdict in federal court for a qui tam whistleblower against a medical device company that had retaliated against our client for filing a qui tam lawsuit under the False Claims Act, which resulted in the federal Medicare and California Medicaid programs recovering in excess of $25 million.
Developed and prosecuted coordinated Medicaid appeals and litigation on behalf of a group of hospitals that resulted in a landmark settlement of approximately $95 million with the State.
Health Information Exchange
Worked on behalf of a client to effect statutory changes to a state law that would allow for the creation of one of the nation's first state-wide health information exchanges.
Health System Affiliation
Acted as corporate counsel to a large health system during a major affiliation, negotiating deal documents and advising on structural and various legal issues, which ultimately lead to the creation of the second largest non-profit health system in New England.
Payor-Provider Joint Venture
Worked with an insurance company and a network of primary care practices to create a joint venture, providing patients with access to high-quality, personalized health care in a community setting.
Sale of Teaching/Community Hospital
Assisted with the sale of a 500-bed teaching and community hospital to the teaching hospital of a major university, making this hospital system one of the largest in the country.
Appellate Tax Board Decision Appeal
Represented a trade association, on behalf of a health insurer, before the state Supreme Judicial Court in a successful appeal of an Appellate Tax Board decision.
Sale of Nursing College
Worked with a hospital in the sale of its nursing college to a nearby university, including negotiation of a management agreement to allow the university to operate the college pending regulatory approvals.
Acquisition of Urgent Care Centers
Represented a private equity group in acquiring the stock of two entities which owned 13 urgent care centers.
Assisted a tax-exempt health care organization to draft new bylaws following extensive discussions with board committees and the full board to assure that both the mission and governance structure of the organization were fully captured in the new bylaws.