News
Q3/2024 Life Science Law Update – Key developments for pharma & device companies in EU
31 October 2024
Howard University on a management services agreement with Adventist HealthCare to build a new replacement hospital as part of their overall strategy to serve the health care needs of the community and region.
Vanderbilt University on transfer of its medical center, dozens of ancillary businesses and sites, and a 50-hospital affiliated network to a newly formed independent organization.
St. Louis University on acquisition of St. Louis University Hospital from Tenet Healthcare and contribution of hospital assets to newly formed joint venture with SSM Health.
The University of Pennsylvania on its exclusive license and collaboration agreement with Novartis for the development of novel CAR-T therapies.
Fred Hutchinson Cancer Research Center in its initial founding, investment, licensing, collaboration, contractual and shareholder matters, and initial public offering of Juno Therapeutics.
Fred Hutchinson Cancer Research Center in its license and collaboration agreements with Faraday Pharmaceuticals.
A large multi-site hospital system in a series of adverse audit findings to enhance its financial and administrative compliance policies and procedures, and delivered comprehensive research compliance training.
Assist multiple hospitals to establish affiliated research institutes, advise on federal grant and contract law, draft research policies and agreements, and create federal regulatory compliance structures.
Draft conflict of interest policies for academic medical centers and advise on issues that arise in negotiating licensing agreements and other commercial arrangements.
Help payers on behalf of provider associations to influence coverage and reimbursement proposals and resolve coverage and reimbursement challenges.
Hospitals and academic medical centers in matters involving claims of fraud in connection with federally funded programs, including clinical research programs.
Numerous public and private hospitals and academic medical centers on establishing health care fraud and abuse compliance programs.
Medical centers on HIPAA compliance, policies and procedures, privacy, and information security. We are also involved in data breach prevention efforts and security incident investigations.
Advised a national health care company on applicable laws and regulations for delivery of physician visits and consultations over the internet.
Advised on various regulatory aspects of international telemedicine, including cross-border health care, data privacy, and medical device aspects.
Advising a major hospital on efforts to establish administrative office locations and clinical research sites across four continents.
Advised an institution on preparing guidelines for the launch of its digital health project in China, addressing regulatory constraints and proposing measures to manage regulation.
Conducted audits and facilitated reporting for several hospital Human Research Protection Programs to assess compliance with FDA and the Office of Human Research Protections (OHRP) regulations.
American Hospital Association, the Association of American Colleges, and three individual hospitals on fending off a rule to cut more than US$600m to Medicare providers of outpatient hospital services.