McDermott Will & Schulte, a global law firm

Emily Jane Cook serves as counsel to clients in the healthcare sector from start-ups to established market leaders on a wide range of critical regulatory matters to ensure compliant business operations. Her guidance allows these organizations to prospectively and retrospectively manage the risks associated with operating in a high-complexity and highly-regulated sector.

A national authority on the 340B drug pricing program, Emily also helps clients across the country navigate a wide range of complex federal and state healthcare regulations. Her counsel encompasses issues such as navigating federal and state fraud and abuse laws, development of innovative models for healthcare delivery, Medicare provider-based and co-location rules, pharmacy laws and licensure, graduate medical education, and federally qualified health centers. This depth of knowledge across many regulatory issues allows her to provide her clients with comprehensive legal advice and guidance, which allows them to fully evaluate risks in their business and clinical operations. She works closely with colleagues in McDermott’s diverse practice areas to deliver fully realized solutions for her clients.

Emily’s deep insights into US healthcare regulation stem from her previous tenure at the US Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA). For more than five years, she worked with providers and across government agencies to address regulatory barriers to healthcare delivery. She advised senior HHS leadership on Medicare and Medicaid regulation and reimbursement issues affecting rural communities and providers, and served as senior policy advisor to the National Advisory Committee on Rural Health and Human Services.

Emily is an active member of the American Health Law Association, where she most recently served as the Chair of their Medicare and Medicaid Institute. She is also a member of the firm’s Health/White Collar cross-practice group.

With a practice focused primarily on the development, delivery and implementation of digital health solutions, data and research, Jennifer S. Geetter works closely with both adopters and developers to bring their innovative healthcare solutions to patients and providers. In order to design and deploy digital health technologies effectively, Jenn offers valuable guidance on key issues, like patient on-boarding, provider implementation, privacy and regulatory issues. She advises global life sciences, healthcare and informatics clients on legal issues attendant to digital health, biomedical innovation, research compliance, global privacy and data security laws, and financial relationship management. Jennifer represents a broad range of clients, including the following:

• Mobile app, mHealth, and other digital health technology companies and platform providers
• Informatics, data broker and data aggregator companies
• Pharmaceutical, device and biologics companies
• Health plan, institutional healthcare provider and other enterprises
• Research institutes

Clients seek Jennifer out for her knowledge on the development of data and biospecimen registries and real-world evidence (RWE). She advises healthcare and life sciences stakeholders in considering the complex regulatory and implementation challenges that arise when developing these registries and other digital care solutions, including research, compliance, privacy, interoperability, and data governance, access and curation. Jenn also considers a range of other issues that impact how registries are built, including data governance strategies and application. She has built a strong reputation for counseling clients through registry development, with special emphasis on navigating the unique legal nuances around genetic information, biospecimens, sensitive data and other special use cases. Jennifer assists these clients with a range of projects, including the following:

• Health Insurance Portability and Accountability Act (HIPAA), Federal Trade Commission (FTC), and state and federal privacy, security and breach response preparedness and response
• Development and implementation of data-sharing strategies and platforms to achieve business objectives, particularly in connection with biomedical innovation, healthcare reform, electronic health record implementation and quality assurance requirements
• Data privacy, data mapping and data use strategies for mobile apps and other mHealth and digital technologies
• Research compliance, research program structure, and operational and compliance infrastructure
• Complex research affiliation agreements and arrangements
• Scientific review and research misconduct proceedings and investigations (internal and with government involvement)
• Biobanking and registry development and compliance, including emerging issues in the future, unspecified use of biospecimens and genomic data

In her work with digital health clients on strategic and compliance counseling, Jennifer is especially knowledgeable on interoperable, comprehensive data collaborations and data webs, and human subject research compliance. Her forward-thinking and strategic vision have benefited clients in the development of comprehensive data strategies concerning areas such as privacy, security, data mapping, secondary data use, availability and interoperability.

Joseph (Joe) M. Parise advises healthcare clients on a wide range of transactional and regulatory matters across the United States. He serves as counsel to private equity firms and their portfolio companies, physician practices, practice management companies, behavioral health providers, hospitals and health systems.

Joe has experience executing a variety of transactions within the healthcare industry, including mergers, acquisitions, joint ventures, affiliations and divestitures. He also works with clients to navigate the complex strategic and regulatory issues associated with those transactions.

He also provides guidance to clients on sector-specific regulatory issues including with respect to the practice of medicine, dentistry and physical therapy, state licensure and certificate of need, behavioral health and behavior analysis, and pharmacy and clinical laboratory matters.