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 benefitted clients in the development of comprehensive data strategies concerning areas such as privacy, security, data mapping, secondary data use, availability and interoperability.

Show Less

• Assisted in the development and deployment of network research arrangements
• Advised clients on public trust and data stewardship best practices
• Assisted developers and adopters of digital health technologies to conduct regulatory analysis of user experiences to facilitate to the deployment of patient-facing digital health tools

Show Less

• The American Lawyer, Global Pro Bono Attorney of the Year, 2013
• McDermott’s Outstanding Achievement Award for Commitment to Pro Bono and Service to the Community, 2004

Show Less