Data governance in support of LHS initiatives for precision oncology implicates an intricate web of statutes, regulations, guidance, policies, and practices. Statutes and subordinate regulations collectively set the legal framework for the governance of ‘omics and other health information, health and safety of precision oncology technologies, professional practice, intellectual property (IP) rights, clinical research, as well as coverage and reimbursement. However, institutional/organizational policies and practices interpret and implement this body of law, regulation, and guidance in ways that may not accord with the values and preferences of Canadians in supporting LHS initiatives for precision oncology. Improving
Canadian systems for data generation that enable individualized care decisions and services, as well as improving the efficiency of clinical trials, is a Health Canada priority.
This research activity aims to analyze legal, policy, and practice enablers and impediments to:
- Generation and utilization of real-world evidence
- Data generation, access, and use within and across provincial health systems, research institutions, the not-for-profit sector, and the private sector
- Legal implications for patient control of data, enabled by blockchain technology.