Canada’s Drug Agency releases roadmap for linking registry and health data to support rare disease care

Canada’s Drug Agency’s new roadmap guides registry teams in linking data to improve rare disease decision-making, addressing privacy, consent, and data-sharing challenges across jurisdictions.

Canada’s Drug Agency, in partnership with organizations including ICES and Health Data Research Network Canada (HDRN), has launched a new roadmap aimed at enhancing decision-making and improving care for patients with rare diseases. This roadmap is designed to support teams managing patient and disease registries in Canada, offering guidance on linking real-world data (RWD) from registries with administrative health services to address critical research and policy questions.

The roadmap provides practical resources for registry teams in two key documents:

• A guide on data linkage – This document outlines an eight-step process with essential best practices and considerations for registry teams working to link data records effectively.
• Informed consent guidelines – This supplementary document addresses critical elements for developing or updating informed consent forms.

The importance of data linkage

Data linkage is the process of integrating information from multiple sources about the same individual to create a more holistic view of patient health. By combining data from disease registries—datasets containing detailed information about patients with specific diseases— with administrative health data, stakeholders can gain insights into patient outcomes, the impact of diseases, and health system resource use.

Patient and disease registries are integral to research, providing RWD on disease progression, clinical effectiveness, and healthcare outcomes. However, registry data alone may not fully convey the context of patient care, especially for rare diseases. RWD from administrative health databases, which includes records from hospital visits, physician services, and pharmacies, complements registry data by providing a broader, more detailed view of healthcare utilization and outcomes.

For registry managers, linking these RWD sources offers several key advantages:

• Improved disease insight: By combining registry and administrative data, registry teams can gain a more comprehensive view of disease burden and patient outcomes.
• Reduction in data duplication: Data linkage minimizes redundant data collection by using relevant data already available in administrative datasets.
• Monitoring patient status and resource use: Linked RWD enables registry teams to track patient status and healthcare utilization, such as medication adherence, by monitoring prescription fills and refill frequency.

These benefits not only improve registry efficiency but also provide valuable information for researchers and policymakers seeking to understand and manage rare disease impacts.

Addressing challenges in data linkage

While data linkage offers significant potential, registry teams may encounter several challenges. Privacy laws and ethical standards differ across provinces, complicating data sharing between jurisdictions. Funding agreements can also restrict data disclosure, and the processes of linking and cleaning data can incur substantial costs. Another critical concern is ensuring that patient consent is obtained appropriately, especially when linking identifiable health data.

The roadmap addresses these challenges by providing structured guidance to help registry teams navigate privacy legislation, ethical considerations, and funding constraints. It also includes tools for optimizing consent forms, ensuring that patients are well-informed about how their data will be used.

The release of this roadmap aligns with Canada’s Drug Agency’s expanded mandate and supports the federal government’s National Strategy for Drugs for Rare Diseases. This strategy aims to enhance evidence generation and use real-world data to inform treatment and policy decisions. By expanding pan-Canadian data collection and improving access to health data, the roadmap seeks to strengthen healthcare and improve outcomes for rare disease patients across Canada.