Becoming Interoperable
The Canadian health data ecosystem is shifting toward a more interoperable and governance-focused framework. This shift reflects growing recognition that healthcare data is foundational to care delivery, public health insight, and system coordination across Canada.
Initiatives like the Connected Care for Canadians Act (Federal Bill S-5), and Ontario’s More Convenient Care Act (Bill 11) and Primary Care Act (Bill 13) align with principals in the Pan-Canadian Health Data Charter, and attempt to form a legislative cornerstone of this major shift.
Federal Bill S-5, which was tabled in February 2026 ,and has gained significant momentum, positions FHIR® as the health data interoperability standard. The Bill addresses information blocking and outlines enforcement mechanisms intended to reduce interoperability barriers created by proprietary architectures. This initiative aligns to data sovereignty, driven by the imperative to ensure governance, and mitigate exposure and risks to Canadian health information.
This shift aligns Canada with broader international interoperability trends seen in jurisdictions such as Australia, Germany and the United States).
With FHIR as a national standard for health data interoperability and value creation, Canada is positioned to transition from basic data connectivity to a more intelligent and operationally connected ecosystem that delivers real-time value including opportunities for prospective care management. By mandating vendor accountability and prohibiting data blocking under Bill S-5, the healthcare system can now shift from storing and exchanging dense, fragmented, non-computable data and documents, to an architecture that supports comprehensive, semantically structured, standardized, and queryable data.
This modernization shift is expected to deliver significant impacts across the ecosystem:
- For Patients: Seamless care continuity across providers to improve access to care, including virtual care, enhanced outcomes and better health equity in under-served populations.
- For Hospitals: Early cost projections of transitioning to FHIR-based automation for reporting requirements alone is projected to save mid-to-large hospitals at least $450k annually, while simultaneously reducing the 20M+ hours that Canadian doctors lose each year to administrative paperwork.
- For Federal Agencies: By aggregating clinical data from provinces and territories into standardized formats, the ability to measure system performance and run other population-level insights on comprehensive, accurate data will improve, without adding manual burden.
- For Provincial and Territorial Ministries: The Federal Bill S-5 provides a basic interoperability framework upon which provincial and territorial ministries can significantly improve the management of population health, while maintaining cost efficiencies, custody and control of their data, manage IT vendors, lower admin burdens, while meeting national benchmarks.
Other Significant Impacts Include:
- Operational and Analytical Opportunities: Turning fragmented patient records into a unified data engine that validates quality and accuracy right at the source, significantly reduces administrative burden and costly delays
- Building a Foundation for Scalable Innovation: Upon a high-quality unified data source, intelligent and defensible analytics and insights can run to ensure on-time public health monitoring and delivery of best-practices to front lines.
What is Clear with Bill S-5
Bill S-5, the Connected Care for Canadians Act, establishes a federal regulatory framework to prohibit data blocking by health IT vendors and ensure seamless data exchange. The Bill shifts Canadian healthcare technology towards national interoperability standards, empowering the Ministries of Health, Provincial and Territorial Authorities, and Providers with better oversight and sovereignty, and providing the Federal Ministries with financial enforceability for vendor management.
Under the proposed Bill S-5, vendors have new requirements to adhere to:
- No More "Locked" Data: Under S-5, the legislation seeks to reduce interoperability barriers created by proprietary data exchange limitations that prevent Canadian healthcare providers and health agencies from exchanging patient records across systems.
- Mandatory API Access: Standardized FHIR® APIs intend to support authorized data exchange across healthcare systems.
- Usability Mandate: Vendors must provide data, in a way that the receiving system can actually read and integrate into its own systems, i.e. ‘data usability’
- Fees and Penalties: As per Bill S-5, Federal oversight and the ability to levy penalties onto vendors, and determine what constitutes ‘reasonable fee charges’ for data access and exchange.
- Reporting: Federal oversight also includes requesting documentation from the vendor on their technical specifications and business practices to prove they aren't blocking data.
- Public Accountability: The Bill allows the ability to publicly disclose vendors who fail to meet interoperability standards, which is a significant deterrent for companies competing for large provincial contracts.
The Technical Interoperability Stack
According to Senate testimony and Health Canada's interoperability plan, several interoperability standards and implementation frameworks are increasingly referenced across Canadian interoperability initiatives and federal guidance discussions, including:
- HL7® FHIR (Fast Healthcare Interoperability Resources): The globally adopted health interoperability standard for structuring and sharing data.
- CA:FeX (Canadian FHIR Exchange): A set of Canadian-specific specifications that define exactly how FHIR should be implemented across different provinces to ensure national consistency.
- SNOMED CT: The standard clinical terminology used for coding medical diagnoses, procedures, and clinical findings to ensure everyone uses the same "medical language".
- LOINC: The standard for identifying laboratory observations and clinical results.
- OAuth 2.0 & OpenID Connect: The security and identity frameworks used to verify that the person or system accessing the data is authorized to do so.
- SMART on FHIR: A protocol that allows third-party apps to run "on top of" electronic health records, enabling third-party applications to integrate securely with healthcare platforms.
It is expected, but not currently mandated that upcoming regulations will address standards around bulk data. FHIR Bulk Data Access allows hospitals or clinics to move population records at once in a standardized format, preventing vendors from using ‘unreadable data dumps’, financial pay walls or manual administrative processes.
From Legislative Intent to Practical Application
Bill S-5 establishes a necessary foundational framework that supports interoperability, data sharing and addresses system-wide fragmentation and burdens. However, clarity around practical implementation and enforcement are still evolving. In a recent brief Digital Health Canada shared stakeholder concerns that must be addressed to successfully deliver on the promise of a truly connected care system. Concerns include:
- Non-technical Interoperability: While FHIR is the established technical standard, information sharing challenges are frequently operational and organizational, not purely technical. For appropriate data to be usable in real-time at the point-of-care, with privacy, security and auditability intact, alignment across governance, workflows, departments, consent models, and operational change management is also required.
- Data Blocking Clarity and Enforcement: Definitions around what constitutes intentional data blocking versus necessary cybersecurity restrictions are still evolving. This lack of clarity can make effective procurement, auditing and monitoring of vendor adherence challenging, adding to technical complexity.
- Security and Privacy Risks: Managing increases systems’ exposure to cybersecurity threats, identity and access management practices, cross-border data transfers to prevent inappropriate access or secondary data use for financial or commercial gain, and clear approaches for data storage, retention, and exchange.
- Patient and Provider Burden: Concerns that data sharing may increase the administrative workload for hospitals, clinics and care-providers, and that the value of shared data in improving care is not guaranteed in all cases were raised.
- Data Sovereignty: Mechanics and processes to ensure data is governed by Canadian legal frameworks, rather than foreign laws like the US CLOUD Act.
How Smile Digital Health Supports the Canadian Ecosystem
Smile Digital Health provides the foundational framework to move ecosystems from the currently fragmented (often legacy or vendor-locked) silos of data, workflows and processes to validated, queryable, semantically structured and standardized data. The Smile OmniVera solution addresses Bill S-5 by:
- No Vendor Lock-in: Consolidating and standardizing data from all fragmented systems into a single source-of-truth health repository, that is usable and exchangeable
- Ensuring Data Sovereignty: Ensuring Canadian health information governed by Canadian governance frameworks and legal requirements
- National Scale: Validating data quality and accuracy at the ingestion source, with the ability to expand at mega-volumes
- Cross-jurisdictional capability: Smile’s solutions support FHIR-based IPS (International Patient Summary) to ensure coordinated and timely care across borders.
- Proven Expertise: Leveraging national implementation expertise from FHIR implementations in Australia, Malaysia, the US, and public health agencies like the WHO and the CDC
Smile Digital Health is a Canadian-born Global Recognized Health Technology Company that Builds Solutions on HL7® FHIR®