On June 6, 2024, the Minister of Health, the Honourable Mark Holland, introduced Bill C-72, An Act respecting the interoperability of health information technology and to prohibit data blocking by health information technology vendors ("Bill C-72"). Coined the Connected Care for Canadians Act ("CCCA"), Bill C-72 sets out Canada's plan to enable (not establish) a more connected healthcare system, in which health information can be securely accessed by patients and shared between providers, when needed. It seeks to establish a framework that enables the safe and secure exchange of health data, giving patients better access to, and more control over, their personal health information.
The timing of Bill C-72 is interesting as Parliament is set to commence its summer break on June 21st. Accordingly, we do not expect any further developments until the Fall. Moreover, the substance of Bill C-72's main requirements and enforcement powers have been left to yet-to-be released regulations.
Key Objectives
Based on comments from the Ministry of Health and the Preamble to Bill C-72, the law has five notable objectives:
- Enhance Patient Safety: By facilitating timely access to health records from multiple sources, Bill C-72 aims to reduce harm to patients caused by things like unnecessary or duplicative tests, longer wait times and hospital stays, and medical error. The idea is that patients, family members, caregivers, and health care providers all benefit from having access to the full picture of a patient's health status.
- Improve Access to Health Information and Services: Canadians, and their health care providers, should be able to access their health information simply, securely, and digitally. Further, Bill C-72 acknowledges the use of digital tools to increase accessibility, particularly for remote and underserved communities.
- Support Health System Innovation: The framework will encourage the adoption of new technologies and data-driven solutions to enhance health outcomes for patients.
- Provide a National, Connected, Health Case System: The framework is designed to promote cooperation and consultation among federal, provincial and territorial governments, as well as Indigenous peoples and other key stakeholders, to establish common interoperability standards in order to create a connected health system.
- Protect Privacy: The legislation emphasizes the importance of safeguarding personal health information while enabling its mobility across different health care providers. How these obligations will interplay with provincial and territorial personal health information laws has yet to be addressed.
Provincial Application
In a similar way to how PIPEDA (Canada's private sector privacy legislation) is a federal law that only applies in certain provinces and the territories, the CCCA would only apply in a province or territory that does not have its own requirements that are "substantially similar" to, or exceed, those established under the CCCA.
The Governor in Council is empowered to make orders that any provision of the CCCA or the regulations apply in any province or territory. Such decisions will need to be made in accordance with the criteria and process to be provided for in the regulations.
Health Canada's press release1 indicates that federal, provincial, and territorial governments are currently working together on the implementation of a Pan-Canadian Interoperability Roadmap that would address common interoperability and data standards. Bill C-72 aims to accelerate the adoption of these standards and enable secure information sharing across platforms and health systems.
Implications for Service Providers
The bulk of the obligations under Bill C-72 fall on service providers, not provincial or territorial health care systems.
Bill C-72 imposes obligations on "health information technology vendors" which are broadly defined as "an individual, corporation, joint venture, partnership or unincorporated organization or association that licenses or sells health information technology or supplies it as a service."
"Health information technology" is also broadly defined to include "hardware, software, integrated technologies, intellectual property and upgrades that are designed for creating, maintaining, accessing, using or exchanging electronic health information or that support such activities."
"Electronic health information" and "personal health information" are defined with reference to, among other things, information concerning or collected in the course of any "health service" provided to an individual. However, Bill C-72 does not define "health service".
In light of these broad definitions and concepts, any service provider with customers operating within, or in support of, the Canadian healthcare system will want to keep a close eye on the Bill as it moves through the legislative process.
Under Bill C-72, health information technology vendors in Canada would be subject to the following obligations:
- Interoperability Requirement: Vendors must ensure that the health information technology they license, sell, or provide as a service is interoperable, meaning it must allow users to easily, completely, and securely access and use all electronic health information and exchange all electronic health information with other health information technologies. Additional standards for interoperability may also be included in the regulations.
- Prohibition of Data Blocking: Vendors are prohibited from engaging in data blocking, which is defined as practices or acts that prevent, discourage, or interfere with the access to, use, or exchange of electronic health information. Specific practices and acts constituting data blocking will be detailed in the regulations.
Ultimately, vendors are expected to align their products and services with these obligations to support the creation of a connected, secure, and person-centered health system.
Enforcement
Bill C-72 includes the following enforcement tools:
- Regulatory Compliance: Vendors may be required to provide information or documents necessary for the Minister of Health to verify compliance with the interoperability and data blocking provisions of Bill C-27 or any associated regulations. Any such requirements will be included in the regulations.
- Addressing Complaints: Bill C-72 also indicates that the regulations may include a regime for handling complaints related to a vendor's non-compliance with the interoperability requirements or data blocking prohibition.
- Administrative Monetary Penalties: A system of administrative monetary penalties may be established by the regulations for vendors that contravene the interoperability requirements, prohibition of data blocking, or any provisions of the regulations. The amount of these penalties or the method for determining the amount will be set in the regulations.
- Review Processes: The regulations may also address the review of decisions made following compliance verifications or complaints, as well as reviews of notices of violation or penalties imposed under the system of administrative monetary penalties.
Enforcement would fall to the Ministry of Health, and presumably Health Canada. While Health Canada has an active investigations and enforcement branch, enforcement of technical requirements like those introduced under Bill C-72 do fall outside Health Canada's current repertoire. In light of this, it will be interesting to see how provinces and territories with substantially similar requirements under separate legislation will approach and allocate enforcement obligations.
Implications for Health Care Providers and Patients
Bill C-72 does not introduce any direct legal obligations on health care providers. However, it will impact how health care providers select, engage, and manage their technology vendors as the CCCA will require that they use and licence health infromation technology that aligns with the national framework. This transition will require careful planning, investment, and training to ensure that the systems in place, or put in place, are compliant with the new regulations, to the extent they are applicable. Health care providers should also watch this legislation closely as it may require amendments to existing contractual relationships with technology vendors to ensure compliance, or early termination in the event that an existing technology vendor is unwilling to align their product with the new requirements.
Conclusion
The CCCA represents a bold step forward in creating a more integrated and patient-centered health care system in Canada. While the transition will pose challenges, it also offers opportunities for innovation and improved care delivery.
Footnote
To view the original article click here
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.