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National Rules for Health Data Sharing

Full Title: An Act respecting the interoperability of health information technology and to prohibit data blocking by health information technology vendors

Summary#

This federal bill would set national rules for how health information technology (HIT) must connect and share electronic health information. It requires vendors to make their products interoperable and bans data blocking by vendors. The Act applies in a province or territory only if the federal government issues an order after finding that local rules are not as strong. It takes effect on a date set by order in council (Bill — Purpose; Application; Coming into Force).

  • Requires HIT vendors to make systems interoperable and allow secure, complete exchange of electronic health information, except where privacy laws restrict it (Bill — Interoperability and Data Blocking).
  • Prohibits data blocking by vendors; details and examples will be set in regulations (Bill — Definitions; Regulations).
  • Lets the federal government set technical standards, a complaints process, verification powers, and administrative monetary penalties (Bill — Regulations).
  • Applies province-by-province by federal order if local requirements are not “substantially similar to or exceed” the Act (Bill — Order).
  • Violations are not criminal offences; enforcement uses administrative penalties, not the Criminal Code (Bill — Section 126 of Criminal Code).
  • Key terms are broadly defined, including electronic health information and HIT (Bill — Definitions).

What it means for you#

  • Households (patients)

    • You should get easier, more complete, and secure access to your electronic health records when your providers’ systems use compliant technology (Bill — Interoperability and Data Blocking).
    • Your information can be shared across different systems and care settings, unless privacy laws say otherwise (Bill — Interoperability).
    • Changes will roll out only in provinces or territories covered by a federal order, and after the Act comes into force (Bill — Application; Coming into Force).
  • Health care professionals

    • You should have timelier access to patients’ records from other systems, which can reduce repeat tests and errors (Bill — Interoperability).
    • Vendor practices that block access or data exchange will be banned once the regulations define them (Bill — Prohibition; Regulations).
    • Your workflows may change as vendors update software to meet federal standards (Bill — Regulations).
  • Health care organizations (clinics, hospitals, pharmacies)

    • When procuring or renewing HIT, you will need vendors whose products meet federal interoperability rules in any covered province or territory (Bill — Interoperability; Order).
    • You may face transition work to connect systems and enable exchange features once standards are set (Bill — Regulations).
    • Privacy laws still govern what information you may access or share (Bill — Interoperability).
  • Health information technology vendors

    • You must ensure products you license, sell, or provide as a service are interoperable and do not engage in data blocking as defined in regulations (Bill — Interoperability and Data Blocking; Regulations).
    • You may be subject to verification requests, a complaints process, and administrative monetary penalties for non-compliance (Bill — Regulations).
    • You will need to align with technical standards that can be updated by reference in regulation (Bill — Regulations; Incorporation by reference).
  • Provincial and territorial governments

    • The Act applies only if the federal government finds your jurisdiction lacks similar or stronger requirements and issues an order (Bill — Order).
    • Adopting comparable standards could avoid federal application (Bill — Order).
    • Federal regulations will set the criteria and process used to make that determination (Bill — Regulations).

Expenses#

Estimated net cost: Data unavailable.

  • No explicit appropriations or funding amounts are stated in the bill text (Bill — general).
  • Federal administration and enforcement costs will depend on future regulations establishing verification, complaints, and penalties. Data unavailable (Bill — Regulations).
  • Potential administrative monetary penalty revenue depends on future regulations and enforcement volumes. Data unavailable (Bill — Regulations).
  • Vendor compliance costs will depend on the final technical standards and timelines. Data unavailable (Bill — Regulations).
ItemAmountFrequencySource
Federal administration/enforcementData unavailableOngoingBill — Regulations
Appropriations in billNone statedN/ABill — general
Administrative monetary penalties (revenue)Data unavailableVariableBill — Regulations
Vendor compliance costsData unavailableOne-time and ongoingBill — Regulations

Proponents' View#

  • Improves patient safety and care by ensuring providers can access complete, timely records across systems, including for virtual care and mobile patients (Preamble; Bill — Interoperability).
  • Reduces vendor lock-in and data silos by prohibiting data blocking and requiring data exchange across HIT products (Bill — Interoperability and Data Blocking).
  • Sets a national floor of standards to support a connected and secure health system, while respecting provincial privacy laws (Bill — Interoperability; Order).
  • Creates clear enforcement tools, including verification, a complaints process, and administrative monetary penalties, to drive compliance (Bill — Regulations).
  • Allows technical standards to stay current through incorporation by reference, so systems can align with evolving industry norms (Bill — Regulations; Incorporation by reference).

Opponents' View#

  • Federal overreach risk: health delivery is provincial; applying federal rules by order could duplicate or conflict with provincial regimes (Bill — Order).
  • Regulatory uncertainty: key details (standards, what counts as “data blocking,” penalty amounts, complaint handling) are deferred to regulations, creating implementation risk until they are published (Bill — Regulations).
  • Compliance burden: vendors may face significant costs to retrofit systems; costs could be passed through to providers and, indirectly, patients. Data unavailable (Bill — Interoperability; Regulations).
  • Patchwork risk: if only some provinces are brought under the Act, interoperability could remain uneven across Canada (Bill — Application; Order).
  • Privacy and security concerns: broader data exchange can increase exposure if safeguards are weak, though the Act defers to privacy laws and requires secure access (Bill — Interoperability).

Timeline

Jun 6, 2024 • House

First reading

Healthcare
Technology and Innovation