Regulation - LGIC

Establishing a flexible approach to setting the prescribed electronic format to enable electronic access to personal health information

Regulation Number(s):
(not assigned)
Instrument Type:
Regulation - LGIC
Bill or Act:
Personal Health Information Protection Act, 2004 (PHIPA)
Summary of Decision:
ONTARIO REGULATION 56/23 made under the
PERSONAL HEALTH INFORMATION PROTECTION ACT, 2004
Made: March 23, 2023
Filed: March 27, 2023
Published on e-Laws: March 28, 2023
Printed in The Ontario Gazette: April 15, 2023
AMENDING O. REG. 329/04 (GENERAL)

ONTARIO REGULATION 58/23 made under the
CONNECTING CARE ACT, 2019
Made: March 23, 2023
Filed: March 27, 2023
Published on e-Laws: March 28, 2023
Printed in The Ontario Gazette: April 15, 2023
AMENDING O. REG. 571/20 (SECTION 46 OF THE ACT)

ONTARIO REGULATION 57/23
made under the CONNECTING CARE ACT, 2019
Made: March 23, 2023
Filed: March 27, 2023
Published on e-Laws: March 28, 2023
Printed in The Ontario Gazette: April 15, 2023
AMENDING O. REG. 376/19 (ADDITIONAL OBJECTS OF THE AGENCY)
Analysis of Regulatory Impact:
Work is currently underway analyzing possible administrative and compliance costs to businesses and professionals that may result from this regulatory proposal. Based on preliminary analysis, there are no anticipated quantitative costs for almost all HICs in relation to this proposed regulatory change. When setting the format, Ontario Health would conduct appropriate consultations to ensure that the standards set out are feasible and aligned to provincial priorities for the health care sector.

By having clear standards and expectations, health care providers would be better able to provide patients with their PHI in an electronic format that best meets their needs to manage their health status and treatment plans. Making access to PHI and thereby the provision of health care more expedient is an important component of supporting health care capacity in this pandemic recovery.

To further inform this analysis we encourage you to provide your feedback.
Further Information:
Proposal Number:
22-HLTC027
Posting Date:
September 23, 2022
Summary of Proposal:
Ontarians can request their personal health information (PHI) electronically in the prescribed electronic format, which is currently PDF, or in an electronic format agreed upon by the individual and the HIC. However, the minimum standard of PDF limits how patients can interact with their data. PDF is a static format that shows PHI at only one moment in time and data cannot be easily exported and imported into other apps and tools for analysis. Furthermore, there is a risk that PDF files may one day become obsolete as new digital health tools enter the technology landscape.

The proposed regulation would allow Ontario Health (OH), as the provincial body responsible for interoperability and digital health standards, to specify the electronic format of PHI, subject to prior Minister approval, for HICs to use when providing individuals with access to their PHI. The proposed regulation would also require OH to post the formats on its website. Alternatively, the proposed regulation would authorize HICs to provide access in another electronic format that is agreed to by the HIC and the individual.

Additional regulations are also proposed under the Connecting Care Act, 2019 to expand OH's mandate to include the function of specifying the prescribed electronic formats, and to extend OH's good-faith immunity to this function.

The proposed regulation seeks to improve upon the existing regulation by promoting prescribed electronic formats that are up-to-date based on provincial and international standards for interoperability and information sharing, and allow for patients to better use their data to manage their health care journey. By enabling more flexibility in electronic formats, patients would have clear expectations on how to access their PHI electronically and while also promoting formats that are congruent with the up-to-date technologies available in the provincial digital health landscape.

This proposed regulatory amendment is one of a number of recent and proposed changes to PHIPA regulations designed to enable Ontarians to have better, more effective access to their personal health information.
Contact Address:
Digital Health Program Branch
Digital Health Division
Ministry of Health
1075 Bay St., 12th floor
Toronto, ON M5S 2B1
Email: digitalhealthdivision@ontario.ca
Effective Date:
July 1, 2023
Decision:
Approved