Health Canada Reminds EHR-based Medical Device Manufacturers of Regulatory Rules

Health Canada issued a notice reminding manufacturers of electronic health record-based medical devices to obtain a medical device license and/or establishment license, as appropriate.

The notice also includes links to guidances that may help determine whether an EHR component, accessory or module is a medical device, as well as guidances on risk classifications and authorizations.

Which EHR software programs are considered a medical device (SaMD)?

The criteria for determining whether a piece of electronic health record (EHR) software constitutes a medical device (SaMD) depends on what its intended use is. If a healthcare provider uses an EHR to review and update a patient’s medical records or place orders for medications, procedures or tests, the software is not considered a medical device.

However, components, accessories or modules within an EHR-based medical device that have a medical purpose, such as to assist or replace a diagnostic or treatment decision, are considered medical devices and therefore are subject to regulatory oversight under the Medical Device Regulations.

What issues are caused by EHR-based SaMDs?

Two issues associated with EHR-based medical devices that may pose a risk to patient safety have been reported by Health Canada.

EHR-based medical device risks include:

1. Unauthorized EHR-based medical devices may be available on the Canadian market and in clinical use without the appropriate regulatory oversight.
    
2. Information provided by EHR manufacturers to healthcare facilities, healthcare providers and users about introducing or modifying medical devices within an EHR system may not be adequate.

Reminders to EHR-based medical device makers

Software components, accessories or modules with a medical purpose, such as to assist or replace a diagnostic or treatment decision, are regulated as medical devices by Health Canada.

Manufacturers or importers may not sell or advertise an EHR-based medical device without the necessary authorization of a medical device license and/or establishment license, as appropriate.

As a manufacturer, it is your responsibility to inform healthcare facilities, healthcare providers and users of any new or modified medical devices within the EHR.

Emergo by UL will continue to post updates to Health Canada guidance as they become available.