Are EMRs Medical Devices?

NOTE - THIS POST IS NO LONGER VALID. HEALTH CANADA IS CHANGING ITS DEFINITION OF PATIENT MANAGEMENT SOFTWARE AND EMRS AND EHRS WILL NO LONGER BE CONSIDERED MEDICAL DEVICES. CLICK HERE FOR MORE INFO.

ITAC Health and MEDEC met with Health Canada by teleconference on Tuesday, August 10, 2010, to discuss issues surrounding Patient Management Software. One of the issues that required clarification was the question of whether or not Electronic Medical Records (EMRs) were Medical Devices under the Medical Devices Regulations. Health Canada clarified its interpretation as follows:

EMRs that are only intended to store and view patient information, and provide no analysis or decision support respecting diagnosis or treatment, do not fit the definition of a medical device (for example: the system captures and displays age, weight, notes about a patient’s appointment, patient test results, order processing, scheduling, or managing patient movement).

This would include software that would scan all of the patient records in a database, and based on some pre-determined criteria (age, gender, chronic diseases (diabetes, hypertension, heart disease), date of last test or immunization and combinations thereof), would flag to the physician, other heath care provider or admin staff to contact the patient and schedule the appropriate followup visit or test.

Such EMRs are not medical devices and do not require a medical device license unless they also perform one or more of the functions below and are used for diagnostic and/or treatment purposes.

EMRs are classed as Class II devices if they are used for the purpose of monitoring a physiological condition, state of health, illness or congenital deformity. This includes any patient management software involved in data manipulation, data analysis, data editing, image generation, determination of measurements, graphing, flagging of results, identifying a region of interest or performing calculations. Only software performing calculations that directly impact diagnosis and/or treatment of a patient merits a Class II designation.

For example:

1. An EMR that analyzes and provides the necessary information to flag drug interactions and patient allergies for a specific patient is a Class II device.

2. An EMR that receives and analyzes lab data for a specific patient and flags values that are out of the normal range is a Class II device.

There are few, if any, situations where an EMR will be classed as a Class I device. Health Canada is reviewing its definition of Class I devices to include only those devices that use real time data as an adjunct to a monitoring device for the purpose of aiding in treatment and/or diagnosis.

ITAC Health strongly recommends that if a manufacturer, vendor or distributor of an EMR has any doubt as to the appropriate classification of their product, that they contact Health Canada for a ruling. Be sure to maintain documentation of any advice provided by Health Canada on the classification of EMR products.