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Based upon information gathered by ITAC Health, the following has been posted on the ITAC Health Blog.

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).

(Bottom line - Ed) 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.

Click here to read the full posting - ITAC Health - Are EMRs Medical Devices?

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Read More: http://blog.canadianemr.ca/canadianemr/2010/08/itac-health-are-emrs-medical-devices.html