A Bombshell for EMRs in Canada - Classification of EMRs as 'Medical Devices'  |  October 6, 2009  

Few heard the sound of the bombshell launched by Health Canada on August 31, 2009 which hit the EMR industry right between the eyes. In addition to all of the difficulties that EMR vendors face in reaching conformance with provincial requirements in order to be 'approved applications' in a specific province, vendors now have a new challenge - one that could have more far reaching consequences for the EMR industry and for physicians using Electronic Medical Records.

Let me explain.

On August 31, 2009, Health Canada released a Notice - file number: 09-122095-269: Subject: Classification of Medical Devices Class I or Class II patient management software.

The Notice states that "any patient management software used only for archiving or viewing information or images, and not involved in the primary acquisition, manipulation and transfer of data, is considered a Class I medical device. Class I devices will require that manufacturers, distributors and importers obtain an establishment license.

"Patient management software involved in data manipulation, data analysis, data editing, image generation, recording of measurements, graphing, flagging of results or performing calculations is considered a Class II medical device, as is any primary workstation that interfaces directly with a system (imaging or other type) by acquiring data and then sending data to an image generating, viewing or storage device. Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a medical device license."

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So how does this impact the EMR market?

EMR software that acquires and manipulates data (e.g. lab results - presenting the information as graphs) will require to be ISO certified by August 31, 2010 in order to be sold in Canada. In other words, vendors now have less than one year to reach ISO certification or be in a position where they will by law not be allowed to sell their software. Obviously this has far reaching implications for physicians and for the EMR industry as a whole. This is not a one time effort and involves achieving and maintaining certification - not simple and definitely costly in the long term.

Does Health Canada have an appreciation of the complexity of the EMR/EHR industry from a technical and business perspective? I doubt it based on what I have read about this impending change.

For example:

• What will be the cost to EMR vendors in order to achieve ISO certification?
• Will this put EMR vendors out of business?
• What could be the impact on provincial EMR programs if vendors that have been conformance tested are unable to achieve ISO certification? Will programs have to cease operations or be put on hold until certification can be achieved?
• Will this push up the cost of EMRs for physicians due to the increased cost for vendors to achieve ISO certification?
• Will vendors who have existing users, but have not been ISO certified have to pull their products off the market? Would this leave physicians without an EMR in their practices and force them to look for new products?
• How would these changes impact patient care?

These are but a small number of questions that I am sure will surface over the next few months.

If you are a physician, EMR vendor, EMR software implementation specialist or anyone involved in the industry, please take a few minutes to add your thoughts to this dicussion by clicking on the 'Comments' link below.

Alan Brookstone
Canadian EMR