On August 31, 2009 Health Canada, Canada’s medical device regulatory authority, posted classification information for Patient Management Software (pdf). This action is similar to the FDA’s proposed rule for the regulation of Medical Device Data Systems (MDDS), nearing finalization. The Canadian announcement begins with a reminder of its definition of “medical device” which is similar to although not identical to the U.S definition. This definition includes Patient Management Software as a medical device. In addition, Canada defines an “active” device as one that requires an energy source, and “active diagnostic device” as one that is intended to supply information for the purpose of detecting, monitoring or treating a physiological condition, state of health, illness or congenital deformity. Based on these definitions patient management software is declared to be first a medical device, and then an active medical device.
The next question is the appropriate classification of this type of active medical device under the Canadian classification system. The Canadian system has four device classifications which is similar to the European system. The U.S., of course, has three classifications.
Patient Management Software that is used only for archiving or viewing information or images, and is not involved in the primary acquisition, manipulation or transfer of data is deemed to be a Class I device. This definition is somewhat more restrictive than that for a U.S Class I MDDS. Any Patient Management Software that goes beyond these restrictions is a Canadian Class II device. Furthermore such software is categorized as an active diagnostic device. This includes software involved in data manipulation, graphing, flagging of results or performing calculations. Workstations that interface with such software are then also in Class II. The inclusion of the work station appears to directly address the illusive question of when does a computer become a medical device. As a result of these new distinctions some software that was previously Class I (in Canada) will now be Class II. The manufacturers of such systems sold in Canada have been granted a one year transition period to meet those aspects of Class II regulation that are different from or in addition to those for Class I. This defined transition period is a more explicit statement than the FDA has provided in the draft MDDS rule.
The distinctions between system functions made in Canada are somewhat different from those initially defined by the FDA for MDDS. None-the-less they reflect essentially the same issues and concerns which are that (1) any software that receives and manipulates patient data is a medical device, and (2) that the appropriate classification depends in part on exactly what the software does with the data. Only minimal data handling activities are in the least stringent regulatory classification, while classification and therefore regulatory scrutiny will increase along with the sophistication of what the software does.