Classification of Software Scenerios

ITAC Health recently submitted a number of software scenarios to Health Canada to get a sense of what constitutes a Class I or Class II medical device.

The following list is a guide only and does not represent any definitive rulings by Health Canada. Companies in doubt as to whether their software is a Class I or Class II device can contact Health Canada's Medical Devices Bureau for a ruling. To initiate an action for a ruling, send an email containing a basic description of your company and the software in question (very brief) together with contact information for someone in your company who can discuss the application with Health Canada. The email can be sent to: DEVICE_LICENSING@hc-sc.gc.ca. Health Canada will contact you to discuss the process and any additional information required. More information can be found on the Health Canada website.

For scenarios where it is indicated that the class is (to be determined), this is the class Health Canada is leaning towards, but does not have enough information to provide firm advice at this time. Companies selling such software should contact Health Canada at the email address above.

1. Physician Software System - Scheduling and billing only, no manipulation or alteration of clinical data: Not a medical device

2. Physician Software System - Records and displays demographic and clinical data only with no manipulation or alteration of data: Class I

3. Physician Software System - Electronic Medical Record - contains decision support functions, manipulates and displays data in different formats: Class II

4. Physician Software System - Accesses and uses information and decision support functions provided by provincial or regional electronic health record systems: Class II

5. Electronic Health Record System - Custom developed by a health care organization or government health ministry (e.g. chronic disease registry, public health surveillance) for exclusive use by that health care organization or government health ministry: Not a medical device for sale or distribution

6. Electronic Health Record System - Custom developed by a health care organization or government health ministry (e.g. chronic disease registry, public health surveillance) and is given to, or sold to another health care organization or government health ministry: Class II

7. Electronic Health Record System - Custom developed by a health care organization or government health ministry (e.g. chronic disease registry, public health surveillance) where a private sector developer retains ownership of the end-product which is subsequently sold to another health care organization or government health ministry: Class II

8. Commercial Off-the-Shelf (COTS) Software - that is not healthcare specific but is used for clinical applications or is integrated into a health information system (e.g. office automation software, email software, operating systems, database software, web portal software, etc.): Not a medical device

9. Custom developed middleware that is developed to facilitate communications between health information systems and is distributed to multiple health care organization or jurisdictions (e.g. translation of proprietary clinical codes or messages into standard formats such as HL7 or SNOWMED CT) - Class I (to be determined)

10. COTS middleware that is not healthcare specific but is used to facilitate communications between health information systems: Not a medical device

11. Security system software that is not healthcare specific but is used to control access to and use of health information systems (e.g. encryption software, authentication systems): Not a medical device

12. Hospital administrative and financial systems (e.g. materials management, general ledger, billing): Not a medical device

13. Hospital ADT (admissions, discharge and transfer) systems: Not a medical device

14. Hospital clinical management systems (e.g. pharmacy, lab, diagnostic imaging, computerized physician order entry): Class II (to be determined)

15. Consumer health platforms - software systems available to consumers and healthcare providers on the internet that allow consumers and healthcare providers to enter, view, graph and manipulate personal health information (e.g. Microsoft HealthVault, Google Health): Class II (to be determined)