ITAC Health is advising its members that Health Canada will be issuing a revised definition for “Patient Management Software” with respect to medical device licensing. According to ITAC Health, the new definition will be less restrictive than the definition contained in Health Canada’s 21 May 2010 notice on this subject. An FAQ addressing this matter is expected from Health Canada before the end of November.
I am attending a workshop on certification of patient management software hosted by ITAC Health and MEDEC. There has been considerable debate in the Canadian health IT community ever since Health Canada notified the community of it’s intent to consider what it calls patient management software as a medical device and impose relevant licensing regulation. A presentation by Health Canada this morning did little, it seems, to clarify the confusion and perhaps raised even more questions.
Health Canada did share their current working definition for patient management software. This definition did not appear in the May notice from Health Canada and it is the first time that I have seen it. According to Health Canada, patient management software:
– provides the only means and opportunity to capture
or acquire data from a medical device for aiding directly
in diagnosis or treatment
– replaces a diagnostic or treatment measurement or
calculation made by a professional
The second half of this definition is still apparently subject to infernal discussions at Health Canada.