Health Canada Medical Device Certification – Differing Views?

Just under two weeks agoI attended and blogged about a workshop on the Health Canada medical device regulations hosted by ITAC Health, MEDEC, and COACH. This workshop explored the applicability of these regulations to health IT software. Since that workshop I have learned that various stakeholders have different views on the extent to which the Health Canada regulations should apply to health IT software.

The HIT vendor community appears to support application of the Health Canada regulations to HIT software. On 7 September 2010 ITAC Health published a blog post summarizing their position on the Health Canada regulations.  This post states that “ITAC Health supports the application of Health Canada’s Medical Device Regulations (MDR) as they apply to patient management software defined in Health Canada’s Notice dated May 21, 2010.  This regulation is appropriate for patient management software products that manipulate and interpret clinical data, which require a high standard of quality.”

According to a comment posted by Brenda Seaton on the “Canadian EHR Professionals” LinkedIn group discussion forum, healthcare CIOs “have pushed back because of the very legitimate operational challenges, of which legacy systems are one“.    Based on what I am hearing from other sources,  these concerns are causing Health Canada to reconsider their definition of patient management software.

So, it appears that the community is divided on the application of the Health Canada regulations, with the vendors lining up in support of the regulations and the health IT user community working behind the scenes to lobby for additional changes to the regulations.  There is little public information available regarding these discussions and the views of the various stakeholders.  Does anyone have any additional insight that they can share?


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