Healthcare Software

Are EMRs Medical Devices? A brief ITAC / MEDEC Conference Summary

I attended a 1-day ITAC / MEDEC conference in Toronto yesterday on Patient Management Software being classified by Health Canada as a medical device and the implications of it.

The core of the conference dealt with the notice from Health Canada: Classification of Medical Devices Class I or Class II patient management software

ITAC before the meeting released this interpretation of it which they extracted following a teleconference with Health Canada.

The conference itself mainly surrounded the implications of the notice and some of the things to expect from it, namely the challenges of:

• Knowing if your software needs to get approved
• What classification does it belong to
• The process of getting software certified
• Having your organization be audited
• What to do after your certificate expires

The notice mainly had the same implications of an FDA audit, which makes sense, since the regulation incorporates the post-market approval process of the USFDA.

One of the more interesting portions was the consumer panel where the 3 speakers gave their opinion on the notice. Paraphrasing, they said:

• The doctors (given by the CTO of the CMA, Bill Pascal)
  • We want more consistent standards and more support for patient management systems.
• The government (given by the Executive Director, Corporate Information and Technology Branch of Saskatchewan Health, Neil Gardner)
  • We want to approach the problem from a risk management perspective.
• The hospital (given by the CIO of the UHN, Lydia Lee)
  • We need to work with the vendor community to create better software and adopt their processes to improve the quality of our own in-house development.

They all spoke in favour of the notice saying that it will help make health software better and improve patient safety, but whether or not this is true, is debatable.