Scope and Definition of Software Subject to Quality and Safety Standards

One of the big challenges in our recent discussions with Health Canada was the scope of software to be considered for licensing and the definition of that scope. The definition that Health Canada is landing on is as follows (from their draft FAQ - note that this has not yet been published and could be subject to change):

Software regulated as a medical device:

1. Provides the only means and opportunity (meaning in real time) to capture and acquire data from a medical device for aiding directly in diagnosis or treatment; or
2. Replaces a diagnostic or treatment decision made by a physician

This is a very restrictive definition that limits the software that is subject to licensing to software that is "adjunct" or connected directly to another medical device. Health Canada can provide no examples of what might fit the second part of the definition... but its expected that it may include expert systems that replace human clinical judgement in the future.

The other wrinkle in the Health Canada definition was that even though something might be considered a medical device, it doesn't require licensing unless it is sold. This then excluded ASP delivered solutions and any software developed in-house.

As an Industry we need to figure out the scope of software to be considered. We found that the Infoway blueprint was a useful frame of reference. So here's the challenge to the ISC - What components of the Infoway blueprint should be subject to quality management and safety standards? Are there software systems not included in the Blueprint that should be included (think consumer health platforms, smartphone apps, etc.)? Should there be an exception for in-house developed applications?

Post your replies on the blog.