[mmkhd]

Your coments about the application workflow are very true. And I think this strengthens my argument that it is hard for open source software to enter this market. The cosultants/companies that implement these systems for hospitals would have to get together to push open source. And I guess hat it would be very hard to find enough open source developers with the domain specific knowledge. This points to a development style with a single company behind such a software. These companies are often not as "open-sourcey" when it comes to documentation as "real" open source projects. And this would make it less interesting for the above mentioned consultants/companies to band together to push open source because only that single company that mainly develops the software and does consulting for it, would profit.

My comments on software validation were perhaps not as clear as I would have liked them to be. Of course the regulators are not looking at every line of code. It would have to be the buyer that would have to look at that documentation, so that everything is in order when an FDA inspection occurs (if at all). And maybe it is wishful thinking that the developers should take validation into account while developing, because you can only do so much with an operational/functional qualification on site. Perhaps I am thinking that way because I am looking at it from the perspective of a research organization that develops some of its software in house (workflow!). Companies contracting with us certainly do want to see the validation documentation that was produced during development.