IMHO, I think the development efforts at ASTM to develop the CCR could also support/lead to software certification programs. That body would be a natural pick for something like software certification in addition to CCHIT.
Richard Wayne Wilson wrote: > Certification is certainly a can of worms. In the past a strong case > has been made for certification to ensure public safety. Electrical > components in the US are certified by Underwriter's Laboratory (UL), > electrical installations are certified by passing a local inspection > process, and more to the point clinical trials software is certified by > an FDA process. > See here for an interesting document on how to test software. > http://www.fda.gov/cdrh/comp/guidance/938.html#_Toc517237962 > > The gist of it is that a given set of inputs should always yield the > same outputs, and that testing happens in phases: > > The software developer tests (or sub contracts the test) > The installation at the user site is tested (usually by the software > company or installer) > Changes are tested > > In particular, the requirements for testing are flexible and one can > 'self-certify' if needed. Here is the excerpt: > > "Validation activities should be conducted using the basic quality > assurance precept of "independence of review." Self-validation is > extremely difficult. When possible, an independent evaluation is always > better, especially for higher risk applications. Some firms contract out > for a third-party independent verification and validation, but this > solution may not always be feasible. Another approach is to assign > internal staff members that are not involved in a particular design or > its implementation, but who have sufficient knowledge to evaluate the > project and conduct the verification and validation activities. Smaller > firms may need to be creative in how tasks are organized and assigned in > order to maintain internal independence of review." > > One can see from the description of how an 'internal' validation should > take place that the open source world could very well implement > cross-validation schemes. > > Finally if software is developed with unit test capabilities, it is > quite easy to repeat unit tests upon software modification, so this does > not become much of a burden either. > > > > Yahoo! Groups Links > > > > > > > Yahoo! Groups Links <*> To visit your group on the web, go to: http://groups.yahoo.com/group/openhealth/ <*> To unsubscribe from this group, send an email to: [EMAIL PROTECTED] <*> Your use of Yahoo! Groups is subject to: http://docs.yahoo.com/info/terms/
