As we go forward in discussions about standards in software, we need some new definitions. Unfortunately Health Canada has destroyed the term "patient management software". And of course there is the endless debate about whether a standard for medical device software is appropriate for EMRs, EHRs, Etc. There are many ways to slice and dice the definitions of software used in health care. Based on the issues raised during the Health Canada discussions and to clarify our language I propose the following definitions:
Medical Device Software (MDS) is any software that is used to:
- Control a medical device
- Receive and display data output directly from a medical device
- Receive, analyze and display data output directly from a medical device
MDS would include firmware imbedded into medical devices.
Clinical Management Software (CMS) is any software that is used to:
- Collect, process, store and display data used to support clinical decision making
- Combine and display clinical data from multiple sources
- Create and present new data through the analysis of clinical data (e.g. alerts)
CMS would include EMRs and EHRs. Anything below the HIAL.
EHR Infrastructure Component Software (EICS) is any software that is used to:
- Collect, process, store and communicate clinical data other than at the point of care (i.e. not CMS or MDS)
- Network or otherwise connect CMS systems and MDS systems
EICS would include middleware, software supporting security and privacy services, regional and provincial registries and repositories, etc. Anything in the HIAL or above.
Even these definitions can get confusing. For example, hook an electronic stethoscope up to a CMS and it becomes an MDS (at least according to Health Canada's proposed definition of software to be regulated as a medical device. I'm open to suggestions or alternate definitions. However, I will be using these definitions for my own analyses in the coming weeks.