Health Canada has indicated that it plans to release an updated
notice on classifying patient management software in the coming
weeks, modifying the notice it released on August 31,
2009.1 The previous notice outlined the approach taken
by the Medical Devices Bureau of Health Canada to classify patient
management software as either a Class I or a Class II medical
Application of the Notice
The notice refers to "patient management software,"
suggestive of software that manages patient health records (e.g.,
eHealth records); however, the notice is intended to apply to
medical software using patient personal health information and/or
patient data for reporting, monitoring or analysis. Medical imaging
software or patient diagnosis software that is sold as stand-alone
software – that is, not always sold as part of a licensed
medical device – would be subject to this notice.
Classifying Software as a Class I or Class II Medical
Software that reports previously recorded information and does
not perform any kind of analysis or decision making is classified
as a Class I Medical Device. This would include software that is
used solely for archiving or viewing information or images and is
not involved in the acquisition, manipulation or transfer of data.
Software involved in the "transfer of data" refers to
software that communicates with other software or devices using
Patient management software intended to analyze or interpret
patent health information or data is classified as a Class II
Medical Device. This would include software involved in data
manipulation, data analysis, data editing, image generation,
recording of measurements, graphing, flagging of results or
performing calculations. Additionally, any workstation interfacing
directly with an imaging generating, viewing or storage device is
classified as a Class II medical device.
Health Canada's updated notice is expected to give more
clarity to the way the department will regulate patient management
software, but is not expected to change the way in which patient
management software is classified.
1. A copy of the notice can be found here.(http://tinyurl.com/y95vbnr)
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