ITAC Health has published a guide in the form of an FAQ for ICT vendors who manufacture and sell patient management software in Canada. The FAQ includes more than 60 questions frequently asked by vendors and other health system stakeholders.
In responding to the questions, ITAC Health conducted a review of documentation published by Health Canada on its website, presentations by Health Canada officials, ISO 13485:2003 and various guides to ISO 13485:2003 published on the Internet. ITAC Health also interviewed officials from Health Canada, accredited registrars, Provincial Chief Information Officers (CIOs), CIOs from major health care organizations, and expert consultants.
Comments on a draft of this document were also provided by MEDEC members (Canada’s Medical Device Association) with experience working with Health Canada on the regulation of devices including devices that are stand alone software.
It is recommended that all ITAC member companies download and read this document as soon as possible.
Download FAQ on Patient Management Software Licensing.