Lydia Lee, VP & CIO of the University Health Network and President Elect of COACH presented the following questions every healthcare CIO needs to ask about Health Canada's requirement for licensing patient management software. She was hosting a special meeting of COACH on the Health Canada ruling in Toronto on February 2nd, 2010:
Questions Every Canadian Healthcare CIO Needs to Ask Now:
1.Do you have an inventory of all existing patient management software in use in your organization?
2.How will you communicate with your vendors/partners to inquire about their Class I and Class II licensing status with Health Canada?
3.What, if anything, can you do to assist your vendors/partners to meet their Class I and Class II licensing requirements?
4.What are your vendors’/partners’ plans for obtaining Class I and Class II licenses, if they do not have them already?
5.How will you monitor vendor/partner licensing compliance on an ongoing basis?
6.Are your Board of Directors, Senior Management and Legal Counsel aware of this Health Canada ruling?
a.What is your process to add this requirement to your organization’s Certificate of Compliance process? How will you update this on an ongoing basis?
7.How will you ensure that your organization’s procurement process includes a mandatory requirement for Class I and II Licensing for patient management software?
a.What language will you need to add to IT RFP templates used by your organization?
8.Does your organization develop “patient management software”? If yes:
a.What is the purpose(s) for the in-house developed patient management software?
b.Is the in-house developed patient management software distributed to other users or organizations beyond your own organization?
c.Do you have a documented agreement with the organization to which you distributed the patient management software for the ongoing support commitment, SLAs, etc.?
d.Do you have a set-aside for Class I and II compliance (ISO 13485) in your operating budget?
e.Who in your organization (in your IT department) will be accountable for maintaining ISO 13485?
9.How will you communicate information about this change to the organization at large to create awareness regarding these new requirements?
b.Staff responsibilities (IT staff, closet developers, researchers, etc.).