HL7 Gender Harmony Project Sex-for-Clinical-Use (SFCU) Issues

Thank you for the questions regarding the implications of voting to abstain. In the case that a person abstains from a vote, the vote proceeds and the abstention counts toward quorum requirements but does not affect the final decision. In this case, if the SPCU proposal were to receive more negative votes than affirmative votes, The SPCU proposal would be rejected and any change from the originally proposed SFCU will require a different approach to be proposed and the issue to be reopened to change from the original SFCU.

The task of defining an anatomical inventory will need to wait until resources arrive to do that work. The Gender Harmony Project has indicated that they have an interest in working on Anatomical Inventory as part of their next phase.


Best Regards,
Joanie Harper
Standards Specialist
Canada Health Infoway

Hi everyone,

Thanks for the great ongoing dialogue on this issue. CIHI is supportive of Canada abstaining from the vote given that consensus has not been reached. I'd also be curious to know more about the implications of abstaining. Does it make sense to defer an explicit position on next steps until after this week's HL7 meetings in Nevada have wrapped up? I'm not sure what sort of information we might receive from those meetings in advance of the vote.

Thanks to everyone for your ongoing hard work on this!

Shannon O'Connor
Program Consultant, Data Standards
Canadian Institute for Health Information

Thanks for this summary Francis.

For me, it would be helpful to understand the implications of abstaining from the vote. What are the possible outcomes? For example, could we end up with the original SFCU concept as the new standard? Or could abstaining from the vote contribute to the lack of a solution to separate gender from sex from being implemented at all in HL7 and we would proceed with status quo? I agree anatomical inventory is where we want to go and would like to hear more about the next steps for this.

I heard at the last HL7 SFCU working group that Alberta Health Services has been using the SFCU concept since 2018. I wonder if it would be helpful to understand how this has been implemented so as not to cause harm to clients and find out if there are key learnings that would apply to the HL7 solution.

I'm so appreciative of this group and the thoughtful input to this important work.

Thanks!
Lindsay

Hi all -- and I'm sorry to have not been able to regularly contribute, during these last months, to this important work.

I agree with those who are concerned about Canada choosing to "go its own way". I don't think we should do that. It's completely antithetical to why we participate in standards-setting.

As Francis has noted, we can use an abstain vote on this ballot to convey a message to HL7. Our vote should explicitly note that we did not achieve a national consensus and there are strongly held dissenting views within our national decision-making group.

This is certainly true. For my part, I continue to have concerns related to the implementability and (related to this) the patient-safety of approaches such as anatomic inventory. I worry that this approach is theoretically possible but will, in practice, complicate care pathways where the patient's sex is today used as a logic driver for the clinical workflow. My view is that such complication creates an unacceptably high risk -- and this risk would affect care safety for the entirety of the Canadian population. I very much fear that this way of fixing a broken thing could break a working thing.

My concerns on this matter are informed by my personal experiences in three specific areas.

• I have been contributing, over many years now, to the computable care guidelines (CCG) initiative, specifically including WHO's SMART Guidelines work. I am confident the proposed SFCU would be a practical and implementable approach that WHO could adopt in its SMART Guidelines and that we could adopt on domestic CCG projects -- but I believe the anatomic inventory approach is not.
• I have significant experience in low and middle-income countries (LMIC), where a more complicated anatomic inventory approach would simply not be feasible for the digital health solutions widely deployed in these settings (whereas SFCU could be). I appreciate we are casting a domestic vote... but it is on an international standard. It seems inappropriate for Canada to not consider such implications, especially when a cornerstone of our global assistance efforts over the last decade specifically focus on support for addressing glaring health and social issues related to women and girls.
• As a purely practical matter, I have worries about the conformance-testability of digital health solutions' logic that would be expected to be driven off a more complicated data set. My experience within IHE is that a complicated standard undermines both solution vendor adoption and the ability to successfully do testing for conformance and interoperability. Such impediments would negatively impact our ability to foster adoption of a new specification within our ecosystem.

I applaud the impending victory of, at long last, de-conflating sex and gender within the portfolio of HL7 standards. I appreciate there are teammates who do not feel the same regarding SFCU as I do and who believe anatomic inventory is the only acceptable path forward. For this reason, I support a vote on this ballot reflective of there being strongly held dissenting views within our national standards community. Finally, however, I support our national adoption of the updated international standards, once the balloting is concluded.

I'm very sorry this has turned into a rather long post. I've tried hard to thoughtfully make clear my position and the underlying reasoning behind it.

Warmest regards, and stay safe and well, everyone,
Derek

I cannot support something that makes change but will still cause harm. So I choose to abstain from the vote and would consider joining the organ inventory project if I'm available when they meet.
I'm not sure enough about how these things work to know if moving forward with a Cdn alternative is a good approach since these systems are international and I feel it would be sidelined/overruled by what the Americans develop. And, a Cdn approach will need more work before it's ready so we can avoid the 'male and female typical' language.

Hi folks,

Thanks for all of your feedback. I think we all agree anatomic inventory is the solution, it is a matter of where HL7 is at with planning this project and when we can begin work on it.

At the SFCU subgroup meeting we did propose Parameter for Clinical Use as the data name. The concern from HL7 was that parameter is ambiguous and can be misused by clinicians and implementers. The original scope of the Gender Harmony project is to ensure tests, interventions, and treatments that have a sex-specific setting or range are applied correctly to the individual patient. The word sex was used to indicate the scope of this intent.

As for the Unknown value option, I think Unknown – Apply settings or reference ranges that are safe for all populations is a better alternative to Unknown sex characteristics

Given your responses thus far, I think we have these options to consider

1. Abstain from SFCU vote and ask to join the HL7 anatomic inventory project (more info needed)
2. Abstain from SFCU vote and proceed with a Canadian alternative – see below
3. Abstain from SFCU vote and start work on a Canadian version of the anatomic inventory

Here is the suggested Canadian alternative to SFCU if we want to pursue it

1. Change SFCU to Parameters for Clinical Use
2. Refine the proposed value set options and allow only single selection for each order - see below
2a. Apply female-typical settings or reference ranges
2b. Apply male-typical settings or reference ranges
2c. Apply specified settings or reference ranges (see comments)
2d. Unknown. Apply settings or reference ranges that are safe for all populations

Please share your thoughts on the above options. If you have other options or issues please let us know

Francis Lau, Aaron Devor, Karen Courtney, Kelly Davison, Roz Queen
UVic Digital Health Equity Team