Sex Parameter for Clinical Use (SPCU)

Hi all,

Has anyone else had any experience with HL7’s Gender Harmony IG. They are proposing 5 data elements they propose to collect, and I’ve been looking at how it aligns with our current Gender archetype.

  • ‘Gender identity’ - seems well aligned.
  • ‘Pronouns’ - seems well aligned.
  • ‘Name to use’ - is not part of the Gender archetype and is more aligned with formal demographics management from our POV.
  • Recorded sex and gender’ - I quite like this concept as a potential enhancement or replacement for our ‘Administrative gender’ data element (which we had aligned with previous HL7 work), as a ‘bucket’ for the mess that is the ambiguous, unspecified, poorly specified, or poorly recorded, sex and gender records. Unfortunately, it also currently includes ‘Sex assigned at birth’ (SAAB), which I still think is quite distinct and clinically important. SAAB is a solid data element for recording a life-long baseline from an anatomical/ biological/genetic POV, especially when compared to a current self-declared ‘Gender identity’ to highlight alignment (cis) or divergence (trans).
  • Sex Parameter for Clinical Use (SPCU) - I find this concept rather troubling. It is intended to be used in specific contexts, mainly targeted towards lab and imaging order entry as I understand it. The intent is for the referring clinician to classify/label the patient as ‘male-typical’, ‘female-typical’ or ‘specified’ (with links to relevant evidence/observations) for the purpose of the specific order only. The categorisation is effectively lumping a range of clinical parameters/observations that includes organ inventory, recent hormone lab tests, genetic testing, menstrual status, obstetric history, pregnancy status etc under a single category that will be used to trigger the application of appropriate reference ranges, interpretation of a test result, or support/ensure appropriate radiation shielding by the receiving organisation.

I’m particularly curious about what other clinicians and SMEs think about SPCU in terms of clinical accuracy and safety.




Definitely agree with your assessment, Heather . though I actually prefer Administrative rather than Recorded, since I would hope that Administrative is about what needs to be recorded (for good or bad) to align with jurisdictional requirements.

I share your anxieties about SPCU but I can also see its value/ need when (again rightly or wrongly) a lot of safety protocols and reference ranges take a binary view.

I like the idea that it can be applied contextually, ‘in the context of this lab test’ or ‘this imaging study’ and even has the option to say basically ‘its complicated’.

So, on balance, I think I’m in favour. The alternative is to provide the lab etc with the background complex biological data/ circumstances so that they can decode, but the requesting clinician is much more likely to be able to make that judgement, and be able to involve the patient in the discussion.

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As I understand it, the Sex Parameter for Clinical Use, will only be used when there is a mismatch between the Administrative/Recorded Sex or Gender and on how the receiver should treat the sample/set up a device/perform a procedure/interpret the result. SPCU is described “In cases where there is a patient level SPCU, the patient level value can be used as a default”, so it will only be relevant when there are exemptions. So the “female-typical” and “male-typical” values are in practice redundant, unless one want to mark that there is a discrepancy.

From a patient integrity perspective that can actually be positive, as the requester only tell for example an external lab, “treat this sample differently from what is said in the recorded sex, don’t ask why”. No reasons needed.

On the other hand, the “Specified” value allows to go into details, but should only be used when there is a good reason.

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I find this post quite interesting as I have recently finished the requirements’ analysis on the gender. Based on this analysis, gender could be specified using three different dimensions:

  1. Genotype: The genetic marker of a person. This parameter is rarely recorded and is centered around pediatric, genetic and oncologic use cases.

  2. Phenotype: Represents the usually recorded gender by a healthcare professional either by checking it or just assuming the gender of a patient.

  3. Sociotype: Represents the gender identity of the patient. Currently, I would use the value set proposed by the Austrian government, as the Swiss government is still trying to figure this out. And I expect Switzerland just to take over what other governments decided to do.

And thanks to this post I got a glance at the archetype Gender and I realize how administrative-focused it is, instead of representing the clinical aspect.

Based on your post, the HL7’s Gender Harmony IG document and my understanding of the socio-medico aspect of gender, the “Sex Parameter for Clinical Use (SPCU)” would represent the Geno- or Phenotype of the patient. And I would have specialized the Gender archetype to include these two dimensions more specific to the clinical use cases, by adding Genotype and Phenotype as fields to the archetype. Here a snapshot of my xmind:

Hi Lucas,

Thanks for the mind map. Helpful

Genotype is intentionally not represented in the ‘Gender’ archetype. The misuse section points towards lab tests for recording this - “Not to be used for recording genetic or chromosomal sex. Currently this is usually recorded as a laboratory test result. Formal representation of ‘Genetic sex’ is not yet well defined and may involve the combination of information axes, including chromosomal and receptor data, mosaic variants and diagnoses.”

We were not sure if it is possible for the determination of phenotype to be understood and assigned consistently by all clinicians. So we designed the data elements that reflect common clinical practice, using ‘Sex assigned at birth’ as a proxy for ‘anatomical or biological sex’ and the way some think of phenotype. It reflects estimates that in 95%+ of situations visually assigning ‘anatomical or biological sex’ can be done by direct observation of external genitalia at or soon after birth. This may need to be revised retrospectively in some situations as more information comes to light eg more information about incongruent internal reproductive organs, hormones, genotype results etc. Values are male, female, intersex, and indeterminate (usually only temporary for newborns until further testing is completed) - as per what eventually gets sent to a birth registry for the initial ‘Sex’ registered on the initial birth certificate.

Not sure what you mean by sociotype - is this synonymous with gender identity (male/female/non-binary etc) or expression or something else… but I’m assuming this grouping is self-identified and potentially changing/evolving over the lifetime? Or is it something different?



“Sociotype” is a term I’ve introduced to denote the gender identity of an individual, aiming for consistency with “genotype” and “phenotype.”

Considering your feedback and referencing HL7’s Gender Harmony Implementation Guide (IG), I would have applied on the following three options:

  1. Specialize the “Gender” archetype to include “genotype,” noting this approach introduces a breaking change as it removes the chromosomal sex statement in the misuse section.
  2. Develop a new archetype for “Clinical Gender,” addressing the use case outlined in “Sex Parameter for Clinical Use (SPCU).”
  3. My preferred option: Establish a “Cluster” archetype encompassing the criteria set forth in HL7’s Gender Harmony IG. This approach draws on similar reasoning to that discussed for “Age” during the Norwegian Work Group Meeting on February 1, 2024.