Health Evidence Knowledge Accelerator (HEvKA) Daily Progress March 9, 2026

[Brian Alper]

Monday March 9

9 people (AB, BA, CE, HL, JD, JL, KS, KW, NR) participated in up to 3 active working group meetings.

The AI-structured Eligibility Criteria Working Group discussed the handling of criteria related to multiples of upper limit of normal, e.g. expressing an exclusion criterion that a laboratory value was not > 2x the upper limit of normal.  We reviewed prior modeling using valueExpression and using offset, but ultimately determined the optimal modeling is to use valueQuantity and consider the 'upper limit of normal' as a unit of measure. We updated the example in CTIS2025-523977-40-00 Eligibility Criteria - ARMYDA Study on Coronary Plaque Change with Semaglutide in Diabetes with ACS with an example in JSON like:

 {

      "extension": [

        {

          "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/relevant-for-automated-matching",

          "valueBoolean": true

        }

      ],

     "code": {

        "coding": [

          {

            "code": "76625-3",

            "system": "http://loinc.org",

            "display": "Alanine aminotransferase [Enzymatic activity/volume] in Blood"

          }

        ]

      },

      "valueQuantity": {

        "code": "UNL",

        "unit": "upper limit of normal",

        "value": 2,

        "system": "http://hl7.org/fhir/characteristic-offset",

        "comparator": ">"

      },

      "exclude": true,

      "description": "Severe hepatic dysfunction (ALT >2× upper limit of normal)."

    }

We noted that the determination of what value is the upper limit of normal is not part of the specification of the eligibility criteria — that value would be found in the patient data in an Observation Resource and will vary by patient depending on the specific laboratory testing that is done.

The Project Management Working Group revised the AI-Powered Clinical Trial Eligibility Criteria (Vulcan/EBM) 2026 May Connectathon Track to improve the Long Description, Specification Information, Track Kick Off Call, and Testing Scenario details.

The Statistics on FHIR Working Group continued to prepare for submission of an article introducing SEVCO Release 2.0, then prepared the JSON concept for future publication of SEVCO Release 3.0

Releases on the FEvIR Platform

Computable Publishing®: M11 Report Authoring Tool Release 1.1.0 (March 9, 2026) adjusts the helper text to match the ICH M11 Clinical electroic structured harmonised protocol (CeSHarP) - Template adopted by CHMP on 11 December 2025 and coming into effect on 11 June 2026.

Quote for Thought

“Enthusiasm is a kind of genius, because it makes ordinary things seem worth doing.” — Amelia E. Barr

To get involved or stay informed: HEvKA Project Page on FEvIR Platform, HEvKA Project Page on HL7 Confluence, View a consolidated list of presentations, videos, posters, journal articles, and book chapter mentions related to HEvKA, COKA, EBMonFHIR and the FEvIR Platform at https://ComputablePublishing.com/media. or join any of the groups that are now meeting in the following weekly schedule:

(The current week’s agenda can always be found at: https://fevir.net/resources/Composition/29272).  

Weekly Meeting Schedule and Link: 

Day	Time (Eastern)	Team
Monday	9-10 am	AI-Structured Eligibility Criteria
Monday	10-11 am	Project Management WG
Monday	2-3 pm	StatisticsOnFHIR WG (a CDS EBMonFHIR sub-WG)
Tuesday	9-10 am	Measuring the Rate of Scientific Knowledge Transfer WG
Wednesday	8-9 am	Computable EBM Tools Development WG
Wednesday	9-10 am	Communications(Awareness, Scholarly Publications) WG
Wednesday	11 am - 12 pm	StudyRegistryRecordProfile WG (a BRR EBMonFHIR sub-WG)
Thursday	8-9 am	EBM Implementation Guide WG (a CDS EBMonFHIR sub-WG)
Thursday	9-10 am	Making Guidelines Computable WG
Friday	9-10 am	Statistic Terminology WG
Friday	10-11 am	GRADE Ontology WG
Friday	12-1 pm	Project Management WG

 

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Brian S. Alper, MD, MSPH, FAAFP, FAMIA, FGIN

CEO, Computable Publishing LLC

bal...@computablepublishing.com

 

 

 

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Lead, HEALTH EVIDENCE KNOWLEDGE ACCELERATOR

 

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