FHIR Working Group Meeting

Evidence-Based Medicine on FHIR

Health Evidence Knowledge Accelerator (HEvKA) Updates

Joanne Dehnbostel:

jdehnbostel@computablepublishing.com

© 2019+ Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

2023-01-18

Agenda

• EBMonFHIR Introduction
• Health Evidence Knowledge Accelerator (HEvKA) formerly COVID-19 Knowledge Accelerator (COKA)Introduction
• EBM/HEvKA related Updates
• FEvIR Platform Resources and Tools
• Slides are available at: https://tinyurl.com/EBMonFHIR-update
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© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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EBM-ON-FHIR INTRODUCTION

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence-Based Medicine is…

• “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients” (Sackett D, 1996)
• “integration of clinical expertise, patient’s values and best available evidence in process of decision making related to patients health care”(Sackett D, 2002)
• “integration of best research evidence with clinical expertise and patient values”(Sackett D, 2000)

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence-Based Medicine is…

“The EBM-oriented clinicians of tomorrow have three tasks:

a) to use evidence summaries in clinical practice;

b) to help develop and update selected systematic reviews or evidence-based guidelines in their area of expertise; and

c) to enroll patients in studies of treatment, diagnosis and prognosis on which medical practice is based.”(Masic 2008)

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence = Analyzed Data

• Evidence = Data + Context
• Evidence is often published in journals
• Data in FHIR + Context in journals does not interoperate

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence

Data

Evidence to Guidance to Action

• Evidence is often published in journals
• Guidance is often in decision support tools
• Action can be in FHIR – but do these things interoperate?

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Evidence

Data

Guidance

Action

The Health Knowledge Flow we want

Data Analysis, Synthesis, and Interpretation.

EVIDENCE

Guidelines, Recommendations, Decision Aids, Decision Support

GUIDANCE

Observations and Measurements.

DATA

Healthcare (testing and intervention) decision-making and implementation

ACTION

EBMonFHIR extends FHIR to EBM data

• FHIR Resources for Evidence-Based Medicine (EBM) Knowledge Assets project (EBMonFHIR) started 2018.
• The goal of EBMonFHIR is to provide interoperability (standards for data exchange) for those producing, analyzing, synthesizing, disseminating and implementing clinical research (evidence) and recommendations for clinical care (clinical practice guidelines).

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© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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EBMonFHIR extends FHIR to EBM data

• The EBMonFHIR project (HL7 PSS-2124) is formally named FHIR Resources for Evidence-Based Medicine Knowledge Assets (EBM-on-FHIR)
• EBMonFHIR sponsored by 3 HL7 Work Groups
• Clinical Decision Support (CDS)
• Clinical Quality Information (CQI)
• Biomedical Research and Regulation (BRR)

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Prior to 2020 EBMonFHIR met for one hour per week…

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© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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HEALTH EVIDENCE KNOWLEDGE ACCELERATOR (HEvKA) INTRODUCTION

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Health Evidence Knowledge Accelerator (HEvKA)

• A virtual organization – no cost, no contracts
• Open, transparent – all meetings
• Engages multiple global collaborative groups, organizations, and individuals
• A way for any to volunteer to accelerate development and implementation of standards for evidence exchange
• The organization formerly known as COVID-19 Knowledge Accelerator (COKA)
• In 2022 in COKA we had 79 people from 13 countries participated in up to 632 active working group meetings.

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© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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Health Evidence Knowledge Accelerator (HEvKA)

�Content and support tools for making science computable and facilitating HEvKA projects can be found on the 

Fast Evidence Interoperability Resources (FEvIR) Platform https://fevir.net/resources/Project/29394

The FEvIR HEvKA Project Page can be found at https://fevir.net/resources/Project/29272 

The FEvIR platform includes evidence-related resources in current (R5) FHIR format.

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© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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HEvKA has 13 active working groups

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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For all of these meetings: Join Microsoft Teams Meeting

If you wish to learn more about HEvKA please go to

https://tinyurl.com/HEvKA

Scientific Evidence Code System (SEVCO) Updates�

Standard terminology is essential to the communication of evidence.

SEVCO is an open effort to define terms for the expression of

• study design,
• statistics, and
• risk of bias

Each of these has a weekly working group meeting.

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Scientific Evidence Code System (SEVCO) Updates�

• The SEVCO code system (in FHIR resource form) can be viewed as it is being developed Scientific Evidence Code System (SEVCO) -- DRAFT ONLY (Not published for current use),
• Anyone is welcome to comment on any term by finding the term in the Term Detail view and clicking the Comment button

https://fevir.net/27270

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Scientific Evidence Code System (SEVCO) Updates

• To join the Scientific Evidence Code System Expert Working Group to vote on the terms and definitions in this code system, just go to the Scientific Evidence Code System (SEVCO) Project Page and click the Join the Group button.
• Members of the Expert Working Group can vote on any term that is open for voting in the Term Detail view and clicking the Vote button, or by viewing all terms open for vote at Computable Publishing®: My Ballot.

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Scientific Evidence Code System (SEVCO) Updates

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• Current progress on term development includes:
• 75 of 75 (100%) Study Design terms approved
• 145 of 241 (60%) Bias terms approved
• 0 of 26 Rating of Bias terms approved
• 84 of 139 (60%) Statistic terms approved
• 0 of 100 Statistical Model terms approved
• 304 of 581 (52%) TOTAL terms approved

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• The first version ready for release includes 75 Study Design terms and 124 Bias terms and can be viewed at https://fevir.net/sevco. It is used in the studyDesign element of the ResearchStudy Resource.

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• We are close to submission of a journal article introducing the study design code system

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Project Coordination Updates

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Working Groups for Project Coordination include:

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• Knowledge Ecosystem Liaison
• Project Management
• Communications

Knowledge Ecosystem Liaison Updates�

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• Collaboration with members of the GRADE Working Group to discuss representation of GRADE vocabulary for certainty of evidence and evidence-to-decision judgments-resulted in HEvKA GRADE Vocabulary Working Group

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• Coordination with the European Food Safety Authority (EFSA) and Evidence-Based Toxicology Collaboration (EBTC)

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• Agency for Healthcare Research and Quality (AHRQ) related efforts -- Systematic Review Data Repository (SRDR), Evidence-based Practice Centers (EPCs), and the CEPI Evidence Discovery and Retrieval (CEDAR) Project – resulted in a HEvKA Setting the SRDR Platform on FHIR Working Group.

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Knowledge Ecosystem Liaison Working Group�

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Learning Health Systems Collaborative and Pain Management/Opioid Use LHS Learning Community (POLLC) 

• Platform developments supporting the creation, searching, and viewing of Classifications of knowledge resources will soon be ready to provide the preliminary infrastructure for functional portals like that shown in the Learning Health Systems Portal (Demo).

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Towards LHSs in Action: Pain/Opioids*

Diagram from: LHS Cycle from ACTS Future Vision

Osheroff JA (Project Lead; project participants here). ACTS Learning Health System (LHS) Concept Demonstration [Internet]. Rockville (Maryland): Agency for Healthcare Research and Quality (AHRQ), AHRQ evidence-based Care Transformation Support (ACTS) Initiative; [2021 Oct]. Available from: https://covid-acts.ahrq.gov/display/PUB/ACTS+LHS+Concept+Demonstration

BPM+ (John Svirbely) is modeling chronic pain mgt guidance, including buprenorphine use for chronic pain

Lead from UMN EPC (Mary Butler) analyzing evidence/ guidance on buprenorphine for chronic pain; considering FEvIR.net as platform

*See here for more on the LHS learning community working on this use case

Exploring with MedMorph (Maria Michaels) ways to leverage that initiative to gather and leverage pain/opioid care results for public health, new evidence generation

Exploring with CPGonFHIR Community (Maria Michaels/others) ways to leverage that IG to develop living guidance/CDS on pain/opioids/buprenorphine, put it into action, and monitor care results. Consider implications of new CDC pain/opioid guideline

Exploring with BPM+ Community how to prepare organizations to leverage interoperable clinical pathways (Organizational Adoption and Change Management (OACM) WG’s - Readiness Assessment and Maturity Model) and leverage BPM+ models (overview) to help CDOs vet and implement these pathways (John Svirbely, OACM WG)

Working with CDOs to identify and close care gaps related to pain/opioids, including leveraging buprenorphine better (see this slide deck)

Exploring with EBMonFHIR/HEvKA (Brian Alper/others) ways to leverage their approaches and platforms to make pertinent evidence computable/ interoperable – and produce care gap report.

Exploring with BPM+ (Davide Sottara) interplay between BPM+ models and EBMonFHIR/HEvKA

Consider synergies with AHRQ Challenge for combining real world data and systematic reviews

Communications Working Group�

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• There two key Introductory Pages where you can find information related to the Health Evidence Knowledge Accelerator (and EBMonFHIR and FEvIR Platform):
• Health Evidence Knowledge Accelerator (HEvKA) Confluence page within the EBMonFHIR project Confluence page within the HL7 Confluence page.
• Health Evidence Knowledge Accelerator (HEvKA) project page at https://fevir.net/resources/Project/29272 on the FEvIR Platform -- We added 32 links to presentations (PPT and Video) that can serve as introductory materials.
• Projects describing sets of citations include:
• COVID-19 Knowledge Accelerator mentions in publications
• EBMonFHIR mentions in publications

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• On December 27, we provided an RFI response to the Office of Science and Technology Policy (OSTP)/Office of the National Coordinator (ONC) Request for Information (RFI) on Data Collection for Emergency Clinical Trials and Interoperability Pilot.

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Communications Working Group�

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Communications Working Group is currently working on a JAMIA Open submission of 'Introduction to EBMonFHIR’

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6 conferences with open calls for presentations were selected for consideration:

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1. HL7 FHIR DevDays (DevDays 2023) https://www.devdays.com/devdays-2023/ June 6-9, 2023 in Amsterdam (or Hybrid online); Proposals due Feb 1
2. Sci-K (2023 ACM Web Conference) https://sci-k.github.io/2023/ April 30-May 4, 2023 in Austin, Texas; Proposals due Feb 6
3. The First International Workshop on Semantics in Dataspaces (SDS 2023) https://dbis.rwth-aachen.de/SDS23/ April 30-May 1, 2023 in Austin, Texas; Proposals due Feb 6
4. EBHC Conference 2023 https://www.ebhcconference.org/home.it-IT.html October 25-28, 2023 in Taormina, Sicily; Proposals due Feb 28
5. SciDataCon-International Data Week (SciDataCon-IDW Salzburg 2023) https://www.scidatacon.org/IDW-2023-Salzburg/submit/ October 23-26, 2023 in Salzburg (and hybrid); Proposals due Mar 31
6. Guidelines International Network (GIN 2023) https://g-i-n.net/conference_2023/welcome Sep 19-22, 2023 in

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Project Management Working Group�

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This working group administrates the other meetings including:

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• Administrates scheduling changes based on participants’ schedules

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• Creates weekly agendas to be included on the website

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• Maintains the email distribution lists for daily and weekly HEvKA updates

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Standards Development Updates

• Standards Development Meetings
• EBM Implementation Guide Working Group
• Eligibility Criteria Working Group
• Common Metadata Framework Working Group
• GRADE Vocabulary Working Group

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We have made numerous changes to 5 FHIR resources that we developed ArtifactAssessment, Citation, Evidence, EvidenceVariable, EvidenceReport) as well as the ResearchStudy Resource and RelatedArtifact Datatype. Open items are noted as FHIR Tracker items.

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EBMonFHIR Implementation Guide WG �(a CDS EBM sub-WG)

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FHIR Management Group(FMG) has approved the development of an Evidence Based Medicine Implementation Guide (EBM IG). (see https://fevir.net/resources/Project/29736)

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http://build.fhir.org/ig/HL7/ebm/index.html , repository will be maintained at https://github.com/HL7/ebm.

• ActivityDefinition Resource -- RecommendationAction Profile
• ArtifactAssessment Resource -- CertaintyOfEvidence Profile – Classification Profile -- OutcomeImportance Profile -- RecommendationJustification Profile -- RiskOfBias Profile
• Citation Resource -- GuidelineCitation Profile -- RecommendationCitation Profile -- StudyCitation Profile
• Composition Resource -- EvidenceMap Profile -- EvidenceReport Profile -- EvidenceReportConstructor Profile
• Evidence Resource -- NetEffectEstimate Profile -- OutcomeEvidenceSynthesis Profile -- StudyOutcomeEvidence Profile -- ParticipantFlow Profile – StatisticalModel Profile
• EvidenceVariable Resource -- EvidenceDataset Profile -- EvidenceReportSubject Profile -- InterventionDefinition Profile -- NetEffect Profile -- OutcomeDefinition Profile -- RecommendationEligibilityCriteria Profile -- StudyEligibilityCriteria Profile – SearchStrategy Profile – ParticipantFlowMeasure Profile
• Group Resource -- StudyGroup Profile -- StudyGroupGroup Profile
• ImplementationGuide Resource -- ClinicalPracticeGuideline Profile
• PlanDefinition Resource -- RecommendationPlan Profile

Eligibility Criteria Working Group Updates

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Developments to support expression of structured eligibility criteria with FHIR include:

• The EvidenceVariable StructureDefinition
• Eligibility Criteria specification with EvidenceVariable with 10 examples so far
• Confluence page descriptive summary and examples of specific EvidenceVariable.characteristic elements described at https://confluence.hl7.org/display/BRR/Compact+Reference+for+Evidence+Variable
• Eligibility Criteria via EvidenceVariable (video recording) presented at the July 2022 CodeX mCODE Community of Practice Meeting (see Monthly Meeting Minutes)
• Eligibility Criteria Matching Software Demonstration
• Eligibility Criteria Matching Software Library
• FHIR Representation of Eligibility Criteria for Clinical Trials project from the HL7 Biomedical Research & Regulation (BRR) Work Group
• Handling of eligibility criteria in ClinicalTrials.gov data with the Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter
• The HL7® Biomedical Research and Regulation (BRR) Work Group completed the proposal for an Eligibility Criteria for Clinical Trials Implementation Guide and discussed the coordination between this proposal and the Evidence Based Medicine Implementation Guide. We need to decide whether this will become a part of the EBM implementation guide or remain separate.

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Common Metadata Framework Updates

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A project page for the Common Metadata Framework project is available at https://fevir.net/resources/Project/29201

Following a publication of Categorizing metadata to help mobilize computable biomedical knowledge (by a working group within the Mobilizing Computable Biomedical Knowledge (MCBK) Standards Working Group), we started a Common Metadata Framework Working in February 2021.

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We are working on the metadata structures used and shared on the FEvIR Platform as a real-world implementation and practical application. 

The Common Metadata Framework Working Group recently added Profiles to the developing Evidence Based Medicine Implementation Guide, including: Classification, Participant Flow, and Participant Flow Measure

and developed proof-of-concept code in preparation for using Classification Profiles of ArtifactAssessment Resource as a search index on the FEvIR Platform.

Platform Development Updates

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The Fast Evidence Interoperability Resources (FEvIR) Platform (https://FEvIR.net) is set up to support a hub for data exchange using the HL7® FHIR® standard. (FHIR is the registered trademark of Health Level Seven International (HL7) and the use does not constitute endorsement by HL7.) The FEvIR Platform has many tools to view and create FHIR resources in human readable form without needing to code in JSON.

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The FEvIR Platform has 11 Builder Tools that are available when logged in, and 17 Viewer Tools that are available without logging in.

The FEvIR Platform has 5 Converter Tools. 

The FEvIR Platform has 6 Specialized Tools.

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https://FEvIR.net)

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Platform Development Updates

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https://fevir.net/resources/Project/106031

�FEvIR™ API Release 0.1.0 (December 21, 2022) supports 2 interactions:

• 1 -- a GET request with input of a single FEvIR Object Identifier (FOI) and an authentication token and response of the selected Resource as a JSON object.
• 2 -- a GET request with input of a single ClinicalTrials.gov record identifier (NCTId) and an authentication token and response of the ClinicalTrials.gov record data as a FHIR Bundle Resource. This is still in beta development and you currently need to know the resource identifier for the API

See https://fevir.net/apidoc for instructions

After signing in on the FEvIR Platform, go to your profile page to create an API token

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Computable EBM Tools Development Working Group Updates

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Example projects to demonstrate parts of ‘Evidence And Guidance Linked Expressions’ (EAGLEs) include:

• Bariatric Surgery Decision Example of FHIR Resources which currently has 108 Resource instances including 23 different types of Resources or Profiles.
• AWMF Demo: Thromboembolieprophylaxe bei COVID-19 Erkrankung (prophylaktische Dosierung) with 1 PlanDefinition, 1 Citation, 1 ArtifactAssessment, 9 Evidence and 1 EvidenceReport Resources associated.
• S3-Leitlinie Endometriumkarzinom with 215 recommendations and 204 citations automatically generated from a guideline with data in JSON form.
• Bariatric Surgery Decision Example of Implementation Tools with 6 OutcomeDefinition Profiles linked from 17 Evidence Resources and 6 ArtifactAssessment Resources, and that can be used with the ‘Summary of Findings Constructor’ or ‘Summary of Net Effect Contributions Constructor’ with the “Generate Evidence Report” button to automatically generate Composition Resources (EvidenceReport Profile).

The current attention of this group is review of approaches to facilitate data entry for many different datatypes with automated conversion to FHIR. 

So far, the Computable EBM Tools Development Working Group  has reviewed and refined the specifications for display of boolean, date, and dateTime datatypes using the FEvIR™: ActivityDefinition Builder/Viewer.

Research Development Updates

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ResearchonFHIR working group https://fevir.net/resources/Project/52228

We are currently working through the HL7 FHIR-based tools and initiatives to support clinical research project, evaluating the findings of a scoping review of 203 tools and a systematic review of 49 published uses of FHIR for clinical research. https://fevir.net/resources/Project/52228

HEvKA has 13 active working groups

© 2019 Health Level Seven ® International. Licensed under Creative Commons Attribution 4.0 International HL7, Health Level Seven, FHIR and the FHIR flame logo are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.

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For all of these meetings: Join Microsoft Teams Meeting

If you wish to learn more about HEvKA please go to

https://tinyurl.com/HEvKA

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Questions/Comments, email balper@computablepublishing.com

jdehnbostel@computablepublishing.com

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