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HL7 EHR Clinical Research Functional Profile
Linda King1 , Mitra Rocca2 1. Eli Lilly and Company
2. Novartis Pharmaceutical Corporation15 January 2009
Orlando, Florida
eClinical Forum and PhRMA EDC/eSource Taskforce
Richard Perkins, Catherine Celingant, Suzanne Bishop
OutlineOutline
• Overview of the HL7 EHR Clinical Research Profile
• Certification Commission for Health Information Technology (CCHIT) & Clinical Research
• Status of EU- Clinical Research Functional Profile Mapping
• Normative Ballot Reconcilation
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Project Sponsors & Participants
Global Participants:• Bayer
• Boehringer Ingelheim
• Bristol Myers Squib
• Cerner Corporation
• ClinPhone Inc.
• Eli Lilly and Company *
• FDA
• Glaxo SmithKline *
• Hoffman La Roche *
• Lundbeck
• Millennium
• National Cancer Institute
• Northrop Grumman
• Novartis
• Pfizer *
• Procter & Gamble *
* Gold Level Members
Sponsors:
In Cooperation With:
HL7 EHR & RCRIM Workgroups
CDISC
EDC/eSource Task Group
EHR CR Project OverviewEHR CR Project Overview
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• Develop a Global EHR/Clinical Research Functional Profile (EHRCR-FP)
• Identify critical requirements for clinical research utilizing EHR systems through:– Expansion of the HL7 EHR FM R1 to include clinical research requirements
– Providing the profile to both CCHIT and EURORECOutcomes:• EHR Vendors: provide with requirements for
incorporating clinical research functions into their systems
• Research Sponsors: provide basis for evaluating EHR systems as source data systems
• Healthcare: Understand operational functionality required for clinical research
• Regulators: gain confidence in the reliability of EHR systems as source for clinical research data
HL7 EHR Clinical Research BackgroundHL7 EHR Clinical Research Background
• HL7 EHR Clinical Research Functional Profile passed the HL7 May 2008 ballot cycle (Informative)
• HL7 EHR Clinical Research Functional Profile team are interested in having this profile accepted as a normative standard.
• HL7 EHR Clinical Research Functional Profile in Jan. 2009 Ballot Cycle
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Electronic Health Records for Electronic Health Records for Clinical Research Clinical Research
Status Report on CCHITStatus Report on CCHIT
CCHIT & Clinical ResearchCCHIT & Clinical Research
• Created a multi-stakeholder planning committee in order to get on the Certification Commission for Health Information Technology (CCHIT) Roadmap
• Submitted a joint (ANSI, AHIMA, HL7, CDISC, eClinical Forum/PhRMA, HIMSS/EHRA, NCI) environmental data scan form on Dec. 31, 2008 to CCHIT to consider Clinical research on their 2010 roadmap
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Electronic Health Records for Electronic Health Records for Clinical Research Clinical Research
Status Report on submission of EHRCR Status Report on submission of EHRCR Functional Profile to EURORECFunctional Profile to EUROREC
ApproachApproach
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Global Clinical Research User Requirements…
User RequirementUser Requirement Tier 1 (Core)Tier 1 (Core)RelevanceRelevance Regulatory LinkRegulatory Link
System and Data Security Requirements
System shall have an audit trail to include recording date/time/author of any data creation, change, or deletion
CSUCI: D2b, D2c, D2f, D2g
Part 11: 11.10 e
ICH GCP: 4.9.3, 5.5.4
21 CFR: 312.62
… and reason …
Essential
Optional (future)
International RegsInternational Regs
International RegulationsInternational Regulations
Conformance CriteriaConformance Criteria
HL7 EHRCR FPHL7 EHRCR FP
IN.2.2 Auditable Records
Criteria 3,4,8,9,15
Conformance CriteriaConformance Criteria
EuroRec EHRCR FPEuroRec EHRCR FP
GS002183.02 The audit log contains create/edit/ deleted events.
GS002188.01 Audit log records include date and time of recordable events.
GS002191.01 An audit log record includes the user identity associated with a recorded event.
GS002192.01 An audit log record contains the outcome status of a recorded event.
HL7 EHRs-FM Conformance Criteria
HL7 EHRs-FM Conformance Criteria
…Mapped to Existing Criteria
+ New Criteria Needed to Meet Clinical Research Needs
EuroRec Fine Grained Statements
EuroRec Fine Grained Statements
+ New Criteria Needed to Meet Clinical Research Needs
Status: EHRCR Profile to EuroRec
• Several face-to-face meetings with EuroRec (contact: Jos Devlies)
• Mapping & Submission materials almost complete
• EuroRec has provided us with an online tool to specify the subset of fine-grained statements that will become the EHRCR functional profile
• Submission of complete profile, including additional research-related fine-grained statements, expected by end 1st Qrt. 2009
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Addressing
Negative Ballot Comments
CDISC CDASHCDISC CDASH
1. There were 28 conformance criteria referencing CDISC CDASH Version 1
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CDISC CDASH
Non-CDASH Related comments
Total
No. of Affirmatives with Comments
8 37 45
No. of Negatives with Comments
47 6 53
Examples from Other EHR Functional ProfilesExamples from Other EHR Functional Profiles
1. Child Health Profile
The system SHALL capture patient vital signs, including weight, height or length, head circumference, blood pressure, temperature, heart rate, respiratory rate, and severity of pain as discrete elements of structured or unstructured data.
2. Behavioral Health Functional ProfileThe system SHALL provide the ability to validate
clinical terms and coded clinical data against
nationally recognized, standard terminologies
including the Diagnostic and Statistical Manual
(DSM).
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Examples from Other EHR Functional ProfilesExamples from Other EHR Functional Profiles
3. Long Term Functional ProfileThe system SHALL provide the ability to capture
specialized medical equipment and each prosthetic,
orthotic, or implantable device as unique, discrete
entries.
4. Personal Health Record (PHR) FMThe system SHALL provide the ability to capture
information related to allergy, intolerance, and
adverse reaction to drug, dietary or environmental
triggers as unique, discrete entries.
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CDISC CDASH ExampleCDISC CDASH Example
Before: The system SHALL collect a minimum set of Medication data as modeled by CDISC CDASH Release 1 “highly recommended” data elements for this domain
After: Use EHR FM Existing Criteria and add one criteria to handle Therapy details:
“The system SHALL provide the ability to capture details of a therapy, including therapy name, start and stop dates”
CDASH will be referenced only in the introduction.
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Thank you!
Questions?
Linda King
Mitra Rocca
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Backup
Mapping in ProgressMapping in Progress
10 Apr 2023 Copyright EHR/CR Project 2007 18
Categories of RelevanceCore – must have to meet minimum requirements Future – future need or nice to haveMaybe – needs discussionNot relevant – not relevent now or everNew – a new criteria being proposed by EHRCR to
meet Clinical Research User Requirements
Categories of RelevanceCore – must have to meet minimum requirements Future – future need or nice to haveMaybe – needs discussionNot relevant – not relevent now or everNew – a new criteria being proposed by EHRCR to
meet Clinical Research User Requirements
EuroRec EHRCR Approach and Plan
1. Kick-off Team Meeting – June 11, 20082. Map our Clinical Research user requirements to the EuroRec repository –
Completed 1st round Aug. Currently refining and assessing criteria to be added
3. Work out a process for how the resulting profile could be used and how it fits with labeling plans for EHR being developed by EuroRec – Oct, 2008 (at eCF meeting)
4. Develop a submission to EuroRec for approval of our EU Clinical Research profile – Outline developed, Oct, 2008
5. Identify additional criteria (draw from HL7 EHRCR Functional Profile standard) to submit to EuroRec for inclusion in the repository – 4Q, 2008
6. Finalize mapping to User Requirements and HL7 EHRCR profile post HL7 ballot reconciliation – Jan, 2009
7. Provide new fine-grained statements as an uploadable file for implementation within the EuroRec repository – Feb, 2008
8. Use the EuroRec-supplied online tool to subset the EHRCR Profile. – Feb, 2008
9. Do a mock assessment against a commercial EHR system to see what the gaps are – 1Q 2009
10. Communicate with stakeholders (who, what, when, how) – 1Q 200911. Refine the EuroRec EHRCR FP based on mock assessment and
stakeholder feedback – 2Q 2009
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