Reminder: Do not include any PHI or PII in Confluence. If you require 508 accessibility assistance or any other support for this system, then please send an email to onc-jira-questions@healthit.gov
Challenge
Clinical Decision Support (CDS) is the user facing representation of clinical guidance. Effective CDS interventions require availability of computable biomedical knowledge, person-specific data, and a reasoning or inference mechanism that combines these elements to generate and present helpful and actionable information to clinicians, individuals, or caregivers in the right way – at the right time. In order to optimize these benefits, CDS interventions must be made more easily shareable and implementable so that any organization can easily acquire and deploy CDS interventions. To this end, standards must be advanced to enable either the routine or regular consumption of CDS interventions through a Web service or the repeated import and update of CDS artifacts into CDS systems.
Scope Statement
To identify, define and harmonize standards that facilitate the emergence of systems and services whereby shareable CDS interventions can be implemented via:
- Standards to structure medical knowledge in a shareable and executable format for use in CDS, and
- Standards that define how a system can interact with and utilize an electronic interface that provides helpful, actionable clinical guidance
In order to facilitate integration of a system with CDS interventions, the scope includes standards to refer to data in electronic health records and standards to map recommendations to locally implementable actions.
Value Statement
Health information technologies designed to improve clinical decision making are particularly attractive for their ability to address the growing information overload clinicians face and to provide a platform for rapidly incorporating knowledge into care delivery.
Standardized expressions of Clinical Decision Support have a number of important benefits including:
- Increased quality of care and enhanced health outcomes for individuals and populations
- Improvement in workflow
- Avoidance of errors and adverse events
- Improved efficiency, cost benefit, and provider and patient satisfaction
- Reduced latency for incorporating new clinical knowledge and evidence-based guidelines into clinical practice
Focusing the S&I Framework community on Clinical Decision Support through the Health eDecisions Initiative will enable the translation of interventions into implementable components, increasing the speed and ease of adoption by the provider community.
Implementation Guide Resources
IG Artifact | Date Uploaded | Description |
Balloted DSS IG R1 | 9/3/2013 | Final DSS IG Release 1 submitted to HL7 ballot on 8/31 |
Balloted vMR Templates IG R1 | 9/2/2013 | Final vMR Templates IG Release 1 submitted to HL7 ballot on 8/31 |
Balloted vMR XML IG R1 | 9/2/2013 | Final vMR XML IG Release 1 submitted to HL7 ballot on 9/2 |
Balloted vMR Logical Model Release 2 | 9/2/2013 | Final vMR Logical Model R2 submitted to HL7 ballot on 8/31 |
Balloted vMR Logical Model Release 2 Supplementary Files | 9/2/2013 | Supplementary files submitted for HL7 ballot with vMR Logical Model R2 on 8/31 |
DSS Standard, Release 2 | 9/2/2013 | Final DSS Standard R2 submitted to HL7 ballot on 8/4 |
CDS Knowledge Artifact, Release 1 | 9/2/2013 | Final CDS Knowledge Artifact R1 submitted to HL7 ballot on 8/4 |
HL7 Artifacts
HL7 Artifact | Intended Use | Description | Use Case |
HL7 Implementation Guide: Clinical Decision Support (CDS) Knowledge Artifact Implementations, Release 1.1 (Draft Standard for Trial Use – DSTU) | CDS artifact implementers and users | XML schema for representing CDS knowledge artifacts (rules, order sets, and documentation templates) | Use Case 1: Clinical Decision Support Knowledge Artifact Implementation Guide |
Decision Support Service Implementation Guide Release 1.1 (DSTU) | CDS guidance service implementers and users | Implementation guide for delivering CDS guidance as a Web service | Use Case 2: Decision Support Service Implementation Guide |
Virtual Medical Record (vMR) Logical Model Release 2 (DSTU) | Implementers and users of CDS artifacts and guidance services | UML data model for the CDS domain. Used by the CDS Knowledge Artifact and Decision Support Service Implementation Guides | Use Case 1: Clinical Decision Support Knowledge Artifact Implementation Guide Use Case 2: Decision Support Service Implementation Guide |
vMR XML Specification Release 1 (DSTU) | Implementers and users of CDS artifacts and guidance services | XML schema derived from the vMR Logical Model. Used by the CDS Knowledge Artifact and Decision Support Service Implementation Guides | Use Case 1: Clinical Decision Support Knowledge Artifact Implementation Guide Use Case 2: Decision Support Service Implementation Guide |
vMR Templates Release 1 (DSTU) | Implementers and users of CDS artifacts and guidance services]] | Terminology bindings and other constraints placed on the vMR. Used by the CDS Knowledge Artifact and Decision Support Service Implementation Guides | Use Case 1: Clinical Decision Support Knowledge Artifact Implementation Guide Use Case 2: Decision Support Service Implementation Guide |
Decision Support Service Release 2 (DSTU) | CDS guidance service implementers and users | Defines a Web service framework for CDS guidance services, including SOAP and REST interfaces. Used by Decision Support Service Implementation Guide | Use Case 2: Decision Support Service Implementation Guide |
Target Outcomes
- Alignment with Meaningful Use
- The product of this initiative will help providers achieve meaningful use of HIT and their quality improvement goals through addressing a known barrier to CDS development, adoption, and implementation
- Repositories or catalogues can emerge, supplied by a range of content creators such as societies or content vendors, whereby CDS artifacts can be selected and imported into HIT systems
- Each intervention will represent a standardized expression of a guideline that can be accessed by EHR system developers and users to simplify the process of incorporating guidelines into EHRs
- Clinical Decision Support Services can interact with EHRs and/or other Health Information Technology implementations
- Alignment with other S&I Initiatives, e.g., Query Health (HQMF)
- Close the gap between standard availability and widespread use/value
- Perform outreach to medical professional societies and guidance authors to promote their development of CDS interventions in addition to traditional guideline publications
Timeline
Updated version of the deliverables and timeline can be found on the Health eDecisions Homepage
|
Expected Deliverables
Updated version of the deliverables and timeline can be found on the Health eDecisions Homepage
- Agreement on the Project Charter
- Now
- Use Case and Functional Requirements
- End of August 2012
- List of Relevant Standards
- End of October
- Standards Support and Coordination Plan
- December 2012
- Implementation Guidance
- January/February 2013
- Pilot applications, Plans, and Lessons Learned
- March/June 2013
Relevant Standards and Stakeholders
Relevant Standards, Schemas, Formats, Terminologies, and Value Sets
- ArdenML
- Arden Syntax
- AHRQ eRecommendations Format
- CDSC L3
- CREF
- GELLO
- GEM (Guideline Elements Model)
- HITSP C32
- HL7 Care Record
- HL7 CCDA (Consolidated Clinical Documentation Architecture)
- HL7 Decision Support Service (DSS) Specifications
- HL7 Context Aware Information Retrieval (InfoButton)
- HL7 Model Interchange Format
- HL7 QRDA (Quality Reporting Documentation Architecture)
- HL7 Virtual Medical Record (vMR) data model
- HQMF
- IHE Care Management Profile
- IHE Retrieve Clinical Knowledge Profile (Profile for InfoButton)
- IHE RFD (Retrieve Clinical Format for Data Capture)
- IHE RPE (Request for Procedure Execution)
- IHE Request for Clinical Guidance Profile (an implementation of HL7 DSS)
- IHE Sharing Value Sets
- NQF Value Sets
Relevant Stakeholders
- Content and Guideline Creators (such as but not limited to):
- Content Publishers
- HIT Vendors
- Academic and Community Provider Organizations
- Medical Societies
- Public Health Agencies and other Government Agencies (CDC, NIH, NLM, FDA, etc.)
- Standard Terminology Suppliers
- Pharmaceutical and Medical Device Companies
- Medical Research Organizations
- Content Integrators (such as but not limited to):
- Providers implementing clinical content in an HIT system
- OpenCDS
- Clinical Decision Support Consortium
- Content Publishers who offer CDS services
- Content Implementers (i.e. consulting firms)
- HIT Vendors
- HIEs
- Content Users (such as but not limited to):
- Practitioners
- Case Managers
- Patients
- Provider Organizations (including VA and DoD)
- Payers and their agents involved in revenue cycle
- Public Health Agencies
- Compliance, regulatory, and legal entities
- Pharmacies and MTM Services
- Standards and Schema Development Agencies (such as but not limited to):
- GLIDES (GuideLines Into DEcision Support)
- CDSC (Clinical Decision Support Consortium)
- HL7 (Health Level Seven International)
- IHE (Integrating the Healthcare Enterprise)
- NQF (National Quality Forum)
- HITSP (Health Information Technology Standards Panel)
- OMG (Object Management Group)
- Quality Measurement Entities (such as but not limited to):
- NQF (National Quality Forum)
- NCQA (National Committee for Quality Assurance)
- CMS/PQRS (Center for Medicare and Medicaid Services, Physician Quality Reporting System)
- JCAHO (Joint Commission)
- BTE (Bridges to Excellence)
- QOPI (Quality Oncology Practice Initiative)
- ACIP (Advisory Committee on Immunization Practice)
Potential Risks
- Risk 1: Including implementation of clinical/treatment guidelines may increase scope.
- Mitigation/Response: Identify and manage scope by aligning to Meaningful Use Stage 3 target timelines.
- Risk 2: Insufficient “end-user” input (e.g. physicians, clinicians, technology vendors).
- Mitigation/Response: Evaluate role and type of initiative participants; invite additional participants early in the initiative process to balance representation.
- Risk 3: Data reconciliation process may be negatively impacted due to a lack of value sets and terminology standards.
- Mitigation/Response: Keep abreast and adopt developments and alignment strategies from the HIT Standards Committee and from the HIT Policy Committee. Such information may be part of an implementation guide.
- Risk 4: Services integration may be negatively impacted due to a lack of standards.
- Mitigation/Response: Identify gaps and partner with appropriate organizations to close them.
- Risk 5: EHR vendors may resist opening their architectures to services integration.
- Mitigation/Response: Identify and communicate the benefits early in the process; ensure EHR vendors are represented in the initiative participants (see Risk 2). As this initiative matures with deliverables, incorporation into MU3 would likely be an incentive for vendors to come aboard.
- Risk 6: Standards and solutions may not scale to small vendors and small practices.
- Mitigation/Response: Ensure that proposed standards and solutions are modular/scalable.
- Risk 7: Proposed project timeline does not reflect actual deadlines in relevant SDO Balloting.
- Mitigation/Response: Identify support to help mitigate this issue including inviting SDO members to participate in our work group and working with SDOs on out-of-cycle balloting. Change expectations in the HeD timeline. Begin working with the SDOs ASAP.
- Risk 8: Proposed project timeline is significantly faster than what has traditionally been possible through participant effort alone.
- Mitigation/Response: Monitor and communicate timeline, deliverables and progress frequently to all stakeholders; identify and request increased or reallocated resources (as needed).
Initiative Contacts
Initiative Coordinator | Ken Kawamoto | kensaku.kawamoto@utah.edu |
ONC Leadership | Jacob Reider | jacob.reider@hhs.gov |
ONC Leadership | Alicia Morton | alicia.morton@hhs.gov |
SME | Aziz Boxwala | aziz.boxwala@meliorix.com |
SME | Bryn Rhodes | bryn@veracitysolutions.com |
Project Manager | Jamie Parker | jamie.parker@esacinc.com |
Use Cases Lead | Anna Langhans | anna.langhans@accenturefederal.com |
UC2 Harmonization Lead | Atanu Sen | atanu.sen@accenture.com |
Standards Lead | Anna Langhans | anna.langhans@accenturefederal.com |
Standards Lead | Divya Raghavachari | divya.raghavachari@accenturefederal.com |