Overview of Request for Comments ONC 2017 Interoperability Standards Advisory ONC looking for comments on any last revisions, additions, or recommendations for the ISA’s 2017 online edition before they lock-in all of the ISA’s 2017 improvements to make the “2018 Reference Edition.” The ISA is a dynamic, coordinated catalog of standards and implementation specifications that can be used to meet interoperability needs in healthcare. The ISA will play a role in ONC’s efforts to implement the 21st Century Cures Act and serve as a way to harness industry input on interoperability standards best fit for a particular use in health IT. Last year, ONC shifted from a static “document-based” ISA to a more interactive online platform, which allows for ongoing updates to occur throughout the year.

Overview of Request for Comments ONC 2017 Interoperability Standards Advisory 2018 “Reference Edition” ISA to be published later this year ONC looking for input to ensure ISA reflects the latest/most accurate information about standards. ONC intends to add new components to the ISA, including: Consumer-based interoperability needs as recommended by the former Health IT Standards Committee New section on includes administrative standards and implementation specifications developed in coordination with CMS Educational and informational resources to allow for better understanding of health IT interoperability concepts New questions and answers submitted for stakeholder feedback Comments accepted through November 20, 2017 HL7 Policy Advisory Committee requesting comments from WGs by October 15

Overall Instructions Please review each section being requested from CQI, and define the following: Whether the standards and implementation specifications named (name, version, etc) ARE STILL THE RIGHT ONES Whether EACH of the SIX characteristics reported for EACH standard/implementation specification is still correct: Standard Process Maturity (Final, Balloted Draft, In Development) Implementation Maturity (Production or Pilot) Adoption Level (0 to 5 Dots for Low, Low-Medium, Medium, Medium-High, High) Federally Required (Yes/No) Cost (Free or $) Test Tool Availability (Yes, Yes($), Yes-Open, No, N/A) Whether the emerging standards and emerging implementation specifications listed ARE STILL THE RIGHT ONES Whether EACH of the SIX characteristics reported for EACH standard/implementation specification is still correct (same as above) Whether there are any updates/corrections to be made on the “Limitations, Dependencies, Preconditions for Consideration” or “Applicable Security Patterns for Consideration” sections Section I - D: Functional Status/Disability – CDS/CQI Interoperability Need: Representing Patient Functional Status and/or Disability HL7 Comment from 2016: We recommended considering PROMIS, acknowledging it is not an official standard and comes with the associated risk. Standards not maintained by an SDO or similar organization increases risks for implementers. While appropriate experts have developed many standards with the best of intentions, failure to move such standards into formal SDO organizations and processes leaves the standards without a clear plan for ongoing maintenance, update, and support. However, we still suggest including this standard where ONC can clearly identify that it is not under active maintenance by a formal SDO, and should clearly state the risks to implementers. HL7 Comments for 2017: Comment Section I - M: Patient Clinical “Problems” (i.e., conditions) – PATIENT CARE / CQI Interoperability Need: Representing Patient Clinical “Problems” (i.e., Conditions) HL7 Comment from 2016: We submitted a comment that many systems capture/document conditions in other code sets – ICD-9/ICD-10. We suggested these other standards be recognized for current use (e.g., ICD-10) or as part of historical analysis/analytics/CDS (e.g., ICD-9). Similarly, for reporting HEDIS Quality Measures, SNOMED equivalents are not provided. Rather code sets such as ICD and CPT are used. We need better rationale/wording to have this addressed. Section I - S – Social Determinants – PATIENT CARE/CQI ? Interoperability Need: Representing Depression HL7 Comment from 2016: We suggested to add 69724-3 – PHQ-4, which was not needed so need better rationale if still needed. Section II - D – Clinical Quality Measurement - CQI Interoperability Need: Sharing Quality Measure Artifacts for Quality Reporting Initiatives HL7 Comment from 2016: We made the following suggestions that were not addressed: Suggest to add a roadmap consideration under Limitations, Dependencies, and Preconditions: CQL-based HQMF major release 2 expected in 2017. Suggest to add a roadmap consideration under Limitations, Dependencies, and Preconditions: The CQF on FHIR will be transitioned to FHIR Clinical Reasoning. Suggest to add FluentPath as an emerging standards. Please review and provide any updated suggestions that make a better case why it should be included. Section II - E – Clinical Quality Reporting - CQI It appears neither of our suggestions were addressed. Please review and provide any updated suggestions that make a better case why it should be included. • Section III - B – Clinical Decision Support Services - CDS (CQI MIGHT BE INTERESTED…) o Interoperability Need: Providing Patient-Specific Assessments and Recommendations Based on Patient Data for Clinical Decision support  Typo: QICore/QuICK should be QICore/QUICK o Interoperability Need: Retrieval of Contextually Relevant, Patient-Specific Knowledge Resources from Within Clinical Information Systems to Answer Clinical Questions Raised by Patients in the Course of Care  The adoption level for “HL7 Version 3 Standard: Context Aware Knowledge Retrieval Application. (“Infobutton”), Knowledge Request, Release 2.” should be 4 bullets. [clarify rationale] o Please review and provide any updated suggestions that make a better case why it should be included. • Section VI – Questions o ONC is asking for feedback on specific questions. The following questions jumped out for (specific) workgroups to review:  17-1. In what ways has the ISA been useful for you/your organization as a resource? ONC seeks to better understand how the ISA is being used, by whom, and the type of support it may be providing for implementers and policy-makers. • All WGs: Reflect on what HL7 member organizations have done that we want to contribute.  17-3. An Appendix II has been added that includes educational and informational resources as recommended by the Health IT Standards Committee/2017 ISA Task Force. Are there other topics and/or existing resources which would be helpful to include in this area to increase stakeholder understanding of health IT interoperability issues? • All WGs: Anything to add?  17-4. Are there additional Interoperability Needs (with corresponding standards) that represent specific sociodemographic, psychological, behavioral or environmental domains that should be included in the ISA? • CBCC, CIC, Behavioral Health, LongTerm Care, Learning Health System CQI MIGHT BE ALSO INTERESTED…  17-7. Is the existing ISA format used for listing standards and implementation specifications applicable for listing Models and Profiles? Are there additional or different attributes that should be collected for them? Are there additional models and/or profiles that should be listed? • ALL WGs – Any relevant EHR Profiles, DAMs and other models should be considered. Section 218(b) of the PAMA directs CMS to establish a new program to promote the use of Appropriate Use Criteria for ordering and furnishing certain advanced imaging services AUC: criteria that are evidence-based and are established to assist professionals who order and furnish certain advanced imaging services to make the most appropriate ordering and treatment decision for a specific clinical condition for an individual. There are four major components of the AUC program: Establishment of AUC (November 15, 2015) Identification of mechanisms for consultation with AUC (April 1, 2016) Commence AUC consultation by ordering professionals, and reporting on AUC consultation by furnishing professionals (January 1, 2017) Identify outlier ordering professionals (annually after January 1, 2017)

Sample

Sections for CQI Review/Comment Section I - D: Functional Status/Disability – CDS/CQI Interoperability Need: Representing Patient Functional Status and/or Disability HL7 Comment from 2016: We recommended considering PROMIS, acknowledging it is not an official standard and comes with the associated risk. Standards not maintained by an SDO or similar organization increases risks for implementers. While appropriate experts have developed many standards with the best of intentions, failure to move such standards into formal SDO organizations and processes leaves the standards without a clear plan for ongoing maintenance, update, and support. However, we still suggest including this standard where ONC can clearly identify that it is not under active maintenance by a formal SDO, and should clearly state the risks to implementers. HL7 Comments for 2017: We recommended considering PROMIS, acknowledging it is not an official standard and comes with the associated risk. Standards not maintained by an SDO or similar organization increases risks for implementers. While appropriate experts have developed many standards with the best of intentions, failure to move such standards into formal SDO organizations and processes leaves the standards without a clear plan for ongoing maintenance, update, and support. However, we still suggest including this standard where ONC can clearly identify that it is not under active maintenance by a formal SDO, and should clearly state the risks to implementers. Comment

Sections for CQI Review/Comment Section I - D: Functional Status/Disability – CDS/CQI

Sections for CQI Review/Comment Section I - M: Patient Clinical “Problems” (i.e., conditions) – PATIENT CARE / CQI Interoperability Need: Representing Patient Clinical “Problems” (i.e., Conditions) HL7 Comment from 2016: We submitted a comment that many systems capture/document conditions in other code sets – ICD-9/ICD-10. We suggested these other standards be recognized for current use (e.g., ICD-10) or as part of historical analysis/analytics/CDS (e.g., ICD-9). Similarly, for reporting HEDIS Quality Measures, SNOMED equivalents are not provided. Rather code sets such as ICD and CPT are used. We need better rationale/wording to have this addressed. HL7 Comments for 2017: Comment

Sections for CQI Review/Comment Section I - M: Patient Clinical “Problems” (i.e., conditions) – PATIENT CARE / CQI

Sections for CQI Review/Comment Section I - S – Social Determinants – PATIENT CARE/CQI ? Interoperability Need: Representing Depression HL7 Comment from 2016: We suggested to add 69724-3 – PHQ-4, which was not needed so need better rationale if still needed. HL7 Comments for 2017: Comment

Sections for CQI Review/Comment

Sections for CQI Review/Comment

Sections for CQI Review/Comment

Sections for CQI Review/Comment Section II - C – Clinical Decision Support CDS/CQI Interoperability Need: Shareable Clinical Decision Support HL7 Comments for 2017: Agree with CDS WG statements Comment Interoperability Need: Provide Access to Appropriate Use Criteria Interoperability Need: Communicate Appropriate Use Criteria

Sections for CQI Review/Comment

Sections for CQI Review/Comment

Sections for CQI Review/Comment Section II - D – Clinical Quality Measurement - CQI Interoperability Need: Sharing Quality Measure Artifacts for Quality Reporting Initiatives HL7 Comment from 2016: We made the following suggestions that were not addressed: Suggest to add a roadmap consideration under Limitations, Dependencies, and Preconditions: CQL-based HQMF major release 2 expected in 2017. Suggest to add a roadmap consideration under Limitations, Dependencies, and Preconditions: The CQF on FHIR will be transitioned to FHIR Clinical Reasoning. Suggest to add FluentPath as an emerging standards. Please review and provide any updated suggestions that make a better case why it should be included. HL7 Comments for 2017: Recommend CQL-based HQMF STU 2.1 to address the QDM content expressly created for use with CQL. The STU has been tested in pilots addressing drafts for all eCQMs currently in the CMS programs. Suggest FHIRPath as an emerging standard (previously called FluentPath and now renamed). Suggest a roadmap consideration under Limitations, Dependencies, and Preconditions for FHIR Clinical Reasoning List HQMF Normative (R1) instead of HQMF STU 2.1

Sections for CQI Review/Comment Section II - D – Clinical Quality Measurement - CQI

Sections for CQI Review/Comment Section II - E – Clinical Quality Reporting - CQI It appears neither of our suggestions were addressed. Please review and provide any updated suggestions that make a better case why it should be included. HL7 Comments for 2017: Suggest a roadmap consideration under Limitations, Dependencies, and Preconditions for FHIR Clinical Reasoning for Clinical Quality Reporting QRDA Category I STU 4 for implementation of eCQMs in 2018 and QRDA Category I STU 5 for implemention of eCQMs in 2019. QRDA Category III STU 2.1 for aggregate reporting in 2018 and 2019

Sections for CQI Review/Comment Section II - E – Clinical Quality Reporting - CQI

Sections for CQI Review/Comment Section III - B – Clinical Decision Support Services - CDS (CQI MIGHT BE INTERESTED…) Interoperability Need: Providing Patient-Specific Assessments and Recommendations Based on Patient Data for Clinical Decision support HL7 Comment from 2016: Typo: QICore/QuICK should be QICore/QUICK HL7 Comments for 2017: Comment Interoperability Need: Retrieval of Contextually Relevant, Patient-Specific Knowledge Resources from Within Clinical Information Systems to Answer Clinical Questions Raised by Patients in the Course of Care HL7 Comment from 2016: The adoption level for “HL7 Version 3 Standard: Context Aware Knowledge Retrieval Application. (“Infobutton”), Knowledge Request, Release 2.” should be 4 bullets. [clarify rationale]. Please review and provide any updated suggestions that make a better case why it should be included.

Sections for CQI Review/Comment Section III - B – Clinical Decision Support Services - CDS (CQI MIGHT BE INTERESTED…)

Sections for CQI Review/Comment Section VI – Questions ONC is asking for feedback on specific questions. The following questions jumped out for (specific) workgroups to review: 17-1. In what ways has the ISA been useful for you/your organization as a resource? ONC seeks to better understand how the ISA is being used, by whom, and the type of support it may be providing for implementers and policy-makers. All WGs: Reflect on what HL7 member organizations have done that we want to contribute. HL7 Comments for 2017: Comment

Sections for CQI Review/Comment Section VI – Questions (cont.) 17-3. An Appendix II has been added that includes educational and informational resources as recommended by the Health IT Standards Committee/2017 ISA Task Force. Are there other topics and/or existing resources which would be helpful to include in this area to increase stakeholder understanding of health IT interoperability issues? All WGs: Anything to add? HL7 Comments for 2017: Comment

Sections for CQI Review/Comment Section VI – Questions (cont.) 17-4. Are there additional Interoperability Needs (with corresponding standards) that represent specific sociodemographic, psychological, behavioral or environmental domains that should be included in the ISA? CBCC, CIC, Behavioral Health, LongTerm Care, Learning Health System CQI MIGHT BE ALSO INTERESTED… HL7 Comments for 2017: Comment

Sections for CQI Review/Comment Section VI – Questions (cont.) 17-7. Is the existing ISA format used for listing standards and implementation specifications applicable for listing Models and Profiles? Are there additional or different attributes that should be collected for them? Are there additional models and/or profiles that should be listed? ALL WGs – Any relevant EHR Profiles, DAMs and other models should be considered. HL7 Comments for 2017: Comment