Introduction to the ISA

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Regenstrief Institute comments on the 2018 ISA

Thank you for the opportunity to provide comments on the 2017 edition of the ISA. We want to start by thanking ONC for their efforts to continually improve the ISA. The evolution of the format greatly improves its usefulness and navigation, especially the web-based layout and in-context comments. 

The added clarity on standards for observations and observation values is also a very important and welcome improvement. Across many interoperability needs, the ISA pairing of LOINC and SNOMED CT is an appropriate and helpful distinction.

Since publication of the 2017 edition, the ISA has expanded considerably in scope. It now includes a new section for Administrative Standards and interoperability needs around research and public health. The spectrum from public health to clinical care (including its administrative component) to clinical research is much more a continuum than discrete domains. We strongly support building towards a common, shared infrastructure across this spectrum and thus having them together in the ISA makes sense. However, the current set of interoperability needs across these domains are not very clearly defined and appear more to be generic labels for existing standards rather than actual use cases. Similarly, it is unclear why Administrative standards needs a separate section, when those standards also have the components of vocabularies and structures (and, perhaps later, models). 

We strongly agree with the suggestions made by the IVD Industry Connectivity Consortium (IICC) that ONC should add two new interoperability needs naming the LAW – Laboratory Analytical Workflow Profile and LIVD – Digital Format for Publication of LOINC to Vendor IVD Test Results standards. 

As we previously recommended, there are three high-value, well-established domains where the ISA can recommend additional vocabulary standards. They are a) Clinical measurements and observations, b) Clinical document types, and c) Patient reported outcome measures, survey instruments, and other standardized patient assessments.

There are large scale implementations around the world who have implemented the vocabularies in this way. And this usage has been recommended previously in the U.S. in many contexts, including the CHI initiatives, HITSC, and others.

Specifically, we recommend adding these areas to the ISA Section I: Vocabulary/Code Set/Terminology Standards and Implementation Specifications:

Clinical measurements and observations

Interoperability need: send, receive, and use clinical measurements and observations

Standard for observations: LOINC

Standard: SNOMED CT

Clinical document types

Interoperability need: send, receive, and use clinical documents

Standard: LOINC

Patient reported outcome measures, survey instruments, and other standardized patient assessments

Interoperability need: send, receive, and use patient reported outcomes measures, survey instruments and patient assessments

Standard: LOINC

Daniel J. Vreeman, PT, DPT, MS, FACMI
Director, LOINC and Health Data Standards, Regenstrief Center for Biomedical Informatics
Regenstrief-McDonald Scholar in Data Standards, Indiana University School of Medicine
Research Scientist, Regenstrief Institute, Inc 



FHA's Comments on ONC's ISA new edition


SECTION VI: Questions and Requests for Stakeholder Feedback

Section II: Content/Structure Standards and Implementation Specifications

Under “Case Reporting to Public Health Agencies”,

  1. HL7 FHIR Implementation Guide: Structured Data Capture (SDC) Release 1. The page link is broken.


Section V: Administrative Standards and Implementation Specifications

  1. Under “V-A: Health Care Claims and Coordination of Benefits”

“Health Care Claims or Equivalent Encounter Information for Retail Pharmacy Claims” is listed twice and one of the two links is broken. It leads to an unavailable temporary link.


ISA comments to be submittedAfterGails comments.docx

MiHIN's Comments to the ISA

On behalf of the Michigan Health Information Network Shared Services (MiHIN), we are pleased to submit comments to the ONC's ISA. 

MiHIN ISA Comments.pdf

Minnesota e-Health Initiative Coordinated Response to ISA 2018

Thank you for the opportunity to provide input on the 2018 Interoperability Standards Advisory. The Minnesota e-Health Initiative (Initiative) is pleased to submit comments as a public-private collaborative focused on advancing the adoption and use of electronic health records and other health information technology, including health information exchange. The Initiative is guided by a legislatively-authorized 25-member advisory committee. Activities of the Initiative are coordinated by the Minnesota Department of Health, Office of Health Information Technology.

The Initiative recognizes the need to continually update the community on the most current standards and implementation specifications necessary to achieve interoperability. The tabular presentation can provide implementers with a single reference point for implementation specifications. In addition, the Initiative supports standards that are responsive to the needs of 1) providers across the care continuum; 2) individuals, families, and caregivers; and 3) all communities to advance health equity and support health and wellness.

Please consider the attached comments related to the 2018 Interoperability Standards Advisory.

Contact Kari Guida, Senior Health Informatician, Office of Health Information Technology, Minnesota Department of Health at with any questions.


MN e-Health Initiative 2018 ISA Coordinated Response.pdf
ISA 2019 Reference Edition Feedback - Epic.pdf
CAQH CORE ISA Comment Letter 10.01.18.pdf

Pharmacy HIT Collaborative's Comments on ONC's Proposed 2018 ISA

On behalf of the membership of the Pharmacy Health Information Technology Collaborative (Collaborative), we are pleased to submit comments for the 2018 Interoperability Standards Advisory comment period.The Collaborative has been involved with the federal agencies, including the Office of the National Coordinator (ONC), developing the national health information technology (HIT) framework since 2010.  The Collaborative is supportive of the proposed standards for clinical health IT interoperability purposes. Pharmacists provide patient-centered care and services, maintain various secure patient care records, and as part of the integrated health care team, they are directly involved with other health care providers and patients in various practice settings.  Pharmacists are users of health IT and are especially supportive of interoperability standards incorporating HL7, SNOMED CT, LOINC, RxNorm, and NCPDP SCRIPT, and NCPDP Real Time Formulary and Benefits (currently under development).  The Collaborative supports use of these particular standards which are important to pharmacists for allergy reactions, immunization historical and administered, immunization registry reporting, medications, medication allergies, patient problems, smoking status, reporting to public health agencies, clinical decision support services/knowledge artifacts, drug formulary checking, and electronic prescribing (including new versions). 

CMS Data Element Library HITWG Comments on the ONC 2018 ISA

CMS Data Element Library HITWG Comments on the ONC 2018 Interoperability Standards Advisory (ISA)

The Centers for Medicare and Medicaid (CMS) Data Element Library (DEL), Health Information Technology Workgroup (HITWG) evaluated the 2018 Interoperability Standards Advisory and offer the following comments based on an analysis against the data classes and related health IT vocabulary codes for the federally required post-acute care (PAC) assessment instruments. 

Section I – Vocabulary/Code Sets/Terminology Standards and Implementation Specifications

  • I-D: Functional Status/Disability
    • Recommendation: The CMS DEL HITWG recommends referencing the CMS DEL for the Functional Abilities and Goals Assessment (Prior Functioning and Everyday Activities, Self-Care, Mobility).  The assessment is completed (in full or in part) on patients receiving post-acute care in Inpatient Rehabilitation Facilities (IRF), Skilled Nursing Facilities (SNF) and Nursing Facilities (NF), Medicare Home Health Agencies (HHA), and Long-Term Care Hospitals (LTCH). Items in the assessment are also used the Functional Assessment Standardized Items (FASI) tool used for patients served by home and community-based service providers.
    • Other Comments: There is an opportunity for the ISA to further define the areas of functional status include in this section (e.g. Activities of Daily Living (ADLs), Instrumental Activities of Daily Living (IADLs), Mobility, Mental/Cognitive, Hearing/Speech/Vision). 
      • In the past cognitive status was included in functional status in a Consolidated Clinical Document Architecture (C-CDA) document. It has recently been moved from functional status to a separate area and the name changed to mental status. 
      • If mental status is not included in this section, then it appears to be a gap in the ISA.
      • Similar to mental/cognitive status, it is not clear if hearing, speech and vision status is considered part of functional status or if it is a gap in the ISA.  
  • I-L: Nursing - Representing Clinical/Nursing Assessments
    • Recommendation: The CMS DEL HITWG recommends including the CMS post-acute care clinical assessments and referencing the CMS DEL for related LOINC and SNOMED codes.  CMS assessments include:
    • Other Comments:
      • Each clinical assessment includes a subset of assessment items organized by clinical categories which could be referenced in individually in this section or in other sections of the ISA (e.g. see comments on functional status).  
      • The HITWG recommends updating the category name from “Nursing” to “Clinical” or Clinical/Nursing to reflect that the category is not limited to only nursing but other clinical disciplines as well. 
      • The Section on Limitations, Dependencies, and Preconditions for Consideration appears to have a missing reference to Systematized Nomenclature of Medicine – Clinical Terms (SNOMED CT). (see below)
      • Limitations, Dependencies and Preconditions for Consideration

        • Assessment are represented as question/answer (name/value pairs
        • Codes should generally be chosen form two axes: clinical finding and situation  with explicit context
        • When representing validated scales, LOINC should be used for the question and LOINC answer (LA codes) should be used for the answers
        • See LOINC projects in the Interoperability Proving Grounds
        • For more information about observation and observation values, see Appendix II for an informational resource developed by the Health IT Standards Committee
  • I-S: Social, Psychological, and Behavioral Data:
    • General Comment for this Section
      • Recommendation: The DEL HITWG recommends that this section include an assessment of behavioral symptoms (physical behaviors directed toward others, verbal behaviors directed toward others, and other types of behaviors including self-harm).  The CMS DEL MDS v1.16 assessment for Behavioral Symptoms includes this type of assessment and could be referenced if there was an appropriate section designated for this type of behavioral data.
    • Representing Depression
      • Recommendation:  
        • The DEL HITWG recommends that the Logical Observation Identifiers Names and Codes (LOINC) codes referenced in this section be updated to reflect the latest codes for the Patient Health Questionnaire-2 (PHQ-2) and Patient Health Questionnaire-9 (PHQ-9).  CMS Assessments include the PHQ-2 and PHQ-9 and reference different LOINC codes. The HITWG has verified with Regenstrief Institute (RI) that the codes in the ISA should be updated.
HITWGComments ONC 2018 ISA_2018-07-19.docx

HL7 Comments to ONC - ISA Update for 2019 Reference Edition

Attached are Health Level Seven International’s comments on ONC’s Interoperability Standards Advisory (ISA) in preparation to update the ISA for the 2019 “Reference Edition”. Should you have any questions about our attached comments, please contact Charles Jaffe, MD, PhD, Chief Executive Officer of Health Level Seven International at or 734-677-7777. We look forward to continuing this discussion and offer our assistance to ONC.

HL7 Response Letter ISA 2019 10.01.18 Final.docx