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This file is created on 2021-09-17 06:00:28am

About the ISA

Comment

Health information blocking

I am a Senior Advantage Kaiser Permanette Medicare member. I have written and filed numerous complaints about Kaiser EHR blocking but I am still not able to access certain medical information such as: MRI,CT,X-RAYS PATHOLOGY REPORTS AND OTHER WRITTEN diagnostic reports. Kaiser does not respond to my question. WHY. CAN YOU HELP ME CORRECT THIS INJUSTICE ACCORDING TO THE CARES ACT,

ISA Structure

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ISA Timeline and Comment Process

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Data Element: Medications

Challenge to capturing medications is those that medications that don't make the typical clinically documented med list such as herbal and at times OTC medications.  These often are documented narratively in nurses or physician notes dependent on the type of EMR or documentation system. 

Data Element: Patient's Goals

Patient's goals are likely to be robustly documented in the Nurses Care Plan, depending on the type of EMR.   Would want to be able to capture current and active goals and those goals that have been completed or resolved. 

Data Element: Health Concerns

This data element may have merit, especially if there are differences in the data element for Patient Goals and Encounter Diagnosis; but may be redundant...Also, maybe difficult to capture if it is not entered in a discrete field as part of the Nursing Care Plan or Physician Treatment Plan

Support of the Gravity Project’s Submission to Include SDOH

To: The Honorable Donald Rucker, M.D. National Coordinator for Health Information Technology U.S. Department of Health and Human Services 330 C Street SW, 7th Floor Washington, D.C.  20201   Re: In Support of the Gravity Project’s Submission to Include Social Determinants of Health in the U.S. Core Data for Interoperability   Dear National Coordinator Rucker: I write on behalf of the Gravity Project to ask for your quick help with a major opportunity—adding structured social determinants of health (SDOH) data to the U.S. Core Data for Interoperability (USCDI). The Gravity Project has done considerable groundwork and submitted the SDOH data elements to the Office of the National Coordinator (ONC), and ONC, in turn, has elevated the submission to the next step. The Gravity Project’s submissions would add critical domains such as food insecurity, housing instability, transportation insecurity, social isolation, and stress to the USCDI, integrated with core clinical activities such as assessments, diagnoses, interventions, and outcomes.  As a healthcare provider for many years, I have seen firsthand the impact SDOH has on managing care and improving outcomes for patients. The challenges with meeting the needs of all seeking care have been exacerbated by COVID and have highlighted the inequities in the healthcare system. Addressing SDOH will be essential to ensure adequate care is received by all by including data elements to accurately and timely identify social needs and match those needs with community resources. The inclusion of SDOH as a new data class in USCDI, as proposed by the Gravity Project, will provide a consistent method to document and communicate these factors during a health care encounter. The Gravity Project has over 1,200 collaborators nationwide, representing diverse stakeholders who are committed to the goals of this project, standardize data collection and coding, and seamlessly exchanging SDOH data among all caregivers.   Sincerely,  Dr. Lisa Lucas National Director Healthcare Informatics SAS Institute        

American Association of Colleges of Nursing submits comments

Please see attached PDF

AACN ONC Comments 2021.pdf

Comments from the College of American Pathologists

Please see attached.

CAP Comments on ONC-ISA.pdf

terminologies referenced by ISA

It would be very useful to have an "index," so to speak, of all the terminologies/code sets/vocabularies referenced by ISA and where in ISA they're referenced. Does such a thing already exist?

FAQs

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Vocabulary/Code Set/Terminology

Allergies and Intolerances

Representing Patient Allergic Reactions

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Representing Patient Allergies and Intolerances; Environmental Substances

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Representing Patient Allergies and Intolerances; Food Substances

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Representing Patient Allergies and Intolerances; Medications

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Tighten up the applicable starter sets

The various identified "starter value sets" in this section presents a confusing overlapping collection. The three items listed as "representing drug classes" are not equivalent and only the SNOMED CT (SCT) Product hierarchy is actually aligned with actual drug class concepts. SNOMED CT Drug product class concepts are uniquely valuable because NLM links SCT product class concepts to the appropriate RXNorm drug ingredients to support Drug class to RxNorm or even NDC codes identification via available APIs at RxClass. The other two suggested sets (Common Drug Classes for Allergy and Intolerance documentation and Common Drug Substances for Allergy and Intolerance documentation) do not represent useful drug classes and should not be listed in the Drug Classes for Allergy and Intolerance documentation section. For the Representing Medication section, the listed set Clinical Drug Ingredient (2.16.840.1.113762.1.4.1010.7) (RxNorm ingredient codes) is a subset of all potential drug ingredient RxNorm codes that was based on a historical review of common drug ingredients listed as causes of allergy or intolerance in clinical records done a number of years ago. While this list has not been updated, it is useful. I suggest adding to the suggestions in this section the set you will remove from the "class" set as it is the list of every ingredient or related code type in RxNorm - over 25,000 codes. This is the Common Drug Substances for Allergy and Intolerance documentation (2.16.840.1.113762.1.4.1186.1) set.

Clinical Notes

Representing Clinical Notes

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Cognitive Status

Representing Patient Cognitive Status

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COVID-19 Novel Coronavirus Pandemic

COVID-19 Novel Coronavirus Pandemic

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Demographics

Representing Patient Contact Information for Telecommunications

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Representing Nutrition Assessment, Diagnosis, Interventions and Monitoring/Evaluation

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Emergency Medical Services

Representing Health Care Data for Emergency Medical Services

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Encounter Diagnosis, Assessment and Plan

Representing Assessment and Plan of Treatment

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Representing Patient Dental Encounter Diagnosis

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Representing Patient Medical Encounter Diagnosis

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Family Health History

Representing Patient Family Health History

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Functional Status/Disability

Representing Patient Functional Status and/or Disability

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Goals

Representing Patient Goals

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Health Care Providers, Family Members, and Other Caregivers

Representing Health Care Providers

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Representing Provider Role in Team Care Settings

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Representing Relationship Between Patient and Another Person

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Health Concerns

Representing Patient Health Concerns

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Imaging (Diagnostics, Interventions and Procedures)

Representing Imaging Diagnostics, Interventions and Procedures

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Immunizations

Representing Immunizations – Administered

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Representing Immunizations – Historical

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Industry and Occupation

Representing Patient Industry and Occupation

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Laboratory

Representing Laboratory Tests

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Representing Laboratory Values/Results

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Medications

Representing Patient Medications

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Nursing

Representing Clinical/Nursing Assessments

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Representing Nursing Interventions

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Representing Outcomes for Nursing

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Representing Patient Problems for Nursing

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Patient Clinical “Problems” (i.e., conditions)

Representing Patient Clinical “Problems” (i.e., Conditions)

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Preferred Language

Representing Patient Preferred Language (Presently)

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Pregnancy Status

Representing Patient Pregnancy Status

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Procedures

Representing Dental Procedures Performed

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Representing Medical Procedures Performed

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Provenance

Representing Data Provenance

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Document Metadata

The Document Metadata defined in IHE XDS/XCA/XDR/XDM and in IHE MHD (using FHIR DocumentReference); provides full Provenance for the document the metadata describes. The metadata also describes things beyond just Provenance. See https://profiles.ihe.net/ITI/HIE-Whitepaper/index.html#2-principles-of-ihe-for-health-document-sharing

Document Digital Signature

The IHE-Document Digital Signature (DSG) profile Implementation Guide provides a method for digitally signing documents. Where documents are any form of stream of bytes including CDA and FHIR-Documents. The DSG profile is normative and can provide integrity protection with attribution to the signer.  The Normative publication at IHE is --  https://profiles.ihe.net/ITI/TF/Volume1/ch-37.html The Document Digital Signature (DSG) Profile defines general purpose methods of digitally signing of documents for communication and persistence. Among other uses, these methods can be used within an IHE Document Sharing infrastructure (e.g., XDS, XCA, XDM, XDR, and MHD). There are three methods of digital signature defined here: Enveloping, Detached (manifest), and SubmissionSet.
  • An Enveloping Signature is a Digital Signature Document that contains both the signature block and the content that is signed. Access to the contained content is through removing the Enveloping - Digital Signature. Among other uses, this method should not be used with Document Sharing infrastructure.
  • A Detached Signature is a Digital Signature Document that contains a manifest that points at independently managed content. Detached signatures leave the signed document or documents in the original form. Among other uses, this method is recommended for use with a Document Sharing infrastructure to support Digital Signatures, as this method does not modify the original Document Content. This method uses the Document Sharing “SIGNS” relationship provides linkage.
  • A SubmissionSet Signature is a Detached Signature Document that attests to the content in a SubmissionSet by: containing a manifest of all the other Documents included in the SubmissionSet, and a reference to the SubmissionSet. The Document Sharing “SIGNS” relationship may be used but is not required.
Ink-on-paper signatures have been a part of the documentation process in health care and have traditionally been indicators of accountability. Reliable exchange and storage of electronic data between disparate systems requires a standard that implements equivalent non-repudiation to prevent document creators from denying authorship and rejecting responsibility.

IHE - Document Sharing

The IHE Document Sharing includes Provenance of documents that are shared.  See the IHE whitepaper describing the Foundations of Document Sharing exchanges https://profiles.ihe.net/ITI/HIE-Whitepaper/index.html# see the normative specification on Document Sharing metadata     https://profiles.ihe.net/ITI/TF/Volume3/ch-4.1.html#4.1.3

Public Health Emergency Preparedness and Response

Representing Healthcare Personnel Status

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Representing Hospital/Facility Beds Utilization

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Representing Laboratory Operations (Population Laboratory Surveillance)

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Representing Mass Vaccination Status

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Representing Population-Level Morbidity and Mortality

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Race and Ethnicity

Representing Patient Race and Ethnicity

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Research

Representing Data for Biomedical and Health Services Research Purposes

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Sex at Birth, Sexual Orientation and Gender Identity

Representing Patient Gender Identity

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Representing Patient Sex (At Birth)

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Representing Patient-Identified Sexual Orientation

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Social, Psychological, and Behavioral Data

Representing Alcohol Use

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Representing Depression

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Representing Drug Use

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Representing Exposure to Violence (Intimate Partner Violence)

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Representing Financial Resource Strain

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Representing Food Insecurity

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Representing Housing Insecurity

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Representing Level of Education

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Representing Physical Activity

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Representing Social Connection and Isolation

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Representing Stress

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Representing Transportation Insecurity

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Tobacco Use

Representing Patient Electronic Cigarette Use (Vaping)

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Removed Reference

Removed “See LOINC projects in the Interoperability Proving Ground” since LOINC has been removed from the Standards in this section.

Representing Patient Second Hand Tobacco Smoke Exposure

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Representing Patient Tobacco Use (Smoking Status)

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Units of Measure

Representing Units of Measure (For Use with Numerical References and Values)

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Vital Signs

Representing Patient Vital Signs

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Content/Structure

Admission, Discharge, and Transfer

Sending a Notification of a Long Term Care Patient’s Admission, Discharge and/or Transfer Status to the Servicing Pharmacy

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Sending a Notification of a Patient’s Admission, Discharge and/or Transfer Status to Other Providers

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Sending a Notification of a Patient’s Encounter to a Record Locator Service

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Care Coordination for Referrals

Referral from Acute Care to a Skilled Nursing Facility

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Referral to a Specialist - Request, Status Updates, Outcome

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Referral to Extra-Clinical Services - Request, Updates, Outcome

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Care Plan

Documenting and Sharing Care Plans for a Single Clinical Context

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Documenting and Sharing Medication-Related Care Plans by Pharmacists

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Documenting Care Plans for Person Centered Services

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Domain or Disease-Specific Care Plan Standards

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Sharing Patient Care Plans for Multiple Clinical Contexts

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Clinical Decision Support

Communicate Appropriate Use Criteria with the Order and Charge to the Filling Provider and Billing System for Inclusion on Claims

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Provide Access to Appropriate Use Criteria

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Sharable Clinical Decision Support

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Documentation of Clinical Notes

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Clinical Quality Measurement and Reporting

Reporting Aggregate Quality Data for Quality Reporting Initiatives

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Reporting Patient-level Quality Data for Quality Reporting Initiatives

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Sharing Quality Measure Artifacts for Quality Reporting Initiatives

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Data Provenance

Establishing the Authenticity, Reliability, and Trustworthiness of Content Between Trading Partners

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Document Metadata

The Document Metadata defined and used by IHE XDS/XDR/XCA/XDM provides complete Provenance for the document, in addition to other functionality. see IHE publication -- https://profiles.ihe.net/ITI/HIE-Whitepaper/index.html#26-value-of-metadata The IHE metadata is described -- https://profiles.ihe.net/ITI/TF/Volume3/ch-4.1.html#4.1.3 Where each element contributing to Provenance is highlighted.

Document Digital Signature

IHE Document Digital Signature (DSG) profile Implementation Guide provides digital signature capability across any kind of document. This includes CDA and FHIR-Documents with the same solution.  Find the normative specification from IHE -- https://profiles.ihe.net/ITI/TF/Volume1/ch-37.html 37 Document Digital Signature (DSG) The Document Digital Signature (DSG) Profile defines general purpose methods of digitally signing of documents for communication and persistence. Among other uses, these methods can be used within an IHE Document Sharing infrastructure (e.g., XDS, XCA, XDM, XDR, and MHD). There are three methods of digital signature defined here: Enveloping, Detached (manifest), and SubmissionSet.
  • An Enveloping Signature is a Digital Signature Document that contains both the signature block and the content that is signed. Access to the contained content is through removing the Enveloping - Digital Signature. Among other uses, this method should not be used with Document Sharing infrastructure.
  • A Detached Signature is a Digital Signature Document that contains a manifest that points at independently managed content. Detached signatures leave the signed document or documents in the original form. Among other uses, this method is recommended for use with a Document Sharing infrastructure to support Digital Signatures, as this method does not modify the original Document Content. This method uses the Document Sharing “SIGNS” relationship provides linkage.
  • A SubmissionSet Signature is a Detached Signature Document that attests to the content in a SubmissionSet by: containing a manifest of all the other Documents included in the SubmissionSet, and a reference to the SubmissionSet. The Document Sharing “SIGNS” relationship may be used but is not required.
Ink-on-paper signatures have been a part of the documentation process in health care and have traditionally been indicators of accountability. Reliable exchange and storage of electronic data between disparate systems requires a standard that implements equivalent non-repudiation to prevent document creators from denying authorship and rejecting responsibility.

Diet and Nutrition

Exchanging Diet and Nutrition Orders Across the Continuum of Care

Comment

Drug Formulary & Benefits

Allows Pharmacy Benefit Payers to Communicate Formulary and Benefit Information to Prescriber Systems

Comment

Electronic Prescribing

Allows a Long Term or Post-Acute Care to Request to Send an Additional Supply of Medication

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Allows a Pharmacy to Notify a Prescriber of Prescription Fill Status

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Allows a Pharmacy to Request a Change to a Prescription