Clinicians on Workshop W01

Laura Heermann PhD, RNIntermountain Healthcare

Clinicians on Workshop W01 Tuesday May 18, 2021

Russ Leftwich MDIntersystems

Jim McClay MDUNMC

For Meeting Materialhttps://tinyurl.com/May2021CICCoF

https://tinyurl.com/May2021CICCoF

The Technology of Interoperability - What are the 21st Century Cures Regulations Talking About?

James McClay, MD, MSDepartment of Emergency Medicine

University of Nebraska Medical Center

FHIR in The FUTURE

Objectives

• At the end of this session participants will be able to:

• Describe the Cures Act Timeline• Identify the core technologies required by the Cures Act regulations• Develop familiarity with Fast Healthcare Interoperability Resources

Federal Regulatory Bodies

Interoperability Roadmap 2015 Timeline

• 2015-2017: Send, receive, find and use priority data domains to improve health care quality and outcomes. • 2018-2020: Expand data sources and users in

the interoperable health IT ecosystem to improve health and lower costs. • 2021-2024: learning health system, with the

person at the center of a system that can continuously improve care, public health, and science through real-time data access.

Healthcare Information Interoperability

• “Interoperability is ability of two or more systems or components to exchange information and to use the information that has been exchanged”

• Technical Interoperability – the ability to move information from one place to another

• Semantic Interoperability – the ability to understand the data. Both the sender and the receiver systems can use the data unambiguously

• Process Interoperability – The ability for humans to coordinate activities• Clinical Interoperability – “Clinical Interoperability is the ability for two or more clinicians

in different care teams to transfer patients and provide seamless care to the patient”

Standard computer dictionary: a compilation of IEEE standard computer glossaries. New York,NY: Institute of Electrical and Electronics Engineers; 1990.

ONC 2021-2024 and Beyond:learning health system, with the person at the center of a system that can continuously improve care, public health, and science

through real-time data access.

Core Interoperability Technologies in Cures Regulations• Trusted Exchange Framework and Common Agreement (TEFCA)

https://www.healthit.gov/topic/interoperability/trusted-exchange-framework-and-common-agreement

• Data Standardization around the United States Core Data for Interoperability (USCDI) specificationhttps://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi

• Standardized Application Programmer Interface (API) for Patient and Populations Serviceshttps://www.cms.gov/Regulations-and-Guidance/Guidance/Interoperability/index

• Use of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR)

http://hl7.org/fhir/R4/


https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi

https://www.cms.gov/Regulations-and-Guidance/Guidance/Interoperability/index


Final Rule Timeline for implementation of Interoperability Technologies• TEFCA

• USCDI – 4/2021

• FHIR API – 12/2022

• FHIR Bulk Export 12/2023

Trusted Exchange Framework and Common Agreement (TEFCA)

• Establishes a new framework for nationwide information exchange

• Leverages existing infrastructure and organizations• Uses connections established between Qualified Health

Information Networks (QHINs)• Has the Sequoia Project serving as the single Responsible

Coordinating Entity (RCE), selected by the Office of the National Coordinator for Health IT (ONC)

TEFCA Principles.• Standardization• Transparency• Cooperation and non-

discrimination• Privacy Security and

Safety• Access• Population-Level Data

TEFCA Stakeholders

Uses of TEFCA for data exchange

Organization











United States Core Data for Interoperability (USCDI)

• Standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange

• Open collaborative update process and schedule.

HL7 FHIR® US Core Implementation Guide

Assessment and Plan of Treatment

Care Team Members

Clinical Notes• Consultation Note • Discharge Summary Note• History & Physical• Imaging Narrative• Laboratory Report

Narrative• Pathology Report

Narrative• Procedure Note• Progress Note

Goals• Patient Goals

Health Concerns

Immunizations

Medications• Medications• Medication Allergies

Smoking Status

Provenance• Author• Author Time Stamp• Author Organization

Procedures

Problems

Laboratory• Tests• Values/Results

Patient Demographics• First Name• Last Name• Previous Name• Middle Name (incl.

middle initial)• Suffix• Birth Sex• Date of Birth• Race• Ethnicity• Preferred Language• Address• Phone Number

Unique Device Identifier(s) for a Patient’s Implantable Device(s)

Vital Signs

• Diastolic BP• Systolic BP• Body height• Body weight• Heart Rate• Body temperature• Pulse oximetry• Inhaled oxygen

concentration• BMI percentile per

age and sex for youth 2-20

• Weights for age per length and sex

• Occipital-frontal circumference for children >3 years old

USCDI Based on Standard Terminology Systems

• LOINC -- Logical Observation Identifiers Names and Codes • SNOMED CT® -- Systematized Nomenclature of Medicine Clinical

Terms• CDC ISS -- CVX --Vaccines Administered• National Drug Code (NDC)• RxNorm – Medications• HL7 Version 3 – Value sets• OMB race & ethnicity• HCPCS, CPT-4, ICD-10











Application Programmer Interface (API)

• A set of services offered by a programming library that can be used by another program to achieve its own goals (Benson 2021 pg 82)

• FHIR is based on Representational State Transfer (REST) API principles• Individual resources are identified by URLs (points to stored object)• Stateless interaction: All information necessary is contained in the resource• Client and Server are separate: the client isn’t concerned with data storage and the

server isn’t concerned with the user interface• Layered System: Intermediary systems can enforce security, provide load-balancing,

etc. (cloud-based systems)

• FHIR can accommodate other messaging approaches

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App Registration

Required Capability(ies) Applicable Standard(s)

None; Dynamic Registration permitted

Secure Connection

1st time Authentication & App Authorization + (get refresh token)

Data Response (query)

Subsequent Authentication & App Authorization + (refresh token)

Search

Documentation

SMART Application Launch Framework IG

Argonaut Data Query IG Server

OpenID Connect + SMART Application Launch Framework IG

FHIR (Release 2) + ARCH + Argonaut Data Query IG Profiles


None; Must be made publicly accessible

Associated API CoC

• Must support patient-and clinical- access

• Must support access to a single patient’s data & multiple patients data

• Must support “Standalone Launch” and “EHR Launch”

• Refresh tokens with a lifetime of at least 3 months

Additional Context

Associated API CoC

New API Certification Criteria 170.315(g)(10) to replace (g)(8)Standards-based API for patient and population services

19

App Registration

Required Capability(ies) Applicable Standard(s)

None; Dynamic Registration permitted

Secure Connection

1st time Authentication & App Authorization + (get refresh token)

Data Response (query)

Subsequent Authentication & App Authorization + (refresh token)

Search

Documentation


Argonaut Data Query IG Server

OpenID Connect + SMART Application Launch Framework IG

FHIR (Release 2) + ARCH + Argonaut Data Query IG Profiles


None; Must be made publicly accessible

Associated API CoC

• Must support patient- and clinical- access

• Must support access to a single patient’s data & multiple patients data

• Must support “Standalone Launch” and “EHR Launch”

• Refresh tokens with a lifetime of at least 3 months

Additional Context

Associated API CoC

New API Certification Criteria 170.315(g)(10) to replace (g)(8)Standards-based API for patient and population services

The ARCH15 Specific FHIR Resources

Aligned to support the USCDIReferenced in new 170.315(g)(10) certification

criterion

What is the API Resource Collection in Health (ARCH)?

Patient

MedicationStatement

AllergyIntolerance

ProcedureCondition

Medication Device

ObservationDiagnosticReport

MedicationOrder

DocumentReference

Care PlanGoal

ProvenanceImmunization

20











Fast Healthcare Interoperability Resource (FHIR)

• R4 of FHIR specification contains 145 types of resources divided into:

• Foundation• Base• Clinical• Financial• Specialized

The FHIR specification provides:• Healthcare domain resources (the content)• Infrastructure for exchanging resources (RESTful API)• Definitional and ontology narrative describing relationships • A framework for determining conformance (testing and safety)• Resources for management workflows.

• References between resources build up the record.

Tomorrow, we’ll explore FHIRin more detail

FHIR is Adaptable

• FHIR resources can be adapted to particular use cases through the creation of PROFILES

• https://www.hl7.org/fhir/profiling.html• Example: US Realm Address and Telephone

• FHIR resources can be EXTENDED where needed• https://www.hl7.org/fhir/extensibility.html• Every element in a resource can have extension child elements

• FHIR Implementation Guides provide official instructions• HL7 FHIR US Core Implementation Guide

https://www.hl7.org/fhir/profiling.html

https://www.hl7.org/fhir/extensibility.html

https://www.hl7.org/fhir/us/core/

HL7 FHIR Accelerator Program The accelerator program at HL7 is an organizing principle for the FHIR community – the people who define use cases, build and test the specification and write the applications.

https://www.hl7.org/about/fhir-accelerator/

https://www.hl7.org/about/fhir-accelerator/

Gravity Project

https://www.hl7.org/gravity/

Creating national standards for representing SDoH data in EHRs

Launched in 2018Initial funding from RWJOver 800 stakeholders

https://www.hl7.org/gravity/

Making EHR Data More Available for Research and Public Health (MedMorph)

• Sponsored by CDC

• Funded by HHS and PCORTF

• Leverage FHIR, APIs and the USCDI reference architecture for data exchange in support of:• patient-centered research

questions • public health surveillance

system requirements

• FHIR Bulk Data Access (Flat FHIR) API specification

https://www.cdc.gov/csels/phio/making-ehr-data-more-available.htmlhttp://build.fhir.org/ig/HL7/fhir-medmorph/

https://www.cdc.gov/csels/phio/making-ehr-data-more-available.html

http://build.fhir.org/ig/HL7/fhir-medmorph/

Testing the Specifications: FHIR Connectathons

Checking compatibility between products in a non-competitive environment

Health Systems, HIT vendors, Government entities, computer scientists, clinicians, consultants

Value of FHIR Connectathon• FHIR Safety Testing Checklist

• Implementation • Conformance• Date/Time zone• Search and matching• Deletion• Privacy• Security

(http://hl7.org/fhir/safety.html )

• Supporting Resource Definition Maturity• Level 0: Draft• Level 1: artifact logically complete (no errors)• Level 2: tested between at least 3 system

(approved by FMG)• Level 3: balloted for trial use• Level 4: tested, published, stable• Level 5: 2 ballot cycles, 5 implementations, >1

country• Level 6: Normative

• Testing Implementation Guides• Developing a community

of developers and implementers.

http://hl7.org/fhir/safety.html

Up to date information

• Interoperability technology• FHIR• Terminology Systems• Other interoperability Standards

Benson, J. Grieve, G. (2021) Principles of Health Interoperability, 4th edition. Springer. ISBN 978-3-030-56883-2 (eBook)

Conclusion• Cures Act Regulations require use of

advanced technology for interoperability

• TEFCA supports data sharing security and privacy• USCDI specifies what to share• ONC approved APIs describe how

we’re going to share.• FHIR Describes the format of what

we share

Documents

Clinicians on Workshop W01