clinicians on workshop w01
TRANSCRIPT
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
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/
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
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/
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
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/
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
18
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
SMART Application Launch Framework IG
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
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
SMART Application Launch Framework IG
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
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/
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
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/
Gravity Project
https://www.hl7.org/gravity/
Creating national standards for representing SDoH data in EHRs
Launched in 2018Initial funding from RWJOver 800 stakeholders
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/
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.
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