Interoperability

Trusted Core interoperability across providers, payers, and networks

Integration moves data using standards (e.g., HL7 v2, FHIR, C-CDA, DICOM, X12). Interoperability ensures those exchanges are clinically meaningful, auditable, and compliant, using a combination of U.S. Realm implementation guides (IGs), vendor documentation, connectathons, industry testing and certification ttols, and national networks so providers, payers, and patients can trust the results.

What Interoperability Means in the U.S.

The U.S. model is unique. Regulations and programs from ONC, CMS, and HHS set the rules of the road (HITECH, certification, Promoting Interoperability, CMS interoperability rules). Implementation guides and profiles translate policy intodoable workflows that preserve the legal medical record, provenance, and patient safety.

Learn more about Interoperability:

Sections:

TEFCA - National Health Information Exchange

TEFCA establishes a national network for interoperability, defining baseline expectations for secure, nationwide health data exchange. The RCE (operated by the Sequoia Project) oversees the framework, designates QHINs (Qualified Health Information Networks), and governs participation and compliance. Existing frameworks like Carequality and networks like CommonWell are aligning with TEFCA, enabling cross-network query and exchange. This allows providers to retrieve clinical documents, imaging, and referrals across organizational boundaries, and increasingly enables payers to participate for coverage discovery, care coordination, quality measurement, and prior authorization context.
The Sequoia Project – ATSP/ONC designated Recognized Coordinating Entity (RCE)

For providers: enables cross-organizational query and exchange for transitions of care, referrals, imaging, and clinical document retrieval, regardless of EHR vendor or network affiliation.
For payers: supports expanding participation in national exchange for use cases like care coordination, HEDIS/quality measurement, risk adjustment, and prior authorization context.

Where we fit: We help you evaluate HIN / QHIN options, enroll, and operationalize TEFCA alongside Direct, IHE, and EMR-native exchange, ensuring alignment with your existing workflows, compliance posture, and strategic roadmap.

Direct Secure Messaging

Direct Secure Messaging (DSM) is the modern, HIPAA-compliant alternative to fax, built on IHE exchange profiles like XDR and XDM, with encrypted message delivery using S/MIME and X.509 certificates anchored in the DirectTrust trust framework. It’s a foundational interoperability mechanism used by hospitals, physicians, practices, healthcare organizations, and even individual departments for secure clinical document exchange.

Scale: More than 2.8 million trusted addresses exist in the DirectTrust National Provider Directory (source: DirectTrust.org). Link: https://www.ihe.net/ihe_domains/devices/

For HISP-enabled EHRs, documents received via Direct can be imported directly into the patient’s chart as C-CDA documents, such as Continuity of Care Documents (CCDs), discharge summaries, or referrals. These files retain embedded metadata (encounters, timestamps, provenance) and can include attachments like PDFs, images, or FHIR bundles packaged as XDM ZIP files.

Care Team member reading a direct message — Interacting with a direct message

Provider Use Cases

Referrals and consults between primary care, specialists, and ancillary providers
Hospital discharge summaries sent to community providers
Transitions of care from acute to post-acute settings
Clinical attachments for prior authorizations or claims (e.g., with CDex)
360X closed-loop referral tracking

Benefits

End-to-end encryption with full trust validation
Patient-level EHR-to-EHR communication with demographic linkage
Seamless chart import for C-CDA documents
Direct integration with scheduling and referral workflows
Leverages the same IHE building blocks used across TEFCA HINs and QHINs

Example: Children’s National Hospital in Washington, D.C. uses Direct for both provider referrals and external care coordination—achieving real-time, standards-based communication without relying on legacy fax.

Link: https://www.childrensnational.org/for-healthcare-professionals/refer-a-patient/accessing-records/direct-messaging

Our role: We deploy and integrate DirectTrust HISPs, map Direct flows into EHR workflows, and validate C-CDA content for compliance and provenance.

IHE - Integrating the Healthcare Enterprise

Integrating the Healthcare Enterprise (IHE) is a global initiative that develops integration profiles to enable standards-based interoperability across healthcare systems. In the U.S., IHE is formally recognized and incorporated into federal regulations through the Office of the National Coordinator for Health IT (ONC), which references its profiles within the 45 CFR § 170 certification criteria and the Trusted Exchange Framework and Common Agreement (TEFCA).

IHE’s work underpins many ONC-certified capabilities, including document sharing, identity management, and audit trails—core functions required for secure, interoperable health information exchange.

IHE USA, a regional deployment arm supported by HIMSS, plays a critical role in validating and promoting these profiles through Connectathons, Interoperability Showcases, and implementation guidance tailored to U.S. Realm needs. IHE profiles like XDS, XCA, and XCPD form the technical backbone of TEFCA (Trusted Exchange Framework and Common Agreement), enabling query-based exchange of legal medical records across Qualified Health Information Networks (QHINs). By harmonizing HL7, DICOM, and other standards into actionable workflows, IHE ensures that clinical data is not only exchanged, but exchanged with semantic integrity, provenance, and trust.

Devices

The Devices domain (DEV) tackles the challenge of integrating point-of-care medical devices—like monitors, infusion pumps, and ventilators—into enterprise systems such as EHRs. Profiles like DEC and ACM ensure consistent data exchange and alert management, enhancing patient safety and enabling real-time clinical decision support.

Link: https://profiles.ihe.net/DEV/index.html

U.S. Realm - Devices (DEV)

DEV profiles like DEC and ACM are used to integrate point-of-care devices (e.g., monitors, pumps) with EHRs and clinical systems. They support real-time data exchange and alert management, improving patient safety and workflow efficiency. USCDI Relevance: Device data (e.g., Unique Device Identifier) is part of USCDI v3, especially for implantable devices and patient safety tracking.

PCD-01 (DEC) – Device Enterprise Communication
PCD-04 (ACM) – Alert Communication Management

Use DEC (PCD-01) for device→EHR gateways; ACM for safe alert routing, both show up in ONC guidance

Endoscopy

IHE Endoscopy focuses on standardizing workflows and data exchange in digestive endoscopy. It supports structured reporting, image archiving, and pathology order coordination, helping bridge procedural documentation with broader clinical systems. Sponsored by Japanese informatics organizations, it reflects strong international collaboration.

Link: https://profiles.ihe.net/ENDO/index.html

U.S. Realm - Endoscopy

While primarily developed in Japan, IHE Endoscopy supports structured reporting and image exchange for digestive procedures. U.S. adoption is limited but growing in academic and specialty settings. USCDI Relevance: Not directly referenced in USCDI, but overlaps with imaging and procedure documentation standards.

No U.S.-specific profiles. Limited adoption.

IT Infrastructure

The IT Infrastructure (ITI) domain underpins cross-domain interoperability. It defines foundational profiles for identity management, document sharing, and audit trails. ITI is the backbone for health information exchange, enabling secure, standards-based communication across disparate systems.

Link: https://profiles.ihe.net/ITI/index.html

U.S. Realm - IT Infrastructure (ITI)

ITI profiles like XDS, PIX, PDQ, and ATNA are foundational for HIE, identity management, and audit trails. Widely adopted in U.S. health information networks, including TEFCA and Carequality frameworks. USCDI Relevance: ITI enables transport and security for USCDI data classes, supporting certified EHR technology under ONC rules.

XDS/XDS.b – Cross-Enterprise Document Sharing
XCA – Cross-Community Access
XCPD – Cross-Community Patient Discovery
ATNA – Audit Trail and Node Authentication
DSUB – Document Subscription
MHD – Mobile access to Health Documents (Aligns with USCDI/US Core)
MHDS – Mobile Health Document Sharing (FHIR-based XDS)
XUA – Cross-Enterprise User Assertion
DSG – Document Digital Signature
RFD – Retrieve Form for Data Capture

IT Infrastructure (ITI) is the backbone of U.S. HIE: TEFCA QHINs must use IHE XCPD/XUA; XCA rides on top for query/retrieve.

Pathology and Laboratory Medicine

PaLM unifies anatomic and clinical pathology workflows, covering specimen tracking, diagnostic reporting, and biobank integration. It supports structured data exchange for lab results, imaging, and molecular diagnostics, ensuring semantic rigor across diverse lab specialties.

Link: https://wiki.ihe.net/index.php/Category:PaLM_Profile

U.S. Realm - Pathology and Laboratory Medicine (PaLM)

PaLM profiles standardize lab orders, results, and specimen tracking. Sponsored by CAP, they align with CLIA and LOINC-based workflows in U.S. labs. USCDI Relevance: Lab results are a core USCDI data class. PaLM supports structured exchange of these elements.

XD-LAB – Lab Result Reporting (Aligns with USCDI/US Core)
ILW – Laboratory Workflow

U.S. labs: standardize on HL7 v2 LOI/LRI/eDOS; use PaLM where it complements local LIS/EHR.

Patient Care Coordination

PCC addresses longitudinal care workflows—referrals, care plans, discharge summaries, and maternal health. It’s the glue between specialty domains, enabling continuity of care across providers and time. Profiles like 360X and IPS support closed-loop referrals and international patient summaries.

Link: https://wiki.ihe.net/index.php/Category:Patient_Care_Coordination

U.S. Realm - Patient Care Coordination (PCC)

PCC profiles like 360X, XPHR, and Care Plan support longitudinal care, referrals, and transitions. They’re embedded in C-CDA templates used in U.S. EHR certification. USCDI Relevance: PCC profiles help populate USCDI elements like care plans, advance directives, and clinical notes.

360X – Closed-Loop Referral
XPHR – Exchange of Personal Health Record
DCP – Dynamic Care Planning shares and updates patient care plans
APHP – Antepartum Summary

U.S. closed-loop referrals via 360X are born from ONC/HIMSS work; implemented via Direct and IHE profiles.

Pharmacy

The Pharmacy domain (PHARM) standardizes medication workflows in both hospital and community settings. It supports prescribing, dispensing, administration, and treatment planning. Profiles like CMPD and HMW help automate collaboration between prescribers and pharmacists, improving medication safety and reconciliation.

Link: https://www.ihe.net/ihe_domains/pharmacy/

U.S. Realm - Pharmacy (PHARM)

While NCPDP SCRIPT is used for retail pharmacy in the U.S., the IHE Pharmacy (PHARM) domain supports inpatient and institutional medication workflows—where HL7-based profiles like Prescription (PRE), Dispense (DIS), and Medication Treatment Plan (CMPD) enable structured communication between prescribers, pharmacists, and administration systems. PHARM is designed for closed-loop safety, semantic clarity, and integration with clinical decision support, aligning with USCDI medication data classes and informing FHIR US Core mappings, though it is not directly referenced in ONC certification criteria.

HMW – Hospital Medication Workflow
PRE – Prescription Order
DIS – Dispense Order
CMPD – Medication Treatment Plan

“U.S. retail uses NCPDP; inpatient leans HL7 v2; PHARM profiles exist but are not included in U.S. certifications. These IHE Pharmacy profiles compliment NCPDP and may be used locally for inpatient pharmacy in addition to HL7v2

Quality, Research and Public Health

QRPH repurposes clinical data for secondary uses—quality reporting, public health surveillance, and research. It enables structured data capture, aggregate reporting, and registry integration. Profiles like BFDR-E and CRPC support vital records, clinical trials, and chronic disease management.

Link: https://www.ihe.net/ihe_domains/quality_research_and_public_health/

U.S. Realm - Quality, Research and Public Health (QRPH)

QRPH profiles like BFDR-E, CRPC, and EHDI support public health reporting, clinical research, and quality measurement. Used by CDC, CMS, and registries for secondary data use. USCDI Relevance: Many QRPH data elements overlap with USCDI+, especially in maternal health, cancer, and public health domains.

BFDR-E – Birth and Fetal Death Reporting
CRPC – Cancer Reporting to Public Health
EHDI – Early Hearing Detection and Intervention
RFD – Retrieve Form for Data Capture

Used by programs/registries (e.g., EHDI); adoption varies by state/agency - treat as program-specific.

Radiation Oncology

IHE-RO ensures safe, interoperable workflows in radiation therapy. It connects planning systems, treatment delivery, and documentation tools. Sponsored by AAPM, it emphasizes precision, safety, and efficiency in oncology care through tested integration profiles.

Link: https://www.ihe.net/ihe_domains/radiation_oncology/

U.S. Realm - Radiation Oncology (RO)

IHE-RO profiles standardize treatment planning, delivery, and documentation. Sponsored by AAPM and ASTRO, they’re used in oncology clinics to ensure safe, interoperable workflows. USCDI Relevance: Not directly included in USCDI, but imaging and procedure documentation elements may apply.

IHE-RO Profiles – Sponsored by AAPM and ASTRO

Radiology

Radiology is IHE’s founding domain, pioneering profiles like Scheduled Workflow and XDS-I.b. It standardizes imaging acquisition, reporting, and sharing across PACS, RIS, and EHRs. With deep DICOM and HL7 integration, it remains central to diagnostic imaging interoperability.

Link: https://www.ihe.net/ihe_domains/radiology/

U.S. Realm - Radiology (RAD)

U.S. Use: RAD profiles like SWF, PIR, XDS-I.b, and MRRT are widely adopted in PACS/RIS systems. They support imaging acquisition, reporting, and sharing across enterprise and HIE networks. USCDI Relevance: Imaging results are part of USCDI. RAD profiles help ensure structured, interoperable image data exchange.

SWF.b – Scheduled Workflow
PIR – Portable Image Result
MRRT – Management of Radiology Report Templates
XDS-I.b – Imaging Document Sharing

Each year IHEUSA and HIMSS host the North American IHE Connectathon, where vendors gather and test their products.

Prior Authorizations with Da Vinci FHIR IG's

The Da Vinci program defines payer-provider workflows that combine rules, CDS, and transactions to streamline prior authorization while maintaining clinical integrity and regulatory compliance:

CRD - Coverage Requirements Discovery

CDS Hooks service that checks coverage rules during ordering. CRD enables real-time discovery of payer requirements (e.g., prior auth, documentation, step therapy) by invoking CDS Hooks from the provider’s EHR. It surfaces actionable guidance at the point of care, reducing delays and administrative burden.

Links:

Da Vinci - Coverage Requirements Discovery
https://hl7.org/fhir/us/davinci-crd/
CDS Hooks
https://cds-hooks.org/
CDS Hooks Library
https://cds-hooks.hl7.org/

DTR - Document Templates and Rules

Executes CQL rules to gather required documentation, often with the aid of a SMART app. DTR automates the retrieval and population of payer-required forms using computable logic (CQL), reducing manual effort and ensuring completeness. It can launch SMART on FHIR apps to guide clinicians through documentation workflows.

Link:
Da Vinci - Documentation Templates and Rules
https://hl7.org/fhir/us/davinci-dtr/

PAS - Prior Authorization Support

Bridges FHIR with X12 to submit/track the prior auth. PAS translates FHIR-based prior authorization requests into X12 278 transactions, enabling electronic submission and response tracking. It supports synchronous and asynchronous workflows, aligning with HIPAA transaction standards.

Link:
Da Vinci Prior Authorization Support (PAS) FHIR IG
https://hl7.org/fhir/us/davinci-pas/

CDex - Clinical Document Exchange

For attachments and evidence. CDex enables secure, standards-based exchange of clinical documentation (e.g., progress notes, labs, imaging) between providers and payers. It supports both push and pull models, ensuring that prior auth decisions are based on complete, timely evidence.

Link:
Da Vinci Clinical Data Exchange (CDex)
https://hl7.org/fhir/us/davinci-cdex/

SMART on FHIR: launched within or from the EMR (provider side) or as payer-hosted apps (plan side) with narrow scopes, launch context, and full audit. These apps enable modular, role-specific workflows that respect user permissions and clinical context.

Payer Interoperability Mandates & Options

Payers face CMS mandates that are directly supported by Da Vinci and CARIN implementation guides:

Patient Access API

Member-authorized access to claims/clinical data via FHIR. Enables third-party apps to retrieve longitudinal health records, supporting CMS interoperability mandates and consumer empowerment.

Link:
Da Vinci Payer Data Exchange (PDex) Patient Access API
https://hl7.org/fhir/us/davinci-pdex/

Provider Access API

Povider-facing access under appropriate consent/attribution. Supports value-based care by enabling clinicians to retrieve payer-held data (e.g., coverage, encounters, clinical history) to inform treatment and reduce duplication.

Link:
Da Vinci Payer Data Exchange (PDex) Provider Access API
https://hl7.org/fhir/us/davinci-pdex/provider-access-api.html

Payer-to-Payer

Member data portability across plans. Facilitates bulk FHIR exchange of claims and clinical data between payers during enrollment transitions, ensuring continuity of care and regulatory compliance.

Link:
Da Vinci Payer Data Exchange (PDex) Payer-to-Payer bulk API
https://hl7.org/fhir/us/davinci-pdex/payertopayerbulkexchange.html

Plan-Net

Provider directory. Standardizes how payers publish network data (e.g., clinicians, facilities, specialties) to support public-facing search tools and regulatory transparency.

Link:
Da Vinci PDex Plan Net
https://hl7.org/fhir/us/davinci-pdex-plan-net/

Formulary

Drug tiers/coverage. Exposes plan-specific formulary data including drug tiers, prior authorization, and cost-sharing to support consumer decision-making and app-based transparency.

Link:
Da Vinci PDex US Drug Formulary
https://hl7.org/fhir/us/davinci-drug-formulary

CARIN for Blue Button

EOB/claims views (inpatient/outpatient/pharmacy/oral/professional non-clinical). Enables consumer-directed access to financial data, supporting benefit navigation and third-party app integration.

Basis Profiles: Supports sharing with providers and other payers without member cost. Theses profiles are referenced by Da Vinci.

Link:
CARIN Consumer Directed Payer Data Exchange (CARIN IG for Blue Button®)
https://hl7.org/fhir/us/carin-bb/

Payers have the following three paths to data quality, while meeting the CMS Mandate

Outsource to a third-party, that will provide the provider-trained teams and handle the ingestions and integrations
Build in-house with provider-trained healthcare integration and interoperability experts.
If provider-owned, leverage their providers’ integration teams and vendor platforms.

Meeting the CMS Mandate — but at what cost?

Payers are under intense pressure to comply with CMS interoperability requirements. Some teams ship quickly without seasoned healthcare integration expertise, which can degrade clinical data quality and integrity. Even when APIs are live, the resulting information may be inaccurate, incomplete, or operationally unusable for providers, other payers, or third parties.

CMS Mandate Technical Review: We look under the hood, schemas, vocabularies, profiles, provenance, and workflow, to ensure compliance that clinicians can trust.

Validate clinical context, semantics and provenance, chain of custody, sensitivity, confidentiality across FHIR and C-CDA.
Harden identity and attribution for Patient/Provider Access and Payer-to-Payer flows.
Enforce auditability and security controls that stand up to HIPAA/OCR review.
Prove production data quality, edge cases, and error handling.

How Interops Team™ Helps

TEFCA: strategy and alignment, QHIN, HIN evaluation/enrollment, Breach Procecures
IHE & HL7: Interoperability Implementation Guides
Direct Secure Messaging: HISP integration, workflow integration.
Provider identity management: EMPI design, PIX/PDQ governance, merge/overlay controls.
Document exchange: MHD, XDS, DSUB, ATNA/XUA, FHIR Audit Event, audit and node security.

Prior Authorizations: CRD/DTR/PAS/CDex architecture and EMR integration.
Payer APIs: Patient/Provider Access, Payer-to-Payer, Plan-Net, Formulary, CARIN BB.
Integrations: Ingestion, Normalization, Transformation, Testing & conformance
Governance & compliance: HIPAA/Source/CLIA alignment, provenance, HIPAA Audit Trail

Need help with TEFCA + Direct + Da Vinci?
We can assess your current state and deliver a standards-aligned, clinically safe roadmap.