Encore OS — Documentation

Version: 1.1.0
Last Updated: 2026-05-15
Owner: Product / Compliance / CL / PM / PF
Purpose: Decision-grade matrix for choosing ONC pathway (Full certification, modular certification, or alignment-only), with criterion-level coverage and implementation gaps.

1) Executive Summary and Decision Framework

Encore OS already has meaningful ONC-oriented groundwork in specs and partial implementation, especially around FHIR, patient access, C-CDA, information blocking, and prior authorization. Strongest existing anchors:

CL-16 and CL-16-EN-02 for FHIR/USCDI and SMART-aligned patient access.
PM-55 for ONC HTI-1 patient access + information blocking workflow.
CL-48 for C-CDA generation and transition workflows.
PM-52 and PM-10 for Da Vinci CRD/DTR/PAS trajectory.
Existing compliance baseline in ONC_CERTIFICATION_ROADMAP.md, REGULATORY_COMPLIANCE_TRACKER.md, and AUTHORITATIVE_REFERENCES.md.

Most important missing areas for certification readiness:

Conditions and Maintenance of Certification artifacts (Real World Testing, Insights condition, attestations cadence, CHPL documentation artifacts).
Public health reporting criteria (f-family) and transport criteria (h-family) at certification depth.
Design/process criteria (g(3) Safety-Enhanced Design, g(4) QMS, g(5) Accessibility-centered design) as ONC evidence artifacts.
Predictive DSI transparency and HTI-2 additions (j(20), j(21)).

1.1 Path Comparison

Path	What it means	Approx effort	Ongoing burden	Best fit
Full ONC Certification (broad module scope)	Certify broad criterion set with ONC-ACB/ATL and full Conditions/Maintenance obligations	12-24+ months	High	If commercial strategy depends on certified module breadth and formal CHPL posture
Modular ONC Certification (targeted)	Certify a constrained criterion package (typically API-centric and selected supporting criteria)	6-12 months	Medium-High	If payer/customer contracts need certified capability but not full criterion surface
ONC Alignment-Only (no certification filing)	Implement standards and compliance posture without formal ONC testing/certification artifacts	3-9 months	Medium	If near-term value is interop/compliance readiness without CHPL listing

1.2 Required Artifacts by Path

Artifact	Full	Modular	Alignment-only
ONC-ACB engagement	Required	Required	Not required
ONC-ATL test execution	Required	Required (for in-scope criteria)	Not required
CHPL listing	Required	Required (for certified module)	No
Real World Testing plan/results	Required	Required (for certified scope)	Optional internal
Insights Condition reporting	Required	Required	Optional internal
Mandatory disclosures URL	Required	Required	Optional
Hosted documentation URL	Required	Required	Optional
Annual attestation package	Required	Required	Internal governance only
Inferno/SITE/Cypress conformance evidence	Required	Required for selected criteria	Strongly recommended internal

1.3 Decision Triggers

Trigger	Recommendation
Contract explicitly requires CHPL-listed module	Choose modular or full certification
Strategic product positioning requires “certified” market claim	Choose modular now, full later if needed
Priority is interoperability delivery speed with lower overhead	Choose alignment-only with certification-grade internal evidence
Multi-state payer expansion requires auditable API posture quickly	Choose modular certification focused on API and information blocking evidence

2) 45 CFR §170.315 Criteria Gap Matrix (Criterion Families)

Coverage Status Legend:

None
Spec-only
Spec + partial impl
Spec + impl-complete
Certified-ready

2.1 (a) Clinical Criteria

Criterion	Title	In-scope for BH	Owning core	Existing spec(s)	Implementation evidence	Coverage status	ONC test tool	Standards / SVAP posture	HTI rule context	Recommended action
`a(1)`	CPOE - medications	Yes	CL	`CL-05`, `CL-06`	Partial eRx workflow and medication structures	Spec + partial impl	SITE + certification method	NCPDP/RxNorm ecosystem	HTI-4 impacts med standards timelines	Split into cert-oriented enhancement with testable CPOE acceptance
`a(2)`	CPOE - laboratory	Yes	CL	`CL-09`	HL7/FHIR lab ingestion exists; full certification flow not complete	Spec + partial impl	NIST/public health suites + cert method	HL7 v2/Lab standards	HTI alignment via USCDI	Add explicit certification test matrix for lab order entry and result linkage
`a(3)`	CPOE - diagnostic imaging	Usually limited for BH	CL	No dedicated cert-ready spec	No dedicated evidence surfaced	None	Certification method	Imaging standards as applicable	N/A or limited by service line	Confirm N/A policy by product scope and document rationale
`a(4)`	Drug-drug / drug-allergy checks	Yes	CL	`CL-06`, `CL-45`	Allergy tracking implemented, interaction logic partial	Spec + partial impl	Certification method	RxNorm/SNOMED ecosystems	HTI-4 adjacent	Add required interaction logic evidence package and override logging
`a(5)`	Demographics	Yes	PM/CL	`PM-01`, `PM-55`	Demographics tables + APIs partially mapped	Spec + partial impl	Inferno + cert method	USCDI v3 baseline	HTI-1	Normalize to USCDI v3 required fields and value sets
`a(6)`	Problem list	Yes	CL	`CL-46`	Problem list features present; FHIR cert mapping incomplete	Spec + partial impl	Inferno + cert method	USCDI + terminology	HTI-1	Add profile-conformant export + terminology conformance tests
`a(7)`	Medication list	Yes	CL	`CL-05`	Medication data exists; full cert test evidence not assembled	Spec + partial impl	Inferno + cert method	USCDI + RxNorm	HTI-1/4	Add gap closure on code-set fidelity and API outputs
`a(8)`	Medication allergy list	Yes	CL	`CL-45`	Implemented allergy workflows + partial FHIR mapping	Spec + partial impl	Inferno + cert method	USCDI + terminology	HTI-1	Add inferno-oriented conformance test assets
`a(9)`	Clinical decision support	Yes	CL	`CL-08`	Internal CDS exists; not ONC cert evidence packaged	Spec + partial impl	Certification method	CDS evidence requirements	HTI-1/HTI-2 interplay	Add cert-specific CDS intervention, source, and audit artifacts
`a(10)`	Drug-formulary and preferred drug list checks	Yes	CL/PM	No dedicated ONC cert spec found	No dedicated cert evidence	None	eRx suite + cert method	NCPDP/RxNorm ecosystem	HTI-4 adjacent	Create dedicated spec or enhancement for formulary checking
`a(11)`	Smoking status	Yes	CL	Covered indirectly in assessments and USCDI mapping specs	Partial via assessments; not explicitly certified	Spec + partial impl	Inferno + cert method	USCDI v3	HTI-1	Add explicit smoking-status criterion acceptance and FHIR mapping
`a(12)`	Family health history	Possibly in-scope	CL	No clear dedicated criterion spec	No evidence confirmed	None	Certification method	USCDI profile scope dependent	HTI-1	Decide in-scope status and either implement or document exclusion
`a(13)`	Patient-specific education resources	Usually yes	PM/CL	Portal and engagement specs (`PM-12`, `CL-26`)	Patient education workflows not mapped to criterion artifacts	Spec-only	Certification method	Patient engagement standards	HTI-1 adjacent	Add criterion-specific educational resource mapping and audit trail
`a(14)`	Implantable device list	Typically not BH core	CL	Explicitly treated as N/A in roadmap	No implementation expected	None	Certification method	Device UDI standards	N/A for BH scope	Keep N/A with formal scope memo
`a(15)`	Social, psychological, behavioral data support	Yes	CL	`CL-18`, `CL-40`	SDOH/intake features exist	Spec + partial impl	Inferno + cert method	USCDI+ BH relevance	HTI-1/HTI-2 trajectory	Align value sets and criterion-specific export/reporting evidence

2.2 (b) Care Coordination Criteria

Criterion	Title	In-scope for BH	Owning core	Existing spec(s)	Implementation evidence	Coverage status	ONC test tool	Standards / SVAP posture	HTI rule context	Recommended action
`b(1)`	Transitions of Care	Yes	CL	`CL-48`, `CL-12`	C-CDA tooling in progress, not fully cert-ready	Spec + partial impl	SITE C-CDA tools	C-CDA companion guide versions changing	HTI-1 baseline updates	Finish validation harness and transmission evidence
`b(2)`	Clinical information reconciliation/incorporation	Yes	CL	`CL-12`, `CL-05`	Partial reconciliation functions	Spec + partial impl	SITE/C-CDA tooling	C-CDA + USCDI	HTI-1	Build cert test cases for reconciliation workflows
`b(3)`	Electronic prescribing	Yes	CL	`CL-06`	Current eRx path exists; production-grade NCPDP transition pending	Spec + partial impl	eRx Testing Suite	NCPDP SCRIPT 2023011 deadline	HTI-4	Execute HTI-4 upgrade program and test suite readiness
`b(4)`	Real-time prescription benefit	Often in-scope if eRx scope includes it	CL	Mentioned in CL-06 enhancement planning	No cert-ready implementation confirmed	Spec-only	eRx Testing Suite	RTPB standard v13	HTI-4	Add dedicated implementation spec and go/no-go decision
`b(5)`	Incorporate laboratory tests/results	Yes	CL	`CL-09`	Lab ingestion partially present	Spec + partial impl	Public health + cert method	HL7 v2/FHIR mapping	HTI-1	Expand to criterion-specific reconciliation and provenance checks
`b(6)`	Data export	Yes	PF/CL	`PF-44`, `CL-20`	Export capabilities implemented in parts	Spec + partial impl	Certification method	EHI export requirements	HTI-1	Consolidate EHI export criterion evidence packet
`b(7)`	Security tags - summary of care (send)	Yes	CL/PF	No dedicated DS4P send spec	No criterion-level evidence	None	SITE/C-CDA tools	DS4P required	HTI-1	Create DS4P send spec and labeling pipeline
`b(8)`	Security tags - summary of care (receive)	Yes	CL/PF	No dedicated DS4P receive spec	No criterion-level evidence	None	SITE/C-CDA tools	DS4P required	HTI-1	Create DS4P receive/processing policy + tests
`b(9)`	Care plan	Yes	CL	`CL-03`, CL-16 mappings	Care plan data exists; cert conformance incomplete	Spec + partial impl	C-CDA + Inferno as applicable	USCDI/C-CDA	HTI-1	Add canonical care-plan export and validation evidence
`b(10)`	EHI export	Yes	PF/CL/PM	`PF-44`, `PM-55`	Partial implementation across modules	Spec + partial impl	Certification method	EHI export + Cures posture	HTI-1	Single governed EHI export control plane and tests
`b(11)`	Decision support interventions / predictive DSI transparency	Yes	PM/CL/GR	`PM-64`, `CL-08`	Mentioned but no dedicated ONC transparency package	Spec-only	Certification method	ONC DSI source attributes	HTI-1	Author dedicated criterion spec with full source attribute disclosures

2.3 (c) Clinical Quality Measure Criteria

Criterion	Title	In-scope for BH	Owning core	Existing spec(s)	Implementation evidence	Coverage status	ONC test tool	Standards / SVAP posture	HTI rule context	Recommended action
`c(1)`	CQM - record and export	Yes	CL	`CL-51`	Spec present, implementation not complete	Spec-only	Cypress	QRDA ecosystem	HTI roadmap dependent	Build QRDA generation and certification test pipeline
`c(2)`	CQM - import and calculate	Yes	CL	`CL-51`	Partial quality calculations in product; not cert packaged	Spec + partial impl	Cypress	QRDA + measure logic	HTI roadmap dependent	Add ONC cert method coverage and validation data
`c(3)`	CQM - report	Yes	CL	`CL-51`, `CL-35`	Reporting exists operationally but not ONC cert-targeted	Spec + partial impl	Cypress	CMS quality reporting guides	HTI-1 adjacent	Formalize ONC reporting output conformance
`c(4)`	CQM - filter	Yes	CL	`CL-51`	No cert-oriented evidence bundle identified	Spec-only	Cypress	Taxonomy/value-set versions matter	HTI-1 adjacent	Implement filter conformance + replayable test fixtures

2.4 (d) Privacy and Security Criteria

Criterion	Title	In-scope	Owning core	Existing spec(s)	Implementation evidence	Coverage status	ONC test tool	Standards / posture	HTI context	Recommended action
`d(1)`	Authentication, access control, authorization	Yes	PF	`PF-01`, `PF-30`	Mature auth/RBAC foundations	Spec + impl-complete	Certification method	HIPAA + ONC controls	HTI-1	Add criterion-specific traceability matrix
`d(2)`	Auditable events and tamper resistance	Yes	PF/PM	`PF-40`, `PM-55`	Audit logs exist, PM info-blocking log exists	Spec + partial impl	Certification method	HIPAA audit controls	HTI-1	Add immutable FHIR-specific audit stream and cert evidence
`d(3)`	Audit report(s)	Yes	PF	`PF-91`	Dashboard spec exists, not fully implemented	Spec-only	Certification method	Reporting evidence	HTI-1	Deliver audit report artifact generator for certification
`d(4)`	Amendments	Yes	CL/PM	Scattered in clinical documentation specs	Not mapped as ONC criterion	Spec-only	Certification method	HIPAA overlap	HTI-1	Add explicit criterion ownership and tests
`d(5)`	Automatic log-off	Yes	PF	No dedicated ONC criterion spec	Platform behavior likely present but undocumented for cert	None	Certification method	Security UX policy	HTI-1	Create criterion-level evidence and timeout policy tests
`d(6)`	Emergency access	Yes	PF/CL	Break-glass references in compliance tracker	Partial references, no criterion package	Spec-only	Certification method	Emergency access controls	HTI-1	Define and test emergency access workflow formally
`d(7)`	End-user device encryption	Yes	PF/IT	IT compliance tracker references	No explicit criterion implementation package	None	Certification method	HIPAA device controls	HTI-1	Add policy/evidence package for endpoint encryption controls
`d(8)`	Integrity	Yes	PF	Core platform safeguards exist	Not mapped in ONC cert format	Spec-only	Certification method	Data integrity checks	HTI-1	Add signed evidence for integrity controls
`d(9)`	Accounting of disclosures	Yes	CL	`CL-11`, CL-11 enhancements	Implemented for Part 2 disclosures	Spec + impl-complete	Certification method	Part 2 + HIPAA overlap	HTI-1	Extend to full ONC accounting criterion mapping
`d(10)`	Authentication credential management	Yes	PF	PF auth/RBAC specs	Core exists, cert evidence package not assembled	Spec + partial impl	Certification method	Credential lifecycle controls	HTI-1	Produce criterion-level credential management controls documentation
`d(11)`	Encryption and hashing of authenticated credentials	Yes	PF/IT	IT tracker notes deferred credential-at-rest hardening	Partial	Spec + partial impl	Certification method	HIPAA + crypto controls	HTI-1	Prioritize vault migration and certify traceability
`d(12)`	Encrypt authentication assertions	Yes	PF	No dedicated cert spec	No direct evidence bundle	None	Certification method	SAML/SMART assertion encryption	HTI-1	Author dedicated criterion spec
`d(13)`	Multi-factor authentication	Yes	PF	Mentioned in trackers/specs; no standalone criterion spec	Partial/Deferred operationally	Spec-only	Certification method	MFA requirements	HTI-1	Add dedicated MFA criterion implementation and evidence

2.5 (e) Patient Engagement Criteria

Criterion	Title	In-scope for BH	Owning core	Existing spec(s)	Implementation evidence	Coverage status	ONC test tool	Standards / posture	HTI context	Recommended action
`e(1)`	View, Download, and Transmit (VDT)	Yes	PM/CL	`PM-12`, `PM-55`, `CL-16`	Portal exists; API scope incomplete for certification posture	Spec + partial impl	Inferno + cert method	USCDI/FHIR + patient rights	HTI-1	Complete patient-driven SMART access and evidence
`e(2)`	Secure messaging	Yes	PM/CL	`PM-14`, `CL-48`	In-app messaging and C-CDA transmission efforts exist	Spec-only	SITE/Direct tools	Direct/transport requirements	HTI-1	Differentiate in-app messaging from ONC Direct-compliant messaging and close gap
`e(3)`	Patient health information capture	Yes	PM/CL	No dedicated ONC criterion spec identified	No evidence package found	None	Certification method	Patient-submitted data standards	HTI-1	Add dedicated spec for capture, provenance, and reconciliation

2.6 (f) Public Health Criteria

Criterion	Title	In-scope for BH	Owning core	Existing spec(s)	Implementation evidence	Coverage status	ONC test tool	Standards / posture	HTI context	Recommended action
`f(1)`	Immunization registry reporting	Sometimes	CL/PM	No dedicated ONC criterion spec	No VXU-style cert evidence	None	NIST Immunization Test Suite	HL7 v2 immunization guides	HTI-1	Decide scope by contracts; if in-scope, author full spec
`f(2)`	Syndromic surveillance reporting	Usually limited for BH, but contract-dependent	CL/PM	No dedicated criterion spec	No evidence found	None	NIST Syndromic Suite	HL7 v2 syndromic guides	HTI-1	Keep as conditional scope item with documented decision
`f(3)`	Electronic lab reporting (ELR)	Potentially relevant	CL	Lab ingestion exists, but no ELR outbound certification spec	No cert evidence found	None	NIST ELR Suite	HL7 v2 ELR	HTI-1	Add outbound/reporting scope decision and implementation plan
`f(4)`	Cancer registry reporting	Often N/A for BH	CL/PM	No dedicated spec	No evidence	None	Public health tooling	Registry standards	HTI-1	Document N/A unless oncology service lines added
`f(5)`	Reportable lab tests/conditions	Contract-dependent	CL/PM	No dedicated spec	No evidence	None	Public health tooling	Public health condition reporting	HTI-1	Evaluate by state/public-health mandates
`f(6)`	Antimicrobial use and resistance reporting	Usually N/A for BH	CL	No dedicated spec	No evidence	None	AU/AR CDA validator	CDA AU/AR guides	HTI-1	Document N/A unless service scope expands
`f(7)`	Health care surveys reporting	Usually limited for BH	CL/PM	No dedicated spec	No evidence	None	NHCS validator	CDA NHCS guides	HTI-1	Document N/A or add if payer/contract requires

2.7 (g) Design and Performance Criteria

Criterion	Title	In-scope	Owning core	Existing spec(s)	Implementation evidence	Coverage status	ONC test tool	Standards / posture	HTI context	Recommended action
`g(3)`	Safety-enhanced design	Yes	PF/CL/PM	No ONC-specific SED spec	No NIST 7741 evidence package	None	Certification method	NIST IR 7741 usability process	HTI-1	Create SED spec and study artifact template
`g(4)`	Quality management system	Yes	PF/GR	No dedicated QMS criterion spec	No ONC-ready QMS artifact set	None	Certification method	QMS attestation expectations	HTI-1	Create QMS governance/evidence spec
`g(5)`	Accessibility-centered design	Yes	PF/CL/PM	`PF-93`, CL portal enhancements	Accessibility work in progress, not mapped to ONC criterion artifacts	Spec + partial impl	Certification method	WCAG 2.1 AA + Section 504	HTI-1	Add ONC-centered accessibility evidence matrix
`g(6)`	C-CDA creation performance	Yes	CL	`CL-48`	C-CDA generation path in progress	Spec + partial impl	SITE/C-CDA tools	C-CDA performance and validity	HTI-1	Finish benchmarking + validation artifact set
`g(7)`	Application access - patient selection	Yes	CL/PM	`CL-16`, `PM-55`	Partial API surfaces	Spec + partial impl	Inferno	FHIR/SMART	HTI-1	Finalize patient-level access semantics and tests
`g(8)`	Application access - data category request	Yes	CL/PM	CL-16 + PM-55	Partial	Spec + partial impl	Inferno	FHIR/USCDI mappings	HTI-1	Complete category-level filtering and conformance tests
`g(9)`	Application access - all data request	Yes	CL/PM	CL-16 + PM-55	Partial (`$everything` path not fully cert-ready)	Spec + partial impl	Inferno	FHIR all-data semantics	HTI-1	Add production-ready all-data request behavior and evidence
`g(10)`	Standardized API for patient and population services	Yes	CL/PM	`CL-16`, `CL-16-EN-02`, `PM-55`	FHIR edge facade exists but SMART/CapabilityStatement/cert harness incomplete	Spec + partial impl	Inferno	US Core, SMART, USCDI v3	HTI-1	Build inferno CI harness + complete SMART and metadata endpoints

2.8 (h) Transport Criteria

Criterion	Title	In-scope	Owning core	Existing spec(s)	Implementation evidence	Coverage status	ONC test tool	Standards / posture	HTI context	Recommended action
`h(1)`	Direct Project	Yes (for transition workflows)	CL/PM	`CL-48`, `PM-14`	HISP adapter patterns exist; not full cert-ready direct stack	Spec + partial impl	SITE Direct Testing	Direct transport standards	HTI-1	Implement full Direct flow, delivery notifications, and certification tests
`h(2)`	Direct edge protocols, XDR/XDM	Yes if Direct scope chosen	CL/PM	No dedicated h(2) cert spec	No certified-ready evidence found	None	SITE Direct + edge tools	XDR/XDM requirements	HTI-1	Add explicit h(2) implementation spec if cert path selected

2.9 (j) HTI-2 Additions

Criterion	Title	In-scope	Owning core	Existing spec(s)	Implementation evidence	Coverage status	ONC test tool	Standards / posture	HTI context	Recommended action
`j(15)`	Prior auth API - coverage requirements discovery	Yes (payer operations)	PM	`PM-52`, `PM-10`	Spec track exists, implementation incomplete	Spec-only	Inferno/Da Vinci conformance	CRD	HTI-2	Execute phased implementation with payer pilots
`j(16)`	Prior auth API - documentation templates/rules	Yes	PM	PM-52 + PM-10	Spec exists	Spec-only	Inferno/Da Vinci conformance	DTR	HTI-2	Add DTR rule engine and endpoint-level conformance tests
`j(19)`	Prior auth API - prior auth support	Yes	PM	PM-52 + PM-10	Spec exists, not complete	Spec-only	Inferno/Da Vinci conformance	PAS	HTI-2	Implement PAS transaction lifecycle + evidence
`j(20)`	DSI workflow triggers (client)	Yes	PM/CL	Mentioned in standards references only	No dedicated implementation	None	ONC tooling as released	CDS Hooks STU2	HTI-2	Create dedicated spec and client integration plan
`j(21)`	Subscriptions (client)	Yes	PM/CL	Mentioned in standards references only	No dedicated implementation	None	ONC tooling as released	FHIR subscriptions backport	HTI-2	Create dedicated spec and phased event subscription strategy

2.10 SVAP / Version Cutover Flags (Cross-Criterion)

Standard area	Legacy baseline	New baseline	Operational impact
USCDI	v1	v3 (required by late 2025 cutover windows in ONC tooling references)	Update mappings in CL-16/PM-55 and all certification test fixtures
US Core	STU3.1.1	STU6.1.0	Resource profile conformance changes for Inferno
SMART App Launch	1.0	2.0	Update OAuth flows, scopes, and app registration expectations
NCPDP SCRIPT	2017071	2023011	eRx/billing ecosystem upgrade with HTI-4 timing
C-CDA companion guide	R2	R4.1	Document generation/validation updates in CL-48

3) Conditions and Maintenance of Certification Matrix

Condition/Maintenance Area	Current repo coverage	Status	Primary anchors	Gap summary	Recommended action
Information Blocking governance	Present in PM-55 and compliance tracker	Spec + partial impl	`PM-55`, `REGULATORY_COMPLIANCE_TRACKER.md`	Need full denial taxonomy, workflows, and annual governance packet	Build criterion-to-exception control matrix and reporting automation
API Conditions of Certification (terms, fees, transparency, maintenance)	Partial conceptual coverage	Spec-only	PM-55, CL-16 family	Missing formal policy/doc artifacts expected in certification workflows	Add API condition governance spec + publishable artifacts
Real World Testing (RWT)	No dedicated spec/doc found	None	N/A	Missing annual plan/results framework	Create RWT spec and evidence template
Insights Condition metrics	No dedicated spec/doc found	None	N/A	Missing data capture + submission process	Create Insights metrics pipeline spec
Communications condition	Not explicitly documented	None	N/A	Missing formal communications guardrail artifact	Add policy spec tied to legal/compliance workflows
Annual attestation process	Not explicitly documented	None	N/A	Missing attestation calendar and artifact assembly	Add attestation operations spec
Assurances	Not explicitly documented	None	N/A	Missing signed assurance framework and controls mapping	Add assurances package spec
Mandatory disclosures URL	Not explicitly documented	None	N/A	Missing customer-facing disclosures publication workflow	Add disclosures publication spec
Hosted docs URL	Not explicitly documented	None	N/A	Missing certification-oriented hosted docs surface	Add docs publication and versioning policy
Trusted Exchange / TEFCA evolution	Scoped in enhancement	Spec + partial impl	`CL-16-EN-01`	Needs operational partner onboarding and cert interplay decisions	Keep as phased item with go/no-go contract trigger

4) ONC Tooling Readiness Matrix

Tool	URL	Main criterion coverage	Current readiness	Evidence today	What is required to pass
Inferno Framework	inferno.healthit.gov	`g(10)`, API-centric criteria, related HTI updates	Partial	CL-16/PM-55 specs, partial FHIR facade	CapabilityStatement, SMART full flow, profile-conformant resources, CI harness
SITE / Edge Testing Tool	site.healthit.gov	C-CDA, Direct, related certification tooling	Partial	CL-48 and direct adapter concepts	Complete Direct/XDR/XDM implementations and validation workflows
ONC Conformance Test Tools index	ONC Conformance Test Tools	Cross-criterion test resources	Partial	Resource inventory known	Build test execution program tied to each selected criterion
C-CDA Testing	C-CDA testing entry	`b(1)`, `b(2)`, `g(6)` and related	Partial	CL-48 generation work	Full schema/content validation and regression tests
Direct Testing	Direct testing entry	`h(1)`, `h(2)`, transition transport	Partial	HISP adapter pattern exists	Production Direct stack, delivery notification, edge protocol coverage
Cypress	healthit.gov/cypress	`c(1)`-`c(4)` CQM	Low	CL-51 spec only	Implement QRDA/CQM engine with Cypress-ready fixtures
eRx Testing Suite	erx.healthit.gov	`b(3)`, `b(4)`	Low-Partial	CL-06 path exists but HTI-4 transition pending	Upgrade standards and execute full eRx conformance tests
NIST Immunization Suite	NIST Immunization Suite	`f(1)`	Low	No dedicated criterion implementation	Build/report immunization messaging if in-scope
NIST Syndromic Suite	NIST Syndromic Suite	`f(2)`	Low	No dedicated criterion implementation	Build/report syndromic feeds if in-scope
NIST ELR Suite	NIST ELR Suite	`f(3)`	Low	No dedicated ELR certification flow	Build/report ELR transport and validations if in-scope
AU/AR CDA validator	AU/AR validator	`f(6)`	Low	None	Implement and validate AU/AR submissions if in-scope
NHCS validator	NHCS validator	`f(7)`	Low	None	Implement and validate NHCS submissions if in-scope
CPOE Evaluation Tool	Leapfrog CPOE tool	CPOE quality and safety corroboration	Low	None	Add pilot validation workflow if pursuing broader quality evidence
IHE Testing Tools	IHE tools	Interoperability profile validation	Low	None	Map relevant IHE profiles to cert scope and execute tests

5) ONC Resource Adoption Assessment (Non-Certification Resources)

Resource	URL	Current use in repo	Coverage status	Recommendation
Health IT Playbook	playbook.healthit.gov	Mentioned as resource category; no dedicated adoption spec	None	Create cross-core adoption guide tied to CL/PM/PF implementation patterns
ONC Implementation Resources hub	Implementation Resources	Referenced in ONC pages; not operationalized in compliance docs	None	Add periodic review cadence and artifact intake process
SITE hub	site.healthit.gov	Known as test hub; no internal runbook in compliance docs	Spec-only	Add certification test-ops runbook and ownership model
ONC Certification overview	Certification of Health IT	Mapped in roadmap/tracker	Spec-only	Keep updated with HTI release changes and ACB process updates
ONC Conformance tools page	Conformance tools	Partially reflected in docs	Spec-only	Convert to criterion-to-tool matrix (this document is first pass)
SAFER Guides (2025 updates)	Resources hub entry	Not explicitly mapped to specs	None	Add safety assessment program and annual review requirement
Security Risk Assessment Tool	SRA Tool	Mentioned in ONC ecosystem references only	None	Create customer operational workflow and internal readiness checklist
Patient Engagement Playbook	Health IT Playbook ecosystem	No direct operational mapping	None	Create PM-12/CL-26 adoption enhancement and content governance
Get It, Check It, Use It guide	Resources hub	Not integrated into patient guidance workflows	None	Add patient education/copy strategy for portal engagement

6) Recommended Next-Step Batches (Post-Decision)

These are not implemented in this document. They are recommended work packages after path selection.

Batch A: Decision Lock

Choose one path: Full, Modular, or Alignment-only.
Set scope statement by criterion family and target deadlines.
Name accountable owners and evidence calendar.

Batch B: Critical Safety and Conditions

New specs for Real World Testing, Insights condition, and attestation packaging.
Dedicated predictive DSI transparency spec (b(11)).
SAFER Guides adoption and governance spec.

Batch C: Modular Certification Core

Production conformance for g(10) (Inferno-ready API package).
Direct transport criterion hardening (h(1) / h(2)).
Patient engagement criterion completion (e(1)/e(2)/e(3) as selected).
d-family criterion evidence bundle finalization.

Batch D: Public Health Decision and Execution

Formal in-scope/N/A determinations for f(1)-f(7).
Implement only contract-required public health criteria.
Build corresponding NIST validation workflows.

Batch E: HTI-2 Extensions

Implement and certify j(15)/j(16)/j(19) to production level.
Add new specs for j(20) CDS Hooks client and j(21) subscriptions client.

Batch F: ONC Resource Adoption

Health IT Playbook operational adoption guide.
Patient engagement playbook integration plan.
SRA tool integration and annual safety review process.

Batch G: Governance and Process Updates

Refresh ONC_CERTIFICATION_ROADMAP.md.
Refresh REGULATORY_COMPLIANCE_TRACKER.md ONC rows.
Update compliance-review workflows to enforce criterion checks in future spec authoring.

7) Cross-References and Sources

7.1 External ONC/HHS Sources

7.2 Internal Compliance and Spec Sources

7.3 Known Internal Consistency Notes

PF-96 file header indicates complete status while registry/tracker entries may lag in some contexts.
ONC_CERTIFICATION_ROADMAP.md is intentionally high-level and should be refreshed after path selection.

Appendix A: Current ONC Readiness Scorecard (Snapshot)

Area	Score (0-5)	Rationale
API foundation (`g(10)` track)	2.5	Strong specs and partial implementation, missing certification harness and full SMART readiness
Information blocking operations	2.0	Governance direction present, still missing full annual artifact machinery
C-CDA and transitions	2.0	Strong CL-48 scope, not yet complete and validated end-to-end for certification
eRx track	2.0	Core direction present, HTI-4 standard transition pending
Public health criteria	0.5	Mostly unscoped/unimplemented for certification
Conditions/Maintenance of Certification	1.0	Major artifacts missing (RWT, Insights, attestation operations)
Tooling operationalization (SITE/Inferno/Cypress)	1.5	Inventory known, execution program not formalized

Overall snapshot: 1.8 / 5.0 for certification readiness; 2.5 / 5.0 for alignment-only interoperability posture (revised down from 3.0 per May 2026 analysis — USCDI v3 is now the baseline and most BH competitors already meet that bar).

Appendix B: Immediate No-Regret Actions (Regardless of Path)

Finalize and run Inferno-aligned test harness for current FHIR API scope.
Normalize USCDI v3 mapping inventory and close known terminology gaps.
Formalize information blocking denial taxonomy and review queue disposition standards.
Add explicit criterion ownership tags to each ONC-relevant spec.
Create one annual ONC compliance calendar (deadlines, attestations, test windows).
Create DS4P send/receive spec (CL-63) for §170.315(b)(7)/(b)(8) — critical for Part 2 SUD data exchange.
Create DEA EPCS spec (CL-64) for 21 CFR 1311 — required for MAT prescribing.
Create Contexture HIE integration spec (PF-108) — highest-ROI Arizona move for DAP/TI 2.0.
Create EKRA compliance spec (PF-107) — P0 legal priority due to NorthSight relationship.
Create DSI transparency spec (CL-65) for §170.315(b)(11) — required before AI features ship.

Note: Alignment score revised from 3.0/5.0 to 2.5/5.0. USCDI v3 is now the baseline (Jan 1, 2026); most BH competitors already meet that bar. Target 4.0/5.0 within 6 months. See docs/compliance/ONC_REGULATORY_READINESS_IMPLEMENTATION_PLAN.md for the full implementation plan with 12 new skills and 12 new specs.

Compliance Posture

Module Compliance Trackers

ONC Certification

Evidence Packages

ONC Health IT Certification Gap Matrix

1) Executive Summary and Decision Framework

1.1 Path Comparison

1.2 Required Artifacts by Path

1.3 Decision Triggers

2) 45 CFR §170.315 Criteria Gap Matrix (Criterion Families)

2.1 (a) Clinical Criteria

2.2 (b) Care Coordination Criteria

2.3 (c) Clinical Quality Measure Criteria

2.4 (d) Privacy and Security Criteria

2.5 (e) Patient Engagement Criteria

2.6 (f) Public Health Criteria

2.7 (g) Design and Performance Criteria

2.8 (h) Transport Criteria

2.9 (j) HTI-2 Additions

2.10 SVAP / Version Cutover Flags (Cross-Criterion)

3) Conditions and Maintenance of Certification Matrix

4) ONC Tooling Readiness Matrix

5) ONC Resource Adoption Assessment (Non-Certification Resources)

6) Recommended Next-Step Batches (Post-Decision)

Batch A: Decision Lock

Batch B: Critical Safety and Conditions

Batch C: Modular Certification Core

Batch D: Public Health Decision and Execution

Batch E: HTI-2 Extensions

Batch F: ONC Resource Adoption

Batch G: Governance and Process Updates

7) Cross-References and Sources

7.1 External ONC/HHS Sources

7.2 Internal Compliance and Spec Sources

7.3 Known Internal Consistency Notes

Appendix A: Current ONC Readiness Scorecard (Snapshot)

Appendix B: Immediate No-Regret Actions (Regardless of Path)

​1) Executive Summary and Decision Framework

​1.1 Path Comparison

​1.2 Required Artifacts by Path

​1.3 Decision Triggers

​2) 45 CFR §170.315 Criteria Gap Matrix (Criterion Families)

​2.1 (a) Clinical Criteria

​2.2 (b) Care Coordination Criteria

​2.3 (c) Clinical Quality Measure Criteria

​2.4 (d) Privacy and Security Criteria

​2.5 (e) Patient Engagement Criteria

​2.6 (f) Public Health Criteria

​2.7 (g) Design and Performance Criteria

​2.8 (h) Transport Criteria

​2.9 (j) HTI-2 Additions

​2.10 SVAP / Version Cutover Flags (Cross-Criterion)

​3) Conditions and Maintenance of Certification Matrix

​4) ONC Tooling Readiness Matrix

​5) ONC Resource Adoption Assessment (Non-Certification Resources)

​6) Recommended Next-Step Batches (Post-Decision)

​Batch A: Decision Lock

​Batch B: Critical Safety and Conditions

​Batch C: Modular Certification Core

​Batch D: Public Health Decision and Execution

​Batch E: HTI-2 Extensions

​Batch F: ONC Resource Adoption

​Batch G: Governance and Process Updates

​7) Cross-References and Sources

​7.1 External ONC/HHS Sources

​7.2 Internal Compliance and Spec Sources

​7.3 Known Internal Consistency Notes

​Appendix A: Current ONC Readiness Scorecard (Snapshot)

​Appendix B: Immediate No-Regret Actions (Regardless of Path)

1) Executive Summary and Decision Framework

1.1 Path Comparison

1.2 Required Artifacts by Path

1.3 Decision Triggers

2) 45 CFR §170.315 Criteria Gap Matrix (Criterion Families)

2.1 (a) Clinical Criteria

2.2 (b) Care Coordination Criteria

2.3 (c) Clinical Quality Measure Criteria

2.4 (d) Privacy and Security Criteria

2.5 (e) Patient Engagement Criteria

2.6 (f) Public Health Criteria

2.7 (g) Design and Performance Criteria

2.8 (h) Transport Criteria

2.9 (j) HTI-2 Additions

2.10 SVAP / Version Cutover Flags (Cross-Criterion)

3) Conditions and Maintenance of Certification Matrix

4) ONC Tooling Readiness Matrix

5) ONC Resource Adoption Assessment (Non-Certification Resources)

6) Recommended Next-Step Batches (Post-Decision)

Batch A: Decision Lock

Batch B: Critical Safety and Conditions

Batch C: Modular Certification Core

Batch D: Public Health Decision and Execution

Batch E: HTI-2 Extensions

Batch F: ONC Resource Adoption

Batch G: Governance and Process Updates

7) Cross-References and Sources

7.1 External ONC/HHS Sources

7.2 Internal Compliance and Spec Sources

7.3 Known Internal Consistency Notes

Appendix A: Current ONC Readiness Scorecard (Snapshot)

Appendix B: Immediate No-Regret Actions (Regardless of Path)