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Version: 2.0.0 Last Updated: 2026-05-15 Source: CL-PM-SPEC-REVIEW Finding 4.4, ONC 21st Century Cures Act, May 2026 Compass Artifact Analysis Owner: Product / Compliance / CL / PM / PF This document maps Encore Health OS specs to ONC Health IT Certification criteria (45 CFR Part 170), provides a trigger-based escalation framework, and integrates competitive landscape findings.

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Strategic Recommendation: Alignment-Only → Modular → Full

Current path: Alignment-Only. Build to ONC criteria without formal certification filing. Certify when a named trigger event fires.
PathCostTimelineAnnual Maint.Fit for Encore
Alignment-Only$0 external; ~500–1,000 hrs internalContinuous$0Current path
Modular (e.g., (g)(10)/(g)(31))~150K–150K–300K9–12 months from kickoff~30K–30K–80KWhen trigger fires
Full / Base EHR400K–400K–1M+18–24 months100K–100K–250KNot before Series A

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Trigger Events (Alignment → Modular)

  1. Named AHCCCS-contracted ACC-RBHA or CARF/Joint Commission-accredited multi-state SUD chain writes “ONC-certified CEHRT” into mandatory RFP requirements
  2. Clinical AI feature ships that triggers HTI-1 §170.315(b)(11) DSI transparency obligations
  3. Encore wins a TI 2.0 cohort or AHCCCS RHTP subaward where EHR functionality is scored
  4. Information blocking enforcement materially escalates ($1M per violation CMPs are live; joint HHS-OIG/ASTP enforcement alert issued September 4, 2025)

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Trigger Events (Modular → Full)

  1. Large hospital-affiliated psychiatric customer requires CEHRT for Medicare hospital PI reporting
  2. Multi-state expansion into Medicaid programs with active PI-successor incentives
  3. HTI-5 re-introduces Patient Access API requirements

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Competitive Landscape

Of 11 named BH EHR competitors, 10 are ONC-certified. Certification is table stakes for enterprise BH EHR.
VendorONC CertifiedNotes
Kipu HealthYesAlso HITRUST-certified; ISO 42001 AI management
Sigmund AURAYesHIPAA + SOC 2 Type II + ONC
AZZLY RizeYesIncludes EPCS for MAT
Lightning StepYesBH-only platform
Procentive (Ensora Health)YesEnsora portfolio
TenEleven eCR (Ensora)YesEnsora-owned
EchoVantage (Ensora)YesEnsora portfolio
ICANotesYesBuilt for BH
Qualifacts (4 products)YesLargest BH vendor by certification footprint
EHRYourWay (Adaptamed)YesSLI Compliance certified
BestNotesNoSmaller practices/SUD focus

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Readiness Scores

AreaScoreTarget (6 mo)
API foundation (g)(10) track2.5 / 5.04.0
Information blocking operations2.0 / 5.03.5
C-CDA and transitions2.0 / 5.03.0
eRx track2.0 / 5.02.5
Public health criteria0.5 / 5.01.0
Conditions/Maintenance1.0 / 5.02.0
Overall Certification Readiness1.8 / 5.03.0
Overall Alignment Posture2.5 / 5.04.0
Note: Alignment score revised from 3.0 to 2.5 per May 2026 analysis — USCDI v3 is now the baseline and most BH competitors already meet that bar.

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Mapping: Encore Health OS Specs to ONC Criteria

ONC CriterionDescriptionEncore Health OS Spec(s)Status
§170.315(a)(1)–(3)CPOE (meds, lab, imaging)CL-05, CL-06, CL-09Spec + partial impl
§170.315(a)(4)Drug-drug/allergy checksCL-06, CL-45Spec + partial impl
§170.315(a)(5)DemographicsPM-01, PM-55Spec + partial impl
§170.315(a)(6)Problem listCL-46Spec + partial impl
§170.315(a)(7)Medication listCL-05Spec + partial impl
§170.315(a)(8)Medication allergy listCL-45Spec + partial impl
§170.315(a)(9)Clinical decision supportCL-08Spec + partial impl
§170.315(a)(14)Implantable device listN/A (BH focus)N/A
§170.315(a)(15)SDOH/behavioral dataCL-18, CL-40Spec + partial impl
§170.315(b)(1)–(2)Transitions of care / reconciliationCL-48, CL-12, CL-05Spec + partial impl
§170.315(b)(3)E-prescribingCL-06Spec + partial impl
§170.315(b)(6)Data exportPF-44, CL-20Spec + partial impl
§170.315(b)(7)/(b)(8)DS4P send/receiveCL-63 (new)Not Started
§170.315(b)(10)EHI exportPF-44, PM-55Spec + partial impl
§170.315(b)(11)DSI transparencyCL-65 (new), PM-64, CL-08Spec-only
§170.315(c)(1)–(4)CQM record/import/report/filterCL-51Spec-only
§170.315(d)(1)–(13)Privacy and securityPF-01, PF-30, PF-91, CL-11Mixed
§170.315(e)(1)VDT (View, Download, Transmit)PM-12, PM-55, CL-16Spec + partial impl
§170.315(f)(1)Immunization registry (ASIIS)CL-66 (new)Not Started
§170.315(f)(5)eCR reportable conditionsCL-67 (new)Not Started
§170.315(g)(7)–(9)Application access APIsCL-16, PM-55Spec + partial impl
§170.315(g)(10)Standardized FHIR R4 APICL-16, CL-16-EN-02, PM-55Spec + partial impl
§170.315(h)(1)–(2)Direct transportCL-48, PM-14Spec + partial impl
USCDI v3Demographics, problems, meds, etc.PM-01, CL-01, CL-04, CL-05, CL-10Partial

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Parallel Tracks (Non-ONC but Critical)

TrackSpecPriorityStatus
DEA EPCS (21 CFR 1311)CL-64 (new)P1 — required for MATNot Started
Contexture HIEPF-108 (new)P1 — AHCCCS DAP 8.0%Not Started
EKRA compliancePF-107 (new)P0 — NorthSight riskNot Started
HITRUST e1PF-109 (new)P2 — Kipu parityNot Started
USCDI+ BH profilesCL-16-EN-03 (new)P2 — proactiveNot Started
Surescripts certificationPM-73 (new)P3 — production eRxNot Started
SAMHSA reportingGR-26 (new)P3 — grant complianceNot Started

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Gaps and Priorities

  1. USCDI v3 alignment: All FHIR resources must target USCDI v3 (baseline as of Jan 1, 2026). US Core 6.1.0 profiles are the conformance target.
  2. DS4P for Part 2: CL-63 must implement confidentiality coding before any production FHIR exchange involving SUD data.
  3. FHIR R4 API (g)(10): CL-16 + PM-55 must complete SMART App Launch v2, CapabilityStatement, and Inferno-passing conformance.
  4. Information blocking: PM-55 must complete denial taxonomy, review queue, and annual governance packet.
  5. DEA EPCS: CL-64 is prerequisite for MAT prescribing — half the AHCCCS-funded SUD market.
  6. Contexture/HIE: PF-108 is the single highest-ROI Arizona-specific move — DAP incentives flow through Contexture.
  7. DSI transparency: CL-65 required before shipping AI clinical features to avoid HTI-1 compliance exposure.
  8. EKRA: PF-107 is P0 — shared-founder NorthSight relationship requires immediate legal review.

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Phased Timeline

PhaseFocusTarget
Days 0–30Contexture agreement; NLM UMLS license; EKRA legal memo; USCDI v3 data model alignment; HITRUST e1 scopingImmediate
Days 31–90FHIR R4 USCDI v3 endpoints + SMART v2; DS4P coding; DAP SOW submission; HITRUST e1 readiness90 days
Months 4–6HITRUST e1 assessment; Contexture live exchange; Inferno-passing (g)(10) alignment; first DSI disclosure6 months
Months 6–12Trigger decision gate; HITRUST i1 readiness; DEA EPCS engagement; USCDI+ BH pilot mapping12 months
Months 12–24If triggered: Drummond engagement for modular certification24 months

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References