Encore OS — Documentation

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 OS specs to ONC Health IT Certification criteria (45 CFR Part 170), provides a trigger-based escalation framework, and integrates competitive landscape findings.

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.

Path	Cost	Timeline	Annual Maint.	Fit for Encore
Alignment-Only	$0 external; ~500–1,000 hrs internal	Continuous	$0	Current path
Modular (e.g., (g)(10)/(g)(31))	~ $150K–$ 300K	9–12 months from kickoff	~ $30K–$ 80K	When trigger fires
Full / Base EHR	$400K–$ 1M+	18–24 months	$100K–$ 250K	Not before Series A

Trigger Events (Alignment → Modular)

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

Trigger Events (Modular → Full)

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

Competitive Landscape

Of 11 named BH EHR competitors, 10 are ONC-certified. Certification is table stakes for enterprise BH EHR.

Vendor	ONC Certified	Notes
Kipu Health	Yes	Also HITRUST-certified; ISO 42001 AI management
Sigmund AURA	Yes	HIPAA + SOC 2 Type II + ONC
AZZLY Rize	Yes	Includes EPCS for MAT
Lightning Step	Yes	BH-only platform
Procentive (Ensora Health)	Yes	Ensora portfolio
TenEleven eCR (Ensora)	Yes	Ensora-owned
EchoVantage (Ensora)	Yes	Ensora portfolio
ICANotes	Yes	Built for BH
Qualifacts (4 products)	Yes	Largest BH vendor by certification footprint
EHRYourWay (Adaptamed)	Yes	SLI Compliance certified
BestNotes	No	Smaller practices/SUD focus

Readiness Scores

Area	Score	Target (6 mo)
API foundation (g)(10) track	2.5 / 5.0	4.0
Information blocking operations	2.0 / 5.0	3.5
C-CDA and transitions	2.0 / 5.0	3.0
eRx track	2.0 / 5.0	2.5
Public health criteria	0.5 / 5.0	1.0
Conditions/Maintenance	1.0 / 5.0	2.0
Overall Certification Readiness	1.8 / 5.0	3.0
Overall Alignment Posture	2.5 / 5.0	4.0

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.

Mapping: Encore OS Specs to ONC Criteria

ONC Criterion	Description	Encore OS Spec(s)	Status
§170.315(a)(1)–(3)	CPOE (meds, lab, imaging)	CL-05, CL-06, CL-09	Spec + partial impl
§170.315(a)(4)	Drug-drug/allergy checks	CL-06, CL-45	Spec + partial impl
§170.315(a)(5)	Demographics	PM-01, PM-55	Spec + partial impl
§170.315(a)(6)	Problem list	CL-46	Spec + partial impl
§170.315(a)(7)	Medication list	CL-05	Spec + partial impl
§170.315(a)(8)	Medication allergy list	CL-45	Spec + partial impl
§170.315(a)(9)	Clinical decision support	CL-08	Spec + partial impl
§170.315(a)(14)	Implantable device list	N/A (BH focus)	N/A
§170.315(a)(15)	SDOH/behavioral data	CL-18, CL-40	Spec + partial impl
§170.315(b)(1)–(2)	Transitions of care / reconciliation	CL-48, CL-12, CL-05	Spec + partial impl
§170.315(b)(3)	E-prescribing	CL-06	Spec + partial impl
§170.315(b)(6)	Data export	PF-44, CL-20	Spec + partial impl
§170.315(b)(7)/(b)(8)	DS4P send/receive	CL-63 (new)	Not Started
§170.315(b)(10)	EHI export	PF-44, PM-55	Spec + partial impl
§170.315(b)(11)	DSI transparency	CL-65 (new), PM-64, CL-08	Spec-only
§170.315(c)(1)–(4)	CQM record/import/report/filter	CL-51	Spec-only
§170.315(d)(1)–(13)	Privacy and security	PF-01, PF-30, PF-91, CL-11	Mixed
§170.315(e)(1)	VDT (View, Download, Transmit)	PM-12, PM-55, CL-16	Spec + partial impl
§170.315(f)(1)	Immunization registry (ASIIS)	CL-66 (new)	Not Started
§170.315(f)(5)	eCR reportable conditions	CL-67 (new)	Not Started
§170.315(g)(7)–(9)	Application access APIs	CL-16, PM-55	Spec + partial impl
§170.315(g)(10)	Standardized FHIR R4 API	CL-16, CL-16-EN-02, PM-55	Spec + partial impl
§170.315(h)(1)–(2)	Direct transport	CL-48, PM-14	Spec + partial impl
USCDI v3	Demographics, problems, meds, etc.	PM-01, CL-01, CL-04, CL-05, CL-10	Partial

Parallel Tracks (Non-ONC but Critical)

Track	Spec	Priority	Status
DEA EPCS (21 CFR 1311)	CL-64 (new)	P1 — required for MAT	Not Started
Contexture HIE	PF-108 (new)	P1 — AHCCCS DAP 8.0%	Not Started
EKRA compliance	PF-107 (new)	P0 — NorthSight risk	Not Started
HITRUST e1	PF-109 (new)	P2 — Kipu parity	Not Started
USCDI+ BH profiles	CL-16-EN-03 (new)	P2 — proactive	Not Started
Surescripts certification	PM-73 (new)	P3 — production eRx	Not Started
SAMHSA reporting	GR-26 (new)	P3 — grant compliance	Not Started

Gaps and Priorities

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

Phased Timeline

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

Compliance Posture

Module Compliance Trackers

ONC Certification

Evidence Packages

ONC Certification Roadmap

Strategic Recommendation: Alignment-Only → Modular → Full

Trigger Events (Alignment → Modular)

Trigger Events (Modular → Full)

Competitive Landscape

Readiness Scores

Mapping: Encore OS Specs to ONC Criteria

Parallel Tracks (Non-ONC but Critical)

Gaps and Priorities

Phased Timeline

References

​Strategic Recommendation: Alignment-Only → Modular → Full

​Trigger Events (Alignment → Modular)

​Trigger Events (Modular → Full)

​Competitive Landscape

​Readiness Scores

​Mapping: Encore OS Specs to ONC Criteria

​Parallel Tracks (Non-ONC but Critical)

​Gaps and Priorities

​Phased Timeline

​References

Strategic Recommendation: Alignment-Only → Modular → Full

Trigger Events (Alignment → Modular)

Trigger Events (Modular → Full)

Competitive Landscape

Readiness Scores

Mapping: Encore OS Specs to ONC Criteria

Parallel Tracks (Non-ONC but Critical)

Gaps and Priorities

Phased Timeline

References