> ## Documentation Index
> Fetch the complete documentation index at: https://docs.encoreos.io/llms.txt
> Use this file to discover all available pages before exploring further.

# ONC Certification Roadmap

> 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 /…

**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.

***

## 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)

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)

### 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

***

## 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 Health OS Specs to ONC Criteria

| ONC Criterion         | Description                          | Encore Health 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

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.

***

## 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 |

***

## References

* [ONC Certification Program](https://www.healthit.gov/topic/certification-ehrs/certification-program)
* [ONC Certification Gap Matrix](./ONC_CERTIFICATION_GAP_MATRIX.md)
* [ONC Regulatory Readiness Implementation Plan](./ONC_REGULATORY_READINESS_IMPLEMENTATION_PLAN.md)
* [CL-16 FHIR Interoperability](../../specs/cl/specs/CL-16-fhir-interoperability-data-exchange.md)
* [PM-55 ONC HTI-1 Patient Access](../../specs/pm/specs/PM-55-onc-hti1-uscdi-v3-patient-access-api.md)
* [REGULATORY\_COMPLIANCE\_TRACKER.md](./REGULATORY_COMPLIANCE_TRACKER.md)
* [AUTHORITATIVE\_REFERENCES.md](./AUTHORITATIVE_REFERENCES.md)