Editor's Draft · Community Specification
CMS-Aligned Network Specification
Technical and operational requirements for Health Information Networks seeking recognition under the CMS Health Technology Ecosystem.
Scope
The immediate focus of this specification is the use cases currently defined in the CMS Interoperability Framework: patient access, payer access (for specific permitted activities), and provider access. Patient access is the top priority, followed by payer access and provider access. The specification has also been written with future use cases in mind, including proxy and caregiver access, and notification flows such as patient encounter notifications; where requirements for those use cases are not yet specified, this document identifies the gaps rather than foreclosing them.
Abstract
This document specifies the technical and operational requirements a Health Information Network MUST meet to be recognized as a CMS-Aligned Network (Network) under the CMS Health Technology Ecosystem (HTE).
The specification covers the three core obligations of a CMS-Aligned Network, the three required connectivity pathways plus one optional pathway, patient matching, auto-registration, authentication, authorization, query handling, National Provider Directory (NPD) publication, audit logging, security validation, fees, and accountability.
This specification deliberately covers network obligations only. Trust pathways for apps, EHRs, providers, and payers are referenced where they intersect network behavior but are specified elsewhere.
Status of This Document
This is an editor's draft assembled from working-group materials. It has no normative force on its own. The authoritative source for CMS-Aligned status is the CMS Interoperability Framework published by CMS at cms.gov/health-technology-ecosystem/interoperability-framework. Where this document and the Framework conflict, the Framework controls.
This draft is offered as a consolidated rendering of network-side requirements so that implementers can evaluate conformance against a single artifact. Working-group input is welcome on operational specifics (auto-registration profiles, audit standards, dispute resolution, presumptive-eligibility scope).
1Conformance
The keywords MUST, MUST NOT, REQUIRED, SHALL, SHALL NOT, SHOULD, SHOULD NOT, RECOMMENDED, MAY, and OPTIONAL in this document are to be interpreted as described in BCP 14 (RFC 2119, RFC 8174) when, and only when, they appear in all capitals.
A network conforms to this specification when it satisfies every MUST in §§ 3–14 and is in good standing under § 15.
2Terminology
Network (CMS-Aligned Network). A governed exchange layer, combining technology, trust agreements, and shared operating rules, that enables multiple organizations to send and receive standardized health data without building custom point-to-point connections to every counterparty. Within the Health Tech Ecosystem, networks serve as the routing and trust infrastructure that connects data originators — providers, payers, and other health systems — to applications and platforms that ultimately serve patients, enabling interoperability at scale across the ecosystem. For purposes of this specification, "Network" refers specifically to a Health Information Network recognized by CMS as meeting the obligations defined herein.
Consider aligning this definition to 45 CFR 171.102, which defines a Health Information Network or Health Information Exchange as:
An individual or entity that determines, controls, or has the discretion to administer any requirement, policy, or agreement that permits, enables, or requires the use of any technology or services for access, exchange, or use of electronic health information:
- Among more than two unaffiliated individuals or entities (other than the individual or entity to which this definition might apply) that are enabled to exchange with each other; and
- That is for a treatment, payment, or health care operations purpose, as such terms are defined in 45 CFR 164.501 regardless of whether such individuals or entities are subject to the requirements of 45 CFR parts 160 and 164.
Aligning to 45 CFR 171.102 would ground the spec's network definition in existing regulatory text and may affect which entities are in scope as Networks.
Home Network. The single Network through which a given participant (app, data holder, delegated tech solution) is onboarded and held to be in good standing.
Camp A (current spec model): Apps connect via a home Network. The home Network onboards the app, establishes its good standing, and acts as the trust anchor and routing intermediary for cross-network queries. Other Networks respond because the home Network vouches for the app — not because they have a direct relationship with it.
Camp B (direct-connect model): The architecture should allow apps to connect on their own steam directly to all Networks. Apps may choose to outsource cross-network operations to a Network operator as a convenience, but the architecture should not require home-network gating as a structural constraint. Trust should be derivable from federal credentials alone, without a home Network intermediary in the path.
Data Holder. A HIPAA covered entity (provider organization or payer) that holds patient records and exposes them via a network.
Connector. A tech solution or intermediary that initiates a targeted query against a specific endpoint identified in NPD — for example, when a payer has evidence (e.g., a received claim) that a patient's data resides at a particular provider endpoint. Connectors have direct query rights under applicable HIPAA authority.
Tech Solution. A patient-facing application, third-party delegated software, or other ecosystem participant that originates queries.
Federal Trust Signal. A federally grounded credential or attestation that travels with an actor (e.g., ONC certification, CARIN Code of Conduct, DirectTrust accreditation, DiME seal, IAL2 verification, Medicare App Library listing, NPD listing, HIPAA covered-entity status, X.509 credential).
Good Standing. As defined in § 4.3: completed home-network onboarding, current on obligations, no active unresolved complaints, passed operational health checks, not suspended.
Inter-Network Settlement. A commercial arrangement in which one Network compensates another for carrying or fulfilling queries that originate from the first Network's participants — analogous to transit fees or peering settlements in telecommunications. Settlement is prohibited for patient-directed access traffic (§ 14.3) and is optional for other traffic types.
NPD. National Provider Directory. The authoritative public registry of ecosystem participants, endpoints, and inter-network connections.
RLS. Record Locator Service.
Use Case. One of: patient access, treatment, payment, operations, prior authorization, payer-to-payer.
Dynamic Client Registration (RFC 7591). The general IETF OAuth 2.0 mechanism by which a client registers itself with an authorization server programmatically, presenting a signed software statement at the /register endpoint as the software_statement parameter. This is the wire format; the software statement itself can be issued by different authorities (CMS, a CA, or others) representing different trust paths. UDAP is one specific profile that implements dynamic client registration using X.509 certificates; it is not a synonym for dynamic client registration in general.
Software Statement (CMS-signed). A short-lived JWT signed by CMS that asserts a client's status in a CMS-maintained registry and binds it to a verified jwks_uri. Presented as the software_statement parameter during RFC 7591 Dynamic Client Registration. CMS-signed software statements can streamline dynamic registration for many client types — patient-facing apps, payers, providers, delegated tech solutions — as CMS extends its registry coverage. To date, CMS's most concrete commitment is the Medicare App Library for patient-facing apps; the architecture accommodates broader use as that coverage grows.
Software Statement (UDAP). An X.509-anchored signed JWT per the HL7 FAST Security Implementation Guide (HL7 FAST UDAP IG, sometimes called FAST Security) — one specific implementation of RFC 7591 dynamic client registration. Trust is validated against the trust community CA recognized by the CMS-Aligned framework. See § 7.1 for the open architectural question of whether UDAP remains a required path alongside CMS-signed software statements.
3Architecture Overview
The HTE architecture establishes a federal floor that is mandatory for participants who choose to be CMS-Aligned. Above the floor, networks compete and differentiate freely.
3.1 Non-Goals
A CMS-Aligned Network is NOT required to:
- sign a common agreement with other networks;
- share liability with other networks;
- adopt common pricing or governance.
3.2 What Networks MUST Do
Every CMS-Aligned Network MUST:
- Meet the three core obligations in § 4.
- Support all three connectivity pathways in § 5.
- Use the CMS-approved patient matching logic (§ 6).
- Honor auto-registration and presumptive eligibility for participants in good standing on another home Network (§ 7).
- Authenticate participants using a federally grounded credential — IAL2 for patient-facing (B2C) flows, a recognized software statement for system-to-system (B2B) flows — no portal login may be required as a precondition (§ 8).
- Implement authorization per patient preferences (§ 9).
- Respond to authorized queries completely and without undue obstruction, subject to applicable access controls and authorization requirements (§ 10).
- Publish to NPD (§ 11).
- Produce audit logs accessible to patients (§ 12).
- Maintain HITRUST security validation (§ 13).
- Comply with the fees floor (§ 14).
- Remain accountable to CMS for ongoing compliance (§ 15).
- Attest to the same "rules of the road" of all other CMS-Aligned Networks (§ 17).
4The Three Core Obligations
4.1 Respond to queries for data holders on the network
A Network MUST respond when an authorized query reaches the network and a data holder on the network holds matching data, across every Use Case the network's participants engage in. This includes, at minimum, patient access, treatment, and payment queries within applicable use cases.
A Network MUST NOT decline to respond solely because the originating query came from a participant whose home network is different.
4.2 Vouch for participants in good standing
A Network MUST maintain the operational status of each of its onboarded participants and MUST report good standing (or lack thereof) when queried by another Network or by NPD.
A Network MUST NOT attest to federal legal compliance on behalf of its participants. Operational status only.
A Network MUST suspend a participant's good-standing report when the participant has been suspended or flagged by the network, or has failed an operational health check that the network publishes.
4.3 Respond to credentialed tech solutions from other home networks
When a tech solution presents valid Federal Trust Signals and is reported in good standing on its home Network, the receiving Network MUST respond to its queries.
The receiving Network MUST NOT impose duplicative trust gating on top of the Federal Trust Signals and the home-network good-standing report. Operational coordination (abuse contacts, rate-limit coordination, ops contacts, support channels) MAY be required.
5Connectivity Pathways
A Network MUST support all three of the following pathways. A fourth pathway is OPTIONAL and operates outside the CMS-aligned obligation structure.
5.1 Pathway 1 — Intranetwork
The Network serves queries against data holders that have contracted directly with the Network as their home network.
Assumptions
- The participant has a direct contract with the Network.
- The Network is in good standing as CMS-Aligned.
Conformance
- The Network MUST respond to authorized queries for any data holder on the network across applicable use cases.
5.2 Pathway 2 — RLS Network Search ($match)
Discovery uses $match against the published RLS endpoints of other
CMS-Aligned Networks. Data retrieval may use either federated FHIR (each
responder serves its own data directly) or brokered FHIR (a network broker
aggregates and returns data on behalf of multiple endpoints). Both retrieval modes are
conformant.
Assumptions
- Every Network exposes a standardized RLS endpoint at a known address listed in NPD.
- The endpoint accepts authenticated
$matchrequests from other CMS-Aligned Networks and Apps in the ecosystem. - Common patient matching (§ 6) applies.
Conformance
- A Network MUST expose a standardized RLS endpoint at the address published in NPD.
- A Network MUST accept authenticated
$matchrequests from other CMS-Aligned Networks on this endpoint. - A Network MUST apply the CMS patient matching rule (§ 6) to all queries received via Pathway 2.
- Data retrieval MAY use federated FHIR or brokered FHIR; both are conformant.
The current conformance requirement uses $match as the sole discovery mechanism. Two concerns have been raised:
$matchhas no production use at scale for cross-network Record Locator Service. It is a FHIR operation designed for single-endpoint patient matching, not multi-site federated discovery.- XCPD (Cross-Community Patient Discovery, IHE ITI-55) has established production use for exactly this purpose and should be considered the floor for cross-network discovery.
Proposed for discussion: Networks SHOULD accept either $match OR XCPD for cross-network discovery, with conformance testing requirements to be determined. FHIR-based mechanisms (including $match) may be added or substituted as they reach production readiness at scale.
5.3 Pathway 3 — Targeted Queries Against NPD
The connector queries a specific endpoint by NPI (or equivalent identifier) listed in NPD, when there is evidence the patient has data at that endpoint (e.g., a payer that received a claim from a specific provider). Unlike Pathway 2, Pathway 3 applies when the connector already has evidence of the patient's data location and queries that endpoint directly, without using RLS discovery.
Assumptions
- The connector has direct query rights under HIPAA right of access, treatment/payment/operations purpose of use, or other applicable legal authority.
- NPD listing is authoritative for endpoint discovery.
Conformance
- A Network MUST publish its participants' endpoints to NPD in a form that supports targeted queries by NPI or equivalent identifier.
Rate-limiting and discovery-pattern constraints apply to network-mediated queries (Pathway 2), where the Network is in the query path. In Pathway 3, the connector queries an endpoint directly without Network intermediation; unbounded discovery patterns are governed by endpoint-level controls at the receiving data holder, not by the Network. The specific endpoint-level constraint mechanism is an open question — see Appendix A.
5.4 Pathway 4 — Bilateral Network-to-Network Peering Agreement OPTIONAL
Two networks enter a direct contractual arrangement to exchange data with each other, independent of any CMS-aligned obligation. Each network decides whether to communicate with the other; the arrangement is purely voluntary and bilateral.
Assumptions
- The peering agreement is negotiated bilaterally between the two networks and is not required by CMS-Aligned status.
- The contract governs the terms of communication, settlement, transit, and SLAs between the two networks.
- Neither network's CMS-aligned obligations are fulfilled or affected by this arrangement.
Conformance
- A Network MAY enter into bilateral peering agreements with other networks at its discretion.
- A Network MUST NOT rely solely on a Pathway 4 arrangement to satisfy its obligations under § 4, because the peering is voluntary and either party may withdraw.
6Patient Matching
A Network MUST implement the CMS-approved patient matching logic specified in the CMS Interoperability Framework. The current MVP standard is the 26-combination matching rule.
A Network MUST respond when a query received via any pathway in § 5 matches a patient record across any of the 26 specified combinations, provided that authorization requirements under § 9 are satisfied. A match result alone does not create a response obligation if authorization has not been granted.
The exact field list and combination matrix are explained in a different specification, not duplicated here. Will link when it's available.
7Auto-Registration & Presumptive Eligibility
7.1 Auto-Registration
Registration at any Network data holder uses RFC 7591 Dynamic Client Registration as the shared wire format. A client presents a signed software statement at the /register endpoint as the software_statement parameter. RFC 7591 is the mechanism; the software statement is the trust signal. Different issuers of software statements represent different trust paths — they share the same wire format but are not interchangeable.
CMS-signed software statements can streamline dynamic registration for many kinds of clients — patient-facing apps, payers, providers, delegated tech solutions, and networks acting as clients — without requiring CMS to operate a CA or issue X.509 certificates. A CMS-signed software statement is a short-lived JWT (e.g., 24-hour TTL) signed by CMS that asserts a client's status in a CMS-maintained registry and binds it to a verified jwks_uri. A receiving authorization server can accept it without per-network re-vetting. To date, CMS's most concrete commitment is listing patient-facing apps in the Medicare App Library — that is an important and well-scoped starting point. The architecture of this spec does not treat it as the ceiling: as CMS extends registry coverage to other actor types, the same mechanism applies. See Josh Mandel, "Software Statements for the Medicare App Library," May 26, 2026.
A Network MUST accept a valid CMS-signed software statement as sufficient for dynamic client registration, without additional per-network vetting, for any client type for which CMS has published a registry and issued a statement.
All recognized credential types reduce to RFC 7591 plumbing at the receiving authorization server. The server SHOULD route signature validation by issuer: CMS published JWKS for CMS-signed software statements; UDAP trust community CA chain for UDAP software statements (if UDAP is retained as a recognized path).
When a participant has been onboarded by one home Network using a recognized credential type, every other Network MUST register that participant on a defined timeline without redundant onboarding.
The timeline is set by the CMS Interoperability Framework.
A Network MUST NOT impose duplicative trust gating on top of the federally grounded credentials. Operational coordination (abuse contacts, rate-limit, security procedures, support channels) MAY be coordinated.
7.2 Presumptive Eligibility
A participant that has met its trust requirements and is in good standing on one home Network MUST be allowed by other Networks to operate for a default 90-day presumptive-eligibility period without redundant onboarding.
After 90 days, presumptive eligibility transitions to ongoing recognition unless there is specific cause to suspend.
Three conditions are required:
- The participant meets the trust requirements applicable to its actor type.
- The home Network's onboarding establishes that the participant works in production.
- The participant is in good standing on the home Network.
A Network MAY suspend presumptive eligibility for cause, including operational abuse, security incidents, or a good-standing downgrade on the home Network. A Network that suspends MUST report the suspension to NPD and to the home Network.
8Authentication
Authentication establishes that the party making a request is who they claim to be. The model differs between patient-facing (B2C) and system-to-system (B2B) flows. A Network, and every EHR or data holder it routes to, MUST respond to authorized queries from properly credentialed parties without requiring portal login as a precondition — the credential models below are the accepted authentication path; portal login is not.
8.1 Patient Access — B2C (IAL2 + SMART App Launch)
For patient-directed access, identity is established via IAL2 identity verification through a CMS-approved credential service provider (CSP) — such as CLEAR or ID.me — combined with app authorization via SMART App Standalone Launch.
Reference Implementation — IAL2 with Manual Authorization (SMART App Standalone Launch)
This flow modifies the SMART App Launch v2.2.0 Standalone Launch pattern to support IAL2 patient identity. Three trust pillars are required:
- Patient Authentication (IAL2). The patient is identity-proofed by a CMS-approved CSP
(e.g., CLEAR, ID.me, or a state-issued digital ID card). The CSP issues a high-assurance
id_tokencryptographically proving the patient's verified identity. - Application Authentication (Asymmetric). The trusted app uses Private Key JWT authentication (RS384 or ES384). The app publishes a JWKS URL; the authorization server validates the app's signature against the corresponding public key.
- Patient Consent (Authorization Server UI). Because the IAL2 token establishes identity but
not authorization, the authorization server renders its native SMART App Launch consent UI
so the patient explicitly approves the requested granular FHIR scopes. No portal login is
required — the login screen is bypassed because the IAL2
id_tokenis already present.
Flow summary
The app generates a client_assertion JWT (signed with its private key) that nests the CSP-issued
IAL2 id_token within a cms_smart extension (version: "2", purpose_of_use: "PATRQT"). The
authorization request MUST use POST /authorize (application/x-www-form-urlencoded) — GET
is not permitted because the nested token makes the payload too large for a query string (risk of
HTTP 414). The authorization server validates the app's signature via its published JWKS and
validates the IAL2 id_token, then bypasses the login screen and renders the consent UI. After
the patient approves the requested FHIR scopes, the server issues an authorization code. The
app exchanges it via POST /token with PKCE (code_challenge_method: S256) and a fresh
client_assertion.
This flow is the current reference pattern for SMART App Standalone Launch. The cms_smart
extension is updated to version "2" under § 9.2.1 to accommodate a consent artifact — the
login-bypass mechanism described here remains unchanged.
8.2 Provider and Payer Access — B2B
For system-to-system access by providers and payers, authentication uses the payer-initiated B2B integration pattern grounded in the trust signals established at registration (§ 7). The current reference implementation uses UDAP B2B flows; whether UDAP remains the required mechanism or is joined or superseded by CMS-signed software statements for B2B client types is an open architectural question — see § 7.1.
Reference Implementation — B2B System-to-System Integration
Primary pattern — SMART Backend Services + direct FHIR queries
All system-to-system B2B access uses SMART on FHIR Backend Services (OAuth 2.0 Client
Credentials Grant). The requesting system authenticates to the data holder's authorization
server by presenting a signed JWT client assertion against a published JWKS, obtains a
short-lived access token, and queries the data holder's FHIR API directly using standard
RESTful requests (e.g., GET /Patient/{id}, GET /Observation?patient={id}). No user-facing
login is involved.
This pattern is the floor for all B2B use cases — treatment, payment, operations, prior authorization, and payer-to-payer.
Optional — CDex Task pattern for payer-initiated attachment requests
For use cases requiring asynchronous, payer-initiated clinical attachment requests (e.g.,
claim attachment workflows under CMS-0057-F), the HL7 CDex FHIR Task pattern MAY be
used in place of direct synchronous queries. Under this pattern the network acts as
intermediary: the payer submits a CDex-profiled FHIR Task to the network (POST /Task),
the network performs a governance check and fulfills the task by querying the provider's
FHIR API, then delivers the result to the payer via POST /$submit-attachment. Each
leg uses the same SMART Backend Services authentication described above.
Standards: SMART on FHIR Backend Services, OAuth 2.0 Client Credentials Grant, HL7 FHIR RESTful API, HL7 CDex (optional, for asynchronous attachment workflows).
10Query / Data Exchange
10.1 Respond Completely
When a query is authorized, the response MUST include all relevant data the responder holds for the patient, structured and unstructured, within the applicable Use Case.
The minimum data scope for structured data is USCDI v3 (or the version current at the time of the query, as specified by the CMS Interoperability Framework). Unstructured artifacts within USCDI v3 scope (clinical notes, scanned PDFs, imaging reports, encounter documents) MUST be included where they exist. Artifact types beyond USCDI v3 scope (faxes, ambient listening recordings) SHOULD be included where they exist and where a standard exchange mechanism is available.
No standard currently exists for exchanging ambient listening recordings (e.g., wav/mp3 via DocumentReference). Many organizations do not persist recordings after transcription is complete. The exchange profile for ambient recordings is TBD. "Faxes" means a document-formatted copy (e.g., PDF) where one exists — raw fax transmission is not required.
USCDI v3 defines the superset of data elements that a Network and its Data Holders must be capable of returning — it is not a guarantee that every element is returned on every call. The actual data in any given response is a subset determined by three factors:
- The specific query. A request for a particular FHIR resource type (e.g.,
MedicationRequest) returns only that resource, not the full USCDI element set. - Authorized scopes. The requesting app's granted scopes constrain which resource types and fields are accessible in that session. Scopes are granted and validated by the Data Holder's authorization server — the Network is not the source of truth for what an app may access.
- Use-case-specific constraints. Some use cases carry inherent limits on the data window — for example, a payer may be restricted to clinical data supporting claims from the last 60 days, or to data associated with a specific encounter, even when it holds broader USCDI access rights.
"Supports USCDI v3" means the capability is present and conformant; it does not mean all USCDI elements are returned on every call.
No use case becomes a dead end.
10.2 Use Case Coverage
A Network MUST respond to queries from the actor categories that apply to the use cases its participants engage in:
- patients seeking their own records;
- providers requesting clinical and claims data for treatment;
- payers (where applicable) requesting clinical data supporting claims from the last 60 days;
- payers querying for quality measure reporting;
- prior authorization queries (subject to CMS-0057-F deadlines).
If a network's participants engage in a use case, the network MUST support queries for that use case.
10.3 Purpose of Use Propagation
Every data request MUST declare why the data is being accessed. A Network MUST support the HL7 Purpose of Use code set and apply the correct disclosure rules to each category.
The following codes are REQUIRED, aligned to the approved use cases in § 10.2:
| Code | Display | Level | Use case |
|---|---|---|---|
PATRQT | Patient request | Granular | Patient access |
TREAT | Treatment | High level | Treatment |
HPAYMT | Healthcare payment | High level | Payment (including claims) |
CLMATTCH | Claim attachment | Granular | Claim attachment within payment |
HOPERAT | Healthcare operations | High level | Health care operations |
HQUALIMP | Healthcare quality improvement | Granular | Quality measure reporting within operations |
Purpose of use MUST travel with the request to downstream systems.
When the requesting party is trusted and the purpose of use is properly declared, a Network and its participants MUST NOT impose additional authorization requirements on top. However, patients MAY restrict the data categories an app can access, and a Network MUST honor those restrictions. Patient-scoped restrictions are defined in § 9 (Authorization) and take precedence over this requirement.
10.4 Patient-Contributed Data
Patient-contributed data (patient-reported outcomes, notes, home device readings, lifestyle data) is a planned Phase 2 capability. The write-side obligations — data holder acceptance, format, tagging as patient-contributed, deduplication, and review workflows — are not yet specified and are deferred from v0.3.
Networks and data holders SHOULD design their APIs to accommodate future patient-write flows. Patient choice governs whether patient-contributed data flows when this capability is implemented.
11National Provider Directory Publication
A Network MUST publish to NPD:
- its onboarded participants (apps, providers, payers, delegated tech solutions), where "providers" means both provider organizations and individual practitioners affiliated with those organizations;
- its participants' endpoints in a form that supports Pathway 3 (targeted query by identifier);
- its inter-network connections;
- usage metrics by participant and by use case;
- trust-anchor metadata sufficient for validating any recognized software statement type — specifics are contingent on the architectural decision in § 7.1 (see NOTE below).
The trust-anchor metadata requirement above is contingent on the resolution of the UDAP architectural question in § 7.1. If UDAP is retained as a required path, NPD MUST publish the trust community CA URL and any intermediate CA certificates recognized by the CMS-Aligned framework. The specific metadata schema, certificate format, and refresh cadence are deferred until § 7.1 is resolved by the working group. Until that decision is made, this bullet imposes no concrete implementation obligation beyond publishing whatever trust-anchor metadata corresponds to the software statement types the working group adopts.
Networks that onboard at the organizational level — and do not directly contract with individual practitioners — satisfy the individual practitioner publication requirement by publishing their onboarded provider organizations with NPI cross-references to the corresponding individual practitioner records in NPPES. A Network is not required to independently verify or replicate individual practitioner data that is already authoritatively maintained in NPPES; it MUST publish enough metadata (organization NPI, affiliated practitioner NPIs where known) to support targeted queries by NPI under Pathway 3. Where a network does not hold individual practitioner affiliation data, it SHOULD publish that gap alongside its organizational records so queriers know to fall back to NPPES for practitioner-level resolution.
A Network MUST ingest and publish updates routinely. The ingest/refresh cadence is specified by the CMS Interoperability Framework. This requirement is contingent on CMS providing a scalable NPD ingestion API — see Appendix A, item A7. Until that API is available, Networks SHOULD manually submit updates via CMS's current flat-file process.
NPD MUST also be queryable by any Network, auditor, or participant to confirm an actor's listing and credentials. Trust travels with the actor because it is anchored in NPD as a public, queryable record that any Network can read without bilateral verification.
12Audit Logging
A Network MUST produce audit logs for queries on its network, including:
- who accessed the data;
- when;
- for what declared purpose of use;
- which organizations were involved.
Audit logs MUST be organization-level at minimum. Audit logs MUST be kept for a minimum of 7 years, or longer if required by applicable law (45 CFR 164.530(j)).
A Network MUST facilitate patient-facing audit access so patients can see, through their app, who queried their data. Implementations MUST conform to the IAS Audit Log API Specification (v1.0, February 2026), which defines the FHIR AuditEvent resource model, IAL2 OIDC token-based patient authentication, and endpoint discovery via RLS and NPD.
Patient-facing audit coverage is scoped to network-mediated queries — those passing through an RLS endpoint (Pathways 1 and 2). Point-to-point queries under Pathway 3 are excluded from this requirement because the network is not in the query path and cannot produce a log of traffic it never sees. This limitation is explicitly acknowledged in the IAS Audit Log API Spec (§1.2): "Point-to-point transactions that do not flow through an RLS" are out of scope. Endpoint-level audit obligations for Pathway 3 are governed by the data holder's own HIPAA audit requirements, not this section.
EHRs facilitating ecosystem queries are subject to the same audit obligations as the Network routing through them.
13Security
A Network MUST maintain HITRUST certification, scoped to the network's production environment that creates, receives, maintains, or transmits PHI on behalf of participants. This includes, at minimum, identity verification token validation, query routing, audit log generation, and patient matching reference data storage. Corporate functions that do not touch PHI are out of scope.
HITRUST certification does NOT replace compliance with HIPAA, the Privacy Act, or applicable federal and state privacy and security laws.
Business Associate Agreements (BAAs) MAY be required even where data is not directly brokered (for example, when a participant queries an RLS endpoint under Pathway 3). Networks and participants MUST confirm their BAA obligations under HIPAA.
14Fees & Economics
14.1 Patient-Directed Access
A Network MUST NOT structure fees in a way that gates a patient's federal right to access their own data.
The Fees exception at 45 CFR 171.302 and the ONC information blocking framework establish this floor. Cost recovery is permitted; platform fees structured to defeat patient access are not.
14.2 Above the Floor
A Network MAY set its own commercial terms for:
- premium services beyond baseline;
- prior-authorization service offerings under CMS-0057-F;
- voluntary commercial peering arrangements with other Networks;
- value-added integration services.
14.3 Inter-Network Settlement
For patient-directed access traffic, inter-network settlement is NOT appropriate.
For other traffic types (treatment, payment, operations, prior auth, payer-to-payer), Networks MAY negotiate commercial peering arrangements with settlement, transit fees, or other terms above the federal floor.
15Accountability
A Network is accountable to CMS for meeting the obligations in §§ 3–14. Persistent failure is grounds for delisting from CMS-Aligned status on the same footing as failing any other Framework criterion.
A Network MUST publish operational metrics (response rates, query volumes, response times by use case) so apps and data holders can comparison-shop and so CMS can monitor adoption and performance. Network performance metrics appear in CMS scorecards (Framework criterion #19).
Outages and partial responses happen; the obligation is to meet published response standards over time, not to be perfect.
16July 4, 2026 Framework Requirements
By July 4, 2026, a Network MUST satisfy all four requirements below, as specified in the CMS Interoperability Framework.
16.1 FHIR API Access
A Network MUST provide or facilitate access to data using FHIR APIs that adhere to the HL7 FHIR US Core Implementation Guide, including:
- a complete and valid FHIR Capability Statement;
- USCDI v3 (or later) data elements with terminology compliance — laboratories coded in LOINC, medications in RxNorm, conditions in SNOMED CT.
A Network SHOULD leverage FHIR Bulk Data Exchange to reduce stress on existing systems and enable the exchange of full data records.
16.2 Chart Notes and Clinical Documents
A Network MUST return chart notes and clinical documents — including radiology reports, scanned or faxed labs, and external specialist notes — in human-readable formats (PDF, TIFF, JPG) as FHIR attachments, as specified in USCDI v3. Ambient listening recordings SHOULD be returned where they are persisted and a standard exchange mechanism is available; the exchange profile for ambient recordings is TBD.
16.3 Appointment and Encounter Notifications
A Network MUST provide appointment and encounter notifications for outpatient, telehealth, emergency department, and inpatient encounters using FHIR Subscriptions, where such notifications are permitted by existing law.
Appointment and Encounter Notifications (§16.3) are not included in the July 4, 2026 GA requirements. The Notifications working group has not met in several months due to unresolved questions on network design and structure. This criterion will be revisited once the home-network architecture question (see §2, Terminology — Home Network contested decision) reaches consensus. Networks are not required to implement §16.3 for initial CMS-Aligned recognition.
16.4 Record Locator Service
A Network MUST implement record locator functionality by collaborating with CMS to determine efficient and timely models that:
- reduce query load on the networks;
- aid understanding of data completeness.
Requests to the record locator service MUST be initiable by patients, providers, payers, and value-based care organizations.
17Rules of the Road Attestation
Appendix A · Open Questions
These are gaps identified in source materials that this draft does not resolve. They are flagged here so working-group attention can converge.
| # | Open Question | Source |
|---|---|---|
| A1 | Wire profile of the standardized RLS / federation endpoint (transport, authentication, payload schema for $match requests and responses). |
Framework defers; Connectivity Pathways doc notes this is the baseline interface but the operational profile is not fixed. |
| A1b | Wire profile for brokered FHIR retrieval under Pathway 2 — how a network broker aggregates responses from multiple RLS endpoints and returns them to the requesting Network (payload shape, error handling, partial-response semantics). | Introduced by the shift from federated-only to dual retrieval modes in Pathway 2; not yet specified. |
| A2 | Mechanism for preventing endpoint-spamming under Pathway 3 (geo-search constraints, rate limits, query-shape rules). | Connectivity Pathways doc explicitly raises this as an unresolved question. |
| A3 | Whether networks may charge data holders per query for required HTE use cases, and the same for payer-to-provider queries. | Workgroup Alternative Proposal § 2.3 — raised but not resolved by CMS in source materials. |
| A4 | Definition and scope of the "on-ramp" intermediary role: separate ecosystem role or contracted vendor of the participant? | Workgroup Alternative Proposal § 2.2 — raised but not resolved. |
| A5 | Operational profile for auto-registration timeline and the exact handoff between home-network onboarding and presumptive eligibility at receiving networks. | HTE Reference doc Part II — "defined timeline" referenced but not specified. |
| A6 | Whether a single "Rules of the Road" document signed by all Networks is the right vehicle for cross-network operational standards, or whether criteria-based participation is sufficient. | Workgroup Alternative Proposal § 3.1 vs. HTE Reference doc Part I — disagreement; CMS chose criteria-based. |
| A7 | NPD ingest/refresh cadence, schema, and authoritative trust-registry behavior. NPD currently operates as a static web file requiring manual flat-file submissions — there is no API for routine programmatic ingestion. The MUST in § 11 to ingest and publish updates routinely cannot be met at scale without a CMS-provided ingestion API. This item must be resolved before § 11 can be implemented as written. | HTE Reference doc Part II references publication but the operational profile is open. |
Appendix B · Source Documents Used to Build This Draft
This draft was synthesized from three internal working documents and one public CMS resource. No external sources were invented.
- HTE Network Framing Combined Reference (V2 draft). Part I (the case for the HTE architecture), Part II (Rules of the Road), Part III (trust framework diagram). Internal working document.
- Connectivity Pathways for Discovery. Internal working document defining four pathways; this spec adopts three required pathways and one optional pathway (§ 5.4).
- CMS Networks Workgroup — Meeting Summary and Alternative Ecosystem Proposal. Internal working document. The alternative was not adopted; cited here for gap identification only.
- CMS Interoperability Framework. cms.gov/health-technology-ecosystem/interoperability-framework
Appendix C · Normative References
References below appear in source materials. None are invented.
- RFC 2119 — Key words for use in RFCs to Indicate Requirement Levels.
- RFC 8174 — Ambiguity of Uppercase vs Lowercase in RFC 2119 Key Words.
- RFC 7591 — OAuth 2.0 Dynamic Client Registration Protocol.
- HL7 FAST Security Implementation Guide (HL7 FAST UDAP IG) — Unified Data Access Profiles for B2B Health App Authorization, published through HL7 as the recognized SDO; defines the X.509-anchored software statement used by payers, providers, and networks.
- ONC 21st Century Cures Act Final Rule.
- USCDI v3.
- HL7 FHIR US Core.
- CMS-0057-F — Advancing Interoperability and Improving Prior Authorization Final Rule.
- ONC Information Blocking.
- 45 CFR 171.302 — Fees Exception.