Standards and IGs Index and Resources
Standards and IGs Index and Resources
Standards and IGs Index and Resources
Required Technical Standards
Technical standards help ensure that clinical and administrative data flow securely and efficiently between software applications created by health information technology (IT) developers and used by healthcare providers, patients, and payers. By defining the format and structure of data and providing a common terminology, standards enable information and medical concepts to be shared across systems—leading to enhanced care coordination among payers, providers, and patients, ultimately improving care coordination and patient outcomes. Below is a list of technical standards that are required in the Centers for Medicare & Medicaid Services’ (CMS) interoperability policies.
HL7 FHIR Release 4.0.1
FHIR® is a standard that has been developed and is maintained by HL7®. The FHIR standard defines how healthcare information can be exchanged between different computer systems regardless of how it is stored in those systems. It enables health data, including clinical and administrative data, to be quickly and efficiently exchanged.
FHIR Release 4.0.1 provides the first set of normative FHIR resources. A subset of FHIR resources is normative, and future changes on those resources marked normative will be backward compatible. These resources define the content and structure of core health data, which developers use to build standardized applications.
HL7 FHIR U.S. Core IG STU 3.1.1
This IG establishes the “floor" of standards to promote interoperability and adoption through common implementation and defines the minimum set of constraints on the FHIR resources to create the US Core Profiles. It also defines the minimum set of FHIR RESTful interactions for each of the US Core Profiles to access patient data.
Use Cases: The US Core FHIR profiles are designed to be the base set of requirements for FHIR implementation in the US. All US Realm implementation guides shall use the US Core profiles or shall explicitly state why they are unable to use them.
HL7 SMART App Launch Framework IG 1.0.0
SMART on FHIR provides reliable, secure authorization for a variety of app architectures with the OAuth 2.0 standard. This guide is intended to be used by app developers that need to access FHIR resources by requesting access tokens from OAuth 2.0 compliant authorization servers. The guide defines a method through which an app requests authorization to access a FHIR resource and then uses that authorization to retrieve the resource.
Open ID Connect Core 1.0
OpenID Connect 1.0 is a simple identity layer on top of the OAuth 2.0 protocol. It enables clients to verify the identity of the end-user based on the authentication performed by an authorization server, as well as to obtain basic profile information about the end-user in an interoperable and RESTful manner. This specification defines the core OpenID Connect functionality: authentication built on top of OAuth 2.0 and the use of claims to communicate information about the end-user. It also describes the security and privacy considerations for using OpenID Connect.
United States Core Data for Interoperability (USCDI)
The USCDI is a standardized set of health data classes and component data elements for nationwide, interoperable health information exchange. It sets a foundation for broader sharing of electronic health information to support patient care.
Visit HealthIT.gov for updates to the USCDI
HL7 FHIR Bulk Data Access (Flat FHIR) Specification (v1.0.0: STU 1)
The Flat FHIR IG defines a standardized, FHIR based approach for exporting bulk data from a FHIR server to a pre-authorized client. The data exchange often involves extracting a specific subset of fields from the source system, mapping the fields into a structured file format like CSV, and persisting the files in a server from which the requester can then download them into the target system.
Use Cases: This implementation guide is designed to support sharing any data that can be represented in FHIR such as native FHIR servers, EHR systems, population health tools, and financial systems.
Recommended Implementation Guides
Implementation Guides (IGs) provide implementation information that can be used to meet finalized and proposed regulatory requirements for Application Programming Interfaces (APIs) without the need for independently developed approaches. The recommended IGs below have been developed through an industry-led, consensus-based public process and are publicly available for use at no cost. Additionally, these IGs have use case-specific reference implementations with test data to allow entities to see the APIs in production and support testing and development.
HL7 FHIR CARIN Consumer Directed Payer Data Exchange (CARIN IG for Blue Button®) IG STU 2.0.0
- The CARIN for Blue Button IG uses explanation of benefits (EOB) data to enable beneficiaries to access their claims and encounter data, and share that electronic information through an API.
- Use Cases: The Medicare Blue Button enables beneficiaries to access their Medicare Parts A, B, and D claims and encounter data, and share that electronic information through an API with approved applications, services, and research programs of their selection.
HL7 FHIR Da Vinci Payer Data Exchange (PDex) IG STU 2.0.0
- The HL7 FHIR Da Vinci Payer Data Exchange (PDex) is designed to facilitate the exchange of clinical information by health plans for members and providers that have requested to have their data follow them when they change payers.
- Use Cases: The IG intends to enable payers to create a member’s health history using clinical resources and data that can be understood by providers and saved in their electronic health record (EHR) system. There should be no expectation of the clinical data provided via PDex being derived from the claims data.
HL7 FHIR Da Vinci Payer Data Exchange (PDex) US Drug Formulary IG STU 2.0.1
- The HL7 FHIR Da Vinci Payer Data Exchange (PDex) U.S. Drug Formulary IG defines a FHIR interface to a payer’s drug formulary information for patients and consumers to use during enrollment.
- Use Cases: This IG intends to enable patients to understand the costs and alternatives for drugs that they have been prescribed and to compare their drug costs across different insurance plans.
HL7 FHIR Da Vinci Payer Data Exchange (PDex) Plan Net IG STU 1.1.0
- The HL7 FHIR Da Vinci PDex Plan Net IG covers the requirements and profiles required to enable health plans to publish their healthcare and pharmacy network information and make it accessible via an API.
- Use Cases: This IG intends to define the API that exposes a payer’s provider network (and pharmacies when applicable) for access by a consumer or provider application. However, the resulting API is a query-only API, meaning it doesn’t support modifications to the directory.
HL7 FHIR Da Vinci Prior Authorization Support (PAS) IG STU 2.0.1
- The HL7 FHIR Da Vinci Prior Authorization Support (PAS) defines mapping between FHIR and X12 transactions to enable direct transmission of prior authorization requests (and request/receive immediate authorization) from within EHR systems using the FHIR standard.
- Use Cases: This IG is intended to serve as a workaround for providers and clinical support staff who often send prior authorizations manually by fax or using payer-specific portals or automated phone systems.
HL7 FHIR Da Vinci Coverage Requirements Discovery (CRD) IG STU 2.0.1
- The HL7 FHIR Da Vinci Coverage Requirements Discovery (CRD) defines a workflow to allow payers to provide information about coverage requirements to providers through their clinical systems at the time treatment decisions are made.
- Use Cases: This IG is intended to support APIs for payers with authorization requirements to query provider systems for additional patient information needed to inform the guidance provided—for example by determining what information already exists or what steps have already occurred.
HL7 FHIR Da Vinci Documentation Templates and Rules (DTR) IG STU 2.0.0
- The Documentation Templates and Rules (DTR) IG specifies how payer rules can be executed in a provider context to ensure that documentation requirements are met. This IG is a companion to the Coverage Requirements Discovery (CRD) IG.
- Use Cases: This IG is intended to collect clinical documentation and/or to encourage the completion of documentation that demonstrates medical necessity for ordered items or services.
HL7 SMART App Launch IG Release 2.0.0 to support Backend Services Authorization
- The Backend Services section of the HL7 SMART App Launch IG describes the process by which the client acquires an access token that can be used to retrieve data without the need for runtime end user authorization. This allows systems to interoperate autonomously or without user level authentication and authorization after being registered, authenticated, and authorized at configuration time.
Additional Implementer Support Resources
Below are references to support resources, testing tools, and reference implementations available to support testing and development of conformant IT systems.
Da Vinci Implementation Guide Implementer Support Resources
- The Da Vinci implementer support page contains references to resources for several of the guides mentioned in the CMS Interoperability and Patient Access and CMS Interoperability and Prior Authorization final rules.
- A platform of testing capabilities for servers and clients with tests relevant and to several implementation guides identified in the CMS Interoperability and Prior Authorization Final Rule (CMS-0057), the ONC Health IT Certification, and other specifications.
- Inferno on HealthIT.gov is a public service for running select FHIR conformance tests built with Inferno. This includes server tests relevant and to several implementation guides identified in the finalized CMS-0057 rule and the ONC Health IT Certification Program.
- HL7 IG related Reference Implementations and other Open Source Projects that provide implementers tools for discovery and testing of FHIR specifications.
Technical Questions and Answers
Technical questions may be addressed through the main HL7 FHIR Implementer and Developer Community Zulip Forum.
To obtain an account visit Zulip chat home.
For additional guidance refer to the HL7 Confluence site.
Page Last Modified:
07/01/2024 09:42 AM