HL7

The HL7 Version 3 Implantable Device Cardiac (IDC) Follow-up Summary is a message model for describing an observation of an interrogator at a physical location who is performing an interrogation of a therapeutic medical device (bound to a patient) using identifiable interrogation equipment.

The Unique Device Identifier (UDI) Pattern provides the guidelines for exchanging UDI information associated with medical devices, initially implantable devices in patients.  This document will not give implementation guidance for specific use cases and worfklows, but will set the overarching guidelines for all working groups that need to exchange the unique device identification on the fields and format intended for expressing UDI related data using V2, V3, and FHIR.  The goal of the UDI Pattern is to enable semantic interoperability for recording UDI information on medical devices used on or implanted in patients regardless of the information exchange standard used to move the information across (e.g., HL7 Version 2.x, HL7 v3 messages or CDA, HL7 FHIR).

Incremental update to the EHR System Functional Model (EHR-S FM), encompassing all the EHR functions and conformance criteria found in its predecessor Release 2, and incorporating:

1. Changes to the Record Infrastructure Section to accommodate three additional record lifecycle events (verify, encrypt, decrypt) and ensure compatibility with FHIR Core R4 Record Lifecycle Event Implementation Guide (2019) and recent updates to ISO 21089:2018, Trusted End-to-End Information Flows;
2. Changes to the Glossary Section to support the full set of record lifecycle events (now 27 in total) and corresponding descriptions;
3. Previously identified updates included in the EHR-S FM R2.01 errata version;
4. Changes to the Conformance Chapter to align with characteristics and requirements of recent EHR-S FM R2 based Functional Profiles, including FPs developed for the US Meaningful Use (EHR Incentive) Program, 2011/2014 and 2015 Editions;
5. Domain analysis (models and artifacts) companion to EHR system development and implementation.
6. Adding a header in the TI section on clinical model services (DCMs, CIMI models, FHIR, HL7 template) comparable to TI.4 Standard Terminology and Terminology Services.

Incremental update to the EHR System Functional Model (EHR-S FM), encompassing all the EHR functions and conformance criteria found in its predecessor Release 2, and incorporating:

1. Changes to the Record Infrastructure Section to accommodate three additional record lifecycle events (verify, encrypt, decrypt) and ensure compatibility with FHIR Core R4 Record Lifecycle Event Implementation Guide (2019) and recent updates to ISO 21089:2018, Trusted End-to-End Information Flows;
2. Changes to the Glossary Section to support the full set of record lifecycle events (now 27 in total) and corresponding descriptions;
3. Previously identified updates included in the EHR-S FM R2.01 errata version;
4. Changes to the Conformance Chapter to align with characteristics and requirements of recent EHR-S FM R2 based Functional Profiles, including FPs developed for the US Meaningful Use (EHR Incentive) Program, 2011/2014 and 2015 Editions;
5. Domain analysis (models and artifacts) companion to EHR system development and implementation.
6. Adding a header in the TI section on clinical model services (DCMs, CIMI models, FHIR, HL7 template) comparable to TI.4 Standard Terminology and Terminology Services

The scope of the standard is to define the message for exchanging information electronically between Regulators and Industry, and between sets of regulators. The message provides the ability to describe the contents of the regulatory exchange and all information needed to process the exchange between parties. This message is designed to be flexible enough to be used to support regulatory exchanges for any regulated product.

The Privacy and Security Architecture Framework (PSAF) is the overarching package that contains four balloted specifications and an informative guide.  The specific normative components include: 1) Trust Framework for Federated Authorization Conceptual Model, 2) Trust Framework for Federated Authorization Behavioral Model, 3) Provenance Domain Analysis Model and 4) Audit.  The intent of these standards is to provide an integrated package of a set of standards to advance communication and interoperability among partners in a shared trust framework environment.

Many seemingly healthy babies with Critical Congenital Heart Disease (CCHD) may suffer negative health outcomes if the birth defect is not identified shortly after birth. International efforts have precipitated both program and legislative initiatives to promote and/or mandate universal newborn screening for Critical Congenital Heart Disease using pulse oximetry devices. When pulse oximetry devices are able to exchange data with information systems, the use of standards helps with the seamless exchange of data and improve patient safety. This implementation guide focuses on the transmission of CCHD screening data from the device to the public health program, other potential recipients including providers and electronic health records.

HL7’s Version 2.x (V2) messaging standard is the workhorse of electronic data exchange in the clinical domain and arguably the most widely implemented standard for healthcare in the world. This messaging standard allows the exchange of clinical data between systems. It is designed to support a central patient care system as well as a more distributed environment where data resides in departmental systems.

Early Hearing Detection and Intervention (EHDI) programs exist world-wide to help identify children with hearing loss. Because newborn hearing loss is a neuro-developmental emergency, children with hearing loss need to be identified shortly after birth to help them achieve better communication outcomes. This implementation guide focuses on the transmission of the hearing screening data elements from the hearing screening device to a recipient of data, which may be an electronic health record (EHR) or a Public Health Information System.

The Electronic Nutrition Care Process Record System (ENCPRS) Functional Profile is based on the Electronic Health Record System Functional Model R2 (EHRS-FM). The intent is to develop a standard list of functions and criteria needed for full integration of both the Nutrition Care Process (NCP) and the representative terms from the Nutrition Care Process Terminology (NCPT). The NCP serves as a systematic approach to providing high quality nutrition care. This standardization will encourage the acquisition of EHR systems by nutrition health providers and promote information interoperability between nutrition and food systems and other areas of healthcare. These requirements have been mapped into this functional profile and identify those portions of the HL7 EHR-S Functional Model that apply to patient care in the Nutrition Care Process. Further, these requirements identify functionality toward facilitating ease of use for those involved in patient care using the NCP, thus providing EHR vendors with conformance criteria that are specific to regulated tasks within the NCP in the HL7 International formats.

This project developed an implementation guide constraining CDA Release 2. The implementation guide supports electronic submission of HAI data to the National Healthcare Safety Network. CDC provided NHSN developers, vocabulary experts and CDA experts to support this project. 

Clinical Quality Language (CQL) is a high-level, domain-specific language focused on clinical quality improvement and targeted at measure and decision support artifact authors and implementers.

In addition, this specification describes a machine-readable canonical representation called Expression Logical Model (ELM) targeted at implementations and designed to enable sharing of clinical knowledge.

See the standard at cql.hl7.org.