Standard

This document specifies a set of representational primitives and semantic relations needed for an unambiguous representation of explicit time-related expressions in health informatics. This document does not introduce or force a specific ontology of time, nor does it force the use of a fixed representation scheme for such an ontology. Rather this document provides a set of principles for syntactic and semantic representation that allow the comparability of specific ontologies on time and the exchange of time-related information that is expressed explicitly. This document applies to both the representation of actual phenomena occurring in the real world (e.g. registrations in medical records) and to the description of concepts (e.g. medical knowledge bases). This document is applicable to a) developers of medical information systems where there might be a need for explicit time-related concepts for internal organization (e.g. temporal databases, temporal reasoning systems), b) information modellers or knowledge engineers building models for the systems mentioned in a), c) experts involved in the development of semantic standards on precise subdomains in health care where time-related information needs to be covered, (e.g. in the study of pathochronology, i.e. the discipline dealing with the time course of specific diseases), and d) developers of interchange formats for messages in which time-related information is embedded. This document is not intended to be used directly for — representing what is true in time, — reasoning about time, or — representation of metrological time.

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).

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.

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. 

The present document addresses the requirements for communications between the authorized representatives who can be involved in the responses and actions when handling an emergency. It describes the functional requirements for communications between the authorized representatives involved in the responses and actions when handling an emergency. The level of precision has been chosen to avoid interaction with the specific local, regional or national organizations and diagrams of relations between authorized representatives. It follows from this that adaptations will have to be done when implementing the present document at a local level. Furthermore, the scope of the present document also encompasses various types of services that can bring an added value to this basic scenario or add new scenarios, such as the services brought by other technologies e.g. IoT devices that support communications between authorities during emergencies.