Member Summary


Regenstrief/LOINC
The Regenstrief Institute is a local, national, and global leader dedicated to a world where better information empowers people to end disease and realize true health. The institute is a pioneer in informatics and data standards and is the steward for LOINC (Logical Observations Identifiers Names and Codes) and UCUM (Unified Code for Units of Measure). LOINC and UCUM are stewarded by LOINC and UCUM committees and the professional staff of the Health Data Standards unit of the Regenstrief Institute. At Regenstrief, we are committed to working with others who have similar goals of building seamless networks of health systems and data that live up to the promise of optimal health for all.

SNOMED International
SNOMED International is an international not-for-profit organisation that develops and promotes the use of SNOMED CT®, a comprehensive, multilingual healthcare terminology created for use by healthcare professionals to capture the care of individuals in an electronic health record and facilitate sharing, decision support and analytics (“SNOMED CT”), to support safe and effective health information exchange. The purpose of SNOMED International is to develop, maintain, promote and enable the uptake and correct use of its terminology products in health systems, services and products around the world.

DICOM
DICOM® — Digital Imaging and Communications in Medicine — is the international standard for medical images and related information. It defines the formats for medical images that can be exchanged with the data and quality necessary for clinical use. The vision for the Standard is to achieve compatibility and improve workflow efficiency between imaging systems and other information systems in healthcare environments worldwide. The Standard is cooperatively developed. Its governance has been designed to ensure a balanced representation of stakeholders worldwide who share the vision. The DICOM Standards Committee is proactive to assure compatibility with related standards developed by other standards developing and coordinating bodies including but not limited to ANSI, CEN, JIC, HL7, IEC, ISO and JISC.

IHE International
IHE is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards such as DICOM and HL7 to address specific clinical needs in support of optimal patient care. Systems developed in accordance with IHE communicate with one another better, are easier to implement, and enable care providers to use information more effectively.

openEHR
openEHR is a global, community driven non profit organisation that defines and publishes technical standards for an health record platform along with domain developed clinical models to define content. The principal architectural concepts include the lifelong, patient centric shared health record and future proof data to support health, care, AI and research. All openEHR IP is published under either Apache 2.0 or CC BY licenses.

GS1
GS1, an international Standard Development Organization (SDO), develops and maintains global standards to support multi-sector supply chains, including healthcare. GS1 standards ensure the global, unambiguous identification of objects, locations, and processes, using Automatic Identification and Data Capture (AIDC) methods like barcodes and radio frequency tags. GS1 operates through more than 100 local member organizations that deploy these standards within their respective countries, providing a structured and practical approach to change management.

OECD
We work closely with policy makers, stakeholders and citizens to establish evidence-based international standards and to find solutions to social, economic and environmental challenges. From improving economic performance and strengthening policies to fight climate change to bolstering education and fighting international tax evasion, the OECD is a unique forum and knowledge hub for data, analysis and best practices in public policy. Our core aim is to set international standards and support their implementation – and help countries forge a path towards stronger, fairer and cleaner societies.

CDISC
CDISC was established in 2000 to develop open and freely available consensus-based standards supporting clinical research. The CDISC vision is to amplify data’s impact to advance research by creating connected standards across the study information lifecycle to enable accessible, interoperable, and reusable data for more meaningful and effective research. The CDISC standards are used globally within most clinical research organizations to collect, transform, and analyze their study data and are required for regulatory submission across several agencies.

CEN/TC251
CEN is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union (EU) and by the European Free Trade Association (EFTA). CEN/TC 251 delivers and maintains health informatics standards for Europe, preferably by producing them in co-operation with other SDOs at a global level and by adopting standards from other SDOs. CEN/TC 251 will seek to further increase engagement with other standards development organizations, consortia and fora to enhance efforts to coordinate its work with other organizations that have similar goals, such that stakeholder wishes for fewer, but more universal, global standards for health informatics are recognized and delivered in Europe.

ICCBBA
IICCBBA is an international non-profit organisation that manages, develops, and licenses ISBT 128, the international information standard for the terminology, coding and labeling of medical products of human origin. ICCBBA also manages the allocation of globally unique identifiers to licensed facilities and maintains the ISBT 128 Standard, international databases for Facility Identification Numbers and Product Description Codes, supporting documentation, and educational materials. More information at https://www.isbt128.org/about-iccbba

HL7 International
Founded in 1987, Health Level Seven International (HL7) is a not-for-profit, ANSI-accredited standards-developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery, and evaluation of health services. HL7 is supported by more than 1,600 members from over 50 countries, including 500+ corporate members representing healthcare providers, government stakeholders, payers, pharmaceutical companies, vendors/suppliers, and consulting firms. FHIR (Fast Healthcare Interoperability Resources), a family of standards developed by HL7 is gaining momentum globally. FHIR offers a complete toolbox for interoperability, including technologies such as SMART-on-FHIR, CDS-Hooks, and Bulk Data Access. In addition, FHIR Implementation Guides (IGs) provide specific guidelines for the application of FHIR in different countries and domains. HL7's FHIR Accelerator Program supports communities in creating and adopting high-quality FHIR IGs. Older existing families are the pervasive messaging standard HL7 V2.x and the document-based HL7 CDA R2. HL7 supports both the development and the implementation of standards. Current accelerators include Argonaut, CARIN Alliance, CodeX, Da Vinci, FAST, Gravity Project, Helios, and Vulcan. The vision of HL7 is a future where health data is seamlessly exchanged between different systems and organizations, improving the quality of healthcare globally. The implementation-based International Patient Standard (IPS) is receiving increased interest globally as a method for exchanging data across country borders.

ITU
ITU-T Study Group 21 focuses on multimedia technologies and services for current and future networks, including IP and cable-based networks. Key areas of study:
• Multimedia Systems & Services: Technologies for multimedia applications and services, including digital health, digital inclusion, and active assisted living.
• Telecommunication Systems: Use of telecom systems for content distribution and immersive experiences like virtual reality and augmented reality.
• Broadband Networks: Integration of broadband services with various network types, including fixed wireless access networks.
• Advanced Technologies: Use of cloud computing and AI to enhance multimedia applications and services.
ITU-T SG21 addresses digital health by developing ICT technical standards for multimedia systems that support health services. These include remote healthcare, telemedicine, safe listening, and technologies to enhance quality of life.

ISO/TC215
ISO/TC 215 Health Informatics is a technical committee within the International Organization for Standardization (ISO) dedicated to developing and maintaining international standards for health informatics to facilitate capture, interchange and use of health-related data, information, and knowledge to support and enable all aspects of the health system. The committee's scope includes electronic health records, interoperability, semantic content, pharmacy and medicines, patient summaries, genomics, AI, terminology and coding systems, health data privacy, safety and security, virtual care, traditional medicine, personalized health and more. ISO/TC 215 collaborates with international stakeholders, including governments, healthcare organizations, industry leaders, and other standards bodies, to advance digital health initiatives, improve patient outcomes, and promote the adoption of consistent and reliable health IT standards worldwide. Through its work, ISO/TC 215 also supports regulatory compliance, enhances clinical workflows, and fosters innovation in health informatics.

IEEE
IEEE Standards Association (IEEE SA) is a collaborative organization where innovators raise the world’s standards for technology. IEEE SA provides a globally open, consensus-building environment and platform that empowers people to work together in the development of leading-edge, market-relevant technology standards, and industry solutions shaping a better, safer and sustainable world. For more information, visit https://standards.ieee.org

GMDN Agency
The Global Medical Device Nomenclature (GMDN) is the leading nomenclature for the naming, defining and categorisation of medical devices. The system is used by regulators in almost 70 countries worldwide and has members in around 140 countries across the globe. GMDN supports global harmonisation of regulatory requirements, enabling safer and more effective patient care while fostering innovation and collaboration within the medical device industry. The GMDN Database consists of GMDN Terms. These are the individual names assigned to each medical device in the GMDN Database. There are currently around 25,000 active GMDN Terms, covering a wide range of medical devices. The GMDN is dynamic and designed to be flexible and adaptable to accommodate new and emerging technologies and is continually updated to reflect changes in the medical device landscape. The GMDN is a critical component of the medical device global regulatory infrastructure, with its use extending beyond this into supply chain management, inventory and purchasing and clinical use. The GMDN is a key component of unique device identification (UDI) and since 2013, is a mandatory requirement of the U.S FDA’s UDI Rule. The GMDN Terms for each UDI entry are publicly visible on the online AcessGUDID platform. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also embedded GMDN in its Public Access Registration Database (PARD) for enhanced medical device regulation. The GMDN is used as a data standard by the U.S. FDA and an NHS data standard in the U.K. Australia’s Therapeutic Goods Administration (TGA) has legally mandated the use of GMDN as a requirement for medical devices supplied in Australia, including IVDs and Health Canada has included GMDN in draft guidance published in 2023 for determining medical device applications. The GMDN Agency is the organisation responsible for the maintenance and management of the GMDN database. It is a registered UK charity and non-profit organisation. The GMDN Agency was established to provide health authorities and regulators, healthcare providers, manufacturers and other stakeholders with a system that allows an exchange of medical device information and supports patient safety.

The set of standards “International Patient Summary” has gained in accessibility through its dedicated website.

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