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ISO TC 215 on Health Informatics Develops International Standard on Interoperability of Public Health Emergency Preparedness and Response Information Systems


ANSI Serves as ISO TC 215 Secretariat

In an effort to assure better preparedness for national and international public health emergencies, the International Organization for Standardization (ISO) Technical Committee (TC) 215, Health Informatics, has developed a newly released standard that provides business requirements, terminology, and vocabulary for public health emergency preparedness and response (PH EPR) information systems. The standard is applicable to emergencies that encompass emerging pathogens, including COVID-19, chemical and nuclear accidents, environmental disasters, criminal acts, and bioterrorism.

The international standard, ISO 5477:2023, is relevant to policy makers, regulators, project planners, and management of PH EPR information systems, PH EPR data analysts, and informaticians, and may also be of interest to stakeholders including incident managers, PH educators, standards developers, and academia.

The American National Standards Institute (ANSI), the U.S. member body to ISO, currently serves as the ISO/TC 215 secretariat and U.S. Technical Advisory Group (TAG) Administrator.

About International Standard ISO 5477

Information that drives a decision-making process is the most critical asset during all phases of PH emergencies. To that end, PH EPR information systems play a critical role in fulfilling major PH emergency response functions, including plans and procedures; physical infrastructure; information and communication technology (ICT) infrastructure; information systems and standards; and human resources.

The standard sets forth business rules for PH EPR information systems, and includes an informative framework for mapping existing semantic interoperability standards for emergency preparedness and response to PH EPR information systems. The document, which included input from 34 nations, was developed based on concepts and methodology described in:

  • The World Health Organization (WHO) Framework for a Public Health Operations Centre and Supporting WHO Handbooks A and C
  • ISO/IEC 25012, Software engineering: Software product Quality Requirements and Evaluation (SQuaRE)
  • ISO 30401, Knowledge management systems requirements
  • ISO 13054, Knowledge management of health information standards
  • ISO 22300, Security and resilience vocabulary
  • ISO 22320, Security and resilience emergency management guidelines for incident management
  • ISO 1087, Terminology work and terminology science

“This standard is designed to engage all global stakeholders involved in responding to public health emergencies. It fosters collaboration among participants committed to advancing the Global Health Security Agenda through enhanced information exchange,” said Dr. Nikolay Lipskiy, health scientist, Centers for Disease Control and Prevention (CDC), and project leader. “Our primary objective is to reduce barriers to information interoperability, thus improving critical data timeliness and usability. We anticipate that this pioneering standard will pave the way for additional documents focusing on more specific aspects in the near future.”

“It is crucial to acknowledge the invaluable contributions of the participants in our standard development team, with special recognition to the Federal Electronic Health Record Modernization (FEHRM) office,” added Dr. Lipskiy. “Their dedicated efforts have significantly elevated the quality and impact of this standard, demonstrating a collective commitment to advancing global public health infrastructure.”

About the U.S. TAG to ISO/TC 215, Health Informatics

The U.S. TAG to ISO TC 215, Health Informatics, represents national interests on health information technology (HIT) and health informatics standards at ISO. ANSI administers the U.S. TAG to ISO TC 215 to coordinate national standards activities for existing and emerging health sectors. The U.S. TAG is guided by the ANSI cardinal principles of consensus, due process, and openness.

The scope of ISO TC 215, and consequently of the U.S. TAG, is standardization in the field of 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.

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