January 2026: Major Standards in Information Technology for Health, Devices, and Biometrics

January 2026 brings significant developments in Information Technology and Office Equipment standards, impacting healthcare interoperability, medical device communication, biometric identity verification, and the management of real-world health data. This authoritative update details four newly published international standards that will shape best practices, regulatory compliance, and technological innovation in healthcare IT and personal health devices.

These standards provide essential frameworks for interoperability, data quality, device specialization, and identity assurance—empowering organizations to improve efficiency, protect patient data, and meet emerging regulatory requirements.

Overview

The Information Technology and Office Equipment sector is rapidly evolving, with a surge in demand for robust standards that ensure security, interoperability, and high-quality management of health-related data. The standards covered in this January 2026 update target critical domains including:

• Communication protocols and models for personal health devices (PHDs)
• Specialized device interoperability for respiratory monitoring
• Frameworks for cloud-based and remote biometric identity verification
• Quality management processes for real-world health data across multiple medical sites

Industry professionals, engineers, procurement specialists, and compliance managers will gain vital insight into the requirements, use cases, and benefits of these latest publications—each designed to address emerging trends, support digital health transformation, and reduce risks in clinical and remote care environments.

Detailed Standards Coverage

EN ISO/IEEE 11073-10206:2026 – Abstract Information Model for Personal Health Devices

Health informatics – Device interoperability – Part 10206: Personal health device communication – Abstract content information model (ISO/IEEE 11073-10206:2024)

This international standard defines the abstract, object-oriented content model for personal health devices (PHDs) and the health observations they generate. By leveraging Unified Modeling Language (UML) and adopting IEEE 11073-10101™ nomenclature, it specifies the structure, relationships, and semantic integrity of health measurement data without addressing the exchange protocols themselves.

Scope and Key Requirements:

• Describes a flexible, object-oriented model for PHD data, supporting diverse measurement types and device contexts
• Ensures that information captured and exchanged maintains its complete semantic meaning—critical for clinical accuracy and interoperability
• Includes tables detailing attributes, objects, and standard terminology used across health informatics systems
• Intended for device manufacturers, software developers, EHR integrators, and those validating data lossless exchange
• Does not cover security frameworks—but offers foundations for interoperability and validation

Practical Implementation:

• Facilitates robust data modeling between PHDs and clinical information systems, ensuring consistent interpretation across platforms
• Guides protocol designers in building exchange protocols that maintain full clinical content integrity
• Streamlines conformance and reduces integration errors in complex healthcare networks

Key highlights:

• Roles for UML-based object structures in semantic interoperability
• Clear mapping to IEEE clinical content nomenclature
• Standardizes how PHD observations are represented and validated prior to exchange

Access the full standard:View EN ISO/IEEE 11073-10206:2026 on iTeh Standards

EN ISO/IEEE 11073-10421:2026 – Interoperability for Peak Expiratory Flow Monitors

Health informatics – Device interoperability – Part 10421: Personal health device communication – Device specialization – Peak expiratory flow monitor (peak flow) (ISO/IEEE 11073-10421:2024)

This standard establishes normative definitions and communication protocols for peak expiratory flow monitors in personal telehealth. It specifies how data is communicated between peak flow devices (e.g., for asthma management) and managers such as smartphones, computers, or telehealth systems.

Scope and Key Requirements:

• Covers plug-and-play interoperability between PHD peak flow monitors (agents) and management systems (managers)
• Restricts optionality in underlying frameworks, prioritizing true interoperability and consistent behavior
• Supports only personal, episodic respiratory monitoring (hospital-grade continuous monitoring is out of scope)
• Specifies code usage, profiles, and communication behaviors, referencing ISO/IEEE 11073-20601 and 11703-20601 standards
• Updated for 2026 to improve time support, configuration, normative references, device extensibility, and examples for implementers

Industry Use and Compliance:

• Relevant for device manufacturers, clinicians, and telehealth providers managing respiratory conditions such as asthma and COPD
• Facilitates timely sharing of patient health status and remote clinician intervention, reducing acute care incidents
• Enables integration with central repositories, supporting proactive clinical review and improved patient outcomes

Key highlights:

• Communication profiles for episodic respiratory monitoring
• Defined terminology, profiles, and data formats for plug-and-play operation
• Notable 2026 technical updates for increased use-case support

Access the full standard:View EN ISO/IEEE 11073-10421:2026 on iTeh Standards

ISO/IEC 30108-1:2026 – Biometric Identity Attributes Verification Services (IAVS)

Biometrics — Identity attributes verification services — Part 1: IAVS services

This foundational biometrics standard details the architecture and services required for verifying identity attributes remotely, across service-based and cloud platforms. It establishes a set of interoperable services for managing and verifying identity attributes—incorporating biometrics, biographic information, and document data.

Scope and Key Requirements:

• Provides the IAVS system context, specifying how biometric and identity verification services operate over remote interfaces
• Defines primitive and aggregated service operations for adding, checking, classifying, and verifying biometric/biographic/document data
• Focuses solely on backend (remote) service provision—client-side biometric capture is outside its coverage
• Supports integration with additional authentication services via other parts of the 30108 series
• Specifies conformance requirements, XML schema, error handling, and security guidance
• Technically revised for 2026: adoption of IAVS naming (replacing BIAS), updated encounter models and interface definitions, streamlined fusion identity approach

Industry and Regulatory Application:

• Applicable to biometric service providers, security integrators, identity management solutions, and government authentication portals
• Enhances interoperability across platforms for secure access, e-government, smart card, and remote onboarding programs
• Supports compliance with data security and privacy frameworks during identity assurance

Key highlights:

• Service-oriented architecture for biometric and document verification
• Robust error handling, data definition, and capability interfaces
• 2026 updates clarify encounters, capabilities, and namespacing for integrators

Access the full standard:View ISO/IEC 30108-1:2026 on iTeh Standards

ISO/TR 18727:2026 – Real-World Health Data Quality Management Case Study

Health informatics — Quality management of health data in the real world — Case study

This technical report presents a comprehensive case study on implementing quality management for medical data integration across multiple sites, with a focus on real-world health data (RWD). Drawing from Japan’s MID-NET® Project, it details processes for standardization, hierarchical data storage, code mapping, and validation.

Scope and Key Lessons:

• Outlines a practical quality management process for integrating and standardizing EHR and EMR data across clinical sites
• Details data mapping, harmonization using standard codes (department, disease, drugs, labs, bacteriology), and continuous validation
• Demonstrates reduction of time and cost, improved data reliability, and scalable implementation across countries/regions
• Excludes privacy protection and network security, focusing on data and process reliability

Stakeholders and Best Practices:

• Project owners: regulatory bodies, pharma, research organizations, and healthcare providers
• Roles for EMR/LIS vendors, standard code developers, and governance centers
• Practical tools: real-time validation, syntax verification, and mapping tables
• Recommends governance independence for unbiased quality assurance

Key highlights:

• Practical, technology-agnostic approach to real-world data quality
• Standardization with mapping/local code conversion for harmonized data exchange
• Ready-to-adopt example for global health and clinical data integration projects

Access the full standard:View ISO/TR 18727:2026 on iTeh Standards

Industry Impact & Compliance

Adoption of these January 2026 standards offers organizations multiple benefits—driving interoperability, reliability, and security in the Information Technology and Office Equipment domain:

• Device manufacturers gain prescriptive guidance for building interoperable, future-ready medical and biometric devices
• Health providers and IT vendors reduce integration complexity and minimize data loss, ensuring patient measurements and biometrics preserve their meaning and accuracy
• Health data managers and researchers enjoy improved data quality and cross-site reliability, essential for evidence-based decisions and research
• Compliance officers can align with evolving regulatory demands for device interoperability, health data quality management, and secure identity verification services

Compliance Considerations:

• Evaluate your current platforms and systems against new modeling and service definitions
• Plan for conformance, including data mapping, protocol validation, and structured quality governance
• Factor in transition timelines and inform procurement, engineering, and IT teams of updated requirements early

Benefits of Adoption:

• Increased system interoperability and reduced total cost of ownership
• Enhanced patient safety and data integrity
• Readiness for new telehealth and digital health delivery models
• Reduced risk of regulatory fines or product re-work due to non-compliance

Technical Insights

Common Requirements Across Standards

• Semantic interoperability: Each standard stresses maintaining the semantics of health, identity, or device data throughout storage and transmission
• Unified modeling: Use of UML, XML schemas, and mapping tables ensures data is both machine-readable and easily translatable across systems
• Standard code usage: Code mapping and terminologies—whether for clinical content or health department names—are required for cross-organizational data exchange

Implementation and Best Practices

• Early integration planning: Map out touchpoints for standard adoption in electronic health record systems, device firmware, and backend verification services
• Testing and certification: Use conformance requirements and test cases detailed in the standards as a baseline for product/system certification
• Quality governance: Follow external, independent governance models (as highlighted in the MID-NET® case study) to enhance data quality and organizational trust
• Secure interoperability: While some standards do not provide security frameworks, ensure implementation is paired with security best practices and privacy regulations

Conclusion & Next Steps

Key Takeaways:

• The January 2026 standards deliver essential blueprints for health device communication, biometric service deployment, and real-world health data quality
• They promote interoperability, accuracy, and scalable integration—directly supporting global health IT transformation
• Applying these standards helps your organization stay compliant, competitive, and future-ready in an increasingly regulated and interconnected world

Recommendations:

1. Review each standard’s scope and relevance to your business or technical context
2. Strategically plan system or device updates to ensure full compliance and benefit realization
3. Assign responsibility within your organization for continual monitoring of international standards impacting your field
4. Stay engaged with iTeh Standards for the latest publications, implementation guides, and compliance tools

Explore these and the complete portfolio of Information Technology and Office Equipment standards at iTeh Standards. Stay informed to maintain compliance and drive innovation in your sector.