Unlocking the Power of IT Standards in Healthcare: Accessibility, Video Data, and Product Identification

In today’s rapidly evolving healthcare sector, the effective use of information technology is revolutionizing patient outcomes, data management, and operational efficiency. As health organizations increasingly turn to advanced digital tools and interconnected systems, a clear framework of international IT standards for health care technology is more critical than ever. In this guide, we explore four influential international standards that provide robust guidance for healthcare businesses intent on improving accessibility, data integrity, and system interoperability while unlocking productivity and security at scale.

Overview

Modern healthcare is undergoing a seismic shift, driven by digital transformation, the need for secure data exchange, and the imperative to improve accessibility and patient safety. The implementation of globally recognized standards is no longer a formality—it’s a linchpin for organizations looking to benefit from new technologies, comply with regulations, and future-proof their operations. This article covers:

• The necessity and impact of standards in health IT

• Core areas addressed: Accessibility, clinical video data, medicinal product identification, and ontological interoperability

• Actionable guidance for achieving compliance

• The business case for adopting these standards

By understanding and applying these international IT standards, organizations can avoid common pitfalls, speed up digital deployment, and create safer, more inclusive, and scalable digital health solutions.

Detailed Standards Coverage

ISO/IEC 29138-4:2026 – Applying User Accessibility Needs

Information technology — User interface accessibility — Part 4: Applying user accessibility needs

Implementing new digital health technologies means developing software and systems that everyone—patients, clinicians, and admin staff alike—can access and use confidently. ISO/IEC 29138-4:2026 provides essential guidance on how to apply comprehensive user accessibility needs (UANs) into the procurement, design, and evaluation of ICT products and services for healthcare.

This standard walks through applying UANs derived from the well-established ISO/IEC 29138-1, making them actionable during real-world healthcare IT development. The focus is on transforming general needs, like providing alternatives to visual information or accommodating diverse user abilities, into explicit system requirements. It also offers mechanisms for documenting and justifying accessibility decisions—vital for audit trails and regulatory reviews.

Key requirements covered include:

• Understanding context of use: Identifying who will use the system, in what environment, and for what tasks.

• Customizing accessibility needs: Adapting UANs to specific technologies and settings (e.g., hospitals, remote care portals).

• Evaluation and documentation: Verifying that systems meet accessibility requirements and keeping clear records for compliance.

• Procurement guidance: Ensuring suppliers provide evidence of accessibility features and fit-for-purpose products.

Practical implications extend from interface design for EHR systems to procurement of accessible patient self-service kiosks. By embedding UANs from project inception, teams can minimize costly retrofits, compliantly meet legal obligations, and open digital doors to every member of the healthcare community.

Key highlights:

• Ensures healthcare IT is accessible for users of all abilities

• Facilitates legal and regulatory compliance in digital accessibility

• Embeds accessibility review into ICT lifecycle

Access the full standard: View ISO/IEC 29138-4:2026 on iTeh Standards

ISO/TR 24936:2026 – Endoscopic Video and Related Clinical Information

Health informatics — Endoscopic video and related clinical information

Healthcare is capturing more live procedural data than ever, especially through modern endoscopic and laparoscopic devices. ISO/TR 24936:2026addresses the increasingly complex management and use of video data and associated clinical information generated during procedures.

This technical report outlines the data structures essential for:

• Storing, preserving, and transferring endoscopic procedural videos

• Attaching critical context information—like metadata about patient, clinician, treatment, and device details

• Supporting objective analysis, training, and research

With hospitals and device manufacturers engaging in cross-facility research, advanced device development, and AI-driven analysis, standardization in clinical video data management is a must. ISO/TR 24936:2026 clarifies how to align with other health IT standards such as DICOM and HL7 FHIR for video-linked data, ensuring reliable interoperability and secure patient privacy.

Who needs to comply? Any healthcare provider, research institution, or medtech company involved in the capture, analysis, or sharing of clinical video data—especially for robotics, teaching, and evidence retention.

Practical implementation means specifying file formats, metadata requirements, and privacy protections, ensuring all stakeholders—clinicians, device vendors, IT partners—can seamlessly participate in a secure, standards-compliant ecosystem.

Key highlights:

• Standardizes endoscopic and procedural video data structures

• Facilitates research, training, and evidence retention

• Ensures privacy, integrity, and interoperability with established health informatics standards

Access the full standard: View ISO/TR 24936:2026 on iTeh Standards

ISO/TS 20451:2026 – Implementation for ISO 11616 Data Elements: Unique Identification of Regulated Pharmaceutical Products

Health informatics — Identification of medicinal products — Implementation for ISO 11616 data elements and structures for the unique identification and exchange of regulated pharmaceutical product information

Safe and efficient management of regulated pharmaceutical products is the backbone of modern healthcare. ISO/TS 20451:2026 presents detailed requirements and recommendations for uniquely identifying pharmaceutical products, based on the globally harmonized Identification of Medicinal Products (IDMP) standards—especially ISO 11616, which focuses on the unique identification and specification of pharmaceutical products for global data exchange.

This technical specification supports companies and agencies in:

• Creating, managing, and exchanging compliant pharmaceutical product identifiers (PhPID)

• Capturing all necessary data elements: active substances, strengths, dose forms, package, and device components

• Aligning health IT systems with HL7, FHIR, and IDMP messaging for regulatory and supply chain communication

• Supporting authorities in tracing and verifying medicines across jurisdictions

Regulators, medicinal product manufacturers, and data custodians rely on this standard for consistent, interoperable product information—a critical enabler for safety recalls, pharmacovigilance, and global supply chain integrity.

Key highlights:

• Defines how to structure and exchange unique identifiers for pharmaceutical products

• Aligns medicinal product data for regulatory, clinical, and supply chain uses

• Integrates with HL7/FHIR messaging and global regulatory frameworks

Access the full standard: View ISO/TS 20451:2026 on iTeh Standards

ISO/TS 21405:2026 – Methodology and Framework for the Development and Representation of IDMP Ontology

Health informatics — Identification of medicinal products — Methodology and framework for the development and representation of IDMP ontology

To unlock the full benefits of digital health data, systems must not just exchange data, but understand and process it in uniform, semantically meaningful ways. ISO/TS 21405:2026 introduces a methodology and ontological framework to enable deep interoperability—making health, regulatory, and research data truly findable, accessible, interoperable, and reusable (FAIR).

This standard provides:

• Guidance for building standardized ontologies reflecting the full suite of IDMP standards (especially for substances, dose forms, and product identification)

• Methods for governance and collaborative development of ontologies in line with best practices

• Case studies showing regulatory, manufacturing, and healthcare domain interoperability

• Practical support for research, real-world evidence programs, and cross-border product traceability

The ontological approach enables smarter systems capable of auto-classification, detecting inconsistencies, supporting regulatory compliance, and facilitating innovation—from efficient recalls to AI-driven data analytics.

Key highlights:

• Outlines best practices for developing interoperable ontologies for medicinal products

• Supports global, cross-jurisdictional harmonization and compliance

• Fosters advanced digital health research through semantic interoperability

Access the full standard: View ISO/TS 21405:2026 on iTeh Standards

Industry Impact & Compliance

The adoption of these standards directly impacts business productivity, regulatory positioning, and the capacity to scale new digital health technologies.

Implications for organizations:

• Productivity: Standardized processes reduce the complexity of integrating new health IT tools, speed up deployment, and minimize duplicate effort. Accessible systems widen user adoption and workforce inclusion.

• Security & Privacy: Clear protocols for health data, especially video and medicinal product data, ensure patient safety and regulatory compliance (GDPR, HIPAA, etc.).

• Scalability: Machine-readable ontologies and harmonized data formats support future tech developments, including AI, remote monitoring, and cross-border care.

Risks of non-compliance:

• Regulatory penalties and loss of market access

• Patient safety incidents due to data errors or exclusion

• Increased cost from retrofitting systems for accessibility or data exchange

Benefits of compliance:

• Enhanced patient trust and inclusion

• Streamlined operations and reduced risk

• Competitive advantage and future-proofing in a dynamic market

Implementation Guidance

Adopting these standards starts with recognizing their value and embedding them throughout your organization’s workflow, from procurement to post-market monitoring.

Best practices:

1. Educate teams: Ensure technical, procurement, and design teams understand core requirements and the value of compliance.

2. Integrate early: Embed requirements into project planning, procurement documentation, and vendor contracts.

3. Use standardized tools: Leverage open-source or industry-recognized tools for accessibility evaluation, metadata tagging, and IDMP data handling.

4. Document thoroughly: Maintain clear records for procurement decisions, accessibility adaptations, and data management processes.

5. Continuously review: Regularly assess systems for ongoing compliance, especially as regulations and user needs evolve.

6. Leverage community: Participate in standards bodies, user groups, and regulatory workshops to stay ahead of updates and best practices.

Resources:

• iTeh Standards knowledge base for access to authoritative standards and updates

• ISO/IEC 29138-1 and ISO 11616 for foundational guidance

• HL7, DICOM, FHIR documentation for messaging and data structuring interoperability

Conclusion / Next Steps

Effective integration of IT standards in healthcare technology is a strategic imperative for organizations seeking innovation, compliance, and superior patient outcomes. By adopting the guidance from these four international standards, your organization not only safeguards its operations but also gains the flexibility and trust needed to thrive in the digital era.

Recommendations:

• Review current systems and workflows for alignment with these standards

• Form multidisciplinary teams to drive adoption and training

• Explore the full texts of each standard to inform procurement, development, and operational decisions

• Stay connected with standards updates and regulatory shifts via iTeh Standards

Empower your organization to lead in digital health by making international standards part of your competitive advantage—delivering accessible, secure, and future-ready healthcare IT for all.