Key Standards for IT Applications in Health Care Technology: Boosting Security, Interoperability, and Productivity

Digital transformation is reshaping the health care industry, where advances in information technology are empowering care providers to deliver safer, more efficient, and patient-centered services. Modern health care IT solutions rely on robust technical foundations—defined through international standards—for seamless interoperability, data security, and scalable operations. In this article, we present a comprehensive overview of four pivotal international standards in the domain of IT applications in health care technology. These standards are essential for businesses and organizations aiming to maximize productivity, ensure compliance, and build scalable, future-proof solutions in the dynamic world of digital health.

Overview / Introduction

Health care today is inseparable from technology. From electronic health records (EHR) to cross-border patient data exchange and personalized health guidance, health IT systems have evolved to require global interoperability, stringent data security, and coordinated care delivery. International standards play a critical role in this evolution, providing the technical language, requirements, and best practices for designing, deploying, and updating health IT systems.

By adopting and implementing these standards, health care organizations can achieve:

• Enhanced interoperability between systems—locally and internationally
• Better protection and privacy of sensitive health information
• Streamlined regulatory and compliance processes
• Increased operational efficiency and scalability
• Improved data quality and clinical outcomes

In this article, we demystify four of the most essential standards shaping IT in health care: the HL7 Electronic Health Records-System Functional Model (EN ISO 10781:2025), the Identification of Medicinal Products data standards (EN ISO 11239:2023), the International Patient Summary core data set (EN ISO 27269:2022), and the specifications for Personal Health Decision Support Service Interoperability (prEN ISO 20737).

Each section explains what the standard covers, its practical implications, and how its implementation benefits health care organizations, patients, and IT ecosystems alike.

Detailed Standards Coverage

EN ISO 10781:2025 - HL7 Electronic Health Records-System Functional Model

Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2.1 (EHR FM) (ISO 10781:2023)

The EN ISO 10781:2025 standard defines the functional framework for Electronic Health Record Systems (EHR-S). It provides a comprehensive, user-centric reference list of functions that an EHR system may support. This list is structured to foster consistency in system design, functional expression, and interoperability across diverse care settings—from hospitals and specialized outpatient clinics to primary care centers globally.

At the core, the standard establishes the HL7 Electronic Health Records-System Functional Model (EHR FM), organizing EHR requirements into functional profiles tailored for various domains, such as intensive care or cardiology. Each function is described from a user perspective, ensuring clarity for clinical and administrative stakeholders, not just IT experts.

Implementing this standard ensures EHR systems:

• Align with internationally recognized best practices
• Facilitate system certification and conformance testing
• Enable seamless health information exchange between different IT systems and care settings

The standard incorporates:

• Structured function lists, including identifiers, types, statements, and conformance criteria
• Rules for developing, extending, and deriving functional profiles for specific care environments
• Updated security requirements and record lifecycle event management (including new events such as verify, encrypt, and decrypt)
• Support for integration with modern data models like FHIR, DCMs, and HL7 templates

Health IT vendors, system developers, policy makers, and healthcare providers can leverage EN ISO 10781:2025 to build and procure systems with high assurance of quality, safety, and future interoperability.

Key highlights:

• User-focused functional requirements for EHR systems
• Foundations for interoperability and functional certification
• Detailed conformance models for scalability and customization

Access the full standard:View EN ISO 10781:2025 on iTeh Standards

EN ISO 11239:2023 - Identification of Medicinal Products Data Elements

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration, and packaging (ISO 11239:2023)

EN ISO 11239:2023 standardizes the data elements and structures necessary to uniquely identify and electronically exchange critical information about medicinal products. Covering pharmaceutical dose forms, units of presentation, routes of administration, and packaging, it is one of the central components of the IDMP (Identification of Medicinal Products) standards family.

This standard responds to the global need for harmonized medicinal product data, making it indispensable for regulatory authorities, pharmaceutical companies, health IT system developers, and stakeholders involved in medicine registration and pharmacovigilance.

The standard specifies:

• Core data elements and structures for unique product identification
• Mechanisms for associating translations of medical concepts to support multilingual environments
• Concept versioning for lifecycle tracking and regulatory updates
• Harmonized mapping rules, allowing local and regional terminologies to be linked to global data standards

Adopting EN ISO 11239:2023 enables accurate identification and traceability of medicinal products in electronic health records, e-prescribing, pharmacy systems, and cross-border health data exchange. It plays a critical role in ensuring patient safety, effective medication reconciliation, and harmonized regulatory reporting.

Key highlights:

• Unique, standardized data for pharmaceutical product identification
• Support for multilingual data exchange and updates
• Essential for regulatory compliance and safe health IT integration

Access the full standard:View EN ISO 11239:2023 on iTeh Standards

EN ISO 27269:2022 - International Patient Summary

Health informatics - International patient summary (ISO 27269:2021)

EN ISO 27269:2022 defines the globally applicable minimal core data set for creating an International Patient Summary (IPS) document. The IPS supports the continuity and coordination of care for individuals, especially in situations involving cross-border or unplanned care.

The standard provides a robust, well-defined specification for the data items included in a patient summary, following European guidelines and integrating lessons from global patient summary projects. It offers an abstract model—meaning it specifies what information must be included, not how it is encoded or exchanged in a technical sense.

EN ISO 27269:2022 covers:

• Patient attributes and healthcare provider information
• Allergy and intolerance data
• History of medical problems, procedures, pregnancies
• Medication summaries (linked with IDMP standards)
• Immunizations and medical device information
• Vital signs, results, social history, and plans of care

By adopting this standard, health IT systems, cross-border health services, and national programs can provide clinicians with instant, reliable access to a patient’s essential health information—no matter where, or in what system, it originated.

Key highlights:

• Minimal but comprehensive core data set for international patient summaries
• Enables safe, coordinated, cross-border medical care
• Facilitates interoperability for unplanned and planned clinical scenarios

Access the full standard:View EN ISO 27269:2022 on iTeh Standards

prEN ISO 20737 - Interoperability of Personal Health Decision Support Services

Health informatics - Interoperability of personal health decision support services (ISO/DIS 20737:2025)

prEN ISO 20737 is a forthcoming international standard that defines requirements for making personal health decision support (PHDS) services interoperable. PHDS encompasses digital systems that provide health recommendations, guidance, or alerts tailored to individuals based on their personal health data—supporting self-care, remote monitoring, chronic disease management, and preventive health.

This standard does not define the inner workings of PHDS solutions, but focuses on how these services interact with one another, with data providers (like electronic health records, apps, and devices), and with clients (interfaces delivering guidance to users).

prEN ISO 20737 covers:

• Specifications for the exchange, validation, and processing of health data between PHDS actors
• Requirements for secure and consent-driven data flow
• Mechanisms for semantic data mapping, robust error handling, and audit logging
• Strict privacy and security controls, including encryption and consent management
• Guidelines for multi-endpoint architectures and real-time or near real-time data transmission

PHDS service vendors, digital health innovators, and care providers implementing these requirements can ensure their solutions are interoperable, secure, and trustworthy—helping patients, caregivers, and clinicians confidently adopt digital health tools at scale.

Key highlights:

• Interoperability requirements covering service, data provider, and client roles
• Emphasis on privacy, security, and user consent
• Foundation for trusted, scalable personal health decision support ecosystems

Access the full standard:View prEN ISO 20737 on iTeh Standards

Industry Impact & Compliance

The adoption of international standards in health care IT is a strategic imperative for organizations striving for excellence, compliance, and sustainability. Implementing standards such as EN ISO 10781, EN ISO 11239, EN ISO 27269, and prEN ISO 20737 delivers practical—and often mandatory—business benefits:

Business Efficiency and Productivity

• Standardized IT frameworks improve work processes, speed up system integration, and reduce duplication
• Ready-to-use functional profiles (EHR functions, medication coding, etc.) cut development and onboarding times
• Enhanced data quality and structure enable advanced analytics, improving population health and service planning

Data Security and Patient Privacy

• Built-in conformance models and lifecycle event tracking (e.g., for records) enable hospitals and clinics to meet regulatory requirements (such as GDPR)
• Requirements for consent, encryption, audit logging, and access control foster patient trust and reduce risk of data breaches

Scalability and Interoperability

• Interoperable standards make it easier to scale operations across regions, systems, and providers
• Harmonized data structures support cross-border health initiatives and participation in global health networks

Regulatory and Competitive Advantages

• Certification and demonstrable compliance with international standards improve access to global markets and supply chains
• Aligning with best practices minimizes risk of penalties, downtime, and reputational harm

Not following these standards can expose organizations to legal risks, system fragmentation, higher IT costs, and diminished patient trust.

Implementation Guidance

Adopting these health informatics standards is a multifaceted project, but organizations can succeed by taking a phased and structured approach.

Common Implementation Approaches

1. Gap Assessment: Conduct a thorough review of current systems against standard requirements (EHR features, data flows, coding structures, security controls, etc.)
2. Stakeholder Engagement: Involve IT specialists, clinicians, data stewards, and compliance managers from the outset
3. Profile Customization: Choose or adapt functional profiles and data sets suited to local and clinical needs
4. System Integration: Ensure new and legacy systems are standardized—to support interoperability, data mapping, and secure information flow
5. Testing and Verification: Leverage certification, self-attestation, and conformance testing tools to validate compliance
6. Continuous Improvement: Update systems and processes as standards evolve and new releases become available

Best Practices

• Leverage provider and vendor expertise—select partners experienced with international standards
• Invest in training and change management—ensure smooth adoption across clinical and technical teams
• Iterate and pilot before scaling—start with small-scale deployments to validate approach
• Monitor for updates and engage with standards bodies—standards evolve in response to technology and policy

Resources

Organizations can access full-text standards, technical specifications, and support materials through authoritative platforms such as iTeh Standards and national/regional health informatics committees. Implementation guides, case studies, and best practice documents can further accelerate adoption.

Conclusion / Next Steps

The digital future of health care is here, and it is being built on the foundations provided by robust, international standards. IT applications in health care technology—from secure electronic health records and interoperable medication data to cross-border patient summaries and personal decision support services—rely on these standards for security, scalability, and quality.

Organizations that invest in compliance with EN ISO 10781, EN ISO 11239, EN ISO 27269, and prEN ISO 20737 are positioning themselves at the forefront of eHealth innovation, regulatory readiness, and business resilience. By embedding these frameworks into their IT strategy, health care providers and technology vendors can:

• Safeguard patient data and trust
• Enhance care coordination and outcomes
• Access new markets and streamline compliance
• Build scalable, future-ready digital health solutions

Explore the detailed requirements and implementation resources for these standards today, and unlock a new era of collaborative, secure, and high-performing health care IT.

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