FUNCTIONAL

32+1 ISO/TC 215 HEALTH INFORMATICS STANDARDS ADOPTED IN 2019

 INTEROPERABILITY STANDARDS; TEN (10)

1. ISO/TR 17119: 2015 Health Informatics. Health Informatics profiling framework.

2. ISO/TR 14639-1: 2012 Health Informatics. Capacity based eHealth architecture roadmap.

Part1. Overview of National eHealth Initiatives.

3. ISO/TR 14539-2: 2014 Health Informatics. Part 2. Architectural components and maturity

model

4. ISO/TS 13131: 2014 Health Informatics. Telehealth services. Quality planning guidelines.

5. ISO/TS 17522: 2015 Health Informatics. Provision for health application on mobile /smart

devices

6. ISO 82308: 2011 Health Informatics. Requirements for an electronic health record

architecture.

7. ISO 27789: 2013 Health Informatics. Audit trails for electronic health records.

8. ISO/TR 17975: 2015 Health Informatics. Principle and data requirements for consent in the

collection use or disclosure of personal health information

9. ISO/TR 17791: 2013 Health Informatics. Guidance on standards for enabling safety in health

software.

10. IEC 82304 – 1: 2016 Health Software. Part 1. General requirements for product safety.

TECHNICAL INTEROPERABILITY STANDARDS; Sixteen (16)

1. ISO/TS 14441: 2013 Health Informatics. Security and privacy requirement of HER systems for

use in conformity assessment.

2. ISO 13606-1: 2008 Health Informatics. Electronic Health Record communication. Part 1.

Reference Model.

3. ISO 13606-2: 2008 Health Informatics. Part 2. Archetype interchange specification.

4. ISO 13606-5: 2010 Health Informatics. Part 5. Interface specification.

5. ISO/TR 11636: 2009 Health Informatics. Dynamic on demand virtual private network for

health information infrastructure.

6. ISO 17090-1: 2013 Health Informatics. Public key infrastructure. Part 1. Overview of digital

certificate service.

7. ISO 17090-2: 2015 Health Informatics. Public Key Infrastructure. Part 2. Certificate Profile.

8. ISO 17090-3: 2008 Health Informatics. Public Key Infrastructure Part 3. Policy management

of certification authority.

9. ISO/TR 16056-1: 2004 Health Informatics. Interoperability of telehealth systems and

networks. Part 1. Introduction and definitions.

10. ISO/TR 18307: 2001 Health Informatics. Interoperability and compatibility in messaging and

communication standards. Key Characteristics.

11. ISO/TR 18638: 2017 Health Informatics. Guidance on health informatics privacy education in

healthcare organisation.

12. ISO/TS 21547: 2010 Health Informatics. Security requirement for archiving of electronic

health records. Principles.

13. ISO/TR 21548: 2010 Health Informatics. Security requirement for archiving of electronic

health records. Guidelines.

14. ISO 27799: 2016 Health Informatics. Information security management in health using

ISO/IEC 27002.

15. ISO 25237: 2017 Health Informatics. Pseudonymization.

16. ISO/TR 16056-2; 2004 Health Informatics. Interoperability telehealth systems and networks.

Part 2. Real Time Systems. (Modified Adoption)

SEMANTIC INTEROPERABILITY (CONTENT) STANDARDS; SIX (6)

1. ISO 17523: 2016 Health Informatics. Requirements for Electronics Prescriptions.

2. ISO/TR 12300: 2014 Health Informatics. Principles of mapping between terminological

Systems.

3. ISO/TR 12310: 2015 Health Informatics. Principles and Guidelines for the measurement of

conformance in implementation of terminological systems.

4. ISO/TR 20514: 2015 Health Informatics. Electronic Health Records. Definitions, Scope and

Context.

5. ISO/TR 13972: 2015 Health Informatics. Detailed Clinical Models. Characteristics and

Processes.

6. ISO/TS Health Informatics. Development of terms and definitions for health informatics

glossaries.