ISO, the International Organization for Standardization, is an independent, non-governmental organization, the members of which are the standards organizations of the 163 member countries. It is the world's largest developer of voluntary international standards and facilitates world trade by providing common standards between nations. Over twenty thousand standards have been set covering everything from manufactured products and technology to food safety, agriculture and healthcare.
The Government of India has created a statutory organization as the national standards body which was named as the Bureau of Indian Standards (BIS), with adequate autonomy as well as flexibility in its operations to achieve harmonious development of the activities of standardization, certification marking and connected matters. BIS is a founder member of International Organisation for Standardization (ISO).
Following are the ISO standards notified in the EHR Standards for India 2016 by Ministry of Health & Family Welfare (MoHFW), Government of India -
- ISO 18308:2011 Health Informatics - Requirements for an Electronic Health Record Architecture
- ISO 13606 Health informatics - Electronic Health Record Communication
- ISO/TS 14441:2013 Health Informatics - Security & Privacy Requirements of EHR Systems for Use in Conformity Assessment
- ISO/TS 22220:2011 Health Informatics - Identification of Subjects of Health Care
- ISO/HL7 10781:2015 Health Informatics - HL7 Electronic Health Records-System Functional Model
- ISO 13940 Health informatics - System of Concepts to Support Continuity of Care
- ISO/IEC 14496 - Coding of Audio-Visual Objects
- ISO 19005-2 Document Management - Electronic Document File Format for Long-Term Preservation
- ISO TC 215 set of standards
- ISO/DIS 27799 Health informatics - Information Security Management in Health using ISO/IEC 27002
- ISO 22600:2014 Health informatics - Privilege Management and Access Control
- ISO 27789:2013 Health informatics - Audit trails for Electronic Health Records
- ISO 17090 Health informatics - Public Key Infrastructure