| S. No. | Type | Standard Name | Intended Purpose No. |
|---|---|---|---|
| 1 | Identification & Complete Demographics | ISO/TS 22220:2011 Health Informatics – Identification of Subjects of Health Care | Basic identity details of patient |
| 2 | MDDS – Demographic (Person Identification and Land Region Codification) version 1.1 | Complete demographic for interoperability with E-Governance systems | |
| 3 | Patient Identifiers | UIDAI Aadhaar | Preferable identifier where available |
| 4 | Local Identifier | Identifier given within institution / clinic / lab | |
| 5 | Government Issued Photo Identity Card Number | Identifier used in conjunction with local in absence of Aadhaar | |
| 6 | Architecture Requirements | ISO 18308:2011 Health Informatics – Requirements for an Electronic Health Record Architecture | System architectural requirements |
| 7 | Functional Requirements | ISO/HL7 10781:2015 Health Informatics - HL7 Electronic Health Records-System Functional Model Release 2 (EHR FM) | System functional requirements |
| 8 | Reference Model and Composition | ISO 13940 Health informatics - System of Concepts to Support Continuity of Care | Concepts for care, actors, activities, processes, etc. |
| 9 | ISO 13606 Health informatics - Electronic Health Record Communication (Part 1 through 3) | Information model architecture and communication | |
| 10 | openEHR Foundation Models Release 1.0.2 | Structural definition and composition | |
| 11 | Terminology | SNOMED Clinical Terms (SNOMED CT) | Primary terminology |
| 12 | Coding System | Logical Observation Identifiers Names and Codes (LOINC) | Test, measurement, observations |
| 13 | WHO Family of International Classifications (WHO-FIC) including ICD, ICF, ICHI, ICD-O | Classification and reporting | |
| 14 | Imaging | Digital Imaging and Communications in Medicine (DICOM) PS3.0-2015 | Image, waveform, audio/video |
| 15 | Scanned or Captured Records | JPEG lossy (or lossless) with size and resolution not less than 1024px x 768px at 300dpi | Image capture format |
| 16 | ISO/IEC 14496 - Coding of Audio-Visual Objects | Audio/Video capture format | |
| 17 | ISO 19005-2 Document Management - Electronic Document File Format for Long-Term Preservation -Part 2: Use of ISO 32000-1 (PDF/A-2) | Scanned documents format | |
| 18 | Data Exchange | ANSI/HL7 V2.8.2-2015 HL7 Standard Version 2.8.2 -An Application Protocol for Electronic Data Exchange in Healthcare Environments | Event/Message exchange |
| 19 | ASTM/HL7 CCD Release 1 (basis standard ISO/HL727932:2009) | Summary Records exchange | |
| 20 | ISO 13606-5:2010 Health informatics - Electronic Health Record Communication - Part 5: Interface Specification | EHR archetypes exchange [Also, refer to openEHR Service Model specification] | |
| 21 | DICOM PS3.0-2015 (using DIMSE services & Part-10 media/files) | Imaging/Waveform Exchange | |
| 22 | Other Relevant Standards | Bureau of Indian Standards and its MHD-17 Committee | Standards Development Organizations (SDOs) |
| 23 | ISO TC 215 set of standards | ||
| 24 | IEEE/NEMA/CE standards for physical systems and interfaces | ||
| 25 | Discharge/Treatment Summary | Medical Council of India (MCI) under regulation 3.1 of Ethics | Composition as prescribed |
| 26 | E-Prescription | Pharmacy Practice Regulations, 2015 Notification No. 14-148/ 2012- PCI as specified by Pharmacy Council of India | Composition as prescribed |
| 27 | Personal Healthcare and medical Device Interface | IEEE 11073 health informatics standards and related ISO standards for medical devices | Device interfacing |
| 28 | Data Privacy and Security | ISO/TS 14441:2013 Health Informatics – Security & Privacy Requirements of EHR Systems for Use in Conformity Assessment | Basis security and privacy requirements |
| 29 | Information Security Management | ISO/DIS 27799 Health informatics - Information Security Management in Health using ISO/IEC 27002 | Overall information security management |
| 30 | Privilege Management and Access Control | ISO 22600:2014 Health informatics - Privilege Access control and Access Management and Access Control (Part 1 through 3) | Access control |
| 31 | Audit Trail and Logs | ISO 27789:2013 Health informatics - Audit trails for Electronic Health Records | Audit trail |
| 32 | Data Integrity | Secure Hash Algorithm (SHA) used must be SHA-256 or higher Data Hashing | |
| 33 | Data Encryption | Minimum 256-bits key length | Encryption key |
| 34 | HTTPS, SSL v3.0, and TLS v1.2 | Encrypted connection | |
| 35 | Digital Certificate | ISO 17090 Health informatics - Public Key Infrastructure (Part 1 through 5) | Digital certificates use and management |
The following list is indicative and representative and not comprehensive or definitive. These standards are advised to be used where applicable and as required.
| S. No | Standard | Description |
|---|---|---|
| 1 | ISO 12967:2009 | Health Informatics - Service Architecture (Parts 1 - 3) |
| 2 | ISO 13972:2015 | Health Informatics - Detailed Clinical Models, Characteristics and 2 ISO 13972:2015 Processes |
| 3 | ISO 20301:2014 | Health Informatics - Health Cards - General Characteristics |
| 4 | ISO 21090:2011 | Health Informatics - Harmonized Data Types for Information 4 ISO 21090:2011 Interchange |
| 5 | ISO 8601:2004 | Data elements and Interchange Formats - Information Interchange - 5 ISO 8601:2004 Representation of Dates and Times |
| 6 | ISO 13119:2012 | Health Informatics - Clinical Knowledge Resources - Metadata |
| 7 | ISO 22857:2013 | Health Informatics – Guidelines on Data Protection to Facilitate Trans- 7 ISO 22857:2013 Border Flows of Personal Health Data |
| 8 | ISO 21549-1:2013 | Health Informatics — Patient Healthcard Data — Part 1: General 8 ISO 21549-1:2013 Structure |
| 9 | ISO TS 14265:2011 | Classification of Purposes for Processing Personal Health Information |
| 10 | ISO TS 27527:2010 | Health Informatics – Provider Identification |
