The Ministry of Health and Family Welfare has notified Electronic Health Record (EHR) Standards Version 2016 for India in December 2016 (whilst the earlier version of EHR Standards was notified in September 2013) with an intent to bring standardisation and homogeneity, inter-operability in capture, storage, transmission & use of healthcare information across various Health IT systems.
An Electronic Health Record (EHR) is a collection of various medical records that get generated during any clinical encounter or events. With rise of self-care and homecare devices and systems, nowadays meaningful healthcare data get generated 24x7 and also have long-term clinical relevance.
The goals of standards in electronic health record systems are:
|Sl. No.||Type||Standard Name||Intended Purpose|
Identification & 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|
|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|
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|
|Logical Observation Identifiers Names and Codes (LOINC)||Test, measurement, observations|
|13||WHO Family of International Classifications (WHOFIC) 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|
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|
|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/HL7 27932:2009)||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|
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 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|
|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|
List of Supporting / Complimenting Standards
The following list is indicative and representative and not comprehensive or definitive. These standards are advised to be used where applicable and as required.
|1||ISO 12967:2009||Health Informatics - Service Architecture (Parts 1 - 3)|
|2||ISO 13972:2015||Health Informatics - Detailed Clinical Models, Characteristics and Processes|
|3||ISO 20301:2014||Health Informatics - Health Cards - General Characteristics|
|4||ISO 21090:2011||Health Informatics - Harmonized Data Types for Information Interchange|
|5||ISO 8601:2004||Data elements and Interchange Formats - Information Interchange - 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 TransBorder Flows of Personal Health Data|
|8||ISO 21549-1:2013||Health Informatics - Patient Healthcard Data - Part 1: General Structure|
|9||ISO TS 14265:2011||Classification of Purposes for Processing Personal Health Information|
|10||ISO TS 27527:2010||Health Informatics - Provider Identification|
To access the complete Standards, click here.
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