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Electronic Health Record Standards for India — Vikaspedia
T17 2019/08/23 12:36:29.557346 GMT+0530
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Electronic Health Record Standards for India
This topic provides information about Electronic Health Record (EHR) Standards for India.
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:
Promote interoperability and where necessary be specific about certain content exchange and vocabulary standards to establish a path forward toward semantic interoperability
Support the evolution and timely maintenance of adopted standards
Promote technical innovation using adopted standards
Encourage participation and adoption by all vendors and stakeholders
Keep implementation costs as low as reasonably possible
Consider best practices, experiences, policies and frameworks
To the extent possible, adopt standards that are modular and not interdependent.
The document provides a structured overview of the key EHR standards with respect to Indian healthcare system. For every aspect of data/information that is part of any healthcare record system has been addressed with a short guideline regarding implementation specific to the item-in-context included.
Various nonrelated recommendations from previous edition have been removed to better streamline the set of standards selected and achieve harmony among them.
A detailed recommendation on the interoperability and standards, clinical informatics standards, data ownership, privacy and security aspects, and the various coding systems are also provided.
The set of standards given in earlier edition has been updated with their latest versions as the country moves towards a better implementation.
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
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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