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Electronic Health Record 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.

Electronic Health Record

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.

Goals

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.

Strategic Highlights

  • 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.

Standards at a glance

Sl. No. Type Standard Name Intended Purpose
1

 

Identification & Demographics

ISO/TS 22220:2011 Health Informatics - Identification of Subjects of Health CareBasic identity details of patient
2MDDS - Demographic (Person Identification and Land Region Codification) version 1.1Complete demographic for interoperability with E-Governance systems
3

 

Patient Identifiers

UIDAI AadhaarPreferable identifier where available
4Local IdentifierIdentifier given within institution / clinic / lab
5Government Issued Photo Identity Card NumberIdentifier used in conjunction with local in absence of Aadhaar
6Architecture RequirementsISO 18308:2011 Health Informatics - Requirements for an Electronic Health Record ArchitectureSystem architectural requirements
7Functional RequirementsISO/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 CareConcepts for care, actors, activities, processes, etc.
9ISO 13606 Health informatics - Electronic Health Record Communication (Part 1 through 3)Information model architecture and communication
10openEHR Foundation Models Release 1.0.2Structural definition and composition
11TerminologySNOMED Clinical Terms (SNOMED CT)Primary terminology
12

 

Coding System

Logical Observation Identifiers Names and Codes (LOINC)Test, measurement, observations
13WHO Family of International Classifications (WHOFIC) including ICD, ICF, ICHI, ICD-OClassification and reporting
14ImagingDigital Imaging and Communications in Medicine (DICOM) PS3.0-2015Image, waveform, audio/video
15

 

Scanned or Captured Records

JPEG lossy (or lossless) with size and resolution not less than 1024px x 768px at 300dpiImage capture format
16ISO/IEC 14496 - Coding of Audio-Visual ObjectsAudio/Video capture format
17ISO 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 EnvironmentsEvent/Message exchange
19ASTM/HL7 CCD Release 1 (basis standard ISO/HL7 27932:2009)Summary Records exchange
20ISO 13606-5:2010 Health informatics - Electronic Health Record Communication - Part 5: Interface SpecificationEHR archetypes exchange [Also, refer to openEHR Service Model specification]
21DICOM 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 CommitteeStandards Development Organizations (SDOs)
23ISO TC 215 set of standards
24IEEE/NEMA/CE standards for physical systems and interfaces
25Discharge/ Treatment SummaryMedical Council of India (MCI) under regulation 3.1 of EthicsComposition as prescribed
26E-PrescriptionPharmacy Practice Regulations, 2015 Notification No. 14-148/ 2012- PCI as specified by Pharmacy Council of IndiaComposition as prescribed
27Personal Healthcare and medical Device InterfaceIEEE 11073 health informatics standards and related ISO standards for medical devicesDevice interfacing
28Data Privacy and SecurityISO/TS 14441:2013 Health Informatics - Security & Privacy Requirements of EHR Systems for Use in Conformity AssessmentBasis security and privacy requirements
29Information Security ManagementISO/DIS 27799 Health informatics - Information Security Management in Health using ISO/IEC 27002Overall information security management
30Privilege Management and Access ControlISO 22600:2014 Health informatics - Privilege Management and Access Control (Part 1 through 3)Access control
31Audit Trail and LogsISO 27789:2013 Health informatics - Audit trails for Electronic Health RecordsAudit trail
32Data IntegritySecure Hash Algorithm (SHA) used must be SHA-256 or higherData Hashing
33

Data Encryption

Minimum 256-bits key lengthEncryption key
34HTTPS, SSL v3.0, and TLS v1.2Encrypted connection
35Digital CertificateISO 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.

S. No. Standard Description
1ISO 12967:2009Health Informatics - Service Architecture (Parts 1 - 3)
2ISO 13972:2015Health Informatics - Detailed Clinical Models, Characteristics and Processes
3ISO 20301:2014Health Informatics - Health Cards - General Characteristics
4ISO 21090:2011Health Informatics - Harmonized Data Types for Information Interchange
5ISO 8601:2004Data elements and Interchange Formats - Information Interchange - Representation of Dates and Times
6ISO 13119:2012Health Informatics - Clinical Knowledge Resources - Metadata
7ISO 22857:2013Health Informatics - Guidelines on Data Protection to Facilitate TransBorder Flows of Personal Health Data
8ISO 21549-1:2013Health Informatics - Patient Healthcard Data - Part 1: General Structure
9ISO TS 14265:2011Classification of Purposes for Processing Personal Health Information
10ISO TS 27527:2010Health Informatics - Provider Identification

To access the complete Standards, click here.

Source : Ministry of Health and Family Welfare

Related resources

  1. National Resource Centre for EHR Standards (NRCeS)


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