February 2018
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Approved EHR Standards for India

By Dr. Suman Bhusan Bhattacharyya, Member, EHR Standards Committee, MoH&FW, Govt. of India


Importance of Standards in Healthcare


Different types of data needs to be exchanged if an Integrated Healthcare Enterprise (IHE) needs to be set up
Diverse sources of data sources
A common set of Health Information Exchange (HIE) standards is necessary to achieve interoperability – technical, semantic and process

Approved EHR standards for India

EHR Standards Committee constituted in September 2010 headed by AS&DG(CGHS)
Final draft submitted with request for comments from public in June 2013
Final recommendations submitted in August 2013
Approved and notified in September 2013

What is “Standard”

Standard means a technical, functional, or performance-based rule, condition, requirement, or specification that stipulates instructions, fields, codes, data, materials, characteristics, or actions (45 CFR 170.102)

What is required

Electronic health records are a summary of the various electronic medical records that get generated during any clinical encounter.

Without standards, a life-long summary is not possible as different records from different sources spread across ~80+ years will potentially need to be brought into one summary.

To achieve this, a set of pre-defined standards for information exchange that includes images, clinical codes and a minimum data set is imperative.

General Requirements

RBAC – role-based access control
Digital signature
Audit trail
Accurate transcription
Error-free transmission
Ability to display data in an informative manner – textual & graphical

Approved Standards: Codes

Clinical Terminology (for clinical observations)
•Laboratory Observations
–Regenstrief Institutes LOINC
•Diseases (Diagnosis)
–WHO’s ICD 10

Approved Standards: Others

HL7 V3.0 RIM (Reference Information Model)
HL7 V2.5 (for backward compatibility)
–NEMA’s Digital Imaging & Communication in Medicine (DICOM) PS3.0-2004
–Later revisions can be included as evolved
Clinical Data Format
•HL7 CDA 2.0 (Clinical Document Architecture)
•ASTM CCR (Continuity of Care Record)

Minimum Data Set

Patient Demographics
•Observer Details
•Reasons for visit
•Allergies & Immunization
•Clinical Observations
•Investigation Orders
•Investigation Results
•Treatment Plan
•Date- time Stamp

Preservation, Ownership, Security

To protect the confidentiality, integrity, and availability of information
Threat Sources:
Accidental Acts: Incidental disclosures, Errors and omissions, Proximity to risk    areas, Equipment malfunction
Deliberate Acts: Misuse/abuse of privileges, Fraud, Theft, Extortion, Crime
Environmental threats: Fire, Flood, Weather, Power

EHR Security Mechanisms
Role-Based Access Control
Data Verification
Transport Level Security
Encryption Mechanisms

Ethical and Legal Considerations
Data Retention Policy
Patient Policy/Confidentiality
Patient Consent
Quality of Service (QOS)
Data Ownership: Patient is the owner, provider is the custodian
Dispute Resolution


These standards cannot be considered either in isolation or as “etched in stone for all eternity”.
These will need to undergo periodic (at a maximum of 12 months interval) review and update as necessary.
Currently undergoing revision.
This document must be a “living document”.

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