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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

Interoperability

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)
–IHTSDO’s SNOMED CT
•Laboratory Observations
–Regenstrief Institutes LOINC
•Diseases (Diagnosis)
–WHO’s ICD 10
•Procedures
–WHO’s ICD 10 PCS
•Disability
–WHO’s ICF

Approved Standards: Others

Messaging
HL7 V3.0 RIM (Reference Information Model)
HL7 V2.5 (for backward compatibility)
Imaging
–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
–Laboratory
–Radiology
•Investigation Results
•Treatment Plan
–Medication
•Active
•Discontinued
•Restarted
–Procedures
–Diet
–Life-style
•Outcome
•Date- time Stamp

Preservation, Ownership, Security

Purpose:
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
Authentication
Role-Based Access Control
Data Verification
Transport Level Security
Encryption Mechanisms
Data/Storage
Audit/Log
Anonymisation

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
Non-repudiation
Dispute Resolution

Conclusion

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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