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.
RBAC – role-based access control
Ability to display data in an informative manner – textual & graphical
Approved Standards: Codes
Clinical Terminology (for clinical observations)
–IHTSDO’s SNOMED CT
–Regenstrief Institutes LOINC
–WHO’s ICD 10
–WHO’s ICD 10 PCS
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
•Reasons for visit
•Allergies & Immunization
•Date- time Stamp
Preservation, Ownership, Security
To protect the confidentiality, integrity, and availability of information
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
Transport Level Security
Ethical and Legal Considerations
Data Retention Policy
Quality of Service (QOS)
Data Ownership: Patient is the owner, provider is the custodian
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”.