Explains about Health Record Standards, ICTs, Standards for Healthcare Sector, Ministry of Health and Family Welfare. For more information visit: http://www.transformhealth-it.org/

1. Electronic Health Record
Standardisation in India
Baljit Singh Bedi
Advisor, Health Informatics,
Centre for Dev. for Advanced Computing (CDAC)
Ministry of Communication & IT(MCIT),Govt. of India
&
Member, National EMR Standardisation Committee, MoH&FW & Chair, Sub-
Group, Interoperability;
&
Chair, FICCI IHIN Working Group on HER and Standards
Past President, Telemedicine Society of India(TSI)
&
Ex. Sr. Director & Head, Telemedicine Div.,
Dept. of IT, MCIT, Govt. of India )
International Conf.Transforming Healthcare
with IT(THIT),Bengaluru, 16-17 Oct 2015

2. AGENDA
• Background: Relevance of ICT in Health Sector in
India
• Relevance of Standards for Healthcare Sector-
Case for EHR Standardization
• Ministry of Health & Family Welfare Expert
Committee for Standards
• Notified EHR Standards by MoH&FW
• Important Policy Directions

3. Understanding Information and
Communication Technologies (ICTs)
• Healthcare area is highly Data dependent. Power
of ICTs lies in its capacity to effectively
• Access data
• Store data
• Analyze data
• Transmit data
Utilizing this capability of ICTs has the potential to significantly
contribute in preventive care, improving delivery , disease
control , medical education and training, health management
and health research

4. The Need for Standards for Healthcare Sector
• A set of guidelines/standards optimally leverages
existing technologies, ensure continuity to evolving
technical innovations and deliver cost effective solutions
and sharing medical knowledge
• Would help indigenous enterprises provide the right
platform for eHealth and further provide all with a
practically attainable and sustainable standard of health
care
• To provide a framework for interoperability and scalability
across Health Information Systems and eHealth/mHealth
services within the country and outside
• Electronic Health Record(EHR) is one of the most
important parameter in this standardisation

5. An Example of Accepted Multi Media Tele-
conferencing Standards
The International Telecommunications Union (ITU)-T T.120,
H.320,H.323,and H.324 standards comprise the core technologies
for multimedia teleconferencing (video conferencing).
 The T.120 standards address Real Time Data Conferencing
(Audiographics),
The H.320 standards address ISDN videoconferencing,
 The H323 standard addresses Video (Audiovisual) communication
on Local
Area Networks,
The H.324 standard addresses High Quality Video and Audio
Compression
over POTS modem connections.

6. What is EHR?
A repository of information regarding the health of
a subject of care in computer processable form
Stored and transmitted securely, and accessible
by multiple authorized users
It has a commonly agreed logical information
model which is independent of EHR systems
Purpose is the support of continuing, efficient and
quality integrated health care and it contains
information which is retrospective, concurrent and
prospective
-The "Integrated Care EHR" as defined in ISO/DTR 20514

7. EMR Standards Committee of MoHFW
• Ministry of Health & Family Welfare
(MoH&FW), Govt. of India constituted a
Committee of Experts for Development of
Standards on EMR in Sept 2010 under
Chairmanship of Additional Secretary
&DG,CGHS, MoH&FW
• Objective of above Committee to recommend
a set of EMR Standards for India to be followed
by both public & private healthcare provider
• Procedure for continuous up gradation

8. Activities Undertaken
► EMR Standardisation Committee set up following Sub-Groups in
October 2010:
► Sub-Group Task I : Standards- Terminology, coding standards
► Sub-Group Task II : Data connectivity- including H/W,S/W &
Interoperability
► Sub-Group Task III: Data ownership-Data protection& including
security and legal aspects
► The current EHR standards are a result of the deliberations of the EMR
Standards Committee & Subgroups and consolidation by the Sub-
committee under FICCI of the public comments on the draft report put
up by MoHFW, GoI in their website in May 2013 and deliberations
thereof, finalized in August, 2013.
► Notified in September, 2013 on MoH&FW Website
► National Implementation Committee for roll out has been set up
► Recently a Fourth Sub-Group has been set up to take into
consideration the Legal and manadatory aspects of notified EHR
Standards

9. Identifiers
• Patient Id
• Provider Id
• Payer Id
• Health Plan Id
• Pharmacy Id
Codes &
Terminology
• Disease
Codes
• Procedure
Codes
• Observation
Codes
• Drug Codes
• Surgical
Consumables
Content &
Formats
• Patient
Enrollment –
Registration
• Patient
Medical
Records
• Billing
Formats
• Minimum
Data Sets
• Lab Formats
Messaging
• HL7, EDI,
EDIFACT
Categories of Standards required for
eHealth/mHealth and other Healthcare
Information systems
Security &
Access Control
• Authentication
• Access Control
• Non
Repudiation
• Privacy
Protection

10. Some Healthcare Informatics
Organisations / Standards considered
Organization Standards
National
Recommendations for
Health Information
Infrastructure in India
 Information Technology Infrastructure for Health
(ITIH) framework
 Recommendations on Guidelines, Standards &
Practices for Telemedicine in India
 Indian health information network development
(iHIND) recommendations from the National
Knowledge
International Organization
for Standardization (ISO)
Requirements for Electronic Health Record Architecture
(ISO / TS 18308)
European Committee for
Standardization (CEN)
CEN / TC 251 EN 13606
Code of Federal
Regulations (CFR)
Health Information Technology Standards,
Implementation Specifications, and Certification
Criteria and Certification Programs for Health
Information Technology (Title 45, Part 170)

11. Organization Standards
American Society for Testing &
Materials (ASTM)
Continuity of Care Record (CCR)
Health Level 7 (HL7) HL7 v2.x
HL7 v3
HL7 Clinical Document Architecture (CDA)
EHR - System Functional Model
HL7 & ASTM Collaboration Continuity of Care Document (CCD)
National Electrical Manufacturer’s
Association (NEMA)
Digital Imaging and Communications in
Medicine (DICOM PS 3.0 2004 onwards)
Office of National Coordinator for
Health Information Technology
(ONCHIT) – United States
EHR Meaningful Use
Healthcare Informatics Organisations/
Standards .. Contd.

12. Approved Standards:
Codes
• Diseases (Diagnosis)
– WHO’s ICD 10
• Procedures
– ICD 10 PCS
• Disability
– WHO’s ICF
• Clinical Terminology
(for clinical
observations)
– IHTSDO’s SNOMED
CT
• Laboratory
Observations
– Regenstrief Inst’s
LOINC

13. Messaging, Imaging, Clinical Document
Format
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)

14. Recommended IT Standards – Phase 2
DSM Psychiatric conditions Diagnostic & statistical
manual of mental disorders
NIC/NOC/NANDA Nursing interventions
classification
This is optional
CDT 2, US Dental Procedures This is optional
Unknown AYUSH clinical
terminology, treatment
planning including
medication details
Ayurveda, Yoga, Unani,
Siddha, Homeopathy
systems of medicine as
distinct from the allopathic
(Western) system of
medicine

15. Minimum Data Set (MDS)
• Minimum amount of health information
required about a patient to profile a
disease in a standard format.
• Ensure that the health information is
precise, unambiguous and acceptable to
all stakeholders.
• Represented in such a manner that they
can be easily analysed and conclusions
drawn from the data.

16. EHR-Preservation, Ownership & Security Guidelines
Ethical and Legal
Considerations
• Data Retention Policy
• Patient Policy/Confidentiality
• Patient Consent
• Quality of Service (QOS)
• Data Ownership
• Non-repudiation
• Dispute Resolution
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
• Anonymization
Purpose
•To protect the confidentiality,
integrity, and availability of
information
Guidelines are present in the EHR Standards document

17. MINISTRY OF HEALTH & FAMILY
WELFARE
(Department of Health & Family
Welfare)
NOTIFICATION regarding Clinical
Establishments (Registration &
Regulations) Act 2010 (23 of 2010)
New Delhi, the 23rd
May 2012

18. G.S.R.387 (E).-In the exercise of powers conferred by
Section 52 of the Clinical Establishments (Registration
& Regulations) Act 2010 (23 of 2010),the Central
Government makes the following Rules, namely:-
• …………
• 9. Other conditions for registration and continuation of
clinical establishments.- For registration and continuation
every clinical establishment shall fulfill the following
conditions, namely.-
• ……….
• (iv) Clinical establishments shall provide and maintain
Electronic Medical Record or Electronic Health Records of
every patients as may be determined and issued by the
Central Government or State Government as the case may
be from time to time.

19. National eHealth Authority(NeHA) of
India &Draft National Health Policy 2015
•A major initiative to set up National eHealth Authority(NeHA) of India by
MoH&FW is underway with a Vision to ensure adoption of e-Health and
notified EHR standards in India in an orderly way and thus realize
maximum benefits from use of ICT for all stake-holders in Healthcare
domain. This is reflected in the Draft National Health Policy 2015
• Initial focus of NeHA would be on addressing implementation issues
and promoting mechanisms in support of the same.The concept
document was put up on MoH&FW website for wider discussion before
finalisation
•MoHFW has become a member of IHTSDO in April 2014 . with a view
of widespread adoption of SNOMED-CT in India; MoHFW has also
nominated C-DAC as interim NRC.

20. General Recommendations
• It must be added that these recommended standards
cannot be considered either in isolation or as
“etched in stone for all eternity”.
• This document must be a “living document”
• These will need to undergo periodic review and
update as necessary
A high level Committee has already been set up in
MoH&FW under Chairmanship of Additional
Secretary to review and suggest updation. Draft is
already under advanced stage of finalisation

21. Thank you
bedi11@yahoo.com