Master Class on EMR/EHR Standards by Baljit Singh Bedi,Advisor, Health Informatics, CDAC, India

1. Electronic Health Record (EHR) Standards
- Relevance, Status and Policy Directions in
India"
Baljit Singh Bedi
Advisor, Health Informatics,
Member, National EMR Standardisation Committee, MoH&FW & Chair,
Sub-Group, Interoperability; Member, EHR Review Committee and Legal
Sub-group
Chair, FICCI IHIN Working Group on EHR and Standards
Past President, Telemedicine Society of India(TSI)
Ex. Adviser, CDAC & Sr. Director & Head, Telemedicine Div.,
Ministry of Electronics & IT(MeitY), Govt. of India
THIT 2016- 21-22 Oct 2016-Chennai

2. AGENDA
• Relevance of Standards for eHealth
• Case for EHR Standardization for India
• EHR Standards Initiative by Ministry of Health &
Family Welfare(MoH&FW)
• Notified EHR Standards and Recent Updating
Effort
• Some Policy Directions

3. Understanding Information and Communication
Technologies (ICT) & its Role in Healthcare
• Healthcare area is highly Data dependent. Power of ICTs lies in its
capacity to effectively
-Access data, Store data, Analyze data and 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 and have deeply impacted key
areas of:
Health Management Information System (HMIS) – supporting
Epidemiological & Disease surveillance
Hospital Information Systems- for improved hospital management and
clinical quality of care
Telemedicine /Tele-education solutions for remote quality consultation-
the area includes e-Health, m-Health

4. The Need for Standards for Healthcare
• 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 eHealth/mHealth services within the country and
outside
• Electronic Health Record(EHR) is one of the most
important parameter in eHealth standardisation

5. 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

6. Significance of EHR
•Paperless medical history
•Reduce healthcare costs
•Right treatment at Right time
•Promote evidence-based medicine
•Accelerates Research and building effective
medical practices

7. 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 health
information common to eHealth/mHealth
Security &
Access Control
• Authentication
• Access Control
• Non
Repudiation
• Privacy
Protection

8. MoH&FW Initiative: Activities Undertaken
National EHR Standards Notified by Mo H&FW in September, 2013 its
Website
-EHR Review Committee formed in August 2015 to review the approved
standards and redraft the same with the aim of bringing it in line with
current knowledge and understanding
-Incorporate changes, as deemed fit, in view of India becoming a
member of IHTSDO in April 2014 and SNOMED CT now being available
to all in India; National Release Centre (iNRC) set up at CDAC Pune to
create awareness and issue affiliate license
-A ‘ Legal Sub-group’ set up on 1st
September 2014 by MoH&FW to look
into Accessibility, Privacy, Security and confidentiality of Patient
Health Data

9. MoH&FW Notified Standards(Sept.2013):
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

10. 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)

11. 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.

12. 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

13. EHR Review Committee: Major Revision
Points
A Major Recommendation pertained to updating of EHR Standards
keeping National and International scenario.
EHR Review Committee went into depth through deliberation of a
Sub-Committee. After incorporating public comments, highlights of
draft suggestions are summarised:
• Demography data to include person detail and MDDS from DeitY to
be used for person details.
• Identifier standards and guidelines added to enable sharing of
record across establishments.
• SNOMED CT is clarified as being the primary terminology for all
parts of a clinical record, now that India is member country of
IHTSDO and SNOMED CT is available to all India entities for free.

14. Major Revision Points
• LOINC is recommended for test, measurement and
observations. Mapping with SNOMED CT is also
mentioned.
• WHO Family of International Classification (that
includes ICD, ICF, and few others) is now
recommended for classification and reporting.
• Implementation guidelines sections added for each
of the standards to help in implementing these by
providing sufficient clarity regarding them.
• Minimum Data Set section has been removed as it is
now unnecessary and was in non-conformance with
the recommended ISO 13606 standard and archetype
based structural composition.

15. Major Revision Points-contd.
• Security and Privacy standards are indicated
with clarity.
• List of supporting and complementing ISO
standards streamlined.
• BIS, ISO and other SDOs are now mentioned
for selection of standards not provided for
specifically.
• HL7 messaging standards have been
streamlined to provide greater clarity.

16. Major Revision Points-contd.
• Scanned document standards have been
introduced.
• E-prescription standards have been
introduced.
• Device integration standards have been
specified.
• Guidelines for hardware/software and data
ownership have been revised to provide
greater clarity.

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
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
related standards in India in an orderly way and
thus realize maximum benefits from use of ICT for
all stake-holders in Healthcare domain
The concept document was put up on MoH&FW
website for wider discussion and is under
finalisation incorporating public comments and in
discussion with the state governments

20. Thank you
bedi11@yahoo.com