Electronic Health Record Standardisation in India

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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,
  MoHFW 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
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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 MoHFW
• Important Policy Directions

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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
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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

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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.

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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

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EMR Standards Committee of MoHFW

• Ministry of Health Family Welfare (MoHFW),
  Govt. of India constituted a Committee of
  Experts for Development of Standards on EMR in
  Sept 2010 under Chairmanship of Additional
  Secretary DG,CGHS, MoHFW
• 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

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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 MoHFW 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

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Categories of Standards required for
eHealth/mHealth and other Healthcare Information
systems
Identifiers
Codes Terminology
Content Formats
Messaging
Security Access Control

• Patient Id
• Provider Id
• Payer Id
• Health Plan Id
• Pharmacy Id

• Disease Codes
• Procedure Codes
• Observation Codes
• Drug Codes
• Surgical Consumables

• Patient Enrollment Registration
• Patient Medical Records
• Billing Formats
• Minimum Data Sets
• Lab Formats

• HL7, EDI, EDIFACT

• Authentication
• Access Control
• Non Repudiation
• Privacy Protection

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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)
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Healthcare Informatics Organisations/ Standards
.. Contd.
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 Manufacturers 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
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Approved StandardsCodes

• Clinical Terminology (for clinical observations)
• IHTSDOs SNOMED CT
• Laboratory Observations
• Regenstrief Insts LOINC

• Diseases (Diagnosis)
• WHOs ICD 10
• Procedures
• ICD 10 PCS
• Disability
• WHOs ICF

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Messaging, Imaging, Clinical Document Format

• Messaging
• HL7 V3.0 RIM (Reference Information Model)
• HL7 V2.5 (for backward compatibility)
• Imaging
• NEMAs 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)

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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
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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.

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EHR-Preservation, Ownership Security Guidelines
Guidelines are present in the EHR Standards
document
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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
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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.

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National eHealth Authority(NeHA) of India Draft
National Health Policy 2015

• A major initiative to set up National eHealth
  Authority(NeHA) of India by MoHFW 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 MoHFW 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.
•  

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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 MoHFW under Chairmanship of Additional
  Secretary to review and suggest updation. Draft
  is already under advanced stage of finalisation

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Thank you
bedi11_at_yahoo.com