eHealth Standardisation in India:
Initiatives and Implementation Issues
Baljit Singh Bedi
Advisor, Health Informatics,
Centre for Dev. for Advanced Computing (CDAC)
Ministry of Communication & IT(MCIT),Govt. of India
Ex. Sr. Director & Head, Telemedicine Div.,
Dept. of IT, MCIT, Govt. of India )
&
President, Telemedicine Society of India(TSI)
Geneva, Switzerland, 26-27 April 2012
AGENDA
• Background
• Initiation of National Process for
Standardization
 Two interlinked Indian initiatives in
suggesting a Framework for Information
Technology Infrastructure for Health in
India (ITIH) and proposing Standards &
Practices For Telemedicine In India
• Aspects related to Regulatory and Legal
Framework and Compliance Mechanisms
• Implementation Challenges and Lessons
Learnt
Geneva, Switzerland, 26-27 April 2012
GOVERNMENT PLAYS A LEADERSHIP ROLE IN
CREATING AN ITIH ENVIRONMENT
As a PROVIDER,
the public
healthcare
system is the
largest
integrated
delivery network
in India
Information
Technology
Infrastructure
for Health
As a
REGULATOR,
Govt. will have to
frame and enact
the required legal
and education
frameworks
As a CONSUMER,
Govt. will require
standardised health
information from
various healthcare
Geneva, Switzerland, 26-27 April 2012 providers for policy
decisions
As a PAYER, Govt. will have to
follow the standard protocols
with healthcare providers to
honor its clients’ insurance
claims
ITIH VISION FOR INDIA
“To build Information Technology Infrastructure for
Health in India that will standardize the capture, storage
and exchange of health information in an environment
supported by a robust legal framework and a mature health
informatics education system that will bring administrative
simplification and improve patient care services through a
continuum of care”
Geneva, Switzerland, 26-27 April 2012
The Indian Effort- ITIH: Background
• Healthcare in India delivered by Multitude of
providers, both public & private
• Limited networking among health providers &
stakeholders
• Need for a standard health information system
across the country felt to cover diverse groups for
providing continuum of care to patients
• As part of the Endeavour, Department of IT,
Government of India, undertook initiative for
Defining IT Infrastructure for Healthcare in India
• Initiative being further taken up under Apex Group
under National Knowledge Commission and
Ministry of Health & Family Welfare
Geneva, Switzerland, 26-27 April 2012
Initiation of National Process for
Standardization
• Formation of an Expert Working Group and
its Terms of Reference
• Defining the standards- Key Objectives
• Framework in defining the guidelines and
standards
• Need to look at clinical protocols and
guidelines
• Terms of Reference for Expert Working
Group
Geneva, Switzerland, 26-27 April 2012
Formation of an Expert Working Group
• First step-a careful selection of Experts
-Professional and Industry Associations,
- Academia, Government officials,
-R & D organizations in Health Informatics,
-Major user agencies and decision makers in
hospital administration,
-IT Professionals
-Healthcare application / service vendors, Original
equipment manufacturers, Doctors
A provision to invite other Experts(e.g. Legal experts)
Geneva, Switzerland, 26-27 April 2012
ITIH STUDY RECOMMENDATIONS
•
DATA ELEMENTS
•
HEALTH IDENTIFIERS
•
CLINICAL DATA REPRESENTATION STANDARDS
•
MINIMUM DATA SETS
•
BILLING FORMATS
•
EDUCATION FRAMEWORK
•
LEGAL FRAMEWORK
•
MESSAGING STANDARDS
Geneva, Switzerland, 26-27 April 2012
Categories of Standards required for health
information
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
Messaging
• HL7, EDI,
EDIFACT
• Patient
Medical
Records
• Billing
Formats
• Minimum
Data Sets
• Lab Formats
Geneva, Switzerland, 26-27 April 2012
Security &
Access Control
• Authentication
• Access Control
• Non
Repudiation
• Privacy
Protection
Indian effort
The Issues and Need for
Telemedicine/eHealth /mHealth Standards
• Telemedicine/eHealth /mHealth offers one of the best options
for delivering healthcare for rural & geographically distant
populations.
• Currently 850 million mobiles in use in India all across the rural
and urban population
• Setting up of Telemedicine networks has started to grow both
in Public as well as Private Sector
• In this scenario a set of guidelines/standards will optimally
leverage existing technologies, ensure continuity to evolving
technical innovations and deliver cost effective solutions
Geneva, Switzerland, 26-27 April 2012
Indian effort
Standardisation-The Initiative
• As part of the endeavour, Department of IT, through
deliberations of Technical Working Group under a high
power Committee formulated a set of ‘Standards &
Guidelines for Practice of Telemedicine in India’ in 2003
• Taskforce for Telemedicine in India, constituted in 2005
by the Union Ministry of Health and Family Welfare to
look into various issues to promote implementation of
Telemedicine,
• Specific tasks were assigned to various subgroups
wherein Subgroup I was assigned the following tasks
-To work on inter-operability - standards for data
transmission; software, hardware, training etc.
-To define standards and structures of electronic
medical records and patient data base which could be
accessed on a National telemedicine Grid.
Geneva, Switzerland, 26-27 April 2012
Defining the standards- Key Objectives
A clear vision for the objective of defining standards
• To Increase accessibility to quality medical care to all
• To promote growth of e-Health and HMIS
• To identify and support mechanisms for protecting
privacy & confidentiality of health data and security and
legal issues.
• To broaden international cooperation in the scientific,
legal and ethical aspects of the use of e-Health
• To provide a framework for interoperability and
scalability within and outside world
• To bring profitability to stakeholders
Geneva, Switzerland, 26-27 April 2012
Framework in defining the
guidelines and standards
• Interoperability
• Compatibility
• Scalability
• Portability
The guiding framework need ensure:
• Inclusion of all stakeholders
• Making recommendations vendor neutral
The Expert Working Group also considered clinical
protocols and guidelines. Clinical protocols for
telemedicine practice include scheduling
procedures, consult procedures and equipment
operation procedures
Geneva, Switzerland, 26-27 April 2012
Review of Key Technical Standards
For any developing country embarking
standardizations for e-Health and Hospital
Management Information systems (HMIS)
need study :
• Existing International status
• Organizations working in field and current
adoption of standards
• Standard Development Organizations
(SDOs) and Special Interest Groups (SIGs)
active in standardization process
Geneva, Switzerland, 26-27 April 2012
Clinical Standards
• Clinical standards(or Code Sets) codify information
related to diseases, procedures, clinical observation,
drugs, nursing procedures, etc. These are key to
interoperability for a successful nationwide health
information system that results in increased patient
safety. Categories of clinical standards include:
-The Disease Codes
-The Procedure Codes
- The Clinical Observation Codes
Geneva, Switzerland, 26-27 April 2012
Clinical
Data
CLINICAL DATA RERESENTATION STANDARDS
DISEASE CODES
Currently followed in
India
• None
Benchmarked Codes
• ICD-10
Recommended for India
• ICD-10
• ICD-9-CM
• Read
• SNOMED
Why ICD-10 ?
• Most widely used disease coding system in the world
• Relatively inexpensive to procure (for Government of India for
implementing nationwide)
• Can be modified to suit India’s specific requirements
• Easier to switch to ICD coding system than to any other system
• Easy to implement in India
• SNOMED-CT also under consideration currently
Geneva, Switzerland, 26-27 April 2012
Clinical Data
CLINICAL DATA RERESENTATION STANDARDS OBSERVATION
CODES
Currently followed in
India
• None
Benchmarked Codes
LOINC
Recommended for India
• LOINC
SNOMED
Medcin
Why LOINC(Logical Observation Identifiers,Names and Coding)?
• High level of specificity and wider coverage of codes
• Relatively inexpensive to procure (for Government of India for
implementing nationwide)
• Can be modified to suit India’s specific requirements
• Easy to implement in India
• Used in many countries
Geneva, Switzerland, 26-27 April 2012
Minimum
Data Sets
MINIMUM DATA SET(MDS) FORMAT
• REFERRALS
• DEMOGRAPHICS
Common to
all diseases
MDS is the minimum amount of health information required
about a patient to profile a disease)
Topics Covered
• Primary Health
• Diseases
• Cancer
• DISEASE
ASSESSMENT
– DISEASE STAGE
– RISK FACTORS
– COMPLICATIONS
• TREATMENT
• OUTCOMES
Specific to
each disease
• Diabetes
Geneva, Switzerland, 26-27 April 2012
• Cardio Vascular
Diseases
• Gastro
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.
Geneva, Switzerland, 26-27 April 2012
Standards for Interoperation of
Telemedicine Systems
• DICOM 3.0, HL7have been examined for
suitability
• Specifics have been defined to facilitate
interchange of data
• HL7
– HL7 Data Interchange Details
– HL7 Data Transport Details
• DICOM
– DICOM Transfer Syntaxes
– DICOM Services
Geneva, Switzerland, 26-27 April 2012
Standards for Network / Connectivity
• Physical Connectivity
–PSTN/ ISDN/Leased Line….
–VSAT’s
–Others including DSL, Broad Band, other
wireless networks, etc
• Logical Connectivity
–Based on TCP/IP protocols
Geneva, Switzerland, 26-27 April 2012
Indian effort
ITIH- Impact and Follow up……..
• Recommendations have been adopted by a number
of stakeholders
• Insurance Regulatory Dev. Authority WG on Data
Standards adapted some specific recommendations
• Resource document for standards and EMR for
National Taskforce on Telemedicine Sub Group on
Telemedicine Standards
• Resource material for WG of National Knowledge
Commission for suggesting Indian Health Information
Network Development (I-HIND)
• Some Pilot implementations taking full districts under
contemplation
Geneva, Switzerland, 26-27 April 2012
Legal
Framework
LEGAL FRAMEWORK for HEALTH
INFORMATION: PROPOSAL FOR LEGISLATION
• Existing Indian law does not adequately address
concerns relating to Health Information - need for
legislation necessary to support standardization
• Necessary to understand the specific problems or
experiences of Indian patients and Healthcare
Providers
• Proposed Legislation: A proposal for Legislation
defining the health information, boundaries,
security, consumer control, accountability, public
responsibility, etc. was suggested in ITIH. The
document consists of guidelines on framing a new
health information law.
Currently Information Technology Amendment Act of India Addresses some
of these Issues
Geneva, Switzerland, 26-27 April 2012
Regulatory and Legal Framework and
Compliance Mechanisms
Major Legal Issues- jurisdictional processes being
different across countries, the legal implications of eHealth services will definitely be different for each
country. Some recommendatory aspects taken up by
Sub Group of Taskforce for Telemedicine in India
cover:
 Data Retention Policy
 Patient Privacy / Confidentiality and Security
Standards
 Consent
 Ensuring Quality
 Data Ownership
 Dispute Resolution
 No existing Protocols in India but precedents
available from Abroad
Geneva, Switzerland, 26-27 April 2012
Compliance /Implementation Challenges
• Arriving at a consensus by stake holders to acceptable
standards is a long drawn affair
• Mechanisms of making stake holders comply to laid down
standards is one of the biggest challenge
• Adherence to standards in e-health two perspectives:
information representation & transmission.
• However, India ( and other Developing countries) benefit from
two advantages to start the process of standardization
-not encumbered with too many legacy systems.
-profit from the experience of developed nations (and a few
developing nations)
Geneva, Switzerland, 26-27 April 2012
Compliance /Implementation Challenges
(contd.)
• Face twin challenge in terms of
-Knowledgeable human resource and
-Need to optimize short term financial burden with an
expectation of long term ROI.
• Need for Leadership- who will organize stakeholders around
common purpose;
-to understand the operational mechanism in the country and
proceed accordingly with the policy makers.
The first step of setting up of expert national committee/working
group needs authorization/consent of competent authority for its
recommendations to carry weight
Geneva, Switzerland, 26-27 April 2012
Lessons Learnt
• With large number of Telemedicine/eHealth networks coming
up in India, Ministry of Communication & IT (MCIT) set up a
Technical Working Group in 2002 to suggest standards for
Telemedicine and a study to suggest framework for Standard
based IT Infrastructure for Health. Both recommendations were
available by May 2003. Number of subsequent initiatives
followed up.
• Any legislation activity to take recommendations to mandatory
level has to be spearheaded by the main user Health Ministry
under business rules. This turned out to be a difficult task.
• Initial Recommendations were put up on the Website of MCIT
in September 2003. This
created widespread publicity,
awareness and effort to compliance in the fairly early stages of
proliferating induction of e-Health in India and can be an
example for other developing countries.
Geneva, Switzerland, 26-27 April 2012
Lessons Learnt and Recommendations
(contd.)
• Promotional steps with support from concerned
Ministry/Department to motivate stakeholders to adopt
accepted standards(like concessional
licences,DICOM,HL7 class libraries)
• Remove misconception among providers that adherence
to standards might reduce product’s market (as adherence
to standards would diminish the proprietary features )by
creating awareness about importance and possible future
opportunities
• Incentivize the healthcare providers as per adherence. In
order to incentivize, the evaluation of adherence to
standards needs to be done through establishing national
e-Health services certification infrastructure.
Geneva, Switzerland, 26-27 April 2012
Thank you
bedi11@yahoo.com
Geneva, Switzerland, 26-27 April 2012