eHealth Standardisation in India: Initiatives and Implementation Issues

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eHealth Standardisation in India Initiatives and
Implementation Issues

• Baljit Singh BediAdvisor, Health Informatics,
  Centre for Dev. for Advanced Computing
  (CDAC)Ministry of Communication IT(MCIT),Govt.
  of IndiaEx. Sr. Director Head, Telemedicine
  Div.,Dept. of IT, MCIT, Govt. of India
  )President, Telemedicine Society of
  India(TSI)

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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

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GOVERNMENT PLAYS A LEADERSHIP ROLE IN CREATING AN
ITIH ENVIRONMENT
As a REGULATOR, Govt. will have to frame and
enact the required legal and education frameworks
As a PROVIDER, the public healthcare system is
the largest integrated delivery network in India

Information Technology Infrastructure for Health
As a CONSUMER, Govt. will require standardised
health information from various healthcare
providers for policy decisions
As a PAYER, Govt. will have to follow the
standard protocols with healthcare providers to
honor its clients insurance claims
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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
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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

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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

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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)

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ITIH STUDY RECOMMENDATIONS

• DATA ELEMENTS
• HEALTH IDENTIFIERS
• CLINICAL DATA REPRESENTATION STANDARDS
• MINIMUM DATA SETS
• BILLING FORMATS
• EDUCATION FRAMEWORK
• LEGAL FRAMEWORK
• MESSAGING STANDARDS

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Categories of Standards required for health
information
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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The Issues and Need for Telemedicine/eHealth
/mHealth Standards
Indian effort

• 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

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Standardisation-The Initiative
Indian effort

• 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.

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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

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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

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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

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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

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Clinical Data
CLINICAL DATA RERESENTATION STANDARDS DISEASE
CODES
Currently followed in India
Recommended for India
Benchmarked Codes

• None

• ICD-10

• 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 Indias 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

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Clinical Data
CLINICAL DATA RERESENTATION STANDARDS OBSERVATION
CODES
Currently followed in India
Recommended for India
Benchmarked Codes
LOINC SNOMED Medcin

• None

• LOINC

• 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 Indias specific
  requirements
• Easy to implement in India
• Used in many countries

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Minimum Data Sets
MINIMUM DATA SET(MDS) FORMATMDS is the minimum
amount of health information required about a
patient to profile a disease)
Topics Covered
Common to all diseases

• REFERRALS
• DEMOGRAPHICS
• DISEASE ASSESSMENT
• DISEASE STAGE
• RISK FACTORS
• COMPLICATIONS
• TREATMENT
• OUTCOMES

• Primary Health
• Diseases
• Cancer
• Diabetes
• Cardio Vascular Diseases
• Gastro

Specific to each disease
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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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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

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Standards for Network / Connectivity

• Physical Connectivity
• PSTN/ ISDN/Leased Line.
• VSATs
• Others including DSL, Broad Band, other wireless
  networks, etc
• Logical Connectivity
• Based on TCP/IP protocols

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ITIH- Impact and Follow up..
Indian effort

• 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

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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
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Regulatory and Legal Framework and Compliance
Mechanisms

• Major Legal Issues- jurisdictional processes
  being different across countries, the legal
  implications of e-Health 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

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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)

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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/consen
  t of competent authority for its recommendations
  to carry weight

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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.
  

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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 products
  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.

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Thank you
bedi11_at_yahoo.com