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eHealth Standardisation in India: Initiatives and Implementation Issues

eHealth Standardisation in India: Initiatives and Implementation Issues.

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eHealth Standardisation in India: Initiatives and Implementation Issues

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  1. 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) Geneva, Switzerland, 26-27 April 2012

  2. 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

  3. 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 Geneva, Switzerland, 26-27 April 2012

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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 Geneva, Switzerland, 26-27 April 2012

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Clinical Data CLINICAL DATA RERESENTATION STANDARDS DISEASE CODES Currently followed in India Benchmarked Codes Recommended for India • None • ICD-10 • ICD-9-CM • Read • SNOMED • ICD-10 • 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

  17. Clinical Data CLINICAL DATA RERESENTATION STANDARDS OBSERVATION CODES Currently followed in India Benchmarked Codes Recommended for India 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 India’s specific requirements • Easy to implement in India • Used in many countries Geneva, Switzerland, 26-27 April 2012

  18. 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 Geneva, Switzerland, 26-27 April 2012

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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 Geneva, Switzerland, 26-27 April 2012

  25. 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

  26. 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

  27. 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

  28. 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

  29. Thank you bedi11@yahoo.com Geneva, Switzerland, 26-27 April 2012

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