Electronic Health Record Standardisation in India Baljit Singh

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, Mo. H&FW & 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

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 Mo. H&FW • Important Policy Directions

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

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 e. Health 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 e. Health/m. Health services within the country and outside • Electronic Health Record(EHR) is one of the most important parameter in this standardisation

An Example of Accepted Multi Media Teleconferencing Standards The International Telecommunications Union (ITU)-T T. 120, 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 H 323 standard addresses Video (Audiovisual) communication on Local Area Networks, §The H. 324 standard addresses High Quality Video and Audio Compression over POTS modem connections.

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

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

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 Subcommittee under FICCI of the public comments on the draft report put up by Mo. HFW, Go. I in their website in May 2013 and deliberations thereof, finalized in August, 2013. Notified in September, 2013 on Mo. H&FW 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

Categories of Standards required for e. Health/m. Health and other Healthcare Information systems 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 • HL 7, EDI, EDIFACT Security & Access Control • Authentication • Access Control • Non Repudiation • Privacy Protection

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 Indian health information network development (i. HIND) recommendations from the National Knowledge International Organization Requirements for Electronic Health Record Architecture for Standardization (ISO) (ISO / TS 18308) European Committee for CEN / TC 251 EN 13606 Standardization (CEN) Code of Federal Health Information Technology Standards, Regulations (CFR) Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology (Title 45, Part 170)

Healthcare Informatics Organisations/ Standards. . Contd. Organization Standards American Society for Testing & Continuity of Care Record (CCR) Materials (ASTM) Health Level 7 (HL 7) HL 7 v 2. x HL 7 v 3 HL 7 Clinical Document Architecture (CDA) EHR - System Functional Model HL 7 & ASTM Collaboration Continuity of Care Document (CCD) National Electrical Manufacturer’s Digital Imaging and Communications in Association (NEMA) Medicine (DICOM PS 3. 0 2004 onwards) Office of National Coordinator for EHR Meaningful Use Health Information Technology (ONCHIT) – United States

Approved Standards: 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

Messaging, Imaging, Clinical Document Format Messaging HL 7 V 3. 0 RIM (Reference Information Model) HL 7 V 2. 5 (for backward compatibility) Imaging – NEMA’s Digital Imaging & Communication in Medicine (DICOM) PS 3. 0 -2004 – Later revisions can be included as evolved Clinical Data Format • HL 7 CDA 2. 0 (Clinical Document Architecture) • ASTM CCR (Continuity of Care Record)

Recommended IT Standards – Phase 2 DSM NIC/NOC/NANDA Psychiatric conditions Diagnostic & statistical manual of mental disorders Nursing interventions This is optional classification 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

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.

EHR-Preservation, Ownership & Security Guidelines Purpose • To protect the confidentiality, integrity, and availability of information 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 Ethical and Legal Considerations • Data Retention Policy • Patient Policy/Confidentiality • Patient Consent • Quality of Service (QOS) • Data Ownership • Non-repudiation • Dispute Resolution Guidelines are present in the EHR Standards document

MINISTRY OF HEALTH & FAMILY WELFARE (Department of Health & Family Welfare) NOTIFICATION regarding Clinical Establishments (Registration & Regulations) Act 2010 (23 of 2010) New Delhi, the 23 rd May 2012

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.

National e. Health Authority(Ne. HA) of India &Draft National Health Policy 2015 • A major initiative to set up National e. Health Authority(Ne. HA) of India by Mo. H&FW 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 Ne. HA would be on addressing implementation issues and promoting mechanisms in support of the same. The concept document was put up on Mo. H&FW website for wider discussion before finalisation • Mo. HFW has become a member of IHTSDO in April 2014. with a view of widespread adoption of SNOMED-CT in India; Mo. HFW has also nominated C-DAC as interim NRC.

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 Mo. H&FW under Chairmanship of Additional Secretary to review and suggest updation. Draft is already under advanced stage of finalisation

Thank you bedi 11@yahoo. com