Electronic Health Record Standardisation in India

1. 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, MoH&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

2. 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 MoH&FW • Important Policy Directions

3. 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

4. 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

5. 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.

6. 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

7. EMR Standards Committee of MoHFW • Ministry of Health & Family Welfare (MoH&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, MoH&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

8. 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 MoH&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

9. 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

10. Some Healthcare Informatics Organisations / Standards considered

11. Healthcare Informatics Organisations/ Standards .. Contd.

12. Approved Standards:Codes • Clinical Terminology (for clinical observations) • IHTSDO’s SNOMED CT • Laboratory Observations • Regenstrief Inst’s LOINC • Diseases (Diagnosis) • WHO’s ICD 10 • Procedures • ICD 10 PCS • Disability • WHO’s ICF

13. Messaging, Imaging, Clinical Document Format • Messaging • HL7 V3.0 RIM (Reference Information Model) • HL7 V2.5 (for backward compatibility) • Imaging • NEMA’s 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)

14. Recommended IT Standards – Phase 2

15. 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.

16. 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 • Ethical and Legal Considerations • Data Retention Policy • Patient Policy/Confidentiality • Patient Consent • Quality of Service (QOS) • Data Ownership • Non-repudiation • Dispute Resolution EHR Security Mechanisms • Authentication • Role-Based Access Control • Data Verification • Transport Level Security • Encryption Mechanisms • Data/Storage • Audit/Log • Anonymization Guidelines are present in the EHR Standards document

17. 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

18. 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.

19. National eHealth Authority(NeHA) of India &Draft National Health Policy 2015 • A major initiative to set up National eHealth Authority(NeHA) of India by MoH&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 NeHA would be on addressing implementation issues and promoting mechanisms in support of the same.The concept document was put up on MoH&FW 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.

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

21. Thank you bedi11@yahoo.com