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Master Class on EMR/EHR Standards by Baljit Singh Bedi,


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Master Class on EMR/EHR Standards by Baljit Singh Bedi,Advisor, Health Informatics, CDAC, India

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Master Class on EMR/EHR Standards by Baljit Singh Bedi,

  1. 1. Electronic Health Record (EHR) Standards - Relevance, Status and Policy Directions in India" Baljit Singh Bedi Advisor, Health Informatics, Member, National EMR Standardisation Committee, MoH&FW & Chair, Sub-Group, Interoperability; Member, EHR Review Committee and Legal Sub-group Chair, FICCI IHIN Working Group on EHR and Standards Past President, Telemedicine Society of India(TSI) Ex. Adviser, CDAC & Sr. Director & Head, Telemedicine Div., Ministry of Electronics & IT(MeitY), Govt. of India THIT 2016- 21-22 Oct 2016-Chennai
  2. 2. AGENDA • Relevance of Standards for eHealth • Case for EHR Standardization for India • EHR Standards Initiative by Ministry of Health & Family Welfare(MoH&FW) • Notified EHR Standards and Recent Updating Effort • Some Policy Directions
  3. 3. Understanding Information and Communication Technologies (ICT) & its Role in Healthcare • Healthcare area is highly Data dependent. Power of ICTs lies in its capacity to effectively -Access data, Store data, Analyze data and 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 and have deeply impacted key areas of: Health Management Information System (HMIS) – supporting Epidemiological & Disease surveillance Hospital Information Systems- for improved hospital management and clinical quality of care Telemedicine /Tele-education solutions for remote quality consultation- the area includes e-Health, m-Health
  4. 4. The Need for Standards for Healthcare • 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 eHealth/mHealth services within the country and outside • Electronic Health Record(EHR) is one of the most important parameter in eHealth standardisation
  5. 5. 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
  6. 6. Significance of EHR •Paperless medical history •Reduce healthcare costs •Right treatment at Right time •Promote evidence-based medicine •Accelerates Research and building effective medical practices
  7. 7. 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 • HL7, EDI, EDIFACT Categories of Standards required for health information common to eHealth/mHealth Security & Access Control • Authentication • Access Control • Non Repudiation • Privacy Protection
  8. 8. MoH&FW Initiative: Activities Undertaken National EHR Standards Notified by Mo H&FW in September, 2013 its Website -EHR Review Committee formed in August 2015 to review the approved standards and redraft the same with the aim of bringing it in line with current knowledge and understanding -Incorporate changes, as deemed fit, in view of India becoming a member of IHTSDO in April 2014 and SNOMED CT now being available to all in India; National Release Centre (iNRC) set up at CDAC Pune to create awareness and issue affiliate license -A ‘ Legal Sub-group’ set up on 1st September 2014 by MoH&FW to look into Accessibility, Privacy, Security and confidentiality of Patient Health Data
  9. 9. MoH&FW Notified Standards(Sept.2013): 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
  10. 10. 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)
  11. 11. 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.
  12. 12. EHR-Preservation, Ownership & Security Guidelines Ethical and Legal Considerations • Data Retention Policy • Patient Policy/Confidentiality • Patient Consent • Quality of Service (QOS) • Data Ownership • Non-repudiation • Dispute Resolution 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 Purpose •To protect the confidentiality, integrity, and availability of information Guidelines are present in the EHR Standards document
  13. 13. EHR Review Committee: Major Revision Points A Major Recommendation pertained to updating of EHR Standards keeping National and International scenario. EHR Review Committee went into depth through deliberation of a Sub-Committee. After incorporating public comments, highlights of draft suggestions are summarised: • Demography data to include person detail and MDDS from DeitY to be used for person details. • Identifier standards and guidelines added to enable sharing of record across establishments. • SNOMED CT is clarified as being the primary terminology for all parts of a clinical record, now that India is member country of IHTSDO and SNOMED CT is available to all India entities for free.
  14. 14. Major Revision Points • LOINC is recommended for test, measurement and observations. Mapping with SNOMED CT is also mentioned. • WHO Family of International Classification (that includes ICD, ICF, and few others) is now recommended for classification and reporting. • Implementation guidelines sections added for each of the standards to help in implementing these by providing sufficient clarity regarding them. • Minimum Data Set section has been removed as it is now unnecessary and was in non-conformance with the recommended ISO 13606 standard and archetype based structural composition.
  15. 15. Major Revision Points-contd. • Security and Privacy standards are indicated with clarity. • List of supporting and complementing ISO standards streamlined. • BIS, ISO and other SDOs are now mentioned for selection of standards not provided for specifically. • HL7 messaging standards have been streamlined to provide greater clarity.
  16. 16. Major Revision Points-contd. • Scanned document standards have been introduced. • E-prescription standards have been introduced. • Device integration standards have been specified. • Guidelines for hardware/software and data ownership have been revised to provide greater clarity.
  17. 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. 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. 19. National eHealth Authority(NeHA) of India 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 related standards in India in an orderly way and thus realize maximum benefits from use of ICT for all stake-holders in Healthcare domain The concept document was put up on MoH&FW website for wider discussion and is under finalisation incorporating public comments and in discussion with the state governments
  20. 20. Thank you