1 Health Informatics Standardization: Relevance and Indian Initiatives Baljit Singh Bedi Advisor, CDAC (Sc. Society of MCIT, Govt. of India ) Past President, Telemedicine Society of India(TSI) & Member, National EMR Standardization Committee, MoH&FW & Chair, Sub-Group, Interoperability; Chair, FICCI EHR Subcommittee & Ex. Sr. Director & Head, Telemedicine Div., Dept. of IT, MCIT, Govt. of India) Regional Workshop on Establishment of NMCN. MoH&FW, February,2014, Lucknow
2 AGENDA Background - Role of ICT in Healthcare Indian Initiatives in proposing Standards Case for EHR Standardization - Benefits/Relevance of EMR/EHR Ministry of Health & Family Welfare Expert Committee for Standards Some Policy Directions
3 Background-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 Predictive Analytics 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 Standardisation- Indian Initiative Initiative in suggesting a Framework for Information Technology Infrastructure for Health(ITIH) in India (First effort for suggesting a Standard EHR for India) National efforts in proposing Recommendations on Guidelines, Standards & Practices For Telemedicine In India National Knowledge Commission s India Health Information Network Development (I-HIND) EHR Standardization Initiative of MoH&FW
5 GOVERNMENT PLAYS A LEADERSHIP ROLE IN CREATING HEALTH INFORMATION STANDARDISATION ENVIRONMENT As a PROVIDER, the public healthcare system is the largest integrated delivery network in India Health Information Exchange Standards As a REGULATOR, Govt. will have to frame and enact the required legal and education frameworks As a PAYER, Govt. will have to follow the standard protocols with healthcare providers to honor its clients insurance claims As a CONSUMER, Govt. will require standardised health information from various healthcare providers for policy decisions
6 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
7 Framework in defining the guidelines and standards Interoperability Compatibility Scalability Portability The guiding framework need ensure: Inclusion of all stakeholders Making recommendations vendor neutral Standards also needs to look at clinical protocols and guidelines. Clinical protocols for telemedicine practice include scheduling procedures, consult procedures and equipment operation procedures
8 The Need for Standards EMRs and almost any other information-oriented system in a clinical environment cannot be used without well-defined standards for representing and communicating information Data need to be exchanged between multiple, heterogeneous systems and might be used by very different applications Standards are needed for several different uses: Identifying patients, providers, health-care plans, employers Transferring patient data across different systems
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 HL7, EDI, EDIFACT Authentication Access Control Non Repudiation Privacy Protection Lab Formats
10 EHR (Electronic Health Record) The ISO definition of Integrated Care EHR (Electronic Health Record) is a repository of information regarding the health of a subject of care in computer processable form, stored and transmitted securely, and accessible by multiple authorised users. (interoperability, security, integrated). It has a commonly agreed logical information model which is independent of EHR systems. (interoperability). Its primary purpose is the support of continuing, efficient and quality integrated health care and it contains information which is retrospective, concurrent and prospective (time span)
11 EHR Characteristics A life-long medical record in digital format Clear, well-organized, legible documentation Allows data access in real-time from anywhere, anytime Shared amongst all stakeholders so, able to seamlessly exchange data with related solutions Grows in size from birth till death Requires addressing issues ranging from patient privacy and security to interoperability, and errorfree transmission of information
12 Role of electronic health records (EHRs) in supporting basic medical research and clinical trials Collection of research data for clinical trials can become a by-product of the routine care of the patients Research data may be analyzed directly from the clinical data repository Representing medical knowledge that can be reused through the use of clinical data analytics, Evidence Based Medicine, etc. for improving patient care
13 National Expert Committee for Recommending Standard EMR/EHR set up by Ministry of Health & Family Welfare Expert Committee
14 EMR Standards Committee 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 upgradation
15 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, Notified in September, 2013 on MoH&FW Website
16 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
17 Healthcare Informatics Organisations / Standards considered Organization Standards National Recommendations for Health Information Infrastructure in India International Organization for Standardization (ISO) European Committee for Standardization (CEN) Code of Federal Regulations (CFR) Information Technology Infrastructure for Health (ITIH) framework Recommendations on Guidelines, Standards & Practices for Telemedicine in India Indian health information network development (ihind) recommendations from the National Knowledge Requirements for Electronic Health Record Architecture (ISO / TS 18308) CEN / TC 251 EN Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology (Title 45, Part 170)
18 Healthcare Informatics Organisations/ Standards.. Contd. Organization Standards American Society for Testing & Materials (ASTM) Health Level 7 (HL7) HL7 & ASTM Collaboration National Electrical Manufacturer s Association (NEMA) Continuity of Care Record (CCR) HL7 v2.x HL7 v3 HL7 Clinical Document Architecture (CDA) EHR - System Functional Model Continuity of Care Document (CCD) Digital Imaging and Communications in Medicine (DICOM PS onwards) Office of National Coordinator for Health Information Technology (ONCHIT) United States EHR Meaningful Use
19 Approved Standards: Codes Diseases (Diagnosis) WHO s ICD 10 Procedures WHO s PCS Disability WHO s ICF Clinical Terminology (for clinical observations) IHTSDO s SNOMED CT Laboratory Observations Regenstrief Inst s LOINC
20 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) PS Later revisions can be included as evolved Clinical Data Format HL7 CDA 2.0 (Clinical Document Architecture) ASTM CCR (Continuity of Care Record)
21 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.
22 Minimum Data Set Patient Demographics Observer Details Reasons for visit Allergies & Immunization Clinical Observations Investigation Orders Laboratory Radiology Investigation Results Treatment Plan Medication Active Discontinued Restarted Procedures Diet Life-style Outcome Date- time Stamp
23 Preservation & Security Purpose To protect the confidentiality, integrity, and availability of information Different From Other Industries Regulated (US: HIPAA and other regulations) Community interest Legal issues 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
24 Some Policy Directions: Report of the Steering Committee on Health for 12 th Plan (Incorporating Reports of the Working Groups and deliberations of the Steering Committee Meetings) Health Division Planning Commission Feb. 2012
25 Major emphasis on use of Telemedicine from PHC level and use of EMR A composite HIS should incorporate the following: Out-patient and in-patient information through Electronic Medical Records (EMR).This will help provide the best care based on Standard Treatment Guidelines, reduce response time in emergencies, support the organ retrieval and transplantation programme and improve general hospital administration. It would also help estimate burden of disease and facilitate policy decisions at State and national levels.
26 Major emphasis on use of Telemedicine from PHC level and use of EMR A composite HIS should incorporate the following: Out-patient and in-patient information through Electronic Medical Records (EMR).This will help provide the best care based on Standard Treatment Guidelines, reduce response time in emergencies, support the organ retrieval and transplantation programme and improve general hospital administration. It would also help estimate burden of disease and facilitate policy decisions at State and national levels.
27 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
28 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.
29 Thank You B.S. Bedi: