Report of Sub-Group Task II (data connectivity) with reports of Sub-Group Task I (standards) and Sub-Group Task III (data ownership) incorporated Recommendations On Electronic Medical Records Standards In India Version 2.0 October 2012 Recommendations of EMR Standards Committee, constituted by an order of Ministry of Health & Family Welfare, Government of India 1 Sub-Group Task I (Standards) Members: 1. Prof. Dr. S.V. Mani, TCS, Group Head, Sub-Group Task I 2. Dr. R.R. Sudhir, Shankar Netralaya 3. Ms. Kala Rao, TCS 4. Dr. Ashok Kumar, CBHI 5. Ms. Jyoti Vij , FICCI 6. Dr. Sameer A. Khan, Fortis Hospital Sub-Group Task II (Data Connectivity) Members: 1. Mr. B S Bedi, Adviser, CDAC, Group Head, Sub-Group Task II 2. Dr. Thanga Prabhu, Clinical Director, GE India, Member 3. Dr. Supten Sarbadhikari: Prof, Health Informatics, Coimbatore, Member 4. Mr. Chayan Kanti Dhar, National Informatics Center 5. Mr. Gaur Sundar, Project Manager, Medical Informatics Group, CDAC (Pune), 6. Dr. S. B. Bhattacharyya, Health Informatics Consultant, Ex-President, IAMI Sub-Group Task III (Data Ownership) Members: 1. Prof. Saroj K. Mishra ,SGPGI , Lucknow , Group Head, Sub-Group Task III 2. Prof. Indrajit Bhattacharya , IIHMR, New Delhi 3. Prof. Sita Naik, MCI 4. Dr. Karanveer Singh, Sir Gangaram Hospital 5. Dr. Naveen Jain, CDAC 6. Dr. Arun Bal 7 . Mr. Madhu Aravind, Healthhiway N. B. This document incorporates the recommendations by the various Sub-Groups and consolidated into one document for easy reference. As there was considerable overlap in the areas of recommendations of sub-group Task I responsible for standards and sub-group Task II responsible for data connectivity, most of the recommendations were made primarily by the members of task group II in close consultation with the chairman of sub-group Task I Prof. (Dr.) S. V. Mani. 2 TABLE OF CONTENTS 1. EXECUTIVE SUMMARY .................................................................................................................................. 5 2. BACKGROUND .............................................................................................................................................. 7 3. MAJOR STAKEHOLDERS ................................................................................................................................ 9 4. ELECTRONIC HEALTH RECORDS/ELECTRONIC MEDICAL RECORDS ............................................................... 10 STUDY & ANALYSIS OF NATIONAL EHR/EMR PROGRAMS AROUND THE WORLD ..................................................................... 10 5. INTEROPERABILITY AND STANDARDS ......................................................................................................... 14 GOALS ....................................................................................................................................................................... 14 CATEGORIES FOR ADOPTION OF STANDARDS ...................................................................................................................... 15 Vocabulary Standards ................................................................................................................................................. 15 Content Exchange Standards ...................................................................................................................................... 16 Transport Standards ................................................................................................................................................... 16 Privacy and Security Standards .................................................................................................................................. 17 CLINICAL STANDARDS ................................................................................................................................................... 19 RECOMMENDED HEALTHCARE IT STANDARDS (FOR INDIA) ................................................................................................... 19 HEALTHCARE INFORMATICS STANDARDS ........................................................................................................................... 21 Issues 22 Trends 22 6. EMR MINIMUM DATA SET (MDS) ............................................................................................................... 23 7. OTHER STANDARDS .................................................................................................................................... 27 HARDWARE ................................................................................................................................................................ 27 CONNECTIVITY ............................................................................................................................................................. 27 SOFTWARE ................................................................................................................................................................. 27 8. DATA OWNERSHIP OF EMR ............................................................................................................................ 28 TECHNICAL SECURITY GUIDELINES: ...................................................................................................................... 32 (I) ELECTRONIC DATA STORAGE: ............................................................................................................................... 32 (II ) ELECTRONIC DATA TRANSMISSION: ........................................................................................................................... 32 (III) DATA ACCESS ........................................................................................................................................................ 32 (IV) DATA SHARING: ..................................................................................................................................................... 32 (V) DATA AUDIT: ........................................................................................................................................................ 33 (VI) GENERAL SOFTWARE / APPLICATION REQUIREMENTS: ................................................................................................... 33 ADMINISTRATIVE GUIDELINES: ............................................................................................................................ 33 CERTIFICATION PROCESS: .............................................................................................................................................. 33 PHYSICAL SECURITY GUIDELINES: ........................................................................................................................ 34 10. REFERENCES ............................................................................................................................................... 35 11. ANNEXURES ................................................................................................................................................ 36 ANNEXURE I ................................................................................................................................................................ 36 GO related to Sub-Groups Formation .......................................................................................................................... 36 3 Committee Discussions ................................................................................................................................................ 39 ISP: INTERNET SERVICE PROVIDER .................................................................................................................................. 53 VARIABLE CONTRIBUTION HEALTH PLAN: IN CONTRAST TO A FIXED CONTRIBUTION PLAN, A VARIABLE CONTRIBUTION INVOLVES EMPLOYERS COMMITTING TO A SPECIFIED LEVEL OF BENEFITS FUNDING FOR ITS EMPLOYEES, REGARDLESS OF THE ACTUAL BENEFIT PRICE. EMPLOYERS ARE THUS LOCKED INTO VARIABLE CONTRIBUTION ARRANGEMENTS BECAUSE THEY ARE COMMITTED TO FUNDING A CERTAIN BENEFIT STRUCTURE WITHOUT KNOWING WHAT THE FUTURE COSTS MAY BE IF PREMIUMS ARE RAISED. SEE ALSO FIXED CONTRIBUTION HEALTH PLAN. ............................................................................................................................................................ 63 VITAL STATISTICS: STATISTICS RELATING TO BIRTHS (NATALITY), DEATHS (MORTALITY), MARRIAGES, HEALTH, AND DISEASE (MORBIDITY). VITAL STATISTICS FOR THE UNITED STATES ARE PUBLISHED BY THE NATIONAL CENTER FOR HEALTH STATISTICS. VITAL STATISTICS CAN BE OBTAINED FROM CDC, STATE HEALTH DEPARTMENTS, COUNTY HEALTH DEPARTMENTS AND OTHER AGENCIES. AN INDIVIDUAL PATIENT’S VITAL STATISTICS IN A HEALTH CARE SETTING MAY ALSO REFER SIMPLY TO BLOOD PRESSURE, TEMPERATURE, HEIGHT AND WEIGHT, ETC. ................................................................................................................................................................................ 63 ANNEXURE VI ............................................................................................................................................................. 67 PROPOSED PORTABLE HEALTH RECORD ............................................................................................................................ 67 ANNEXURE VII ...........................................................................................................................................................