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Date: 2025-03-26 Category: Extra Ordinary State: Union Government Country: India

In pursuance of Subrule 1 of Rule 15 of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards

Issued by Bureau of Indian Standards · Not Applicable

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Executive Summary & Key Takeaways

What it means

  • The Bureau of Indian Standards (BIS) has announced the withdrawal of nine Indian Standards related to Health Informatics, effective March 19, 2025. This decision is made in accordance with Sub-rule (1) of Rule 15 of the Bureau of Indian Standards Rules, 2018.

Key Changes

  • Nine Indian Standards pertaining to Health Informatics have been withdrawn.
  • The withdrawn standards cover various aspects of health information technology, including point-of-care medical device communication, service architecture, electronic health record communication, terminological systems, web access to DICOM objects, data protection for trans-border data flows, and safety risks in health software.
  • All nine standards were withdrawn on the same date: March 19, 2025.
  • The specific standards withdrawn are: IS/ISO/IEEE 11073-30300:2004, IS/ISO 12967-2:2009, IS/ISO 13606-1:2008, IS/ISO 13606-5:2010, IS/ISO 17115:2007, IS/ISO 17432:2004, IS/ISO 22857:2013, IS/ISO/TS 25238:2007, and IS/ISO/TR 27809:2007.

Impact Analysis

Stakeholders Affected

  • Consumers and patients whose health information is managed using these standards.

Potential Impacts

  • The withdrawal of standards related to data protection could raise concerns about the security and privacy of patient data if not addressed proactively.

Suggested Action Items

  • Review and update data protection policies and procedures to ensure compliance with applicable regulations.

Key Entities Referenced

Bureau of Indian Standards (BIS): The national standards body of India responsible for formulating and promoting standards for various products and services. Bureau of Indian Standards Rules, 2018: The set of rules governing the operations and functions of the Bureau of Indian Standards. Health Informatics: The field concerned with the acquisition, storage, retrieval and use of information in health and biomedicine. IS/ISO/IEEE 11073-30300:2004: Indian Standard for Health Informatics — Point-of-Care Medical Device Communication Part 30300 Transport Profile — Infrared Wireless. IS/ISO 12967-2:2009: Indian Standard for Health Informatics — Service Architecture Part 2 Information Viewpoint. IS/ISO 13606-1:2008: Indian Standard for Health Informatics — Electronic Health Record Communication Part 1 Reference Model. IS/ISO 13606-5:2010: Indian Standard for Health Informatics — Electronic Health Record Communication Part 5 Interface Specification. IS/ISO 17115:2007: Indian Standard for Health Informatics — Vocabulary for Terminological Systems. IS/ISO 17432:2004: Indian Standard for Health Informatics — Messages and Communication — Web Access to DICOM Persistent Objects. IS/ISO 22857:2013: Indian Standard for Health Informatics — Guidelines on Data Protection to Facilitate Trans-border Flows of Personal Health Data. IS/ISO/TS 25238:2007: Indian Standard for Health Informatics — Classification of Safety Risks from Health Software. IS/ISO/TR 27809:2007: Indian Standard for Health Informatics — Measures for Ensuring Patient Safety of Health Software.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-30032025-262161 xxxGIDHxxx CG-DL-E-30032025-262161 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 256] नई दिल्ली, बुधिार, माच च26, 2025/ / चैत्र 5, 1947 No. 256] NEW DELHI, WEDNESDAY, MARCH 26, 2025/ CHAITRA 5, 1947 भारतीय मानक ब्यरू ो (उपभोक्ता मामल ेजिभाग) अजधसचू ना नई दिल्ली, 24 माच,च 2025 सिं भ:च HQ—PUB017/1/2020—PUB—BIS (1201).—भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण म ें भारतीय मानक ब्यूरो एतिद्वाराअजधसूजचत करता ह ै की जिन भारतीय मानको का जििरण इसके साथ सलं ग्र अनूसूची म े दिया गया ह,ै उन्ह ें कॉलम तीन में इंजगत तारीख को रद्द कर दिया या और िाजपस ल े जलया गया ह।ै अनसु चू ी क्रम िाजपस जलए गए भारतीय मानकों की सख्ं या, िर् चतथा िीर्कच िाजपस जलए िान ेकी स.ं तारीख (1) (2) (3) आई एस/आई एस ओ/आई ई ई ई 11073-30300 : 2004 19 माच च 2025 1 स्ट्िास्ट््य सूचना जिज्ञान — पॉइंट-ऑफ़-केयर मेजडकल जडिाइस कम्युजनकेिन भाग 30300 रांसपोटच प्रोफाइल — इंफ्रारेडिायरलेस 2117 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] आई एस/आई एस ओ 12967-2 : 2009 19 माच च 2025 2 स्ट्िास्ट््य सूचना जिज्ञान — सर्िचस आर्कचटेक्चर भाग 2 सूचना िजृ िकोण आई एस/आई एस ओ 13606-1 : 2008 19 माच च 2025 3 स्ट्िास्ट््य सूचना जिज्ञान — इलक्ै रॉजनक स्ट्िास्ट््य ररकॉडच संचार भाग 1 संिभ च प्रजतरूप आई एस/आई एस ओ 13606-5 : 2010 19 माच च 2025 4 स्ट्िास्ट््य सूचना जिज्ञान — इलक्े रॉजनक हल्े थ ररकॉड च संचार भाग 5 इंटरफ़ेस जिजिि आई एस/आई एस ओ 17115 : 2007 19 माच च 2025 5 स्ट्िास्ट््य सूचना जिज्ञान — पररभार्ीय प्रणाजलयों के जलए िब्िािली आई एस/आई एस ओ 17432 : 2004 19 माच च 2025 6 स्ट्िास्ट््य सूचना जिज्ञान — संििे और संचार — डी आई सी ओ एम पर्सचस्ट्टन्ट ऑजब्िक्ट् तक िेब एक्सेस आई एस/आई एस ओ 22857 : 2013 19 माच च 2025 7 स्ट्िास्ट््य सूचना जिज्ञान — व्यजक्तगत स्ट्िास्ट््य डेटा के रांस-बॉडचर प्रिाह की सुजिधा के जलए डेटा संरक्षण पर दििाजनिेि आई एस/आई एस ओ/टी एस 25238 : 2007 19 माच च 2025 8 स्ट्िास्ट््य सूचना जिज्ञान — स्ट्िास्ट््य सॉफ्टिेयर स ेसुरक्षा िोजखमों का िगीकरण आई एस/आई एस ओ/टी आर 27809 : 2007 9 स्ट्िास्ट््य सूचना जिज्ञान — स्ट्िास्ट््य सॉफ्टिेयर म ें रोगी सुरक्षा सुजनजित करन े के जलए 19 माच च 2025 उपाय जचत्रा गुप्ता, िैज्ञाजनक िी एिं उप महाजनिेिक (हॉलमार्किंग एि ं रेननंग) [जिज्ञापन-III/4/असा./1113/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 24th March, 2025 Ref: HQ-PUB017/1/2020-PUB-BIS (1201).—In pursuance of Sub—rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards hereby notifies that the Indian standards, particulars of which are given in schedule hereto annexed have been cancelled and stands withdrawn from the date indicated against it in the third column.[भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3 SCHEDULE Sl No., Year & Title of the Indian Standard Withdrawn Date of Withdrawal No. (1) (2) (3) IS/ISO/IEEE 11073-30300 : 2004 19 March 2025 1 Health Informatics — Point-of-Care Medical Device Communication Part 30300 Transport Profile — Infrared Wireless IS/ISO 12967-2 : 2009 19 March 2025 2 Health Informatics — Service Architecture Part 2 Information Viewpoint IS/ISO 13606-1 : 2008 19 March 2025 3 Health Informatics — Electronic Health Record Communication Part 1 Reference Model IS/ISO 13606-5 : 2010 19 March 2025 4 Health Informatics — Electronic Health Record Communication Part 5 Interface Specification IS/ISO 17115 : 2007 19 March 2025 5 Health Informatics — Vocabulary for Terminological Systems IS/ISO 17432 : 2004 19 March 2025 6 Health Informatics — Messages and Communication — Web Access to DICOM Persistent Objects IS/ISO 22857 : 2013 19 March 2025 7 Health Informatics — Guidelines on Data Protection to Facilitate Trans-border Flows of Personal Health Data IS/ISO/TS 25238 : 2007 19 March 2025 8 Health Informatics — Classification of Safety Risks from Health Software IS/ISO/TR 27809 : 2007 19 March 2025 9 Health Informatics — Measures for Ensuring Patient Safety of Health Software CHITRA GUPTA, Scientist G & DDG (Hallmarking and Training) [ADVT.-III/4/Exty./1113/2024-25] Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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