Programme of work


BUREAU OF INDIAN STANDARDS


Medical Equipment and Hospital Planning Department

Programme of Work




MHD17 : Health Informatics


  • Scope : (a) Standardization in the field of health informatics, to facilitate capture, interchange and use of health-related data, information, and knowledge to support and enable all aspects of health systems. (b) To coordinate with the work of: i) ISO/TC 215 'Health Informatics': (P-Member) ii) ISO/TC 215/SC 1 ‘Genomics Informatics’: (P-Member)
  • Liaison :
    IEC SyC BDC - Bio-digital convergence - Participating (P)
    ISO/TC 215/SC 1 - Genomics Informatics - Participating (P)
    ISO/TC 215 - Health informatics - Participating (P)
    ISO/TC 215/CAG 02 - Advisory group
    ISO/TC 215/CAG 1 - Executive council, harmonization and operations
    ISO/TC 215/JWG 7 - Joint ISO/TC 215 - IEC/SC 62A WG: Safe, effective and secure health software and health IT systems, including those incorporating medical devices
    ISO/TC 215/SC 1/AHG 1 - Secondary use of genomics data
    ISO TC 215/SC 1/WG 1 - Genomics data sharing
    ISO/TC 215/TF 1 - Task Force on Quantities and Units to be used in e-health
    ISO/TC 215/TF 5 - AI technologies in health informatics
    ISO/TC 215/TF 7 - Telehealth and Virtual Care (TVC) Standards
    ISO TC 215/WG 1 - Architecture, Frameworks and Models
    ISO TC 215/WG 10 - Traditional Medicine
    ISO TC 215/WG 11 - Personalized digital health
    ISO TC 215/WG 2 - Systems and Device Interoperability
    ISO TC 215/WG 3 - Semantic content
    ISO TC 215/WG 4 - Security, Safety and Privacy
    ISO TC 215/WG 6 - Pharmacy and medicines business

Published Standards

SI. No.
IS No.
Title
Reaffirmation Details
No. of Amendments
Degree of Equivalence
1.
IS/ISO 10159 : 2011
ISO 10159 : 2011
Health informatics - Messages and communication - Web access reference manifest
-
Identical under single numbering
2.
IS/ISO 10781 : 2015
ISO HL 10781:2015
Health Informatics HL 7 Electronic Health Record-System Functional Model, Release 2 (EHR FM)
-
Identical under dual numbering
3.
IS/ISO/IEEE 11073-00103 : 2015
ISO/IEEE 11073-00103 : 2015
Health informatics - Personal health device communication: Part 00103 overview
-
Identical under single numbering
4.
IS/ISO/IEEE 11073-10101 : 2020
ICS 01.040.35; 35.240.80
Reviewed In : 2023
Health Informatics — Point-of-Care Medical Device Communication Part 10101 Nomenclature
September, 2023
-
Identical under single numbering
5.
IS/ISO/IEEE 11073-10102 : 2014
ISO/IEEE 11073-10102 : 2014
Health Informatics — Point-of-care Medical Device Communication Part 10102 Nomenclature — Annotated ECG
-
Identical under single numbering
6.
IS/ISO/IEEE 11073-10103 : 2014
ISO/IEEE 11073-10103 : 2014
Health Informatics — Point-of-Care Medical Device Communication Part 10103 Nomenclature — Implantable Device, Cardiac
-
Identical under single numbering
7.
IS/ISO/IEEE 11073-10201 : 2004
ISO/IEEE 11073-10201 : 2004
Health informatics - Point-of-care medical device communication: Part 10201 domain information model
-
Identical under single numbering
8.
IS/ISO/IEEE 11073-10207 : 2019
ISO/IEEE 11073-10207 : 2019
Health Informatics — Personal Health Device Communication Part 10207 Domain Information and Service Model for Service-Oriented Point-of Care Medical Device Communication
-
Identical under single numbering
9.
IS/ISO/IEEE 11073-10404 : 2010
ISO/IEEE 11073-10404 : 2010
Health informatics - Personal health device communication: Part 10404 device specialization - Pulse oximeter
-
Identical under single numbering
10.
IS/ISO/IEEE 11073-10406 : 2012

Health informatics - Personal health device communication: Part 10406 device specialization - Basic electrocardiograph (Ecg) (1 - to 3 - Lead ECG)
-
Identical under single numbering
11.
IS/ISO/IEEE 11073-10407 : 2010
ISO/IEEE 11073-10408 : 2010
Health Informatics — Personal Health Device Communication Part 10408 Device Specialization — Thermometer
-
Identical under single numbering
12.
IS/ISO/IEEE 11073-10408 : 2010

Health informatics - Personal health device communication: Part 10408 device specialization - Thermometer
-
Identical under single numbering
13.
IS/ISO/IEEE 11073-10415 : 2010

Health informatics - Personal health device communication: Part 10415 device specialization - Weighing scale
-
Identical under single numbering
14.
IS/ISO/IEEE 11073-10417 : 2017

Health informatics - Personal health device communication: Part 10417 device specialization - Glucose meter
-
Identical under single numbering
15.
IS/ISO/IEEE 11073-10418 : 2014

Health informatics - Personal health device communication: Part 10418 device specialization: international normalized ratio (INR) monitor
1
Identical under single numbering
16.
IS/ISO/IEEE 11073-10419 : 2016
ISO/IEEE 11073-10419 : 2016
Health informatics - Personal health device communication: Part 10419 device specialization - Insulin pump
-
Identical under single numbering
17.
IS/ISO/IEEE 11073-10420 : 2012
ISO/IEEE 11073-10420 : 2012
Health Informatics — Personal Health Device Communication Part 10420 Device Specialization — Body Composition Analyzer
-
Identical under single numbering
18.
IS/ISO/IEEE 11073-10421 : 2012
ISO/IEEE 11073-10421 : 2012
Health informatics - Personal health device communication: Part 10421 device specialization - Peak expiratory flow monitor (Peak Flow)
-
Identical under single numbering
19.
IS/ISO/IEEE 11073-10422 : 2017
ISO/IEEE 11073-10422 : 2017
Health informatics - Personal health device communication: Part 10422 device specialization - Urine analyser
-
Identical under single numbering
20.
IS/ISO/IEEE 11073-10424 : 2019
IS/ISO/IEEE 11073-10424 : 2016
Health informatics - Personal health device communication: Part 10424 device specialization - Sleep apnoea breathing therapy equipment (SABTE)
1
Identical under single numbering
21.
IS/ISO/IEEE 11073-10425 : 2016
ISO/IEEE 11073-10425 : 2016
Health informatics - Personal health device communication: Part 10425 device specialization - Continuous glucose monitor (CGM)
-
Identical under single numbering
22.
IS/ISO/IEEE 11073-10427 : 2018
ISO/IEEE 11073-10427 : 2018
Health informatics - Personal health device communication: Part 10427 device specialization - Power status monitor of personal health devices
-
Identical under single numbering
23.
IS/ISO/IEEE 11073-10441 : 2015

Health informatics - Personal health device communication: Part 10441 device specialization - Cardiovascular fitness and activity monitor
-
Identical under single numbering
24.
IS/ISO/IEEE 11073-10442 : 2015
ISO/IEEE 11073-10442 : 2015
Health Informatics — Personal Health Device Communication Part 10442 Device Specialization — Strength Fitness Equipment
-
Identical under single numbering
25.
IS/ISO/IEEE 11073-10471 : 2010
ISO/IEEE 11073-10471 : 2010
Health informatics - Personal health device communication: Part 10471 device specialization - Independent living activity hub
-
Identical under single numbering
26.
IS/ISO/IEEE 11073-10472 : 2012
ISO/IEEE 11073-10472 : 2012
Health informatics - Personal health device communication: Part 10472 device specialization - Medication monitor
-
Identical under single numbering
27.
IS/ISO/IEEE 11073-20101 : 2004
ISO/IEEE 11073-20101 : 2004
Health informatics - Point-of-care medical device communication: Part 20101 application profiles - Base standard
-
Identical under single numbering
28.
IS/ISO/IEEE 11073-20601 : 2016
ISO/IEEE 11073-20601 : 2016
Health Informatics — Personal Health Device Communication Part 20601 Application Profile — Optimized Exchange Protoco
-
Identical under dual numbering
29.
IS/ISO/IEEE 11073-20702 : 2018
ISO/IEEE 11073-20702
Health Informatics — Point-of-Care Medical Device Communication Part 20702 Medical Devices Communication Profile for Web Services
-
Identical under single numbering
30.
IS/ISO/IEEE 11073-30200 : 2004
ISO/IEEE 11073-30200 : 2004
Health Informatics — Point-of-Care Medical Device Communication Part 30200 Transport Profile — Cable Connected
-
Identical under dual numbering
31.
IS/ISO/IEEE 11073-30300 : 2004
ISO/IEEE 11073-30300 : 2004
Health informatics - Point-of-care medical device communication: Part 30300 transport profile - Infrared wireless
-
Identical under single numbering
32.
IS/ISO/IEEE 11073-30400 : 2012
ISO/IEEE 11073-30400 : 2012
Health informatics - Point-of-care medical device communication: Part 30400 interface profile - Cabled ethernet
-
Identical under single numbering
33.
IS/ISO 11073-90101 : 2008
IS/ISO/11073-90101 : 2008
Health informatics - Point-of-care medical device communication: Part 90101 analytical instruments - Point-of-care test
-
Identical under single numbering
34.
IS/ISO 11073-91064 : 2009
ISO 11073-91064 : 2009
Health informatics - Standard communication protocol: Part 91064 computer - Assisted electrocardiography
-
Identical under single numbering
35.
IS/ISO 11239 : 2012
ISO 11239 : 2012
Reviewed In : 2023
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging
May, 2023
-
Identical under single numbering
36.
IS/ISO 11240 : 2012
ISO 11240 : 2012
Reviewed In : 2023
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement
May, 2023
-
Identical under single numbering
37.
IS/ISO 11615 : 2017
ISO 11615 : 2017
Health Informatics Identification of Medicinal Products Data Elements and Structures for the Unique Identification and Exchange of Regulated Medicinal Product Information
-
Identical under single numbering
38.
IS/ISO 11616 : 2017
ISO 11616 : 2017
Health informatics - Identification of medicinal products - Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
-
Identical under single numbering
39.
IS/ISO/IEC 11703-20601 : 2018
ISO/IEEE 11073-20601 : 2016
Health Informatics — Personal Health Device Communication Part 20601 Application Profile — Optimized Exchange Protocol
-
Identical under single numbering
40.
IS/ISO 12052 : 2017
ISO 12052 : 2017
Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (First Revision)
-
-
Identical under single numbering
41.
IS/ISO 12381 : 2019
ISO 12381:2019
Health Informatics Explicit time-related expressions for healthcare-specific problems
-
Identical under single numbering
42.
IS/ISO 12967-2 : 2009
ISO 12967-2 : 2009
Health informatics - Service architecture: Part 2 information viewpoint
-
Identical under single numbering
43.
IS/ISO 13119 : 2022
ISO 13119:2022
Health Informatics Clinical knowledge resources Metadata First Revision
-
Identical under single numbering
44.
IS/ISO 13120 : 2019
ISO 13120:2019
Health Informatics Syntax to represent the content of healthcare classification systems Classification Markup Language ClaML
-
Identical under single numbering
45.
IS/ISO 13606-1 : 2008
ISO 13606-1 : 2008
Reviewed In : 2020
Health informatics - Electronic health record communication: Part 1 reference model
November, 2020
-
Identical under single numbering
46.
IS/ISO 13606-3 : 2009
ISO 13606-3 : 2009
Reviewed In : 2019
Health informatics - Electronic health record communication: Part 3 references archetypes and term lists
July, 2019
-
Identical under single numbering
47.
IS/ISO 13606-5 : 2010
ISO 13606-5 : 2010
Health informatics - Electronic health record communication: Part 5 interface specification
-
Identical under single numbering
48.
IS/ISO 13940 : 2015
ISO 13940 : 2015
Health Informatics — System of Concepts to Support Continuity of Care
-
Identical under single numbering
49.
IS/ISO/TS 13972 : 2022
ISO 13972:2022
Health Informatics Clinical information models Characteristics structures and requirements (First Revision)
-
Identical under single numbering
50.
IS/ISO/TS 14265 : 2011
ISO/TS 14265 : 2011
Health informatics - Classification of purposes for processing personal health information
-
Identical under single numbering
51.
IS/ISO/TS 14441 : 2013
ISO/TS 14441 : 2013
Reviewed In : 2023
Health informatics - Security and privacy requirements of EHR systems for use in conformity assessment
May, 2023
-
Identical under single numbering
52.
IS/ISO 16278 : 2016
ISO 16278:2016
Health informatics Categorial structure for terminological systems of human anatomy
-
Identical under single numbering
53.
IS/ISO 17090-1 : 2013
ISO 17090-1 : 2013
Reviewed In : 2023
Health informatics - Public key infrastructure: Part 1 overview of digital certificate services
May, 2023
-
Identical under single numbering
54.
IS/ISO 17090-1 : 2023
ISO 17090-1:2021
Health informatics Public key infrastructure Part 1 Overview of digital certificate services (First Revision)
-
Identical under single numbering
55.
IS/ISO 17090-2 : 2015
ISO 17090-2 : 2015
Health informatics - Public key infrastructure: Part 2 certificate profile
-
Identical under single numbering
56.
IS 17090 (Part 3) : 2008
ISO 17090-3 : 2008
Health Informatics — Public Key Infrastructure Part 3 Policy Management of Certification Authority
-
Identical under single numbering
57.
IS 17090 (Part 3) : 2021
ISO 17090-3:2021
Health informatics Public key infrastructure Part 3 Policy management of certification authority (First Revision)
-
Identical under single numbering
58.
IS/ISO 17090-4 : 2023
ISO 17090-4:2020
Health informatics Public key infrastructure Part 4 Digital signatures for healthcare documents (First Revision)
-
Identical under single numbering
59.
IS/ISO 17090-4 : 2014
ISO 17090-4 : 2014
Health informatics - Public key infrastructure: Part 4 digital signatures for healthcare documents
-
Identical under single numbering
60.
IS/ISO 17090-5 : 2017
ISO 17090-5 : 2017
Health informatics - Public key infrastructure: Part 5 authentication using healthcare PKI credentials
-
Identical under single numbering
61.
IS/ISO 17115 : 2007
ISO17115:2007
Reviewed In : 2023
Health informatics - Vocabulary for terminological systems
March, 2023
-
Identical under single numbering
62.
IS/ISO 17117-1 : 2018
ISO 17117-1:2018
Health informatics Terminological resources Part 1 Characteristics
-
Identical under single numbering
63.
IS/ISO/TS 17117-2 : 2022
ISO/TS 17117-2:2022
Health informatics Terminological resources Part 2 Implementation CapabilityTIC
-
Identical under single numbering
64.
IS/ISO 17432 : 2004
ISO 17432 : 2004
Health informatics - Messages and communication - Web access to dicom persistent objects
-
Identical under single numbering
65.
IS 17762 : 2022
ISO/TR 11636:2009
Health Informatics Dynamic on-demand virtual private Network for health information infrastructure
-
Identical under dual numbering
66.
IS 17763 : 2022
ISO/TR 17522:2015
Health informatics Provisions for Health Applications on mobilesmart Devices
-
Identical under dual numbering
67.
IS 17764 : 2022
ISO TS 19293:2018
Health informatics Requirements for a record of a dispense of a medicinal product
-
Identical under dual numbering
68.
IS 17765 : 2022
ISO TR 21835:2020
Health informatics Personal health data Generated on a daily basis
-
Identical under dual numbering
69.
IS 17766 : 2022
ISO 21091:2013
Health informatics Directory services for healthcare Providers subjects of care and other entities
-
Identical under dual numbering
70.
IS 17767 : 2022
ISO TS 17251:2016
Health informatics Business requirements for a syntax to exchange structured dose information for medicinal products
-
Identical under dual numbering
71.
IS 17768 : 2022
ISO/TS 22756:2020
Health Informatics Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes
-
Identical under dual numbering
72.
IS 17769 : 2022
ISO 17523:2016
Health informatics Requirements for Electronic prescriptions
-
Identical under dual numbering
73.
IS 17770 : 2022
ISO TR 20831:2017
Health informatics Medication management Concepts and definitions
-
Identical under dual numbering
74.
IS 17771 : 2022
ISO 17115 : 2020
Health informatics - Representation of categorial structures of terminology (CatStructure)
-
Identical under dual numbering
75.
IS/ISO/TR 17791 : 2013
ISO/TR 17791 : 2013
Reviewed In : 2023
Health informatics - Guidance on standards for enabling safety in health software
May, 2023
-
Identical under single numbering
76.
IS 17797 : 2022
ISO 22857:2013
Health informatics Guidelines on data protection to facilitate Trans border flows of personal health data
-
Identical under dual numbering
77.
IS 17798 : 2022
ISO TS 20428:2017
Health informatics Data elements and their metadata for describing structured clinical genomic sequence information in electronic health records
-
Identical under dual numbering
78.
IS 17851 : 2022
ISO/TR 22696:2020
Health informatics Guidance on the identification and authentication of connectable Personal Healthcare Devices PHDs
-
Identical under dual numbering
79.
IS 17852 : 2022
ISO TS 21547:2010
Health informatics Security requirements for archiving of Electronic health records Principles
-
Identical under dual numbering
80.
IS 17887 : 2022
ISO 25720:2009
Health informatics Genomic Sequence Variation Markup Language GSVML
-
Identical under dual numbering
81.
IS 17888 : 2022
ISO 27269:2021
Health informatics International patient summary
-
Identical under dual numbering
82.
IS/ISO/TS 17975 : 2022
ISO/TS 17975:2022
Health Informatics Principles and data requirements for consent in the collection use or disclosure of personal health information First Revision
-
Identical under single numbering
83.
IS 18198 (Part 1) : 2023
ISO/TS 11633-1:2019
Health informatics Information security management for remote maintenance of medical devices and medical information systems Part 1 Requirements and risk analysis
-
Identical under dual numbering
84.
IS 18199 : 2023
ISO 11238:2018
Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances
-
Identical under dual numbering
85.
IS 18216 : 2023
ISO/TS 16791:2020
Health informatics Requirements for international machine-readable coding of medicinal product package identifiers
-
Identical under dual numbering
86.
IS 18218 (Part 2) : 2023
ISO/TR 11633-2:2021
Health informatics Information security management for remote maintenance of medical devices and medical information systems Part 2 Implementation of an information security management system ISMS
-
Identical under dual numbering
87.
IS/ISO 1828 : 2012
ISO 1828 : 2012
Reviewed In : 2023
Health informatics - Categorial structure for terminological systems of surgical procedures
May, 2023
-
Identical under single numbering
88.
IS 18301 (Part 1) : 2023
ISO 13606-1:2019
Health informatics Electronic health record communication : Part 1 Reference model
-
Identical under dual numbering
89.
IS 18301 (Part 2) : 2023
ISO 13606-2:2019
Health informatics Electronic health record communication : Part 2 Archetype interchange specification
-
Identical under dual numbering
90.
IS 18301 (Part 3) : 2023
ISO 13606-3:2019
Health informatics Electronic health record communication Part 3 Reference archetypes and term lists
-
Identical under dual numbering
91.
IS 18301 (Part 4) : 2023
ISO 13606-4:2019
Health informatics Electronic health record communication Part 4 Security
-
Identical under dual numbering
92.
IS 18301 (Part 5) : 2023
ISO 13606-5:2019
Health informatics Electronic health record communication Part 5 Interface specification
-
Identical under dual numbering
93.
IS 18302 (Part 1) : 2023
ISO 12967-1:2020
Health informatics Service architectureHISA Part 1 Enterprise viewpoint
-
Identical under dual numbering
94.
IS 18302 (Part 2) : 2023
ISO 12967-2:2020
Health informatics Service architectureHISA Part 2 Information viewpoint
-
Identical under dual numbering
95.
IS 18302 (Part 3) : 2023
ISO 12967-3:2020
Health informatics Service architectureHISA Part 3 Computational viewpoint
-
Identical under dual numbering
96.
IS 18303 : 2023
ISO 27789:2021
Health informatics Audit trails for electronic health records
-
Identical under dual numbering
97.
IS/ISO 18308 : 2011
ISO 18308 : 2011
Reviewed In : 2019
Health informatics - Requirements for an electronic health record architecture
July, 2019
-
Identical under single numbering
98.
IS/ISO 20301 : 2014
ISO 20301:2014
Reviewed In : 2023
Health informatics - Health cards - General characteristics (First Revision)
March, 2023
-
Identical under single numbering
99.
IS/ISO 20302 : 2022
ISO 20302:2022
Health informatics Health cards Numbering system and registration procedure for issuer identifiers
-
Identical under single numbering
100.
IS/ISO/TR 20514 : 2005
Reviewed In : 2020
Health informatics - Electronic health record - Definition, scope and context
October, 2020
-
Identical under single numbering
101.
IS/ISO 21090 : 2011
ISO 21090 : 2011
Health Informatics — Harmonized Data Types for Information Interchange
-
Identical under single numbering
102.
IS/ISO 21549-1 : 2013
ISO 21549-1 : 2013
Reviewed In : 2023
Health Informatics — Patient Healthcard Data Part 1 General Structure
May, 2023
-
Identical under dual numbering
103.
IS/ISO 21549-2 : 2014
ISO 21549-2 : 2014
Reviewed In : 2023
Health Informatics — Patient Healthcard Data Part 2 Common objects
May, 2023
-
104.
IS/ISO 21549-3 : 2014
ISO 21549-3:2014
Reviewed In : 2023
Health Informatics -- Patient Healthcard Data -- Part 3: Limited Clinical Data
May, 2023
-
Identical under dual numbering
105.
IS/ISO 21549-4 : 2014
ISO 21549-4 : 2014
Reviewed In : 2023
Health Informatics — Patient Health Card Data Part 4 Extended Clinical Data
May, 2023
-
Identical under dual numbering
106.
IS/ISO 21549-5 : 2015
ISO 21549-5 : 2015
Health informatics - Patient healthcard data: Part 5 identification data
-
Identical under single numbering
107.
IS 21549 (Part 6) : 2008
ISO 21549-6 : 2008
Reviewed In : 2023
Health Informatics - Patient Health Card Data Part 6 Administrative Data
May, 2023
-
Identical under dual numbering
108.
IS/ISO 21549-7 : 2016
ISO 21549-7 : 2016
Health informatics - Patient healthcard data: Part 7 medication data
-
Identical under single numbering
109.
IS/ISO 21549-8 : 2010
ISO 21549-8 : 2010
Reviewed In : 2023
Health informatics - Patient health card data: Part 8 links
May, 2023
-
Identical under single numbering
110.
IS/ISO 21860 : 2020
ISO 21860:2022
Health informatics Reference standards portfolio RSP Clinical imaging
-
Identical under single numbering
111.
IS/ISO/TS 22077-2 : 2015
ISO 22077-2 : 2015
Health informatics ? Medical waveform format: Part 2 electrocardiography
-
Identical under single numbering
112.
IS/ISO/TS 22077-3 : 2015
ISO/TS 22077-3 : 2015
Health Informatics ― Medical Waveform Format Part 3 Long Term Electrocardiography
-
Identical under single numbering
113.
IS/ISO/TS 22220 : 2011
ISO/TS 22220 : 2011
Reviewed In : 2023
Health informatics - Identification of subjects of health care
February, 2023
-
Identical under single numbering
114.
IS/ISO/TR 22221 : 2006
ISO/TR 22221 : 2006
Reviewed In : 2023
Health Informatics — Good Principles and Practices for a Clinical Data Warehouse
January, 2023
-
Identical under dual numbering
115.
IS/ISO/TS 22272 : 2021
ISO/TS 22272:2021
Health Informatics Methodology for analysis of business and information needs of health enterprises to support standards based architectures
-
Identical under single numbering
116.
IS/ISO 22600-1 : 2014
ISO 22600-1 : 2014
Reviewed In : 2023
Health informatics - Privilege management and access control: Part 1 overview and policy management
May, 2023
-
Identical under single numbering
117.
IS/ISO 22600-2 : 2014
IS/ISO 22600-2 : 2014
Reviewed In : 2023
Health informatics - Privilege management and access control: Part 2 formal models
May, 2023
-
Identical under single numbering
118.
IS/ISO 22600-3 : 2014
22600-3 : 2004
Reviewed In : 2023
Health informatics - Privilege management and access control: Part 3 implementations
May, 2023
-
Identical under single numbering
119.
IS/ISO 22857 : 2013
ISO 22857 : 2013
Health informatics - Guidelines on data protection to facilitate trans - Border flows of personal health data
-
Identical under single numbering
120.
IS/ISO 23903 : 2021
ISO 23903:2021
Health Informatics Interoperability and integration reference architecture Model and framework
-
Identical under single numbering
121.
IS/ISO 25237 : 2017
IS/ISO 25237 : 2017
Health informatics - Pseudonymization
-
Identical under single numbering
122.
IS/IEC/TS 25238 : 2007
ISO/TS 25238 : 2007
Health Informatics - Classification of Safety Risks from Health Software
-
Identical under single numbering
123.
IS/ISO/TS 27527 : 2010
ISO/TS 27527 : 2010
Health informatics - Provider identification
-
Identical under single numbering
124.
IS/ISO 27799 : 2016
ISO 27799 : 2016
Health informatics - Information security management in health using ISO/IEC 27002
-
Identical under single numbering
125.
IS/ISO/TR 27809 : 2007
ISO/TR 27809 : 2007
Health informatics - Measures for ensuring patient safety of health software
-
Identical under single numbering
126.
IS/IEC/TR 80001-2-2 : 2012
IEC/TR 80001-2-2 : 2012
Reviewed In : 2023
Application of risk management for it - Networks incorporating medical devices: Part 2 - 2 guidance for the disclosure and communication of medical device security needs, risks and controls
May, 2023
-
Identical under single numbering
127.
IS/IEC 82304-1 : 2016
IEC 82304-1 : 2016
Health software: Part 1 general requirements for product safety
-
Identical under single numbering
128.
IS/ISO/TS 82304-2 : 2021
ISO/TS 82304-2:2021
Health software Part 2 Health and wellness appsQuality and reliability
-
Identical under single numbering

Standards Under Develpoment

Projects Approved

SI. No.
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TITLE
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Preliminary Draft Standards

SI. No.
Doc No
TITLE
No Records Found

Drafts Standards in WC Stage

SI. No.
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No Records Found

Draft Standards Completed WC Stage

SI. No.
Doc No
TITLE
1
MHD 17 (24645)
Revision of: IS/ISO/TS 22077:2015
Health Informatics Medical Waveform Format Part 2 Electrocardiography First Revision
2
MHD 17 (24647)
Revision of: IS/ISO/TS 22077:2015
Health Informatics Medical Waveform Format Part 3 Long-term Electrocardiography First Revision
3
MHD 17 (25676)
Revision of: IS/ISO 21549:2016
Health informatics Patient Healthcard Data Part 7 Medication Data First Revision
4
MHD 17 (25677)
Health Informatics Medical Waveform Format Part 1 Encoding Rules
5
MHD 17 (25679)
Revision of: IS/ISO/IEEE 11073:2020
Health Informatics Device Interoperability Part 10101 Point-of-Care Medical Device Communication Nomenclature First Revision
6
MHD 17 (25680)
Revision of: IS/ISO/TS 14265:2011
Health Informatics Classification of Purposes for Processing Personal Health Information First Revision
7
MHD 17 (25681)
Revision of: IS 17767:2022
Health informatics Business Requirements for a Syntax to Exchange Structured Dose Information for Medicinal Products First Revision

Finalized Draft Indian Standard

SI. No.
Doc No
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No Records Found

Finalized Draft Indian Standards under Print

SI. No.
Doc No
TITLE
1
MHD 17 (23687)
Health Informatics Introduction to Ayurveda Informatics
2
MHD 17 (23688)

Revision of: IS/ISO 11239:2012
Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms units of presentation routes of administration and packaging First Revision
3
MHD 17 (23689)
Health Informatics Identification of Medicinal Products Data Elements and Structures for the Unique Identification and Exchange of Regulated Medicinal Product Information Amendment - 1
4
MHD 17 (23754)

Revision of: IS/ISO/IEEE 11073:2016
Health informatics Device interoperability Part 20601 Personal health device communication Application profile Optimized exchange protocol First Revision
5
MHD 17 (23773)

Revision of: IS/ISO/IEEE 11073:2004
Health informatics Device interoperability Part 10201 Point-of-care medical device communication Domain information model First Revision
6
MHD 17 (23774)

Revision of: IS/ISO/IEEE 11073:2010
Health informatics Device interoperability Part 10404 Personal health device communication Device specialization Pulse oximeter First Revision
7
MHD 17 (23775)

Revision of: IS/ISO/IEEE 11073:2010
Health informatics Device interoperability Part 10407 Personal health device communication Device specialization Blood pressure monitor First Revision
8
MHD 17 (23776)

Revision of: IS/ISO/IEEE 11073:2010
Health informatics Device interoperability Part 10408 Personal health device communication Device specialization Thermometer First Revision
9
MHD 17 (23777)

Revision of: IS/ISO/IEEE 11073:2010
Health informatics Device interoperability Part 10415 Personal health device communication Device specialization Weighing scale First Revision
10
MHD 17 (23778)

Revision of: IS/ISO/IEEE 11073:2016
Health informatics Personal health device communication Part 10419 Device specialization Insulin pump First Revision
11
MHD 17 (23779)

Revision of: IS/ISO/IEEE 11073:2012
Health informatics Device interoperability Part 10420 Personal health device communication Device specialization Body composition analyzer First Revision
12
MHD 17 (25053)

Revision of: IS/ISO 10781:2015
Health Informatics HL7 Electronic Health Record-System Functional Model Release 2 1 EHR FM First Revision
13
MHD 17 (25054)

Revision of: IS/ISO/IEEE 11073:2016
Health Informatics Personal Health Device Communication Part 10425 Device Specialization Continuous Glucose Monitor CGM First Revision
14
MHD 17 (25055)

Revision of: IS/ISO 21549:2015
Health Informatics Patient Healthcard Data Part 5 Identification Data First Revision
15
MHD 17 (25056)
Health Informatics Framework for Healthcare and Related Data Reporting
16
MHD 17 (25057)
Health Informatics Standard Communication Protocol Computer-Assisted Electrocardiography


Aspect Wise Report

 
 Product:   0
 Code of Practices :    3
 Methods of Test :   0
 Terminology :   2
 Dimensions :   0
 System Standard :   0
 Safety Standard :   0
 Others :    117
 Service Specification :    0
 Process Specification :    0
 Unclassified :    2
 


Annexure-I :List of Indian Standards Withdrawn/Superseded

SI. No.
IS No.
Title
1.
IS/ISO 11238 : 2012
ISO 11238 : 2012
Reviewed In : 2023
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on substances
2.
IS/ISO/TR 11633-1 : 2009
ISO/TR 11633-1 : 2009
Reviewed In : 2023
Health informatics - Information security management for remote maintenance of medical devices and medical information systems Part 1 requirements and risk analysis
3.
IS/ISO/TR 11633-2 : 2009
ISO/TR 11633-2 : 2009
Reviewed In : 2023
Health informatics - Information security management for remote maintenance of medical devices and medical information systems Part 2 implementation of an information security management system ISMS
4.
IS/ISO 12967-1 : 2009
ICS 35.240.80
Health informatics - Service architecture Part 1 enterprise viewpoint
5.
IS/ISO 12967-3 : 2009
ISO 12967-3 : 2009
Health informatics - Service architecture Part 3 computational viewpoint
6.
IS/ISO 13119 : 2012
IS 13119 : 2012
Health informatics clinical knowledge resources metadata
7.
IS/ISO 13606-2 : 2008
ISO 13606-2 : 2008
Reviewed In : 2020
Health informatics - Electronic health record communication Part 2 archetype interchange specification
8.
IS/ISO/TR 16056-1 : 2004
ISO/TR 16056-1 : 2004
Reviewed In : 2015
Health informatics - Interoperability of telehealth systems and networks Part 1 introduction and definitions
9.
IS/ISO/TR 16056-2 : 2004
ISO/TR 16056-2 : 2004
Reviewed In : 2015
Health informatics - Interoperability of telehealth systems and networks Part 2 real - Time systems
10.
IS/ISO/TS 16791 : 2014
ISO/TS 16791 : 2014
Reviewed In : 2023
Health informatics - Requirements for international machine - Readable coding of medicinal product package identifiers
11.
IS/ISO 27789 : 2013
ISO 27789 : 2013
Reviewed In : 2023
Health informatics - Audit trails for electronic health records


Annexure-II :List of Indian Product Standards

SI. No.
IS No. & Year
Title
No Records Found