British Standards Institution

Sector: Governance & Resilience

Overview: Under the direction of the Standards Policy and Strategy Committee, is responsible for UK participation in standardisation relating to health informatics. It provides a forum for representatives of organisations with an interest in developing standards in health informatics to help in achieving common standards in this field throughout Europe and internationally.

Committee standards activity

In Progress (110)

Show entries

Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 9472-20200	Health informatics — Personalized health navigation — Part 20200: Application: Purpose-oriented self-health activities Categories: Unclassified documents Drafting begins : 2024-05-17	Drafting
PD ISO/TS 9472	Health informatics — Personalized health navigation — Reference architecture Categories: Unclassified documents Drafting begins : 2023-06-16	Drafting
PD ISO/TS 9321	Health informatics — General requirements of multi-centre medical data collaborative analysis Categories: IT applications. Health care technology Approval begins :	Approval
PD ISO/TS 9320	Health informatics — Standardized data set for transfer of hemodialysis patients Categories: IT applications. Health care technology Approval begins :	Approval
PD ISO/TS 9166	Health Informatics — Guidelines for self-assessment questionnaire systems Categories: Unclassified documents Proposal begins :	Proposal
PD ISO/TS 7122	Health Informatics — Guidelines for exchanging data generated by POCT (Point of Care Testing) devices between screening center and clinical laboratory Categories: Unclassified documents Drafting begins : 2024-05-17	Drafting
PD ISO/TS 6476	Health Informatics - Logical Model for the Identification of Medicinal Products for ISO 11615 Categories: Unclassified documents Drafting begins : 2023-08-04	Drafting
PD ISO/TS 6337	Safe, effective, and secure health software and health IT systems -- Assurance casesApplication guidance -- Guidance for the use of assurance cases -- safety & security Categories: Unclassified documents Drafting begins : 2024-05-17	Drafting
PD ISO/TS 6268-2	Health informatics — Cybersecurity framework for telehealth environments — Part 2: Cybersecurity reference models of telehealth Categories: Unclassified documents Drafting begins : 2024-10-17	Drafting
PD ISO/TS 6268-1	Health informatics — Cybersecurity framework for telehealth environments — Part 1: Overview and Concepts Categories: Unclassified documents Drafting begins : 2024-05-17	Drafting

Published (232)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 8392:2023	Genomics informatics. Description rules for genomic data for genetic detection products and services Categories: IT applications. Health care technology Published standard begins : 2023-05-24	Published standard
PD ISO/TS 8376:2023	Genomics informatics. Requirements for interoperable systems for genomic surveillance Categories: IT applications. Health care technology Published standard begins : 2024-01-08	Published standard
PD ISO/TS 5569:2023	Health informatics. Conceptual data model for Chinese medicinal herbs Categories: IT applications. Health care technology Published standard begins : 2023-11-08	Published standard
PD ISO/TS 5568:2022	Health informatics. Traditional Chinese medicine. Labelling metadata of human biological sample information Categories: IT applications. Health care technology Published standard begins : 2023-01-26	Published standard
PD ISO/TS 5346:2022	Health Informatics. Categorial structure for representation of Traditional Chinese Medicine clinical decision support system Categories: IT applications. Health care technology Published standard begins : 2022-08-23	Published standard
PD ISO/TS 5118:2022	Health informatics. Categorial structure of representation for evaluation of clinical practice guidelines of traditional Chinese medicine Categories: IT applications. Health care technology Published standard begins : 2022-08-18	Published standard
PD ISO/TS 5044:2023	Health informatics. Information model for quality control of traditional Chinese medicinal products Categories: IT applications. Health care technology Published standard begins : 2023-07-24	Published standard
PD ISO/TS 4425:2023	Genomics informatics. Data elements and their metadata for describing the microsatellite instability (MSI) information of clinical massive parallel DNA sequencing Categories: IT applications. Health care technology Published standard begins : 2023-05-17	Published standard
PD ISO/TS 4424:2023	Genomics informatics. Data elements and their metadata for describing the tumor mutation burden (TMB) information of clinical massive parallel DNA sequencing Categories: IT applications. Health care technology Published standard begins : 2024-01-08	Published standard
PD ISO/TS 24289:2021	Health informatics. Hierarchical file structure specification for secondary storage of health-related information Categories: IT applications. Health care technology Published standard begins : 2021-11-30	Published standard

Withdrawn (116)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 22077-3:2015	Health informatics. Medical waveform format. Long term electrocardiography Categories: IT applications. Health care technology Withdrawn begins : 2023-09-04	Withdrawn
PD ISO/TS 22077-2:2015	Health informatics. Medical waveform format. Electrocardiography Categories: IT applications. Health care technology Withdrawn begins : 2023-09-01	Withdrawn
PD ISO/TS 18530:2014	Health Informatics. Automatic identification and data capture marking and labelling. Subject of care and individual provider identification Categories: IT applications. Health care technology Withdrawn begins : 2016-03-22	Withdrawn
PD ISO/TS 17975:2015	Health informatics. Principles and data requirements for consent in the Collection, Use or Disclosure of personal health information Categories: IT applications. Health care technology Withdrawn begins : 2022-11-24	Withdrawn
PD ISO/TS 16791:2014	Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers Categories: IT applications. Health care technology Withdrawn begins : 2015-10-01	Withdrawn
PD ISO/TS 13582:2013	Health informatics. Sharing of OID registry information Categories: IT applications. Health care technology Withdrawn begins : 2015-12-23	Withdrawn
PD ISO/TR 22221:2006	Health informatics. Good principles and practices for a clinical data warehouse Categories: IT applications. Health care technology Withdrawn begins : 2023-06-27	Withdrawn
PD ISO/TR 21730:2005	Health informatics. Use of mobile wireless communication and computing technology in healthcare facilities. Recommendations for the management of unintentional electromagnetic interference with medical devices Categories: Electromagnetic compatibility. Other \| IT applications. Health care technology Withdrawn begins : 2007-03-09	Withdrawn
PD ISO/TR 11633-2:2009	Health informatics. Information security management for remote maintenance of medical devices and medical information systems. Implementation of an information security management system (ISMS) Categories: IT applications. Health care technology Withdrawn begins : 2021-02-24	Withdrawn
PD ISO/TR 11633-1:2009	Health informatics. Information security management for remote maintenance of medical devices and medical information systems. Requirements and risk analysis Categories: IT applications. Health care technology Withdrawn begins : 2019-08-19	Withdrawn

Message Committee Become a committee member

Committee members

Nominating organizations

B C S - British Computer Society
Committee Manager
Datapharm
Digital Health & Care Alliance
GA4GH - Global Alliance for Genomics & Health
Health and Social Care Information Centre
Human Factors Centre Ltd
M H R A - Medicines and Healthcare products Regulatory Agency
NHS - Information Standards Board for Health and Social Care
NHS England
openEHR
Portfolio I – Information Models
Portfolio II – Terminology and Knowledge Representation
Portfolio III – Security & Privacy
Portfolio IV – Device Interoperability
Portfolio V – Pharmacy & Medicines
Portfolio VI – Health Software & IT Systems
Professional Records Standards Body
Royal Botanic Gardens, Kew
Royal Pharmaceutical Society
SCATA - The Society for Computing &Technology in Anaesthesia
techonology (IT) newtorks incorporating medical devices
University College London
University of Chichester
University of Warwick
University of York

Liaisons with other committees

Individual Capacity - Classifications Specialist
Individual Capacity - Digitial transformation Expert
Individual Capacity - Herbal Medicine
Individual Capacity - Medical sciences and health care facilities
Individual Capacity - Software Development Life Cycle
Individual Capacity - Supply Chain Standards / Healthcare Standards
Individual Capacity – Clinical Informatics
Individual Capacity – Clinical Trials & Regulations Expert
Individual Capacity – Clinical/patient Safety
Individual Capacity – Data Architect
Liaison - IEC/62A/JWG7
Liaison - IST/12
U K Expert - ISO/TC215/JWG7- Application of risk managment to Info
UK Expert - ISO/TC 215/WG 4 - Security
UK Expert - ISO/TC215/WG 1 - Data Structure
UK Expert - ISO/TC215/WG2 - Data Interchange
UK Expert - ISO/TC215/WG6 - Pharmacy and Medicines Business
UK Expert – ISO/TC 215/WG3 - Semantic Content

BSI roles

Committee Chair

Standards Development

IST/35 - Health informatics

Committee standards activity