GB/T 41806-2022Information security technology—Security requirements of genetic recognition data (English PDF)
信息安全技术 基因识别数据安全要求
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
October 14, 2022
Implementation date
May 1, 2023
Scope
GB/T 41806-2022 is the English-translated version of 信息安全技术 基因识别数据安全要求.
GB/T 41806-2022 states the security requirements for handling gene identification data, which it describes as genomic nucleic acid sequence data, functional genomic data and the raw and intermediate data produced while extracting them, together with the related information.
Its contents list basic security requirements, then data collection, including the signing of informed consent, the collection of genetic material and data extraction, then storage and transmission, use and processing, provision and disclosure, deletion, and separate requirements for individual service, research and development and other scenarios; three informative annexes give typical data formats, a sample informed consent template and storage time limits for medical service data.
It applies to processors of such data and can serve regulators and third-party assessment bodies. Issued on 14 October 2022, it has applied since 1 May 2023.
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Document preview — GB/T 41806-2022
National Standard of the People's Republic of China
- ICS
- 35.030
- Classification
- L 80
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Overview
- 4.1 Gene identification data and related information processing activities
- 4.2 Gene identification data and related information application scenarios
- 4.3 Security Risk
- 5 Basic safety requirements
- 6 Data collection
- 6.1 Requirements
- 6.2 Signing of informed consent
- 6.3 Collection of genetic material
- 6.4 Data extraction
- 7 Data Storage and Transmission
- 8 Data use and processing
- 9 Data provision and disclosure
- 10 Data deletion
- 11 Security Requirements for Each Scenario
- 11.1 Overview
- 11.2 Security Requirements for Individual Service Scenarios
- 11.3 Security Requirements for Research and Development Scenarios
- 11.4 Security Requirements for Other Scenarios
- Appendix A (Informative) Gene Identification Typical Data Format
- Appendix B (Informative) Sample Informed Consent Template
- Appendix C (Informative) Time Limit for Medical Service Data Storage
- Reference
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.
1 Scope
This document stipulates the collection, storage, use, processing, transmission, provision, disclosure, deletion and other data processing of genetic identification data and related information. Security requirements for management activities.
This document applies to the processor of genetic identification data and related information to regulate data processing activities, and can also be used for regulatory authorities and third-party assessments.
Institutions provide reference for the supervision, management and evaluation of genetic identification data processing activities.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.
GB/T 25069 Information Security Technical Terminology
GB/T 35273 Information Security Technology Personal Information Security Specification
GB/T 37864 General Requirements for the Quality and Capability of Biobanks
GB/T 37988 Information Security Technology Data Security Capability Maturity Model
GB/T 39335 Information Security Technology Personal Information Security Impact Assessment Guide
GB/T 40660 Information Security Technology Basic Requirements for Biometric Information Protection
GB/T 41479 Information Security Technology Network Data Processing Security Requirements
3 Terms and Definitions
GB/T 25069, GB/T 35273, GB/T 37864, GB/T 37988, GB/T 40660 and GB/T 41479 as defined and below Listed terms and definitions apply to this document.
3.1 Gene identification data subject
A natural person identified or associated with genetic identification data.
Note: referred to as "data subject".
3.2 Gene identification data
Data representing the genetic information of an individual or a population extracted from human genetic material using technical means, the data can be directly or indirectly A human individual or group is identified.
Note 1. Gene identification data refers to genetic data, mainly including genomic nucleic acid sequence data, functional genomic data, and raw data generated during the extraction process. data and intermediate data.
Note 2. Genomic nucleic acid sequence data refers to the use of various sequencing technologies (such as Sanger sequencing technology, high-throughput sequencing technology, mass spectrometry technology at the genome level) etc.) or genotyping technology (such as.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 25069Information security techniques—Terminology
- GB/T 35273Information security technology—Personal information security specification
- GB/T 37864General requirements of quality and competence for biobank
- GB/T 37988Information security technology—Data security capability maturity model
- GB/T 39335Information security technology—Guidance for personal information security impact assessment
- GB/T 40660Information security technology—General requirements for biometric information protection
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Related Standards
GB/T 25069-2022 — Information security techniques—Terminology
GB/T 35273-2020 — Information security technology—Personal information security specification
GB/T 37864-2019 — General requirements of quality and competence for biobank
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