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GB/T 48666-2026Technical requirements for electronic medical record fixed layout document (English PDF)

电子病历版式文档技术要求

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

September 28, 2026

Implementation date

April 1, 2027

Scope

GB/T 48666-2026 is the English-translated version of 电子病历版式文档技术要求.

This standard lays down technical requirements for the fixed layout document format when it is used for electronic medical records. A fixed layout document preserves page appearance across devices, which matters for clinical records that must be displayed, stored and exchanged without changing their look. The audience includes hospital information system vendors, developers of electronic medical record software, health data integrators, and those responsible for records archiving and secure exchange between institutions.

It is a recommended national standard issued under the responsibility of the State Cryptography Administration on 28 September 2026, effective 1 April 2027. The requirement set belongs to the information security and cryptography field, which suggests an emphasis on trustworthy handling of medical documents, though readers should consult the full text for the exact scope. Because the file lists no predecessor, it should be read as a stand-alone reference. Suppliers selling health information software in China may need to understand it for product design and tender responses.

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Document preview — GB/T 48666-2026

National Standard of the People's Republic of China

ICS
35.240.30
Classification
L 67

Issued by: State Administration for Market Regulation; Standardization Administration of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions

Foreword

GB/T 48666-2026 is a recommended national standard (GB/T) of the People's Republic of China, issued on 28 September 2026 by the State Administration for Market Regulation and the Standardization Administration of China, with effect from 1 April 2027.

It is under the responsibility of the State Cryptography Administration.

Classification: ICS 35.240.30; CCS L 67.

1 Scope

This standard lays down technical requirements for the fixed layout document format when it is used for electronic medical records. A fixed layout document preserves page appearance across devices, which matters for clinical records that must be displayed, stored and exchanged without changing their look. The audience includes hospital information system vendors, developers of electronic medical record software, health data integrators, and those responsible for records archiving and secure exchange between institutions.

It is a recommended national standard issued under the responsibility of the State Cryptography Administration on 28 September 2026, effective 1 April 2027. The requirement set belongs to the information security and cryptography field, which suggests an emphasis on trustworthy handling of medical documents, though readers should consult the full text for the exact scope. Because the file lists no predecessor, it should be read as a stand-alone reference. Suppliers selling health information software in China may need to understand it for product design and tender responses.

Remaining clauses in the full document

  • 2 Normative references
  • 3 Terms and definitions

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

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