GOST R 57301-2016 PDF

Full title and description

GOST R 57301-2016 — "Информатизация здоровья. Требования защиты и конфиденциальности систем EHR, используемые при оценке соответствия" (English: Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment). The standard defines security and privacy requirements for electronic health record (EHR) systems and point-of-service clinical systems that interact with EHR infrastructures, for use when carrying out conformity assessment and certification activities.

Abstract

This national standard is the Russian adoption (identical/adopted) of ISO/TS 14441:2013 and specifies a set of technical and organizational requirements intended to protect confidentiality, integrity and availability of personal health data in EHR and point-of-service (POS) systems. It covers risk analysis, security profiles/levels used in conformity assessment, user identification and authentication, access control, session management, audit logging, data integrity and availability measures, cryptographic controls (including use of digital signatures and certificates), and privacy-related controls such as consent and data minimization. The document is intended to support authorities, certifying bodies, vendors and healthcare providers in assessing security and privacy maturity of EHR/POS products.

General information

• Status: Active (in force).
• Publication date: Approved by Rosstandart / Federal Agency on Technical Regulation and Metrology on 30 November 2016; enforced (date of entry into force) 01 January 2018.
• Publisher: National standards body / published availability via Russian standards publishers (published copies available from Standartinform / authorized document libraries).
• ICS / categories: Health informatics / information security in healthcare — OKC/ICS classification around 35.240.80 (health informatics).
• Edition / version: GOST R 57301-2016 (adopted version corresponding to ISO/TS 14441:2013).
• Number of pages: Approximately 98–99 pages (published electronic document length reported as 98–99 pages depending on publisher edition).

Scope

The standard applies to electronic patient record systems implemented at points of service (POS) and other clinical information systems that exchange or interoperate with national, regional or local EHR infrastructures. It is aimed at defining security and privacy requirements to be used as the basis for conformity assessment and certification of such systems, including both technical controls and organizational measures relevant to protecting personal medical data during collection, storage, processing and exchange.

Key topics and requirements

• Security and privacy profiles / levels for conformity assessment (definition of assurance levels used to classify systems for certification).
• Risk assessment and management specific to EHR/POS environments (threats to confidentiality, integrity and availability of personal health data).
• Identification, authentication and authorization mechanisms (including strong authentication and role-based access controls).
• Session management, timeout and secure handling of user sessions.
• Audit logging, accountability and tamper-evident logging for clinical events and administrative actions.
• Data protection controls: integrity checks, backup and recovery, availability planning.
• Cryptographic protections: encryption in transit, recommendations for protecting stored data, use of digital signatures and certificate management.
• Privacy-specific controls: consent management, data minimization, de-identification/pseudonymization where applicable.
• Interoperability considerations and secure interfaces for exchanging clinical data with EHR infrastructures.
• Guidance for conformity assessment processes and evidence required for certification bodies and test laboratories.

Typical use and users

Primary users include EHR and clinical system vendors implementing security/privacy controls; certification bodies and test laboratories performing conformity assessment; healthcare providers (hospitals, clinics, outpatient facilities) deploying EHR/POS systems; national/regional health authorities and regulators responsible for certification or procurement; and integrators or auditors assessing compliance with security and privacy requirements. The standard is used to define baseline requirements for product evaluation, procurement specifications and certification schemes.

Related standards

Identical/adopted from ISO/TS 14441:2013 (Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment). Related normative references and complementary standards commonly cited include ISO/IEC 27001 / 27002 (information security management), ISO 27799 (information security management in health), ISO 18308 (EHR architecture), ISO/IEC 15408 (common criteria concepts) and ISO/IEC 17000-series standards on conformity assessment. The standard is part of the health informatics standards set coordinated by the national technical committee on health informatics (TC 468).

Keywords

EHR, electronic health record, health informatics, information security, privacy, personal medical data, conformity assessment, certification, audit logging, encryption, authentication, access control, POS (point of service).

FAQ

Q: What is this standard?

A: GOST R 57301-2016 is the Russian national standard that sets out security and privacy requirements for EHR and point-of-service clinical systems to be used as the basis for conformity assessment and certification. It is adopted from ISO/TS 14441:2013.

Q: What does it cover?

A: It covers technical and organizational controls for protecting personal health data — including risk assessment, authentication and authorization, session management, audit logging, integrity and availability measures, cryptographic protections, privacy controls (consent and data minimization), secure interoperability and evidence requirements for conformity assessment.

Q: Who typically uses it?

A: EHR and clinical system vendors, certification bodies and test laboratories, healthcare providers, health authorities and auditors use the standard for product evaluation, procurement criteria and certification of EHR/POS systems.

Q: Is it current or superseded?

A: As published it is GOST R 57301-2016 and is listed as in force; it was approved on 30 November 2016 and entered into force on 1 January 2018. Users should check national catalogues or Rosstandart publications for any later amendments or superseding documents before relying on it for certification decisions.

Q: Is it part of a series?

A: The standard sits within the health informatics / GOST R series and was developed under Technical Committee TC 468 (Health Informatization). It is closely linked to other health-informatics and information-security standards and to the international ISO documents from which it was adopted.

Q: What are the key keywords?

A: Key keywords are EHR, health informatics, privacy, security, personal medical data, conformity assessment, certification, access control, audit logging, encryption.