BS EN ISO 11615:2017+A1:2022 Health Informatics Standard

Standard Number: BS EN ISO 11615:2017+A1:2022

Pages: 94

Released: 2022-09-28

ISBN: 978 0 539 14101 6

Name: Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information

Status: Standard

Overview

The BS EN ISO 11615:2017+A1:2022 standard is an essential document for professionals in the field of health informatics, particularly those involved in the identification and exchange of regulated medicinal product information. This comprehensive standard provides detailed guidelines on the data elements and structures necessary for the unique identification of medicinal products, ensuring consistency and accuracy in the exchange of information across various platforms and stakeholders.

Key Features

• Comprehensive Coverage: With 94 pages of detailed information, this standard covers all aspects of medicinal product identification and data exchange.
• Up-to-Date Information: Released on 2022-09-28, this standard includes the latest amendments and updates, ensuring that you have the most current information at your fingertips.
• Global Relevance: As an ISO standard, it is recognized and applicable worldwide, making it a valuable resource for international projects and collaborations.
• Structured Data Elements: Provides a clear framework for the data elements required for the unique identification of medicinal products, facilitating accurate and efficient data exchange.
• Regulatory Compliance: Helps organizations comply with regulatory requirements by providing standardized guidelines for medicinal product information.

Benefits

Implementing the BS EN ISO 11615:2017+A1:2022 standard offers numerous benefits for organizations and professionals in the health informatics field:

• Enhanced Data Accuracy: By adhering to standardized data elements and structures, organizations can ensure the accuracy and consistency of medicinal product information.
• Improved Data Exchange: Facilitates seamless data exchange between different systems and stakeholders, reducing the risk of errors and miscommunication.
• Regulatory Compliance: Helps organizations meet regulatory requirements, reducing the risk of non-compliance and associated penalties.
• Global Standardization: Promotes global standardization of medicinal product information, supporting international collaboration and data sharing.
• Efficiency and Productivity: Streamlines data management processes, improving efficiency and productivity for health informatics professionals.

Who Should Use This Standard?

The BS EN ISO 11615:2017+A1:2022 standard is designed for a wide range of professionals and organizations involved in the health informatics field, including:

• Pharmaceutical companies
• Regulatory authorities
• Healthcare providers
• Health informatics professionals
• Data management specialists
• Software developers and vendors

Detailed Content

This standard provides a detailed framework for the identification and exchange of medicinal product information, covering the following key areas:

• Data Elements: Defines the specific data elements required for the unique identification of medicinal products, including product names, identifiers, and attributes.
• Data Structures: Outlines the structures and formats for organizing and presenting medicinal product information, ensuring consistency and interoperability.
• Regulatory Requirements: Provides guidelines for meeting regulatory requirements related to medicinal product information, including labeling, packaging, and documentation.
• Data Exchange Protocols: Describes the protocols and standards for exchanging medicinal product information between different systems and stakeholders.
• Implementation Guidelines: Offers practical guidance for implementing the standard within an organization, including best practices and case studies.

Why Choose BS EN ISO 11615:2017+A1:2022?

Choosing the BS EN ISO 11615:2017+A1:2022 standard ensures that your organization is equipped with the most current and comprehensive guidelines for the identification and exchange of medicinal product information. This standard is recognized globally, making it an invaluable resource for international projects and collaborations. By implementing this standard, you can enhance data accuracy, improve data exchange, and ensure regulatory compliance, ultimately supporting the delivery of safe and effective medicinal products to patients worldwide.

Conclusion

The BS EN ISO 11615:2017+A1:2022 standard is a critical resource for professionals and organizations in the health informatics field. With its comprehensive coverage, up-to-date information, and global relevance, this standard provides the essential guidelines needed for the unique identification and exchange of regulated medicinal product information. By implementing this standard, you can ensure data accuracy, improve data exchange, and meet regulatory requirements, ultimately supporting the delivery of safe and effective medicinal products to patients worldwide.

BS EN ISO 11615:2017+A1:2022

This standard BS EN ISO 11615:2017+A1:2022 Health informatics. Identification of medicinal products. Data elements and structures for the unique identification and exchange of regulated medicinal product information is classified in these ICS categories:

• 35.240.80 IT applications in health care technology