Health Care Technology Official British Standard

PD ISO/TR 80001-2-7:2015

Comprehensive guide to healthcare IT risk management. Ensure compliance with ISO/TR 80001-2-7:2015 standard. Protect patient data and systems.

Comprehensive Healthcare IT Risk Management with PD ISO/TR 80001-2-7:2015

As the healthcare industry increasingly relies on interconnected digital technologies, the need for robust risk management practices has never been more critical. PD ISO/TR 80001-2-7:2015, a British Standard publication, provides a comprehensive framework for managing the risks associated with the application of IT in healthcare environments.

Ensuring Patient Safety and Data Security

This technical report, developed by the International Organization for Standardization (ISO), offers healthcare organizations a structured approach to identifying, assessing, and mitigating the risks inherent in the use of medical IT applications and IT-related medical devices. By adhering to the guidelines outlined in PD ISO/TR 80001-2-7:2015, healthcare providers can:

  • Protect patient data and sensitive information from unauthorized access, theft, or misuse
  • Maintain the integrity and availability of critical healthcare systems and applications
  • Minimize the risk of adverse events or patient harm due to IT-related failures or malfunctions
  • Comply with relevant data protection and privacy regulations, such as the General Data Protection Regulation (GDPR)

Comprehensive Risk Management Framework

PD ISO/TR 80001-2-7:2015 provides a detailed risk management framework that covers the entire lifecycle of healthcare IT systems and devices. The standard addresses key aspects of risk management, including:

  • Risk Identification: Systematically identifying potential risks, threats, and vulnerabilities associated with the use of IT in healthcare
  • Risk Analysis: Assessing the likelihood and potential impact of identified risks, as well as the effectiveness of existing controls
  • Risk Evaluation: Determining the acceptability of risks and prioritizing them for treatment
  • Risk Treatment: Implementing appropriate risk mitigation strategies, such as technical, organizational, or procedural controls
  • Monitoring and Review: Continuously monitoring the effectiveness of risk management measures and adapting them as necessary

Compliance and Certification

By implementing the guidelines outlined in PD ISO/TR 80001-2-7:2015, healthcare organizations can demonstrate their commitment to patient safety, data security, and regulatory compliance. Compliance with this standard can also serve as a valuable differentiator, showcasing an organization's dedication to excellence in healthcare IT risk management.

The publication is available in both PDF and hardcopy formats, providing healthcare professionals and IT teams with a comprehensive resource to navigate the complex landscape of healthcare technology risk management.

Technical Information

Health Care Technology
BSI Group
978 0 580 83412 7
Specification Details
  • Application of risk management for IT-networks incorporating medical devices
  • Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
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