Clinical safety — DCB0129
DCB0129 sets clinical risk management requirements for manufacturers of health IT systems. It addresses hazards, risk controls and supporting clinical safety documentation across development and maintenance.
Clinical safety and information security matter throughout the imaging pathway. Our commitment is to take these responsibilities seriously—from the systems we develop to the way they are configured, connected and supported.
DCB0129 sets clinical risk management requirements for manufacturers of health IT systems. It addresses hazards, risk controls and supporting clinical safety documentation across development and maintenance.
ISO/IEC 27001 is the international standard for information security management systems. It provides a framework for managing information security risks through organisational and technical controls and continual improvement.
Secure healthcare IT requires attention to access control, data protection, system configuration, vulnerabilities and incident response. These are important considerations when agreeing the design and operation of each deployment.
Contact our team to discuss applicable clinical safety documentation, current certification status and scope, and deployment-specific security responsibilities. Assurance should be assessed against the relevant product, version and service—not assumed across every system.
Tell us what your clinical safety, information governance and security teams need to review.