Updates in the field of artificial intelligence and software-enabled medical device
- Be aware of ISO 42001-the Standard that provides the framework for implementing a comprehensive AI management system that is secure, ethical, and aligned with the latest global standards.
- FDA (Jan-2025) releases Draft Guidance (not yet for implementation): Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations | FDA
- TGA (Sep-2024) releases Consultation: Clarifying and strengthening the regulation of Artificial Intelligence (AI) Consultation: Clarifying and strengthening the regulation of Artificial Intelligence (AI) | Therapeutic Goods Administration (TGA)
- TGA (Dec-2024) releases long-awaited revision of Australian Regulatory Guidelines for Medical Devices (ARGMD) with a new section dedicated to the regulation of software and AI based medical devices (Sep-2024): Understanding regulation of software-based medical devices | Therapeutic Goods Administration (TGA)
- The Bletchley Declaration (Nov-2023) signed by 28 countries (including Australia) and the EU at the AI Safety Summit in Bletchley Park, UK. This declaration establishes a shared understanding of the opportunities and risks posed by frontier artificial intelligence (AI) The Bletchley Declaration by Countries Attending the AI Safety Summit, 1–2 November 2023 | Department of Industry Science and Resources
- European Union Regulation (EU) 2024/1689 laying down rules on AI providing AI developers and deployers with clear requirements and obligations regarding specific uses of AI. This Act is the first-ever comprehensive framework on AI worldwide to ensure that AI systems respect fundamental rights, safety and ethical principles of AI models
- TGA (Nov-2024) releases Complying with medical device cyber security requirements - Guidance for manufacturers and sponsors on cybersecurity of medical devices that include software or electronic components Complying with medical device cyber security requirements | Therapeutic Goods Administration (TGA)
- IEC 80001-1:2021 Application of risk management for IT-networks incorporating medical devices Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software. This document specifies general requirements for organisations in the application of risk management before, during and after the connection of a health system within a health IT infrastructure, by addressing the key properties of safety, effectiveness and security. IEC 80001-1:2021 - Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
- FDA (Sep-2023) issues final guidance: Cybersecurity in Medical Devices: Quality System Considerations and content of Premarket Submissions Cybersecurity | FDA
- IMDRF/CYBER WG/N73FINAL: 2023 Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity (N73).docx (live.com). The SBOM is a tool to support safety as it can help mitigate against the potential for patient harm. Protection of the of the cyber healthcare environment is a shared responsibility of medical device manufacturers and health care providers. This document is intended for devices that contain software (SiMD), including firmware, and software as a medical device (SaMD) with/out AI. It facilitates risk management, vulnerability management and incident response.