Medical Device Regulation and harmonised standards
The regulatory standards and guidance documents below are crucial for ensuring the safety, quality, and efficacy of medical devices in healthcare settings. Here’s a detailed summary of each, along with their harmonisation for medical device regulatory compliance: EU MDR 2017 (European Union Medical Device Regulation) The EU MDR 2017 is a comprehensive regulation that governs […]
AI regulatory standards and risk management guidance
IEC BS 42001 IEC BS 42001 is a standard for Artificial Intelligence Management Systems (AIMS). It provides a framework for organizations to manage AI systems effectively and responsibly. In healthcare, IEC BS 42001 can be applied to: IEC BS 30440 IEC BS 30440 focuses on the ethical considerations in AI system design and development. For […]
Artificial Intelligence in Healthcare
Artificial Intelligence (AI) is a broad field of computer science focused on creating systems that can perform tasks that typically require human intelligence. Here’s an overview of key AI concepts and their application in healthcare: Definition of AI AI refers to the simulation of human intelligence in machines programmed to think and learn like humans. […]
Clinical Risk Management Governance
Overview Clinical Risk Management (CRM) governance is crucial in the development, deployment, and use of digital health technologies within the UK healthcare sector. It ensures that these technologies are safe, effective, and aligned with clinical needs, thereby safeguarding patient health and enhancing care delivery. Importance of CRM Governance Purpose of CRM Governance Integrating CRM Governance […]
Clinical Risk Management File
A clinical risk management file in relation to DCB0129 and DCB0160 NHS safety standards is a comprehensive document that outlines the approach to identifying, assessing, and mitigating clinical risks associated with Digital Health Technologies. It not only provides the safety documentation as required by the NHS Safety Standards but acts as a repository for all […]
What is DCB0160?
DCB0129, otherwise known as “Clinical Risk Management: its Application in the Manufacture of Health IT Systems”, is a standard that provides a framework for Digital Health manufacturers to ensure the clinical risk management of their products. It was made mandatory under the Health and Social Care Act 2012 for any organisation responsible for the development […]
NHS Safety Standards: DCB0129 and DCB0160
Overview of NHS Digital Clinical Risk Management Standards The NHS has established two key standards for clinical risk management in digital health: These standards are mandatory under the Health and Social Care Act 2012 and are crucial for ensuring patient safety in the digital health landscape. DCB0129: Manufacturer Responsibilities DCB0129 outlines requirements for manufacturers of […]
The Shift from Health IT to Digital Health Systems
Introduction to Digital Health Systems Historically, we referred to Health IT systems; today, we embrace the era of Digital Health systems or Digital Health technologies. This evolution reflects our commitment to leveraging technology as a powerful enabler for delivering safe and effective care management. What is a Digital Health System? A Digital Health System is a product designed to provide electronic […]