Beyond the device: addressing system-level risk management in networked healthcare technologies
£59.00
Learn how to address system-level safety risks in connected healthcare technologies, from interoperability and cybersecurity to clinical workflows and post-market surveillance
English
Abstract:
As healthcare becomes increasingly interconnected, patient safety risks are emerging in the gaps between medical devices, networks, data systems and clinical workflows. Traditional risk management frameworks remain essential, but their primarily device-centric focus can leave important system-level hazards insufficiently characterised. Pujitha Gourabathini examines the regulatory and risk management challenges created by networked healthcare technologies, including interoperability failures, data integrity risks, network dependencies and cybersecurity-driven safety hazards.
The article proposes a networked healthcare safety architecture that extends established lifecycle risk management across four interconnected layers (device, integration, network, and clinical workflow) supported by five core principles. The article considers what this approach means in practice for risk management documentation, validation, cybersecurity, post-market surveillance and manufacturer responsibility, and explores how regulatory professionals can address risks that increasingly lie beyond the boundaries of an individual device.
Learning objectives:
- Evaluate the limitations of device-centric risk management when applied to networked healthcare technologies and system-of-systems environments.
- Identify and characterise key system-level hazards arising from interoperability, network infrastructure, data integrity, cybersecurity and clinical workflow interactions.
- Assess how ISO 14971, IEC 80001-1, the EU MDR and emerging US and EU requirements contribute to, and leave gaps in, system-level safety management.
- Understand how to apply the proposed four-layer analytical model to consider risk across device, integration, network and clinical workflow domains.
- Determine practical implications for risk management documentation, design and development, cybersecurity, validation and post-market surveillance.
- Consider how manufacturers can establish defensible system-level safety responsibilities and stakeholder engagement across the connected healthcare ecosystem.
About the author:
Pujitha Gourabathini is a quality and patient safety leader at Becton, Dickinson and Company, San Diego, USA, specialising in risk management strategy. She leads initiatives that strengthen safety, engineering practices, and regulatory confidence through risk frameworks.
Specification:
13 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2026 issue of the Journal of Medical Device Regulation.
