Irina Brass to investigate regulatory and standardization challenges of connected medical devices

The project, REG-MEDTECH (Regulatory and Standardization Challenges for Connected and Intelligent Medical Devices), is run in partnership with the British Standards Institution (BSI) and will examine the critical cybersecurity, software, and algorithmic decision-making challenges posed by connected, intelligent medical devices.

In recent years, several policy and regulatory initiatives have begun to address the security, privacy, safety, and trust implications of connected, intelligent devices, also known as the Internet of Things (IoT). However, there is currently a gap in these initiatives when it comes to the development of standards that underpin regulatory requirements for connected medical devices, software as medical device, and digital healthcare.

Dr Brass said: “Digital healthcare sits at the critical confluence of healthcare provision, medical innovation, and increased reliance on data and the Internet infrastructure. While this is an exciting area of growth and transformation that can benefit society, it is also an area where we see important disruptions to established regulatory processes, frameworks, and internationally harmonised norms that have traditionally ensured a high standard of safety and performance in medical devices and digital healthcare systems”.

To help translate these existing guidelines and regulatory initiatives into practice, REG-MEDTECH has four main objectives:

• Knowledge: integrate the expertise and insights of an interdisciplinary community across cybersecurity, product safety, healthcare, law and regulatory science.
• Network: bridge the communication and coordination gap between cybersecurity organizations, healthcare regulatory agencies, standards-making bodies, central government, and key digital healthcare stakeholders.
• Impact: generate practical tools and workplans for new standards development in this domain, at national and international level.
• National importance: provide guidance to maintain UK’s international leadership in cybersecurity, product safety, and standards-development, especially post-Brexit.

The project consists of two parts – the first will map what current standards for connected, intelligent medical devices already exist and any ambiguous areas in the guidance; and the second will see the development of a practical workplan of new standards to fill in the identified gaps in the cybersecurity, software and algorithmic decision-making challenges in digital healthcare

The project follows from a long-standing partnership between UCL STEaPP and the BSI, the UK national standards body. Last year this included a highly successful MPA Group Project, supervised by Dr Irina Brass, on the standardization of connected and intelligent medical devices, which highlights the importance of research-led education. Dr Saheli Datta Burton (UCL STEaPP), who is currently investigating the Geopolitics of Industrial IoT Standards (GISt) within PETRAS, will also be joining the REG-MEDTECH project as Research Fellow. 

The project is one of 18 announced by PETRAS National Centre of Excellence for IoT Systems Cybersecurity and funded through their 2nd Strategic Research Fund. The fund supports projects that look to answer social and technical cybersecurity challenges of edge devices and systems, whilst considering issues such as privacy, ethics and trust in these technologies.