UCL Department of Science, Technology, Engineering and Public Policy


UCL MPA Students present research at IMPACT 2020

9 September 2020

A group of MPA candidates from UCL STEaPP will be presenting their research on regulatory and standardization challenges for intelligent medical devices at the IMPACT 2020 conference.

Impact 2020 logo

Jan Sassenberg and Gabriella Ezeani, along with fellow MPA candidates Jiehui Song, Natalia Maj and Malla Tedroff and supervised by Dr Irina Brass, have been working with the British Standards Institution (BSI) to gather valuable insights on the regulatory and standardization gaps in intelligent medical devices. Jan and Gabriella will present their findings at the IMPACT 2020 conference on 29 September.

Medical devices are subject to extensive regulatory oversight, with standards playing an important role in ensuring devices’ security, efficacy and safety. However, rapid technological advancements in healthcare and medical devices can often disrupt these established frameworks. Devices, such as pacemakers, and software as a medical device, create novel challenges for regulators and standard-making bodies. Innovative uses of software blur the boundaries between medical and wellness devices, posing risks to device security and patient safety if under-classified. 

Using a mix of horizon scanning and primary data collection through 19 interviews and 50 survey responses, the team have created valuable insights on the regulatory and standardization gaps in the field and proposed recommendations for regulators, standards-making bodies and industry. 

They found that manufacturers need to take a more comprehensive and integrated approach to medical device security and safety and apply standards and regulations across the entire product lifecycle, from development to the safe and secure retirement of the device. Coupled with the increased use of artificial intelligence, the interlink between cybersecurity and patient safety is becoming more critical. Regulations and standards governing this field must take a socio-technical approach and become adaptable to remain fit-for-purpose in this fast-paced industry.  

IMPACT 2020 covers the latest research on the social and behavioural aspects of cybersecurity. It promotes scientific understanding in the community and bridges the gap between academia and industry by facilitating discussion and collaboration with world-leading experts.

You can register to attend the conference using this link.