Date: Monday 20 March 2023
Join the Reg-MedTech Project team (Dr Irina Brass, Dr Andrew Mkwashi) and project partners Paul Sim (BSI Medical Devices Knowledge Manager) and Emma Glass (BSI University Partnership Manager) to discuss the state of play in digital healthcare, the critical cybersecurity and algorithmic integrity challenges posed by connected, intelligent medical devices, and some of the latest regulatory and standardization developments in this field.
In this session, the Reg-MedTech team will present two scenarios to demonstrate the impact of compromised or malfunctioning software-based medical devices and software as a medical device (SaMDs), and why it is difficult to manage their safety, security, and performance. While these devices fall within the ambit of medical device regulations, they raise several challenges for manufacturers, healthcare professionals, patients, and regulators. Their risk profile can change quite dramatically over time, requiring more comprehensive post-market monitoring and surveillance, more training for clinical staff, and new standards and regulatory guidance. BSI representatives Paul Sim and Emma Glass will discuss the changing regulatory and standards landscape for connected, intelligent medical devices, what has been done so far and what still needs to be done to address the growing safety, cybersecurity, and algorithmic trustworthiness challenges these devices raise.
Visit the Reg-MedTech project page to see the team’s work thus far.
For joining details, please contact Claire Coulton (email@example.com)