Hosted by the Medical Engineering Quality and Regulatory Team at the London Institute for Healthcare Engineering (LIHE) and in partnership with the EPSRC King's Health Partners Digital Health Hub, this half-day event dives into the world of digital mental health technologies (DMHTs) and how to navigate the ever-changing regulations. Whether you're King’s staff, a healthcare professional, tech enthusiast, or just curious about the topic, this event is perfect for you.  

Attendees will:

• Gain a clear understanding of the current regulatory landscape for DMHTs, including the roles of MHRA, BSI, NHS, and other key bodies.
• Understand when and how digital tools may be classified as medical devices, and what that means in practice.
• Learn how to navigate regulatory requirements early in the development process, avoiding common pitfalls and delays.
• Explore practical steps for achieving compliance, including evidence generation and clinical evaluation.
• Understand the Digital Technology Assessment Criteria (DTAC) and its importance.

Agenda:

• 12:45 - 1:00 PM: Arrivals and registration
• 1:00 - 2:00 PM: Wellcome/MHRA/NICE project: Qualification, classification, clinical evaluation
• 2:00 - 2:45 PM: BSI talk on conformity assessment routes and clinical evaluation
• 2:45 - 3:00 PM: Break
• 3:00 - 3:45 PM: NHS England talk on Digital Technology Assessment Criteria (DTAC)
• 3:45 - 4:15 PM: King's pitches DMHT case studies on navigating the regulations
• 4:15 - 5:00 PM: Panel discussion hosted by Fiona Costello
• 5:00 - 6:00 PM: Networking drinks & close

The event is free, but please register your attendance here.