Podcasts: Software as a Medical Device

Life sciences regulatory expert Jamie Hatzel discusses digital health with HBW Insight Senior Editor, David Ridley, in this two-part episode of “Over The Counter”. The conversation delves into topics such as the UK and EU regulatory approaches to Software as a Medical Device (SaMDs) and the significance of the approaching  EU artificial intelligence legislation as well as its potential impact in this area.

In this first episode published on 23 July 2023, Jamie Hatzel explains what Software as a Medical Device is and covers some key discussion points, including:

• Clarity on software as a medical device
• Outline of the UK and EU approaches to SaMDs
• The impact of Brexit on the regulatory framework
• Insight into intended use of manufacturers providing software such as symptoms checkers
• EU regulations for medical device software

In the second instalment, published on 7 August 2023, the conversation focuses on artificial intelligence and the effects this will have on software as a medical device. Key discussion points include:

• How will SaMDs function within the new proposed legislation?
• The meaning of “high risk” within the proposed AI Act
• Can a chatbot be considered a SaMD which would fall under the AI act?
• Should companies embrace regulation?