Episode 5 · International

What is the right approach for regulation and evaluation of digital health technologies?

Stephen Gilbert · Professor of Medical Device Regulatory Science, Dresden University of Technology

Jul 2024

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What is the right approach for regulation and evaluation of digital health technologies?

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About this episode

A deep dive into digital health regulation with one of the field's leading experts - covering the DiGA fast track in Germany, PECAN in France, what's coming in the UK, stark differences between the FDA and EU approaches, and what health system leaders, policy makers, and developers should learn from all of it.

Regulation Policy Evidence Implementation

“I don't really see a separation between the modern view of what regulation is and the digital health space on the question of implementation.”
Stephen Gilbert

What we cover

01Flexibility in digital health regulation: adapting to a rapidly changing landscape
02Integrating feedback from clinicians and patients into the regulatory process
03Evaluating digital health technologies holistically, not as isolated tools
04Suites and groupings of digital devices: regulatory approaches that acknowledge flexibility
05Lessons from DiGA (Germany), PECAN (France), and what's coming in the UK
06The stark differences between FDA and EU regulatory approaches - and the deeper reasons behind them
07Regulation's role in promoting interoperability across digital health systems
08Long-term thinking, clear goals, and continuous feedback loops for effective digital transformation
09Why digital transformation in healthcare requires investment and time before yielding dividends

About the guest

Stephen Gilbert

Professor of Medical Device Regulatory Science, Dresden University of Technology

Stephen Gilbert is a Professor at the Faculty of Medicine, Dresden University of Technology (Else Kröner Fresenius Center for Digital Health), leading a multidisciplinary team specialising in regulatory science for medical devices and in vitro diagnostic devices. With over 15 years of expertise in clinical research, computational biology, and regulatory science, he is committed to advancing digital health innovation and governance.

Transcript

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Shubs consults on clinical leadership, evidence strategy, and digital health market access. If this conversation sparked something, it is worth a conversation.

Shubs takes on consulting work with startups, investors, and global organisations across digital health.

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