Episode 5: What is the right approach for regulation and evaluation of digital health technologies?

In this conversation, Shubs Upadhyay interviews Stephen Gilbert, a professor of medical device regulatory science, about the challenges and successes of digital health regulation and implementation.

They discuss the need for flexibility in regulation, the importance of feedback from clinicians and patients, and the evaluation of digital health technologies. They also explore the concept of suites or groupings of digital devices and the need for regulatory approaches that acknowledge their flexibility. Gilbert emphasizes the need for regulation to adapt to the changing landscape of digital health and to ensure that it is fit for purpose.

Stephen also talks about what health system leaders, policy makers and developers can learn from the challenges of the DiGA fast track reimbursement framework in Germany, the PECAN framework in France and what is coming in the UK. As well as calling out the stark differences in approach from the FDA and the EU, Stephen helps understand the deeper reasons for the different approaches.

On evaluation of effectivenss, Stephen emphasizes the importance of integrating different technologies into a cohesive system rather than treating them as isolated tools. The discussion also highlights the role of regulation in facilitating interoperability and promoting the use of digital technologies in healthcare.

A great section on the need for long-term thinking on exactly how we want to transform healthcare delivery, setting clear goals, and continuous feedback loops is emphasized, along with the recognition that digital transformation in healthcare requires investment, embedding and time to get back the ROI.

Takeaways

• Flexibility is crucial in digital health regulation to adapt to the rapidly changing landscape of technology and healthcare.
• Feedback from clinicians and patients should be actively encouraged and integrated into the regulatory process.
• The evaluation of digital health technologies should consider their unique characteristics and the need for holistic assessment.
• Regulatory approaches should acknowledge the flexibility and groupings of digital devices, such as suites, to ensure they are fit for purpose.
• Digital healthcare involves the integration of various technologies, such as teleconsultation and remote monitoring, into a cohesive system.
• Regulation plays a crucial role in promoting interoperability and facilitating the use of digital technologies in healthcare.
• Long-term thinking and clear goals are necessary for effective digital transformation in healthcare.
• Continuous feedback loops and monitoring are essential for evaluating the effectiveness of digital health tools.
• Investment is required for digital transformation in healthcare, and initial costs may be higher before yielding dividends.

Links to papers mentioned:

Paper on regulation, reimbursement approach: flexible groupings
Paper on regulation, reimbursement approach: flexible suites of technologies
A/B testing framework mentioned here

Stephen Gilbert, Professor at the Faculty of Medicine, Dresden University of Technology (Else Kröner Fresenius Center for Digital Health), leads a multidisciplinary team specializing 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.