{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"Global Perspectives on Digital Health","title":"What is the right approach for regulation and evaluation of digital health technologies?","html":"","width":"100%","height":180,"duration":4258,"description":"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. TakeawaysFlexibility 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...","thumbnail_url":"https://img.transistorcdn.com/hZPIZ-J0wiJx5Bagp4XUMpa5ahoYyL_sqq9C89IZlTc/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS85ODYz/N2YyYzVkYzhjMjY2/YWQyMjc4YmU3MWM0/YWE2NS5qcGc.webp","thumbnail_width":300,"thumbnail_height":300}