Table S1.

Predefined research questions

Research questions
• Is there any regulatory/HTA guidance for connected devices in the US and EU, including apps or software in particular?
• What was the approval pathway for any connected devices that have been reviewed by regulatory authorities?
• Which clinical studies or other studies were required by regulatory and HTA bodies in order to grant approval of the selected connected devices?
• What is the impact of selected connected devices on adherence (clinical studies or RWE)?
• What is the impact of selected connected devices on clinical outcomes?
• What is the impact of selected connected devices on health care costs and resources, including doctors’ visits (scheduled and unscheduled visits)?
• What are the potential barriers that need to be overcome to unfold the full potential of these tools?

Abbreviations: EU, European Union; HTA, Health technology assessment; RWE, real-world evidence; US, United States.