Delivering Digital Health Solutions that Patients Need: A Call to Action.

Digital health solutions have the potential to complement traditional healthcare approaches and deliver improved health outcomes, but there are system-wide challenges that need to be addressed. These include fragmentation of the digital health landscape, regulatory processes that lack the agility to accommodate the fast pace of digital health advances, and inadequate transparency around data sharing and data governance. All of these challenges have led to mistrust, limited understanding and sharing of best practices, a lack of digital education and awareness, and insufficient patient and public engagement and involvement.

Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review.

Background: Working with patients through meaningful patient engagement (PE) and incorporating patient experience data (PXD) is increasingly important in medicines and medical device development. However, PE in the planning, organization, generation, and interpretation of PXD within regulatory and health technology assessment (HTA) decision-making processes remains challenging. We conducted a global review of the PE and PXD landscape to identify evolving resources by geography to support and highlight the potential of integration of PE and PXD in regulatory assessment and HTA.