Research and innovation (R&I) actions to be supported under this topic will aim to address this challenge by:

• Developing a framework to integrate patient input and patient-generated data for use in decision making (regulatory, health economic evaluation, reimbursement, healthcare programme design, tailored prescription of therapies, and technology development), benefit-risk evaluation and value assessment of integrated healthcare solutions. Applicants should build on existing frameworks where appropriate and appropriately address ethics considerations.
• Implement several use cases to support and demonstrate the use of the framework, focusing on using patient input and patient-generated evidence to address challenges that are not adequately addressed by other initiatives. These use cases should demonstrate the value of using patient input (PROMs, PPI, PREMs) and patient generated data (digital health data/digital biomarkers) along the healthcare continuum, including showcasing improvements to data interoperability, healthcare workflows and processes, disease prevention, and care, including home-based care.
• Facilitating multi-stakeholder access to patient inputs and patient-generated health data such that actionable harmonised data can be used for quality decision making.
• Comparing/contrasting the properties of the three types of patient input (PROMs, PPI, PREMs), identify differences and opportunities for integrated/complementary use.
• Developing an approach or approaches to integrating PROMs, PPI, and PREMs data into the design of core outcomes sets, end-to-end patient treatment pathways, clinical decision support systems, and treatment guidelines.