Public Consultation

IDERHA (Integration of Heterogenous Data and Evidence towards Regulatory and HTA Acceptance) is a European Innovative Health Initiative (IHI) project launched in 2023 that aims to enable the safe, secure, streamlined sharing of heterogenous healthcare data. Heterogenous health data is an umbrella term that encompasses a wide range of data types that are relevant to individual and population health, health care delivery, and research, and includes Real-World Data (RWD), traditional clinical trial data, social determinants of health, and potentially other data that capture factors that affect health such as air pollution.   

Understanding the current policy challenges 

Over the last year, IDERHA conducted a landscape analysis of current policies for using RWD and Real-World Evidence (RWE). The purpose of the report is to identify policy areas where additional work is needed. This report is not intended to be an exhaustive overview of every document available on this topic. It is unique in that it looks at policies worldwide for regulatory and health technology assessments (HTA), as well as those that affect both medicines and medical devices. The analysis focused on understanding:   

• What do current policies cover?  
• Are there emerging best practices that could be considered broader adoption?  
• Where do challenges remain, and what are emerging policy gaps?  

Click here to view the Executive Summary, here for the Full Report, and here for a recording of the webinar where we presented the report. Or you can go directly to the feedback form; your feedback is very welcome until 22 July.  

Why focus on real-world evidence policies?  

Real-World Evidence (RWE) is a relatively new area of research. Due to its innovative nature, the development of policies that clearly outline how to conduct, assess, and evaluate RWE for public health decision making are lagging behind traditional clinical research approaches. To address this problem, one of the goals of the IDERHA project is to accelerate policy development by building consensus on the use of RWD and RWE in regulatory and Health Technology Assessment (HTA) decision-making for medicines and medical technologies.  

Better understanding your priorities  

With this public consultation, we want to gather your valuable insights and expertise to prioritize where additional work is need to improve and advance policies and guidance documents regarding RWE for Regulatory and HTA decision-making.  

IDERHA recognises the importance of involving diverse stakeholders and the general public in its work on making policy recommendations for sharing, access, use, and reuse of health data in regulatory and HTA decision making. As a result, a public consultation phase is critical for gathering insights, opinions, and concerns from patients, healthcare professionals, policymakers, and the general public.  

Provide your feedback 

Please submit your comments, insights, and feedback on our RWD/RWE landscape report before 22 July. We would particularly like to hear your views on:  

• Whether the report captures the key areas that are of importance 
• Whether there are any key priority areas missing in the report 
• Which areas of development we should be prioritising in future stakeholder engagement work 

By co-creating this body of knowledge on RWE policies and guidance, we aim to develop policy recommendations that will contribute to the rapidly changing nature of the European healthcare regulatory and HTA landscape. While we deeply appreciate and value your contributions, please note that our approach involves careful further analysis and learning from received comments, rather than direct responses to individual submissions. 

We will be continuing to engage relevant stakeholders in further developing policy recommendations for RWD/RWE Regulatory and HTA guidance through targeted workshops in the upcoming years. If you would be interested in updates about this work, please sign up for our mailing list. 

Feedback form 

Thank you in advance for your valuable contributions. These will be critical in the development of a strong and responsive policy framework aligned with the evolving healthcare landscape.

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