Participant Information
Overview of the SHAIPED project
The SHAIPED project operates within the framework of the European Health Data Space (EHDS), the emerging EU regulatory environment designed to enhance access to and reuse of Real‑World Data (RWD). Its objective is to define how the forthcoming Health Data Access Bodies (HDABs) — the entities responsible for enabling authorised secondary uses of RWD — can effectively support the development, evaluation, and deployment of Medical Device Artificial Intelligence (MDAI), understood as Artificial Intelligence systems that meet the regulatory definition of a medical device and are intended to support clinical decision‑making, diagnosis, treatment, or other health‑related functions. This consultation forms part of SHAIPED WP4, which seeks to examine how RWD accessed through HDAB‑related mechanisms may support post‑testing stages’ processes for MDAI, particularly in relation to evidence needs for market certification, post‑market surveillance, clinical follow‑up and Health Technology Assessment (HTA) in reimbursement and pricing decision making.
SHAIPED is coordinated by the Health Data Hub (Plateforme des Données de Santé, HDH, France). This stakeholder consultation is conducted within Work Package 4, led by the Finnish Institute for Health and Welfare (THL, Finland) with co‑leads Charité – Universitätsmedizin Berlin (Germany) and the Instituto Aragonés de Ciencias de la Salud (IACS, Spain), in collaboration with the following SHAIPED consortium partners: the Haute Autorité de Santé (HAS, France), the Digital Health Delegation (DNS, France), the Croatian Institute of Public Health (CIPH, Croatia), the Finnish Medicines Agency (Fimea, Finland), and the Institut National de la Santé et de la Recherche Médicale (Inserm, France).
Purpose of the questionnaire
The purpose of this questionnaire is to better understand the role and perceptions of stakeholders around RWD use in MDAI post‑testing regulatory processes, and how HDABs may contribute to streamlining them. It also aims to gather informed views on how these processes could be structured in settings where MDAI are not yet routinely assessed.
For this study, the definition of RWD is according to the European Medicines Agency — i.e., routinely collected data relating to patient health status or the delivery of healthcare from sources other than traditional clinical trials. This includes Real‑World Data (RWD) used for the training, validation, and testing of MDAI, as well as RWD generated through the deployment and operational use of MDAI within healthcare systems. Relatedly, Real‑World Evidence (RWE) refers to the evidence generated through the analysis of such data.
Why have I been invited to take part?
We are interested both in the views of stakeholders with direct experience in evaluating MDAI and in the perspectives of those who may not yet have assessed these technologies but can provide valuable insight into how such processes could be designed in the future.
Your expertise is valuable because this survey aims to understand current practices, challenges, and future needs related to the use of RWD in MDAI evaluation and decision‑making.
Do I have to take part and can I withdraw?
Taking part in this study is entirely voluntary. You may choose not to answer any question. If, after submitting the questionnaire, you wish to withdraw your participation and request that your data be removed from the study, you may contact the project team at info@shaiped.eu.
What will my participation involve?
If you agree to take part, you will be asked to complete a semi‑structured questionnaire about the current role of RWD in post‑test regulatory processes for MDAI. The questionnaire is expected to take approximately 30 to 45 minutes to complete.
The study team may invite you to take part in a short follow-up call to clarify specific points in your response.
What are the possible benefits and disadvantages of taking part?
There are no direct personal benefits associated with participation. However, your input is valuable for advancing the understanding of how Real‑World Data (RWD) can support deployment processes for Medical Device Artificial Intelligence (MDAI), and for clarifying the potential role of Health Data Access Bodies (HDABs) in streamlining these processes. Your contribution may inform future recommendations aimed at improving the efficiency, consistency, and robustness of evidence generation and decision‑making.
There are no anticipated risks linked to participation. The primary disadvantage is the time required to complete the questionnaire.
How will my data be used, stored and protected?
The information you provide will be used for research purposes within the SHAIPED project. Responses will be analysed mainly at the organisational and thematic level, rather than focusing on individual responses.
Only the minimum personal data necessary for communication and follow-up will be collected, such as your name, email address, organisation, and professional role, where relevant. Responses will be stored securely and handled in accordance with applicable data protection legislation, including GDPR principles. Identifiable information will be accessible only to authorised members of the research team who need it for study administration, analysis, or follow-up.
When reporting findings, responses will be anonymised and summarised to avoid attribution to individual participants unless you or your organisation have explicitly agreed otherwise.
What will happen to the results of the study?
The results of this consultation will be combined with the documentary and literature-based analyses conducted within SHAIPED WP4. Findings may be included in project deliverables, internal reports, scientific publications, presentations, and other dissemination materials produced as part of the SHAIPED project. Results will typically be presented in aggregated and anonymised form. Quotations from responses may be used only in anonymised form, unless explicit permission for attribution has been obtained.
The results will also be made available in project deliverables published on the SHAIPED webpage, and we will send the respective documents to the email address through which we contacted you.
Who is organising the study and who can I contact?
This study is being conducted as part of the SHAIPED project, funded under the Digital Europe Programme. If you have any questions about the study, or if you would like to withdraw your participation, please contact: info@shaiped.eu