This Request for Quote (RFQ) is published to invite suitably qualified organisations to provide proposals for the completion of a Feasibility Report on establishing a Digital Health Validation Lab & Regulatory Sandbox (DHVRS) in Ireland.

The initiative is led by the Connected Health & Wellbeing Cluster (based at Dundalk Institute of Technology – DkIT), alongside a number of supporters, and is co-funded by Government of Ireland and the European Union through the ERDF fund via the Smart Regions funding at Enterprise Ireland. It is also co-funded by key partners including:

• Tallaght University Hospital
• The HSE National Simulation Office
• dConnect Digital Health Innovation Hub

Additional project supporters include EIT Health Ireland-UK, Amazon Web Services (AWS), the Regulated Software Research Centre at DkIT, Cyber Ireland, and the HSE Technology & Transformation unit.

There are two components of the DHVRS; a Digital Health Validation / Simulation Lab, an immersive environment with medical staff and a replica of a health information system for co-design, testing, and validation; and a Regulatory Sandbox, a collaborative process where regulators evaluate the digital solutions in real-world settings, on a time-limited basis, at a small scale, and with appropriate safeguards in place.

See full details in the RFQ RFQ DHVRS Feasibility Report_Final_31.10.25.

• Horizon scanning and modelling that will involve conducting extensive research to map and compare existing models (Validation Labs & Regulatory Sandboxes), drawing on successful implementations in global hubs such as Melbourne, Glasgow, Singapore, and London.

This analysis will distil best practices and strategic insights, enabling the development of a tailored approach that aligns with Ireland’s unique healthcare landscape and regulatory environment, including International regulatory obligations. This will include objective examination of the strengths and weaknesses, opportunities and threats and key risks including constraints and external influences of the proposed DHVRS. It will also highlight International benchmark metrics that could be utilised for a potential DHVRS in the Republic of Ireland.

Please contact breanndan.casey@dkit.ie with any queries.

Project Outline

The project timeline includes the following:

Feasibility Study for a Digital Health Validation Lab & Regulatory Sandbox (DHVRS) is Co-Funded by the Government of Ireland and European Regional Development Fund (ERDF) Regional Programmes through the Northern and Western Regional Programme 2021-2027