Imagine trying to sell a new medical app in eight different countries, but every country has a different set of rules for how to prove it works. This project creates a single, shared rulebook that everyone in Europe agrees on. It's like creating a universal plug adapter so health tech can work anywhere in the EU without starting the paperwork from scratch every time.
Companies developing health apps face a 'regulatory maze' where every EU country has different rules for approval. This makes scaling across Europe expensive and slow.
A comprehensive HTA assessment manual, a searchable evidence library, and a set of checklists for cybersecurity and data handling.
If you are a digiceutical developer dealing with fragmented national reimbursement rules — this project developed a shared assessment manual that speeds up market entry across Europe. It uses a phased adoption path to get your product to patients faster.
If you are an AI health software provider dealing with the challenge of updating software that learns over time — this project developed a specific methodology for iterative assessment. This ensures your AI stays compliant even as it improves.
If you are a health-tech security auditor dealing with inconsistent data protection requirements — this project developed a set of unambiguous criteria and checklists for cybersecurity. This allows for a standardized way to verify data safety across 8 countries.
Based on available project data, the results will be hosted in an open access European repository, suggesting the tools and manuals will be freely available.
Yes, the project aims to create a digital single market for health systems, allowing industry to access a unified European market rather than individual national ones.
Based on available project data, the project focuses on an open access repository and a published manual for consultation, implying a non-proprietary, shared standard.
The system is specifically aligned with key regulations like the European Health Data Space (EHDS) and incorporates criteria for data protection and interoperability.
The project runs from 2024-01-01 to 2026-12-31, meaning the final validated tools will be ready by the end of 2026.
The consortium is well-balanced for market adoption, featuring 16 partners across 8 countries. With a 31% industry ratio (including 5 SMEs), the project ensures that the resulting standards are practical for developers, not just academic. The inclusion of 4 HTA bodies and major medical societies (Cardiology and Diabetes) means the tools are being built by the very people who will decide if a product gets paid for by the state.
Contact Empirica Gesellschaft fur Kommunikations und Technologienforschung mbH in Germany
Contact us to find the specific checklists for your digital health product.
