Digital Health
SMETarget: AI-based diagnostic tool developer
If you are a developer dealing with fragmented national approval processes — this project developed a validated assessment system that accelerates market entry across 11 countries.
EDiHTA · Project
Standardized European Evaluation System for Faster Market Entry of Digital Health Tools
healthPilotedTRL 7
Imagine trying to get a new app approved by doctors and insurance companies, but every country has different rules. This project creates a single, shared rulebook that everyone agrees on. It acts like a universal quality stamp, making it much easier for tech creators to prove their tools actually work and get them into hospitals quickly.
By the numbers
11
Countries involved
5
Major hospitals for piloting
13
Core assessment domains developed
22
Total partners
The business problem
What needed solving
Digital health tools face fragmented and outdated evaluation rules across Europe. This creates a bottleneck that delays market entry and makes it hard for payers to justify costs.
The solution
What was built
A validated digital assessment system and a shared taxonomy for digital health tools. It includes 13 core domains for measuring clinical effectiveness and security.
Audience
Who needs this
AI medical device startupsTelemedicine platform providersHealth insurance reimbursement officersHospital procurement departments
Business applications
Who can put this to work
Healthcare Providers
enterpriseTarget: Large private hospital network
If you are a hospital manager dealing with the risk of adopting unproven telemedicine tools — this project developed a modular evaluation tool that ensures clinical effectiveness and data security.
Health Insurance
anyTarget: Public or private health payer
If you are a payer dealing with uncertainty about the actual value of mobile health apps — this project developed a set of 13 core assessment domains to justify reimbursement decisions.
Frequently asked
Quick answers
What is the cost or price to use this system?
Based on available project data, there is no specific pricing mentioned, but the project aims to create an open repository with guides and methodologies.
Can this be scaled to an industrial level?
Yes, the system is being piloted in 5 major European hospitals and through an open scheme with technology providers to ensure it works at scale.
Who owns the IP or licensing for the assessment tools?
Based on available project data, the specific licensing terms are not listed, but the goal is to provide a ready-for-use European system for all users.
How does this handle EU data regulations?
The project integrates data governance under the European Health Data Space (EHDS) and embeds cybersecurity and data protection directly into the process.
What is the timeline for implementation?
The project runs from 2024-01-01 to 2027-12-31, with the goal of delivering a validated system by the end of the period.
Consortium
Who built it
The consortium is highly diversified with 22 partners across 11 countries, showing strong cross-border alignment. With a 23% industry ratio (5 companies) and 9 'other' organizations (including HTA agencies and clinics), the project balances academic research with practical market application, ensuring the final tool is usable by both developers and payers.
How to reach the team
Contact Universita Cattolica del Sacro Cuore in Italy
Next steps
Talk to the team behind this work.
Contact us to find out how to align your digital health product with the emerging EDiHTA standards.
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