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Results

ASSESS DHT is producing key outputs. Below, you can access materials and publications.

Frameworks for assessing digital health technologies: a scoping review
Collaborative and Cooperative Hospital “In-House” Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values
Examining human-AI interaction in real-world healthcare beyond the laboratory
Cybersecurity requirements for medical devices in the EU and US – A comparison and gap analysis of the MDCG 2019–16 and FDA premarket cybersecurity guidance
Consternation as Congress proposal for autonomous prescribing AI coincides with the haphazard cuts at the FDA
Could transparent model cards with layered accessible information drive trust and safety in health AI?
Letter to the Editor on ‘‘From Concept to Clinic: Living Labs andRegulatory Sandboxes for Health System Digitalization and theIntegration of Innovative Devices Into Clinical Workflows’’
A roadmap for safe, regulation-compliant Living Labs for AI and digital health development
The role of Open Access Data in democratizing healthcare AI: A pathway to research enhancement, patient well-being and treatment equity in Andalusia, Spain
Safe AI-enabled digital health technologies need built-in open feedback 
A transparent and standardized performance measurement platform is needed for on-prescription digital health apps to enable ongoing performance monitoring
FDA launches health care at home initiative to drive equity in digital medical care
How can regulation and reimbursement better accommodate flexible suites of digital health technologies?
Digital health technologies need regulation and reimbursement that enable flexible interactions and groupings
Developing an Evidence Gaps Tool for Developers of DigitalHealth Technologies (DHTs): A Scoping Review of EvidenceRequirements for Evaluating the Value of DHTs
D3.3 Common EU checklist for cybersecurity of digital medical devices
  • December 31, 2024
D3.2 Data quality assessment, labelling and interoperability criteria for health data used to develop, validate, deploy, and use DHT including AI
  • December 31, 2024
D3.1 Data protection and Regulatory compliance criteria for health data used to develop, validate, deploy and use DHT incl. AI
  • December 31, 2024
D1.3 Project Handbook
  • July 3, 2024
D1.2 Quality Plan
  • April 9, 2024
D6.3 Requirements Specification for the Repository of Evidence
D6.1 Engagement and exploitation strategy
D4.5 Manual for piloting assessment methods fordigital health technologies (interim/piloting version of the full manual D4.6)
D4.2 Validation methods for AI-based decision support systems
  • September 2, 2025
D2.2 Landscape and gap analysis of existing value frameworks and methods for the assessment of digital health technologies
D2.1 Taxonomy of DHT for assessment purposes
D1.6 Interim report on communication and dissemination
D1.5 Communication and dissemination plan
D1.4 Data Management Plan
D1.1 Project website and dissemination channels
  • April 5, 2024