Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation
This framework explores how well health data used in digital health devices follow the FAIR principles (Findable, Accessible, Interoperable, Reusable) to support safer and more responsible regulation of digital health technologies.
At a glance
Use when
Evaluating data management in digital health device regulation, designing regulatory assessment criteria, developing policies for IoMT data governance
Avoid when
When dealing with non-digital or standalone medical devices without data-sharing capabilities; when FAIR principles are not a regulatory requirement
Inputs
Health data management practices in digital health devices, regulatory documentation, data governance policies, device architecture descriptions
Outputs
Assessment of FAIR compliance level, recommendations for improving data stewardship in regulatory contexts
How it works
The framework assesses the application of FAIR data principles within digital health device regulation, particularly in the context of Internet of Medical Things (IoMT) systems. It aims to ensure that health data used in these devices are properly managed and governed, supporting trustworthy cyber-risk assessment and mitigation. Although not directly implemented in the cited paper, the framework provides foundational guidance for integrating data governance into threat modeling processes using advanced AI models.
- Project
- INSAFEDARE
- Funding
- Horizon Europe
- Project status
- Ongoing
- HTA domains
- Organisational aspects, Patient and Social Aspects, Aspects Beyond HTA
- Assumptions
- Health data used in digital devices should adhere to FAIR principles to ensure transparency, reuse, and regulatory trust; regulatory bodies can evaluate data quality using structured frameworks
- Strengths
- Supports robust data governance in emerging digital health technologies; aligns with global data standards; enhances regulatory oversight and patient safety
- Limitations
- Still in conceptual stage; limited empirical validation; may require adaptation for specific device types or jurisdictions
- Also known as
- FAIR Assessment Framework for Digital Health Devices, INSAFEDARE FAIR Framework
Questions this answers
- › How can the FAIR principles be applied to health data in digital health devices?
- › What criteria assess whether health data in IoMT devices are sufficiently Findable, Accessible, Interoperable, and Reusable?
- › How does adherence to FAIR principles improve data governance in regulated digital health technologies?
- › What role does FAIR data play in enhancing cybersecurity and trust in IoMT systems?
- › How can regulators evaluate the quality and usability of health data in digital device submissions?
- › What are the implications of poor data management practices on patient safety and system integrity?
References & sources
Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.