Health technologies and the evidence supporting them do not remain static after initial development, authorization, procurement, or clinical adoption.
Evidence may evolve through:
- new clinical findings
- post-market surveillance
- vigilance and safety signals
- recalls and Field Safety Corrective Actions
- software and AI model changes
- cybersecurity developments
- changes in intended use
- certificate or regulatory changes
- manufacturing or quality changes
- new real-world evidence
- changes in standards or regulatory expectations
Research Question
Many established mechanisms already address individual parts of this lifecycle.
When evidence changes, can that change be connected to the decisions, devices, organisations, and stakeholders that previously relied upon the affected evidence?
The initiative investigates awareness, impact assessment, evidence dependencies, communication of uncertainty, and whether continued reliance remains justified.
What This Research Is Not
This initiative is not:
- a new compliance requirement
- a technical standard
- a product-validation exercise
- a predetermined confidence-scoring system
- an assumption that existing regulatory systems are inadequate
- a replacement for PMS, vigilance, QMS, clinical evaluation, regulatory intelligence, or existing lifecycle controls
- a commercial product-development exercise
Working Meaning of Confidence
For exploratory purposes, confidence is the degree of justified reliance a stakeholder can place on evidence for a specific decision at a specific point in time.
This definition is provisional. Researchers are encouraged to challenge, refine, reject, or replace it if evidence supports a better interpretation.
- credibility
- validity
- relevance
- currency
- completeness
- traceability
- consistency
- provenance
- sufficiency for the intended decision
