International collaborative research on maintaining confidence in regulatory and clinical evidence across the health technology lifecycle.
GHTRC brings together researchers, regulatory professionals, clinicians, engineers, legal and governance specialists, and other stakeholders to independently investigate how confidence in evidence is established, maintained, reassessed, strengthened, reduced, or challenged as evidence evolves over time.
GHTRC supports independent international research into how confidence in regulatory and clinical evidence is established, maintained, reassessed, strengthened, reduced, or challenged as evidence evolves throughout the health technology lifecycle.
The initiative is exploratory. It does not begin with a predetermined framework, scoring system, technical solution, or new compliance requirement.
Health technology decisions depend on regulatory, clinical, technical, safety, and real-world evidence that can change throughout the lifecycle. The research examines what happens when later evidence-changing events may affect earlier decisions.
Researchers and subject-matter experts may participate as Contributors, Advisors, or Observers according to their expertise, interest, and intended involvement. Participation is voluntary and multidisciplinary.
GHTRC does not assume that a new framework, technology, regulatory requirement, or infrastructure is necessary. Existing mechanisms may be sufficient, need better implementation or integration, require improvement, or need no further intervention.
Health technology decisions rely on evidence that evolves over time.
Existing mechanisms already address clinical evaluation, post-market surveillance, vigilance, quality management, cybersecurity, regulatory monitoring, change management, and regulatory decision-making. The research does not ask whether lifecycle monitoring exists.
It investigates whether evidence-changing events can be reliably identified and connected to earlier regulatory, clinical, procurement, and healthcare decisions; whether their impact can be assessed; and whether continued reliance on affected evidence remains justified.
How is confidence in regulatory and clinical evidence established, maintained, reassessed, strengthened, reduced, or challenged as evidence evolves throughout the health technology lifecycle?