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FDA Says Digital Tech Use In Trials Should Measure Outcomes Meaningful To Patients

Published

25 August 2026

Topic

opportunities

Sectors

Digital Health

Geography

United States

Source

Read at insidehealthpolicy.com

Verified

Fusion42 · 25 August 2026 · Fusion42 review

The FDA advises clinical trial sponsors using digital health technologies such as wearables to ensure that the data collected measures outcomes meaningful to patients, emphasizing validation and relevance of health outcomes.

This Wire brief sits within Fusion42's coverage of Digital Health.

◆ The Wire takeaway

You need to align your trial technology outputs with patient-relevant outcomes now to meet FDA validation demands and avoid costly rework or rejection.

Coverage

1 source · 25 Aug 2026

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Digital Healthfdaclinical-trialsdigital-healthpatient-outcomesregulation