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Essential Reading for Clinical Trial Leaders

Digital Health
Under Scrutiny

Navigating the FDA's New DHT Framework

The definitive guide to understanding how Digital Health Technologies are reshaping clinical trial compliance—and what your organization must do to stay ahead.

50%
of trials use DHTs by 2025
30%
have proper governance
$2-5M
avg. remediation cost
© 2025 Qointa | A Stefanini Company
) }, // Page 1: The New Reality { type: 'content', content: (

The Compliance Earthquake

The FDA's Quiet Revolution

In 2023-2024, the FDA released twin guidances that fundamentally changed how Digital Health Technologies (DHTs) are regulated in clinical trials.

Wearables, sensors, and mobile apps are no longer convenience tools—they're evidence-generating medical devices subject to full regulatory oversight.

Did You Know?
A fitness tracker measuring steps for wellness is harmless. The same device tracking gait speed in a Parkinson's trial becomes a regulated medical device.
Key Guidances
  • • Digital Health Technologies for Remote Data Acquisition (Dec 2023)
  • • Framework for DHT Use in Drug Development (Mar 2023)
The Hidden Costs
6-12
months of trial delays
$2-5M
remediation costs
20%
of DHT studies face endpoint drift
What Changed?
Device validation now mandatory
Algorithm transparency required
ALCOA++ applies to all digital data
Global role mapping essential
Page 1
) }, // Page 2: Device Classification { type: 'content', content: (

Device Fit & Classification

The "Commercial" Myth

The FDA explicitly rejects the assumption that commercially available devices are automatically trial-ready. Every DHT requires fit-for-purpose validation.

Three Essential Validations
1
Analytical Validity
Does it measure what it claims?
2
Clinical Validity
Is it accurate in your population?
3
Usability Validity
Can users operate it correctly?
Real-World Failure
A cardiovascular study's mid-trial firmware update changed sampling from 100Hz to 80Hz, invalidating 3 months of data. Cost: $4M.
Risk Classification by Region
USA (FDA) 21 CFR 820/812
{['I', 'II', 'III'].map((c) => (
{c}
))}
EU (MDR) Annex VIII
{['I', 'IIa', 'IIb', 'III'].map((c) => (
{c}
))}
UK (MDR) UKCA
{['I', 'IIa', 'IIb', 'III'].map((c) => (
{c}
))}
Classification Impact
  • ✓ Documentation depth
  • ✓ Validation requirements
  • ✓ Import authorization
  • ✓ Post-market surveillance
Page 2
) }, // Page 3: ALCOA++ & Data Integrity { type: 'content', content: (

ALCOA++ in the Digital Age

The New Data Integrity Standard

ALCOA++ extends traditional data integrity principles into the digital realm, requiring end-to-end traceability from sensor to submission.

The ALCOA++ Framework
A
Attributable
L
Legible
C
Contemporaneous
O
Original
A
Accurate
+
Complete
+
Consistent
+
Enduring
+
Available
Digital Data Journey
{['Participant → Sensor', 'Sensor → Mobile App', 'App → Cloud Server', 'Cloud → Algorithm', 'Algorithm → Database', 'Database → Submission'].map((step, i) => (
{i + 1}
{step}
))}
Every handoff must maintain ALCOA++ compliance
Industry Reality
Most sponsors have QMS frameworks for GCP/GMP but lack controls for device-specific risks.
Common FDA Findings:
  • • Missing device-to-participant attribution
  • • Unverifiable timestamps
  • • Absent audit trails for cloud systems
  • • No verification of algorithm reprocessing
Critical Question
"Can you prove your data never changed along the way?"
Without end-to-end traceability, no evidence is admissible.
The Cost of Broken Integrity
$1-3M
avg. remediation cost
100%
data inadmissibility risk
Page 3
) }, // Page 4: Global Compliance { type: 'content', content: (

The Global Compliance Maze

Digital trials promise borderless research, but regulators have built digital borders to match. Every jurisdiction now demands proof of device conformity, role clarity, and data governance.

🇺🇸 USA (FDA)
  • • IND/IDE oversight
  • • Part 11 compliance
  • • Device validation
  • • 21 CFR 820
🇪🇺 EU (MDR)
  • • CE marking required
  • • Importer designation
  • • System producer rules
  • • GDPR compliance
🇬🇧 UK (MHRA)
  • • UKCA marking
  • • UK Responsible Person
  • • Vigilance reporting
  • • Post-market surveillance

Hidden Role Requirements

Manufacturer
Entity that designs, produces, or modifies devices
Importer
Verifies CE/UKCA, labeling, conformity docs
System Producer
Combines CE-marked components into unified system
Authorized Rep
Acts on behalf of non-EU/UK manufacturers
Real Failure Case
6 weeks
Customs detention
$500K
Direct costs
Oncology trial wearables detained in EU for missing importer documentation
Asia-Pacific Considerations
🇯🇵
Japan (PMDA): Device registration + GPSP requirements
🇮🇳
India (CDSCO): 2023 MDR rules + import license
🇦🇺
Australia (TGA): ARTG listing + conformity evidence
🇨🇳
China: Cybersecurity review for data exports
Page 4
) }, // Page 5: The Path Forward { type: 'content', content: (

How to Win in the New Digital Health Economy

The future doesn't belong to the most digital—it belongs to the most prepared.

1
Device Validation
Analytical, clinical, and usability testing for every DHT
2
Version Control
Lock firmware and algorithms; track every update
3
ALCOA++ Integration
End-to-end traceability from sensor to submission
4
Global Role Mapping
Identify manufacturers, importers, system producers
5
DHT-Ready QMS
Integrate device, data, and clinical quality systems
Organizations That Lead:
  • ✓ Anticipate guidance, don't react to it
  • ✓ Integrate regulatory, clinical, and data teams
  • ✓ Prepare documentation before inspection
  • ✓ Treat quality as strategy, not paperwork
The Compliance Advantage
3x
Faster regulatory acceptance
70%
Fewer inspection findings
$5M+
Avoided remediation costs
Critical Question
"Can you prove your devices, data, and decisions are trustworthy—before regulators ask?"
Innovation × Governance = Trust
The New Equation
for Digital Trial Success
Page 5
) }, // Back Cover { type: 'back', content: (

Ready to Build DHT Readiness?

Qointa helps sponsors, CROs, and technology partners achieve digital compliance:

Device classification & validation
Endpoint governance
QMS integration
Global role mapping
ALCOA++ traceability
Audit preparation
Introducing Device360™

Our comprehensive platform includes DeviceReg™ for classification, DeviceFit™ for validation, and integrated modules ensuring ISO 14971 risk files and IEC 62366 usability testing are inspection-ready.

Built for the compliance demands of tomorrow's digital trials.
Get in Touch
Let's assess your digital compliance map
www.qointa.com
info@qointa.com
© 2025 Qointa | A Stefanini Company
#DigitalHealth #ClinicalTrials #RegulatoryCompliance
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Enter your details to receive the full digital health compliance guide

); }; export default DigitalHealthGuide;