Digital health technology guidance

1. Digital Health
Technologies (DHT)
For remote data acquisition in
clinical investigations
FDA DRAFT GUIDANCE DOCUMENT SUMMARY
December 2021

2. DHT Definition
 system that uses computing platforms, connectivity, software
and / or sensors for healthcare and related uses
 DHT can be:
 Only software
 Only hardware
 Both working together

3. Overview
 DHT selection
 Verification and Validation
 Use
 Risk identification
 Risk management

4. Development of DHT
 An unapproved device must satisfy requirements of 21 CFR
part 812
 Resource: CDRH centre of excellence
 Qualification of DHT:
 Drug development tool (DDT)
 Medical device development tool (MDDT)
 Can consider submission to ISTAND program

5. Selection criteria
 Fit-for-purpose
 Usability by trial population
 Willingness by participants
 Feasibility – battery/power
 Operational specifications – data storage, data sync frequency → minimizing
missing data
 Alerts – battery, signal, data collection errors; participant education to troubleshoot
 Environmental factors during operation/storage
 Network system capability
 Privacy and security

6. Consumer / Participant’s own DHT
 Evaluate advantages and disadvantages
 High familiarity
 Consistency of measurement
 Specify minimum technical specifications, operational
specifications
 Precision

7. Verification and Validation
 Benchtop studies → Healthy volunteers → Trial participants
 Involve DHT manufacturers, patients, caregivers, technical personnel
etc.
 Comparison to reference
 Evaluate factors affecting precision
 Evaluate calibration process
 Validation and usability studies
 Software validation
 Novel endpoints should be validated

8. Statistics
 Noninferiority trials may not be appropriate
 Define endpoints
 SAP should prespecify intercurrent events due to DHT and
ways to deal with them

9. Indentifying risks
 Clinical risk
 Risk of injury to participants
 Cybersecurity risks
 Measurement errors
 Privacy
 Address the risk
 EULAs
 Security in transit and storage of data
 Informed consent

10. Record protection
 Use of Electronic Records and Electronic Signatures in Clinical
Investigations Under 21 CFR Part 11 – Questions and Answers
(June 2017)

11. Sponsor responsibilities
 Technical assistance plan
 Risk management plan
 Clinical
 Privacy related
 Safety monitoring plan
 Data sync
 Training for use
 Maintenance of DHTs (cleaning etc.)
 Responding to DHT signals
 Data verification for integrity and continuity
 All updates should be validated, no significant impact on measurements etc.