Table 2.
Minimal functional requirements for the registry
| Requirement | Description |
|---|---|
| Data quality | ‐ Verification mechanism for registration data accuracy |
| ‐ Assignment of unique identifiers to distinct algorithms | |
| ‐ Prevention mechanism for duplicate algorithm registrations | |
| ‐ Accessible audit trail and version management | |
| Accessibility | - Accessible to all potential registrants |
| - Freely available to the public | |
| - User-friendly for contributions | |
| - Electronically searchable | |
| - Offered in relevant languages | |
| - Open 24/7 for submissions and searches | |
| Integration with other sources | - Enable linking with clinical trial identifiers |
| - Enable linking with published study DOIs | |
| - Enable linking with FDA or European Commission device identifiers | |
| - Automate data transfer between third parties, reducing redundancy | |
| Technical functionality | - Routine maintenance and updates |
| - Ensure permanence of entries | |
| - Efficient data storage and management | |
| - Robust data protection against loss and corruption | |
| Governance | - Central global hub for data entry, reducing redundancy |
| - Administered by a non-profit organization like NIH’s clinicaltrials.gov |
AI Artificial Intelligence, NIH National Institutes of Health, FDA Food and Drug Administration, DOI Digital Object Identifier.