Recognized standard
TS 5615:2025
FDA recognition 13-152 · ISO · Software/Informatics
Key facts
| Recognition number | 13-152 |
|---|---|
| Designation | TS 5615:2025 |
| Title | Health informatics - Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | This document reviews the structural changes that have been precipitated by the COVID-19 pandemic in Remote Connected Care and Mobile Health (RCC-MH). The impact of the COVID-19 pandemic on care settings such as home and community care, acute care and outpatient care are reviewed discussing how well… |
At a glance
- None Product codes
- 10–99 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: