| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
065
|
Date of Entry 12/22/2025
|
|
FR Recognition Number
|
13-152
|
| Standard | |
ISO TS 5615:2025
Health informatics - Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics |
|
Scope/Abstract| 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 these healthcare environments were prepared to address the encountered connectivity challenges from a standards point of view. The current standards landscape is reviewed and gaps are identified leading to recommendations for future standards work. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Relevant FDA Guidance and/or Supportive Publications*
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued August 2023.
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
Multiple Function Device Products: Policy and Considerations - Guidance for Industry and Food and Drug Administration, issued July 2020.
Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued 2023.
Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 2016.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2023.
Clinical Decision Support Software - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
General Wellness: Policy for Low Risk Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2019.
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued August 2025.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
