Overview
CEN 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 - is a Technical Specification (ISO/TS 5615:2025) published July 2025. Prepared by ISO/TC 215 in collaboration with CEN/TC 251, this document reviews structural changes in Remote Connected Care and Mobile Health (RCC‑MH) precipitated by the COVID‑19 pandemic, evaluates the existing standards landscape, identifies interoperability and operational gaps, and issues recommendations for future standards work. The CEN version was approved for provisional application with an initial three‑year validity.
Key Topics
The specification organizes analysis and recommendations across practical domains and technical concerns, including:
- RCC‑MH care locations and use cases: hospitals (isolation rooms, remote surveillance), home and community care (telehealth, remote delivery), post‑acute and outpatient care.
- Gaps and challenges across multiple dimensions: safety & quality, deployment, service support, infrastructure, interoperability, operations, and security.
- Standards landscape reviews: annexes summarize nomenclature, communications, telehealth and cybersecurity standards relevant to RCC‑MH.
- Recommendations and path forward: targeted standards work items, interoperability priorities and socio‑technical considerations to accelerate safe, effective, secure remote care.
- Conformance and regulatory context: informative annexes on conformance landscapes and regulatory/legal reactions to pandemics.
Practical Applications & Who Should Use It
CEN ISO/TS 5615:2025 is designed for stakeholders aiming to deploy or govern interoperable remote connected care and mobile health solutions:
- Healthcare IT architects and system integrators planning interoperability between devices, telehealth platforms and electronic health records.
- Medical device manufacturers and digital health vendors aligning device nomenclature, communications and cybersecurity practices.
- Procurement teams and health system leaders creating specifications for telehealth and home‑care services.
- Standards developers and policy makers prioritizing standards work to close pandemic‑revealed gaps.
- Regulators and conformity assessment bodies evaluating safety, data protection and operational readiness for RCC‑MH.
Related Standards (and resources)
- Developed under ISO/TC 215 (Health informatics) in collaboration with CEN/TC 251.
- Annexes provide a consolidated standards landscape (telehealth, cybersecurity, communications, nomenclature) and a bibliography for further reference.
- Useful as a roadmap for organizations seeking standards‑based interoperability, conformance testing and regulatory alignment in remote connected care and mobile health.
Keywords: ISO/TS 5615:2025, CEN ISO/TS 5615, health informatics, remote connected care, mobile health, interoperability, telehealth, cybersecurity, standards landscape.