Overview
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 - reviews how the COVID‑19 pandemic changed Remote Connected Care and Mobile Health (RCC‑MH). The technical specification surveys the current standards landscape, documents connectivity, safety and socio‑technical gaps across care settings (hospital, home and community, post‑acute and outpatient), and issues actionable recommendations and standards work items to accelerate interoperable, secure and effective RCC‑MH and telehealth deployments.
Key topics and technical requirements
ISO/TS 5615 does not introduce normative references but provides a structured analysis and recommendations across these technical topics:
- RCC‑MH definitions and care locations: hospital isolation rooms, remote patient surveillance, telehealth, remote delivery, LTAC and skilled nursing contexts.
- Safety, effectiveness and security (SES): risk‑based approaches to balance rapid deployment with patient safety and clinical effectiveness.
- Interoperability gaps: device and app nomenclature, data exchange, conformance and scalable interoperability solutions for crisis scenarios.
- Deployment and infrastructure: readiness of networks, cloud and edge infrastructure to support remote monitoring and mobile health at scale.
- Service support and operations: lifecycle, maintenance, and socio‑technical challenges (training, workflows, regulatory interfaces).
- Cybersecurity and privacy: landscape review and standards that inform secure RCC‑MH implementation.
- Recommendations and standards roadmap: prioritized standards work items and a path forward to accelerate safe, effective and secure RCC‑MH.
The specification includes informative annexes covering interoperability, telehealth, communications and cybersecurity standards landscapes, nomenclature, conformance, regulatory reactions and socio‑technical considerations.
Applications and who uses it
ISO/TS 5615 is practical for organizations designing, deploying or regulating telehealth and mobile health solutions:
- Medical device and app vendors - to align product design with interoperability and SES considerations.
- Healthcare providers and health delivery organizations - to plan remote patient surveillance, virtual care workflows and conformance expectations.
- Regulators and public health agencies - to understand standards gaps revealed by pandemics and to inform policy.
- Standards development organizations (SDOs) - to prioritize new work items and harmonize approaches across ISO, HL7 and CEN.
- Infrastructure and security vendors, payors and patient advocacy groups - to evaluate operational, privacy and reimbursement implications of RCC‑MH.
Related standards and SDOs
ISO/TS 5615 was prepared by ISO/TC 215 in collaboration with HL7 and CEN/TC 251. It references health informatics concepts (e.g., definitions in ISO standards such as ISO 81001‑1) and maps the standards landscape to guide future interoperability and cybersecurity work for remote connected care and mobile health.