Technology

Standard hardware, open research architecture.

From the sensor in the room to the dashboard: a maintainable, offline-capable development stack with privacy-oriented engineering. Site approval, DPIA and clinical evidence remain separate gates.

Architecture

Data flow in four layers.

Layer	Component	Role
Wearable	Selected smartwatches with adapters	Model-dependent heart-rate, SpO₂ and movement values over Bluetooth Low Energy
Radio bridge	ESP32-S3 (1 per room)	Reads the watch over BLE, captures WiFi-CSI, sends via WiFi
Server	Local appliance (mini-PC)	Storage, analysis, notification logic, dashboard
Interface	Web dashboard	Per-resident status, roles, notifications

The radio bridge: ESP32-S3

One ESP32-S3 module works in each room. It combines Bluetooth 5 (more stable connection to wearables) with WiFi and enough memory for CSI buffering and simple analysis right at the edge of the network.

Bluetooth 5 for stable smartwatch connectivity
WiFi-CSI directly in the radio chip
Local buffering during network outages
Module cost in the single-digit euro range
Roadmap: ESP32-C6 (WiFi 6 / Matter)

Software stack

Proven and maintainable — no exotic special stack:

Backend: Python / FastAPI
Database: SQLite (small homes) to PostgreSQL (hospitals)
Local message bus: MQTT (Mosquitto)
Dashboard: modern web interface
Smartwatch adapters as swappable plugins

WiFi-CSI

Wearable-free sensing — realistically framed.

CSI uses changes in existing WiFi signals to calculate experimental room and movement markers. Performance is validated separately by room, occupancy and endpoint.

Technically prepared

Presence marker / room occupied
Movement and stillness markers
Suspected fall as a research marker

Research roadmap

Breathing / heart rate via radio alone
Person separation in multi-bed rooms
Fine-grained pose recognition

Based among others on Espressif's ESP-CSI toolkit and publicly published CSI sensing research.

Security & privacy

Privacy by design.

🔒

Encryption

Data encrypted at rest and in transit (TLS on the local network).

🏠

Stored locally

Processing inside the facility. Cloud only optional and encrypted.

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Pseudonymisation

Personal identity kept separate from measurement data where feasible.

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Roles & rights

Separate access rights for care, physicians and administration.

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No camera/mic

CSI uses radio only — no image or audio recording.

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GDPR

Data processing agreements and impact assessment as part of rollout.

Status: 8 August 2026

Validation and compliance status.

We distinguish technical implementation, clinical evidence and external approval. A green software test is neither clinical validation nor certification.

Implemented technically

Role- and device-bound access
Hardened sign-in and chained audit events
Secret/compliance checks and automated builds
Automatable SBOM and release evidence

Validation outstanding

Clinical accuracy of low-cost smartwatches
CSI/radar breathing, pulse, sleep and fall markers
Multi-person and multi-bed assignment
Alarm performance under real ward conditions

External approval required

Ethics opinion and signed DPIA
Penetration test, restore and incident exercises
Supplier, DPA and operating approvals
MDR/MPDG pathway and potential ISO/SOC audit

Current classification: the standards register, control catalogue and technical security measures are prepared or partially implemented. There is currently no ISO certification, SOC 2 report, blanket HIPAA approval, ethics opinion for the full scope described, or MDR conformity.

Regulatory path

Stepwise model: comfort first, medical device later.

A fast, responsible market entry — with clear wording at every stage.

Today · Wellness / comfort

Notification system for care staff. No diagnosis, no therapy. This enables a fast pilot operation.

Build-up · Quality

Quality management to ISO 13485, software lifecycle to IEC 62304, risk management to ISO 14971.

Goal · MDR Class IIa

Conformity under the EU Medical Device Regulation as a later stage for selected functions.

Prepared · Evidence

Study protocols and analysis are prepared. Recruitment and effectiveness claims follow ethics and site approval.

Wording policy: as long as there is no MDR conformity, Ethical Saving communicates solely as a notification and comfort system. We deliberately avoid claims such as "detects diseases" or "replaces monitoring".