Enterprise Clinical Governance, Safety &
Data Sovereignty
In the digital health sector, clinical trust is earned through empirical validation and strict regulatory adherence. CuraWave™ is built from the ground up to satisfy the highest standards of NHS digital procurement and medical device risk management.
The NHS DTAC 5-Pillar Scorecard
CuraWave™ satisfies all five core criteria required by NHS England Digital Health Technology Assessment Criteria for national deployment.
Clinical Safety (DCB0129)
Comprehensive clinical hazard log maintained under the oversight of an accredited Clinical Safety Officer (CSO). Clinical Safety Case Report (CSCR) available to NHS Trusts.
Data Protection (UK GDPR)
Data Protection Impact Assessment (DPIA) completed. Article 9 special category data safeguarded via on-device zero-image vectorization. Fully compliant with UK DPA 2018.
Technical Security
Zero open inbound ports. Firmware cryptographically signed. All outbound telecare telemetry encrypted with AES-256-GCM. Aligned with Cyber Essentials Plus.
Interoperability & Standards
Fully compliant with BS 8521-2 (SCAIP telecare protocol over IP) and CENELEC EN 50134-9. FHIR and HL7 ready for seamless integration with NHS EPR systems and primary care consoles.
Usability & Accessibility (WCAG 2.1 AA)
Caregiver dashboard and alert interfaces conform to WCAG 2.1 Level AA accessibility standards. For vulnerable residents, usability is passive: zero operational burden, zero charging, and zero buttons.
DCB0129 Clinical Safety Architecture
The application of clinical risk management to the manufacture of health IT systems is mandated across all NHS procurement pathways. CuraWave™ maintains a living Clinical Hazard Log following the DCB0129 framework, mapping every clinical risk from signal attenuation to caregiver alert acknowledgement.
Clinical Safety Officer (CSO)
Independent UK registered clinician oversees clinical safety sign-off, hazard mitigation, and deployment protocols across pilot sites.
Hazard Log & Mitigation
Identifies 18 distinct potential failure modes (e.g. Wi-Fi disconnection, power failure) with automated hardware fail-safes.
UK MDR 2002 SaMD Pathway
Classified as Software as a Medical Device (SaMD) Class I under UK Medical Devices Regulations 2002 (SI 2002/618 as amended). CuraWave's ambient vital trends assist clinical staff in proactive frailty intervention without active diagnostic control.
The Fall Detection Scope: Complete Clinical Honesty
Unlike legacy pendant manufacturers that bury technological limitations in small print, CuraWave™ provides absolute clarity on fall detection capabilities.
What Legacy Telecare Buries in the Fine Print
Tunstall, Chubb, and conventional wearable pendant vendors state in their technical manuals that their accelerometer-based devices "do not detect 100% of falls". Specifically, they cannot detect:
- × Slow downward slumps or fainting slides from armchairs or beds (insufficient G-force impact).
- × Falls where the resident instinctively breaks their fall with a wall or furniture before hitting the carpet.
- × Any fall occurring while the pendant is charging or left on the bedside cabinet.
The CuraWave™ Difference: Spatial Altitude & Respiration
CuraWave™ does not rely on mechanical impact shockwaves. By monitoring continuous 3D Fresnel altitude and torso displacement, CuraWave detects:
- ✓ Floor-Plane Settling: Recognizes when a human torso remains at floor level (< 0.25m) for > 30 seconds following downward velocity.
- ✓ Post-Fall Respiration: Evaluates nocturnal breathing frequency on the floor to classify distress vs intentional resting.
- ✓ 100% Passive Canopy: Operates constantly across bedroom and bathroom with zero resident action required.
8–10 Hour Integrated Power Resilience
Optical monitoring cameras and cloud-dependent Wi-Fi devices shut down during mains electricity blackouts or local fuse trips—often when elderly residents are most disoriented and at extreme risk of stumbling in the dark.
Integrated Lithium Iron Phosphate (LiFePO4) Battery
Guarantees continuous 8 to 10 hours of uninterrupted ambient RF sensing canopy and local sound alarms during total mains electrical failure.
Edge-Privacy Shield (Zero Raw RF Off-Premise)
Healthcare data governance requires rigorous protection of Article 9 special category health data. CuraWave™ implements a strict Edge-Privacy Shield.
Ephemerality in Local RAM
Raw Channel State Information is vectorized directly in volatile RAM on the local Edge node and discarded within 80 milliseconds. Only discrete alert telemetry frames (e.g. "FALL_CONFIRMED") leave the premises.