Compliance, Safety & Data: Building Trust in Healthcare Technology

Compliance is Non-negotiable

In healthcare, nothing matters more than patient safety, confidentiality, and regulatory integrity. For a device like TruSelv — which sits behind a patient’s bed and displays key patient information — the stakes are even higher. Hospitals, regulators, and patients must trust that the system is safe, secure, and fully compliant with all legal and clinical standards.

Why Compliance & Safety Are Nonnegotiable

• In the hospital environment, a malfunctioning display or incorrect data could lead to serious clinical errors (e.g. allergy mis-display, incorrect medication schedule).
• Regulatory bodies (e.g. MHRA in UK, FDA in US, CE/UKCA in EU) govern how health-adjacent hardware must be designed, tested, documented, and monitored.
• Compliance underpins trust — hospitals won’t adopt a system that can’t be audited, disabled, or managed under strict governance.

Key Regulatory & Safety Standards We Follow

These are the essential frameworks that guide TruSelv’s design, compliance, and deployment in UK healthcare environments.

Standard / Regulation	Purpose / Scope	Relevance for TruSelv
MHRA & UK Medical Device Regulations	Oversee medical device safety, risk management, and reporting obligations.	If a display qualifies as a “medical device,” TruSelv must comply with MDR/UK MDR requirements.
ISO 13485 (Quality Management)	International standard for quality systems for medical device manufacturers.	Ensures consistent processes, documentation, traceability, and design validation.
IEC 60601-1 / IEC 60601-1-2	Defines safety and electromagnetic compatibility for medical electrical equipment.	Required if the unit operates within a patient zone and must limit electrical interference.
UKCA / CE Marking	Certifies conformity to health, safety, and environmental protection standards in the UK/EU.	Required for legal sale and use in the UK and European markets.
DCB0129 / DCB0160 (NHS Clinical Safety)	Clinical risk management standards for health IT manufacturers and NHS deployments.	TruSelv (as manufacturer) meets DCB0129; Trusts must satisfy DCB0160 during implementation.
DSPT (Data Security & Protection Toolkit)	NHS framework for assessing data protection and cybersecurity compliance.	Ensures TruSelv and NHS Trusts handle data securely and meet national standards.
GDPR & UK Data Protection Act	Legal framework for protecting personal and sensitive patient information.	TruSelv uses encryption, access control, and minimization to protect data integrity and privacy.

Safety & Clinical Risk Management

• Hazard Analysis & Risk Assessment — We identify potential failure modes (e.g. display blackouts, stale data, misconfiguration) and evaluate severity, occurrence, and mitigation.
• Safety Case & Hazard Log (DCB0129) — A living document capturing risk mitigations, residual risk, safety assumptions, and design controls.
• Clinical Safety Officer (CSO) — A qualified professional ensures that every software/hardware release is assessed for safety impact.
• Usability & Human Factors Engineering — Ensuring that the display UI is intuitive, minimizes user error, uses consistent iconography, avoids ambiguous symbols.
• Post-market surveillance & maintenance — Tracking incidents, software patching, version rollouts, and field device monitoring.

Data Governance, Security & Privacy

On the 'bedbord App', We only display non-sensitive, necessary information at the bedside (e.g. name, assigned Nurse allergies, schedule). No patient full record is stored locally

Encryption & Secure Communication

• All communications between backend and device are encrypted (TLS).
• Device storage (if any logs) uses encryption at rest; no unencrypted sensitive data stored.
• Firmware and app updates are signed and verified to prevent tampering.

Authentication & Access Controls

• Devices and admin consoles use certificate-based or token-based authentication.
• Role-based access control (RBAC) ensures only authorized staff can change display content.

Anonymization, Audit Logging & Traceability

• Device logs avoid storing personal health identifiers (PHI) unless necessary; we use pseudonymization or hashing where possible.
• All significant events (configuration changes, system failures, access) are auditable with timestamps and user IDs.

Incident Response & Breach Handling

• A documented incident response plan for data breaches, including escalation, notification, investigation, remedy
• Coordinated with NHS / hospital IT security teams and aligned to GDPR breach notification windows (typically 72 hours)
• In trial pilots, we include accessibility testing (per AIS), environment noise & lighting tests, and staff training.
• Provide documentation to procurement teams: safety cases, risk logs, test reports, security assessments, integration notes.

Meeting UK NHS Standards in Practice

• Before deployment, TruSelv Apps must pass NHS DTAC (Digital Technology Assessment Criteria) — covering safety, interoperability, usability, cybersecurity, and data protection.
• Deployment sites (Trusts) must validate DSPT compliance and accept our clinical safety case.

Why This Matters for Patients, Staff & Hospitals

• For patients: trustworthy systems reduce anxiety, prevent errors, and foster transparency.
• For staff: fewer clarifications, less risk, more confidence in displayed data.
• For hospitals: compliance reduces liability, ensures smoother procurement, meets mandated standards.
• For TruSelv: building compliance-first from Day 1 positions us credibly in NHS, UK, and global markets.

In healthcare, compliance, safety, and data security aren’t optional extras — they’re foundational. They distinguish robust, trustworthy technology from risky gimmicks.At TruSelv, we commit to meeting (and exceeding) UK and international healthcare standards, with continuous risk monitoring, user-first design, and deep respect for patient privacy. Because behind every innovation is a human being whose health, dignity, and trust matter most.