HelixOrg

NEWS2 Calculator

National Early Warning Score 2 assessment with support for both SpO2 Scale 1 and Scale 2. Records scores per patient with timestamps, displays risk levels with colour-coded badges on patient rows and in handover reports, and keeps a full score history with detail views.

IV Fluid Reference

Based on NICE CG174 guidelines. Browse IV fluid compositions and guidance, then record fluid entries per patient with fluid name, volume, duration, and route. Entries are summarised in handover reports.

Insulin Reference

Based on JBDS (Joint British Diabetes Societies) guidelines. Includes sub-tools for DKA protocol, hypoglycaemia protocol, VRIII (variable rate IV insulin infusion), perioperative guidance, and an insulin types reference. Record insulin entries per patient with entry type and summary.

MHRA — Medical device classification

Under the UK Medical Devices Regulations 2002, software that is "simply a patient management system or a records storage system" is explicitly excluded from the medical device definition. HelixOrg's core features — patient lists, task tracking, and handover report generation — fall squarely within this exclusion.

The clinical reference tools (NEWS2 calculator, IV fluid reference, insulin protocol reference) replicate manual processes that clinicians would otherwise perform on paper or from printed guidelines. They provide reference information only and do not generate diagnoses, treatment recommendations, or automated clinical alerts. Each clinical tool requires an explicit disclaimer acknowledgement before first use. The NEWS2 calculator outputs the numerical score without interpretive risk classifications in exported handover text, leaving clinical interpretation to the treating clinician.

UK GDPR and Data Protection Act 2018

HelixOrg does not collect, transmit, or process personal data on behalf of the developer. All patient data remains on the user's device. The developer is neither a data controller nor a data processor under UK GDPR. The app implements data protection by design and by default (Article 25): no analytics, no telemetry, no third-party SDKs, no network requests for app data.

Patient data entered by clinicians constitutes special category data (health data) under Article 9 UK GDPR. Responsibility for lawful processing sits with the data controller — the individual clinician or their employing NHS Trust. A mandatory first-launch disclaimer makes this responsibility explicit, requiring users to acknowledge that they are responsible for handling patient data in accordance with their employer's information governance policies and for deleting data when it is no longer needed.

Data retention and storage limitation

UK GDPR storage limitation principles require that personal data is not kept longer than necessary for its purpose. HelixOrg supports this through multiple mechanisms: per-patient deletion with cascade removal of all associated records (tasks, NEWS2 scores, IV fluid entries, insulin entries), a Clear All Data option in Settings, and a configurable shift-end reminder that prompts clinicians to review and clear patient data after a period of inactivity (defaulting to on). The reminder presents options to clear data immediately or defer, supporting routine data hygiene at natural shift boundaries.

Caldicott Principles

The eight Caldicott Principles govern the use of patient-identifiable data in the NHS. HelixOrg supports these principles through its architecture: data is stored only when operationally necessary, access is restricted to the individual device via biometric or passcode authentication, and no data is shared with external parties by the app. Handover reports containing patient-identifiable information include a visible warning banner, require a confirmation step before sharing or copying, and append a footer reminding the recipient to share only via Trust-approved channels.

NHS BYOD guidance

The NHS Transformation Directorate's BYOD guidance requires device-level authentication, encrypted storage, and controls to prevent data exposure on personal devices. HelixOrg addresses these requirements with biometric or passcode app lock, configurable auto-lock timeout, privacy blur in the multitasking switcher, and all data stored locally using Apple's encrypted SwiftData framework. The app also includes an in-app Trust & Compliance notice advising clinicians to confirm compatibility with their Trust's own BYOD and information governance policy before storing patient data.

NICE Evidence Standards Framework

Under the NICE Evidence Standards Framework, HelixOrg's core features (patient lists, task management, handover reports) align with Tier A (System Service) — tools intended to improve system efficiency without directly influencing individual clinical outcomes. The clinical reference tools provide reference information drawn from published guidelines (RCP NEWS2, NICE CG174, JBDS) for clinicians to interpret and apply using their own clinical judgement.

DTAC and DCB0129

The Digital Technology Assessment Criteria (DTAC) and the DCB0129 clinical risk management standard apply primarily to health IT systems formally procured by NHS organisations. HelixOrg is distributed independently via the App Store. The app is designed with awareness of these frameworks, including mandatory disclaimers, clinical tool opt-in with acknowledgement, and data protection controls.

Data Security and Protection Toolkit (DSPT)

The DSPT applies to organisations that access or process NHS patient data. Since HelixOrg stores all data locally on-device and the developer never accesses, receives, or stores any patient data, DSPT completion is not required of the developer. The employing NHS Trust's own DSPT assessment covers the use of apps on staff devices.