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Surgery Assist - AI, Compliance and Regulations

Introducing the Compliance and Regulations of Surgery Assist

Updated over 2 weeks ago

Surgery Assist is a chargeable product. To register your interest please use our Enquiry form here

Surgery Assist is a digital assistant designed to educate and signpost patients to the correct care whilst reducing the demand for GP staff, by using locally trained AI

This document will guide you through Surgery Assist's AI, Compliance and Regulations demonstrating how we place the utmost importance on clinical safety, data privacy and cyber security

AI Explained

What is the AI Digital Assistant?

The AI-powered digital assistant is designed to help manage non-clinical healthcare queries efficiently and safely. The AI is trained locally meaning that we input all questions and answers based on the information you provide us about your Surgery

By automating responses, it helps manage high demand while ensuring that patients with urgent needs receive the attention they require. We have designed our digital assistant using the HHH approach in mind, helpful, honest and harmless

How does it work?

Talking in Your Language

The digital assistant can understand and reply in many different languages using Microsoft Translation Services, patients can type in Spanish, French or any other language and the chatbot will ensure seamless communication to help your patients

Personal Information

The digital assistant uses Microsoft PII (Personally Identifiable Information) Auto-Redaction service to automatically hide or remove personal details, keeping your patients data safe and secure

Answers from the Best Sources

The digital assistant uses a method called RAG (Retrieval Augmented Generation) to retrieve answers from trusted sources that your GP surgery has selected. This ensures that all responses are accurate and relevant, based on information which is specific to your surgery

Supervised Training

To stay up to date and improve over time, the digital assistant is manually trained on a weekly basis. If it cannot answer a question today, it will be trained to handle it in the future, so your feedback and continued use helps it improve every day

What happens to your data?

Read more on Patient Data further down - How Surgery Assist Handles Patient Data

Surgery Assist ensures your data is treated with the utmost care, read below to see how we ensure safety:

  • Safe and secure - All messaged are encrypted and processed within Microsoft's secure system, ensuring confidentiality

  • No guesswork - If the digital assistant doesn't understand a query, it won't guess. Instead it will inform the patient and escalate is necessary

  • No data storage - Personal details provided are not stored, keeping your patients

    information private at all times


Security and GDPR Compliance

If you would like to request any supporting documents please email [email protected]

GDPR

The UK General Data Protection Regulation (GDPR) is a vital framework that mandates strict guidelines for handling personal data in the UK's healthcare sector. Healthcare organisations and health tech companies in the UK must comply with several practices, including implementing robust data protection measures, obtaining consent from patients, having effective incident response plans, facilitating patients' rights, justifying data processing on legal grounds, and complying with international data transfer regulations

Compliance with these regulations ensures ethical handling of sensitive health data, enhances patient trust and security in digital health technologies, and impacts how patient data is managed, shared, and protected

Cyber Essentials Plus

Cyber Essentials Plus is a UK government backed certification scheme that demonstrates an organisation has implemented essential cybersecurity controls and has them independently verified through a technical audit

It means we have been independently tested to prove we have strong protections in place against common cyber threats - like hacking, phishing, or data breaches. For you, it means added reassurance that:

  • Your data is handled securely

  • Our systems are regularly checked by security experts

  • We meet NHS and public sector cyber security expectations

CREST-approved Certification

CREST is a globally recognised accreditation and certification body that sets rigorous standards for penetration testing in the information security industry. Choosing a CREST-approved penetration tester provides several advantages such as high standards of conduct, assurance of quality, comprehensive support and guidance, and insurance protection

CREST certification is particularly valuable for organisations that need to ensure their digital assets are secure against cyber threats and supports compliance with various regulatory requirements such as ISO, GDPR, and PCI DSS

DPIA

A Data Protection Impact Assessment (DPIA) is a process to help an organisation identify and minimise the data protection risks of a project/product, especially for processing that is likely to result in a high risk to individuals

It is a formal process to ensure that personal data is handled safely, legally and with minimal risk. By carrying out a DPIA and providing it to you we:

  • Identify any privacy or data protection risks early

  • Take steps to reduce or remove those risks

  • Illustrate that we are meeting legal duties under GDPR and UK data protection law

View our Data Protection Impact Assessment here


Clinical Compliance


DSPT

The Data Security and Protection Toolkit (DSPT) is an online self-assessment tool used by organisations within the NHS and social care to demonstrate their adherence to data security standards. It helps organisations measure and demonstrate their performance against the National Data Guardian's 10 data security measures

All organisations that have access to NHS patient data and systems must use the DSPT toolkit to provide assurance that they are practising good data security and that personal information is handled correctly

DTAC

The Digital Technology Assessment Criteria is a framework that was introduced by NHS England in 2021. Its primary objective is to ensure that digital health technologies meet essential standards before being used within the NHS and social care environments. The framework evaluates and approves digital health products by focusing on five core areas: clinical safety, data protection, technical security, interoperability, and usability and accessibility

DCB0129

DCB0129 is a mandatory clinical risk management standard in the NHS, specifically for manufacturers and suppliers of health IT systems intended for use in NHS settings. It requires us to demonstrate that our products are clinically safe for patients and healthcare providers to use and do not cause harm. Compliance with DCB0129 is mandatory under the Health and Social Care Act 2012

Manufacturers/suppliers must implement a robust clinical risk management system that includes appointment of a suitably qualified Clinical Safety Officer (CSO), risk analysis, mitigation strategies, and documented evidence of effective risk management

The standard requires us to:

  • Start the clinical risk management process early in the product development lifecycle and continue through to decommissioning.

  • Continuously assess and manage risks throughout the lifecycle.

  • Document and provide evidence of their clinical risk management system including continuous improvement and learning from incidents.

In accordance with DCB0129 we fully comply with the standard and operate a clinical risk management system that enables us to demonstrate the safety of our digital health products through:

  • a clinical safety case report

  • a hazard log

  • a clinical risk management plan

  • structured incident reporting mechanisms, enabling proactive and reactive patient safety measures, investigation, and learning

DCB0160

DCB0160 is a mandatory NHS clinical risk management standard for healthcare organisations that deploy or use digital health systems. It ensures that health IT systems are implemented and operated in a way that safeguards patient safety and supports clinical effectiveness. This standard is mandated under the Health and Social Care Act 2012

Compliance with DCB0160 means a health organisation (surgery) must:

  • Appoint a Clinical Safety Officer (CSO)with demonstrable oversight and ongoing involvement in the clinical safety process

  • Carry out a comprehensive clinical risk assessment prior to go-live and throughout the system lifecycle, including any significant system changes, updates, or decommissioning

  • Maintain detailed clinical safety documentation, including a Clinical Safety Case Report, Hazard Log, and Clinical Risk Management Plan

  • Implement structured incident reporting and investigation, ensuring continuous improvement by learning from incidents and implementing safety improvements

As part of DCB0160 you must produce both a Clinical Risk Management Plan (CRMP) and a Clinical Safety Case Report upon the deployment of a new health IT system. The CRMP outlines the planned risk management activities, while the Clinical Safety Case provides a structured, evidence-based justification that the system is safe for its intended use

Digital clinical risk management has to be a rigorous, methodical, and clearly documented process to ensure that any clinical risks have been assessed and, if required, mitigated appropriately. The purpose of a Clinical Risk Management Plan is to document and schedule the clinical risk management activities to support the safe deployment, maintenance, and decommissioning of the Health IT System. This process must be systematic, well-documented, and demonstrably support both patient safety and regulatory compliance


How Surgery Assist Handles Patient Data

Find our Full Privacy Policy for Surgery Assist (Previously EDATT) here

Summary of Key Points

What personal information do we process?

When you visit, use, or navigate our Services, we may process personal information depending on how you interact with Hanley Health Ltd. and the Services, the choices you make and the products and features you use

Do we process any sensitive personal information?

We do not process sensitive personal information

Do we receive any information from third parties?

We do not receive any information from third parties

How do we process your information?

We process your information to provide, improve, and administer our Services, communicate with you, for security and fraud prevention, and to comply with law. We may also process your information for other purposes with your consent. We process your information only when we have a valid legal reason to do so

In what situations and with which types of parties do we share personal information?

We may share information in specific situations and with specific categories of third parties

How do we keep your information safe?

We have organisational and technical processes and procedures in place to protect your personal information. However, no electronic transmission over the internet or information storage technology can be guaranteed to be 100% secure, so we cannot promise or guarantee that hackers, cybercriminals, or other unauthorised third parties will not be able to defeat our security and improperly collect, access, steal, or modify your information

What are your rights?

Depending on where you are located geographically, the applicable privacy law may mean you have certain rights regarding your personal information

How do you exercise your rights?

The easiest way to exercise your rights is by contacting us. We will consider and act upon any request in accordance with applicable data protection laws


Disclaimer

This is provided for information purposes only and does not replace the official Instructions for Use (IFU), terms of service, or contractual documentation supplied within the product

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