Clinical Assurance Solutions Ltd provides independent Clinical Safety Officer (CSO), digital health assurance, compliance, audit and advisory services to organisations developing, implementing and operating digital health technologies.

We recognise our responsibility to protect confidential, personal and commercially sensitive information and are committed to operating in accordance with applicable legal, professional and ethical standards.

This page provides an overview of our governance arrangements and links to supporting documentation.
 

Professional Standards 

Clinical Assurance Solutions Ltd operates in accordance with recognised principles of:

• Patient safety
• Clinical risk management
• Confidentiality
• Information governance
• Professional integrity
• Data protection
• Continuous improvement

Our aim is to support the safe, effective and compliant development and deployment of digital health technologies.
 

Data Protection

We are committed to processing personal information fairly, lawfully and transparently in accordance with:

• UK General Data Protection Regulation (UK GDPR)
• Data Protection Act 2018
• Applicable information governance requirements

We maintain an up-to-date Privacy Notice describing the personal information we collect, the purposes for which it is used and the rights available to individuals.

Key Principles

• We collect only information necessary to provide our services.
• We do not sell personal information.
• We apply proportionate safeguards to protect information.
• We seek to minimise access to personal information wherever possible.
• We retain information only for as long as necessary.

Privacy notice

Information Security

Protecting information is an important part of how we operate.

We maintain security controls appropriate to the size and nature of our business, including:

• Strong authentication and password management
• Multi-factor authentication where available
• Device and storage encryption
• Secure cloud-based services
• Access controls
• Malware protection
• Secure backup arrangements
• Regular software and security updates

Our objective is to protect information against unauthorised access, disclosure, alteration or loss whilst supporting the efficient delivery of professional services.

Information Security Statement

ICO Registration Certificate

Data Handling and Confidentiality

As part of assurance, audit and clinical safety activities, we may be granted access to client systems, documentation and evidence.

Clinical Assurance Solutions Ltd operates according to the principle of minimum necessary access and applies appropriate confidentiality safeguards throughout the lifecycle of an engagement.

We:

• Respect client confidentiality at all times.
• Restrict information access to authorised activities.
• Do not routinely collect or retain patient information.
• Apply appropriate technical and organisational security measures.
• Retain assurance and clinical safety artefacts only where necessary to fulfil contractual, legal or professional obligations.

Data Handling and Confidentiality Statement

Clinical Safety and Assurance

Clinical Assurance Solutions Ltd supports organisations in meeting their clinical risk management obligations through activities such as:

• Clinical Safety Officer services
• Clinical risk management support
• Digital clinical safety assessments
• DCB0129 support
• DCB0160 support
• Safety case reviews
• Hazard log reviews
• Independent assurance activities

We seek to provide objective, proportionate and evidence-based assurance that supports patient safety and organisational confidence.

Insurance and Professional Responsibility

Clinical Assurance Solutions Ltd maintains appropriate professional indemnity insurance and conducts its activities in accordance with applicable contractual and professional responsibilities.

Insurance details may be provided to prospective clients under suitable confidentiality arrangements where required for supplier due diligence purposes.

Supplier and Client Due Diligence

Supporting information may be made available, where appropriate, to clients and prospective clients during supplier assurance and procurement activities.

This may include:

• Privacy Notice
• Information Security Statement
• Data Handling and Confidentiality Statement
• Evidence of professional indemnity insurance
• Company information
• Relevant policies and procedures

Company Information

Company Name: Clinical Assurance Solutions Ltd

Company Number: 17299593

Email: steve@clinicalassurancesolutions.co.uk

Governance Documents

The following documents are available for review (linked above):

• Privacy Notice
• Information Security Statement
• Data Handling and Confidentiality Statement

Contact

If you have any questions regarding our governance, information handling practices or assurance services, please contact:

Clinical Assurance Solutions Ltd

📧 steve@clinicalassurancesolutions.co.uk