Medtech Digital Compliance.

Providing you with the latest technology to meet your data and cyber security needs

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A data and cyber security service you can trust, now and into the future

Technology is helping shape both the public and private health sectors with ground-breaking innovations for improving patient care, transforming healthcare delivery and addressing global health challenges. We offer comprehensive consultancy services assisting medical supply companies in achieving Digital Technology Assessment Criteria (DTAC) and Data Security and Protection Toolkit (DSPT) compliance through our partnership with Safehand. To supply to the NHS and similar organisation, tech suppliers must be DSPT and DTAC accredited.

CSS Assure has joined in partnership with Safehand, a leading regulatory consultancy, compliance, and training provider specialising in health IT manufacturers and healthcare organisations.Together, we will deliver exceptional services to clients as we continue to expand in the healthcare sector.

Our services

Helping you achieve DSPT

DSPT serves as a self-assessment tool and is a contractual obligation for organisations processing or accessing NHS patient data and systems, evaluating against the National Data Guardian’s 10 data security standards. All organisations that have access to NHS patient information must provide assurances that they have the proper measures in place to ensure that this information is kept safe and secure.

It is also an annual assessment. As data security standards evolve, the requirements of the DSPT are reviewed and updated to ensure they are aligned with current best practice. Organisations with access to NHS patient data must therefore review and submit their annual assessment each year before the deadline.


Helping you achieve DTAC

DTAC sets the national baseline criteria for digital health technologies in use or entering the NHS or social care sectors.

Compliance with DTAC necessitates meeting DSPT security standards, conducting DPIAs (Data Protection Impact Assessments) on systems, appointing a DPO (Data Protection Officer), obtaining a Cyber Essentials certificate, and adhering to DCB129 standards for clinical risk management in health IT systems.

For health organisations like NHS Trusts, we extend support for DCB0160 Clinical Risk Management, ensuring the deployment and use of health IT systems adhere to regulatory standards.

By providing support with DCB0129 and DCB0160 compliance frameworks, we can help ensure that you meet the standards for data transfer and protection in the medical supply chain and health organisations.


Outsourced DPO services

If you supply to the NHS and other healthcare organisation, a data protection officer is mandatory as part of your DTAC compliance.

If you don’t have a DPO in house, we offer our Data Protection Officer as a Service (DPOaaS) and can provide your business with a dedicated expert who will ensure your business operations align with applicable data protection and privacy regulations.

We will use our deep insight of the medtech sector together with our unique experience of working with technology engineers and product owners to understand data compliance during the development stages. We will undertake proactive risk assessments and efficiently handle data subject requests, empowering your organisation to protect sensitive information.

These services enable us to offer you a full-service solution for digital health compliance, while enhancing your data protection and cyber security measures to safeguard sensitive patient information. With CSS Assure, you gain a trusted partner dedicated to safeguarding data and maintaining regulatory compliance, keeping your professional reputation intact and ensuring peace of mind in today’s complex data landscape.


Why CSS Assure?

Three Pillars of technical compliance

We offer a holistic approach covering technical compliance, data protection/cybersecurity, and legal aspects. We ensure full-spectrum defence against cyber threats, regulatory breaches, and data vulnerabilities, leaving no gaps in your security strategy. Alongside our technical, medical and legal partners we offer a one-stop shop - we’re your full service compliance for technology partners.

Comprehensive Expertise across Critical Fields

We offer tailored, innovative, and compliant solutions to meet the unique challenges of various industries. From navigating healthcare regulations to implementing advanced technology and ensuring data protection compliance, our expertise delivers practical and legally sound results.

One team approach

Our best-in-class consultants seamlessly integrate with your team. Gaining understanding of your business and working collaboratively we deliver a unified, high performing solution while managing your security needs, allowing you to focus on what matters most.

International reach & expertise

Our highly skilled teams, strategically located across the UK, EU, and USA, provide clients with the expertise needed to navigate complex regulatory landscapes in multiple jurisdictions. We ensure compliance with local laws and standards, helping businesses expand into new markets smoothly and efficiently while maintaining full regulatory alignment.