What Compliance Requirements Do You Need to Sell into the NHS?

Selling digital health technology into the NHS or private healthcare providers comes with a non-negotiable requirement: compliance. Without it, no product makes it past procurement. With it, you unlock access to the UK’s largest healthcare system and create a foundation for expansion into international markets.

Compliance is the ticket to growth. Yet too many digital health companies underestimate what’s required until they are already in discussions with buyers. By that stage, delays are expensive, relationships are strained, and deals are often put at risk.

Why compliance matters in healthcare sales

When selling into healthcare, compliance is all about building trust. Buyers need reassurance that your technology is safe, secure, and resilient. They want to know it won’t put patients at risk, expose data, or cause integration issues with existing NHS systems.

That’s why compliance frameworks exist. For suppliers, they represent the minimum standard expected in procurement. For buyers, they provide confidence that a product is clinically safe, secure by design, and suitable for frontline use.

Take the example of DTAC. On the surface, it looks like a checklist of clinical safety, cybersecurity, and usability requirements. But for an NHS procurement team under pressure, it is much more than that. DTAC gives them the confidence that a new product can be rolled out without hidden risks or delays. Without that assurance, even the most promising technology will be set aside in favour of a safer, compliant option.

Which compliance requirements matter most?

For NHS suppliers, there are three core areas to address.

• NHS DSPT compliance - The Data Security and Protection Toolkit shows that your organisation protects patient data in line with NHS standards. Every supplier handling NHS data or systems must complete it annually.
• DTAC compliance - The Digital Technology Assessment Criteria evaluates five areas: clinical safety, data protection, cybersecurity, interoperability, and usability. Passing DTAC is essential if you want your product to be adopted by NHS organisations.
• DCB 0129 compliance – If your technology has any clinical component, you will need to produce formal clinical safety documentation and assign a Clinical Safety Officer in line with DCB 0129.

Beyond these, buyers increasingly look for assurance that suppliers meet Cyber Essentials, ISO 27001 compliance, or equivalent international standards. These demonstrate maturity and resilience beyond the minimum NHS baseline. Together, these frameworks form the foundation of selling into healthcare.

Why traditional approaches fall short

The traditional route to compliance has been consultancy. While consultants provide expertise, the costs quickly become unsustainable. With fees of £20,000-£30,000 per framework, often repeated for each new customer or product, compliance becomes a recurring expense that erodes margins.

The alternative is hiring in-house compliance staff and comes with a similar challenge. Salaries of £80,000-£100,000 place this option out of reach for most scale-ups. Even then, a single hire is unlikely to cover the breadth of frameworks required across data protection, cybersecurity, and clinical safety.

Smaller businesses consistently run into this issue, even promising digital health companies with strong products and proven impact get stuck. Compliance becomes the blocker that slows procurement cycles, increases costs, and limits growth.

Turning compliance into a growth enabler

However, with the right approach, compliance moves from a barrier to an enabler.

Modern compliance automation platforms such as Naq streamline the entire process. Instead of tackling each framework in isolation, organisations manage multiple requirements through a single platform. Evidence collection, policy creation, risk assessments, and training are automated, while expert support ensures accuracy and audit-readiness.

The difference is significant. Rather than scrambling to produce documentation mid-procurement, companies can demonstrate compliance from the outset. This not only saves time and reduces costs but also accelerates procurement cycles by giving buyers confidence in the product’s readiness.

Beyond the NHS: why compliance matters everywhere

Although the NHS is often the primary focus, compliance requirements extend well beyond it. Private healthcare providers increasingly expect suppliers to meet the same standards as NHS buyers, especially when patient data or clinical systems are involved.

Internationally, frameworks such as HIPAA in the United States or CE/UKCA marking for medical devices present additional layers of complexity. A company that has invested early in DSPT, DTAC, and ISO 27001 compliance is far better placed to adapt to these requirements and scale into new markets without starting from scratch.

In other words, compliance is not just the gateway to NHS procurement, it is the foundation for long-term, international growth.

Scaling with confidence

Compliance should not be treated as a final checkbox. It should be part of your growth strategy from the beginning. Building compliance into your go-to-market approach enables you to shorten procurement cycles, move into new markets without duplicating effort, and expand internationally with frameworks such as ISO 27001 or HIPAA.

As a health tech compliance platform, Naq combines automation with expert guidance to ensure compliance helps you to scale. Our system covers 20+ frameworks including DSPT, DTAC, DCB 0129, ISO 27001, GDPR, and Cyber Essentials. Policies, evidence, training, and risk management are centralised in one dashboard, giving you a live view of your compliance status at all times.

Crucially, Naq does not just help you become compliant once. The platform continuously monitors regulatory changes, updates your requirements, and ensures you remain audit-ready as new standards emerge. That means you can focus on building and selling your product, while knowing your compliance obligations are under control.

By future-proofing compliance in this way, Naq enables organisations to turn regulatory obligations into a competitive advantage, building buyer confidence and accelerating time-to-revenue.

Taking the next step

Selling into healthcare is complex, but compliance shouldn’t be the reason your deals stall. By embedding compliance into your growth strategy, you unlock NHS contracts faster, strengthen trust with private providers, and set a foundation for international expansion.

Naq helps digital health companies automate compliance, reduce costs, and scale with confidence. If you are ready to turn compliance from a barrier into your fastest route to growth, book a call with our team to learn more about how Naq can help.