SOC 2 for Healthtech: Unlocking Opportunities in the US

As digital health companies grow, expectations around security assurance increase quickly. As discussed in our ISO 27001 blog, UK organisations often start with GDPR, Cyber Essentials, and NHS DTAC, then progress to ISO 27001.

But, when selling into the US market or to global enterprise buyers, another framework often enters the conversation: SOC 2.

SOC 2 is not a legal requirement in the UK, but it can be frequently requested by US based customers, enterprise procurement teams, and investors. Understanding what SOC 2 is, who it applies to, and how to approach it is essential for UK healthtechs operating internationally.

This guide explains what SOC 2 is, how it works, who should consider it, and how Assuric supports teams through the process.

What is SOC 2?

SOC 2 (System and Organisation Controls 2) is a US specific assurance framework developed by the American Institute of Certified Public Accountants (AICPA). It focuses on how organisations protect sensitive customer data, and is designed to provide independent assurance that an organisation has appropriate controls in place to manage security and data risks. Similar to ISO 27001, SOC 2 is not mandatory. It is an attestation framework, meaning an external auditor assesses whether your internal controls are suitably designed and operating effectively.

SOC 2 is built around five Trust Services Criteria (TSC):

Every SOC 2 report must include Security. The other criteria are optional and scoped based on your service offering and customer expectations. You cannot audit only Security if other criteria apply to your services.

For UK healthtechs, SOC 2 is most relevant when working with US healthcare organisations or enterprises that expect US-recognised assurance, and can occasionally be done alongside ISO standards.

What are the Differences Between SOC 2 Type I & Type II?

There are two different SOC report types that often cause confusion: SOC 2 Type I, SOC 2 Type II ⤵

The key differences (as highlighted in the image above)

• SOC 2 Type I - Assesses whether your controls are suitably designed at a specific point in time. It answers the question: are controls in place and designed appropriately?
• SOC 2 Type II - Assesses both design and operating effectiveness of controls over a defined period, typically three to twelve months. It answers the question: do the controls work consistently in practice? Type II reports provide much stronger assurance and, crucially, most enterprise buyers in the US will expect SOC 2 Type II

In practice, SOC 2 Type II is the gold standard. Many buyers will not accept Type I reports, especially for mature products handling sensitive data.

It's worth noting there are also SOC 1 and SOC 3 reports. SOC 1 is a report for organisations whose internal security controls can affect a customers's financial statements, and SOC 3 is a high level overview of systems and controls, and is usually produced for large companies as a marketing report. Both the SOC 1 and SOC 3 frameworks tend to be less relevant for early stage teams.

Who Needs SOC 2?

SOC 2 is not mandatory but can be often requested by enterprise customers, particularly in the US. For healthtechs operating in the US, or thinking about expanding into US markets, some US based healthcare organisations may require a SOC 2 Type II report during due diligence processes,

Without SOC 2, deals can be delayed or blocked entirely. For many teams, it becomes a commercial requirement rather than a purely compliance-driven one.

SOC 2 for Healthtech

As many Assuric readers and customers know, healthtech companies face heightened scrutiny due to the sensitivity of patient data. Importantly, SOC 2 does not replace HIPAA, GDPR, or any of the NHS requirements, but it provides strong operational security assurance.

For UK healthtechs selling into the US, SOC 2 often complements and builds upon the following frameworks:

GDPR - GDPR sets the rules for handling personal data. SOC 2 overlaps on security and privacy controls, but adds independent verification that your controls actually work in practice.

NHS DSPT and DTAC - NHS DTAC and DSPT cover cyber security and data protection for NHS integrations. SOC 2 overlaps on similar security practices but is recognised by US buyers, making it useful when expanding internationally.

HIPAA – HIPAA defines rules for handling US patient data. SOC 2 complements this by providing an audited view of operational security, showing controls are tested and effective.

ISO 27001 – ISO 27001 requires the implementation and auditing of your information security management system. SOC 2 builds on this by assessing whether your controls are operating effectively day-to-day, not just that the system exists.

In short, if you already comply with other common healthtech standards, including GDPR, NHS standards, HIPAA, or ISO 27001, you're in a great place to start SOC 2! SOC 2 nicely builds on the work from these standards, rather than starting from scratch, meaning less work to get the independent assurance you need.

What does the SOC 2 Process Involve?

SOC 2 is flexible by design, meaning there is no fixed checklist! Each organisation will define its own controls based on its systems, risks, and services. While this flexibility can be helpful, it also means preparation and correct evaluation of the Trust Services Criteria is crucial.

Steps to SOC 2 Compliance

While there is no prescriptive checklist, there are some common steps that you might need to go through for SOC 2 compliance:

Define your SOC 2 system scope and boundaries

This involves decidingwhich systems, services, and data are in scope for the audit. This ensures the audit focuses on the parts of your business that matter to your customers.

Document security policies and procedures

Create clear policies covering security, privacy, and operational practices. This includes rules for handling data, managing access, and responding to incidents.

Perform risk assessment and manage risks

Identify potential threats to your systems and data, assess their impact, and put controls in place to reduce risk. SOC 2 focuses on managing risk in practice, not just on paper.

Set up access control and identity management

Define who can access systems and data, and implement processes to manage permissions. This includes monitoring logins, using multi-factor authentication, and reviewing access regularly.

Establish incident response and business continuity plans

Plan for potential security incidents or outages. Document how your team will respond, recover, and communicate, and test these plans to ensure they work.

Provide clear evidence that controls are operating

Collect and organise evidence that your controls are actually working. This could include access logs, change management records, tickets, training completion, and system monitoring reports.

Ongoing monitoring and logging of systems and controls

Continuously monitor your systems and controls, track security events, and review logs to catch issues early. SOC 2 is about proving controls work consistently over time, not just at a single point.

It's worth noting that evidence for SOC 2 audits is mostly operational. Auditors will expect proof such as access logs, screenshots, training records, and change management history. Of course, Assuric can help with all of these steps in record time!

How Long Does SOC 2 Take?

Timelines depend on maturity, scope, and internal resourcing.

• SOC 2 Type I can often be completed in 1 to 2 months
• SOC 2 Type II typically takes 3 to 6 months minimum, depending on the observation period

Factors that affect timing include:

• Existing security controls
• Team availability
• Evidence quality and consistency
• Audit scope and selected Trust Services Criteria

Starting early is key. Many teams begin SOC 2 preparation only after a deal is blocked, which adds unnecessary pressure.

What are the Benefits of SOC 2 Compliance?

Although SOC 2 is not mandatory, it delivers meaningful benefits, particularly for growing SaaS and healthtech companies. We've discussed some of the benefits to SOC 2 compliance above, but here are four of the key benefits:

• Enterprise credibility - SOC 2 signals maturity and professionalism to buyers, partners, and investors.
• Improved security posture - SOC 2 encourages consistent, auditable security practices across the organisation.
• US market access - as mentioned earlier, compliance aligns with expectations of US based customers and healthcare organisations.
• Competitive advantage - compliance differentiates your business in crowded markets where trust matters.

For many organisations, SOC 2 is not just about compliance, but about unlocking growth.

How Assuric Accelerates SOC 2 Compliance

At Assuric, we support healthtech teams through SOC 2 through our AI-powered platform, ensuring compliance isn't the blocker for your enterprise deals. Our goal is to help teams achieve SOC 2 faster, cheaper, and with confidence in what they present to auditors and customers.

Some key benefits include ⤵

• Clarify your SOC 2 scope - Understand which systems, services, and Trust Services Criteria apply to your products and organisation.
• Get a headstart from existing compliance - As shown above, Assuric automatically maps SOC 2 requirements alongside GDPR, NHS DSPT, HIPAA, ISO 27001, and more, allowing users to use existing compliance to their advantage.
• Build and maintain documentation - Create policies and procedures in one place, with version control and approvals.
• Manage risks effectively - Identify and track risks with clear links to controls and evidences
• Audit-ready compliance from the start - Assuric has built-in audit flows, with a clear, structured view of controls and evidence, eliminating the back and forth audit chaos.

If you are planning to sell into the US, responding to SOC 2 requests, or preparing for enterprise procurement, getting started early makes all the difference.

Get in touch to learn more about how Assuric can support your SOC 2 journey 🛡️