ISO 27001 Explained: A Guide for Healthtech Startups & Scale-Ups

When it comes to compliance, healthtech teams often start with the basics. This typically means GDPR compliance, Cyber Essentials, and completing the NHS DTAC requirements. These standards form the foundation you need to operate safely and opens procurement opportunities with healthcare organisations.

Beyond these essentials sits ISO 27001. It often comes into play when working with NHS trusts, larger healthcare organisations or enterprises, or engaging with potential investors who expect formal assurance around information security.

Health data is an increasingly common target for attackers, so best practices in information security are becoming increasingly important. An ISO 27001 certificate is a great signal to customer stakeholders that you take the security of sensitive data, especially patient data, very seriously.

This blog explains what ISO 27001 is, what the certification process involves, who should consider it, and how Assuric supports healthtechs with compliance.

What is ISO 27001?

ISO27001 is a globally recognised information security framework. It provides a clear approach for establishing, implementing, maintaining, and continually improving an Information Security Management System (ISMS).

In simple terms, ISO 27001 helps organisations protect information (including customer and employee data, financial records, patient data, IP) from risks.

ISO 27001 focuses on three core principles:

Confidentiality - information is accessible only to relevant & authorised people
Integrity - Information is accurate, complete and safeguarded against unauthorised changes
Availability - Information is accessible where needed

Importantly, ISO27001 is not a legal requirement. However, certification provides independent assurance that your organisation meets a recognised information security standard. In practice, many buyers, particularly enterprise customer, require ISO 27001 as part of supplier assurance or procurement processes.

What is an Information Security Management System (ISMS)?

An ISMS is a structured framework that an organisation used to manage information assets. The goal of an ISMS is to identify and manage information security risks, reduce the likelihood of security incidents, and continuously improve an organisations security practices. ISO 27001 is the international standard that defines the requirements for an ISMS!

An ISMS is a coordinated set of:

Policies
Procedures
Controls (Organisational, People, Physical and Technological)

Who does ISO 27001 Apply to?

Unlike other regulations, ISO27001 is not mandatory for healthtech. BUT, this doesn't stop certain stakeholders - like the NHS or government bodies - from requiring it. It is also becoming increasingly listed as a requirement as part of public sector procurement frameworks. Complying (or not complying) with the standards can influence buying decisions, so don't write it off.

Similarly, there are no size, industry or location requirements for ISO 27001. It applies to all industries, regardless of company size or location, and the framework is designed for all sectors to meet the requirements. In short: if an organisation handles information that needs protection, ISO 27001 is relevant.

Benefits of ISO 27001 Certification

Although ISO 27001 isn't mandatory, there are many benefits for healthtech companies:

Protecting sensitive health data, ISO 27001 provides a structured way to safeguard sensitive information and reduce the risk of data breaches and incidents.
Builds trust, ISO 27001 Increases confidence among customers, partners, and even investors.
New procurement opportunities, As mentioned previously, certification can open opportunities with large enterprise customers, who often have a high standard for security.
Operational Efficiency: Encourages process standardisation and internal accountability
Incident Preparedness: Enhances response plans for security incidents and data breaches
Competitive Advantage: Certification can differentiate you in a crowded marketplace

What Does the path to ISO 27001 Certification look like?

The ISO27001 certification process follows a defined set of steps, from an inital scope definition and gap analysis, through to external certification audit and ongoing surveillance & improvement.

An overview of the ISO 27001 route and process is shown in the diagram above. While the details vary depending on your organisation’s complexity and current maturity, most journeys include:

Define your scope, context and objectives: Decide what parts of the business, products, systems, locations, and data are included in the ISMS, and set clear information security objectives.
Governance and policy: Assign roles and responsibilities, establish the core ISMS policies and processes, and set up document control and evidence/record keeping.
Risk assessment and treatment: Identify information security risks, evaluate likelihood and impact, choose risk treatments, and document your risk treatment plan.
Training, awareness and communication: Ensure staff understand responsibilities and have had appropriate training
Physical and technological controls: Implement security controls across your technological and physical infrastructure.
Statement of Applicability (SoA): Document which controls are applicable or not with justifications, linking them to your risks.
Continual improvement: Monitor/measure performance, perform management reviews and continually improve the ISMS.
Internal audit: Audit compliance against the standard before you bring in an external auditor.
External certification audit (Stage 1 and Stage 2)
- Stage 1 reviews your documentation and readiness
- Stage 2 tests implementation and evidence in practice
  If successful, the certification body issues your ISO 27001 certificate.
Ongoing surveillance and improvement: Certification is maintained through periodic surveillance audits and continual improvement of the ISMS.

This structured approach allows you to build and evidence the needed security controls over time.

How Long Does ISO 27001 Take?

ISO27001 can typically take anywhere between three to twelve months, with only 19% of organisations getting certified in 3-6 months. Using Assuric, certification in less than 3 months is expected.

Ultimately, the time to certification takes depends on a few factors:

Company size and complexity
Existing security controls
Internal resource availability (speed!)

Starting early reduces pressure when certification becomes a commercial requirement.

How Assuric Supports ISO 27001 Certification

At Assuric, we support healthtech companies through the ISO 27001 journey from start to finish.

Our aim is simple: to help teams achieve certification faster, with less manual work and greater confidence in what they end up presenting to ISO auditors, and eventually to customers.

With Assuric, you can ⤵

Get a head start on compliance: Assuric guides organisations through the clear tasks to certification, showing exactly what needs to be done and how to do it.
Automate policies & key documentation: Using Assuric, teams can create and maintain their ISMS documentation in one place, with our built-in document editor tracking edits, approvals and version control
Streamline risk management: Tailored AI risk suggestions, automated control and evidence tracking, so you stay continuously audit ready.
Utilise ISO specific features: Automated Annex A control implementation tracking, automated Statement of Applicability, CAPA management and more.
Enable pain-free audits: Auditors get a clear and structured view of all policies, controls, and supporting evidence, reducing the back and forth involved in the audit process, and faster audit times.
Ensure no duplicative efforts: Tasks in Assuric are mapped to multiple frameworks, including GDPR, NHS DSPT, HIPAA, SOC 2, Cyber Essentials, and more.

Ultimately, Assuric helps organisations complete every required step in line with the ISO 27001 standard, while still reflecting how they actually operate day to day.

If you’d like to learn more about how Assuric can support your ISO 27001 certification, get in touch.

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