Data Protection Essentials for Healthtech Innovators

The protection and security of patient data is incredibly important. Yet in the fast growing healthtech sector, there is often a knowledge gap in this area, and something that can be left behind against competing priorities. The complexity of health data protection is a challenge for innovators, who often face a steep learning curve, or costly outsourcing.

This guide is designed to help. It outlines the key data protection regulations that apply to Health tech innovators in the UK. We explain what data protection is, what the regulations mean in practice and how startups can meet their obligations while continuing to innovate with confidence and speed.

Why Data Protection Requirements in HealthTech

Operating in a healthcare environment often means processing large volumes of sensitive personal and medical data. In the UK, compliance with the General Data Protection Regulation (GDPR) and the Data Protection Act 2018 ensures that all health data is processed lawfully, securely, and transparently. Any organisation that collects or handles personal or special category data must register with the Information Commissioner’s Office (ICO) and meet strict data protection standards. This includes safeguarding information from misuse, unauthorised access, or accidental loss. Strong data protection practices not only maintain patient trust but also empower HealthTech innovators to advance digital healthcare safely and responsibly.

What is Personal Data?

Personal data is any information the relates to an individual, and that can identify that person, directly or indirectly. Examples include: Name, email, phone number.

What is Special Category data?

Special category data is personal data that needs more protection because it is sensitive. This includes a variety of different data categories, such as ethnicity, religious beliefs, biometric data, and most importantly for healthtech companies: health data. Health Data specifically refers to “personal data relating to the physical or mental health of an individual”.

Anonymised vs Pseudonymised Data

GDPR does not apply to personal data that has truly been anonymised, as the data subject can no longer be identified. Be careful though! As to be truly anonymised, data has to be stripped of personal data so far that it is not possible to be re-identify the individual, even with additional information.

If the data subject could be re-identified with the use of additional information, this would be classed as pseudonymisation, and still be in scope of data protection law. We will do a future article covering anonymisation and pseudonymisation.

Reach out of if you have any further questions on this topic!

GDPR Basics Every HealthTech Founder Should Know

Starting GDPR compliance can be confusing, this section breaks down the key concepts and terms you need to know.

Data Controller vs Data Processor

Under GDPR, companies processing personal data will act as either a Data Controller or a Data Processor (or in some more complicated cases it may be both).

• Data Controller: The organisation that decides why and how personal data is processed. The controller determines the purpose and means of processing, taking overall responsibility for compliance with GDPR and the Data Protection Act.
• Data Processor: The organisation or service that processes data on behalf of the controller. Processors must follow the controller’s instructions and implement adequate technical and organisational measures to keep data secure.
• Subprocessors: Subprocessors are third parties that may process data on behalf of a Processor, and can typically include things like a cloud provider.

For a HealthTech company providing a software solution to a healthcare organisation (such as an NHS Trust), it is likely the healthcare organisation is the Controller, and the digital health solution supplier is the Processor.

If the HealthTech company are providing a direct-to-consumer solution, then it is likely they are the Data Controller in this instance.

What is Lawful Basis for Processing Data?

Before collecting or processing any personal data, every processing activity an organisation completes needs an appropriate lawful basis. This is the legal reason that allows you to process someone’s data in the first place, and is usually determined by the Data Controller.

Article 6: All personal data processing activities require an article 6 lawful basis, of which there are 6 (a to e), and includes things like consent, contract, public task and legitimate interests.

Article 9: if special category data (e.g. health data) is processed, an additional article 9 condition is required, and can include explicit consent, delivery of health and social care and 8 more.

Example: A digital health software supplier to the NHS (such as an EPR) will typically process patient health data using the following lawful cases: Article 6(e) Public task, along with Article 9(h) Health or social care.

What Is a RoPA (Record of Processing Activities)?

A RoPA documents how your company processes personal data: what data you collect, why, who accesses it, and where it’s stored. Every data controller and processor must maintain one.

Think of it as your “data map”, a live record that shows regulators (like the ICO) that you know your data, and you’re managing data responsibly.

What is a DPO (Data Protection Officer) and When Do You Need One?

A DPO is an independent expert responsible for monitoring internal data protection compliance, and providing advice and guidance. A DPO is required if: You process large amounts of special category data, or your data processing involves regular and systematic monitoring

What is a DPIA (Data Processing Impact Assessment) and When Do You Need One?

A Data Protection Impact Assessment (DPIA) is essentially a documented assessment of the potentially impact and risks of a project involving potentially high risk data processing activities. It includes detailed information of the processing involved, including subprocessors, and a risk assessment with an outline of potential mitigations where appropriate.

A DPIA is a legal requirement for any processing of personal data likely to present a high risk to the rights and freedoms of individuals. This would include large-scale processing of health data and/or the use of novel technology.

Therefore, it is generally a requirement for Healthtech companies to complete a DPIA, or to assist a healthcare organisation deploying their solution (the Controller) to complete their own.

NHS DSPT & DTAC for Safe and Secure Health Data

The Data Security and Protection Toolkit (DSPT) is a required assessment if you process NHS patient data. A key part of this is evidencing core data protection activities such as clear roles (such as a DPO), security controls, staff training, and up-to-date RoPAs and DPIAs.

The NHS DTAC (Digital Technology Assessment Criteria) is the NHS’s checklist for assessing if a digital health product is safe, secure and ready for use. Data protection features prominently, including evidencing a number of the above activities. Look out for a helpful article covering DTAC in more detail soon!

Key Steps for GDPR Compliance

Now we understand the key concepts under GDPR, there are 5 key steps to get started with:

1. Register with the ICO

Any organisation processing personal data in the UK must register with the Information Commissioner’s Office (ICO) and pay the required data protection fee, unless an exemption applies. Registration confirms that the organisation recognises its responsibilities under the UK GDPR.

2. Publish a Privacy Notice

Provide a clear and accessible Privacy Notice setting out what personal data is processed, for what purpose, and on what lawful basis. It should also explain how data is shared, retained, and protected, and how individuals can exercise their rights.

Where processing is carried out on behalf of the NHS, the NHS acts as the Data Controller and provides the primary privacy notice. The AVT scribe service should maintain its own notice describing its role as a Data Processor.

3. Know Your Data

Maintain a RoPA to document what data is processed, how it is collected, stored, and secured, and who has access to it. The RoPA should identify data categories retention periods, and any potential third parties involved.

This is also where it's key to understand your role: Controller or Processor - and, where health information is processed, ensure that lawful basis and special category condition under UK GDPR are identified.

4. Appoint a Responsible Individual

Designate a person to oversee data protection compliance. This may be a Data Protection Officer (DPO) where required by law, or a data protection lead in smaller organisations.

If the company operates across borders, appoint a UK or EU representative as appropriate to ensure regulatory liaison and accountability.

5. Conduct a DPIA

Before undertaking any activity that involves high-risk processing, such as handling health or consultation data, carry out a DPIA. A DPIA should describe the processing, identify potential risks to individuals, and record the measures taken to mitigate them.

The DPIA demonstrates compliance with the principle of data protection by design and by default, ensuring that privacy risks are identified and addressed at the outset.

Simplify GDPR Compliance with

Book a free demo with Assuric and discover how we help Healthtech innovators protect data, reduce compliance risk, and meet requirements with confidence and speed. We provide everything from automated RoPA and DPIA features in our platform, to expert fractional DPO and data protection consultancy services.