Regulatory compliance for healthcare software
Navigating UK healthcare regulatory compliance is a high-stakes process where even minor missteps can cause major setbacks. Whether you’re updating a legacy system or building something entirely new, our team combines regulatory expertise with development best practices to keep your software aligned, audit-ready, and built to last.
With 200+ healthcare projects behind us, we know how to engineer peace of mind where it matters most.
The importance of regulatory compliance for healthcare software
In August 2022, a serious reminder of the risks linked to poor compliance surfaced. Advanced Computer Software Group, a provider for the NHS, suffered a cyberattack that exposed the personal and medical data of more than 82,000 patients.
Among the compromised information were instructions on accessing the homes of nearly 900 patients receiving care. The incident disrupted essential NHS services, including NHS 111, and jeopardised patient safety. The attack originated from a customer account that lacked multifactor authentication.
Following a thorough investigation, the Information Commissioner’s Office concluded in 2025 that a company subsidiary had failed to implement sufficient security measures, breaching data protection law. The result was a fine exceeding £3 million and significant reputational damage.
What’s the takeaway here?
Regulatory frameworks exist for a good reason. Healthcare software is designed to protect sensitive patient data and ensure systems are clinically safe and secure from exploitation.
Noncompliance can lead to fines, operational disruptions, and loss of trust. All those are consequences that no healthcare provider or software vendor can afford.
Regulatory compliance in the healthcare industry provides reassurance about security and safety:
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For healthcare software development companies, compliance demonstrates a commitment to developing safe, secure, effective, and accessible healthcare solutions.
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For healthcare organisations, it signals that you are providing high-quality, safe healthcare services supported by equally high-quality, secure, and accessible systems.
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For patients, compliance offers the confidence that you are utilising reliable healthcare software that is accessible and safeguards your data.
Threats and risks associated with healthcare software noncompliance
The case of Advanced Computer Software Group highlights how failing to comply with data protection regulations can compromise patient safety and lead to severe financial penalties. Yet the consequences of noncompliance go far beyond fines and breaches. The broader impact touches every aspect of a healthcare organisation's operations and reputation.
Legal ramifications
Beyond fines, noncompliance can lead to legal actions from regulatory bodies and potential lawsuits.
Reputational damages
Cybersecurity incidents rarely go unnoticed. A data breach can quickly erode patient, partner, and investor trust.
Operational inefficiencies
Cyberattacks like ransomware can disrupt systems, delay patient care and emergency responses, and interrupt essential services.
When viewed against the potential fallout, investing in compliance is safer and more cost-effective than reacting to a crisis after it hits. The good news is that understanding the UK healthcare regulatory landscape can put you in control before problems arise.
UK-wide regulatory bodies overseeing healthcare software development
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK authority responsible for ensuring the safety and high quality of medicines, medical devices, and, increasingly, software classified as medical devices.
Between 2021 and 2023, the agency launched its Software and AI as a Medical Device Change Programme, aiming at modernising the regulatory framework in response to the rapid growth of AI and software-based health solutions. While not fully implemented as of mid-2025, this programme is set to shape the future of UK SaMD regulation. Organisations developing clinical software or AI-based tools should monitor their progress closely to maintain future-proof compliance and make timely product or process adjustments.
ICO
The Information Commissioner's Office (ICO) is the UK’s independent data protection and privacy regulator, reporting directly to Parliament.
Appointed by the Crown, the Information Commissioner oversees the correct implementation and enforcement of data protection and privacy regulations under the UK GDPR and the Data Protection Act 2018.
NICE
While the National Institute for Health and Care Excellence (NICE) doesn’t directly regulate software or technologies, it sets health and social care standards.
NICE becomes particularly relevant to software and digital health through its evidence standards framework for digital health technologies and its health technology assessment (HTA). In other words, NICE assesses technologies, including software, to determine their efficiency and cost-effectiveness for use within NHS bodies.
Although NICE does not directly regulate technologies or software, it plays a pivotal role in shaping standards across health and social care, and successfully navigating the NICE assessment can be a key factor for tech companies to access the UK market.
England-only regulatory bodies
CQC
The Care Quality Commission (CQC) regulates healthcare providers in England.
While it does not directly oversee software, it becomes relevant when a digital solution is integrated into healthcare service delivery (for example, a telemedicine platform). In such cases, providers must register with the CQC and ensure that services delivered via the software are safe, effective, caring, and responsive, in line with the CQC’s assessment criteria.
NHS England
Unlike the MHRA or ICO, the National Health Service (NHS) England doesn’t act as a regulatory body. Instead, it sets standards for digital health tech adoption across NHS clinics or integration with NHS services, systems, and data.
The examples of NHS England’s enabled standards include:
- DCB0129 and DCB0160 Clinical Risk Management Standards
- Digital Technology Assessment Criteria (DTAC), a widely adopted framework for assessment and adoption of digital health technologies
- Enforcement of FHIR, HL7, and SNOMED CT as the main healthcare data interoperability standards
Remember: Failing to meet NHS England’s criteria (regardless of other forms of compliance) may limit your solution’s uptake across NHS bodies and restrict access to the UK healthcare market.
Developing healthcare solutions in Scotland, Wales, and Northern Ireland
When building healthcare software for further adoption in Scotland, Wales, and Northern Ireland, your healthcare app must comply with UK-wide regulations from the MHRA and ICO.
In addition, NHS England’s Digital Technology Assessment Criteria (DTAC) is widely used nationwide for healthcare applications. And finally, the guidelines and frameworks of local regulatory bodies:
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Health and Social Care Board (HSCB) for Northern Ireland
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NHS National Services Scotland (NSS) and Digital Health and Care Directorate for Scotland
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Digital Health and Care Wales (DHCW) in Wales
You’ve come to the right place. We help healthtech companies navigate challenges and securely and efficiently bring their digital solutions to life.
Essential UK standards and frameworks for healthcare software
UK MDR 2002
The UK MDR 2002, issued by the MHRA, regulates medical devices and software as medical devices (SaMD). The regulation establishes the legal framework for ensuring the safety and performance of medical devices placed on the UK market.
When software meets the definition of a medical device, it must follow the same regulatory pathway as physical devices: undergo classification, complete the appropriate conformity assessment, obtain UKCA or CE marking, and be registered with the MHRA.
UKCA/CE marking
Software that qualifies as a medical device or supports the function of a medical device must be UKCA or CE marked. These markings confirm that the product meets relevant UK safety, health, environmental, and performance standards.
Determining whether a standalone software or application qualifies as a medical device (and therefore requires registration and marking) can be complex. To assist with the software classification, the MHRA developed a detailed guide, including decision flowcharts that clarify whether your software falls under the category of a medical device, an in vitro diagnostic device, or an active implantable medical device, and if so, what regulatory steps are required.
DCB0129 and DCB0160 Clinical Safety Standards
Mandated under the Health and Social Care Act 2012, DCB0129 and DCB0160 are essential clinical safety standards for UK healthcare software development companies and deployers. These standards are particularly critical for applications that interact with NHS systems or process personal health data.
Common hazard categories addressed through DCB0129/DCB0160 compliance:
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Data entry and data accuracy hazards: incorrect data input or autocorrect errors
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Data transmission and synchronisation hazards: loss of connectivity during data transfer
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User interface hazards: critical info hidden or improperly displayed, or ambiguous button labels
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Clinical decision support hazards: incorrect alerts on medication intake
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Security and privacy hazards: improper access control or unencrypted patient data
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Interoperability hazards: incompatible data formats
Evidence standards framework for digital health technologies
Developed by NICE, the evidence standards framework for digital health technologies (DTH) provides healthcare technology companies with a structured, tiered approach to generating and presenting evidence required to prove their digital health products are clinically effective and bring value to the UK healthcare system.
The framework helps healthtech companies classify their digital health technologies based on primary functions, such as delivering health information, supporting self-management, or aiding in diagnosis, and assigns them to different evidence tiers. The classification clarifies what types and levels of evidence are required for a given product to be considered safe, effective, and suitable for adoption by NHS evaluators and commissioners.
ISO 13485
ISO 13485 is an internationally recognised quality management system (QMS) standard specifically designed for organisations involved in medical device design, development, production, installation, and servicing. If you plan to develop software that qualifies as a Software as a Medical Device, abiding by this standard is necessary.
UK GDPR and the Data Protection Act 2018
To comply with GDPR in the UK and the Data Protection Act 2018, healthtech companies must implement a range of specific technical, organisational, and procedural measures tailored to the sensitive nature of health data. These principles should be central to your approach to processing personal data.
Consent and transparency
- Obtain explicit consent from users for collecting or processing their health data
- Provide clear privacy notices explaining what data is collected, why, and how it will be used
- Include easy-to-use options for users to withdraw consent at any time
Data minimisation and purpose limitation
- Collect only the minimum necessary data relevant to the app’s function
- Use data strictly for the purposes explicitly stated to users
Security measures
- Implement strong data encryption (e.g., AES-256)
- Use secure authentication methods
- Conduct regular security audits and penetration testing
- Maintain detailed audit trails of data access and processing activities
- Incorporate automatic session timeouts and secure backup and disaster recovery protocols
Data subject rights
- Enable functionality for users to easily access, correct, export, or delete their health data through the app interface
- Facilitate data portability so users can transfer their data to other services if desired
By embedding these measures from the design phase and maintaining them across the app’s lifecycle, healthcare apps can ensure robust GDPR compliance, protect patient trust, and meet all legal requirements in the UK.
Digital Technology Assessment Criteria (DTAC)
Although DTAC compliance is not a legal requirement, it has become the de facto standard for digital health technologies aiming to be adopted by NHS organisations and social care providers across the UK.
Passing DTAC demonstrates to medical staff and patients that your digital health tool meets high NHS standards for clinical safety, security, data protection, and usability and is safe for all members of society.
What DTAC means for digital healthtech companies:
Why it matters
What’s required
Clinical safety
Why it matters
Ensuring the app won’t cause any harm to patients
What’s required
- Appoint a Clinical Safety Officer
- Conduct formal clinical risk assessments
- Develop a clinical risk management plan, hazard log, and clinical safety case report
Data protection
Why it matters
Maintaining patient trust and compliance with UK GDPR and the Data Protection Act 2018
What’s required
Implement “privacy by design,” ensuring secure handling and confidentiality of patient data throughout the app’s lifecycle
Technical assurance
Why it matters
Ensuring software security and stable performance
What’s required
Adhere to recognised security standards like the NHS Data Security and Protection Toolkit (DSPT) and Cyber Essentials
Interoperability
Why it matters
Enabling efficient data exchange and avoiding data silos
What’s required
Ensure your app can accurately and securely communicate with the NHS and other external systems
Usability and accessibility
Why it matters
Ensuring the app is easy to use for all users, including those with disabilities
What’s required
Design with accessibility in mind, following the WCAG 2.1 AA accessibility framework and NHS service standards
In summary, DTAC acts as a practical framework for healthtech companies to align with NHS priorities. By meeting these criteria, healthcare apps are better positioned for nationwide adoption, user trust, and long-term impact in the UK healthcare system.
How to build compliant healthcare software: a step-by-step plan and successful strategies
Any software development project requires rigour, dedication, and skill. But when it comes to healthcare, the bar is even higher. Crafting software solutions for this sector demands deep industry knowledge and an unwavering commitment to safety and accuracy.
Here’s a structured plan to help you build functional and fully compliant healthcare software.
Discovery and requirements gathering
Got an idea for a healthcare software product? That’s a promising start, but the real work begins now. The foundation of your healthcare solution concept starts with:
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Defining the intended use of your software
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Identifying the primary user groups
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Analysing competitors and current market offerings
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Identifying inefficiencies and gaps in existing solutions
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Outlining functional and non-functional requirements based on these insights
Regulatory compliance planning
Next, determine whether your product qualifies as a medical device or falls under general healthcare software. This distinction shapes your regulatory path and impacts the features, processes, and documentation you need.
Solution architecture design
Once regulatory pathways are clear, it's time to think about the structure and transform software requirements into a resilient technical blueprint. When designing the healthcare solution’s architecture, consider:
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Functional modules and user paths
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Data security and compliance support by design, including features like audit logs or consent tracking
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Functionality for disaster recovery, e.g., redundant databases and rollback options
UI/UX design
Healthcare design must do more than look good; it must support clarity, accessibility, and critical decision-making. Focus on:
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User-centred workflows: Build around real-life clinician, admin, or patient routines. Prioritise minimal clicks, streamlined documentation, and easy access to vital data.
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Accessibility-first: Meet WCAG 2.1 AA standards, including screen reader compatibility, high contrast options, keyboard navigation, and adjustable text sizes.
Development
Developing healthcare software feature by feature will help bring the solution safely to life while maintaining comprehensive documentation and traceability. Prioritise the following aspects:
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Following OWASP security guidelines and conducting code reviews
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Implementing MFA, secure data storage, and access controls
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Maintaining version control with detailed commit histories
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Using CI/CD pipelines with integrated security scans and linting
For seamless integration of your solution with external systems, like EHRs, diagnostic tools, wearables, or NHS systems, make sure your software supports common data standards, including FHIR, HL7, and SNOMED-CT for data consistency across systems.
Testing and QA
In Agile software development, testing goes in parallel with the development, verifying and validating each newly created feature. In healthcare, testing goes far beyond mere requirements verification. It’s about proving that your software is safe, effective, and resilient under a range of conditions. Your QA strategy should include:
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Functional and regression testing to ensure all core software features are developed as expected.
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Usability and accessibility testing to validate the solution’s design, seamless user experience, and availability to people with disabilities.
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Performance testing to check the software’s stable functioning under normal and extreme loads.
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Integration testing to ensure your solution seamlessly integrates with third-party systems and can securely exchange sensitive data.
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Security testing, including penetration tests, vulnerability scans, and risk assessments, to ensure your solution has all necessary security features in place to comply with industry and data protection regulations.
Deployment
The go-live process for a healthcare solution must be safe, controlled, and thoroughly documented. Like every stage in the development lifecycle, deployment is not just another engineering step; it also marks a critical compliance milestone. At this stage, key tasks include:
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Creating and storing deployment documentation, such as release notes, rollback plans, and risk mitigation strategies.
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Performing the final round of security checks, confirming that the firewall, access controls, and encryption protocols are in place.
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Ensuring safe migration by mapping data between the new and legacy systems, cleaning datasets, and retaining audit trails.
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Going for a staged rollout, starting small with one clinic or internal testing before full-scale deployment.
Monitoring and support
Post-launch, your work continues. Ongoing monitoring and support ensure the solution stays secure, reliable, and compliant over time:
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Establish real-time monitoring, tracking uptime, error rates, latency, and user behaviour.
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Define clear escalation paths for outages, data breaches, or patient safety risks.
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Enable users to submit issues and suggestions.
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Use automated compliance monitoring tools that alert you when new vulnerabilities or legal updates impact your software.
Disclaimer: The content on the Vention website is intended for general informational purposes only and should not be considered legal, financial, or professional advice. To the extent allowed by law, Vention disclaims all liability for any actions or inactions based on the material available on this website.
Development tips from Vention experts
Software as a Medical Device (SaMD) is typically classified under UK MDR 2002 and often requires UKCA or CE marking, which imposes stricter demands on development. Understanding and addressing these from the outset is essential for compliance.
For example, appointing a Clinical Safety Officer (CSO) early, especially if your solution will operate within NHS environments, is a wise move. The CSO oversees risk management and ensures that documentation, evidence, and safety protocols are fully in place.”
Project Manager at Vention
Development tips from Vention experts
Opt for a modular architecture design by breaking the software functionality into independent modules like patient records, appointment scheduling, or data analytics.
Compared to monolithic, a modular architecture will ensure, first of all, faster development of your solution, as well as greater scalability and easier maintenance after launch.”
Mikhail Dashuk
Engineering Manager at Vention
Development tips from Vention experts
In healthcare software development, maintaining comprehensive documentation is essential, and the testing process is no exception.
It’s especially important in cases when your software falls into the category of SaMD. We recommend documenting all testing activities and keeping all deliverables (like test plans, test scripts, description of verification and validation activities performed, system-level test protocols, and test results reports) in accordance with IEC 62304 and ISO 13485 to facilitate your solution’s compliance.”
Oksana Boreyko
QA Director at Vention
Our healthcare IT services
Sometimes, the right advice is all it takes to move forward. Vention provides expert healthcare IT consulting to help you overcome technical and regulatory challenges, whether building a compliant app from scratch, migrating to modern infrastructure, or upgrading legacy systems. Our guidance is grounded in real-world experience across 200+ healthcare projects.
Got a bold idea for a digital health solution? Let’s make it real. From EHR/EMR platforms and telehealth systems to clinical management tools, SaMD and AI-powered diagnostics, we offer Agile healthcare software development services. Always on time, on budget, and built to help you meet regulatory compliance every step of the way.
Need full confidence in the safety, security, and performance of your healthtech solution? Vention’s QA experts test every layer of your product, covering functionality, performance, usability, accessibility, compatibility, and security. With the right balance of manual and automated testing, we ensure reliable results without overspending your time or budget.
We conduct in-depth security audits and penetration tests to uncover vulnerabilities across your app and IT environment. Our team reviews your compliance and security posture, identifies gaps, and recommends the most effective fixes. As a result, you benefit from reduced risk, stronger protection, and alignment with UK healthcare regulations.
Why choose Vention for your digital health solution
Deep healthtech expertise
With over 20 years of experience and 200+ healthtech projects under our belt, Vention brings our tried-and-tested methodologies and a deep understanding of the healthcare industry to every healthtech project.
UK-based engagement team
We’re not just remote partners, we’re local, too. With a clear understanding of the UK’s unique regulatory environment, we help you develop digital health solutions that meet NHS expectations, protect patient data, and improve care outcomes.
Stress-free partnership
When you work with Vention, you gain engineering peace of mind. Our teams operate with autonomy, precision, and full accountability, freeing you to focus on strategic outcomes rather than day-to-day oversight.
ISO 27001-certified
We take data security seriously. Our ISO 27001 certification proves that our information security management system meets the highest international standards, so your data stays protected at every stage.
Built for compliance
We understand the complexity of UK healthcare regulations, from MHRA and UK GDPR to NICE guidance and DTAC criteria. Compliance is considered in every phase of development, from discovery to deployment.
Advanced tech expertise
AI and ML are transforming healthcare, and we’re leading the charge. Whether AI-powered diagnostics, predictive analytics, or intelligent health assistants, we’ve done it before and are ready to build it for you.
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Urban
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