The app on your phone isn't just an app
Imagine this common scenario: a junior doctor, wanting to double-check a patient's stroke risk, downloads a new app that calculates the score instantly. It's quick, easy, and seems incredibly helpful. But what are the hidden professional responsibilities that come with that simple tap of a 'calculate' button?
While clinicians are experts in medicine, they aren't expected to be experts in software regulation. However, as technology becomes more integrated into our daily practice, the line between a "digital textbook" and a "medical device" is blurring. Understanding this distinction is becoming essential for safe and professional practice.
This article aims to provide a simple, practical guide for UK clinicians to understand their role in using medical apps safely and to know what to look for, as governed by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA's litmus test: moving beyond information to action
So, when does a simple app become a regulated medical device? The core principle from the MHRA is straightforward. An app is likely a medical device if it is intended by its manufacturer to be used for a specific medical purpose.
Here's a simple comparison to make the distinction clear:
- This is NOT a Medical Device: An app that simply displays a static, digital copy of a NICE guideline, a chapter from a textbook, or the BNF. It is providing information for you to interpret, much like a book.
- This IS a Medical Device: An app that takes patient-specific data (like age, diagnosis, or blood pressure) to calculate a risk score (e.g., QRISK3), recommend a specific drug dose, or analyse an image to suggest a diagnosis. It is performing a calculation or interpretation on data for a specific patient.
The "intended purpose" stated by the manufacturer is the key. If the app is designed to go beyond just providing information and actively helps in diagnosis or treatment for an individual, it crosses the line into medical device territory.
Looking for the quality seal: the UKCA mark explained
The most important symbol to look for when assessing a medical device app is the UKCA mark.
The UKCA (UK Conformity Assessed) marking is a declaration by the manufacturer that their app meets all the essential safety, quality, and performance requirements of UK medical device law. For those familiar with European regulations, it serves a similar purpose to the CE mark.
A UKCA mark represents a significant commitment to quality and safety. It signifies that the manufacturer has undergone a rigorous assessment process, which includes:
- A robust Quality Management System to control design and development.
- A designated Clinical Safety Officer responsible for ensuring the app is safe.
- A documented process for managing clinical risks and responding to user feedback.
The red flag: If an app performs a clear medical device function (like calculating a dose or risk score) but you cannot find a UKCA mark associated with it, it is very likely not compliant with UK regulations and should be used with extreme caution, if at all.
The clinician's role: due diligence and professional judgement
It is crucial to state that it's not your job to be a regulator. You are not expected to conduct a deep audit of every app you use.
However, it is your responsibility to apply professional judgement. As per GMC guidance, clinicians have a duty to use information and tools that are evidence-based, reliable, and in the best interests of their patients. This includes performing a quick "sense check" on the digital tools you choose to use in your practice.
A simple checklist for clinicians:
- Check for a UKCA Mark: Look in the app's 'About' section, on the manufacturer's website, or in the app store description. Its presence is a key indicator of regulatory compliance.
- Identify the Manufacturer: Is it a clear, identifiable company with contact details, or an anonymous developer? Reputable manufacturers will be transparent about who they are.
- Look for Evidence: Do they cite their sources? Do they reference the clinical studies, formulas, or guidelines their tool is based on? A lack of references is another red flag.
- Consider the Context: Does the output make sense based on your own clinical knowledge and understanding of UK practice? Always apply your own expertise.
Our philosophy: information, not calculation
At iatroX, we have thought deeply about this regulatory landscape. We have made a deliberate choice to operate as a high-quality, AI-powered information resource, not a regulated medical device.
This fundamental decision shapes how our features work:
- Ask iatroX: This feature retrieves and presents direct, referenced information from guidelines, acting like an expert librarian who finds the exact text you need. It does not calculate a score or recommend a specific treatment for an individual patient.
- Brainstorm: This tool functions as a brainstorming and differential diagnosis educational aid. It helps you explore possibilities and access relevant guideline information, augmenting your own clinical reasoning rather than providing a definitive 'answer'.
- Question Banks: These are clearly designed for educational and self-assessment purposes to help you test your knowledge.
The bottom line is that our approach allows iatroX to provide powerful, AI-driven support for your clinical work without placing the regulatory burden of a medical device onto the platform or its users. We provide the evidence; you make the clinical decision.
Conclusion: empowering safe digital practice
To summarise, the key takeaways for any clinician using health apps are:
- An app that calculates or interprets patient data for a medical purpose is likely a medical device.
- A compliant medical device app in the UK should have a UKCA mark.
- It is your professional duty to perform simple checks on the digital tools you use.
Using digital tools is undoubtedly the future of medicine. By being informed, asking the right questions, and being selective about the apps you trust, UK clinicians can embrace this innovation safely and professionally, ensuring technology serves its ultimate purpose: delivering the best and safest outcomes for patients.
Call to action / disclaimer
To learn more about how software and apps are regulated in the UK, we encourage you to visit the MHRA's official guidance pages.
Disclaimer: This article is for informational purposes only and does not constitute legal or regulatory advice. Clinicians should always apply their own professional judgement.