Why do I need to check my health app meets NHS DTAC clinical safety standards?
You need to identify and check your health app has mitigations in place for any risks that could harm a patient’s health. Do this as early as possible when you develop your health app and use this process as a road map for development. It can highlight how to improve the usability of your health app for the benefit of your users: patients or healthcare professionals. Otherwise, it can be difficult to go back and make changes or revisit hazard and mitigations to an already established health app.
Here are some examples of risks we’ve identified in health apps during a DTAC assessment:
How do you assess my health app so it complies with NHS DTAC clinical safety standards?
At ORCHA we look at the documents you have in place, and the people you have involved in the development of your health app (Android, Apple or web-based app).
We assess your health app against the standard DCB0129, which is an NHS standard you need to comply with to be used in NHS organisations.
You will need to share 3 specific documents and keep records internally for your processes.
These 3 specific clinical safety documents include:
What is needed to be a clinical safety officer (CSO) and how do I find one?
The clinical safety officer (CSO) needs to be clinically trained, so they need to have a current valid registration as a healthcare professional. For the DTAC, the CSO needs to have undergone appropriate risk management training. For example, at ORCHA, our Medical Director and CSO is Dr Tom Micklewright.
Some organisations that offer clinical safety risk management training can also supply clinical safety officers (CSO) to help set up a process and maintain it.
So, you can hire a CSO or have your own in-house CSO who is a registered clinician that has undertaken an appropriate training course.
What if I don’t have documentation for NHS DTAC clinical safety standards, including those that show compliance with DCB0129?
Clinical safety documentation, including those that show compliance with DCB0129, are your assurance that what you are doing doesn’t lead to unmitigated risk to patients.
If something were to go wrong, you can point to these documents to demonstrate that you did everything you possibly could to mitigate the risks of that in your health app.
This is why it’s important to understand at an early stage what the risks are for using your health app and how you can mitigate them.
Your clinical safety documentation should be passed over to the NHS organisation that will commission your health app, and they will then do their own risk assessment of your health app, including the use of your health app within clinical practice.
By having independent external validation, for example through ORCHA checking your documents, this helps you prepare for important conversation with NHS organisations when they want to commission your health app, so it is used in the most safe and effective way. This means that your health app will be used by the people and for the purpose you intended and designed it for.
Another benefit of getting help in preparing your documents ahead of any procurement, is that we can speed the process up and reduce the risk of gaps or problems being flagged at crucial points in contracting discussions.
Is the NHS DTAC only for medical devices?
The DTAC asks if your health app is a medical device, and if it is then you need to provide the appropriate registration details and documentation.
If your health app is not a medical device, then you need to explain this too.
We do find that some health apps are in fact medical devices, and they may be unaware that they are. We encourage them to independently go through the medical device certification process to obtain the appropriate EU CE or UK CA marking and classification.
The DTAC covers all digital health products (including health apps), whether they are or aren’t a medical device, and you need to evidence this in either case. And part of the DTAC process is complying with standards such as the DCB0129, and others such as the ISO14971 if your health app is a medical device.
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At ORCHA we help deconstruct the clinical safety requirements for the DTAC into over 70 short questions, to provide you with a granular and clear picture of how clinically safe your digital health product is.
The NHS Digital Technology Assessment Criteria (DTAC) is an assessment that digital health products, such as Apple, Android and web apps, need to go through to be commissioned by the NHS in the UK.
There are five key areas that an NHS DTAC covers when assessing a digital health product. These include:
Whilst NHS waiting lists are so long, and doctors are under so much pressure, we must all think differently about how we take care of our health.
That’s the view of two thirds of respondents in a new poll*. Sixty-eight per cent were willing to look at new ways to self-manage their health, including using health apps. Only 8% disagreed with the use of health apps to help the NHS.
But ORCHA (the Organisation for the Review of Care and Health Apps) warns that whilst there are some topflight health apps available, the market is so flooded, and the quality so variable, that there needs to be more guidance on choosing good apps.
Liz Ashall-Payne, founding CEO of ORCHA, said:
“Great health apps are, right now, being prescribed by doctors to help their patients sleep better, manage their mental health, keep fitter, monitor medicine usage and much more. But all of us need better advice on how to choose a good quality app. Consistently, more than half of the health apps we review fail to reach the standard required to be used by the NHS.”
Everyone knows not to open an email attachment sent by a stranger. But we are far less cautious when downloading health apps – and the consequences could be as bad or worse.
ORCHA commissions an annual check of consumer attitudes towards the use of health apps. This year’s research has revealed that thousands of people are unwittingly downloading untested health apps to assist with complex conditions such as epilepsy and diabetes.
Zero per cent (yes, 0%) of respondents surveyed by One Poll in March 2023* who had used a health app had checked whether it was backed by a clinical team with professional credentials.
“That’s the equivalent of buying a random box of pills with no MHRA (Medicines and Healthcare products Regulatory Agency) approval and swallowing a handful of them, hoping for the best,”
said ORCHA’s research director Dr Simon Leigh.
Instead, 30% of those app users had checked consumer reviews on app stores, feeling this gave them adequate protection.
Dr Leigh said:
“We’ve proven through academic studies that good consumer reviews are not a safe indicator of the quality of the app.** In fact, as a rule, the higher starred the consumer reviews, the less compliant the apps are in terms of the required standards and accreditations. Consumers are putting far too much faith in anecdotal observations by others.”
ORCHA recommends that consumers carefully consider which health apps they choose – these guidelines should help.
SECURE – How secure is this app and does it have a clear privacy policy? Do not tick any box without reading the text and understanding what this means. Better quality apps will let you tick and untick permissions so you can change your mind later. Be aware that you may be giving this app permission to share your sensitive data with third parties.
ASK – Have you asked a healthcare professional about your app choices? Doctors and nurses will be able to recommend a variety of top-quality apps, allowing you to make a good choice.
FIND – Where did you find this app? Was it on an NHS or charity approved app library? Was it on your organisation’s app library? With 300,000 health apps now on app stores, where there is only light oversight, it is harder to find a quality product.
EVIDENCE – Does your app demonstrate clear evidence that it was developed by someone with medical expertise? More complex apps, such as those which help monitor or diagnose conditions, will be subject to medical device regulations and should be backed by clinical trials or observational studies.
ORCHA warns that when choosing apps, consumers should not just look for high download numbers and consumer starred reviews on app stores. These are not always indicators of quality.
For example: One diabetes app which is currently available on app stores, and which has 500,000 plusdownloads, includes a Bolus calculator, used to calculate insulin dosage. According to the Evidence Standards Framework (a benchmarking system checking health app quality, used by NICE), this app requires a randomised clinical trial to check its effectiveness and an observational trial to check it is safe for patients to use. However, the ORCHA team found no evidence of either, above a user testimonial. ORCHA scored this app very poorly (36%) for professional assurance (65% is pass rate).
Liz Ashall-Payne said that health apps had the power to revolutionise the delivery of health services but the market needed to be regulated.
“We know from our in-house research that nearly six million GP attendances and 600,000 A&E admissions could be prevented annually if digital tools were deployed which encouraged patients to manage their health at home.
“And this is just the tip of the iceberg. There are tremendous cost and efficiency savings to be made right across the NHS.
“There are some fantastic digital tools now available, but all the products we use must be scrutinised in exactly the same way as medicines.”
* The independent research by One Poll questioned 2000 consumers in March 2023.
Following the inquiry into digital transformation in the NHS, the cross-party Health and Social Care Committee has now published its recommendations, which is forward-thinking.
We are pleased to see that the report emphasises the need for a core infrastructure that can effectively deliver safe health apps to the public across the NHS and Social Care. At ORCHA, we have already taken steps in this direction by providing Health App Libraries and Digital Health Formularies to NHS and Social Care organizations, which align with the report’s ambitions.
While progress has been made in some regions of the UK, it is important to acknowledge that universal implementation is still lacking, resulting in inefficiencies and creating disparities between areas. However, we believe that by addressing these challenges, we can overcome the current postcode lottery scenario.
The committee report rightly points out that there is a lack of a systematic and consistent approach to assessing and demonstrating the quality standards of third-party health apps against the Digital Technology Assessment Criteria (DTAC) by the Department and NHS England. We fully agree that needs improving, as using an unsuitable health product can have a negative impact on people’s well-being and deter them from embracing digital channels in the future.
In line with the report’s recommendations, we have conducted over 24,000 assessments of health apps, and DTAC assessments since its introduction in 2021, enabling us to identify excellent apps that can genuinely enhance an individual’s health and well-being. However, this process has also highlighted that a staggering 80% of health apps on the market do not meet the necessary quality standards.
To address this issue, the committee suggests that the Department and NHS England collaborate to establish a comprehensive accreditation scheme for third-party healthcare apps, alongside the current practice of recommending specific apps on some nhs.uk webpages. Moreover, the scheme should be easily accessible for individuals, enabling them to verify whether a healthcare app they are using or considering is recommended by the NHS.
We have witnessed the positive impact that a health app library, complemented by a well-executed communications campaign, can have. For example:
Therefore, we hope that this report will inspire more organizations to recognize the benefits of implementing a safe health app library, which continuously assesses and ensures the security of health apps for patients.
Ideally, as recommended in the report, NHS England should establish centralised systems to manage this infrastructure, promoting greater efficiency and providing universal access to all patients. If such a framework were put in place, we would be delighted to contribute to the development of a comprehensive solution.
For further discussions on establishing the core infrastructure for safe digital health, we invite you to contact us.
You can read the full report at the following link: https://committees.parliament.uk/committee/81/health-and-social-care-committee/news/196058/government-must-address-past-mistakes-to-deliver-digital-transformation-in-the-nhs/