The Swedish health app PainDrainer™, a digital self-management device designed for individuals suffering from chronic pain, has won the inaugural Nordic Health App Award.

PainDrainer™ was chosen for its innovative chronic pain management solution, which uses patient-centric AI technology. The app also demonstrated strong evidence backing and readiness for market regulation.

The Nordic Health App Award scheme was developed by Nordic Innovation to showcase the potential of digital health across the Nordic states.

The Nordic region aims to be the most integrated health region in the world by 2030, according to the Nordic Council of Ministers. To facilitate this, the entire Nordic region has become the first in the world to have a cross-border programme to unify digital health standards across multiple countries.

Known as the NordDEC, the objective of the cross-border scheme is to ensure safe digital health can be delivered to patients across across Sweden, Denmark, Norway, Finland and Iceland.

ORCHA worked with the Nordic Interoperability Project to develop the NordDEC framework.  The five finalist apps and overall winner PainDrainer will all received a free benchmark against the NordDec, carried out by ORCHA.

Anders Tunold-Hanssen, CEO and Project Manager, Nordic Interoperability Project AS, said: “The five finalists and the winner of the Nordic Health App Award 2023 all showcase the huge potential we have within digital health in the Nordics. But to build a healthcare system that’s sustainable and integrated by 2030, we must bridge the gap between innovation and implementation, between health-tech and healthcare. NordDEC can be that bridge.

“A shared Nordic solution will not only create a bigger and more attractive home market for our winners, but it will also attract international health tech pioneers.”

Fiona Costello, SVP of National Accreditations at ORCHA, said: “Our congratulations to PainDrainer – and our team at ORCHA look forward to guiding them through the NordDEC process. This award scheme is a great way to highlight the immense talent and entrepreneurialism across the Nordic region.”

PainDrainer™ is a digital self-management device designed for individuals suffering from chronic pain. Through a mobile application, users can log their daily activities and pain levels, allowing the app’s Artificial Neural Network to identify unique pain triggers. With 95% correct predictions after 20 days, the app then offers personalized recommendations to enhance quality of life and alleviate pain.

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:  

• Signposting to a resource that is no longer available, and the patient not having access to that in a time of need  

• Entering a number that is not flagged as ‘outside of an acceptable range’, such as an insulin dose or body temperature  

• Data that is entered and processed in a way where it doesn’t end up in the right place, for example it doesn’t identify a patient correctly, or end up in the right record 

• Important data that is not included in a patient’s record, which could affect a diagnosis or treatment decision, such as recent prescription or allergy  

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:   

1. Clinical risk management system – this outlines your organisational safety processes, so who is involved, what training they have had, any process you have for auditing your platform and any third-party platforms that fit into it.
2. Clinical safety case report – this talks specifically about the current iteration of your app, and the scope of usage. Including what is it, what does it do, what is the intended use and what testing you have done. This includes if you have done any clinical safety tests to look for risks, and if you have done testing, what were the outcomes? Finally, has this report been authored and/or signed off by a relevant clinical safety officer (CSO)?
3. Hazard logs – Each app you develop requires a hazard log, which records any risks to patients that may arise from use of the app. The initial likelihood and severity of these risks must be recorded, as well as any control measures you will put in place against these risks. Then you must record the residual risks to ensure that they are of an acceptable level.

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.  

Contact us  

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:  

• Clinical safety  

• Data protection  

• Usability and accessibility  

• Technical security  

• Interoperability (if applicable)