NHS Humber and North Yorkshire Integrated Care Board looks after the NHS spending and performance across a region home to 1.7million people.
One of the biggest challenges facing the Humber and North Yorkshire Health and Care Partnership is managing the growing lists of patients waiting for access to treatment and care. So as part of its Recovery in Primary Care Plan, it has been working to improve the outcomes and experience for patients with planned appointments or interventions, focusing on prevention and management of long-term conditions.
The team identified that health apps can offer convenient and effective ways for people to improve their health whilst waiting for surgery, in preparation days before surgery, then to speed recovery and improve condition management after discharge.
To uphold consistent clinical standards, the team wanted a specific set of apps for each target area. They wanted to know that ach app meets clinical, data and security standards, and decided that less complicated, low risk apps would achieve a higher recommendation rate from clinicians and adoption rate by patients.
The Board already had a working Health App Library provided by the Organisation for the Review of Care and Health Apps (ORCHA), giving its public a source of safe health apps across a wide variety of health conditions. So, it asked the team at ORCHA how this platform could be utilized to actively put the right apps in the hands of the right people at the right time. To target those waiting for surgery or for those wanting to manage and maintain their long-term health and well-being needs.
As part of its big update at the start of 2023, knowing a Health App Library needs to be as relevant to an audience as possible, ORCHA enabled the Library to be highly configurable. One such feature is its ability to easily add a dedicated campaign landing page to the Library that drives targeted health app adoption. Designed to a health provider’s specific needs, the page feature images, copy, video and specific apps to address the needs of a specific patient cohort.
Working closely with Humber and North Yorkshire Board, ORCHA created a Waiting Well and Beyond campaign. This included:
During August and September, the programme saw 7,648 people visit the page, and approximately 27% of these people download a health app as a result (1,021 on page downloads and an equal number of off-site downloads).
Based on NICE evidence, each download helps save the NHS £93 in costs. And so over eight weeks, this campaign not only helped provide support to people when they needed it, improving their health, but also saved the NHS £189,906. If this continues over one year, the saving could be over one million pounds (£1,006,706).
Commenting on the campaign, Carrie Cranston, Strategic Digital Programme Support Manager, Humber and North Yorkshire Health and Care Partnership said: “Our ICB were looking at how we could maximise our elective care recovery programme, to reduce the capacity in demand for local services across Humber and North Yorkshire.
“ORCHA have supported us in promoting the use of self-care apps within our local population and this campaign has allowed us to begin the wholesale adoption of digital health within our local communities.”
We are delighted that the Government has accepted most of the recommendations from the Health and Social Care Select Committee. However, we are surprised by their decision to reject what we consider a straightforward recommendation – introducing an accreditation scheme for third-party healthcare apps verified by the NHS.
This is a crucial step that could significantly benefit the NHS and people’s health, and it’s something that could be easily put into practice.
The demand for these healthcare technologies is clear. A significant 68% of people express their desire to use an NHS-verified app as part of their healthcare, and a remarkable 93% of health and care professionals believe in the potential of health apps to have a positive impact.
Moreover, countless technologies are readily available to meet this demand, thanks to significant investments from the NHS, clinicians, and the digital health industry.
To ensure that these apps maintain high standards in clinical, privacy, security, and usability aspects, much like medicines, we require a quality-check scheme. The NHS Digital Technology Assessment Criteria already serves this purpose.
To ensure safe distribution, continuous assessment, and a unified platform for healthcare professionals to safely prescribe these apps to patients, ORCHA, founded by clinicians and supported by the NHS National Innovator Accelerator Programme, possesses the necessary technology. We have assessed 24,000 technologies to date, providing Health App Libraries for the public and Digital Health Formularies for professionals in 70% of regions.
All the necessary components are in place, yet without government support, they remain disconnected. The crucial element of trust that would come with a central accreditation scheme is currently missing.
So, what’s the impact of this decision?
Well, despite the lack of UK regulation or NHS involvement, half of the UK public already chooses to use health apps. Our assessments have revealed that 80% of apps available in app stores fall short of quality standards, putting the UK public at risk.
Without a centralised system, app assessment and distribution are constrained, fragmented, and duplicated. Consequently, the NHS leverages digital health in only a small fraction of its potential applications.
For instance, just 2% of individuals with COPD currently use health apps, despite clinical studies confirming that the right apps can enhance outcomes and reduce the need for frequent medical appointments. Imagine the potential relief on our healthcare system during the Winter Pressures if primary care had access to the right set of digital tools.
In England, 7.19 million people are waiting for routine operations like hip or knee replacements. Integrating digital health into this pathway could significantly reduce deterioration while awaiting surgery, optimise health, and improve recovery outcomes.
This presents a substantial opportunity to enhance efficiency in prevention, urgent care, treatment, and discharge processes.
While it’s promising that the Government plans to introduce a new app, it’s important to recognize that a single app cannot cater to the diverse healthcare needs of our population. After all, there are 70,000 medicines listed in the BNF. Why should we assume that one app can meet everyone’s needs?
The NHS is under immense pressure, and Digital Health presents a practical and effective solution. However, for it to reach its full potential, a centralised system is essential.
We sincerely hope that the Government will reconsider its decision.
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.
We asked Paul S Weston, Director of Review & Accreditation at ORCHA, and Adam McCabe, Senior Digital Health Assessor at ORCHA, to answer your top 5 questions about clinical safety requirements you need for your health app to pass an NHS DTAC assessment.
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 is difficult to go back and make changes to an established health app.
Here are some examples of risks we’ve identified in health apps during a DTAC assessment:
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 (iOS) or web-based app).
We assess your health app against the standard DCB0129, which is an NHS standard you need to pass to be used in NHS organisations.
You will need to share 3 specific documents and keep records internally for your processes.
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 your app in scope. So 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? And finally, has this report been 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 likelihood and severity of these risks must be recorded, as well as any control measures you will put in place against these risks.
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 the training.
Ideally the CSO will have expertise in the clinical area that your health app helps with, for example a diabetologist could identify risks, when you develop your health app, if it helps people with diabetes.
Clinical safety standards 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.
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.
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.
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:
We can help guide you through an NHS DTAC to improve your chances of getting commissioned by an NHS organisation, or you can do it as a self-assessment.
Want to learn more? Email us at email@example.com or watch the webinar: NHS DTAC – spotlight on clinical safety.