There are over 370,000 healthcare apps available to download. While an app store may offer the opportunity for consumers to rate the app, it doesn’t offer any robust effectiveness, security, or governance controls. Enter ORCHA, the app library that tests and verifies digital health solutions for the NHS as well as government bodies in nine other countries...
Where did ORCHA begin?
I started working clinically in the NHS around 25 years ago as a speech and language therapist in complex paediatric care. I always felt really frustrated that I could only see one patient at a time, especially with waiting times and treatment times. So that took me on a journey of wanting to improve quality and efficiencies. Long before laptops and iPhones, I was interested in stripping out waste in a pathway and making sure that we could see more patients.
That took me on a journey of system change and system redesign to speed up processes. Then when I started to see digital health and health apps, I got really excited because I identified that these tools are scalable, they can be given to one person or one million people - everybody can have access to help at the same time. Back then, there were only around 35,000 digital health apps - but more importantly, nobody was using them.
Why was there a slow uptake in the use of health apps?
Amongst both consumers and health care providers, the first problem was that people were not aware that these solutions existed, especially so amongst those with long term conditions. Secondly, they didn't know how to access them. The third and a huge challenge, is trust in effectiveness and safety. And the fourth, for health care providers, is how to manage ongoing risk; these tools keep changing, how do we govern the ongoing future risk of these things? It didn't matter which country I worked in; everybody was blocked by those same barriers.
So, there must have been a catalyst?
It was a bit serendipitous. I was completely obsessed with this problem, spoke to anybody who talked to me about this as a challenge. Then one day I was talking to a developer who wanted advice about how to get into the NHS. I said, ‘actually the problem is bigger than just you and your product’. I started to detail the problem and he said, ‘that's really interesting, have you written a business plan for a company for that?’ I said, I hadn’t and he said ‘well I think you should and I think that you should let me give that to some investors’.
So, I came home, wrote a business plan and sent it to this chap, with no NDA. A week later, I was travelling with work and almost bought a biography of Sir Terry Leahy, the Chief Exec at Tesco at the airport. Anyway, a few days after that, I got a call from... Sir Terry Leahy! He said ‘I’ve had your business plan...’ So, then we had this Dragon's Den conversation, he liked the idea and said that both he and Bill Currie who invested in ASOS would like to invest. That was in July 2015.
I met my co-founder, a digital lawyer, quite soon after. He'd worked in some very early stage start-ups during the dot com era, he'd also been a commercial director in a big corporate and outsourcing and then he'd also been an NHS Chief Exec, so was a perfect fit. So ORCHA began.
What is ORCHA?
Our mission is to distribute high quality digital health solutions to people who need them. Only 20% of digital health solutions on the open market meet regulatory requirements and every day five million people download a health app. So, the size of the problem is massive.
In order to find the ones that are high quality, we do five things...
- We review and accredit digital health solutions. We have taken a very innovative, layered approach to our review process. The ORCHA baseline review, assesses the functionality and role of an app and then checks it against +350 appropriate measures - this includes seeing if it meets standards such as GDPR, data security, OWASP guidelines, the NICE evidence standards framework and medical device regulations. On top of that we can add additional checks, depending on our customer’s needs. Often there may be criteria specific to a country, such as language needs or local standards. Crucially , our review engine continuously re-reviews apps, so when a product is updated, even with seemingly minor changes, we automatically conduct another review.
- Digital libraries hosted nationally, regionally, locally or organisationally. ORCHA can support through a specific lens, such as mental health, diabetes, dementia… a digital health library, that’s home branded and targeted. These libraries are basically highly sophisticated search engines which allow you to find a long list of good products, then filter according to your personal preferences. We can also layer technical preferences to cater for unique differences such as hearing visual or cognitive impairments.
- Working with healthcare professionals to use that library as a formulary. Ever been to the doctor and they’ve used a little book before prescribing drugs? Well ORCHA is the equivalent for digital health. Doctors use our libraries to find the right digital health solution and with our Pro Accounts, can accurately recommend the app by a text message or email to a patient.
- A multi-tiered or granular solution. We work with healthcare teams and understand that the product recommended could be different depending on where the patient is on their pathway. There isn’t one size fits all for drugs, and neither is there for apps. Different people need different apps at different points in their pathway. We work with organisations to map the best apps to their patient pathways, enabling digital health to be firmly embedded into processes and systems.
- The ORCHA procurement framework. To help organisations to effectively commission and distribute apps, we put high quality products into our framework for organisations such as the NHS. This means the app can be paid for on behalf of their patients at the point of prescription or recommendation. There is then a payment back to the innovator for that tool to manage the ongoing economic sustainability of the apps.
How is ORCHA paid for?
Our business model, put simply, takes a little bit of money from each of those five steps. So, governments or government bodies pay us to do due diligence and the review process. We charge a licence fee to CCGs and NHS Trusts for building and managing bespoke health app libraries and pro app prescription tools. Innovators also pay us for reports and advice on how they can improve to meet standards.
Can the public access ORCHA?
In 50% of NHS regions, there will be a free public health app library to meet local health priorities, commissioned by a CCG or Trust, that ORCHA runs.
Alongside this, professionals can search across our 6,000 app reviews at appfinder.orcha.co.uk. So, if you’re interested in products around cancer you can see that out of thousands of apps, which 44 have reached our minimum threshold. Looking at breast cancer, the figure falls to 10.
This costs £4 a year for a standard account, or £23 a year to also have additional features such as the digital prescription feature, favourites, and access to webinars - they're all CPD accredited and give the flexibility to search in different ways, for different sectors or demographics.
How do you keep on top of changes in governance and legislation?
To keep pace with changes in technology and regulation, every six months ORCHA works with world leaders in digital health to ensure that its review platform takes into account the latest medical, IT and usability practice and expectations.
We've just launched our review version 6 which incorporates a whole load of new regulations including the NICE Evidence Standards Framework for Digital Health Technologies; which is an effectiveness and value assessment. It also includes the ISO 82304-2 standards, which is one of the most important new standards in the digital health space; this standard looks at medical but also technical requirements such as security and storage.
Will Brexit affect your libraries?
The biggest challenge / opportunity moving out of the EU is that the Medical Device Directive is changing to Medical Device Regulations. Here in the UK we will be having a UKCA process, which will be different.
You can look at this through two lenses. So, the opportunity is that the UK could become a hot house for innovation. If they make the processes such that innovators can get through that process and achieve an endorsement to the relevant class certification then they will be able to be used and incorporated into care across the UK. What that will mean is that more investors will invest in innovations coming to the UK. The challenge is if you're an innovator you now have to go through two processes one for the UK and one for Europe. So that doubles your regulatory challenges.
Is ORCHA just useful for regulatory compliance?
It’s more about quality and safety. There are about two and a half thousand standards, regulations and best practice guides available to us. It's a confusing landscape and some of those regulations are not proportionate so if you have a product that helps you practice yoga, and that's a very low risk product, it probably isn't going to hold any data, it's probably not going to share any data, it's not a clinical or medical product therefore the assessment of that product needs to be proportionate to the risks involved. However, if you've got a product that is telling you to see a doctor or take a drug then the risk of that going wrong could be quite significant.
So, 2020. The year of COVID-19. Has this year seen a rise in the uptake of healthcare apps?
Yes, there’s been a 25% increase from four to five million downloads every day of health apps. Then across our health app libraries we've seen a 200% increase in traffic and a staggering 6,500% increase in doctors and nurses using ORCHA pro accounts to conduct app prescriptions.
In the current climate, people accept tech as an alternative to a drug or face to face consultation. But the problem is, there are thousands of apps - there are 19,000 digital health apps for mental health.
On Google Play or the Apple app store they just don't segment down enough. So, within that space of mental health you've got everyday anxiety to schizophrenia to suicide to eating disorders and this is basically the challenge. Our research has found that only 26% of mental health products meet the regulatory requirements. But when you drill down into sub-categories, for example in suicide prevention, only five percent are good.
So, 95% of suicide apps aren't fit for purpose?
Yes. It's scary. And if you think about the consequence of downloading something that's going to give you bad advice in that scenario… That was the original problem that we wanted to solve and still want to solve. If people are going to download stuff at least give them good stuff. Otherwise, it’s a bit like having an open market of drugs. ORCHA is helping to change that.