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E-clinical: the rise of new health technologies

Published on 13/04/15 at 08:02am
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Wearable health tech like the Nike FuelBand can sync with smartphone apps – but can they go from being fads for the health-conscious to helping the seriously ill?

In the UK the NHS is generally considered to be traditionally resistant to new technology, but it has been forced to embrace it in recent years. 

The tech creep started in 2006, when the-then Labour government launched three pilots in 2006, known as the ‘Whole System Demonstrators’, to test the benefits of assistive technologies like telecare and telehealth.

The pilots were the largest of their kind in the UK – over 3,000 patients were recruited in Cornwall, Kent and Newham to receive an assistive technology or to act as controls by receiving usual care. 

Telemedicine fell out of vogue when analyses found no differences between the groups in terms of contacts with general practice, use of health services, quality of life or psychological outcomes – and it was found not to be cost-effective in addition to standard support and treatment. 

Yet nearly 10 years later the NHS is still looking for ways to tap into the power of technology to improve patient care and reduce demand on its services. 

This is reinforced by Tim Kelsey, NHS England’s national director for patients and information, who says: “Commissioners should prioritise their strategies for putting data and technology to work for citizens and local communities.” 

Kelsey’s mention of data, as well as technology could be revealing. While there was a wider economic case for the telehealth pilots, it was difficult to make a clear financial case for investors. 

Now in the era of ‘big data’ there may be more scope for financial return by providing what the NHS now calls ‘technology-enabled care services’ – an umbrella term to describe “technologies such as self-care apps that have the potential to transform the way people engage in and control their own healthcare, empowering them to manage it in a way that is right for them”.

These devices collect and share the personal health data that apps and wearables make accessible to users. Professor James Barlow, FitBit wearer and chair in technology and innovation management in healthcare at Imperial College Business School, explains: “I have had discussions with pharma companies going back around 10 years and they have always been in the same position: ‘We want a piece of the action, but it’s been difficult to make any money from apps.’

“Now that there’s more focus on the use of data to speed up drug development they’re beginning to see that they can get good real-time data on how a patient’s condition is changing and how a drug is affecting them and being used. It’s given the proposition of these devices another dimension – at least for some of the more progressive companies.

“For some conditions, or people who have complicated health needs, there might be a preventative argument for prescribing these devices and the data should be part of your ongoing health care.” 

Many commentators suggest that apps and wearable technologies will enable the successful implementation of technology-enabled services and represent the new face of the failed telehealth schemes.

Already, there are more than 20,000 healthcare smartphone apps available from over 300 companies devoted to ‘digital health’, and there has been a massive rise in those focussing on wearable technology.

By 2018 70% of healthcare organisations will have invested in digital technology such as apps and wearables, according to research firm IDC Health Insights. In the US the healthcare device market is worth $3 trillion. And in the UK, figures compiled by Kantar Media show the health and fitness wearable tech market has an estimated 13.1 million users in 2015.

Currently, 6.7 million adults currently use health and fitness wearable devices and smartphone apps for activities such as monitoring their heart rate, recording steps taken and calculating fitness levels. 

But pharma companies must design apps and wearables for patient needs that are much more specific than this. According to the Department of Health, around 15 million people in England now have at least one long-term condition.

However, figures from the World Health Organization suggest that as many as half of medicines prescribed for people with these conditions are not taken as intended. 

And unlike the fitness fad followers – of whom research suggests a third will have stopped using their wearable device a year after purchase, once the novelty may have worn off or they have achieved the goal they set out to meet when purchasing – people with chronic illnesses are necessarily in it for the long haul.

So there may be an opportunity for apps and wearables to fulfil roles such as health coach, diagnosis, monitoring and helping to improve compliance. 

Who should integrate the data?

But this will only be feasible if pharma apps are physically linked with patient management through electronic records, Barlow says. “One of the big issues is the fact that none of these devices are integrated into the NHS. If it’s only the user that gets the data and acts on it then that’s only half the benefit. 

“We need doctors and other healthcare professional to be able to view it too. There’s a huge appetite for these technologies and devices but it needs integration to get the full value.”

It is not clear who should hold the responsibility of integrating the different sources of information that apps and wearables collate and store, or who should be responsible for sharing that with the NHS.

“Sadly there is not the readiness or the willingness to take that on in the NHS,” Barlow says. “We have had years of experience with telehealth, and there is an evidence base for when it can work, but healthcare professionals are not keen to be swamped with what they see as additional data that they have to interpret. 

“But somebody has to take the initiative, whether its pharma or someone else almost doesn’t matter – but there needs to be integration. It could be pharma, mobile phone companies or IT firms, or makers of specialist sensors – but none have been keen to take on the role. There’s a perception that they don’t want to be liable as there are big risks involved in data security and ethics and who’s to blame when something goes wrong.” 

And while some of these other industries may focus on helping the affluent and tech-savvy get even fitter, the need for integration of health devices with patient care presents an unprecedented opportunity for pharma to innovate and to lead.

Tech companies simply cannot do what pharma does well: bringing years of understanding of patients, diseases, healthcare professionals and the regulations of patient data storage and management of big data in clinical trials.

Potential regulatory pitfalls

Another major challenge the industry faces is how to regulate the apps, which will become more of an issue as the technology proliferates. In this next phase, reliable, approved gadgets will be needed to take personal-data-tracking from a hobby to the next level: becoming a normal part of daily life for most people. 

The NHS announced plans in November 2014, as part of its Personalised Health and Care 2020 strategy, to introduce a ‘kitemark’ to safely validate healthcare apps. The strategy also commits to giving everybody online access to their GP records, viewed through approved apps and digital platforms, by 2015.

The plans are yet to materialise – NHS England says they will publish proposals by June this year and official endorsing of apps will begin by the end of 2015.

And while patients and the industry wait, there is the potential for problems, as well as for gains. As technology becomes more personalised and more sophisticated there are more pitfalls for pharma, along with opportunities.

In the US, the FDA has taken its first steps towards regulating health wearables.

In January the regulator released draft guidance on how wearable devices for medical purposes could be regulated, and also rules that define and distinguish consumer wearables from more serious healthcare technology.

There are genuine concerns about data security. A report by the Ponemon Institute, a US-based data privacy research firm, shows medical identity theft jumped 22% last year as more health data went electronic and health information – including that uploaded and shared by personal health devices – became more common. 

In the UK the Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating apps, smartphone-connected devices and wearable technologies that constitute a medical device: defined in very general terms as “any software which is ‘standalone’ i.e. not a part of a physical medical device at its time of being first placed onto the market, and which is intended to be used in the treatment, prevention, alleviation or diagnosis of a medical condition.” 

Yet it’s still not clear where a technology-enabled care device ends and a medical device begins, particularly as these technologies become more sophisticated and more targeted, as companies seek to hone in on the needs of patients with specific conditions.

Under the current EU regulatory framework, medical devices need to be CE marked by their manufacturer before they may be placed onto the market for sale, or put into use.

There are three EU directives which govern the way in which medical devices are regulated, and the requirements the manufacturer has to meet to CE mark them.  One covers the vast majority of medical devices used in and on humans such as infusion pumps; another covers diagnostic medical devices such as blood glucose meters and tests to screen, diagnose and monitor various diseases; and a third covers implantable devices such as implantable pacemakers. None strictly speaking cover apps and wearable devices. 

The MHRA’s head of regulatory affairs, Rob Higgins, says: “In the UK apps, wearables and other technology-enabled care devices are monitored for safety and compliance by the MHRA’s adverse incident centre, through which users and manufacturers can report adverse incidents which have occurred though the use of medical devices.”

In theory there are penalties for companies that fail to adhere to any safety and compliance rules, Higgins says. This is meted out by the MHRA’s device compliance and central enforcement unit – taking to task any manufacturers who are found to be placing non-compliant or unsafe medical devices onto the market.

Despite what Barlow describes as the ‘minefield’ around the regulation of health devices, the enthusiasm from pharma is continuing apace. This was evident at the Mobile World Congress, the world’s largest industry exhibition of mobile technology, which was held in Barcelona in March.

The event showed the unique space occupied by healthcare bodies, pharma companies and technology firms, all vying for the same market and suggesting there may be more mileage in partnership than in competing. 

At the conference research firm GfK presented data highlighting that health and fitness trackers and smart watch technology – like the anticipated Apple Watch just launched in March – are likely to merge over the coming years.

Already in the US health app producer Mango Health has launched a drug adherence app specifically designed for the Apple Watch. The UK isn’t being left behind in this growth. Last year UK firms exported services worth £33 million of digital healthcare. Dr Paul Zollinger-Read, a former GP in Essex who is now chief medical officer at Bupa, sees the value of these kinds of devices in the patients he used to see as a doctor.

“This is not Star Trek, these things are literally just around the corner,” Zollinger-Read says. “By 2024, the availability and use of these products will be so widespread that they will fundamentally change the way we diagnose and manage conditions.” 

Bupa – along with GSK and US mobile network provider Verizon – has signed up to a WHO campaign launched in 2013 called Be Health, Be Mobile. The consortium is aiming to tackle major global health problems including cancer, heart disease, dementia and diabetes.

There are other schemes already up and running. Last year Google announced it was working on contact lenses that can track blood sugar levels in real time.

The collaboration with Novartis will see the development of lenses that are thinner than a human hair and contain a microchip that can take a reading once a second.

As life sciences and high tech converge, pharma’s challenge is to bring its unique strengths to the fore and find the courage to become a leader in this rapidly evolving arena.

James Barlow was a speaker at the eyeforpharma Barcelona 2015 conference in March

 

Four healthcare-first wearables

The AXA PPP Health Tech & You awards highlight some of the best and most innovative examples of healthcare devices, which are being showcased at an exhibition at the Design Museum in London between 10 March and 26 April.

Deyan Sudjic, director of the Design Museum, says: “The digital revolution is breaking down doors in the health industry. We’re about to witness a transformation of the global healthcare industry, led by an independent, consumer-led health tech market. 

“This radical change is breaking on to a community of medical practitioners whose purpose is about to be dramatically enhanced – or challenged – by the growth of patient-led healthcare. But when a GP’s face appears by Skype on our mobile phone, can he or she still sit on the Mount Olympian pedestal of yesterday’s world?”

Babylon (nominated in most innovative provider category)

Babylon Healthcare Services has developed the world’s first integrated digital healthcare service providing healthcare in more convenient and accessible ways. Babylon can deliver healthcare direct to a smartphone anywhere, anytime.  Any UK resident is able to download the app, which gives them access to instant consultations with clinicians. 

WARE (nominated in manage my health category)

This unique wristband is worn at night and is specifically aimed at people living with bipolar disorder. It provides them with a way to measure, monitor and manage their sleep, to ultimately become aware before a possible relapse – as sleep acts as a prominent biomarker in bipolar patients.

Otoscope & Opthalmoscope (nominated in signs & symptoms category)

Developed by Cupris Health, it turns smartphones into medical devices using clip-on attachments which connect to a web-based service, allowing clinical information to be securely transmitted between healthcare practitioners and patients. The first two devices, the otoscope (for ear examinations) and the ophthalmoscope (for eye examinations), capture and securely store clinical images and patient data in the cloud for sharing between clinicians. 

Flowy (nominated for best R&D product)

This game digitally delivers breathing retraining, which is the oldest technique known to reduce anxiety. Six minutes of play is said to limit symptoms of anxiety and panic attacks. 

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