Biden Vs Faulkner, whose data is it any way.
Having a common enemy, a common ‘bad guy’ will always help a cause. A figurehead to rally against is one of the best motivators for the creation of a movement. Maybe in the last few weeks the Biden vs Faulkner showdown will be the catalyst for a new lease of life for the patient data movement. If the reports are true the Chief Executive of Epic; the Digital Health multinational may have ignited a new enthusiasm for patient data openness, by challenging Joe Bidden as to why on earth a patient would want access to their own data.
The conversation is said to have gone like this; Faulkner was amongst a group of healthcare executives gathered together to discuss with Biden the Cancer Moon-shot. The internet based magazine Politico reported that Faulkner raised questions about the utility of patients being given access to their own health records in a digital format.
“Why do you want your medical records? They’re a thousand pages of which you will understand 10,” she allegedly told Biden.
“None of your business why, I, the patient want access to my information,” Biden is said to have responded. “If I need to, I’ll find someone to explain them to me and, by the way, I will understand a whole lot more than you think I do!”
The culture of digital health organisations in the UK and Ireland has changed over the last decade so substantially that Faulkner’s comments sent many of us into shock. I distinctly remember arriving in Ireland and in 2014 and being asked to take part in a patient advocacy roundtable. At this event the gentleman who represented the Parkinson’s patients of Ireland towered over me and demanded that I, “… stop pussy footing around and get my data shared if it means that a cure can be found for this god-awful disease!” His premise was that if I didn’t he would and he wanted his information now, on a memory stick so that he could give it to an academic.
In the US we are told that the way the patient portal payment structure was created for meaningful use means that vendors were paid on a ‘log in attempt’ basis, this meant it was in the vendors interest to lodge a member of staff in waiting rooms and ‘help’ patients log in to their records, just the once. Pretty much taking the meaning of the phrase meaningful use and throwing it away.
We can also think back to the National Programme for IT in the UK and its version of patient access, HealthSpace, I can place a clear reason why that didn’t take off too, it was so very very hard to authenticate yourself before you could use the service. It required to visit a library with three forms of ID, to receive a letter with a PIN and then set up a significant password structure, the drop off rate before people got to view their records was huge, and understandably so. And yet here we are in 2017 with a new start up bank, N26, who have the technology to allow you to authenticate who you are with a camera on a mobile phone, from the safety of your own bedroom you can have a bank account up and running in eight minutes! Technology moves quickly and really does allow us to implement the digital health dreams we have.
So there are a few technology examples of Faulkner being right, well at least the technology not facilitating her being wrong! But, now glance over to Finland and Catalonia two regions that have proven the ideals that Biden has described for patient access to information to not just be the art of the possible but be actually here now, information in the hands of the patient and making a difference to the care being delivered.
The first time I heard the solution that Finland has created to this issue I was in awe; the work is a partnership with Microsoft and shows the innovation and ingenuity of the possible through partnership, clever thinking and a will to put the patient at the centre of what can be done. In Finland the national electronic health record is effectively a set of data that is mirrored to two windows. The first is the clinical EHR, the first place the clinician sees information about their patient, the second window is the patient version of the same, the key difference is the patient can add information to the record via their ‘window’. The patient can add free text or wearable gathered data or home held diagnostic information, the clinician can see this information and decide to add it to the clinical side of the record. The clinical governance of the information is still held with the clinician but the ability is now presented to the clinician for them to value the patient input to the record and move it over to their ‘window’ on the information, thus giving it the clinical validity it deserves.
Suddenly the comment made by Faulkner become even more ludicrous; the patient information is not only about them and owned by them but now has real clinically valid input into the care being prescribed and practiced, let’s not forget that this is the person Faulkner is worried won’t understand the information, they are now an author of some of the information.
The next success story here must be the amazing work that Tic-Salut have done across Catalonia in this area. They have created an eco-system throughout the region that has driven a new type of credibility to the delivery of patient access to information. The proliferation of health apps is huge; in Catalonia the market place for these apps to be released into has been created by the health system itself. An accredited app store for the healthcare system built to allow patients and clinicians to use health apps with confidence. Unique though to Catalonia is the arrangements put in place around the data that these apps can use. If you have an accredited health app one of the conditions is where the data is made available, not just within the app but in a secure, audited and protected way the data can be used within the health care systems own information systems. What Tic-Salut have done here is ensure that the lines between clinical data created by clinicians can be blurred with the data created or collected by the citizen and patient without overloading the clinical team with data, after all data is only useful when it becomes information.
Then we come to our own projects; in Ireland we have a decade long history of under investment in digital health to first get over to allow patients digital access to information, but, in Epilepsy we are seeing an almost immediate patient impact by having access to information. The patient portal trialled in the delivery of care for patients with Epilepsy has been a huge success for many reasons. First and foremost the portal and its functions have been co-designed by the patients and families themselves, the elements you can do with the portal are exactly what the patient wanted to be able to do. So viewing the clinical note is there as a function that has been seen as being useful but also the new ability to record a seizure, its severity and frequency and type has enabled a new paradigm in the delivery of care.
The ability for a patient to be significantly involved in reviews of medication efficacy through the capture of data has seen around 100 patients come off anti-epilepsy drugs since the portal has been introduced. I have championed digital solutions for the care of epilepsy since coming to Ireland in 2014, largely because of the passion that clinicians and patients, the careers and the special interest groups have shown for what can be done here. I hope that this light house on the art of the possible in Ireland can continue in to 2018.
In Ireland we have a plethora of digital health start-ups and new organisations. The Jinga Life team for me are delivering a solution that is a ‘light at the end of the tunnel’ for what can be done in Ireland. A design unlike any I have seen in healthcare, truly a delight to use and see. The concepts of Jinga Life is to concentrate on the key member of the family who is ‘tasked’ with the care organisation of the family. In their research over 90% of care is managed and organised by the female in the family. The Jinga Life portal allows the family member a tool to organise that care and to provide new data that can become clinical information to the clinician. Part of the success on the build of Jinga Life is its clinical and patient focus, definitely one to watch and one that I hope will show Faulkner yet again how wrong she is.
In the same week that Ireland launches its Open Data portal this data debate rages on, whose data is it anyway? Much can be discussed here but one thing we do know, its not the data of the digital vendors that are out there, and we need to seize back the ability to get at that data. A patient engaged, involved and aware of the information that is used for their care is a patient that can be part of the clinical delivery process, a patient empowered to help themselves.
In healthcare we have landed on the moon many times with small steps for man and giant leaps for mankind. Data is the next big Neil Armstrong moment for healthcare!
In 1853, Florence Nightingale started what we know today as the modern profession of nursing. Interestingly she also helped popularise the graphical presentation of statistical data. Was this the initial lunar landing for data in healthcare?
In 1895, Wilhelm Rontgen’s invention of the x-ray made a giant leap forward in the history of medicine. For the first time ever, the inner workings of the body could be made visible without having to cut into the flesh of a patient.
Another 40 years on in the late 1920s, Penicillin was discovered by Scottish scientist Alexander Fleming, revolutionising the medical treatment of infections.
If one were to ask Christian Bernard or Louis Washkansky, a 54-year-old grocer, suffering from diabetes and incurable heart disease if this 40 year cycle of giant leaps in healthcare are anything to go by and you will get a resounding yes. After all Bernard was to revolutionise the clinical consideration of the art of possible with the first ever heart transplant which benefited Mr. Washkansky who bravely stepped up as the first recipient in the world.
Bringing modern computing into the 40 year cycle of healthcare has been more of a challenge it would seem; advances in the home PC were transformational during the 80’s and 90’s in the way we live our lives and transact our work and yet are still heading towards that same exponential change for healthcare.
40 years on brings us to today [and the next few years]. We are ready for the next small step for man and giant leap in healthcare. In today’s modern healthcare system we continue to have incremental improvements and technological advances that have measurable benefits to society, bringing us into a healthier state. But it is data and its use that will bring about the next giant leap forward.
The use of data is on the brink of taking electronic medical records, genetic information, and wearable data and transforming it into information that will support decision making and the development of new technologies that will change the way we care for our patients.
Here in Ireland we speak about our ‘grand ambition’ to allow the patient to truly control their health data by 2020.
Subra Suresh, president of Carnegie Mellon University, says with the use of information and data; “we will move from reactive care to immediate, proactive prevention and remediation, from experience-based medicine to evidence-based medicine, and to augment disease-centred models with patient-centred models.”
Imagine a time when a graduate doctor will not only have the six years medical training and their immediate supervisor’s knowledge at their disposal to treat a patient but the capabilities from millions of lines of data to support diagnostic decision making, the art of the possible with the phenomenon we call cognitive computing. The transformation of the data to information will provide suggested diagnosis based on test results, information gleaned from the patient but may also prompt further questions or tests that might aid in a refined diagnosis.
Imagine a time where a patient can provide a full medical history to any healthcare practitioner across the globe by simply allowing access to their health record stored in the cloud. Where a patient can see who has viewed and added to their record anywhere and at any time.
We don’t need to imagine these scenarios, early adopters are already realising the bright future data is providing in healthcare.
Kaiser Permanente has fully implemented a new computer system, HealthConnect, to ensure data exchange across all medical facilities and promote the use of electronic health records. The integrated system has improved outcomes in cardiovascular disease and achieved an estimated $1 billion in savings from reduced consultations and lab tests.
Blue Shield of California, in partnership with NantHealth, is improving healthcare delivery and patient outcomes by developing an integrated technology system that will allow doctors, hospitals, and health planers to deliver evidence-based care that is more coordinated and personalised. This will help improve performance in a number of areas, including prevention and care coordination. (The big-data revolution in US health care: Accelerating value and innovation Basel Kayyali and David Knott. http://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/the-big-data-revolution-in-us-health-care )
The future is bright and the future of healthcare is data. The future of patient care in Ireland is certainly bright as we develop Information Services and the eHealthIreland structures to truly turn data in the system into information that can, with care be used to change the way in which care is delivered to the patient and the population of Ireland.
To be able to start an evolution is quite an exciting prospect. In my last role (Clinical Research in the NHS) we knew we had to move to an environment where data was considered to be open due to policy, legislation and for the transparency that the industry wanted to achieve. Here in Ireland there is a move from a legislative point of view to open data however the value of a truly open data environment is only just beginning to really catch on.
I still hold with the fact that open data benefits patients, if a patient wants to be able to get at their own information they absolutely should be able to. Getting there is fraught with risk to any delivery project though. Access controls are not easy to implement, data ‘ownership’ needs to be resolved and the method of access needs to be considered. However all of these elements that we must find a solution to in Ireland if we are to move to a situation where we can share digital clinical records!
The value of open data to the patient though in a world where the internet of things is becoming a permanent feature and the wearable healthcare device more and more prevalent is significant. We are trying to imagine a world where the patient is able to apply their own self recorded information to their record so why would we not consider that the patient should be able to take the information the health service has about them and apply this to their own health and wellbeing tools.
A colleague came to see me recently about a new projects and we got on to the subject of wearables, her partner had been given a Fitbit for his 45th birthday, he had started running and competing with a couple of his colleagues, the gamification of health and wellbeing in true action. However she was quite worried as this chap had gone from a standing start to running 5k plus 4 times a week, no health checks just a competition with his colleagues. If we had open data for this chap could he apply his clinical information to his Fitbit type record and get some analytics based advice on how much he should run, how quick and how frequently rather than simply turning his health into a competition that could have dire consequences.
Open data that is aggregate information, that doesn’t identify the patient, but can be used to analyse the health delivery of a country is also of huge potential. Two areas spring to mind, the ability to support new innovations in the analytical space where the delivery function has information is a rich vein that Ireland ought to be able to tap into in the same way as the NHS has done. By providing information in an open and transparent manner new fast thinking and bright organisations will be able to do way more with the data than the large health care providers can, and this will add to the delivery capability of health and improve the Intellectual Property of the nation, truly health and wealth.
The other area we are looking into is anonymised patient experience data. Not just social media although symptom analysis of Twitter for some hospitals is really beginning to deliver benefits. More simply a tool known as ‘Happy or Not’ is being piloted in the Irish healthcare system. It is a simple solution in that a patient can tap the happy or unhappy face on a unit in prominent parts of a major hospital. This data can then openly be made available to the public and the healthcare system to enable the diagnosis of difficult times in hospital or to allow decisions about where to go for care, this kind of transparency and openness is a big business change but the benefits to the patient are starting to outweigh the difficulty in getting there.
The data for mapping where power lines are in Ireland is open data, a data set that we have taken and applied to one of the modules within the Health Atlas, why? Well if we are flying doctors into a RTA or a remote area to assist with a heart attack then this data becomes essential. Flying doctors with maps adds to efficiency and safety and is largely based on open data sources.
As the patient becomes less suspicious of digital health platforms we envisage the openness of health data to grow and grow. Take the Babylon health solution and the change in acceptance of where the patient data is. Patients in Ireland can now pay a small fee and have a ‘FaceTime’ consultation with a clinician at a time that is convenient to them, in a space that doesn’t fill up an A&E that is at capacity and with an outcome that is right for the patient.
This kind of attitude change can only enhance our journey to being able to use data in an open and responsible way for the good of health delivery and the safety of patients.
Originally published at – http://businessvalueexchange.com/blog/2015/07/27/open-data-for-a-new-healthcare-it-system/
Every modern healthcare system professes to use and need data analytics to provide care for patients. The acceptance and use of data and tools to support this is different dependent on geography and culture. Conversations with healthcare providers in Russia, Europe and the US in recent months have enabled a magnifying glass to be applied to these differences. What these differences reveal is that there could be a model that breaks down the known issues relating to healthcare provision through ‘magnificent use’ of information and that this can be learnt through an understanding of geographic or cultural differences to enable a data rich healthcare system based on access to information that delivers insight.
The promise of data to support healthcare and clinical research is here. The European Commission believes that the mobile health market alone will reach a value of $6.9 billion by 2017. Imagine the data and the controls required to manage a market that buoyant. Also consider the data asset that the penetration of technology will bring and the disruptive improvement to healthcare.
However let us not let the obvious go unnoticed. The inefficiencies of two ‘IT Worlds’ become obvious at the interface between them. Inefficiencies between lifesciences delivery and care provision supported by information systems that have seen significant investment are quite profound, wherever you apply the magnifying glass. And the problem will become more impactful without a disruption that is the catalyst for a collaborative response across several care settings.
Countries, clinical research organisations and the life science industries all have a desire to change how they deliver clinical research. Each day that a drug is delayed from entering the market sponsors lose up to $8m1. Data collected comparing Europe wide statistics to the US puts only 18% of trials in Europe achieving time and target whilst in the US it is just 7%2. Everyday that a new drug is not on the market is another day that a person with an illness can not access the new innovative cure or drug that will ease the illness.
Take the sheer size of the diabetes population. There are 283 million people with diabetes, which makes diabetes the third most populous country in the world!3 In 2012 there were 212 new diabetes drugs in development4, innovations that with the right environment to trial are trying to expand treatment options that improve quality of life and provide value for money.
What does history tell us?
Healthcare professionals and business intelligence experts that were part of the conversations in the development of this piece from Russia have an eye on the NHS in England as an example of how to make this work. From an NHS perspective this concept probably makes the UK professional stop and think more carefully about the current situation within the NHS. It is, let’s face it, perceived to be controversial from inside the UK. The NHS has a cradle to grave clinical record. A healthcare system that is free at the point of care, and a system that the UK NHS should be proud of. It may not quite be a digital system and in recent times it has been portrayed as controversial in its approach; however it is the envy of other countries that would thrive on the opportunity to have the level of data available. Yet for many reasons the NHS is still to activate this asset to its full potential, which is something that the Russian participants in this research look at with incredulity.
The NHS is there for all to see, how it is structured, its coverage of the UK and its sheer size and volume. It has a rich history from which lessons can be learned in relation to information systems and access to data, and many organisations are looking here to understand how to do it. The NHS understands what its data asset is, but is still not quite able to release the asset appropriately.
The Russian perspective, they made clear, is very much based on culture and how their system has evolved over time. Perhaps the easiest way to illustrate this is to initially remove the healthcare element. Deploying business intelligence capability into Russian business arenas has been met with resistance. Whilst perhaps something of a stereotype, the average Russian business does not expect to have open data in any form, and would not expect to share business intelligence capability across the organisation, unlike in the UK and US where concepts of business intelligence have moved so close to open data initiatives that they often fall under the same executive responsibility. Therefore the application of business intelligence into the Russian environment initially met with resistance. This was until the implementers realised the ‘sales pitch’ for business intelligence should be to make it clear to the ‘coal face’ worker that access to data would help them do a better job for the good of their position.
With this in mind a conversation with healthcare professionals about how they share information with clinicians about patients with a specific focus on clinical research was enlightening. The starting point for research data in Russia is that if it is research that can be applied to the Russian healthcare economy then information would and should be provided freely based on the clinician’s approval. A patient could opt out, by talking to the specific clinician who was providing the information. However it would be a clinician- based decision that would be related to the healthcare outcome rather than the patient’s wishes.
Patients in Russia are said to be aware of research opportunities but are not likely to drive access to such research; this will often be prompted by the clinician. Quite a different model to other countries, which are moving to consent based models driven by patients.
Industrial leadership, societal challenges and excellent science are the three key headlines for EU wide prioritisation of research. The 2020 programme within Europe is not disease centric; it has a goal of integrating research innovation into the care pathway and tries to ensure that the impact on the participant from an information point of view is kept to a minimum. However, the European programme is not about utilising any single data source or standard, it is about the integration and innovation of systems at the centre of care provision. Adopting the European 2020 approach however is a political decision that each country considers and interprets in a slightly different way. This European goal has an additional priority of international cooperation. Understanding why international collaboration has not yet been successful pan-EU or indeed between the UK and the US was also considered during the creation of this piece.
Delivery of care and access to clinical research from the patient perspective is different in each of the countries considered here. However the parallel industry- centric growth in IT and the delivery of trials is clear and yet significant benefit is still to be released. It is reported that over 40% of clinical trial data is entered into a health record or Electronic Data Capture (EDC) system of some type5, 57% of R&D spend is within clinical development and in some countries clinical records have been digitised to cover 90% of the population, and yet there is no real solution to make linkages in a seamless fashion that exploits technology and standards.
A suggested move to data citation when delivering clinical research could be a route to try to bring about an additional data standards based revolution without creating a rule book. If this were made a part of the pathway from a clinical trial then this could change thinking to such a degree that the barriers to the use of this technology asset could begin to be removed.
A revolution in waiting
The difference between countries is striking. The European 2020 programme is about putting the patient at the centre of any trial with information ‘floating’ out, whereas the Russian model appears, on initial analysis, to be about the excellence of the clinical researcher and supporting that learning with an outcome that can be applied locally. The model in the UK is about facilitating research conducted by the NHS as professionally and with as high a quality outcome as possible. In the US, the model seemed to be more akin to a hunting analogy. Researchers and scientists at the National Institute for Health in the US discussed how their current programmes of work are geared towards early stage research, before the patient is involved, the testing of ‘failed’ compounds to understand what failed means and where success may be grabbed from the jaws of failure.
European time to grant to be no more than eight months is the desire described by the senior team at the EHR4CR collaboration in Brussels in the first quarter of 2014. The median time taken from ethics approval to an NHS organisation having permission to run a trial and being open for recruitment was 21 days in quarter three of last year in the NHS. The focus on set-up times is bringing rewarding outcomes across EU countries.
General legal and ethical issues around the reuse of data for clinical research remain an issue for many countries worldwide. The World Health Organization Global eHealth Observatory survey in 2009 contained five legal questions. The questions were very general due to the nature of the audience, however the output indicated concerns around the legality of consent to take part in research and how it should be collected.
In Europe we are obliged to gain consent and apply it to the access of patient information; we treat this as one of the most important elements of the research pathway and yet this is probably the single largest barrier to the resolution of the problem. The need to ensure the patient has consented, record the consent, make it easy to change the consent, and the ability to access the information of the consented is the ‘golden fleece’ for clinical research.
At EHR4CR a change to the approach to data was suggested: to change the approach to be about who makes use of the information rather than who owns it. This was compared to the aboriginal concept of land ownership. Those that make use of it have control of it; they must take care of it and protect it at all times and if it is not useful to them they must, with permission, hand it to the next person who can make use of it. It’s a nice theory and may well be acceptable to the researcher and participant if a trust in this care could be built and applied, but the change to legislation, and global attitudes, would have to be significant to enable this to work.
Competing with the EU revolution: the US approach
Moving analysis to the US and its approach to the access of clinical information for the provision of care and clinical research provides an indication of even more differences, barriers and opportunities. In the US, data is without doubt an asset that is so prolific it is almost tangible. Organisations from tech start-ups through to large behemoth sized consultancies profess to be delivering something new, something that can revolutionise care at the point where the patient is directly impacted.
Data in the US has been collected for over 30 years based on inputs and outcomes. The concept of public and open data exists and yet until recently perhaps had not been latched upon. The expertise that exists in the technology market in the US is astounding and is starting to release benefits into the care pathway, often without the same consideration for privacy that certainly exists in the UK. This exposure of data is often from open data and the application of big data solutions that enable data linkage that generates insight.
Attitudes to the delivery of clinical research in the US are a key difference noted during the preparation of this article. In the UK a large proportion of clinicians are willing and able to deliver clinical research when their institution or patient asks, however in the US there appears to be a reluctance to take part in clinical research unless that is the role you have chosen. Whilst the number of open global trials is said to be increasing, the number of clinicians that consider research part of the ‘day job’ is decreasing and more so in the US. When asked why, several researchers cited a fear of the unknown and the quantification of the risk factor for them and their patients. A survey conducted by the Duke University in Durham, North Carolina, observed that patients taking part in a trial still consider themselves the equivalent of a guinea pig.
Despite the attitudes, and to some degree the missed chances to use the commercial care model to fuel the research model in the US, there is a success to be understood. The success is two-fold: the NIH who focus on the delivery of academic clinical research and who are starting to build infrastructure to be able to make use of each data set as it becomes available and Clinical Research Organisations (CRO) have realised that the data they have and the data they can get hold of is as strong an asset to them as a commercial relationship. Indeed several CROs are beginning to market themselves as data organisations. Will the CRO be the way that the global need to enable clinical research can reach a position where standardisation of systems is possible? If it is, it will be at a pound and dollar cost; CROs are after all commercial organisations, and yet it will be for the good of research delivery globally and will achieve a standardisation of sorts, even if that is driven to some degree by market forces.
What the world needs
There is a lot to learn from each other: large pharmaceutical companies are beginning to come together and share data and experiences. Europe has the EHR4CR group where nations are starting to share how to make the environment work, and yet there is still much to do. Delivery of high quality clinical research to a timescale and quantity required can be achieved through the use of analytics to support delivery. There are a number of different ways in which this can be achieved; in an ideal world all parties would work together and wherever the opportunity presents itself we will try to do just that.
References – 1. Beasley ‘Recruiting’ 2008. 2. State of the Clinical Trials Industry: A Sourcebook of Charts and Statistics, Centre Watch, 2008. 3. EHR4CR Conference – Brussels 2014. 4. PhRMA 2012 – profile of the pharmaceutical industry. 5. Integrating Electronic Health Records and Clinical Trials: An examination of Pragmatic issues. Michael Kahn, University of Colorado.
Bryony Walsh is a project manager at the NIHR CRN, she has volunteered her perspective of what it is like to do this role in our organisation and how no day is an average day…
My time as a Project manager at the NIHR CRN will always vary enormously depending on our current priorities. There isn’t really such a thing as a ‘typical day’, every day is very different. That’s one reason why I enjoy the role so much!
One thing that is consistent however is that every day starts with working through a batch of seemingly never ending emails that have managed to squeeze themselves into your inbox since last time you looked, (On the plus side, Fridays email battle will always be accompanied by a pain au chocolat or a croissant!).
I project manage the Open Data Platform (a way to bring data sets together enabling users to interact with the data), The App Centre (a single point of access for solutions which support research) and the Reference Data Service (a service establishing consistency across all NIHR CRN systems). Being able to deliver, navigate and progress through these projects is an interesting and worthwhile challenge of every day.
Our work encourages us to bring along creative thinking. There isn’t always an obvious solution; we frequently have to think out of the box. We need to be driven and innovative, and have a positive can do attitude. As project managers we spend a lot of time being pulled in lots of directions, we are here to work collaboratively though. We need to try and figure out what to do next despite often high amounts of uncertainty. However, if at any point it gets too much; you always know you can raid the CIO’s office, which is more like a tuck shop, for a Cadburys crème egg or a fig roll!
Finishing a piece of work is always very rewarding but there is always another challenge just around the corner so it’s important to be highly adaptive. An example, my recent activities have varied from reviewing and producing lessons learnt on a recent project to being filmed for a communications video to making a 1950’s computer out of a cardboard box, it’s important to acknowledge that the challenges and obstacles we face will vary every day. This keeps you on your toes and makes every day motivating and interesting!
I would describe us as working in an open culture; it is a very friendly and respectful environment. The way of working is very inclusive with everyone involved in the decision making, which is very empowering and something that appeals to me about our organisation.
Our organisation enables you to have a good work/life balance. Recently 15 of us from across the organisation, entered into a Triathlon. We would like to do it again next year if we can get enough volunteers! We also hold ‘lunch and learns’, numerous coffee mornings and Christmas parties giving us the opportunity to get to know those people (who you don’t necessarily sit with) better. This helps us all work together towards a common goal and even have fun along the way.
Our team is made up of likeminded people who come to work to make a difference. They believe in what they are doing and are passionate about making a change. It is encouraging and rewarding to work in an environment of supportive and positive people.
The professional development aspect at the NIHR CRN is excellent. We are supported by training courses, mentoring and (in my personal opinion) the most useful style of development which is ‘being thrown in at the deep end’. We are given opportunities to push ourselves to our professional limits, whilst always knowing that support is there. I have been fortunate enough to have been given valuable opportunities to present to large numbers of people, something that when I first started here 18months ago would have terrified me. Now I find the experience both rewarding and exhilarating and thrive on the task.
I would say that we work in an intellectually challenging environment, but one that presents fantastic opportunities. You are rewarded by the benefits you are adding which make the delivery a satisfaction. In addition, being aware that we are delivering something that will make a real difference, you do get a genuine feeling that you are creating to the greater good.
See moe from Bryony at – Bryony Walsh
I look forward to the list of expectatons and predictions for 2014 coming out in the different press outlets, what books, films and music will we all fall for in 2014. But even more importantly for us as we move to 2014 is to do a little horizon scanning of what ‘elements’ will impact on the role we are here to support delivery of in 2014, and if we can how do we get ready for it.
New technology innovations have been spoken about a great deal in the run up to the turn of the New Year. Light weight curved glass, drone delivery of internet shopping and the digital currency revolution to name but three that have hit the press as exciting innovations for 2014, but more importantly for us is to consider what innovations in clinical provision and research do we need to build capacity, capability and systems to support.
A subject that has been hitting the news in December and January is how do we stop the march towards antibiotic immunity, most importantly for us is what does a research programme look like that can deliver solutions for this problem. My simple technology response to this is to speed up access to data for researchers to find new innovative ways that, with the patient consent in place, information can become derived from the point of care or directly from the patient. Without the veracity of information and an easy way for patients to provide consent this problem will be difficult to conduct research into it and therefore is a problem we need to consider offering help to resolve. Providing tools and standards to the research networks to help support this is a key consideration for 2014.
The next most talked about innovation in clinical research is the arrival of stratified medicine. Stratified medicine describes an approach in which specific clinical characteristics are used to predict therapeutic response, allowing delivery of the most effective and safe treatment pathway for patients.
For research this means looking at large groups of patients to try and find ways of predicting which treatments they are likely to respond to. It involves looking in detail at disease areas and their genetic make up. Researchers want to find out if some treatments are more likely to work in specific diseases and what particular changes to the patients genes disease and treatment brings about.
This is one step towards something referred to as personalised medicine. Personalised medicine uses genetic and other information to diagnose and treat disease. Once we have carried out research with large groups of patients, we may be able to predict response to treatments. Then we hope we will be able to tailor treatment very precisely to an individual person’s illness. The compute power to research this area is significant, projects like those being developed by Genomics England will lead the way in 2014 and will be at the forefront of releasing benefits to patients, the NHS and Life Sciences Industry to ensure that personalised medicine can be made an efficient reality. Our organisation has a role in delivering this type of research, ensuring that the appropriate researchers are available to offer their skills in this area and wherever possible offering tools to help manage the delivery of this portfolio of research delivery.
The trend for opening up data continues to be pushed across the digital world. The Life Sciences industry is keen to follow this example where ever it is safe and appropriate to do so.
Whilst obviously a controversial figure Julian Assange referenced two key principles to opening up data in a recent interview for Eric Schmidt and Jared Cohen’s book The New Digital Age. Firstly he states that human civilisation is built upon our complete intellectual record; thus the record should be as large as possible to shape our time and inform the future. Secondly he goes on to say, because different elements could seek to pervert the truth it is in everyone’s best interest to get as much information as possible into an open record that is accessible and searchable for all. In the last year we have taken great strides in opening up and linking the data we have as a networked organisation, enabling the networks to have access to a wider information set and therefore meet both of the principles above. In 2014 the challenge will be in the opening up of appropriate data to a wider audience, providing the necessary checks and balances in doing so and ensuring the appropriate use of it
Sharing our information is linked to the principles of open data but is subtly different for us. Sharing meta data or reference data is a piece of work that has been started in 2013 and will come to fruition in 2014. The delivery of services that share appropriate meta data about clinical research in England will further smooth the path to setting up research in England, facilitating smooth contact points with the life sciences industry and ensuring that data quality is improved across the global economy.
What else is on the horizon, the leap forward in operational systems and their capability is clear across our organisation, the business change this will enable is less clear but we have the understanding of what we want to get to and the right resource in place to react positively to change. I always said that Information Technology and Systems ought to be the stabilising agent to change rather than the catalyst for it, but, innovation in 2014 looks more and more likely to be the catalyst and the agent, and that innovation will ask new questions of us that we must be able to answer.
2014 is looking like another exciting year.
I have been asked to present at a summit of CIOs (http://www.ciouksummit.com/) later this week on the subject above and therefore thought it would be of use, and hopefully of interest to get some of the ideas down on here.
What our organisation needs is the ability to provide interoperable systems, link legacy systems to new shiny systems, and utilise open data standards and capabilities. We have tried to use that word open in a different way by opening up our data to information managers across the research eco-system, allowing them to create open queries that can be shared across the organisation, and therefore providing the catalyst for service improvement.
For those that visit here often you will know something about the systems we are deploying and the legacy we are trying to improve upon, but for new readers and to allow us to take stock of where we are I wanted to try to gather my thoughts on where we are going and what we are starting to achieve.
First a note, this is not an advert for our suppliers, we have however gathered a selection of suppliers around our delivery that are today helping us to make a difference. We have a strategy of not having an enterprise wide supplier and trying to seek out the best systems for each need we have. Our critical infrastructure is a mixture of Oracle and Microsoft and recent additions of Linux, which whilst giving the infrastructure team a headache it does mean we have the most appropriate solution for each of our systems.
We have effectively created our own private cloud solution that is scaled appropriately, it is not the size and capability of going to Amazon or Google but provides us what we need and allows our hosts the University of Leeds to provide a high level of support to the business and provides our system suppliers the ability to deploy systems on to our own infrastructure.
The information systems themselves are a series of integrated modules rather than one solution size that fits all. The entry point into our systems is a solution known as CSP. This is a bespoke system using Oracle platforms. As a solution it provides workflow and reporting support to the NHS as it works through the process of achieving permission to deliver clinical research at a local level. However there is no way we could describe CSP as ‘cutting edge’, when it was built the horrible phrase bleeding edge probably applied as the team tried to shoe horn the most benefit out of new Oracle sub systems, whereas now, two years later, it delivers what it needs to but doesn’t utilise all of the possibilities of the infrastructure it is landed upon.
The next module along the work flow is our new Central Portfolio Management System (CPMS). CPMS acts a central spine for all data collected about clinical research, it has work flow elements integrated to CSP and our other sub systems and will, once live in late January, be the central system for performance management data of clinical research. It is this system that we are changing our Information Systems strategy around, changing users into fans and ensuring that we achieve an organisation that can make the most of its data and the volume of capable users.
Underpinning these two systems is the Reference Data Service (RDS). The RDS is a simple idea realised, the ability to master and expose reference data relating to clinical research in the UK. What has been fascinating about the development of the RDS though has been the external interest in having system to system access to it. This is an interest that has caught us all on the hop a little but one that we can satisfy through the industrialisation of the RDS. Having large organisations from the Life Sciences industry building connectors to the RDS so that they can consume data about structures of the NHS, researchers, resources and even the UK terminology will make it easier for research to be done in the UK, making this truly ‘cutting edge’ in our world.
The system that started us on the path to innovation and the one we pin any conversations about ‘cutting edge’ development and the ‘open organisation’ to the most is the Open Data Platform (ODP). ODP is a series of Apps available from the new NIHR CRN App Centre, the apps associated to ODP are those that allow varying levels of access to the information we collect and enable the user to apply business intelligence tools to the data to develop insight that is gathered from the information we hold.
The infrastructure in place for the ODP enables the organisation to utilise a dispersed capability to develop new apps that can then be used across the UK, delivering specific data based insight into research and enabling the work force to build solutions that meet needs as quickly as the technology can be adopted.
The App Centre itself will, in 2014, become the front door to the tools the organisation has deployed and enable SMEs involved in research in the UK to surface their innovations to clinical researchers, business intelligence leads and perhaps most importantly public and patients interested in clinical research.
A development in pilot today is the ability to surface disease specific trials directly into clinical systems and disease pathways within these systems. Doing this will prompt and enable the clinician to offer access to the clinical trial at the point of care directly to the patient, in theory this will enable a change to the landscape of access to clinical trials, the pilot will provide us with the evidence and therefore the impetus to do this across a wider care setting.
We are becoming an open organisation through the systems we have developed and how they facilitate a change to our culture, information systems are a facilitator or supporting agent to culture change, if they are the catalysts then I would not be sure that they will become imbedded in our business. Information Systems shouldn’t be the reason for cultural change to occur, becoming an open organisation is the need of the organisation, the innovation of systems merely facilities this being possible.
The speed we build and adopt new systems has improved significantly over the last two years and that enables the reaction times of the organisation to adopt new technology where there is an identified business need that brings about an improvement to the service we offer, in other words business led change using technology to adopt change at speed.
Exactly where we want to be!
Security and research information is a hot topic right now for a number of reasons, not least the transparency agenda and the desire, quite rightly, to be as open as possible about data relating to the conditions and outcomes of clinical trials. However the information security of research data more generally has always been an area that is difficult to quantify. Go back to the excellent ‘The Cuckoo’s Egg’ by Cliff Stoll and there is debate regarding the perceived value of research data:
“… our data was either worth nothing or zillions of dollars. How much is the structure of an enzyme worth? What’s the value of a high temperature super conductor? The FBI thought in terms of bank embezzlement; we lived in a world of research.”
Clinical research is big business. Nations and companies compete to be first to deliver new drugs and treatments to patents. This means the security of clinical research data is under pressure, particularly when juxtaposed with the transparency agenda and our desire to open data up as much as we can to facilitate improved performance through insight derived from information.
But what is open data? The comedy answer is that it is data that is open! But it is as simple as that for our organisation and, I believe, for clinical research data generally. We need to transform the power of open data to make it useful. We need to make open data valuable, to do this we need to show the value that open data creates.
Open data, to our organisation is:
“…data that can be made use of by anyone within the organisation through analysis, linkages, and evidence based delivery.”
So, many will say not really open at all then, as we are limiting access to the detailed elements of information to within the clinical research organisation. But, even that is far more open than we have been able to orchestrate in the past and is a starting point for how we begin to open up appropriate information.
Compared to two years ago we have made great strides forward in our ability to be more transparent. For example, apps to enable the public to see what research is underway in the NHS and systems to enable the life sciences industry to track their study throughout the NHS.
The definition of protecting open data stretches beyond the definition of information security. The easiest way to understand how to protect the open data is to break down the principles of what impacts on it:
Content: The what – Information relating to the performance of a clinical trial in the NHS, the resources it uses, the resource it requires and the content of the trial.
Scope: The why – To enable insight from data through the linkage to other data and through the exposure, via business intelligence tools that enable information to be delivered to decision makers.
Policing: The rules – Data relating to competing industry partners shall not be made available other than in aggregate form. Data linkages to other data sources both within the organisation and open data sources can be done by those within the organisation.
Stakeholders: The who – Only bona fide individuals from within the organisation shall have access to the full data set. Decisions to open up further will be taken in conjunction with all stakeholders.
Lifespan: The when – As near real time as possible and clearly identified at the point in time it is from.
Now these key principles are known, defined and agreed across the business it becomes much easier to then create matching key principles for securing and governing the open data:
Managing the re-use of data. This becomes more important with open data. As the authoring organisation, there is a need to know, and to some degree control, where data is re-used, particularly where data linkages are possible. The implications of reputational damage from the reuse of data need to be managed and the owner or author of open data always needs to be maintained so that data can be traced back to the originator.
Corporate responsibility for the delivery of open data and the governance of it is done through the policing of a code of conduct for the use of data. Enforcing outcomes due to the result of non-compliance becomes a corporate responsibility. The outcome though, needs to be commensurate with the non-compliance, so the removal of a licence to use the open data could be a balanced measure to misuse.
Triggers for the review of the open nature of the data also need to be in place. An external review of data, maybe even an organisation-wide audit can enhance the definition of open data and the trust in this. As an organisation the NHS has an Information Governance review each year, which we now comply with as an organisation and as we further enhance our definition of open data we will audit our own open data policies and procedures.
An area of great care that has to be considered is ‘small numbers’. Can linking open data in small numbers break confidentiality and expose identifiers that should remain secure? A policy on the opening up of data relating to ‘small numbers’ has to be created and adhered to.
The veracity of open data, the speed at which open data is created and linked to other data sources needs to be managed and governed. The data that we open up has quickly become a big data set, which requires additional policies and procedures to protect it.
The design of open data security can make or break its implementation. Even the word ‘open’ can cause some issues and certainly there is a nervousness around the concepts of opening up data in any industry, which is why great care needs to be taken to demonstrate the business benefits and clearly communicate the checks and measures in place.
For our organisation the business benefits of a secured open data solution are:
By releasing these benefits the value of open data becomes apparent and the checks and measures in place allow a wider audience to be considered for access to the data. Open data needs to be actionable but also beautiful and simple. Open data creates the power to disrupt, improve and make the world a better place and makes research easier to complete, more quickly, more successfully and at a lower cost.
An expert in the field recently said to me that he was fond of a clinical research ‘reverse adage’, “A month in the lab can save 30 minutes in the library,” he had a recent version of this he shared, “A years worth of a clinical trial can save a day analysing data!”.
Did you know that the ‘father’ of Epidemiology also created Data Visualisation as we know it today. As we move towards our own “AppCentre” being live and the creation of more Apps within ODP that allow new and exciting insights to be possible from our data, I wanted to share with you an event that is often seen as being the catalyst for the need to understand how data can be visualised to answer questions and how intelligence should always be the reason for collecting data.
In the mid-19th century, the Soho district of London had a serious problem with filth due to the large influx of people and a lack of proper sanitary services: the London sewer system had not reached Soho. Many cellars had cesspools of night soil underneath their floorboards. Since the cesspools were overrunning, the London government decided to dump the waste into the River Thames. This action contaminated the water supply, leading to a cholera outbreak.
On 31 August 1854, after several other outbreaks had occurred elsewhere in the city, a major outbreak of cholera struck Soho. Over the next three days 127 people on or near Broad Street died. In the next week, three quarters of the residents had fled the area. By 10 September, 500 people had died and the mortality rate was 12.8% in some parts of the city. By the end of the outbreak, 616 people had died.
This outbreak is best known for the physician John Snow’s study of it and his discovery that cholera is spread through contaminated water. John Snow was a sceptic of the then dominant miasma theory that stated that diseases such as cholera or the Black Death were caused by pollution.
By talking to local residents, Snow identified the source of the outbreak as the public water pump on Broad Street. Snow took his evidence in the form of data lists to the London government to ask them to remove the handle from the pump, thus closing it down and disrupting the link to the spread of the disease. The government of the time did not believe Snow’s data and were wedded to the idea that the illness was spread through the air. Snow was convinced he was correct, so he considered how to portray the data differently.
He decided to use a spot map to illustrate how cases of cholera were centred on the pump. He also made a solid use of statistics to illustrate the connection between the quality of the source of water and cholera cases. Snow’s efforts to connect the incidence of cholera with potential geographic sources centred on creating what is now known as a Voronoi diagram. He mapped out the locations of individual water pumps and generated cells which represented all the points on his map which were closest to each pump.
Snow’s study was a major event in the history of public health and health geography and influenced public health and the construction of improved sanitation facilities beginning in the 19th century. This can be regarded as the founding event of the science of epidemiology.
As we move towards the “AppCentre” being live and populated with new ways of looking at data to create insight I thought it would be useful to reflect on the beginnings of Data Visualisation and Business Intelligence and use this famous “case study” to elaborate on how new ways of answering questions can prompt new exciting questions that can evolve how we will work and deliver.
Our Open Data Platform and AppCentre are built on QlikView technology, a solution that enables us to gain insight from the linkage of big data sets and the visualisation of these.
The National Institute for Health Research is charged with improving the health and wealth of the nation through clinical research. That’s no small task, and cutting edge Information Systems are key to achieving it. Not only do we need systems that reinforce the NIHR’s position as the most integrated health research system in the world, we also need to embrace concepts such as Big Data and Open Data – ideas capable of making “UK plc” the destination of choice for running commercial clinical research studies. But how do we make sure we make the right choices, and what does this mean on a day-to-day level, and how on earth do we secure all that data?
Innovation in information systems has been pushed hard at the health economy in recent times, with only some success. The average nurse on the ward is bored of being promised something new that will make life easier, so this time we have to deliver. Six and a half thousand NHS staff are involved in research activity, so the challenges include how to help these people to collaborate, how to avoid duplicating work, and how to ensure that conducting research at the point of care is as easy as it possibly can be whilst being secure and of a high quality.
Our role is to make the NHS accessible to researchers, but what is the first thing we need to do with Information Systems to do this? When we ask that question, we are told: simplify them, make them faster, make them bigger, make them more secure, make them portable. So are we innovators or prioritisers?
In the last five years, the number of participants involved in research in England has trebled, and the systems we deploy need to handle growth of data at such an exponential rate. However,data in itself is not enough. We also need to transform data into information, and then create the means to gather insight from that information. This is now a demand of the researcher, but also the research participant. Tell me what my involvement in research has achieved, is now a legitimate question that anyone conducting research needs to answer, and therefore we need to provide systems to facilitate it.
Does this lead us towards a massive corporate strategic infrastructure, one big solution for lots of needs and problems? Emphatically, no. What we need is the ability to provide interoperable systems, link legacy systems to new shiny systems, and utilise open data standards. We have tried to use that word “open” in a different way by opening up our data to information managers across the NHS, allowing them to create open queries that can be shared across the organisation, and providing to the catalyst for service improvement. So far it’s working!
…. but the next challenge is how to secure open data, what do we need to do with it and how open is it really… All questions we will start to answer over next six months.
Thanks for reading, if you want to know more get in touch or follow me @r1chardatron.