“Beloved actor Robin Williams was found dead on Monday, police reported. He was 63.
According to his publicist, Williams had been battling severe depression.” (Huffington Post, August 11th)
As a teen, we’d all seen Dead Poet’s Society in which he played inspirational teacher, John Keating. We didn’t just watch it. We felt it. “Oh Captain, my Captain.” It was a film which allowed us as teens to discuss suicide. He taught us something of self expression, through fiction. He inspired us to indeed, seize the day. Carpe Diem. We felt his awkward authenticity. Or perhaps, his real-life authentic awkwardness. He had to manage his mental health publicly. There were occasions when you could see through the exterior, and see how hard that was.
One of my favourite of his films, is Good Will Hunting. Whilst cliched fiction, I have always enjoyed the park scene, in response to the boat painting discussion in which Will (Matt Damon) disrespectfully hits raw notes in Sean’s (the role played by Williams ) life. Matt Damon’s character hits out at criticism of his chosen path in life and avoiding the expectations of others. He counters, “At least I won’t be unoriginal.” That is perhaps a comic’s greatest fear.
Whilst playing a psychologist, and asking his client to open up, Williams manages to do the same for himself on the screen. He somehow touches a genuineness in that role, perhaps revealing an ability for self-examination which not all of us possess. Whilst playing a character, I believe in that role we see much of what it meant to him being authentic as an actor and as a human being. He discusses the value and need we have of revealing who we really are. The importance of being oneself. And the grit of authentic experience. Comics are famous for being less than happy on the inside. Extrovert exteriors can be used to mask the inner storms and insecure introvert.
We, Joe Public outsiders, will never know the real Robin Williams, but I believe this WTF radio interview with Marc Maron captured some of the authentic him, from 2010.
It comes with a ‘bad language’ warning if the title doesn’t give it away (mainly at the start):WTF interview April 26, 2010.
Mark gets Robin talking about playing the early days Mork, stand up clubs in the seventies and fellow comedians and experiences, learning his art. He talks about fears and authenticity, plagiarism and ‘the celebrity’.
The art of being a comic seems to have been fraught with fear of failure and fear of feelings, but a need to use them to engage with an audience. “What do you do with the anger? What do you do with the fear? ” He openly agrees with the interviewer, ”Big Time”. But he also shares how he deals with them. He shares his optimism on second chances, on alcoholism and heart surgery. He talks about divorce and living ‘in a different game as two units’, and how well his family manages it. They talk about sharing insecurities with the audience, and where they draw the line between sentiment and overstepping the mark, looking for approval from the audience. Effectively wanting to know from them, the universal question which makes the world go round, “do you love me?”
Talking about therapy they close by talking with humour, he puts the whole subject of dying over in the WTF category. He reveals through comic interpretation, discussion with his conscience. There is a fine boundary between his comedy humour and revealing his innermost thoughts. There may be many wondering about that interview today.
His acting has been part of my life since I can remember watching films, and he touched the lives of many he will never know. My kids have laughed raucously watching him as Professor Brainard in Flubber only this week, in the summer holidays.
He was the deep Sean McGuire. He was the humorous DJ, Adrian Cronauer. He was the desperate & committed parent in Mrs. Doubtfire. He was engaged John Keating. He was the Fisher King. He enjoyed exploring dark traits in characters such as in the role of photo shop technician-turned-stalker in One Hour Photo. At the heart of each one was a glimpse into a conflicted character.
He was so much more. He was original. He was it seems, the very complex, Robin Williams.
The investment to date may seem vast if, like me, you are unfamiliar with the amounts of money that are spent in research [in 2011 an £800M announcement, last summer £90M in Oxford as just two examples], and Friday revealed yet more money, a new £300M research package. It is complex how it all adds up, and from mixed sourcing. But the stated aim of the investment is relatively simple: the whole genomes of 75,000 people [40K patients and 35K healthy relatives] are to be mapped by 2017.
Where the boundary lies between participation for clinical care and for research is less clear in the media presentation. If indeed participants’ results will be fed back into their NHS care pathway, then both aims seem to be the intent of the current wave of participants.
“The ultimate aim is to make genomic testing a routine part of clinical practice – but only if patients and clinicians want it.” [Genomics England, how we work]
The infrastructure of equipment is enormous to have these sequences running 24/7 as was indicated in media TV coverage. I’m no maths whizz, but it appears to me they’re building Titantic at Genomics England and the numbers of actual people planned to take part (75K) would fit on the lifeboats. So with what, from whom, are they expecting to fill the sequencing labs after 2017? At Genomics England events it has been stated that the infrastructure will then be embedded in the NHS. How is unclear, if commercial funding has been used to establish it. But at its most basic, there will be no point building the infrastructure and finding no volunteers want to take part. You don’t build the ship and sail without passengers. What happens, if the English don’t volunteer in the desired numbers?
What research has been done to demonstrate the need or want for this new WGS project going forwards at scale, compared with a) present direct care or b) existing research facilities?
I cannot help but think of the line in the film, Field of Dreams. If you build it they will come. So who will come to be tested? Who will come to exploit the research uses for public good? Who will come in vast numbers in our aging population to exploit the resulting knowledge for their personal benefit vs companies who seek commercial profit? How will the commercial and charity investors, make it worth their while? Is the cost/benefit to society worth it?
All the various investors in addition to the taxpayer; Wellcome Trust, the MRC, Illumina, and others, will want to guarantee they are not left with an empty shell. There is huge existing and promised investment. Wellcome for example, has already “invested more than £1 billion in genomic research and has agreed to spend £27 million on a world class sequencing hub at its Genome Campus near Cambridge. This will house Genomics England’s operations alongside those of the internationally respected Sanger Institute.”
Whilst the commercial exploitation by third parties is explicit, there may also be another possibility to consider: would the Government want:
a) some cost participation by the participants? and
b) will want to sell the incidental findings’ results to the participants?
“Regier et al. 345 have estimated the willingness-to-pay (WTP) for a diagnostic test to find the genetic cause of idiopathic developmental disability from families with an affected child. They used a discrete choice experiment to obtain WTP values and found that these families were willing to pay CDN$1118 (95% CI CDN$498-1788) for the expected benefit of twice as many diagnoses using aCGH and a reduction in waiting time of 1 week when compared to conventional cytogenetic analysis.”
“Moreover, it is advisable to minimise incidental findings where possible; health care professionals should not have an obligation to feedback findings that do not relate to the clinical question, except in cases where they are unavoidably discovered and have high predictive value. It follows that the NHS does not have an obligation to provide patients with their raw genome sequence data for further analysis outside of the NHS. We make no judgement here about whether the individual should be able to purchase and analyse their genome sequence independently; however, if this course of action is pursued, the NHS should provide follow-up advice and care only when additional findings are considered to be of significant clinical relevance in that individual…” [13]
How much is that cost, per person to be mapped? What is the expected return on the investment?
What are the questions which are not being asked of this huge state investment, particularly at a time when we are told he NHS is in such financial dire straits?
Are we measuring the costs and benefits?
Patient and medical staff support is fundamental to the programme, not an optional extra. It should not be forgotten that the NHS is a National Service owned by all of us. We should know how it runs. We should know what is spends. Ultimately, it is we who pay for it.
So let’s see on paper, what are the actual costs vs benefits? Where is the overall and long term cost benefit business case covering the multi-year investment, both of tangible and intangible benefits? In my personal research, I’m yet to find one. There is however, some discussion in this document:
“The problem for NGS is that very little ‘real’ information is available on the actual costs for NGS from the NHS perspective and the NHS Department of Health Reference Costs Database and PSSRU, where standard NHS costings are listed, are generally not helpful.” [13 – PHG, 2011]
Where are the questions being asked if this is really what we should be doing for the public good and for the future of the NHS?
Research under good ethics and bona fide transparent purposes is a public asset. This rollout, has potential to become a liability.
To me, yet again it seems, politics has the potential to wreck serious research aims and the public good.
Perhaps more importantly, the unrestrained media hype carries the very real risk of creating unfounded hope for an immediate diagnosis or treatment, for vulnerable individuals and families who in reality will see no personal benefit. This is not to undermine what may be possible in future. It is simply a plea to rein in hype to reality.
Politicians and civil servants in NHS England appear to use both research and the notion of the broad ‘public good’, broadly in speeches to appear to be doing ‘the right thing to do’, but without measurable substance. Without a clear cost-benefit analysis, I admit, I am skeptical. I would like to see more information in the public domain.
I question whether the propositions of the initiative have been grasped by Parliament and society as a whole, although I understand this is not a ‘new’ subject as such. This execution however, does appear at least, massive in its practical implications, not least for GPs if it is to become so mainstream, as quickly as plans predict. It raises a huge number of ethical questions. Not least of which will be around incidental findings, as the Radio 4 interview raised.
The first I have is consideration of pre-natal testing plans:
“Aside from WGS of individuals, other applications using NGS could potentially be more successful in the DTC market. For example, the use of NGS for non-invasive prenatal testing would doubtless be very popular if it became available DTC prior to being offered by the NHS, particularly for relatively common conditions such as Down syndrome…” [
and then the whole question of consent, particularly from children:
“…it may be almost impossible to mitigate the risk that individuals may have their genome sequenced without their consent. Some genome scan companies (e.g. 23andMe) have argued that the risks of covert testing are reduced by their sample collection method, which requires 2ml of saliva; in addition, individuals are asked to sign to confirm that the sample belongs to them (or that they have gained consent from the individual to whom it belongs). However, neither of these methods will have any effect on the possibility of sequencing DNA from children, which is a particularly contentious issue within DTC genomics.” [13]
“two issues have emerged as being particularly pressing: first is the paradox that individuals cannot be asked to consent to the discovery of risks the importance of which is impossible to assess. Thus from a legal perspective, there is no ‘meeting of minds’ and contractually the contract between researcher and participant might be void. It is also unclear whether informed consent is sufficient to deal with the feedback of incidental findings which are not pertinent to the initial research or clinical question but that may have either clinical or personal significance…” [PHG page 94]
“What we don’t want to say is those 10 years you have between 70 and 80, although clearly you are not going to be working, are not going to be valuable to somebody.
Clearly they are. You might be doing all sorts of very useful things for your family or local society. That’s what we are worried about and that’s the problem with the Department of Health’s calculation.
There are lots of people who adopt the fair-innings approach; ‘you’ve had 70 years of life you’ve got to accept that society is going to bias its investments in younger people.”
[14 – see Channel 4] Yet our population is ageing and we need to find a balance of where roles, rules and expectations meet. And question, how do we measure human value, should we, and on what basis are we making cost-based care decisions?
Clinical environment changes make engagement and understanding harder to achieve
All this, is sitting on shifting, fundamental questions on how decision making and accountability will be set, in a world of ever fragmenting NHS structure:
“More problematic will be the use of specific genomic technologies such as NGS in patient pathways for inherited disorders that are delivered outside the clinical genetics services (such as services for FH, haemophilia and sickle cell disease) and NGS that is used for non-inherited disease conditions. These will be commissioned by GP consortia within established care pathways. Such commissioning of companion diagnostics would, in theory be evaluated first by NICE. However, it is not clear what capacity NICE will have across a broad range of uses. In practice it seems likely that GP consortia may make a variety of different decisions influenced by local experts and pressure, funding and different priorities. Particular questions for NGS will include: How will commissioners be provided with the necessary evidence for decision-making and can this be developed and coordinated at a national level? How will commissioners prioritise particularly when it may be necessary to invest early in order to achieve savings later? What (if any) influence may commissioners be able to exert over the configuration of test providers (for example the rationalisation of laboratories or the use of private testing companies)? [13]
Today (August 8th) the public row between Roche and the Government through NICE became apparant on cancer treatment. And again I found myself asking, what are we not funding, whilst we spend on genomics? If you did not you hear Sir Andrew Dillon & the discussion, you can listen again on BBC Radio 2 iPlayer here. [It’s in the middle of the programme, and begins at 01:09.06.]
Questions, in search of an answer
Where has the population indicated that this is the direction of travel we wish our National Health Service to take? What preparation has been made for the significant changes in society it will bring? When was Parliament asked before this next step in policy and huge public spend were signed off and where is the periodic check against progress and public sign off, of the next step? Who is preparing the people and processes for this explosive change, announced with sparklers, at arms length and a long taper? Are the challenges being shared honestly between policy, politicians and scientists, being shared with patients and public: as discussed at the stakeholder meeting at St.Barts London, 3rd October 2013 (a key panel presentation: 45 minute video with slides)? When will that be shared with the public and NHS staff in full? Why does NHS England feel this is so fundamental to the future of the NHS? Must we abandon a scuppered and sinking NHS for personalised medicine on personal budgets and expectations of increased use of private health insurance?
Is genomics really the lifeboat to which the NHS is inextricably bound?
Not everyone may have understood it that way, but if not, I’d like to know what was meant.
I would like to understand what is meant when Genomics England spokespeople say the future holds:
“Increasingly to select most appropriate treatment strategy. In the longer term, potential shift to prevention based on risk-based information.”
or
“Review the role of sequencing in antenatal and adult screening.”
I would welcome the opportunity to fully understand what was suggested at that Board meeting as a result of our shared risk pool, and readers should view it and make up their own mind. Even better, a frank public and/or press board meeting with Q&A could be rewarding.
The ethical questions that are thrown up by this seem yet to have little public media attention.
Not least, incidental findings: if by sequencing someone’s DNA, you establish there is something for their health that they ought to be doing soon, will you go to that patient and say look, you should be doing this…. these are incidental findings, and may be quite unexpected and separate from the original illness under investigation in say, a family member, and may also only suggest risk indicators, not clear facts.
If this is expected to be mainstream by 2018, what training plans are in place as indicated needed as a “requirement for professionals across the NHS to be trained in genetics and its implications”? [presentation by Mark Bale, DoH, July 2014]
When will we get answers to these questions, and more?
Because there is so much people like me don’t know, but should, if this is our future NHS under such fundamental change as is hyped.
Because even the most esteemed in our land can get things wrong. One of them at the St.Bart’s events quotes on of my favourite myths attributed wrongly to Goethe. It cannot be attributed to him, that he said, ” “Whatever you can do or dream you can, begin it. Boldness has genius, power and magic in it.” You see, we just hear something which sounds plausible, from someone who seems to know what they are talking about. It isn’t always right.
Because patients of rare disease in search of clinical care answers should be entitled to have expectations set appropriately, and participants in research know to what they, and possibly family members indirectly, are committed.
Because if the NHS belongs to all of us, we should be able to ask questions and expect answers about its planning, how we choose to spend its budget and how it will look in future.
These are all questions we should be asking as society
Fundamentally, in what kind of society will my children grow up?
With the questions of pre-natal intervention, how will we shape our attitudes towards our disabled and those who are sick, or vulnerable or elderly? Are we moving towards the research vision Mr.Hunt, Cameron and Freeman appear to share, only for good, or are we indeed to look further head to a Gattacan vision of perfection?
How may this look in a society where ‘some cornflakes get to the top‘ and genetic advantage seen as a natural right over those without that ability? In a state where genetics could be considered as part of education planning? [16]
For those with lifelong conditions, how may genetic screening affect their life insurance when the Moratorium expires* in 2017 (*any shift in date TBC pending discussion) ? How will it affect their health care, if the NHS England Board sees a potential effect on equity of access? How will it affect those of us who choose not to have screening – will we be penalised for that?
And whilst risk factors may include genomic factors, lifestyle factors some argue are even more important, but these change over time. How would those, who may have had past genetic screening be affected in future requirements?
After the August 1st announcement, [11] The Wellcome Trust‘s reporting was much more balanced and sensible than the political championing had been. It grasps the challenges ahead:
“Genomics England has ambitious plans to sequence 100,000 genomes from 75,000 people, some of whom will also have cancer cells sequenced. The sheer scale of the plans is pretty daunting. The genetic information arising from this project will be immense and a huge challenge for computational analysis as well as clinical interpretation. It will also raise a number of issues regarding privacy of patient data. Ensuring that these genetic data can be used maximally for patient benefit whilst protecting the rights of the individual participant must be at the heart of this project.
At the beginning of the Human Genome Project, scientists and funders like the Wellcome Trust knew they were on a journey that would be fraught with difficulties and challenges, but the long-term vision was clear. And so it is with the plans for Genomics England, it will most certainly not be easy…”
Managing change
Reality is that yet again, Change Management and Communications have been relegated to the bottom of the boarding priorities list.
This is not only a research technology or health programme. Bigger than all of that is the change it may bring. Not only in NHS practice, should the everyday vision of black boxes in GP surgeries become reality, but for the whole of society. For the shape of society, in age and diversity. Indeed if we are to be world leaders, we have potential to start to sling the world on a dangerous orbit if the edges of scope are ill defined. Discussing only with interested parties, those who have specific personal or business interests in genomic research and data sharing, whilst at Board meetings not clearly discussing the potential effects of risk stratification and personalisation on a free at the point of delivery health service is in my opinion, not transparent, and requires more public discussion.
After all, there are patients who are desperate for answers, who are part of the NHS and need our fair treatment and equity of access for rare disease. There is the majority who may not have those needs but knows someone who does. And we all fund and support the structure and staff in our world class service, we know and love. We want this to work well.
Future research participation depends on current experience and expectations. It is the latter I fear are being currently mishandled in public and the media.
Less than a month ago, at the NHS England Board Meeting on July 3rd, Lord Adebowale very sensibly asked, “how do we lead people from where we are, and how we take the public with us? We need to be a world leader in engaging all the public”
Engagement is not rocket science. But don’t forget the ethics.
If this project is meant to be, according to MP George Freeman [George 2], akin to Kennedy launching the Space Race, then, by Fenyman [12], why can they not get their public involvement at big launches sorted out?
Is it because there are such large gaps and unknowns that questioning will not stand up to scrutiny? Is it because suggesting a programme will end the NHS as we know it, would be fatal for any politician or party who supports that programme in the coming year? Or do the leading organisations possibly paternalistically believe the public is too dim or uninterested or simply working to make ends meet to care [perhaps part of the 42% of the population who expected to struggle as a result of universal welfare changes, one in three main claimants (34 per cent) said in 2012 they ‘run out of money before the end of the week/month always or most of the time’] ? But why bother will the big press splash, if it should not make waves?
“Let us make recommendations to ensure that NASA officials deal in a world of reality in understanding technological weaknesses and imperfections well enough to be actively trying to eliminate them. They must live in reality in comparing the costs and utility of the Shuttle to other methods of entering space. And they must be realistic in making contracts, in estimating costs, and the difficulty of the projects.
Only realistic flight schedules should be proposed, schedules that have a reasonable chance of being met.
If in this way the government would not support them, then so be it. NASA owes it to the citizens from whom it asks support to be frank, honest, and informative, so that these citizens can make the wisest decisions for the use of their limited resources. For a successful technology, reality must take precedence over public relations… [June 6th 1986. Six months after the disaster, the Report to the Presidential Commission (Appendix F)]
The key is not the landing, it’s understanding why we launched in the first place.
Space may not be the most significant final frontier out there in the coming months that we should be looking at up close. Both in health and science. Our focus in England must surely be to examine these plans with a microscope, and ask what frontiers have we reached in genomics, health data sharing and ethics in the NHS?
[10] November 2013 ISCG – political pressure on genomics schedule http://www.england.nhs.uk/iscg/wp-content/uploads/sites/4/2014/01/ISCG-Paper-Ref-ISCG-009-001-ISCG-Meeting-Minutes-and-Actions-26-November-2013-v1.1.pdf
[16] Education committee, December 4th 2013 including Prof. Plomin From 11.09:30 education and social planning http://www.parliamentlive.tv/Main/Player.aspx?meetingId=14379
*****
For avoidance of confusion [especially for foreign readership and considering one position is so new], there are two different Ministers mentioned here, both called George:
“The UK is set to become the world leader in ground-breaking genetic research into cancer and rare diseases, which will transform how diseases are diagnosed and treated, thanks to a package of investment worth more than £300 million.” [DH press release, August 1 2014. [2] ]
“…with their medical details “opened up” to private healthcare firms, says David Cameron.”
This was the next step in the programme, hailed as an historic moment, a giant leap forward for genomics.
The photo call for the symbolic signing included Jay Flatley President, Chief Executive Officer and a member of the Board of Directors of Illumina, Inc, Sir John Chisholm Executive Chair of Genomics England & Chair of Nesta, together with Dame Sally Davies Chief Medical Officer and Mr. George Freeman [George 2] MP for mid-Norfolk, and the newly appointed Life Sciences Minister.
Fewer than twelve months before an election the Government has decided to commit commercially to a US based company, in a programme which Mr.Cameron himself said, has had controversy. That c-word is one the Conservatives will want to avoid in the coming election campaign.
This Channel 4 [4] film from almost 2 years ago, (December 2012) raises many questions as valid today as then. At that time, in contrast with today’s approach, the programme suggests that consent for research and data use would be assumed for all.
The inestimable Jon Snow asked then, why is the Business Department announcing this [the launch of the pilot programme, when focused then first in rare cancers]? The public may understand that commercial pharma, charities and the State work hand-in-glove (as Mr.Cameron’s 2011 vision stated), but as Jon Snow asks, not yet understand how this commercial venture will benefit the NHS long term as well as individual patients and the public as a whole? Is it concrete on benefits to patients vs benefits to UK plc?
So what was the key press message which came over?
The coverage of the week since August 1st, expounded the belief that through Genomics England Ltd we will do away with chemotherapy in the future. I believe this should be the source of a raging debate, but it passed by with little more than a few waves.
The original review given last summer to Genomics England including listing the rare diseases which may affect the 6% of the population, suggests one consideration, targeting those with very high likelihood of familial links and therefore success.[6] or Patients selected with a high probability of a single gene disorder. There are obviously great challenges in turnaround time for the genetic processing to be useful in clinical decision making. Considering whether or not it is timely or accurate enough to be of clinical benefit in acute cancer care clinical decision making will be vital. It is also what is being promised to patients who sign up, a faster, more efficient, improved offering on what is available already in the NHS genetic services today.
The interested population and profession would do well to get an independent medical update on the status of this, to understand it better if this is now established and its reliability, so what participants sign up for, is what they get on the tin:
“Results are provided for patients in a timely fashion (e.g. within 8 weeks) and with sufficient clinical accuracy (not yet established for WGS) [whole genome sequencing].” [page 3 of 8]
And what was the press result and public reaction to the news?
As one example, look at lunchtime on Friday August 1st, Radio 2 callers to the Jeremy Vine show. They included two undergoing chemo who felt they had to call in, to tell others, chemo is not always as bad as it sounds and make sure you don’t give up on it, refuse treatment or wait for this new genetic solution.
The impression was given, there is a new wonder solution within grasp on the horizon. This seemed to me rather reckless and unfairly manipulative on the ill and vulnerable to give them a blanket hope, that their cancer treatment may become so much better, soon. These are real people’s lives, not guinea pigs with which one can feel free to trial hypothesis and hype. If anyone now refuses chemo as a result of the Friday fantasy projections, their health may have been directly impacted. I would like to have heard a DH or Genomics England press manager speaking, not allowing such public free rein, to ensure it was factually accurate. But I’m guessing that Genomics England as an ALB is not really ready for press yet [their public engagement and education programme isn’t ready yet they confirmed when asked in July in an FOI], and the DH perhaps at arms length, thinks, it’s not their responsibility and outside their remit. Stuck in the middle, we have the commissioning body, NHS England.
How might this involve all of us, our NHS and cross into care.data?
In most recent memory, NHS England tried and so far failed in February 2014, to engage the public and clinicians in the extraction of our GP stored health records, in the care.data initiative. Care.data languishes in some sort of unknown black hole at the moment, with little public engagement and pilots promised ‘for autumn’. Both programmes are run under the auspices of Mr. Kelsey at NHS England Patients and Information Department, and arms length from the Department of Health. Last summer, Tim Kelsey and Sir Bruce Keogh presented a paper to the Board on Genomics and its interaction with NHS patient records. [7]
Given that the Genomics paper indicated that care.data and NHS held patient records were of paramount importance to NHS England I would like to have seen more transparency over this, including informed public and parliamentary debate:
“Issues of data ownership and transparency are of paramount importance to NHS England as set out in the Mandate and given the hugely positive developments in Care.Data. Geraint Lewis is leading this work, and has begun work to consider how the sequencing data might be held, connected to patient records and subsequently be exploited. It will also look at the connections between this work and the establishment of care data in the NHS. The NHS England data and informatics team will retain oversight of the informatics and data work and discussions continue on how it can best inform and support the implementation of business plan of Genomics England Limited.”
There has been almost no public statement from NHS England on genomics and our data management in the same discussion, until now. George Freeman MP [2] said on BBC Radio 4 (Starting from 2:46.30 in interview with Sarah Montague:
“It’s absolutely not the care.data initiative discussed earlier in the year. This is 100K patients, all volunteering and all providing their consent. It’s completely anonymised data in the data set, the only person who would be able to come back to the patient and make a link with the genomics and the diagnosis, is their doctor. We’re creating a database so that NHS researchers and industry researchers, can look at the broad patterns. 90% of patients with that variation, get that disease, this drug works in 50% of patients…It’s completely anonymised, there is no basis on which you could make the link. The only person who can make the link is the NHS clinician.”
Whilst this is NOT the same initiative, it intends to use some of the same data for those people who actively consent to participate in the 100K Genome Project.
The data will be extracted from care.data [which ‘assumes consent’ or requires active opt OUT, depending how you view it] to include longitudinal, phenotype data across a person’s lifetime. I spoke to the Genomics England media team last autumn, 2013, which confirmed this intent at that time.
The trouble is for Mr. Freeman [2] and these statements, that the public knows ‘anonymous’ in care.data turned out to not be anonymous at all. ICO and HSCIC [8] are still working this out. [HSCIC has just published its first review of pseudonymisation review 9] It was discovered that far from being released only to clinicians and researchers, our hospital data has been shared with all sort of unexpected third parties, without consent. [see the Partridge Review]. This surprised and shocked many, to public outcry and the resultant loss of trust [15] in the programme has yet to be rebuilt. So some listeners may well and understandably have had concerns that their data may be used for purposes to which they have not agreed.
Some say that genetic data by its very nature, despite stripping data identifiers, cannot be non-identifying, or stay that way:[16]
“It only takes one male,” said Yaniv Erlich, a Whitehead fellow, who led the research team. “With one male, we can find even distant relatives.” [Jan 2013]
“If they choose to share that’s a very admirable thing because by sharing freely, progress for everyone is accelerated, and if someone is not comfortable we should respect that too and find ways for them to still participate in research,” he said.
What are the next steps – or should we expect, one giant leap?
As regards care.data from all, it is I believe reasonable, that we should we ask: how we should expect our care.data to be used, and trust for what restricted purposes it will be extracted and stored for the future? What mechanisms will separate consent for care.data commissioning from this kind of research? How will citizens trust this data sharing now as the Department for Patients and transformation care.data proposals seem still open ended in scope in particular for social care [17], and alongside other ever widening government data sharing? [18] How will the public know where the future boundaries of care.data scope creep lie?
If anything has been learned from care.data to date it must be this: We should continue to ask for more public involvement in policy and planning, not just the post-event PR if the state wishes to ensure success and prevent surprises. What happens next for this data programme, and for our national programme of genomics, 100K?
[10] November 2013 ISCG – political pressure on genomics schedule http://www.england.nhs.uk/iscg/wp-content/uploads/sites/4/2014/01/ISCG-Paper-Ref-ISCG-009-001-ISCG-Meeting-Minutes-and-Actions-26-November-2013-v1.1.pdf
[16] The Whitehead Institute for Biomedical Research in Cambridge, Mass in the WSJ, Jan 2013: “”It only takes one male,” said Yaniv Erlich, a Whitehead fellow, who led the research team. “With one male, we can find even distant relatives.”
For avoidance of confusion [especially for foreign readership and considering one position is so new], there are two different Ministers mentioned here, both called George:
Five months after the most recent delay to the care.data launch, I’ve come to the conclusion that we must seek long-term excellence in its performance, not content ourselves with a second-rate dress rehearsal.
“Sharing our medical records, is like playing Chopin. Done well, it has the potential to demonstrate brilliance. It separates the good, the bad and the ugly, from the world-class players. But will we get it right, or will we look back at repeat dire performances and can say, we knew all the right notes, but got them all in the wrong order?”
The vast majority were from organisations which are data users, some names familiar from the care.data press coverage in spring, [Beacon Consulting, Harvey Walsh] plus many university and charity driven researchers.
Sir Kingsley Manning, Sir Nick Partridge and Andy Williams [The CEO since April 2014] all representing HSCIC, spoke about the outcomes of the PWC audit, which sampled 10% of the releases of identifiable or pseudonymous data sharing agreements for closer review, and what is termed ‘Back Office’ access (by the police, Home Office, court orders) in the eight years as the NHS IC prior to the HSCIC rebrand and changes on April 1st, 2013.
“The standard PwC methodology was adopted for sample testing data releases with the prevailing governance arrangements. Samples were selected for each of the functional areas under review. Of the total number of data releases identified (3,059); approximately a 10% sample was tested in total.” (Report, Data Release Review June 2014)
I believe it is of value to understand how we got here as well as the direction in which the HSCIC is moving. This is what the meeting sought to do, to first look back and then look forward. They are Data Controller and Processor of our health records and personal identifiable data. As care.data pathfinder pilots approach at a pace, set for ‘autumn’, the changes in the current processes and procedures for data handling will not only effect records which are already held, from our hospital care and other health settings‘, but they will have a direct effect on how our medical records extracted from GP practices will be treated, for care [dot] data in the future.
Data Management thus far has failed to meet the standards of world class delivery; in collection, governance and release
It made me think, that sharing our medical records, is like playing Chopin. Done well, it has potential for brilliance. It separates the good, the bad and the ugly, from the world-class players. Even more so, when played as part of suite, where standards are understood and interoperable . Data sharing demands technical precision, experience and discipline. Equally, gone wrong, we can look back at past performances and say, we had world class potential and knew all the right notes, but got them all in the wrong order. Where did we fail? Will we learn, or let it repeat?
The 2.5 hour event, focused more on the attendees’ main interest, how they will be affected by any changes in the release process. Some had last received data before the care.data debacle in February put a temporary halt on releases.
As a result of planned changes, will some current data customers find, that they have already received data for the last time, I wonder?
After the initial review of the critical findings in the Partridge report, the discussion centred on listening to suggestions what may be done in England to prevent future fails. But in fact, I think we should be going further. We should be looking at what we are doing in England to be the world-class player that the Prime Minister said he wants.[5]
We are focused on making the best of a bad job, when we could be looking at how to be brilliant.
To me, the meeting missed a fundamental point. Before they decide the finer points of release, they need to ensure there will be data to collect. There was not one mention of the public’s surprise that our data was collected and had been sold or shared with each of them until last spring. So now that the public in part knows about it, the recipients should also consider we are watching them closely.
Data users are being judged as one, by their group performance
What the data recipients may or may not be conscious of, is that they too each are helping to shape the orchestra and will determine the overall sound that is heard outside.
They may not realise that as data recipients, we citizens, the data providers, will see and hear their actions and respond to them all collectively, in terms of what impact it may have on our opt in/out decision.
I heard on Monday one or two shriller voices from global data intermediaries claiming that others had been receiving data whilst their own requests had been overlooked. As of last Friday, HSCIC said 627 requests were on standby, waiting for review and to know whether or not they would receive data. Currently HSCIC is getting 70 new requests a month. Bearing in mind the attendees were mostly data users, they can be forgiven that they were mostly concerned about data release and use, but they did in part also raise the importance of correct communication, governance and consent of extraction. They realise without future public trust, there is no future data store.
One consultancy however, seemed to want to blame all the other players for their own past mistakes, though there was no talk of any blame in any discussion otherwise. They asked, what about the approvals process for SUS (Secondary Uses Service data), how are those being audited and approved, is it like HES? How about HSCIC getting their act together on opt out, putting power back in the hands of patients, they asked. What about the National Cancer Registries, ONS (Office of National Statistics), all the data which is not HES, will there be one entrance point to access all these data stores for all requests? And as for insurance concerns by patients, the same said, people were foolish to be concerned. Why, “if they don’t get our health data then all the premiums will go up.”
My my, it did feel a little like a Diva having a tantrum at the rest of the performers for messing up her part. And she would darn well pull the rest of them into the pit with her if she was going to get cancelled. In true diva style, I’m sure that company didn’t even realise it.
But all those data recipients are in the same show now – if one of them screws up badly, the critics will slam them all. And with it, their providers of data, we patients, will not share our data. Consent and confidentiality are golden tickets and will not be given up lightly. If all the data-using players perform well, abide by the expected standards, and treat both critics, audience and each other with proper etiquette, then they will get their pay, and get to stay in the show. But it won’t be a one time deal. They will need to learn continuously, do whatever the show conductor asks, and listen and learn from the critics as they perform in future, not slacking off or getting complacent.
Whilst the meeting discussed past failings in the NHS IC, I hope the organisations will consider what has truly shocked the public is some of the uses to which data has been put. How the recipients used it. They need to examine their own practices as much as HSCICs.
The majority of the attendees were playing from the same score, asking future questions which I will address in detail in part two.
The vast majority asked, how will the data lab work? And other Research users asked many similar and related questions. [This from medConfidential [6] whilst on the similar environment for accredited safe havens, goes some way to explaining the principle of a health research remote data lab (HRRDL).]
Governance questions were raised. Penalties were an oft recurring theme and local patient representative group and charity representatives, asked how the new DAAG lay person appointments process would work and be transparent.
Other questions on past data use, were concerned with the volume of Back Office data uses. The volume of police tracing for example. How person tracing by the border agency, particularly with reference to HIV and migrant health, which may reveal data to border agencies which would not normally be shared by the patients’ doctors. “If people are going to have confidence in HSCIC, this was a matter of policy which needed looking at in detail. ” The HSCIC panel noted that they also understood there were serious concerns on the quantity of intra-government departments sharing, the HMRC, Home and Cabinet Offices getting mentions. “There was debate to be had”, he said.
They’re collectively recovering from unexpected and catastrophic criticism at the start of the year. It is still having a critical effect on many organisations because they don’t have access to the data exactly as they used to, with a backlog built up after a temporary stop on the flow which was restarted after a couple of months. HSCIC has reviewed themselves, in part, and any smart attendees on Monday will know how each of their organisations have fared. The audit has found some of their weaknesses and sought to address them. There is a huge number of changes, definitions and open considerations under discussion and not yet ready to introduce. They realise there is a great amount of work still to be done, to bring the theory into practice, test it out, edit and get to a point where they are truly ready for a new public performance.
But none of the truly dodgy sounding instruments have been kicked out yet. I would suggest there are simply organisations which are not themselves of the same standards of ethics and physical best practices which deserve to manage our data. They will bring down the whole, and need rejected – the commercial re-use licenses of commercial intermediaries. And the playing habits of the data intermediaries need some careful attention, drawing the line between their clinical support work and their purely commercial purposes. The pace may have slowed down, but data is still flowing out, and there was no recognition that this may be without data protection permission or best practice, if individuals aren’t aware of their data being used in this way. The panel conducted a well organised and orderly discussion, but there were by far more open questions, than answers ready to be given.
What we do now, sets the future stage of all data sharing, in the UK and beyond – to be brilliant, will take time to get right
How HSCIC puts into action and implements the safeguards, processes and their verbal plans to manage data in the short and medium term, will determine much for the future of data governance in England, and the wider world. Not only in terms of the storage and release of data – its technical capability and process governance, but in the approach to data extraction, fair processing, consent, communication and ongoing management.
This is all too important to rush, and I hope that the feedback and suggestions captured on the day will be incorporated into the production. To do so well, will need time and there is no point in some half-ready dress rehearsal when so much is yet to be done.
The next Big Thing – care.data
When it came to care.data, Andy Williams said it had been a serious failing to not recognise that patients view their GP records quite, totally differently, from the records held at a hospital. Sharing their HES data.
“And it is their data, at the end of the day,” he recognised.
So to conclude looking back, I believe where data sharing has reached, is leaps and bounds ahead of where it was six months ago. The Partridge Review and its recommendations recognises there are problems and makes 9 recommendations. There is lots more the workshop suggested for consideration. If HSCIC wants to achieve brilliance, it needs to practise before going out on a public stage again. The excellence of Chopin’s music does not happen by chance, or through passion alone. To achieve brilliance we cannot follow some romantic notion of ‘it will all be alright on the night’. Hard edged, technical experience knows world-class delivery demands more.
So rolling out care.data as a pathfinder model in autumn before so much good preparation can possibly be done, is in my opinion, utterly pointless. In fact, it would be damaging. It will be like pushing a grade 5 school boy who’s not ready into the limelight, and just wishing him luck, while you wait whistling in the wings. But what will those in charge say?
[9] Classic comedy Morecambe & Wise, with Andre Previn – all the right notes, but not necessarily in the right order https://www.youtube.com/watch?v=-zHBN45fbo8
[10] Blog post part two: care.data is like playing Chopin – or will it be all the right notes, but in the wrong order? [Part two – future]
“That November farewell, given in aid of a Polish charity, came at the end of a difficult six-month British sojourn, which had included concerts in Manchester (one of the largest audiences he ever faced), Glasgow and Edinburgh, where the non-religious Chopin had unwillingly endured Bible readings by a pious patroness anxious to convert him to the Church of Scotland. Finally back in London, the composer-pianist spent three weeks preparing for what turned out to be his final recital by sitting wrapped in his coat in front of the fire at St James’s Place, attended by London’s leading homeopath and the Royal Physician, a specialist in tuberculosis. A week after the concert, he was on his way home to Parisian exile and death the following year.”
Born Zelazowa Wola, Poland of a French emigrant father and Polish mother, he left Poland aged 20, never to return. Well known and by some controversially for his long romantic liaison with novelist George Sand (Aurore Dudevant) after they separated his health failed and in 1848 he paid a long visit to Britain where he gave his last public performance at the Guildhall. He died in Paris.
How our data sharing performance will be judged, matters not just today, or in this electoral term but for posterity. The current work-in-progress is not a dress rehearsal for a care.data quick talent show, but the preparations for lifetime performance and at world standard.
How have we arrived where we are now, at a Grand Pause in the care.data performance? I looked at the past, reviewed through the Partridge Review meeting in [part one here] the first half of this post from attending the HSCIC ‘Driving Positive Change’ meeting on July 21st. (official minutes are online via HSCIC >> here.)
Looking forward, how do we want our data sharing to be? I believe we must not lose sight of classical values in the rush to be centre stage in the Brave New World of medical technology. [updated link August 3rd]* Our medical datasharing must be above and beyond the best model standards to be acceptable technically, legally and ethically, worldwide. Exercised with discipline, training and precision, care.data should be of the musical equivalent of Chopin.
Not only does HSCIC have a pivotal role to play in the symphony that the Government wishes research to play in the ‘health & wealth’ future of our economy, but they are currently alone on the world stage. Nowhere in the world has a comparable health data set over such length of time, as we do, and none has ever brought in all it’s primary care records into a central repository to merge and link, as is planned with care.data. Sir Kingsley Manning said in the current July/August Pharma Times article, data sharing now has to manage its reputation, just like Big Pharma.
Pharma Times – July/Aug 2014 http://www.pharmatimes.com/DigitalOnlineArea/digitaleditionlogin.aspx
Countries around the world, will be watching HSCIC, the companies and organisations involved in the management and in the use of our data. They will be assessing the involvement and reaction of England’s population, to HSCIC’s performance. This performance will help shape what is acceptable, works well and failings will be learned from, by other countries, who will want to do the same in future.
Can we rise to the Challenge to be a world leader in Data Sharing?
If the UK Government wants England to be the world leader in research, we need, not only to be exemplary in how we govern the holding, management and release of data, but also exemplary in our ethics model and expectations of each other in the data sharing process.
Regular readers here or on twitter, may notice the new-look.
I’m moving away from The Amateur Book Blogger banner, and will be posting simply as me, as I go on. The start of the summer holidays seemed as good a day as any, to saunter out into the sunshine on my own. [I may even see if it’s worth updating my resultant twitter handle @TheABB]. The reason? This week, the View From Here Magazine announced it will be closing on November 1st, 2014. After seven years on the writing team, it is not only the end of an era, but perhaps the start of a something new.
I started on the comms side, announcing writing events and industry news, and later moved into interviews. It’s been an amazing experience. Editor Mike French was a great remote-mentor. We’ve met only once, at the launch of his latest novel, Convergence, in The Dandelion Trilogy. Mike both enabled and encouraged me to interview some great writers, editors, scouts and publishers, every quarter. I learned something new each time, from every contribution, and had great fun. All of which I enjoyed, but some stand out in the memory more than others, and every one was unique.
Thank you to all whom I have interviewed since 2006, but also to readers and fellow unpublished writers who supported me, the team, and made the community at The View From Here what it is. With eclectic tastes, I learned much on writing, but also enjoyed the art of the creative collective.
The most recent interview I did for them, was here, with Isabel Allende. In her wide ranging career, it was hard to know what to ask and how to narrow it down, but one thing stays with me, in all she said, on the role of a writer:
“Writers have no obligation to comply with the official story or the official version, their only obligation is with their own consciousness. Honesty above all.”
The other part of my writing recently has been more akin to her engagement in politics and civil society. I’ve been on twitter really only for the last nine months, throughout the difficult pregnancy of care.data, pronounced care [dot] data. If you missed it, that’s the government proposed scheme to suck up our GP medical records, merge them with data already held at the central Health and Information Centre from our hospital care, and then use the new, richer record for commissioning purposes and potentially more, as yet undefined. Since our hospital and other health sourced-data is already sold to private companies and will continue to be so in future, but without having asked for informed consent, I’ve been a very skeptical critic and lay voice for positive changes for these wide secondary uses. [In case you’ve landed here for the first time, I’ve a background in tech database implementations, communications and change, and I took it upon myself to fully understand and follow the subject, a year ago when I came across the topic online, by accident.]
It looks now, as though some improvements on past failings will happen, but much remains undefined in detail, and as we all know, that’s where the devil likes to sup. I look forward to seeing some of the recently discussed changes and definitions in the Care Act, for example, becoming concrete.
So, that’s the reason for the insignificant changes on my part, and should I explain the image? I’ve chosen my favourite coffee mug for my header photo, with my favourite scarf. I use both often. The latter, reminds me a little of Bridget Riley’s op art. As a retro fan that appeals to me. The former, depicts the cover of Susan Stebbing’s most popular work Thinking to some purpose (1939) which was described on the cover of the first Pelican Books edition as being:
“A manual of first-aid to clear thinking, showing how to detect illogicalities in other people’s mental processes and how to avoid them in our own”
The work arose out of a synopsis she wrote for a series of radio broadcasts intended for the BBC. Published on the eve of the Second World War, Stebbing wrote:
“There is an urgent need to-day for the citizens of a democracy to think well. It is not enough to have freedom of the Press and parliamentary institutions. Our difficulties are due partly to our own stupidity, partly to the exploitation of that stupidity, and partly to our own prejudices and personal desires.”
Her words seem very timely.
To borrow from Wikipedia here: “This metaphor seems to me to be appropriate, because potted thinking is easily accepted, is concentrated in form, and has lost the vitamins essential to mental nourishment. You will notice that I have continued the metaphor by using the word ‘vitamins.’ Do not accept the metaphor too hastily: it must be expanded.”
“Potted meat is sometimes a convenient form of food; it may be tasty, it contains some nourishment. But its nutritive value is not equivalent to that of the fresh meat from which it was potted. Also, it must have originally been made from fresh meat, and must not be allowed to grow stale. Similarly a potted belief is convenient; it can be stated briefly, sometimes also in a snappy manner likely to attract attention. A potted belief should be the outcome of a belief that is not potted. It should not be held on to when circumstances have changed and new factors have come to light. We should not allow our habits of thought to close our minds, nor rely upon catch-words to save ourselves from the labour of thinking. Vitamins are essential for the natural growth of our bodies; the critical questioning at times of our potted beliefs is necessary for the development of our capacity to think to some purpose.”
So here’s to that, my ‘critical questioning’ may have shifted from one arena into another, but I hope I continue ‘thinking to some purpose’.
I have children who are entitled, come September, to the universal free school meal programme. Department of Education advice came out last week. See here >>universal infant free school meals.
I wonder whether this will bring back a national treasure to benefit those who need it most, or is it just a Pandora’s box of problems?
I must admit to feeling ignorant. How much evidence is there, that FSM for all, benefits those who need it more than a means tested system? There is certainly evidence of need, but how do we best address that need?
All the average parent can know well, is how the new system will affect our own child’s experience of school meals.
NetMums did a survey of lots of us. There are simple practical things which policy ignores, such as 4 year-olds starting school usually start on packed lunch only for a half term to get to grips with the basics of school, without having to manage trays and getting help to cut up food. The length of time they need for a hot meal is longer than packed lunch.
But it raises common concerns too which perhaps need more attention, many of which seem to be coming in, in drips of similar feedback: reduced school hall and gym access because the space will need to be used for longer due to increase in number eating hot meals, lack of good kitchen facilities, fears over cooked food quality.
The theory that a nutritious, hot meal at lunch time for all infants, is not what will be delivered in reality. All are valid concerns, over which parents have little control.
How will this change the standards and quality of food compared with today, What considerations have been made for food waste and Is it the wisest way for state money to be best spent to help all who really need it?
Firstly, let’s take to task the nutritional decision making. New standards are now mandatory again, after having been, and then not been – instead left at heads’ discretion. Swings and roundabouts.
There is a blanket ‘low fat’ approach. The trouble is, this often also means ‘replace all fat with fake stuff for flavour’. It fails to recognise that not all fats are nutritionally equal. Cholesterol is often branded a villain, but is a necessary building block for the body. Whilst parents are lambasted for creating obesity in our children and that we don’t understand enough about food, I don’t know that I agree the Government does either.
Whilst I fully understand the popular and State-driven drive for cutting down obesity levels, cutting out fat across all the food groups may not be the key to achieving it, and improving national health. This ‘low-fat is good’ approach is controversial, and low fat in particular in dessert, replaced with artificial sweeteners, also potentially harmful, is a false choice. I believe that a gentle paleo approach to food, back to basics, is a better choice. Throw out artificial things, and eat almost everything that is natural, in moderation. Not all fats are the same. Children who are growing, need the kind of fat that is in milk. It’s not the same as chips. Sugar, yes, cut it out, but don’t replace with artificial sweeteners. Not everything served on plate should be classed food.
The whole programme of child health in school is based on sweeping generalisations, but they’re not made to apply to all schools equally. We can be told an awful lot of twaddle of how our kids should eat and exercise by state-sent leaflets in book bags. Add to that, the fact that the BMI comparison is flawed, and its communications to parents method is fundamentally flawed. (Letters saying your perfectly healthy, well proportioned child is obese, or underweight, partly due to its tool as an average cross group measure, in the National Child Measurement Programme (NCMP) anyway. But that’s another, longer story.) It’s no wonder parents are confused, not knowing the best thing to do on these school meals or not.
“On 17 June 2014 the department announced a new set of simplified standards. The new standards are designed to make it easier for school cooks to create imaginative, flexible and nutritious menus. They will be mandatory for all maintained schools, academies that opened prior to 2010 and academies and free schools entering into a funding agreement from June 2014, and will come into force from January 2015.
One significant change in the new standards is that lower fat milk or lactose reduced milk must, from January 2015 be available for drinking at least once a day during school hours. The milk must be offered free of charge to pupils entitled to free school meals, and to all pupils where it forms part of the free school lunch to infants.”
There is conflicting information about milk consumption and asthma for example, so I’d like to see more information around this, on expected benefits overall. The milk given to them to drink often is UHT, skimmed and processed. If you take all the good stuff out of the milk, is it doing the kids who drink it any good? I’d like to know. We should know the general standards and calorie and nutritional content of their meals in both the theoretical guidelines and ask at practical local level on the ground, because one hot meal at lunchtime, a balanced diet does not make. We need to know what the kids are getting, in order to try and fit it into the bigger picture of their whole intake.
Secondly, we haven’t talked much about waste.
Currently, my children every week, eat both hot lunches and packed lunches from home. I pay the school’s private provider, for regular, hot lunches three days a week, and I provide packed lunch on two. (I can see ahead of time online, what’s on the provider’s menu, and I can plan and coordinate with the rest of what and how we eat, according to our family schedule.)
From September, I will no longer be able to choose to book and pay for those meals myself. And I will no longer be able to choose for some days and not others. It’s all or nothing.
The local provider will also no longer permit parents of Reception-Year 2 children to book meals and pay for them, so even if I am fortunate enough and wanted to, I can’t opt out of the state system and pay for only those meals my children will actually eat.
The result is, if I want to continue the mix of hot and packed lunch choice I make for them, based on our family life, schedule and the nutritional content of what I want them to eat, I am required to sign them up for all five days, and either they get the imposed routine and eat more hot dinners – or carry on with our current set-up and two days a week the other hot lunches will go to waste.
However having spoken to my local school meal service today, they confirmed that after 4 weeks they plan to have a review of waste, and cut back on food provided. They won’t be paid less.
The net result, the local private provider will receive more money from the State, for my children’s hot lunches, than I pay myself now. And likely as not, there will be food wasted as well, because the providers will need to allow that some children may take it up all days.
I understand that to administer detailed choices would potentially be costly. But already we have moved admin cost back from parent to school. From September, schools will need to administer how many children are taking up the meals, and any changes in numbers week on week. Until now, I could manage it with the provider online.
However, it need not increase the admin cost to schools or state, if I could continue to book for my children, as I do now, selecting their days and meals in advance, there would be a more cost effective use of our State money, without any change in administration. It would be up to the provider to bill as used, not blanket. Surely in these days of electronic charging, not hard, and could be made without manual intervention by the state, except for regular audits, which will need to happen anyway in any well governed accounting system.
Is this the wisest use of helping those in real need?
It feels as though the Government simply doesn’t trust us to feed our children properly. I think most I know do a fairly good job. And before anyone has a go at making it a class or wealth issue, I fundamentally disagree. You get good and bad parenting and cooking skills across the board. No one is perfect. I know families who are well off but their nanny takes them to McDonalds more than one night a week for tea. Families in poverty and moving out of poverty should get support in school meals for children, but I dislike the sweeping TV benefits-hype notion that ‘poor people can’t feed their children properly.’ As if somehow, wealth is an indicator of capability or ‘doing a good job’. I do believe that parents will always try and do the best to feed their children. There are of course the rare and horrific Daniel P. exceptions whose whole care was failed by parents and State alike. They will always exist and we as a society and State need to think how they can be best addressed. But is a rushed and inflexible system of school meals going to really address those exceptions? I don’t think so. That’s not what this is about and we shouldn’t let genuine individual cases, as well as media hype of individual suffering railroad discussions.
How was it done in the past? Some were granted the support of free school meals, so if they were then, and still are now what has driven the need for change? Is this new system, in fact a huge political admission that welfare support is not enough for the many, many families where both parents work hard and still find each month a stretch to get good food on the table every day of the month? I believe so.
{ Sept 5th 2014 update confirms: 4 in 10 children are classed as living in poverty – but may not meet the welfare benefit criteria according to Nick Clegg, on LBC. That’s a scandalous admission of the whole social system failure. He believes working parents can’t afford to feed their children properly? So fix the overall income levels, welfare, social housing balance. Not FSM. The statement that schools ‘have to manage lunch anyway’, shows a failure to understand what an average primary is like. Not the best political collected response to a flagship policy which he should expect to be quizzed on in ‘Back to School’ week. Hats off to the nine year-old who nailed it.}
I welcome anything that will help families feed their children well. However, school dinners does not necessarily mean good nutrition. I remember friends who got FSM vouchers and chose chips as a main course and chocolate brownie for pud. The work by the Trussel Trust and others, shows what desperate measures are needed to help children who need it most and simply ‘a free school meal’ is not necessarily a ticket to good food, without rigorous application and monitoring of standards, including reviewing in schools what is offered vs what children actually eat from the offering.
Parents know what their children like and will eat. There is a risk some children will simply eat less if they don’t like what’s on offer.
The entitlement is also not applied to all primary children equally, but infants only. So within a family some children are entitled and others are not. Will this reshape family evening meals, where now one has ‘had a hot meal already today’ and others have not? Feedback so far seems to indicate that there are great unknowns, and that the practical application of this policy will not live up to the nice theory.
It feels like we’re being distracted, with a pretty sticking plaster on a gaping social wound.
A personal perspective
I know our family will be happy to save any money we can, having just taken on a mortgage for our first home. But we are very fortunate, and to be honest, I just feel like we’re not entitled to it. I want the funds to go where most needed. I’ll be glad to have extra money at home, but we manage without it and I’ll still send them some days with packed lunch. Yes if it were only about cash and ‘entitlement’, we could choose to give any savings to school funds or another charity, but I also hate food waste. I worry that the quality of food standards will fall, for everyone. Why will this time be different compared with standards which were so poor in the past?
Why impose this method on all without rigorous planing and evaluation and a transparent communication of that to parents and schools? My school certainly doesn’t feel that has happened or been communicated, and has had a ‘a couple of emails”. And they are a great primary school who care about things being done well. At the end of summer term, ‘it’s a bit of an unknown.’ And as for parents, we got an SMS and asked how many might be interested back in March I think. Nothing since then. If this is such a key initiative and so important for the future well being of our kids, why are parents should be being well informed.
I now have to decide, to keep my kids in hot dinners, take them out, or keep our as-is preferred mix but feel wasteful.
Where do you draw the line between support and interference in our family life?
You could say don’t look a gift horse in the mouth, but it’s what is going into the mouths of our children that matters most. Jamie Oliver did his darnedest to educate and bring in change, showing school meals needed improvement in quality across the board. What has happened to those quality improvements he championed? Abandoned in free school & political dogma. There is clearly need when so many children are growing up in an unfairly distributed society of have and have-not, but the gap seems to be ever wider. Sheffield in 2012 had a 22% child poverty rate. Where is the analysis for true quality change, rather than change for a point of policy?
Is our children’s health a political football, which is being given as a concession in this Parliament, now rushed through to get checked-off, without being properly checked out first?
I’m not sure I trust the state imposed food standards to do a good job if the funding should be reduced in future, quality will fall again, back to the bad old pre-Jamie days.
Quality must be paramount if we are now expecting to see a larger portion of society, starting out with school meals, fed by State defined standards.
It seems there were pilots and trials but we haven’t heard much about them. There is plenty of history, but where is current discussion? I agree with David Laws, on the closure of school kitchens, but this mother believes current infrastructure and education should be fundamental to this programme, not coming in later as a secondary support measure. I wouldn’t normally choose to link to the Mail, but no other broadsheet seems to have covered it since the Department for Education guidance was issued last week.
Mr. Laws MP said,
“It is going to be one of the landmark social achievements of this coalition government – good for attainment, good for health, great for British food, and good for hard working families. Ignore the critics who want to snipe from the sidelines.”
I don’t want to be a critic from the sidelines, I’d like to be an informed citizen and a parent with choice. [and please, stop using hard working families, it indicates some sort of value judgement, which is borrowed from the coalition partners and not in a good way]
This is a consumer choice and health issue, having an effect on a practical aspect of my parenthood. It’s not a tenet of education substance.
Like these people and their FOIs, I want to ask and understand. I have questions: How will it affect the majority? Will this have a positive effect on the nutrition children get, which may be inadequate today? What guarantees are there that adequate food safety and quality issues are properly and independently governed? Will it be overall less costly and beneficial to children and parents? Will it reduce stigma? Will it increase hot dinners consumed and reduce packed lunch intake? (So much less healthy, we are told.) Is the cost worth the benefit for a minority or even for the many? Will it benefit the health of all our children?
Free, but what will it really cost?
Honestly, I don’t know. But that’s my main concern. It’s being done in such a rush without due transparency and communication, I don’t think anyone knows.
I looked in two previous posts at the background theory [1] to commercial uses of our data, then, the background to my concerns of commercial use with data intermediaries. [2] This is now part three, my glimpse into commercial use in real-world practice. It’s become rather a saga.
Here’s the short version: “In general commercial uses of data, I am increasingly learning that if you don’t pay for the product, you are the product. We need to shout a bit louder, that we are not a product for sale. It’s not only that there is an increased risk in a move of our health records from binder to byte and broadening access to them. We take issue with the change of approved purposes from care, to commercial use.”
At the Health Select Committee on July 1st, [3] I believe Sir Manning misses the key issue the public has with care.data and health record sharing, when he gave a response to Q562 to David Tredinnick MP:
‘We made big mistakes over the last 10 years’
“I am saddened by some of the comments that have been made this afternoon about the lack of trust and also by the impugning of our motivation. […]
We made big mistakes over the last 10 years, and we have a once-in-a-generation chance to get it right. I am absolutely clear that we have to engage the public in an open debate about the balance of risks and benefits. There will always be risks with data. There were risks with the Lloyd George envelope; notes were lost, they flew and went all over the place. There will always be risks, but those risks and the benefits are both enhanced by the technology.”
Whilst I applaud Sir Manning’s apology, and his call for open debate, I think he misses here the fundamental point of disagreement the public has with the HSCIC current practice. Selling our health data.
It’s not only that there is an increased risk in a move from binder to byte and broadening their access.We take issue with the change of approved purposes from care, to commercial use.
And these commercial (ab)uses in current form must stop if we are to trust the governance system in future.
Health Records for Commercial sale
HSCIC currently sells our health records for commercial purposes, to intermediaries with commercial re-use licenses, and had no consent nor our permission for this in the past, it continues to do so in the present and appears to have no concern or intention to stop doing so, for the future.
Mr. Kelsey added at the HS Committee,
“We have a very big job to do, and I hope that you will hold us to account in delivering it.”
To which I can only reply, it is you who say it. But who is accountable? The Open Debate which Sir Manning calls for has not been taken up by NHS England. We are told this is a programme of national importance, one which Mr. Kelsey has repeatedly said, including to the Health Select Committee previously, on which the entire future of the NHS depends. Why then, no national discussion, no news since the pause and a focus on updated communications of the current plan. The current plan with flaws in consent collection, scope determination, confusion of purposes.
There are so many ways this could be improved and gotten right, but not by November and without public debate.
How can you insist a programme so vital for the entire future of the NHS yet encourage no public discussion? This seems to be a theme in NHS England recent programmes. [4] The decision to outsource the GP support services was taken in private sessions, not available to the public like the rest of the Board Meetings [5]. Other programmes, pilot and actual plans for implementation go on without public discussion.
There’s been no apology for the data sharing policy developed since 2010 which has encouraged commercial trading and enabled this erosion of security, confidentiality and trust in the data management system of our nation’s health records. No one at the Department of Health has said, we got this policy wrong. No one at NHS England, the same people if under a different label. Poor Sir Manning at the Information Centre who carried out their policy, has been left to say there were ‘big mistakes’ made. But not by him since July 2013.
Trust and care.data off course
That our trust now lies in tatters, is not the fault of the Health Select Committee member to whom Sir Manning says, he is saddened and disappointed. It’s not Joe Public’s fault who had no idea this was going on, until six months ago. Where did these policies and plans since 2010 come from? Where did the use of our data go so astray and why is flagship care.data now so terribly off course? Mr. Cameron outlined it in 2011. What happened in the three years?
Health records for sale
As I wrote in a previous post,
“Some of that data goes back into our health market as business intelligence, both for NHS and private use, for benchmarking, comparisons and making commercial decisions. In our commissioning based marketplace, this re-use of data is now becoming normalised.”
But should it be normal that our medical records are for sale?
When celebrity Michael Schumacher’s notes are for sale, [6] being offered concretely to the media, we all see that is wrong. Just imagine 70 million copies of Schumi’s record, each with our own name on it, being offered to anyone outside of those who need it for our care. Offered to these commercial for-profit data intermediaries. It’s not a theory – this is what is happening to our records, today. Don’t accept the ‘anonymised’ statements, they’re simply not true. Identifiable data and pseudonymous data has been sold. The register confirms it, and that was only a 10% sample.
“To earn the public’s trust in future, we must be able to show that our controls are meticulous, fool-proof and solid as a rock.”
I think banning data sharing for commercial use and re-use would be a good start.
What is it to be used for and why?
When we think of our health records being used by others, we need to separate the uses of the data, in order to understand different ways it is used, who uses it and why. Data once it is processed becomes knowledge which is used as Business Intelligence. It is common in discussion to conflate use in care with care.data. It’s even in the name. But the uses of care.data are secondary. Not to be used by clinicians caring for us, not replacing hospital notes to give to consultants when we are referred for a hospital stay. Not providing discharge papers. It’s only approved for commissioning and sketchily [imo] approved for risk stratification. [ref p.5 ] [8]
care.data extracted from GP surgeries, is not even approved for research purposes, but to read all the recent debates you’d think research depended on it. Research using GP extracted patient data, is not an approved use of care [dot] data. Research using GP extracted patient data is not an approved use of care [dot] data. Repeat, ad nauseaum.
What is already being done, and what is used legitimately i research such as public health (albeit without our past knowledge or consent), is with our hospital data, HES, SUS, Mental Health data, usually with CAG review, and through 251 approval sometimes through DAAG review at HSCIC – it is available and is on sale to all sorts of other non-care providers. And that is planned to continue.
The records extracted so far, when not used for research appear in recent years increasingly used for comparison, the concept of ‘ranking and spanking’ professionals and providers of healthcare. They are also used in commissioning, payment validation and understanding costs and spending. But beyond that, there are all sorts of others who still come under the umbrella of ‘health purposes’ but don’t directly benefit the NHS or individual patients. What is their demand and what are they being supplied?
In the newly created NHS marketplace, customers at individual level are patients, or at a market level they could be any part of the healthcare buying structure, a GP practice, a Clinical Commissioning Group, a Hospital Trust.
The challenge of any demand and supply chain process, is that you need a market willing to pay at the price you are prepared to sell. And you need to offer what they want to buy. For that, the buyers must see a value in the data they want to obtain. Where is the value for these areas of use: Generic NHS Business Intelligence, Generic Commercial Intelligence and Pharmaceutical intelligence?
Health records as Business Intelligence
Some companies take data and process it before selling it to NHS and other health providers in England. This provides a third party service and skill set which the HSCIC nor the NHS Trust for example, has themselves, such as IMS Health.
So business intelligence used for the benefit of the NHS, makes sense and is necessary to a greater or lesser degree depending on your attitudes to comparison websites, green/red flagging professionals and commissioning. Benchmarking was provided by Tribal until that part of their business was bought out by Capita.
These companies’ experience and market is healthcare. The kind of knowledge they can give to the NHS is highlighted in their case studies.
So for clinical care, and for commissioning at individual organisations, these tools are clearly useful and use individual patient level data. [9]
Al sorts of other places and individuals perform these services. They include a wide range of commercial organisations, small and large.
Health records as Commercial Marketing Intelligence
Commercial buyers however, can include wanting data for identity verification, fraud prevention and background checks. Services such as Experian offer. These may be what the loose definition in the Care Act would say are now banned, but are they? What is to say that a company which offers the use of private health services, healthy eating or pharmaceutical marketing is not providing information to others, for the promotion of health?
“Experian employs more than 12,500 people in 34 countries worldwide, supporting clients in more than 60 countries. Annual sales are $3.1 billion (£1.7bn/ v2.5bn).”
Identity verification can be done, matching data across a biographic footprint, ” in databases, established for 45 million UK citizens and hold in excess of 1 billion records.”
“Experian public sector currently works with 380 plus local authorities, 52 police and investigatory bodies, as well as central government agencies including DVLA, HMRC, DWP and the Cabinet Office.” [10]
There is clearly a lot of data sharing in the public sector, about which we may understand very little. But mostly the buyers of data want to sell something. Companies buy lists of people to use in marketing campaigns, who might be interested in what they’re selling — and companies also want to learn more about their current customers.
This is where I find the level of detail and what is done with our data, more than a little freaky.
Every UK consumer is classified into one of 22 types, aggregated into six groups. The 22 types are linked to six decision-making styles, providing insight into consumers’ motivations when using different media and the processes they go through in deciding about products and services.
I don’t know what segment I am in. But I know that I will have data stored in many of those different data sources they mention. So do they actually know more about my habits and inclination, that I have self-awareness? If their tool has over 850 million input sources which they process, it’s more than likely. 34 million email addresses, 20 million mobile phone numbers, 49.7m names and addresses.
Experian may well have much of this data from the electoral roll (unless like me, you opted out of these uses) but in the HSCIC January-April 2014 register of releases [7] data was given to Experian for use in Mosaic. (see July – 132kb right of page)
“Mosaic is Experian’s powerful cross-channel consumer classification designed to help you understand the demographics, lifestyles, preferences and behaviours of the UK adult population in extraordinary detail.” [12]
That they understand and track my behaviours probably better than I do, and at such detailed level, I find surprising and invasive. In fact, I find it threatening in a similar vein to the visceral reaction that the Facebook experiment generated this week online.
As SF Gate reported,
“Using unsuspecting members as human guinea pigs is repugnant. And when the biggest social network on the planet does it, can its leaders be trusted with their own technology?”
This idea that just because one can and the technology permits it, does not mean that one should. It just feels wrong to find out others may manipulate our thinking and behaviours in such a targeted way. Just as Experian does with consumer data:
“Within rural areas we are able to pick out the individual households that are likely to be commuting to towns and cities nearby…”[12]
Individual households? Understanding my behaviours, gives them information which they use to nudge or influence my decision making. Understanding our behaviour ‘in extraordinary detail’ helps companies market and sell more to customers.
There are other re-uses even for health purposes, which seem less transparent and more about us as general consumers, rather than for our health. For example, the use of HES data is in social marketing targeting:
“In this way, companies who process data such as Beacon Dodsworth received data in the last year and offered it for commercial exploitation by others “HES data may be used by pharmaceutical companies “to improve [their] social marketing / media awareness campaigns”. Others included OmegaSolver and Harvey Walsh.”
These companies have re-use licenses for data. what that means is better explained here by medconfidential. [14]
How will HSCIC know how data will be used after release and how will it be audited and how often? When it comes to human tissue, the HTA only audits tissue banks in the UK once every three years. That’s a long time in between audits if something has gone horribly wrong in best practice.
Health records as Commercial Pharmaceutical Intelligence
To global pharma it is again not the data itself which is of value, but in the knowledge it reveals. The pharma business intelligence. It can show at an individual level what is being prescribed or show any gaps it reveals, which will allow pharma, to address ‘unmet clinical need.’ The data already compares hospital prescribing and reports make recommendations used by NICE on what drugs to use and recommend. My concern is that to treat the worried well who have cash to spend, will deflect attention from the needs of the sick and poor and that even if only at postcode level, we will be targeted for pharmaceutical marketing.
“The parties will initially look at how anonymised, integrated health data can be used to identify unmet clinical need in patients with diabetes. In the UK, diabetes affects approximately 2.9 million adults overall, with more than 90% of these patients having type 2 diabetes. This makes diabetes one of the most common chronic medical conditions and represents a significant strain on U.K. health services.”
Astra has another Memorandum with IMS Health. So we, whose data it is, have zero transparency and can request no accountability for the use of our data once it has left the HSCIC.
And it matters because when there are data breaches in these companies, we should know whether our data has been involved.
In January 2012 AstraZeneca signed a three year partnership with IMS MOU[16] and stated it builds on AstraZeneca’s existing ‘real-world’ data and research partnership with HealthCore in the US, the health outcomes research subsidiary of WellPoint. Wellpoint which had a massive breach a year ago, July 2013. So how do we know where our data was stored, and if it were involved or not? Here is what pharma use data for, to analyse “unmet clinical need.”
“The partnership with IMS Health will give AstraZeneca access to pre-existing anonymised electronic health records, which include clinical outcome, economic and treatment pattern data. In addition, the companies will jointly develop a customised research and data analysis platform. The information will provide a deeper insight into how medicines that are already on the market are working in real-world settings across Europe, painting a picture of unmet needs …”
We can look at this more than one way. Some feel strongly commercial use should exclude Big Pharma. On the one hand, the State and Government does not own manufacturing of drugs nor medical products. Though we used to do both. Recently, that we did own, has been increasingly sold to commercial buyers or venture capitalists.
The State and pharma work together, often through University research, to create future health solutions, drugs and the drive towards personalised medicine and diagnostic tests. When companies which own our data are sold and bought internationally what happens to our data they own? Boots Alliance bought data from HSCIC, and they are about to be bought by US Walgreens. So many questions.
Those more informed than me will know all about the challenges of pharmaceutical companies, the patent cliff, mergers and diversification. IP, diagnostic tests and generics in the market. Big Pharma and the State are working together in much research to find solutions and discoveries to current and future medical issues.
How far does cooperation stretch and when does it become inappropriate? Is commercial interest supportive of State practice or driving decision making policy? Should commercial companies fund any costs at our NGOs? And do those which buy the most data, get a bigger slice of the influence of what conclusions reports using the data, reach? Whilst there is a public move to #Alltrials I believe we should demand #Allreports in the public interest as well. I would like to have transparency at HSCIC how their reports are funded, when working with partners which are frequently commercial pharma partnerships.
Mr. Hunt recently defended to the Health Select Committee the reasons why a commercially supported pharma lobbying group was used to advise on the NHS Commissioning plan – the Specialised Healthcare Alliance. Supported by 14 pharma companies, these corporate members are contributing £12,000 each towards the costs of the Alliance for 2014.
Are we really seeing transparency on who is driving change in our health service?
The Richness of our records open for Exploitation
The value of Big Data is only extracted by exploiting its richness. And these days, with mobile phones, social media and shopping habits tracked by the minute, the average citizen like me, it seems can’t easily avoid being part of it, whether we want to be or not.
But if we don’t even have the right to control and own our data and we can’t control the knowledge generated from it, how can we control who knows what about us and what they use it for? If we’re unaware of its existence, how can we understand its impact on our life to make free and uninfluenced choices in what we buy, for example? Or understand how we may be segmented and discriminated against. And this is aside from the assumption that the data held is accurate and that as a result, no mistaken judgements are being made about us.
As for our health data, how can we control its use by these massive data managers if we don’t even know who they are at the end of a chain of re-use licenses?
Put Business Intell, Commercial Intell and Pharma together
The vast amounts of data already held and analysed to the nth degree by these data intermediaries, means that making even more data available to them is going to increase the segmentation and risk of identification. They already have data on individuals and is it not enough that they make analysis at household level as shown by Mosaic? Individual health level data seems that they could put a final piece in the puzzle and know exactly who in which house had which ailments, their lifestyle risk factors could be refined and these data brokers would be able to look inside our very bodies.
One which fits data together, we do know from the HSCIC data release register, and press reports in March, is Harvey Walsh. The company tracks individuals pathway data, over time and the website now says:
“Harvey Walsh use non-sensitive and non-identifiable HES data for patient pathway mapping that is used by the healthcare industry with the NHS to improve the quality of healthcare management and service delivery by better understanding how patient cohorts move around the healthcare system.”
[Harvey Walsh’s system] “AXON holds non identifiable and non-sensitive HES (Hospital Episode Statistics) data and other sources of data including GP Practice Prescribing, QOF, Demographic and NHS personnel data sets.”
Data snapshots combine to give a Picture over a Lifetime
So now, not only can these companies understand us in infinite detail, but can do so over our lifetime. We are tracked over time and anaylsed not as a snapshot, but as a living album of snaps, moving across time. They know what we do commercially, in our lifestyle and how it interacts with our health and what may affect our consumer habits and help nudge our decision making. Put them together, and it starts to feel like I’m on The Truman Show.
I’d like to know though, once the data is processed, what happens to the new combined knowledge set, it creates? The original raw data as extracted may not be given to others, but is it the same product and protected, if it now shows up as a small piece, in a bigger jigsaw?
Omega Solver took their product offline this year, after privacy campaigners identified the risk of identifying individuals.
Acxiom as a world data leader example, is a company which provides consumer data and analytics for marketing campaigns and fraud detection. Its databases contain information about 700 million consumers worldwide.
“For more than 40 years, Acxiom has been a leader in harnessing the powerful potential of data.”
It seems others share my concerns, as this article on how data brokers use of our data is creepy, from Julia Angwen showed up in my alert feed this week, and another in ProPublica from last September. As she says,
You can see more on this, in her interview with PBS News:
Our lifetime data is attractive to commercial marketing and all sorts of organisations who wish to understand us and sell to us. The one purpose, possibly the least trusted I have not really touched on. Hospital records have been shared with insurers and used for refining policy. Records have been sold to re-insurers, even since January 2014. And these insurers mine and use data much more deeply than we want to imagine. In fact, as I finish this I see the FT front page tomorrow carries a current story how insurers trawl our Big Data.
FT Insurers trawl Big Data
HSCIC Data Sharing Agreements will prevent Data Merger?
IMS Health UK & Ireland’s general manager, Michael Sanvoisin shows that exploiting the different data sets ‘out there’ in Big Data, is kind of the whole point. [17]
“The smartest use of data will be the effective combination of all the various sources of open data and patient information services available in the marketplace, augmented by companies’ own internal information and data from other reliable and reputable sources.”
IMS Health is working in partnership with the MHRA – and in particular the clinical practice research datalink (CPRD) – to help the UK increase its capabilities to build cohorts of patients for clinical trials. This has led to the linkage of IMS Health’s Hospital Treatment Insights (HTI), the aggregation of HES and prescribing data, to the CPRD. This powerful linked dataset enables the identification of specific patient cohorts and allows companies to monitor patient flow between primary and secondary care. IMS Ardentia’s Costed Care Pathways (CCP) sequences clinical events together with detailed financial information to give a longitudinal view of a particular patient care pathway.” [17]
When these global companies have in addition, bought data from HSCIC, where is the transparency for patients to know what internal practice at these private companies prevents all data becoming one Big Data set, in identifiable or pseudonymous formats, and sold or shared onwards with others?
The Recent register states explicitly, that IMS will not do this, that the data will not be sold onwardly, but how about theknowledge they create from it?
“ANDromeda is an engagement tool enabling greater market access with a tailored need across all functions within pharmaceutical companies.
And in the UK, are involved in work shaping our health market: “that may involve looking at how primary care organisations operate or focusing even closer on area-level commissioning, such as GP consortiums.”
Where is our Data being Used?
“The effective combination of IMS Health’s proprietary data assets, in addition to the vast swathes of open data being made available, can help inform key strategic decisions for both the NHS and pharma. Moreover, it can drive an increase in joint working towards shared benefits and therefore transform healthcare services in the UK and beyond.”
“in the UK and beyond.” So I ask myself, which countries outside the UK have received our medical records? Remembering that non-US citizens have no privacy rights in the US, if it landed there, we can say good bye to ever getting control of that knowledge back again.
Indeed HES extracts have been given to places in the US, specifically the University of California, the FOI request I got back confirmed. The Partridge Report contained two examples of data which has gone to Kyoto University. Yes, Japan. And remember, if the data is completely aggregated and anonymised it’s not included in these registers, because it is open, green data. So what exactly went to California, Japan and who knows where else. No one knows 100%. The Report only sample tested 10% of all releases.
IMS received 251 access (which is required for confidential data without consent) for identifiable data extracted from hospital pharmacy systems, sent to HSCIC and linked with HES (hospital records). The main customer for these products will be the pharmaceutical industry. (Lines 101-2).
IMS Health is massive, as is the global health data they hold.
On the IMS One intelligent cloud, the company connects more than 10 petabytes of complex healthcare data on diseases, treatments, costs and outcomes to enable our clients to run their operations more efficiently.
Drawing on information from 100,000 suppliers, and on insights from more than 45+ billion healthcare transactions processed annually, IMS Health’s 9,500+ professionals drive results for over 5,000 healthcare clients globally. Customers include pharmaceutical, medical device and consumer health manufacturers and distributors, providers, payers, government agencies, policymakers, researchers and the financial community.
Another user of our data is Optum UK (formerly United Health Group, and if that sounds familiar it was Simon Stevens [18] last employer). I wonder for example, does that mean it is also used by Optum Insight in the US? This presentation by Christopher M. Blanchette, shows different data providers of ‘RWE’ real-world evidence and where their data is sourced.
If international companies have NHS England patient data and re-use licence, is it likely in to have been exported around the world or how can we know in which locations it is used? I want to know how often data is given directly to International companies? How often is data given to companies in the UK, who have foreign centres outside the UK, which would routinely share that data with their central systems and therefore export it? It is a basic right of data management to require fair processing for identifiable data, to know who has it for what purpose.
How do we protect consumers’ concerns?
And as US Commissioner Julie Brill’s report shows, in the States there are concerns how this data is used and they are acting on it. Are we doing the same here?
Dr.Neil Bhatia in Hampshire, a GP who founded the non-commercial website care-data.info, asked HSCIC in an FOI request for the data *about him* which was released to these type of intermediaries. He was told, the data controller, the Health and Information Centre, does not know. And he can’t ask for what data is held in pseudonymous format – even though the data is pseudonymous with a key to make it linkable with new identifiable data coming in, so to me, that makes little sense. It is by its nature, re-identifiable.
But if HSCIC won’t release it in a Subject Access Request (SAR), we can then only surmise, whether our individual data was contained in bulk data transfers. So from the released data register, we should look at what types of companies are using pseudonymous (so called ‘amber’ data), and assume our own data was indeed included.
Overseas Data Distribution and Protection
care.data, it was said at the Health Select Committee meeting by Mr.Kelsey in March, was only for use in the UK but the HES/SUS data application form includes a field for use overseas. So, does that mean policy for export has changed for all data, or should they have spoken more precisely meaning only that “GP data extracted in care.data” was only to be used in the UK?
Because IMS, again, already has access to primary data from CPRD and secondary care data according to line 10 from HES. And whilst, it states “[Note added 28/3: The data are onwardly released only in aggregate form] I am curious – where does ‘onward’ mean? There is no Ltd. on the company name, no territory or geography indicated in the register. So if data is released to an American firm, should we assume it sits on US servers and is accessed directly by their US staff? Does onward only restrict them from giving the raw, identifiable data they received, to others outside IMS? Is it availble in non-aggregate form inside the whole of the IMS system? I, in the general public, can’t tell from the register and IMS is hardly going to tell me. We should be able to find out. I’ve found it a challenge, and my FOI request to HSCIC [14] to find out what data may have been given to US or Asian organisations, was tougher than my entire lifetime of dental appointments combined. It shouldn’t be difficult. Patients should be able to easily ask, to whom did you give my health data and where, for what?
Do we know enough about the plans to use and commercially re-use our data for commercial ‘health purposes’ as being broadly defined in the Care Act? If not, patients should be asking. GPs don’t have time.
Why does it matter? Because legal jurisdiction of data is still (perhaps outdatedly) physically geographic at least in aspects with which I am familiar. When working on global implementations of confidential employment data, we had to gain legal advice from each territory submitting data, on how we should legally properly manage data from over 50 countries in the world and its access by regional and global teams in the US, Europe or Asia. And on simple terms, we should always handle, process and use data in a way the individual expects and feels common-sensed appropriate to the purpose for which it was submitted. British citizens are not protected by US privacy laws because they apply only to US citizens.
“Existing laws do not sufficiently address data brokers’ handling of sensitive data in marketing or risk mitigation contexts,”
says Julie Brill’s statement. Well they don’t protect us Brits, at all, so I want to know if it’s being used abroad.
Few in England, will expect their data to have been made as freely available at identifiable individual pathway level, as it appears to have been in recent years. Do I at least have the chance to protect my children’s future data privacy, if not my own now?
Surely we can trust Data Protection Laws?
Because of the legal status of data which is deemed “de-identified” or “anonymized”, it is claimed they don’t violate our rights to health information privacy – Data Protection law accords us only the right to fair processing, not to prevent its processing, due to the the Health and Social Care Act 2012 which requires its extraction — but if it’s possible to re-identify longitudinal data sets – and if the whole point of getting these data sets together is to combine them, surely common sense would say, it may be legal, but that doesn’t make it right. There are other DPA expectations which HSCIC also fails to meet. The Minimum data required, for example. Deletion. Accuracy. I am guessing that every single one of the eight Principles have been broken by our data extracted before the HSC Act 2012. Yet, everyone seems to be ignoring this.
When it comes to Data Protection, identifiable data is treated differently from anonymous data. Amber individual level ‘pseudonymous’ data, is not the same as aggregated anonymous statistics and the care.data privacy impact assessment [19] confirms the risk of re-identification, yet the data is being treated as if it is anonymous. I can’t believe people working in the field believe themselves these data groups should be looked on as being equal. In my opinion, it’s not so much a case of wearing rose-tinted spectacles, it’s more like a blindfold on the wise monkeys; hear no evil, see no evil. [20]
I can quite clearly state on behalf of many, we feel that our rights to privacy have been and continue to be violated, no matter what the letter of the law says.
Whilst HSCIC may see only its own data sharing practices in a silo, that’s not how the impact of its sharing works in real life. It’s a join the dots between different data sets from different sources.
Can Good Governance Give us Confidence?
We are told that data-sharing agreements make it illegal for the data to be combined with other data held by the recipient, to make it identifying. But if the Data Controller doesn’t know what data the company already has, and doesn’t even keep track of what data has been given to them already, it must be impossible for individuals within these massive corporations to know the impact of adding their piece of the jigsaw puzzle. Over time, they will not track either, what from their company has already gone into creating the Big Data picture.
We could only rely on release controls and good governance, but for the past ten years reported in HSJ and the Partridge Review, it appears some datasets have been inappropriately shared without audit, which would have spotted the mistake. Governance is simply inadequate. In my opinion, not with malicious intent. Rather, simply, the data sharing strategy has been too fast for its own good practices to keep up. Now, it has to catch up fast.
As awareness increases, so too is the push back on the privacy grab. How do we feel about losing our individual rights, the removal of confidentiality and consent, the right to freedom from cold-calling, and to know who has our data for what reasons. And do we feel the same if we lose those rights in the name of commercial or public interests?
The British public is pushing back on banking failures and resents increasingly to see the minority of individuals benefiting commercially at the expense of the many. We resent the paternal state definition of the ‘Public Good’.
The public interest considered by CAG in reviews of data release applications, must consider protecting both the public interest in research access to confidential patient data and the public interest in a confidential health service. Add to that the public interest of providing a national health service, and its safe to say ‘the public interest’ will be hard to satisfy for all of the people, all of the time and will be subjective.
“that the purpose for which the data will be used should be in the public interest and for the provision of health and care services; [and] that any approved processing must respect and promote the privacy of patients and care service users… ” (Hansard, 10 March 2014, Col.137)
Perhaps even more subjective, is the atmosphere of public interestand how interested the public is, in how how level decisions affect us on the ground. Certainly, Snowden and other data sharing revelations have coloured the muddy backdrop of how our data is gathered and used by others, and increased calls for transparency.
The Department of Health will be furious with the Home Office I expect this weekend, as they triggered a massive outcry over the perceived lack of transparency and scrutiny afforded to MPs and civil society over the Data Retention and Investigatory Powers Bill. Even Radio 2 gave it 20 minutes coverage. [22] (From 01:36.40) This kind of governmental out-of-touchness with the public and the perceived desire to hide something in the rush to the new legislation, is what undermines trust in all areas of the public-state relationship.
It implies a paternal notion, of “we know best, so just trust us little children.” Well, that ain’t gonna fly. Seahaven is not “the way the world should be.”
Patient empowerment to own our Health Records
This flawed process, within and beyond NHS data sharing, has also created a sense of loss and disempowerment. Whilst presentations are all about ‘patient centred’ care, and ‘personalised medicine’ sounds so about the individual patient, it seems safe to say patients have been left out of the digital decision making and sharing how those decisions will affect the public on the ground. This for care.data, should have been central to plans to ensure support and success. There are still unfilled positions supposed to be filled by patient organisations or patients on the tech board.
It seems endemic to new programmes too. Or have patient organisations been widely involved in the genomic plans for the nation and not told us? Unlikely.
The talk thus far, does not match the walk. Knowledgable patient involvement is as desired by some of those leading parts of NHS patient engagement, as a chocolate teapot is useful. One is documented having said on another programme, “this was not a suitable point for patient involvement.” Either you want patients involved or not. Involved means from the beginning. Not as the decoration at the end, a way to tick the engagement box.
The notional idea of patient empowerment in this programme is tokenism, if the most basic principle of care, the only thing I can control in my consultation – my patient confidentiality – is treated with such little respect.
Is the public good really defined and does it outweigh the private good and our long established rights of consent and confidentiality? Does it vary depending on circumstance and if so, who decides?
It certainly doesn’t seem to be us, the patients in healthcare. Nor as citizens in any other field of our personal data.
If you don’t pay for the product, you are the product
In general commercial uses of data, I am increasingly learning that if you don’t pay for the product, you are the product. Maybe we need to shout a bit louder, that we are not a product. We do not all want the knowledge of our health & lifestyle to be for sale.
We’ve got used to these third party uses through the recent media revelations and the acceptance that current Government seems to be prepared to sell anything the State has in its possession. I wonder how representative that is of what the people would choose to do?
So at the risk of repetition, let’s not forget the basics:
The list of past customers in the Partridge Review of those who received data before April 2013 shows the extent of what was hidden from us for twenty years.
Should we be asking, what may be hidden still?
By stretching the scope of the potential discussion around the ‘industrialisaton’ and use of our health records for secondary purposes, we must not normalise the basics which we at first, found so surprising. We need to get them fixed first. Then, only then, will patients be willing to look at broader future scope. If I can’t trust you to manage my hospital record when I broke an ankle, why would I want to trust you with my genomes in future? It reveals a complete disconnect at NHS England level with the public in care.data thinking.
Come back to reality and listen to patients’ real concerns. We don’t want our data given to third parties, these data brokers and intermediaries or to continue re-use licenses. Even if it’s for ‘the promotion of health’ the purposes in the Care Bill.
And honestly? NHS England and the Department of Health shouldn’t want that acceptable in policy either, because they need to know who has our data, to govern it to make sure it is acceptable. As Sir Nick says in his report, the future data governance must be:
“meticulous, fool-proof and solid as a rock”
One more big mistake in who received our data in the future, and all cards will be off the table. For this to work, you need to properly manage it. And all this at the time where NHS England has now decided to outsource population wide databases, through the Steria outsourcing. Ha. Get that outsourcing security wrong, and for all your future programmes, as Truman would say, “Good morning, and in case I don’t see ya: Good afternoon, good evening, and good night!”
In the words of more Americans for whom I have a respect & love of their self-determined own words, Simon and Garfunkel, ‘Slow down, you move too fast.’
Julie Brill’s Statement made a recommendation in the US:
“A second accountability measure that Congress should consider is to require data brokers to take reasonable steps to ensure that their original sources of information obtained appropriate consent from consumers.”
We should feel that we consent to this mining of our health, wealth and lifestyles and know what is done with that knowledge. I feel disempowered because in finding out how my health data is used, I’ve discovered a brave new world of how my personal data is used. By commercial business. By Government. By suits and wonks as may be nicknamed. I am not equipped or informed enough to understand it all, but I’m doing my best to find out.
We need to trust in the people who manage these systems, who drive the policy and who advise the two, to work together and make technology work well for the rest of us. It should work well with privacy and security, and functionally.
Patients must speak up and Ask Questions
Patients must start asking more questions about these commercial uses and re-use licenses, because whilst the commercial intermediaries may access data for the purposes permitted in the Care Act, we are not a partner in patient engagement. Our data is being mined in the name of NHS improvement. Our samples being gathered in the name of science.
We are the product for sale. Our name, and everything else about us.
[3] Health Select Committee July 1st, 2014: http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/health-committee/handling-of-nhs-patient-data/oral/11192.html
[9] IMS Health Ardentia http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Technology/Technology%20Platforms/Ardentia/Ardentia_Royal_Free_PLICS.pdf
[10] Experian Public Sector http://www.experian.co.uk/assets/identity-and-fraud/authenticate-for-public-sector.pdf
[17] IMS Health using NHS patient data http://www.imshealth.com/deployedfiles/ims/Global/Content/Solutions/Healthcare%20Analytics%20and%20Services/Healthcare%20Outcomes/IMS_HTI.pdf
“These days, when we use the word “privacy,” it usually has a political meaning. We’re concerned with other people and how they might affect us. We think about how they could use information about us for their own ends, or interfere with decisions that are rightfully ours. We’re mindful of the lines that divide public life from private life. We have what you might call a citizen’s sense of privacy.
Virginia Woolf, 25th January 1882 – 28th March 1941
“To be silent; to be alone. All the being and the doing, expansive, glittering, vocal, evaporated; and one shrunk, with a sense of solemnity, to being oneself…”
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