Tag Archives: NHS

Blue Sky Thinking – Civil Aviation Authority plans to cut medical services – public consultation appears to be tick-box

Updated March 2016: the world class services at the centre have been closed. Class 1 and 3 medical certificates are no longer provided via the aeromedical centre at Gatwick.

The most recent CAA update of January 2016 confirmed that the plans would go ahead despite almost universal objection to many principles and the way it would be done. Unsurprisingly, there were only 15 responses to the 3rd consultation.

CAP 1338 was the third of three documents published by the Civil Aviation Authority in 2014-15, which had only 15 responses. The first two were CAP 1214 (www.caa.co.uk/cap1214)
and CAP 1276 (www.caa.co.uk/cap1276) which includes the 40 original responses to consultation, including major airlines, BALPA, the Honourable Company of Air Pilots (guild founded in 1929), aeromedical doctors and other professionals. All of which objected.

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Blog published October 28, 2015:

If government divests the state of our expertise along with our infrastructure, how will we ensure services continue to deliver universal public good?

The NHS is struggling to monitor the safety and efficacy of its services outsourced to private providers, according to a report published in the Independent in April. Now consider an outsourced medical service where the safety and efficacy is reduced, for our commercial airline pilots. #Whatcouldpossiblygowrong?

If you looked very hard at the Civil Aviation Authority’s website over the last year you would be forgiven for missing the links to the consultation to outsource or divest from its medical services. [1]  This is the service organisation of 30 or so staff who ensure in a part state owned set up, that newly qualifying pilots for commercial airlines and air traffic controllers are fit for the job. And not only British pilots, but others come from outside the country, so great is its reputation. It is the last state-owned of 4 such centres, and based at Gatwick.

Pilots have unique needs and unique fitness-to-fly checks to pass, as documented by Aida Edemariam in last weekend’s Guardian: “The medicals especially, Bor says, mean facing “the risk of losing one’s job… as often as every six months”.”

The initial consultation, now a year ago, suggested outsourcing the service to the private sector. Today it seems the prefered path is complete divestment from the delivery of its services. The second part of the seemingly tick-box exercise closed today. [5]

Tick-box, because the plans are going ahead despite almost every response to the consultation voicing concerns or serious questions, including from major airlines. Balpa at the time hadn’t been able to adequately respond in the original Oct-Dec 2014 timeframe. Many other suggestions and ideas were raised, but from the CAA consultation response to criticisms it seemed blue-sky thinking, creative alternative solutions differing from the CAA plans, was not welcomed.

It seems that in a bid to become lean, akin to having less to pay for on the balance sheet, the government is selling off not only concrete assets but losing British state-led skills in services at which we excel. It is asking commercial companies to fill the gap and many question if there is sufficient expertise in the commercial market to deliver.

There are five key concerns here. The first, is that without the state to hold accountable for the service, airlines and pilots must foot the bill they can no longer control, in a near monopoly market. Elsewhere in health, spending on outsourcing these services has  reportedly rocketed.

The second, is quality control. How will quality of delivery be maintained for services which operate entirely for the benefit of the public good, but are now be required to turn a profit?

And the third is continuity of service. How will the universality of these services be maintained, offered fairly and to whom?

The fourth is whether the UK should sacrifice its unique leadership position of respected medical expertise in European and global flight safety?

And finally and most importantly, pilots, airlines, and healthcare professionals questioned in the last quarter of 2014 whether safety may be put at risk if the cost cutting move at the Civil Aviation Authority goes ahead.

This cut to regulatory oversight is part of the bonfire of red tape.

Responding to plans outlined by the Civil Aviation Authority in a public consultation [1] last autumn, professionals overwhelmingly suggested service improvements could be made without outsourcing what one airline called “the priceless nerve centre of expertise in the CAA”.

Based at the CAA’s Gatwick headquarters, the aeromedical centre offers the initial medical examinations required for commercial airline pilot and air traffic controllers and periodic checks thereafter. It also undertakes assessments of the fitness of pilots to return to flying after illness.

“All pilots who hold a commercial licence undergo an annual Class 1 medical assessment with an Aeromedical Examiner, increasing to every six months from the age of 60, or 40 if they are undertaking single pilot operations. [source: whatdotheyknow.com ]
The CAA expects to reduce overall costs by outsourcing all of its aeromedical non-mandatory functions, outlined in consultation plans that were discussed with potential providers at meetings in mid April. [2] But unions suggested the CAA is putting commercial pressures before the public interest and denounced the plans.

Steve Jary, Prospect national officer for aviation, said:

“The CAA executive board needs to listen and put safety, not commercial interests at the heart of its decision making.”

In its follow up consultation response in early 2015, the CAA said it does not believe in putting a price on public safety and it realised that cost and value are sensitive issues.

The national value of excellent medical services to pilots in any business model on paper however, may be impossible to put a price on in practice. It was especially sensitive earlier this year as the plans for change coincided with the climate of raised passenger awareness following the Germanwings flight 9525 on March 24.

Long before this, in response to the October 2014 consultation, the Honourable Company of  Air Pilots, a professional guild, wrote:

“As long as human pilots are part of the aviation safety chain, it is essential that their fitness to operate is monitored and supported by an expert community without fear of or bias from commercial pressures.”

Lacking in detailed financial analysis it is hard to see from the consultation how alternative solutions measure up against private provision. Specifically there was no estimate in the document of the cost of the CAA meeting its statutory obligations. [3]

One of the three airlines that responded in consultation, suggested the CAA could be seen to be outsourcing the commercially viable part of the service:

“The Aeromedical centre only seems to account for £500k out of the £3 million …and could potentially be seen as the most profitable element.”

By contracting out to a commercial provider, and introducing the need to make a profit, some respondents are concerned it would further increase costs to industry or individuals, and the CAA acknowledged this. Fees could potentially rise in what will be effectively a monopoly market, as in April there were only three other approved providers for this service, across all of the UK. Two are already operated by the same public private partnership and although part owned by government, are essentially commercially run.

Free from Treasury control, the Civil Aviation Authority is self-funding but sits under the wing of the Department of Transport, accountable to the Secretary of State for Transport. [4] But Government support was questioned by a pilot in the consultation, who wrote:

“If the CAA and the Department for Transport cannot resolve this without destroying the CAA medical service then we might as well pack it all in.”

Pressure has reportedly come from EASA, the European Aviation Safety Agency to follow regulatory best practices and separate the duties of the authority from the delivery of services.

However a group representing 15 CAA (UK) approved medical examiners, with a mean of 22 years experience, suggested this regulatory issue could be resolved in other ways, and said:

“Outsourcing any part of the medical department would remove essential functions, weakening the ability to respond to or promote future regulatory changes.

“Fragmentation will introduce inefficiency as work which should be integrated will be on at least two sites – never helpful.”

The medical service provided by the CAA is recognised as a market leader across Europe. It influences European and worldwide aeromedical policy and as one airline wrote in the consultation, has “rebuffed some of the more non evidence based demands of the European Aviation Safety Agency.”

Maintaining that globally respected expertise, say the CAA plans, is a third reason for redesigning a medical department fit for the future but many respondents believe that outsourcing will achieve the opposite.

The Honourable Company of  Air Pilots suggested the plans would have:

“an adverse impact on flight safety and diminish unacceptably the UK’s aviation medicine competency, research capability and global reputation for excellence and leadership.”

Headcount of currently over 30 full time equivalent staff could be reduced to eight if outsourcing plans go ahead and the service operates at its minimum regulatory duties.

Last year’s preparations for the outsourcing included an event in May open to providers through the NHS Partner’s Network of the NHS Confederation at which one was an NHS provider, but all others were private sector contracting organisations.

The Public and Commercial Services Union believes there is no provider which could fill the gap if the CAA stops providing its services in the current form. They said:

“We are requesting that this consultation be halted and consultation commences with the recognised trade unions on options within this paper to retain all existing services in-house.”

In April, the CAA said: “We are continuing to explore options for the future provision of medical services. Safety remains our number one priority and we will ensure that any changes that are made will be designed to enhance the UK’s excellent safety record. All medical requirements relating to pilots are set at international level and regulated nationally and will remain in force and unchanged regardless of any decisions relating to the provision of medical services in the future.”

Mr Haines,  explained at the April Board Meeting that “there would be a further discussion at the Board on the outcome of the CAA’s medical review consultation.” What that was is yet to be published. Transparency has not been the board’s strongest point in 2015.

Consultations are about allowing the public a chance to participate in democratic processes in order to play their part in determining the outcome. This consultation appears to have changed little of the plans.

There should be public debate around what we need our service institutions for, what value we place on a universal public good where cost and benefit cannot be personalised, and where change requires meaningful public consultation.  These changes are too important to be reserved for niche interested parties or for them to be a tick box exercise in which the planned outcome goes ahead regardless of the majority feedback. Public consultation in its present form, appears to offer little in the way of checks and balances in today’s democracy. Some are described as farcical.

Changes made in the public interest should be transparent, accountable, and robust to stand up to meaningful challenge.

As the Treasury seems set on its course, I wonder if they are using blue sky thinking to divest from our wealth of knowledge, staff and skills wisely, or plucking justification for ideology out of thin air?

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References:

[1] Responses to consultation on the future structure of the CAA’s Medical Department: http://www.caa.co.uk/docs/33/CAP%201276%20Future%20structure%20of%20CAA%20Medical%20Department.pdf

[2] The prior information notice: http://ted.europa.eu/udl?uri=TED:NOTICE:99734-2015:TEXT:EN:HTML  (not yet a full tender notice)

[3] Financial detail limited: https://www.caa.co.uk/default.aspx?catid=1350&pagetype=90&pageid=16369

[4] CAA independent but accountable to Department of Transport http://www.parliament.uk/business/publications/written-questions-answers-statements/written-question/Commons/2014-09-10/209031

[5] Autumn 2015 consultation part two

Reputational risk. Is NHS England playing a game of public confidence?

“By when will NHS England commit to respect the 700,000 objections  [1] to secondary data sharing already logged* but not enacted?” [gathered from objections to secondary uses in the care.data rollout, Feb 2014*]

Until then, can organisations continue to use health data held by HSCIC for secondary purposes, ethically and legally, or are they placing themselves at reputational risk?

If HSCIC continues to share, what harm may it do to public confidence in data sharing in the NHS?

I should have asked this explicitly of the National Information Board (NIB) June 17th board meeting [2], that rode in for the last 3 hours of the two day Digital Health and Care Congress at the King’s Fund.

But I chose to mention it only in passing, since I assumed it is already being worked on and a public communication will follow very soon. I had lots of other constructive things I wanted to hear in the time planned for ‘public discussion’.

Since then it’s been niggling at me that I should have asked more directly, as it dawned on me watching the meeting recording and more importantly when reading the NIB papers [3], it’s not otherwise mentioned. And there was no group discussion anyway.

Mark Davies. Director at UK Department of Health talked in fairly jargon-free language about transparency. [01:00] I could have asked him when we will see more of it in practice?

Importantly, he said on building and sustaining public trust, “if we do not secure public trust in the way that we collect store and use their personal confidential data, then pretty much everything we do today will not be a success.”

So why does the talk of securing trust seem at odds with the reality?

Evidence of Public Voice on Opt Out

Is the lack of action based on uncertainty over what to do?

Mark Davies also said “we have only a sense” and we don’t have “a really solid evidence base” of what the public want. He said, “people feel slightly uncomfortable about data being used for commercial gain.” Which he felt was “awkward” as commercial companies included pharma working for public good.

If he has not done so already, though I am sure he will have, he could read the NHS England own care.data listening feedback. People were strongly against commercial exploitation of data. Many were livid about its use. [see other care.data events] Not ‘slightly uncomfortable.’  And they were able to make a clear distinction between uses by commercial companies they felt in the public interest, such as bona fide pharma research and the differences with consumer market research, even if by the same company.  Risk stratification and commissioning does not need, and should not have according to the Caldicott Review [8], fully identifiable individual level data sharing.

Uses are actually not so hard to differentiate. In fact, it’s exactly what people want. To have the choice to have their data used only for direct care  or to choose to permit sharing between different users, permitting say, bona fide research.  Or at minimum, possible to exclude commercially exploitative uses and reuse. To enable this would enable more data sharing with confidence.

I’d also suggest there is a significant evidence base gathered in the data trust deficit work from the Royal Statistical Society, a poll on privacy for the Joseph Rowntree Foundation, and work done for the ADRN/ESRC. I’m sure he and the NIB are aware of these projects, and Mark Davies said himself more is currently being done with the Nuffield Trust.

Work with almost 3,000 young for the Royal Academy of Engineering people confirmed what those interested in privacy know, but is the opposite of what is often said about young people and privacy – they care and want control:

youngpeople_privacy

NHS England has itself further said it has held ‘over 180’ listening events in 2014 and feedback was consistent with public letters to papers, radio phone-ins and news reports in spring 2014.

Don’t give raw data out, exclude access to commercial companies not working in the public interest, exclude non-bona fide research use and re-use licenses, define the future purposes, improve legal protection including the opt out and provide transparency to trust.

How much more evidence does anyone need to have of public understanding and feeling, or is it simply that NHS England and the DH don’t like the answers given? Listening does not equal heard.

Here’s some of NHS England’s own slides – [4] points included a common demand from the public to give the opt out legal status:

legal

 

Opt out needs legal status

Paul Bate talked about missing pieces of understanding on secondary uses, for [56:00] [3] “Commissioners, researchers, all the different regulators.” He gave an update, which assumed secondary use of data as the norm.

But he missed out any mention of the perceived cost of loss of confidentiality, and loss of confidence since the failure to respect the 9nu4 objections made in the 2014 aborted care.data rollout. That’s not even mentioning that so many did not even recall getting a leaflet, so those 700,00K came from the most informed.

When the public sees their opt out is not respected they lose trust in the whole system of data sharing. Whether for direct care, for use by an NHS organisation, or by any one of the many organisations vying to manage their digital health interaction and interventions. If someone has been told data will not be shared with third parties and it is, why would they trust any other governance will be honoured?

By looking back on the leadership pre- care.data flawed thinking ‘no one who uses a public service should be allowed to opt out of sharing their records, nor can people rely on their record being anonymised’ and its resulting disastrous attempt to rollout without communication and then a second at fair processing, lessons learned should inform future projects. That includes care.data mark 2. This < is simply daft.

You can object and your data will not be extracted and you can make no contribution to society, Mr. Kelsey answered a critic on twitter in 2014 and revealed that his thinking really hasn’t changed very much, even if he has been forced to make concessions. I should have said at #kfdigital15, ignoring what the public wants is not your call to make.

What legal changes will be made that back up the verbal guarantees given since February? If none are forthcoming, then were the statements made to Parliament untrue? 

“people should be able to opt out from having their anonymised data used for the purposes of scientific research.” [Hunt, 2014]

We are yet to see this legal change and to date, the only publicly stated choice is only for identifiable data, not all data for secondary purposes including anonymous, as offered by the Minister in February 2014, and David Cameron in 2010.

If Mark Davies is being honest about how important he feels trust is to data sharing, implementing the objection should be a) prioritised and b) given legal footing.optout_ppt

 

Risks and benefits : need for a new social contract on Data

Simon Denegri recently wrote [5] he believes there are “probably five years to sort out a new social contract on data in the UK.”

I’d suggest less, if high profile data based projects or breaches irreparably damage public trust first, whether in the NHS or consumer world. The public will choose to share increasingly less.

But the public cannot afford to lose the social benefits that those projects may bring to the people who need them.

Big projects, such as care.data, cannot afford for everyone’s sake to continue to repeatedly set off and crash.

Smaller projects, those planned and in progress by each organisation and attendee at the King’s Fund event, cannot afford for those national mistakes to damage the trust the public may otherwise hold in the projects at local level.

I heard care.data mentioned five different times over the two-day event  in different projects as having harmed the project through trust or delays. We even heard examples of companies in Scotland going bust due to rollouts with slowed data access and austerity.

Individuals cannot afford for their reputation to be harmed through association, or by using data in ways the public finds unreasonable and get splashed across the front page of the Telegraph.

Clarity is needed for everyone using data well whether for direct care with implied consent, or secondary uses without it, and it is in the public interest to safeguard access to that data.

A new social contract on data would be good all round.

Reputational Risk

The June 6th story of the 700,000 unrespected opt outs has been and gone. But the issue has not.

Can organisations continue to use that data ethically and legally knowing it is explicitly without consent?

“When will those objections be implemented?” should be a question that organisations across the country are asking – if reputational risk is a factor in any datasharing decision making – in addition to the fundamental ethical principle: can we continue to use the data from an individual from whom we know consent was not freely given and was actively withheld?

What of projects that use HES or hospital secondary care sites’ submitted data and rely on the HSCIC POM mechanisms? How do those audits or other projects take HES secondary objections into account?

Sir Nick Partridge said in the April 2014 HSCIC HES/SUS audit there should be ‘no surprises’ in future.

That future is now. What has NHS England done since to improve?

“Consumer confidence appears to be fragile and there are concerns that future changes in how data may be collected and used (such as more passive collection via the Internet of Things) could test how far consumers are willing to continue to provide data.” [CMA Consumer report] [6]

The problem exists across both state and consumer data sharing. It is not a matter of if, but when, these surprises are revealed to the public with unpredictable degrees of surprise and revulsion, resulting in more objection to sharing for any purposes at all.

The solutions exist: meaningful transparency, excluding commercial purposes which appear exploitative, consensual choices, and no surprises. Shape communications processes by building-in future change to today’s programmes to future proof trust.

Future-proofing does not mean making a purpose and use of data so vague as to be all encompassing – exactly what the public has said at care.data listening events they do not want and will not find sufficient to trust nor I would argue, would it meet legally adequate fair processing – it must build and budget for mechanisms into every plan today, to inform patients of the future changes to use or users of data already gathered, and offer them a new choice to object or consent. And they should have a way to know who used what.

The GP who asked the first of the only three questions that were possible in 10 minutes Q&A from the room, had taken away the same as I had: the year 2020 is far too late as a public engagement goal. There must be much stronger emphasis on it now. And it is actually very simple. Do what the public has already asked for.

The overriding lesson must be, the person behind the data must come first. If they object to data being used, that must be respected.

It starts with fixing the opt outs. That must happen. And now.

Public confidence is not a game [7]. Reputational risk is not something organisations should be forced to gamble with to continue their use of data and potential benefits of data sharing.

If NHS England, the NIB or Department of Health know how and when it will be fixed they should say so. If they don’t, they better have a darn good reason why and tell us that too.

‘No surprises’, said Nick Partridge.

The question decision makers must address for data management is, do they continue to be part of the problem or offer part of the solution?

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References:

[1]The Telegraph, June 6th 2015 http://www.telegraph.co.uk/news/health/news/11655777/Nearly-1million-patients-could-be-having-confidential-data-shared-against-their-wishes.html

[2]  June 17th NIB meeting http://www.dh-national-information-board.public-i.tv/core/portal/webcast_interactive/180408

[3] NIB papers / workstream documentation https://www.gov.uk/government/publications/plans-to-improve-digital-services-for-the-health-and-care-sector

[4] care.data listening feedback http://www.england.nhs.uk/wp-content/uploads/2015/01/care-data-presentation.pdf

[5] Simon Denegri’s blog http://simondenegri.com/2015/06/18/is-public-involvement-in-uk-health-research-a-danger-to-itself/

[6] CMA findings on commercial use of consumer data https://www.gov.uk/government/news/cma-publishes-findings-on-the-commercial-use-of-consumer-data

[7] Data trust deficit New research finds data trust deficit with lessons for policymakers: http://www.statslife.org.uk/news/1672-new-rss-research-finds-data-trust-deficit-with-lessons-for-policymakers

[8] Caldicott review: information governance in the health and care system

Clause 88 – the bingo clause of the Deregulation Bill?

Lord Tunnicliffe asked in Parliament on November 20, 2014: “are these  new clauses a licence for regulators to approve regulations that kill people to save money?”

Imagine an unsafe care home where children or the elderly are at risk.

Imagine its staff with fewer professional registration requirements than today.

Imagine the home could legally reject a Care Quality Commission call for changes, citing that to do so would harm the home’s “economic growth”.

Could this ever be reality, if this controversial clause 88(2) of the deregulation bill becomes law? [1]

In bingo, the number 88 is outdatedly and naughtily nicknamed ‘two fat ladies.’

In the media today we often hear about ‘health’ and ‘social care’ issues, and they currently overlap on the future approach to tackling the serious societal implications of obesity.

Headlines more rarely talk about changes to law which could have equally serious implications for the future approach to how we look after our health and care system and its oversight.

However, changes that could affect each of us, are currently in the Lords for review, and my bet is that few beyond their benches and MPs, have had their eyes down on the detail.

The Deregulation Bill – What is the very big bill all about?

It has been on the go for over 18 months, and Richard Grimes addressed some of the concerns in September 2013.[2]

The Deregulation Bill, is a very large bill indeed and is as broad in its content as its title is bland, but it has the potential to be a bombshell in its impact.

Functionally it covers subjects as diverse as busking and the Breeding of Dogs Act. It will make changes to the process the police use to obtain journalistic material [3] and provide a gateway to sell information from birth, death, marriage and civil partnership records.

Some changes in law will specifically affect the NHS: the ‘Road traffic legislation: use of vehicles in emergency response by NHS’, and ‘NHS foundation trusts and NHS trusts: acquisitions and dissolutions’.

Other clauses are area non-specific, such as my ‘bingo clause’, Clause 88(2), that creates a new legal duty for regulators to give regard to promoting economic growth.

The term ‘regulators’ covers a wide range of organisations [4]; you might think of Ofwat responsible for oversight of water and sewage, or the Food Standards Agency, or Human Tissue Authority.

Ken Clarke, joint bill owner with Oliver Letwin MP, wrote in 2013 [5]: “This is the beginning of a fundamental change in the culture of government. We think Reagan would have approved.

“By putting a duty on regulators not to burden business with unnecessary red tape, it will help to ensure that every nook and cranny of Whitehall is relentlessly focussed on growth.”

Will the Deregulation Bill take a gamble with the public interest in our NHS health and  social care provision through the ‘relentless’ duty to promote profit in Clause 88(2)?

Slimming down laws and the administration processes they affect, could of course be a very good thing. Lord Hunt of King’s Heath says of the bill as a whole: “I’ve no problem trying to streamline the regulatory processes, that’s why we broadly support it.”

But what about the detail in practice? Is Letwin and Clarke’s ‘relentless focus on growth’ going to mean compromise in worker safety, or in today’s health and social care market?

Will regulators be less rigorous about requirements and imposing penalties on commercial companies, if a private provider could complain, arguing non-compliance with this clause?

Clause 88(2): a duty to promote economic growth on regulators

Lord Hunt shared his key concern with clause 88(2): “The nub of the issue is ‘will this compromise their main regulatory function?’ I think it’s very ambiguous. He said:

“The health regulators are very unkeen on all of this. It’s pretty clear to me in discussions that they worry about the impact this will have.”

One regulator that could be affected is CQC. A CQC spokesperson said:  “The Government’s response to the report of the Draft Bill Committee’s pre-legislative scrutiny said the duty does not set out how economic growth ranks against existing duties as this is a judgement only a regulator can and should make.

“The quality and safety of services is the primary basis on which we will regulate, and take enforcement action where necessary to protect people who use services. We would not consider a new duty to promote economic growth to override this position.”

How these new regulatory functions will work with their existing duties is unclear.

If they conflict how will it be decided which is considered most important if the law “does not set out how economic growth ranks against existing duties”? Summary guidance [6] on the deregulation bill is that the growth duty does not automatically take precedence over or supplant existing duties held by regulators, but what will that mean in practice?

If the economic growth duty should not make any difference to the key responsibilities of the regulator, why bring in this change at all?

A Department for Business, Innovation & Skills spokesperson said:
“Regulators will be required to be transparent about how they are complying with the growth duty.

“The Government will monitor the implementation of the growth duty through existing reporting mechanisms such as annual reports, published policies and service standards.”

To ring-fence the regulatory functions of health and social care bodies from the effects of Clause 88 (2) Lord Hunt proposed an amendment to 11 of them.[7]

He said: “In earlier discussion with ministers it was made clear they have a preliminary list of 5 regulators that they consider [in health] would fall under the economic growth clause in the bill: The Care Quality Commission (CQC), the Human Fertilisation and Embryology Authority (HFEA), the Human Tissue Authority (HTA), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Professional Standards Authority.

“I cannot for the life of me, see why the health regulators are in there. I hope that the government will be able to take some, or all of them out.”

But the amendment was not supported on February 11 by the government and instead it only promised further discussion before the next stage of the bill.

What changes will it make and are they in the Public Interest?

A year ago in February 2014 [8], MPs in the House of Commons, Caroline Lucas, Jonathan Edwards, John McDonnell and Jeremy Corbyn MPs proposed the removal of this same clause, requiring the desirability for economic growth, and they had concerns:

…”that this Bill represents a race to the bottom and an obsession with GDP growth at any cost which is not in the public interest.”

If the aim of the deregulation bill is to streamline services and remove red tape it should be very clear what purpose will be served through the changes and what consequences will be unleashed as a result.

However it appears that the government wants to get the bill through in principle and leave the practical detail of such risk analysis to be defined by regulations set out after it is law.

Regulations are not subject to the same parliamentary scrutiny and discussion as primary legislation, and some feel they are harder to veto.

Lord Hunt said: “It’s a very unsatisfactory way of doing it, there’s no guarantees and the government can just produce and list and then change that at any time in the future.

It is not the first time that Mr. Letwin’s proposals have been open ended and could have unforeseen consequences. [9]

Lord Hunt asked: “it’s a very open ended piece of legislation and the thing to ask is will it inhibit these key health regulators in protecting the public?”

Of key concern is whether regulators will be inhibited from taking actions in the public interest because of the potential for legal challenge by private interests.

If this sounds familiar, you may have heard similar language on deregulation in discussion of the behemoth of deregulation playing in parallel internationally: the TTIP, the Transatlantic Trade and Investment Partnership (TTIP). [10]

How the consequences of these national and international deregulation changes are inter-related is impossible to fully understand given the lack of public information available.

Public Consultation and Professional Voice given too little regard The Deregulation Bill and the effects of the duty to promote economic growth will spread across all our regulatory bodies.

Like the obesity discussion, the Bill is complex, it’s cumbersome, and whilst appearing to have good intentions, hard to understand how changes will be applied in practice.

It also appears at times to lack common sense and to ignore experienced professional opinion.

The Equality and Human Rights Commission felt that: “applying this growth duty to the EHRC poses a significant risk to the EHRC’s independence, and therefore to its compliance with the Paris Principles.”

The Government therefore risks the possibility of the EHRC’s accredited “A” status being downgraded and of putting the UK in breach of its obligations under EU equality law.

But Clause 88(2) will be applied to this body which promotes worker rights and fairness.

Social care is to become less regulated by scrapping the need to register staff with Ofsted.

Baroness King of Bow said in the Lords debate on November 18th: “There is a feeling in the [social care] sector and indeed elsewhere that there has been quite simply inadequate debate around these very serious and important issues.”

Lord Reid of Cardowan in the Lords on February 5th said: “There are occasions during a ministerial career where, on study, what seems a relatively small decision becomes an obviously profound and very risky decision […] having listened to this debate, I have the impression that this is one of them.”

The potentially harmful consequences of these changes demand greater public scrutiny.

Will this bill future-proof the regulatory protections of health, environmental, safety, and social care, and prioritise the public interest?

If instead a duty to profit should be put first, one day the words of Lord Tunnicliffe may come back to haunt us: “Are these new clauses a licence for regulators to approve regulations that kill people to save money?” [11]

We may then look back to find why failings happened, look to this bill, and shout, ‘bingo!’

Notes:

The third reading is on 4 March and Lord Hunt has submitted an amendment to take out the The Human Fertilisation and Embryology Authority (HFEA) and Professional Standards Authority (PSA) for Health and Social Care from being covered by the growth clause.

As the Bill is amended and re-written, clause numbers will change. Clause 88(2) was the number of the duty to promote growth clause on February 11 2015 in the House of Lords debate.

A version of this article was first edited, amended and published by Open Democracy on February 25, 2015.

References:

[1] http://www.publications.parliament.uk/pa/bills/lbill/2014-2015/0058/lbill_2014-20150058_en_9.htm#pb16-l1g91

[2] https://www.opendemocracy.net/ournhs/richard-grimes/bonfire-of-citizens-rights

[3] http://www.theguardian.com/media/2014/jan/31/secret-hearings-police-journalists-deregulation-bill

[4] List of regulators: http://discuss.bis.gov.uk/focusonenforcement/list-of-regulators-and-their-remit/

[5] http://www.conservativehome.com/platform/2013/07/ken-clarke-oliver-letwin.html

[6] www.gov.uk/government/uploads/system/uploads/attachment_data/file/274552/14-554-growth-duty-draft-guidance.pdf

[7] http://www.publications.parliament.uk/pa/bills/lbill/2014-2015/0058/amend/ml058-III-Rev.htm

[8] https://www.nuj.org.uk/news/nuj-backs-reasoned-amendment-to-deregulation-bill/

[9] http://www.theguardian.com/politics/2014/dec/30/downing-street-files-oliver-letwin-poll-tax

[10] https://www.opendemocracy.net/ourkingdom/linda-kaucher/eu%27s-giant-and-secretive-deregulation-blitz

[11] http://www.publications.parliament.uk/pa/ld201415/ldhansrd/text/141120-gc0001.htm

Launching genomics, lifeboats, & care.data

On Friday 1st August the media reported the next giant leap in the genomics programme in England, suggesting the 100K Genomics Project news was akin to Kennedy launching the Space Race. [1] [from 2:46.30].

“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] ]

Whilst Mr. Cameron & George Osborne visited the arson-damaged Eastbourne Pier, the lifeboat staff and firemen who attended, back in Downing Street, representatives led by George Freeman MP signed the £300M investment package, the next step in the genomic investment plan, with American Jay Flatley, CEO of Illumina.

Mr. Cameron first announced this research drive shared with commercial pharmaceutical companies on 6th December 2011 and famously said ‘every willing patient should be a research patient'[3] (video) and they would consult to change the NHS Constitution to enable it:

“…with their medical details “opened up” to private healthcare firms, says David Cameron.”

George Freeman_ 100K

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.

“We will look back in 20 years’ time and the blockbuster chemotherapy drugs that gave you all those nasty side effects will be a thing of the past,”said Jeremy Farrar Director of the Wellcome Trust, reported Sky. [5]

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.”

NHS England Board paper, July 2013 [7]

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?

{Part two continues here}

******

[1] “It’s a hugely ambitious project, it’s on a par with the space race how Kennedy launched 40 years ago.” [from 2:46.30 BBC Radio 4 Int. Sarah Montague w/ George Freeman]

[2] Downing Street Press Release 1st August – genomics https://www.gov.uk/government/news/human-genome-uk-to-become-world-numb

[3] 6th December “Transcript of a speech given by Prime Minister at the FT Global Pharmaceutical and Biotechnology Conference” [https://www.gov.uk/government/speeches/pm-speech-on-life-sciences-and-opening-up-the-nhs]

[4] 10th December 2012 DNA Database concerns Channel 4 http://www.channel4.com/news/dna-cancer-database-plan-prompts-major-concerns

[5] Wellcome Trust- comment by Jeremy Farrar http://news.sky.com/story/1311189/pm-hails-300m-project-to-unlock-power-of-dna

[6] Strategic Priorities in Rare Diseases June 2013 http://www.genomicsengland.co.uk/wp-content/uploads/2013/06/GenomicsEngland_ScienceWorkingGroup_App2rarediseases.pdf

[7] NHS England Board paper presentation July 2013 http://www.england.nhs.uk/wp-content/uploads/2013/07/180713-item16.pdf

[8] ICO and HSCIC on anonymous and pseudonymous data in Computing Magazine http://www.computing.co.uk/ctg/news/2337679/ico-says-anonymous-data-not-covered-by-data-protection-act-until-its-de-anonymised

[9] HSCIC Pseudonymisation Review August 2014 http://www.hscic.gov.uk/article/4896/Data-pseudonymisation-review

[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

[11] Wellcome Trust August 1st 2014 The Genetic Building Blocks of Future Healthcare

[12] Fenyan – For successful technology reality must take precedence over PR http://jenpersson.com/successful-technology-reality-precedence-public-relations/

[13] Next Steps in the Sequence – the implications for whole genome sequencing in the UK – PHG Foundation, funded by the PHG Foundation, with additional financial support from Illumina. The second expert workshop for the project was supported by the University of Cambridge Centre for Science and Policy (CSaP) and the Wellcome Trust http://www.phgfoundation.org/file/10363

[14] Anti-elderly drugs proposals rejected by NICE: Channel 4 http://www.channel4.com/news/nice-assessment-elderly-health-drugs-rejected-contribution

[15] The Royal Statistical Society identifies a Trust Deficit

 [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.”
[17] Adult Social care ISCG,  2014 http://www.england.nhs.uk/iscg/wp-content/uploads/sites/4/2014/01/ISCG-Paper-Ref-ISCG-009-002-Adult-Social-Care-Informatics.pdf  “Personalisation – citizens should increasingly be empowered to have choice and control over their care; and there will be increasing numbers of people funding their own care and caring for others”

*****

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:

One. George Osborne [George 1] MP for Tatton, Cheshire and the Chancellor

Two. George Freeman [George 2] MP – The UK’s first-ever Minister for Life Sciences, appointed to this role July 15th 2014 [https://www.gov.uk/government/ministers/parliamentary-under-secretary-of-state–42]

*****

Hear no evil, see no evil, speak no evil – the impact of the Partridge Review on care.data

3wisemonkeysThe Partridge Review came out on Tuesday 17th and everyone should read it. But not just the summary. Both the full version and [1] summary are here.

So what is positive about these massive revelations? At long last it appears that the hands have come off the ears and the real issues are being listened to.

My summary: “NHS England cannot now put a hand over its eyes & hope care.data issues are only about communications.”

I feel somewhat relieved that the issues many have been concerned about for the last ten months, have now been officially recognised.

Amongst them,  it has confirmed the utter lack of clear, publicly transparent and some quite basic, governance procedures.

It’s no surprise then, that our medical records, on at least two occasions in this sample 10% review of the releases, have gone to undocumented destinations. (Let’s ignore the fact of the other 90%!? of which we have no visibility yet).

At least eight insurers or re-insurers were in this 10% sample, so how many times did such companies get it, in the other 90% which has not been reviewed and we haven’t heard about?

How will ‘promotion of health’ purposes exclude them in future? In my opinion, it won’t.

Why would an insurance company be excluded if it requests data in order to provide health care coverage?

This is the wording of the Act, not ‘for the benefits of the NHS’ or any other more ‘friendly’ patient facing framing.

Care Act 2014At the NHS Open Day on Tuesday, the same day as the release, a panel spokesperson stated that commercial information intermediaries [2]  will continue to be approved recipients. Gah – why this is such a bad idea, I wrote about here. [3]

The Partridge review said there had been no complaints.  [4] MedConfidential pointed out an example of those of which they know. Kingsley Manning told the Health Select Committee [5] on 8th April, there had been seventeen opt outs of Hospital Episode Statistics, ever.  Fourteen in 2013 and three prior to 2013.

“Q377Chair: There is not an opt-out rate for care.data yet, presumably.

Kingsley Manning: No, not on that, but in terms of the number of people who have acted to opt out, it is 3 opt-outs up until April 2013 and a further 14 opt outs since 1 April 2013.”

Would I be wrong to suspect each was accompanied by a  complaint? You don’t usually opt out of something you are happy with.

The reason for these low numbers of both complaints and opt out in the wider public? WE DID NOT KNOW. The public didn’t know we had anything to be unhappy about. Many still do not.

As soon as I fully understood the commercial selling of my family’s patient records, this below is the query for advice / complaint I made in January to ICO, before the launch was postponed.

I wanted some guidance from an outside body, because I was being told the law permitted this extraction, so what good would a further complaint to HSCIC do? I had already written to my MP and had a response from the Secretary of State / Department of Health (which tried to tell me patient identifiable data was not shared with third parties), as well as feedback to my concerns raised by email with HSCIC, all of which only tried to reassure me. I had no one to otherwise raise concerns with. The ICO advisor I spoke to told me at that time, that they had had many similar complaints.

I’ll be blunt and say now, especially since the Open Day [more on that later, especially on the content of care.data FAQs we received], I think it’s fair to say I am far better informed about care.data than most in the public. When Mr. Kelsey asked for a show of hands, how many had heard of care.data, all put their hands up. Bearing in mind the rooms were full of highly involved people, NHS England staff, CCG and PPG leaders, and few ‘ordinary patients’ like me, and the agenda contained a section on care.data, it’s unsurprising we had heard of it. When Mr.Kelsey asked, “how many of you understand what it is?” the response was around 50%. I’d dispute also, that all of those 50% truly do.

Some of the comms material we were given is factually incorrect, for example, around research. Currently, GP held data planned for care.data extraction and its merger with HES, into Care Episode Statistics (CES), is approved for commissioning purposes but not for research by the GPES group. It’s not approved for research purposes, so its no good telling us how good it is to have it for the benefit of research. What has already been released for research, and continues to be so, is what was already extracted in the past, with or without consent, and informing patients.

Records will not be deleted which raises all sorts of historical reporting concerns if mistakes are identified in retrosepct.

I have spoken with several NHSE Communications people who genuinely asked me, or left me asking the question for them in my own mind, “If I don’t understand it, then how is the public expected to?”

The concerns I had now almost five months ago, seem vindicated by the report. The actions taken since, the loose wording of the Care Act 2014, and little evidence of intention to make any change which is binding i.e. the opt out is only granted at the whim of the Secretary of State, it’s not statutory and that there is no independent governance to be put in place , have done nothing to bolster my confidence these gaps have been filled.

Simon Denegri, Chair of INVOLVE – the UK’s national advisory group on public involvement – and NIHR National Director for Public Participation and Engagement in Research, wrote a response on his blog [6]. I agree with the spirit of his post, and positivity, [he also writes excellent haiku] but where I disagree I outline below. There is room for positive hope for care.data, but first, let’s properly address the past.

“I am sure that many better informed people than I will pore over the detail. Others will use it to strengthen their case that we should put a stop to any manner of data sharing.”

Perhaps most key, I disagree with his fears the report could be used by ‘others.’ I don’t know anyone who wants to see a stop to ‘any manner’ of data sharing, including me. It’s the *how* and *why*  and *with whom*  that still needs work. Some of us may not want it without active consent, but that is part of the how, not if.  It’s not *any* manner that I object to, it’s *this* manner specifically.

I have read the Review in detail and whilst there is much positive in attitude in the Review, the reality of what difference this will make with any real bite, is hard to find.

For example, “The HSCIC will plan a new ‘data laboratory’ service which will protect the public’s information by allowing access to it in a safe environment with HSCIC managed networks and facilities.”  But this is with caveats, as it’s the “default,” Tim Kelsey said on Tuesday to the NHSE Open House. It does not mean *all* and if global third party intermediaries and business intelligence companies are still to receive data, then I can’t imagine the  global likes of IMS Health, or Experian, or Harvey Walsh will send someone along to Leeds every time they want to extract data. Who will  be given special permissions and how will they be decided and recorded, how will it be documented what data they access, if they get a free pass?

Unknown others have direct access to the HES system now through HDIS. Public Health should rightly use our health data, but a  transparent list of all approved organisations here too, would be a positive step.

Simon’s post continues,

“As you would expect from a previous Chair of INVOLVE, Nick Partridge, has secured fundamental changes in the governance of HSCIC and data releases going forward.  These include patients and the public sitting on the main committees reviewing data releases, open publication of data releases and a programme of ‘active communication’ with the public”.

Patients and public on the DAAG committee. If they are informed about data governance law and good practices, yes, if it’s just ‘representative’, not so useful. But DAAG is HSCIC staffed, and HSCIC has a legal and policy remit from the Department of Health and in its roadmap to distribute data, and will create ‘a vibrant market of data intermediaries’, as it would be wrong to exclude private companies simply on ideological grounds.  So the concept of ‘independent’ is flawed. Where are the teeth needed to reject an application, if it’s in the interest of the reviewing body, to accept it?

“It’s my view that the Partridge review, its recommendations, and the swift response from the Health and Social Care Information Centre (HSCIC), offers us the opportunity of a fresh start with the public on this issue.” [S.D.]

This could be used as an opportunity to brush the past aside and say time for a fresh start, but it can only be so if there is confidence of change.

NHS England cannot now put a hand over its eyes and hope the issues go away or that it’s only about communications.

The past needs fisking, issue by issue, to avoid they happen again. And the real risks need addressed, not glossed over. Why?

Because let’s assume the public all thinks it’s fine, and none of us opt out. Then through these still flawed process holes, a huge data leak. The public loses trust all over again, and the opportunity for the care.data benefits is lost forever.

Get it right now, and you build a trustworthy and seaworthy future, for the future public good.

There are other more detailed questions I would raise, [I previously worked in functional database design amongst other things] and I will believe these recommendations will have an effect, if and when I see the words become actions. The Review by PwC and Sir Nick Partridge is a positive listening and speaking exercise, but the plans must become reality with actions, some under legislation, in my view.

And perhaps the simplest, unspoken point seems to being deliberately ignored as if just not seen, unmentioned, except by data protection gurus [7]. There is legal obligation to provide information to citizens before their data is released, in a transparent way, to whom and for what purpose. What happened to Fair Processing? [8] Past and present?

Sir Kingsley Manning, Chair of HSCIC, asked in the Guardian on 22nd January [9] that we have ‘intelligent, grown up debate’ about data sharing. Well my hand is certainly off my mouth. I wrote a feature in my local paper and I’m still speaking to anyone I can to promote fact-based informed decision making.  But wider Public Debate is still sorely lacking [BBC Question Time anyone?] Through it, I’d like to encourage wider knowledge of the why, who and what of secondary purposes of data sharing and to ensure we can get it done transparently and safely.

Why?

To ensure we, as patients, continue to trust telling our GPs and hospital consultants all the information that we need to, and have no fear it will be held against us by an insurer or others.

We need to trust we will not be penalised whether through disclosure, by stigma and exclusion from policy or care; or whether by opting out, we could be penalised for not participating and not get ‘advantages’ offered to others, just like store loyalty cards.

We may think the insurance debate is irrelevant, if like me, we are not ‘self-payers’ or don’t use a private insurer. With a £30bn gap in planned budget and needed spend over the next five years, someone is still going to be paying for our healthcare.

If it’s not the State, then who? The risk more of us will pay for our own care in future is real. If not for us, for our kids, and their privacy will be a whole different ball game if genomics gets involved.

Meanwhile, we are told for care.data identifiable personal data is crucial for patient safety tracking. In my opinion, patient safety will be harmed if confidence in confidentiality fails. The relationship between clinician and patient will be harmed. And no number of Dr. Foster Intelligence reports by tracking quality or safety, will be able to fix those failures which it has helped create.

Perhaps most tellingly, NHS England is still to make a statement on the Review. There is no news yet here.

It still seems to me the NHS England leadership and its data sharing policy carried out through IC past and present, wants to continue without grown up debate under the PR motto ‘it’s all going jolly well’, and to act with the attitude of a teenager, who with a shrug of the shoulders will tell you:

‘It’s easier to ask for forgiveness than permission.’

***********

January 25th, 2014 – my ICO complaint / guidance request

{abbreviated only to show  issues I feel still need addressed}

Dear ICO
I would like to ask for your urgent advice.

I am a mother of X children under 12. […] Our confidential patient data is being extracted via care.data to the HSCIC. Until my recent research to understand what this was all about, I did not know that HSCIC stored all our patient confidential health data from all sorts of health providers: Hospitals, Mental Health, National Child Measurement Programme, [10] Immunisations and Health visitors.

I have not knowingly given my permission for our data to be stored or transmitted to or from HSCIC in any format in the past. If by signing a consent form for treatment I also signed consent for sharing with this central body, it was without my knowledge and therefore without informed consent.

I have significant concerns over its use, now that I understand how widely our patient data may be used and now even shared abroad. [11] […]

There is no public information on :

1. How long our data will be stored for  – data retention and data deletion and cross border governance
2. There is no opportunity for health record deletion of anything which was simply a mistake i.e.: recorded on the wrong record, or a misinformed opinion on lifestyle entered by the GP, not fact
3. How will future governance be assured that it will not be slackened to allow less strict pseudonymisation, and identifiable releases; for example to US firms who establish themselves in the NHS England healthcare market?

I do not believe that the legal rights created through the Health and Social Care Act are sufficient justification to overrule the Common Law of Confidentiality, and the Data Protection Act 1998. [And the data shared before 2012 was not covered by the Act which did not exist and was not retrospective.] Even if the dissent codes are applied, patient data has been or will be extracted to the HSCIC (without my permission) and it will contain identifiable items such as clinician name, practice and CCG locations, and referral dates which may be used as identifiers to connect with HES data stored at HSCIC – since HSCIC also holds data in the Personal Demographics Service [PDS], [12] I believe they may also link the data [13] then to my personal demographic identifiers. Just an undefined or internal  governance procedure to suggest that they would not, when it is technically possible, is not sufficient oversight. […]

I do not consent for the use of our [hospital HES or other] data in health research – because it has not been explained to me, what that term means and the implications of this assumed consent.

I cannot know what the other future uses will be for our health information stored today. I do not feel that I can apply any fair processing to their health records due to the lack of publicly available information and scope of the full uses of their data today and in future. […]

Sincerely,
Jen Persson
XXXXXXX

———————————

[1] The Partridge Review Summary and Full report http://www.hscic.gov.uk/datareview

[2] On selling data to Intermediaries and the governance which permits it  https://medconfidential.org/category/press-releases/

[3] Commercial users of NHS patient data – third party use – my blog http://jenpersson.com/flagship-care-data-2-commercial-practice/

[4] Complaints and why confidence needs restored https://medconfidential.org/2014/press-release-partridge-review-patients-need-proof-to-restore-confidence/

[5] Health Select Committee 8th April 2014 http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/health-committee/handling-of-nhs-patient-data/oral/8416.html

[6] Simon Denegri’s blog response to the Partridge Review http://simondenegri.com/2014/06/17/partridge-reviews-elegant-demolition-of-past-practice-on-personal-data-offers-opportunity-for-fresh-start-with-the-public/

[7] Information Rights and Wrongs – Jon Baines’ blog http://informationrightsandwrongs.com/2014/06/18/the-partridge-review-reveals-apparently-huge-data-protection-breaches/

[8] ICO Processing Data Fairly and Lawfully http://ico.org.uk/for_organisations/data_protection/the_guide/principle_1

[9] The Guardian, January 22nd 2014 ‘Lack of Debate on the Sale of Patient Information‘ http://www.theguardian.com/society/2014/jan/22/debate-sale-patient-information?CMP=twt_gu

[10] National Child Measurement Programme data managed by HSCIC http://www.hscic.gov.uk/ncmp

[11] Data use in the USA Memorandum between DH, HSCIC and the US  Dept of Health and Human Services to include exploring secondary stores http://www.healthit.gov/sites/default/files/hhsnhs_mou_final_jan_21.pdf

[12] Personal Demographics Service http://systems.hscic.gov.uk/demographics/pds/contents data already stored at HSCIC

[13] Data Linkage Service at HSCIC to manage the requests for data which is stored in different silos and brought together on request http://www.hscic.gov.uk/dles

Image courtesy of an interesting post on the history of the featured monkeys: http://frontiersofzoology.blogspot.co.uk/2013/04/why-are-three-wise-monkeys-usually-apes.html

What our grandparents called it.

I regularly talk with friends about food. Often over food. I like food. I like cooking. And as a result tend to use as unprocessed-as-possible ingredients, and start most things from scratch.

I have friends who can’t cook, or won’t cook, and I have friends who like the paleo direction, as I do. There is no right answer. But I do think that whatever we use to prepare our meals, we need to be aware of how it is packaged and marketed, in making our choices.

Some labels have more meaning than others. Fairtrade. Farm fresh. Or Red Tractor. Labels which look and sound good aren’t always exactly what they say on the tin, or what we think they mean. Or they mean different things in different countries. Like ‘Bio’ often conflated with organic.

Why do we need these packaging terms at all? Are they all genuine, of substance and meaningful for consumers, or are they marketing ploys?

I think often, on closer inspection, we may find these marketing labels are used to segment the market and make those who can, pay more for ‘better quality’ and ‘choice’ . It does not necessarily mean there is much  substantive difference behind the label.

Consumers should in theory drive the market by buying what we want. But do we know what we want or are we led by marketing?

Are we nudged in the direction of the product the vendors want to sell us though clever marketing?

The total 2013 UK advertising spend reached a new high of nearly £14bn, topping pre-financial crash levels for the first time in six years. Companies must think that is money, worth spending.

How free is our choice?

I would like to think we collectively focus on the core value of what we want as a consumer not just for ourselves but for society. Decent, affordable, production aware, nutrition for all.

However reality is that those who can afford choice, worry whether it is organic or bio, chemical free or free range. Those who cannot afford it, are left with the ‘value’ ranges. It’s never marketed as ‘the cheapest option.’

When I was a teen in school, “Home economics,” classes were compulsory but the content changed to become focused on things we were ‘all’ ‘capable of’ – homemade pizza for example.  Now we ask ourselves why are so many of our generation and their kids obese? We seek solutions for weight management. Could we not go back to basics, and fix the root cause – teach all of our kids to cook, and I mean, simple, real, food? Teach us all to understand food labels. Accompanied by a living wage for all, we could both eat more simply and I believe it would make savings in health benefits.

We need our children educated not to fall for marketing without understanding it.

Uninformed, we cannot make informed choice.

Our food and our health and inexorably linked.

When it comes to healthcare, we keep hearing labels, and ‘choice’, and it’s wrapped in plenty of packaging. Patient empowerment. Personalised medicine. Patient centred care. I do wonder if we don’t over-complicate simple things.

Can care be anything else *but* patient centred?

Let me ask the question – could we consider just going back to plain language. Without having to put it through ‘Plain English’ first? Patients need care. From other people. Professionals in whom we trust. Drop the patient-centric, patient-led language.

Let’s just have, as our grandparents used to call it, [1] ‘care’.

Don’t misunderstand me. I am passionate about patient and citizen participation. It’s why I have spent all my free time of the last ten months understanding care.data and the recent NHS market changes. But it’s the way it is packaged to us, I would like more people to explore and to question whether we really need all the outside layers, or whether it detracts from the most important questions.

Is all the talk around patient-centric really a move towards passing responsibility for payment?

Most people are responsible in their own healthcare as far as they can be. When we can help ourselves, we mainly do. Most people actually are not that good at asking for help, even when they need it. We like to be self-reliant. We know we could eat better, drink less, exercise more.  We know we need to manage our treatments and lifestyle. We do, and honestly, if we don’t always do it, it’s not going to help us by repackaging the responsibility, which we know we already have. The majority of people are as responsible as they feel able to be.

Many are pushed to their limits in society of how much more responsibility they can take on. They struggle to feed and care for their families, and don’t ask for help until they really have no other option. We may not want or be able to take on extra responsibility. When we are vulnerable, we trust others to help us.

Choice in those circumstances, is a luxury that’s not high on the priority list.  Choice becomes a catchphrase, not a reality. It’s not just that for everyone, but that’s the point. Choice becomes open to some, and closed to others. Some can choose organic, others are left with the ‘value range.’

It’s not perhaps PC to stand up and ask this of everyone with the best of ‘patient-centred’ intentions.  I love and commend the intentions here.[2]

I love the spirit that patient leaders intend to ‘enable’ patient empowerment, but what does that really mean?

To me, it infers the belief we patients have no power and therefore no responsibility, right now. It infers we need some seismic shift in current care. I disagree. Care in which I have been involved has always been about a co-operaton between the professional and patient needs, and respectful. It’s what our professionals *do*. It’s  already a partnership of trust and we trust professional opinion to take much of the responsibility for our care, in our best interest.

Yes we can get labelled as a bed or a surname. Yes, there is always room for improvement. Some have had awful individual experiences. It is perhaps a luxury of relativley good health that my family has experinced simple and good care, and perhaps it is for those who have more complex conditions that the system must focus improvement.

But are we not in danger of getting so focused away from care and on the patient-power as marketing jargon that we forget that the patients are simply, people, in need of professionals, who care?

We lose focus on asking how is the delivery of that care being supported by those responsible for it, from the top down?

Are we so focused on the solution, and this drive for change, that we are not asking, what is the root cause behind this need?

When we hear farm fresh and bio, we tend to conflate them with healthy, and better for us. If a package says tomatoes, vs bio tomatoes, which do you go for? But just the word ‘bio’ may be a meaningless marketing term. It’s a promotional tool, to make us want it. It is not the same as regulated words which mean not chemically treated, for example.

And so it is with health.

In all this ‘talk’ of patient power, is the real deal deliberately obfuscated?

Being told we should have choice,  is to make us want something, demand something, create a demand in patients that in fact, we may not want at all, but start to believe we do.

Is there really a patient desire across so many of us for choosing our own hospitals or do we not just want to go somewhere near, which our families can visit to get good care? Reducing monetary inefficiences is becoming conflated [3] with overall improvement – seeing care only as a supply chain product.

Is there really a need for the drive for ever more comparison data between consultants and between GPs which we are told supports ‘choice’?

Is a market being created, for which there is little public desire?

In a market driven by payment-by-results, fewer patients can mean fewer pounds. GP Boundaries are due to be abolished in October 2014.  More GPs are going to be forced to close if nothing changes in funding. Or they amalgamate or are taken over by corporate private management, like this practice. [3b] ‘Choice’ may exacerbate these changes. And it was foreseeable, as Sir Kinglsey Manning predicted in 2006 in the Inevitable Decline of the GP Partnership. 

Are we being manipulated into wanting what others want us to want? Is the patient-centric conversation keeping us distracted from the overriding factor in current policy – the drive from top-down to cut costs? The choice made by Government to create a gap between need and what is being provided from the public purse strings?

Between the 2012 Nuffield Report [4] and today’s £30bn, there must be reliable numbers somewhere. As a lay patient, it’s hard to know what is reliable and how to get an informed understanding.

It will be even harder to make a patient choice, if there’s no money available to offer any services to choose from.

If we can’t afford to be self-payers, privately insured, what then? This is the real impact patient choice will have. Some will have choice, and many will have none. Some will have care, and many will have none.

We will have facilities closed, which cannot offer care. And facilities open, where patients cannot afford to go.

Twenty years on, Yes Minister still makes me laugh. It’s possibly even less PC now, than it was then. But are some of the storylines still relevant? Perhaps more than ever.

“Get rid of 300 of your people, and get some doctors, and nurses, and get some patients.” | Yes, Minister – the Compassionate Society

We hear now increasingly of the secondary care closures, and the looming primary care crisis in GP recruitment and we ask, what shall we do?

We need to stand up and demand fixes for the root causes and not pussy foot around with words and the PC solution to an artificial need, which avoids the basic issues. Shortage of cash and staffing.

Patients must better understand the changes in this market creation for it to work – but not all change is equally good

University fees still make studying medicine expensive, even if part supported. GPs are not always, contrary to some media-hype, the best paid in medicine. It is interesting to look at a study in the unit costs of health and social care [5]. When students draw towards the end of their expensive studies it is unsurprising many look for the best paid jobs and specialisms may appeal.  I recently spoke with one mid-year student about her future and she was looking at brain surgery or psychology. The reason? She thought GPs in the future of the NHS was ‘too unpredictable’.

The seniority pay system has been scrapped for new entrants and reduced for those already in, so they can’t look forward to natural salary progression with really good benefits later on either.

Top and tail, the profession has been hacked off, in both senses.

Against a backdrop of regular undermining like the ‘maggotgate’ scandalous misrepresentation in the media, top-down imposed changes have been a heavy burden on GPs who continue to put patients first and care for us.

They’re coping with  a technical support system [6] under constant tinkering with its admin processes which may not offer any local benefit, changes to core work [7], potential outsourcing [8] and job losses, the destabilisation of support, and both increased marketisation [9] and general lack or stalling of funding since 2010. [10]

And that’s only from an outsider patient’s point-of-view. Patients, ask your GPs.

It feels to me very much as if ministers want to pass the buck (pun intended) back to patients – if we’re responsible for the management of our care today, we’ll likely be responsible for the cost of it tomorrow.

The concept of promoting patient choice, of patient-led decision making though fundamentally not flawed, deflects from the responsibility of others in care provision. It suggests that the patient is to be solely responsible. There are of course aspects of care we can and should manage ourselves. But I don’t feel this is the primary driver of the initiative, in annual reports and roadmaps. It is all about budget, lack of budget and reduced budget.

“Choice” has become the marketing watchword to package the market force of competition to patients.

It has driven wedges between services and broken others apart, causing the lack of integration which is the very thing they now purport to be key to success in health and social care.

A decentralised, and broken up market is easier to manage by private providers, choice for patients exists only by having multiple providers, which only works if you first break up the NHS single delivery model.

We are told that we are to be risk-stratified this year in GP practices, taking our patient records and analysing them at the practice, CCG or Health and Social Care Centre approved site. By segmenting groups who will be most at ‘risk’ and therefore need higher levels of care, they will also assess those who cost the most. These segments focus for example on COPD, Diabetes, Stroke, and the over 75s repeat hospital admissions.

I worry that there are many vulnerable, such as mental health patients, whose segmentation will stigmatise and put them at risk in ever smaller funding pools.

The idea of personal budgets is a slippery first step, to segmenting out treatments and patients who may or may not be covered by NHS care.

An individual budget, a personal shopping basket, can more easily be analysed by a health insurer for example, or simply reduced by the State to be able to buy less at the State till, without topping it up with our own private contribution.

Over 40% of social care users in England [12] are managed in this way. Social care where the issues of AQF have come well documented, as private providers seek ever to reduce costs.

We are rapidly losing control of that social care market. US investors are snapping up the profitable parts of the sector, with the long term prospect of the wealthy self-pay areas provided for by US investors [13], and the poorer local authority-paid homes? well, we’ll wait and see.

Many elderly are left with ‘the cheapest option’. They may or may not think that it is good value.

If patients are empowered as the new consumers in the healthcare market, we need to speak up for what we want

Let’s cut out all the PC talk and talk to government about getting university (medicine) fees reduced or cut. Stop any new reforms and let the profesionals get on with their job of caring. Let’s cut down on the promotional packaging, and management consultant-speak in healthcare. Drop the patient-led, patient-centric. There are pages and pages in brochures on patient empowerment but patients, we need a bit more revolt, questioning why these changes are needed and what is the root of change required. As so wonderfully put recently, we need ‘revolting patients.’ (p.19) [11] We need patients putting first, but let’s first focus on the care.

Care. That’s what matters. It’s that simple. Not patient empowerment, centric or led packaging and labels. Not parcels of personalised care budgets, packaged as ‘gifts’ and choice to us.

We want as patients for our care and the support of the system of our care to be at the centre of focus.

We need the state to manage that there is enough money in the pot to provide a duty of care for all, fairly, and provide  enough trained professional staff to do so.

There is a darn big hole predicted of £30bn between planned spend and need. It’s not going to all come from savings from thin air, nor to pay for itself, so patients, who do you think the Government is expecting to pay for it?

Changes have already been made in what is ‘free on the NHS’ i.e. possible to prescribe, such as hearing aids, other areas may be under discussion, for example in kidney dialysis.

Patients, we need not be ’empowered’ to wake up to the marketing ploys. Speak up, or we are complicit in our own downfall.

Is this the best path for care in this country, or is it a policy underpinned by an  ideology which has removed the Secretary of State’s Duty of Care [14], a duty to provide, and replaced it with a duty to promote?

“The Secretary of State must continue the promotion in England of a comprehensive health service.”

Let’s challenge the drivers of marketing speak and the market based health provision. A market inevitably leads to those who can afford it, having the choice. And those who can’t, are left with the ‘value’ range. They may be left with nothing at all when they need it, if the duty of care, has been replaced with nothing but promotion.

NHS patient empowerment is like buying organic. It’s a false choice. In a system designed to have fair access for all, we should not look to segment the patients, seen as consumers, into those who can pay the most for choice, and those who cannot afford to.  Nor should we only see the benefits of personalised budgets.

Let’s ask to talk about the basics. Let’s focus on the care and providing enough funds to do it right. At patient events we need to ask what are the planned costs and where is the budget for them? What is about to be merged with Local Authority budgets for social care? What is ring-fenced and what is not? Where will decision making lie in a merged future?

Where is the Social care and Health Strategy and the benefits plan – have you seen one? I haven’t.

Let patients be patients, and professionals get trained and supported to do their job.

Government, of any colour, must ensure responsibility for the duty of care is not passed along the supply chain. These issues are cross-party and cross parliamentary terms.

The NHS belongs to us all, and should be there, for us all, and not create a three-tiered consumer market in health. Those with choice, those with state care from the ‘value’ range’, and those with neither.

Yes, Minister? [15]

********

[1] Ken Loach made Interviews on the birth of the NHS http://www.thespiritof45.com/Interviews-Archives/Health

[2] Prioritising person-centred care – the evidence http://www.nationalvoices.org.uk/evidence

[3] Wall Street Journal – blog – How Eliminating Inefficiences Can Elevate Hospital Pharmacy As A Strategic Asset http://online.wsj.com/article/PR-CO-20140506-908700.html

[3b]  Privatisation behind an Invisibility Cloak – blog by Dr.David Wrigley http://drdavidwrigley.blogspot.co.uk/2014/06/privatisation-behind-invisibility-cloak.html?m=1

[4] the 2012 Nuffield Report- The funding pressures facing the NHS from 2010/11 to 2021/22

[5] Unit Study in Health and Social Care http://www.pssru.ac.uk/project-pages/unit-costs/2013/index.php

[6] Fears for QOF funding as NHS draws up contingency plans to pay GPs from next month http://www.pulsetoday.co.uk/your-practice/practice-topics/qof/fears-for-qof-funding-as-nhs-draws-up-contingency-plans-to-pay-gps-from-next-month/20006085.article
[7] Pulse: Dramatic’ changes to GP contract by next April as Hunt spells out detail of general practice reform, 12 Sept 2013 by http://www.pulsetoday.co.uk/home/gp-contract-2014/15/dramatic-changes-to-gp-contract-by-next-april-as-hunt-spells-out-detail-of-general-practice-reform/20004293.article
[8] Primary care contracting faces cuts and outsourcing, 5 Nov. 2013 by http://www.hsj.co.uk/home/commissioning/primary-care-contracting-faces-cuts-and-possible-outsourcing/5065021.article
[9] NHS shakeup: Private companies see potential to expand their role – Denis Campbell, July 2010 – Firms aim to to gain unprecedented foothold in healthcare system once GPs start spending £80bn of NHS funds – http://www.theguardian.com/society/2010/jul/12/nhs-private-companies-gps-funds
[10] GP Online – Cuts to enhanced services across England will wipe out slim uplifts to GP contract funding agreed for 2011/12, a GP investigation reveals. By Stephen Robinson on the 19 October 2011 www.gponline.com/exclusive-practices-face-28000-service-cuts/article/1099085
[11] Reflections – Have we empowered patients Essay: p.19 Jeremy Taylor, Chief Executive, National Voices
[12] A report by the All Party Parliamentary Groups on Global Health; HIV/AIDs; Population, Development and Reproductive Health; Global Tuberculosis; and Patient and Public Involvement in Health and Social Care – May 2014http://www.patientsorganizations.org/attach.pl/1786/2114/APPG%20Global%20Patient%20Empowerment%20Report.pdf
[13]  Social Care – US investors snap up UK care homes, FT, June 10, 2014 – by Gill Plimmer – http://www.ft.com/cms/s/2/6da9f5bc-f08d-11e3-8f3d-00144feabdc0.html#axzz34kzPdWXd

[14] Health and Social Care Act 2012 http://www.legislation.gov.uk/ukpga/2012/7/section/1

[15] Yes Minister – “The Compassionate Society” (se2 ep1)
Created by Antony Jay & Jonathan Lynn. Broadcast February 23, 1981 – http://www.youtube.com/watch?v=x-5zEb1oS9A

 

 

care.data – the 4th circle

commedia“Will it become a productive process putting patients’ choice and empowerment first, or is it all talk, hurling stones at one another, going round in circles and building nothing?”

Since The Lords voted to reject proposed amendments last week, to legislation which would have emphasised patient empowerment in the programme and shored up trust, I feel a little in limbo.

As patients of the NHS in recent times, we have been bombarded with the language of patient choice, personalised care and patient empowerment. Putting patients first.

But what power or choice do we patients really have in the use of our health data?

It seems that increasingly media articles, meeting minutes and speeches talk of power and patient empowerment, but it feels like in reality we have less and less.

So too we hear repeated how ‘powerful’ our health data is. How the power of data and its management is used, how the concomitant language is used, misused and shared with others, influences decision making around the subject and our patient rights.

All things are subject to interpretation. Whichever interpretation prevails at a given time is a function of power and not of truth. – Friedrich Nietzsche

As a Germanist at university, interpreting Nietzsche was both a cause for celebration and a cause of much gnashing of teeth. Having also studied Italian, I’m mixing my Dante in there, apologies.

The gnashing of teeth, biblical in origin, was reserved by Dante for the fourth circle of Hell, in his most famous work of his trilogy, the Divine Comedy. The fourth circle was the realm of money. It contained two opposite groups, the avaricious and the squanderers. The bridge builders and the destroyers.

Both the hoarders and the wasters are obsessed with development, either promoting it, or stopping it at all costs. And their punishment is to go round in circles, labouring against each other with heavy rocks, from opposing sides for eternity.

My background is in making technology functional for users to make their work easier. Systems only work which  have a proven benefit for the stakeholders. Introducing new systems is not about technology, but about people. If people don’t want to use your system, you can’t make them. They will find a workaround or data quality will be so poor as to make it worthless. Any project with opposing sides, will have some degree of argument and failure for one or more parties. It’s not what working together, should be about.

When I heard the Lords debate, two things struck me.

The first, whilst different arguments were debated they were really not opposed to one another, but trying to find the best way of achieving the project aims. The vast majority were common sensed and aligned. Wellcome and the AMRC support the legislative shoring up of trust. The biggest difference was that citizens’ trust and empowerment were supported better by the amendments, yet the vote went the other way.

The second thing which struck me, was how the language used can sway what we believe. We only believe what we want to believe, after all.

Labelling data as anonymous or de-identified when what is meant is pseudonymous, and mixing in ‘Open Data’ when ‘shared data’, is meant, is not the same thing at all. And it’s very misleading.

The Lords ‘ping pong’ last week again misrepresented, I feel, the weight that anonymous data sharing should have in the debate.

Earl Howe said;

“I stress this point in particular, as I understand that it has been the subject of some confusion. There is already a strong legal framework protecting the confidential and identifiable data held in people’s health and care records, not just the information held by the HSCIC but more generally. The Data Protection Act, which implements the EU data protection directive into UK law, provides powerful protection of information about living individuals. To summarise what is a lengthy and complex provision, it requires all such data to be anonymised except where there is good reason to the contrary. It remains the case that the Data Protection Act continues to offer strong protection of personal data…”

The fact he wants to make such efforts to ‘stress this point in particular’ does not fill me with faith in the system. In fact, I’ll be honest, I feel that on this point he was factually misleading.

Firstly, in terms of extraction.

The default position is to extract fully identifiable and personal data unless individuals object. PCD will leave the practice for all patients, where there is a legal basis i.e. under the HSCA 2012 or Section 251 approval.

So for Earl Howe to focus on anonymous use, detracts from the fact that it is not anonymous upon extraction at all and may be used and is used with identifiers, far more widely than patients might expect once processed. And will be by default, unless people activley opt out.

Misuse and inappropriate levels of risk exposure are made less transparent by the wording of what type of data it is.

Time and time again, even in the Lords last week, I am frustrated to hear inappropriate use of terminology which perpetuates misunderstanding.

We need to be very clear what  differences there are between data sharing and Open Data. Professor Sir Nigel Shadbolt addressed these differences and the release of Open Data at this conference on March 20th 2014. He importantly makes the distinction that the reusable open-to-use-by-anyone data of Open Data definition, is separate from most uses of personal data, even in the current ‘grab’ going on. [his words]

The Open Data movement is not trying to liberate and put out all our personal data.  He sees personal data, fully and properly anonymised, with consent,  will play a role. But we need to understand different ways of handling the different types of data.

Governmental legal guidance in 2010 did not have the interpretation we have been given today of amber, pseudonymous data. In this file you’ll see it’s personal (red) or it’s not (therefore fully anonymous). But it is clearly noted that anything which is not fully anonymous, i.e. what may identify individuals (what HSCIC labels Amber), should be treated no differently from red data.

“If the data to be shared is fully anonymised, then it will be less likely for problems should arise, though consideration still has to be given to the principles in the Data Protection Act 1998 (DPA). If the data required for statistical purposes contains information which may identify individuals (personal data), then the sharing should be approached in the same way as for any other circumstances, as explained in this guidance.”

I have no idea by whom and for whom it was written, but they state they consulted ICO.

We need to be clear, this is important both for public and parliamentary perception to make informed choices and inform the parliamentary care.data and wider data sharing debate.

In Parliament yesterday, Chi Onwurah MP (14 May 2014 : Column 848) said with regard to the Apprenticeships, Skills, Children and Learning Act 2009 – my bold:

It is therefore deeply troubling that the Government have tabled a last-minute new clause to the Bill to authorise data sharing among the Department for Business, Innovation and Skills, Her Majesty’s Revenue and Customs and persons providing services to them when it comes to apprenticeships. This may be both necessary and useful—the actual data to be shared may be entirely harmless—but it should be done transparently, with the right safeguards and accountability in place, and it should be done as part of a coherent strategy. This is clearly not the case here. The “person providing services” could be anyone, from individual consultants to big multinational companies.

We therefore tabled amendment (a) to ask what information was being shared, with whom, by what process, with what accountability, and how it fitted into the Government’s data sharing strategy. If the Minister can answer all those questions, perhaps the amendment will prove superfluous. If not, why not?

Doesn’t it sound rather familiar? Rushed amendment, lack of transparency, loose terminology of data recipients and purposes. If data is presented in wording which is inaccurate, we can only expect its use to be so too.

We need to ask what is the Government’s data sharing strategy and whom does this legislation serve?

Increasingly it seems to me that the Government is firefighting ad hoc bits of data legislation into existing Bills to enable their initiatives which need our personal data. We are being mined on all fronts. Open Data across the board, HMRC plans, DWP, the NPD, DVLA, care.data and more. And mostly, without our consent and often without our informed knowledge.

How is this empowering patients and citizens by removing our choice or rights of autonomy?

Some data sharing programmes may have been addressed and work well. But it takes more than a bathful of corks, to make a watertight boat. It sounds to an outsider, like overall data sharing design and strategy needs to go back to the drawing board and draw up a decent infrastructure. Patching like this, is a waste of time IMO and we can just sit back, and await the future leaks. I just hope they won’t be nightmare stories in health.

All in all, ‘you have a choice’ sounds rather hollow in all manner of fields right now. It’s been a bad week for patient power from where I write. Our local GP practice caring for 4,000 patients is set to close at the end of the month and the list shared out to three already full alternative practices.

Tim Kelsey as Director for Patients and Information outlined in 2012:

“making data available to the public does drive choice in the same way it would in consumer markets such as financial services or mobile telephones or whatever.”

Freed data was seen to walk hand-in-hand with choice. We were told with patient choice, would come patient empowerment. The NHS was turned into a consumer market in the HSC Act 2012.

It’s therefore ironic that the foundations of care.data fail to put patient choice as its cornerstone. It’s not a consent process which is set out by the HSCA 2012 (250-60’ish). It’s a gateway for extraction with no more than fair processing requirement. That loss of autonomy is not giving patients control nor choice. And the choice that is on offer, is limited. Both in scope and time. The only choice offered in the patient leaflet and communications, is to restrict fully identifiable onward data sharing from GPs or from HSCIC. And to be excluded from care.data is a limited offer – before it is launched. After that, the only choice left is to request the data which has been extracted is made pseudonymous, but it is not possible to remove it.

There can be no arguing with what has happened in the past regarding data releases which may no longer be seen as wise. Despite the fact the Information Centre cannot tell us today, (Q272) who all the end users of data have been in the past, we are offered no new barriers to breaches of trust happening again.

The Health and Social Care Act 2012 brought in fundamental changes in both practice and balance of power between patient and provider, and the State. These are changes in society over which we have little control, for now. Come the next General Election, there may be political change and ideology may be different. It may not be. And inevitably in our current political system, it will swing between different thinkings over time. But our health records given up today, are given up for life. Commercial exploitation is a value set being thrust upon us, which we may or may not not embrace. Both in terms of with whom our data is shared, who is managing it and how.

I met my own MP last week, thanked him for sharing my concerns with the Department of Health last October, and discussed the current status of the programme. He asked me, was I against sharing our medical records at all costs? To which my answer was no. No with a number of caveats.

We are used to, what most would see in this country, as a benign government. Events around the world, show us that we should not take it for granted. (I imagine at this point a failed Conservative election 2015, Boris with his cornflake model for society, replaces Cameron at some point in the next term, and wins in 2018 with support of a minority UKIP coalition. My personal result from hell. Don’t forget to vote May 22nd!)

If we have no statutory strength, what do patients really have power over in the choice to share our medical records?

So far we have only an objection to identifiable data sharing. No opt out of other data sharing from HES at all has been offered in patient communications. No opt out form and nothing in law. And Mr.Hunt’s word of ‘an objection which will be respected’ but does not yet match with what he promised on February 25th, and opt out of anonymised data used in research. 

…”we said that if we are going to use anonymised data for the benefit of scientific discovery in the NHS, people should have the right to opt out”

That’s not only on identifiable data as the patient leaflet proposed.  However I fear this may once again become subject to interpretation. Mr.Hunt has the power to make his promise a reality. I would greatly respect what he says, if we see his words become action.

In 2009 Mr.Kelsey voiced his opinion on opt out, in article published in his name in Prospect.

no one who uses a public service should be allowed to opt out of sharing their records. Nor can people rely on their record being anonymised..”

So who holds the power to make the decision? Mr.Hunt, Mr.Kelsey or do they mean what they say, they want empowered patients?

Whilst there are individuals who appear obsessed with pushing forward the promotion of health data sharing, at all costs, whether with their own Life Science company background interests, or with a vision of how we will mash it up with supermarket loyalty cards, others may be pushing back, immovably opposed to the whole idea of removal of GP patient confidentiality.

Unlike the fourth circle of Hell, there appears to be a more commonly held middle ground.

However, reality is that the opt out does not work like that yet. So far, we do not have a communicated choice on amber HES.

So even for those who support some data sharing, whilst trust hangs in the balance, people will not support a system which appears to deliberately disempower us. By first starting with opt out, care.data is skewed to removing patient choice from those who are not paying attention to public issues and we’re not sure of the security of the objection on offer anyway. Those who are alert, mainly dislike the idea of our data being traded with third parties who may use the data to create knowledge which they sell on, for profit. When we see stories of who uses it and how, we feel let down.

It feels both an abuse of trust and of power, that having trusted ‘the system’, we have been failed by its gatekeepers and guardians.

It is ironic that in a society in which news and campaigns persistently remind our children that their bodies are their own, that the knowledge of their workings will be taken from them without their knowledge or future ability to withdraw their consent and remove their records. In their lifetime, it might not only be e-data but biomedical.

Within assumed consent and opt out based on an honour system, is the question of power and control.  There is one person making a decision who can choose whether or not to respect our objection.

We have only his word, that we have an objection to share any individual identifying data from our GP practice.

The patient leaflet says, ‘you have a choice.’

In reaching our choice, I also ask if we are each individually empowered to make it of our own free will, or will we be emotionally ‘encouraged’ to see it as the right thing to do?

Perhaps made to feel selfish if we do not. Is this free and informed, and not coercion?

Citizens must be pro-active to opt out. The last letter from May 2nd online from Mr.Kelsey suggested we can work together, to get care.data right. However,  in the same letter our patient choice, comes at a price. Whilst being encouraged to see reasons to stay opted in and give up our data, we are told of a patient who was misdiagnosed and died.

“In future, this can help prevent cases such as Alison, from Hampshire, who went to her GP suspecting she had a brain tumour, but was prescribed painkillers. She was eventually diagnosed in A&E after a seizure and died less than a year later.”

I feel when I read that, it came across very much as, “see what happens if you don’t share your data? You’ll die prematurely” and the second statement on cancer in A&E made us feel guilt that we may not help us identify why someone else who died.  And if fear and guilt are not strong enough sticks, here’s the carrot, by sharing our data we’ll keep it safer somehow, by entrusting it to the State:

“minimise the risk to a person’s privacy being compromised in an age of increasingly sophisticated digital threats.”

(Erm, let me keep it only accessible by my GP practice then, rather than risk sharing it via Google Cloud?)

Please. Stop chivvying us into doing what you want. We have a choice. The leaflet, which we may or may not have ever received, told us so on the front cover.  You cannot also tell us what to choose.  Big Brother, you don’t have the right to make up our mind for us. No matter your own experiences, whether it’s a family friend’s care, or the terminal illness of a son, or indeed each of our own family experiences. None of us have the right to decide what is a correct decision for others. Neither should Mr. Hunt be asking GPs to ‘sell’ the programme to patients. It’s an abuse of power to coerce a free choice.

I don’t want to feel emotionally manipulated. Just be straight talking and trust us to make up our mind as we see fit.

Overly aggressive charity collector chuggers asking for cash donations on the street, get short shrift these days. It feels like the programme is still trying the same, with mildly threatening tactics in order to use our data, by research charities among others. The lesson why that’s not right seems not to have been learned. The Wellcome Trust clearly does understand what is needed and backed the Lord Howe’s governance and oversight proposal. (Col 1520).

The letter also gave the impression that poor or missed diagnoses in primary care were responsible for disproportionately finding cancer in A&E, which was disputed on social media Twitter by medics suggesting similar use of statistics had been previously corrected, when NHS England retracted it last autumn. Another lesson not learned. Is it an abuse of statistical data if whilst factual, it is knowingly being misunderstood and creating misinformation.  One could also ask, is this not an abuse of the power of data and anecdote?

Dante was a tad cheeky in the Comedy. He sought to create his own immortality. By retelling the stories of the damned, he created his own power over them. He controls the narrative, selecting whose stories get shared and those which do not. He is selective with the truth. He believes that by interpreting others’ stories he could give them, and himself, an eternal life. He puts himself among the great poets who have gone before him and enjoys their glory.

He is led through Hell, by Virgil, someone he both adulates and trusts.

So too patients need leadership we can trust and respect. We need transparent and accurate truth, if we are to build trust. There is no room for emotional blackmail.

There should be no power struggle in a free decision. Like in the Divine Comedy, there’s lots of rights and wrongs, differing ethics  and moral dilemmas to consider. But judgement should not be made.

Personally I believe it is not right that we parents should determine now what should be our children’s choice, with no correction nor future opt out. Not everyone *is* a willing research patient, and that’s OK. Others may want to be as involved as possible. Only 4% of the population are blood donors, but I’m not going to browbeat anyone into doing it who isn’t.

A stick is still a stick, even if you tell us in your opinion, it’s the right thing to do. You want to empower patients? Prove it. Empower us with statutory opt out and trust us to make our own choice.

Put patients first and show us you mean it.

Will it become a productive process putting patients’ choice and empowerment first, or is it all talk, hurling stones at one another, going round in circles and building nothing?

Does Mr. Hunt, Government and NHS England really want to involve patients about decisions made in the NHS, and in the use of our health data in particular?

What powers-at-be are deciding how our data is managed and governed and who can have it and why?

One of my favourite mottos is found in ‘Inferno’, Dante’s Hell.

“The hottest places in hell are reserved for those who, in a time of moral crisis, maintain their neutrality.”

In Dante’s Commedia, treachery against religion and against government are both reserved for Hell’s final circle.

I hope my public stance is helpful. I fear it has become a bit of a rant.  Apathy is neutral. But this is no time for neutrality.  There are those in power who make decisions, those with power who influence them and the rest of us. We need to speak up.

To protect our patient choice and to ask to exercise our patient power, so oft championed in word by NHS England and Government, feels so far, rather a risky position to take and challenge what is yet an empty promise.   But public opinion should not be ignored when considering what is deemed to be in the  Public Interest.  We need a more interested public to understand what it will mean if our health data is given freely to third parties, perhaps cross borders, in pseudonymous form without data protection controls or any need to respect consent or inform us. Not just today, but for our lifetime and beyond.

We need some good interpretation and good bridge builders.

We need leaders we can trust to lead us through this process and positively out the other side.

..”every single NHS patient should have a right to opt out of having their data used in anonymised scientific research. I think that was the right thing to do. Of course we are having a difficult debate, but its purpose is to carry the public with us so that we can go on to make important scientific discoveries.”

[Jeremy Hunt, 25th February 2014 – col 148]

Power to the People, was timely this week. Is it all talk, or do you trust us to make our own choices? Trust is a two-way process. You want us to trust the system? Give us a statutory opt out. Get the governance and oversight procedures sorted out.  Narrow the commercial purposes for which data can be used.

I think patients can see the benefits of the programme, but it’s going to be hell getting to a workable solution if basic patient empowerment is left off the discussion table. After all, it’s our data.

PS: (The remix of power to the people may be better than the original.) Maybe there’s a second chance for most things.