Category Archives: leadership

data, engagement, ethics, human rights, leadership, transparency

Ethics washing in AI. Any colour as long as it’s dark blue?

The opening discussion from the launch of the Institute for Ethics in AI in the Schwarzman Centre for Humanties in Oxford both asked many questions and left many open.

The panel event is available to watch on YouTube.

The Director recognised in his opening remarks where he expected their work to differ from the talk of ethics in AI that can become ‘matters of facile mottos hard to distinguish from corporate PR’, like “Don’t be evil.” I would like to have heard him go on to point out the reasons why, because I fear this whole enterprise is founded on just that.

My first question is whether the Institute will ever challenge its own need for existence. It is funded, therefore it is. An acceptance of the technological value and inevitability of AI is after all, built into the name of the Institute.

As Powles and Nissenbaum, wrote in 2018, “the endgame is always to “fix” A.I. systems, never to use a different system or no system at all.”

My second question is on the three drivers they went on to identify, in the same article, “Artificial intelligence… is backed by real-world forces of money, power, and data.”

So let’s follow the money.

The funder of the Schwarzman Centre for Humanties the home of the new Institute is also funding AI ethics work across the Atlantic, at Harvard, Yale and other renowned institutions that you might expect to lead in the publication of influential research. The intention at the MIT Schwarzman College of Computing, is that his investment “will reorient MIT to address the opportunities and challenges presented by the rise of artificial intelligence including critical ethical and policy considerations to ensure that the technologies are employed for the common good.” Quite where does that ‘reorientation’ seek to end up?

The panel discussed power.

The idea of ‘citizens representing citizens rather than an elite class representing citizens’, should surely itself be applied to challenge who funds work that shapes public debate. How much influence is democratic for one person to wield?

“In 2007, Mr. Schwarzman was included in TIME’s “100 Most Influential People.” In 2016, he topped Forbes Magazine’s list of the most influential people in finance and in 2018 was ranked in the Top 50 on Forbes’ list of the “World’s Most Powerful People.” [Blackstone]

The panel also talked quite a bit about data.

So I wonder what work the Institute will do in this area and the values that might steer it.

In 2020 Schwarzman’s private equity company Blackstone, acquired a majority stake in Ancestry, a provider of ‘digital family history services with 3.6 million subscribers in over 30 countries’. DNA. The Chief Financial Officer of Alphabet Inc. and Google Inc sits on Blackstone’s board. Big data. The biggest. Bloomberg reported in December 2020 that, ‘Blackstone’s Next Product May Be Data From Companies It Buys’. “Blackstone, which holds stakes in about 97 companies through its private equity funds, ramped up its data push in 2015.”

It was Nigel Shadbolt who picked up the issues of data and of representation as relates to putting human values at the centre of design. He suggested that there is growing disquiet that rather than everyday humans’ self governance, or the agency of individuals, this can mean the values of ‘organised group interests’ assert control. He picked up on the values that we most prize, as things that matter in value-based computing and later on, that transparency of data flows as a form of power being important to understand. Perhaps the striving for open data as revealing power, should also apply to funding in a more transparent, publicly accessible model?

AI in a democratic culture.

Those whose lives are most influenced by AI are often those the most excluded in discussing its harms, and rarely involved in its shaping or application. Prof Hélène Landemore (Yale University) asked perhaps the most important question in the discussion, given its wide-ranging dance around the central theme of AI and its role or effects in a democratic culture, that included Age Appropriate Design, technical security requirements, surveillance capitalism and fairness. Do we in fact have democracy or agency today at all?

It is after all not technology itself that has any intrinsic ethics but those who wield its power, those who are designing it, and shaping the future through it, those human-accountability-owners who need to uphold ethical standards in how technology controls others’ lives.

The present is already one in which human rights are infringed by machine-made and data-led decisions about us without us, without fairness, without recourse, and without redress. It is a world that includes a few individuals in control of a lot. A world in which Yassen Aslam this week said, “the conditions of work, are being hidden behind the technology.”

The ethics of influence.

I want to know what’s in it for this funder to pivot from his work life, past and present, to funding ethics in AI, and why now? He’s not renowned for his ethical approach in the world. Rather from his past at Lehman Brothers to the funding of Donald Trump, he is better known for his reported “inappropriate analogy” on Obama’s tax policies or when he reportedly compared ‘Blackstone’s unsuccessful attempt to buy a mortgage company in the midst of the subprime homeloans crisis to the devastation wreaked by an atomic bomb dropped on Hiroshima in 1945.’

In the words of the 2017 International Business Times article, How Billionaire Trump Adviser Evades Ethics Law While Shaping Policies That Make Money For His Wall Street Firm, “Schwarzman has long been a fixture in Republican politics.” “Despite Schwarzman’s formal policy role in the Trump White House, he is not technically on the White House payroll.” Craig Holman of Public Citizen, was reported as saying, “We’ve never seen this type of abuse of the ethics laws”. While politics may have moved on, we are arguably now in a time Schwarzman described as a golden age that arrives, “when you have a mess.”

The values behind the money, power, and data matter in particular because it is Oxford. Emma Briant has raised her concerns in Wired, about the report from the separate Oxford Internet Institute, Industrialized Disinformation: 2020 Global Inventory of Organized Social Media Manipulation “because of how influential the institute is.”

Will the work alone at the new ethics Institute be enough to prove that its purpose is not for the funder or his friends to use their influence to have their business interests ethics-washed in Oxford blue?  Or might what the Institute chooses not to research, say just as much? It is going to have to prove its independence and own ethical position in everything it does, and does not do, indefinitely. The panel covered a wide range of already well-discussed, popular but interesting topics in the field, so we can only wait and see.

I still think, as I did in 2019, that corporate capture is unhealthy for UK public policy. If done at scale, with added global influence, it is not only unhealthy for the future of public policy, but for academia. In this case it has the potential in practice to be at best irrelevant corporate PR, but at worst to be harmful for the direction of travel in the shaping of global attitudes towards a whole field of technology.

#caredata, care.data, empowerment, engagement, health, leadership, Tech

Digital revolution by design: infrastructures and the world we want

1. Digital revolution by design: building for change and people
2. Digital revolution by design: barriers by design
3. Digital revolution by design: infrastructures and the fruits of knowledge

This is Part 4.  Infrastructures and the world we want

At high level physical network infrastructures enable data transfer from one place to another and average users perceive little of it.

In the wider world Internet infrastructure today, this week might be looked back on as, to use a horrible cliché, a game changer. A two-tier Internet traffic system could be coming to Europe which would destroy a founding principle of equality – all traffic is created equal.

In other news, Facebook announced it will open an office in the toe of Africa, a foothold on a potential market of a billion people.

Facebook’s Internet.org initiative sees a further ‘magnificent seven’ companies working together. Two of whom Ericsson and Nokia will between them have “an effective lock down on the U.S market,” unless another viable network competitor emerges.  And massive reach worldwide.

In Africa today there is a hodge podge of operators and I’ll be interested to see how much effect the boys ganging up under the protection of everybody’s big brother ‘Facebook” will have on local markets.

And they’re not alone in wanting in on African action.

Whatever infrastructures China is building on and under the ground of the African continent, or donating ludicrous showcase gifts, how they are doing it has not gone unnoticed. The Chinese ethics of working and their environmental standards can provoke local disquiet.

Will Facebook’s decision makers shape up to offer Africa an ethical package that could include not only a social network, but physical one managing content delivery in the inner workings of tubes and pipes?

In Europe the data connections within and connecting the continent are shifting, as TTIP, CETA and TISA shape how our data and knowledge will be shared or reserved or copyrighted by multinational corporations.

I hope we will ensure transparency designed it these supra-national agreements on private ownership of public firms.

We don’t want to find commercial companies withhold information such as their cyber security planning, and infrastructure investments in the name of commercial protectionism, but at a public cost.

The public has opportunities now as these agreements are being drawn up, we may not get soon again.

Not only for the physical constructions, the often networked infrastructures, but intangible infrastructures of principles and power, co-dependencies around a physical system; the legal and ethical infrastructures of ownership, governance and accountability.

The Open Data institute has just launched a call for the promotion of understanding around our own data infrastructures:

“A strong data infrastructure will increase interoperability and collaboration, efficiency and productivity in public and private sectors, nationally and internationally.”

Sounds like something we want to get right in, and outside, the UK.

Governance of data is physically geographical through country unique legislation, as well as supra national such as European-wide data protection.

In some ways outdated legal concepts in a borderless digital age but one way at least over which there is manageable oversight and citizens should be able to call companies and State to account.

Yet that accountability is questionable when laws seem to be bypassed under the banner of surveillance.

As a result people have somewhat lost trust in national bodies to do the right thing. We want to share data for public good but not for commercial exploitation. And we’re not sure who to trust with it.

Data governance of contractual terms is part of the infrastructure needed to prevent exploitation and enable not restrict sharing. And it needs to catch up with apps whose terms and conditions can change after a user has enrolled.

That comes back down to the individual and some more  ideas on those personal infrastructures are in the previous post.

Can we build lasting foundations fit for a digital future?

Before launching into haphazard steps of a digital future towards 2020, the NIB/NHS decision makers need to consider the wider infrastructures in which it is set and understand under what ethical compass they are steering by.

Can there be oversight to make national and supra-national infrastructures legally regulated, bindingly interoperable and provider and developer Ts and Cs easily understood?

Is it possible to regulate only that which is offered or sold through UK based companies or web providers and what access should be enabled or barriers designed in?

Whose interests should data and knowledge created from data serve?

Any state paid initiative building a part of the digital future for our citizens must decide, is it to be for public good or for private profit?

NHS England’s digital health vision includes: “clinical decision support to be auto populated with existing healthcare information, to take real time feeds of biometric data, and to consider genomics data in the future.”  [NIB plans, Nov 2014]

In that 66 page document while it talks of data and trust and cyber security, ethics is not mentioned once.  The ambition is to create ‘health-as-a-platform’ and its focus is on tech, not on principles.

‘2020’ is the goal and it’s not a far away future at all if counted as 1175 working days from now.

By 2020 we may have moved on or away in a new digital direction entirely or to other new standards of network or technology. On what can we build?

Facebook’s founder sees a futuristic role for biometric data used in communication. Will he drive it? Should we want him to?

Detail will change, but ethical principles could better define the framework for development promoting the best of innovation long term and protect citizens from commercial exploitation. We need them now.

When Tim Berners-Lee called for a Magna Carta on the world wide web he asked for help to achieve the web he wants.

I think it’s about more than the web he wants. This fight is not only for net neutrality. It’s not only challenging the internet of things to have standards, ethics and quality that shape a fair future for all.

While we shape the web we want, we shape the world we want.

That’s pretty exciting, and we’d better try to get it right.

******

1. Digital revolution by design: building for change and people
2. Digital revolution by design: barriers by design
3. Digital revolution by design: infrastructures and the fruits of knowledge
4. Digital revolution by design: infrastructures and the world we want

 

#caredata, care.data, change management, leadership, mental health, NHS, NHS England

Thoughts on Digital Participation and Health Literacy: Opportunities for engaging citizens in the NHS [#NHSWDP 1]

“..smartphones […] the single most important health treatment and diagnostic tool at our disposal over the coming decade and beyond “

That’s what Simon Stevens said at a meeting on “digital participation and health literacy: opportunities for engaging citizens” in the National Health Service this week, at the King’s Fund in London.

It seemed a passing comment, but its enormity from the Chief Executive of the commissioning body for the NHS, made me catch my breath.

Other than inspiration from the brilliance of Helen Milner, Chief Executive of the Tinder Foundation – the only speaker who touched on the importance of language around digital participation – what did I take away from the meeting?

The full text of Simon Steven’s speech is below at the end of this post, but he didn’t elaborate further on this comment.

Where to start?

The first thing I took away to think about, was the impact of the statement. 

“the single most important health treatment and diagnostic tool at our disposal over the coming decade and beyond “

So I thought about that more in a separate post, part two.

The second, was on consent.

This tied into the statement by Tim Kelsey, Director of Patients and Information at NHS England. It seems that the era when consent will be king is fast approaching, and I thought about this more in part three.

The third key learning I had of the day, which almost everyone I met voiced to me was, that the “best bit of these events is the learnings outside the sessions, from each other. From other people you meet.”

That included Roger who we met via video. And GP Dr Ollie Hart. All the tweeps I’ve now met in real life, and as Roz said, didn’t disappoint. People with experience and expertise in their fields. All motivated to make things better and make things work, around digital, for people.

Really important when thinking about ‘digital’ it doesn’t necessarily mean remote or reduce the people-time involved.

Change happens through people. Not necessarily seen as ‘clients’ or ‘consumers’ or even ‘customers’. How human interaction is supported by or may be replaced by digital contact fascinates me.

My fourth learning? was about how to think about data collection and use in a personalised digital world.

Something which will be useful in my new lay role on the ADRN approvals panel (which I’m delighted to take on and pretty excited about).

Data collection is undergoing a slow but long term sea change, in content, access, expectations, security & use.

Where, for who, and from whom data is collected varies enormously. It’s going to vary even more in future if some will have free access to apps, to wifi, and others be digitally excluded.

For now, the overall effect is perhaps only ripples on the surface (like interruptions to long-term research projects due to HSCIC data stops after care.data outcry) but research direction, and currents of thought may shift fundamentally if how we collect data changes radically for even small pockets of society, or the ‘worried well’.

My fifth learning, was less a learning and more the triggering of lots of questions on wearables about which I want to learn more.

#digitalinclusion is clearly less about a narrow focus on apps than applied skills and online access.

But I came away wondering how apps will affect research and the NHS in the UK, and much more.

[Next: part two #NHSWDP 2: Smartphones: the single most important health treatment & diagnostic tool at our disposal – on wearables]

[And: part three #NHSWDP 3: Wearables & Consent: patients will ‘essentially manage their data as they wish’. What will this mean for diagnostics, treatment and research and why should we care?]

*****

Full text of the speech given by Simon Stevens, Keynote speaker:

“The reality is we all can see that we’ve got to change […] as part of that we have got to have more integrated services, between primary and specialist services, between physical and mental health services, and between health and social care services.

“And the guiding principle of that integration has got to be care that is personal, and coordinated around individuals, with leadership of communities and patient groups.

“There is no way that can happen without a strong, technological underpinning using the information revolution which is sweeping just about every other part of the economy.

“We are not unusual in this country in having a health sector which has been a little slower, in some respects, than many other parts of national life to take full advantage of that.

“We are not unusual, because that is the experience of health services in every industrialised country.

“We obviously have a huge opportunity, and have a comparative advantage in the way that the NHS is organised, to put that right.

“We know that 8 out of 10 adults are now online, we know that two thirds of people in this country have got smartphones which is going to be the single most important health treatment and diagnostic tool at our disposal over the coming decade and beyond.

“But we know we have got 6.4m people who are not.

“And so when you of course then get serious about who are those six and a half million people, many of them are our highest users of services with the greatest needs.

“So this is not an optional extra. This has got to be central about what the redesign of care looks like, with a fundamental power shift actually, in the way in which services are produced and co-produced.

“This agenda goes to the heart of what we’ve got to get right, not just on inequalities but around co-production of services and the welcome steps that have been taken by the organisations involved, I think that the point is obviously we have now got to scale this in a much more fundamental fashion, but when you look at the impact of what has already been achieved, and some of the work that has already been done by the Tinder Foundation, you take some of the examples here, with the Sikh community in  Leicester around diabetes, and parenting in other parts of the country, you can see that this is an agenda which can potentially get real quite quickly and can have quite a big impact.

“The early evaluation anyway indicates that about half of people involved say they are leading healthier lives on the back of it, 48% in healthy eating, a third do more physical activity, 72% say they have saved money or time.

“Given that we are often talking about resource poor, time poor communities, that is hugely impactful as well.

“So my role here today, I think is simply to underline the weight that we place on this, as NHS England nationally, to thank all of you for the engagement that you have been having with us, and to learn from the discussion we are about to have as what you see where you see key priorities and what you need from us.”

[March 18, 2015 at the event “Digital Participation and Health Literacy: Opportunities for engaging citizens” held at the King’s Fund, London]

 

care.data, human rights, leadership, NHS, NHS England, politics

Deregulation – the UK Bill and the Titanic TTIP

The Deregulation Bill will go to the Lords Committee stage on 6th November. [For ongoing progress, see here.]

Deregulation Bill

 [graphic added Nov 21st: This was the concluding statement by Lord Tunnicliffe on November 20th.]

I write this in follow up to a previous post of because it’s a big bill with one very important little clause, amongst much detail which needs careful review in the public interest:

What is it? Clause 83: Exercise of regulatory functions, economic growth:

(1) A person exercising a regulatory function to which this section applies must,  in the exercise of the function, have regard to the desirability of promoting  economic growth.

(2) In performing the duty under subsection (1), the person must, in particular,  consider the importance for the promotion of economic growth of exercising  the regulatory function in a way which ensures that—

(a) regulatory action is taken only when it is needed,

and

(b) any action taken is proportionate.

This section of the Deregulation Act which is currently passing through Parliament, suggests the removal of any regulation that conflicts with the interests of a profit-maker.

 

There are domestic and regulatory bodies for which we should carefully consider this implication.

The Deregulation Bill surely creates an ethical conflict or at least challenge, when in law it must consider commercial gain on a statutory footing above other factors?

The clause is openly worded, that regulatory action should be taken only when it is needed and that any action taken should be ‘proportionate’.

That suggests that regulatory interventions should be reduced. Who and how will it be decided when and what is proportionate?

The Bill provides that a person exercising a regulatory function specified by the Minister:

In detail, what does that mean? If it’s not important why include it at all? If it is important, why have we heard so little about it?

That Lord Tunnicliffe would make such a forceful statement should not be taken lightly: …”if our fears comes to pass, these three clauses could wreak havoc in a regulatory regime within this country.”

Which bodies will this affect?

Functions to which section 83 applies:

There is a long list of regulatory organisations at the end of this post.
Click on the organisation’s name below to read about each one.

The implications for them are unclear but should be examined for public bodies whose function today is not for profit.

For one area in particular, and close to my heart, we should understand its impact on  regulation of the NHS; Monitor and CQC, the MHRA and HFEA (Fertility and Embryology) and how about the Human Tissue Authority? A body whose purpose is to:

“manage the interests of the public and those we regulate at the centre of our work. It aims to maintain confidence by ensuring that human tissue is used safely and ethically, and with proper consent.” [Ref: HTA]

It is unclear how this profit aim will be helpful for these bodies in healthcare, especially considering some of the issues in state social care .

A different body where others share a concern about the impact of clause 83 is for the EHRC.

 

The Joint Committee Reported on Human Rights, June 14th 2014 has concerns about the impact of this, listed in this report:

The Government intends this economic growth duty to apply to the EHRC. We believe 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 and the Equal Treatment Directives as implemented by the Equality Act 2010. The Government is therefore risking 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. Unless the continuing discussions between the Government and the Commission satisfy the Commission that the growth duty will not in any way impact upon its independence, we recommend that this duty not be applied to the EHRC.

[Nov 21st update: this clause was specifically debated >  see Column GC229 < and whilst verbal assurances were made, it appears nothing has changed in the Bill, and that the EHRC said in response:

“While we welcome this undertaking we understand that this doesn’t mean that we’ll be removed on the face of the Bill”.

So what value the assurances from  the Minister who will have left his post long before the Bill may be in effect?]

A large number of organisations play a part in securing compliance with the law. They include national regulators, local authorities, and bodies independent of Government, some of which have statutory regulatory functions.  The list below of the main national regulators is not exhaustive, but long. Clause 83 will have a very wide reach.

We should understand just how wide ranging this apparently small function in the Bill may turn out to be.

I believe this clause will serve to mop up the real or imagined economic leakage that the government seeks to collect from all these bodies. Resources that are as yet, untapped.

How will these regulatory bodies promote economic growth?

I wonder how, in the best public interest at all times, economic interest should come first in bodies responsible for oversight?

Will they be compelled to consider [further] cost cutting, selling assets, or charging for services?  Or how about entering into commercial partnerships?

Will the Drinking Water Inspectorate under DEFRA stay entirely independent?

What about the Gambling Commission – in its remit is ‘to protect children and vulnerable people from being harmed or exploited by gambling’?

How will the Office for Nuclear Regulation (ONR) hope to promote economic growth? Or the Forestry commission?

The consequences of such widespread promotion of deregulation and the requirement to actively promote profit seems ill-thought through and given little public attention.

Could it be that under austerity, and desperate to squeeze every drop of monetary gain from our state bodies, that this clause will open the gateway to increased fees, or the start of fees for some current non-charging access by the public to services?

Or will they be encouraged as schools were once, to sell off land and assets? Many of these bodies hold little land. The assets they both produce and hold, is data. It is clear from current practice and the direction of travel across government departments, that information is seen as a commodity and an untapped resource for sale. Perhaps this is an area each body will look at selling?

What about authorities which charge the public fees for services or could do so – the CAA for airspace regulation, the DVLA or the ICO? Will we see an increase in service charges – it is perhaps almost inevitable if the desirability  to promote economic growth is to be given statutory footing.

In addition to looking at what may actively promote commercial growth by direct sale or raising fees, rather than imaginary direct marketing concepts, in order to promote economic growth, will we simply find it more likely that indirect growth is encouraged through change in regulatory practices?

Most importantly perhaps, will we see regulations slackened which cost money to oversee?

Will the organisations which are to be regulated, permitted to do more which promotes commercial interest over other policies, or ethics?

I wonder if a future state aims to deregulate the market in almost every field of activity to enable profits for private commercial businesses, and if the intent is not desirable economic growth for the state directly, but indirectly?

If so, will the ideology that once deregulated, somehow private business interests will contribute more to the economy than they do today, be realised in practice? How has the deregulation of trains, postal services, water and utilities benefited the public interest over economic growth?

If the benefit is to be state economic growth,  whether through revenue direct or indirect, and whether or not it is achieved in the way it may be hoped, there will be other consequences.

Have we learned lessons from other areas in which oversight of regulation has been slackened in recent times, such as banking?

What happened since Banking was deregulated?

Anyone who can look back at the deregulation of the financial markets and say it was all, without any doubt a good thing, should say subprime mortgage deregulation and wash their mouth out.

“Regulation did not keep pace and became mismatched with the risks building in the economy. The Financial Crisis Inquiry Commission (FCIC) tasked with investigating the causes of the crisis reported in January 2011 that: “We had a 21st-century financial system with 19th-century safeguards.” [FCIC report]

“It found widespread failures in financial regulation; dramatic breakdowns in corporate governance; excessive borrowing and risk-taking by households and Wall Street; policy makers who were ill prepared for the crisis; and systemic breaches in accountability and ethics at all levels.” **[FCIC]

In summary,  has any cost risk benefit analysis has been done on the impact of what this widespread cross-market promotion of deregulation and the desirability of economic growth in a regulatory function will mean?

Why may this be seen as a desirable course of action?

Deregulation is tacking its way to its destination through the Lords in the UK. Whether it will reach it before the end of this parliamentary term is perhaps unclear.  But let’s not forget deregulation is the course on which we are set globally, at full steam ahead.

This UK Bill is simply a sponge on the deck of the Titanic of deregulation, the TTIP.

The purpose of the Transatlantic Trade and Investment Partnership is to remove the regulatory differences between the US and European nations. Its plan to cross the Atlantic at break neck speed has been somewhat slowed. But its purpose remains steadfast. There are effectively no tariff restrictions in place any more, so the barriers left to lift are those of regulatory intervention:

“The US and the European commission, both of which have been captured by the corporations they are supposed to regulate, are pressing for investor-state dispute resolution to be included in the agreement.” [The Guardian, Nov 4 2014]

This peer-reviewed  paper looks at the imagined trade and its consequences, “leaving the investment component of TTIP on the sidelines. Going forward, valuable insights could be drawn by further extending the analysis of TTIP’s financial effects.”

[Update Nov 13, letter today in the FT: quotes the same research paper and notes, “Even the most vocal proponents of free trade admit that there’s nothing irrational about opposing such big issues of public policy being traded off behind closed doors.” Nick Dearden, Director, World Development Movement]

Whilst much is made, with some confusion, around the potential for impact on the NHS, TTIP is indisputably very real for the rest of industry and wider market. And any deregulation as a whole touches many NHS bodies.

Despite wide professional and public criticism the TTIP discussions continue with little transparency. Deregulation appears to have become the UK government’s mantra for achieving economic growth, though in coalition not everyone may agree it is right.

In conclusion:

There should be detailed analysis and an impact assessment made for this Deregulation Bill clause 83 as it stands alone.

It must also be seen in conjunction with proposals for deregulation under TTIP,  and the impact analysed for the vast number of regulatory bodies and functions we have under the State wing, for the public good.

I sincerely hope our legislators in the Lords are taking this into account and not as a stand-alone Bill, but in the wider picture of current TTIP trade negotiations, and that the failures created in part through deregulation twenty years ago in banking, are not recycled now across the board.

Can society afford “dramatic breakdowns in governance, risk taking, learning by mistakes, or systemic breaches in accountability and ethics?” ** as we saw as a consequence in banking?

Oversight serves an important purpose.

It is often to ensure a balance between the needs of people, and search for profit. Whilst it is an accepted practice in our market economy, to seek to  make a profit,  oversight and regulation can ensure it’s not at the expense of the greater good.

Some of these public services that the regulatory bodies oversee in England will be harmed if they are not free to all at the point of their delivery. The independence of their ethical decision making will be challenged if it competes with promoting economic growth.

Who will help the public understand what this Deregulation Bill clause really will mean and complete proper and transparent public analysis of its impact for each regulatory authority?

I hope that those responsible for scrutiny of the Bill see value in maintaining first and foremost, independent oversight and ethics, in the Public Interest.

Or will the band continue to play as TTIP sails on? And will the Deregulation Bill pass as is, to promote the desirability of economic growth at all costs?

———

[Update November 21st:

Significant concerns raised in yesterday’s discussion by Lord Tunnicliffe and others on this Clause 83: The promotion of Economic Growth for Regulatory Bodies.

Social Care:
On a previous day of debate (Nov 18th) it appears regulation of Social Care staff is to be scrapped without proper consultation or scrutiny, in Clause 71.

Column GC116: “This is despite the fact that there was no clear support for removing regulation in the original consultation responses.

“The Government did not consult on this issue as part of the consultation in April 2014 on extending outsourcing in children’s social work. During the debate in Committee in the House of Commons on whether the clause should stand part of the Bill, the Deputy Leader of the Commons, Tom Brake MP, acknowledged that there had been no clear support for removing the registration requirement.”

“The Office of the Children’s Commissioner for England raised concerns and stated: “We consider all delegated social care services should be required to have formal registration with Ofsted in addition to an expectation that they will be held to account by rigorous and expert inspection, just as local authorities currently are”.

Scrutiny and Bill quality and clarity:
In particular concerns are raised in the Lords on lack of proper documentation and new legislation included which has not had scrutiny by the HoC or Scrutiny Committee.

Column GC142 “it is inefficient for Parliament to try to scrutinise line by line material which is obscure and possibly not very well expressed in terms of the material we are given and the notes.”
“One is that without a Keeling schedule relating to the particularities of the Bills being amended, it is almost impossible to work out what they are.”

Column GC144 “… that we are discussing now was not discussed in the Commons. It was not discussed by the Pre-Legislative Scrutiny Committee, as we have heard, and there has been no real opportunity to call those who drafted it to account. A blow for better government.”

Lord Tunnicliffe concluded on November 20th:

“We are all on the same side, but if our fears comes to pass, these three clauses could wreak havoc in a regulatory regime within this country that, generally speaking, is doing pretty well.” [Hansard]

My concerns seem founded, supported by many of these comments in recent debate in the Lords. I feel this Bill is a disaster lying in the future path of the Public Interest.  “Iceberg, right ahead!”

End Nov 21st update.]

Please feel free to comment below or find me on twitter @TheABB

*********

List of The National Regulators

Animal Health and Veterinary Laboratories Agency (AHVLA)

Animals in Science Regulation Unit

Architects Registration Board (ARB)

British Hallmarking Council (BHC)

Care Quality Commission (CQC)

Charity Commission for England and Wales

Civil Aviation Authority (CAA)

Claims Management Regulation Unit

Coal Authority

Companies House

Competition Commission

Professional Standards for Health and Social Care (PSA)

Disclosure and Barring Service (DBS)

Drinking Water Inspectorate (DWI)

Driver and Vehicle Licensing Agency (DVLA)

Driving Standards Agency (DSA)

Employment Agency Standards Inspectorate (EAS)

English Heritage (EH)

Environment Agency

Equality and Human Rights Commission

Financial Reporting Council (FRC)

Fish Health Inspectorate (FHI), Centre for Environment, Fisheries and Aquaculture Science (Cefas)

Food and environment research agency (plant and bee health) and (Plant Variety and Seeds)

Food Standards Agency (FSA)

Forestry Commission

Gambling Commission

Gangmasters Licensing Authority (GLA)

Health and Safety Executive (HSE)

Higher Education Funding Council for England (HEFCE)

Highways Agency (HA)

HM Revenue and Customs (Money Laundering Regulations and National Minimum Wage)

Homes & Communities Agency (HCA)

Human Fertilisation and Embryology Association (HFEA)

Human Tissue Authority (HTA)

Information Commissioner’s Office (ICO)

Insolvency Service including Insolvency Practitioner Unit

Intellectual Property Office (IPO)

Legal Services Board (LSB)

Marine Management Organisaton (MMO)

Maritime and Coastguard Agency (MCA)

Medicines and Healthcare Products Regulatory Agency (MHRA)

Monitor

National Measurement Office (NMO)

Natural England

Office of Communications

Office for Fair Access (OFFA)

Office for Nuclear Regulation (ONR)

Office for Standards in Education, Children’s Services and Skills (OFSTED)

Office of Fair Trading

OFQUAL

Office of Rail Regulation (ORR)

Office of the Regulator of Community Interest Companies

OFGEM

Pensions Regulator

Rural Payments Agency (RPA)

Security Industry Authority (SIA)

Senior Traffic Commissioner

Sports Grounds Safety Authority (SGSA)

Trinity House Lighthouse Service (THLS)

UK Anti-Doping (UKAD)

Vehicle and Operator Services Agency (VOSA)

Vehicle Certification Agency (VCA)

Veterinary Medicines Directorate (VMD)

Water Services Regulation Authority (OFWAT)

#caredata, activism, care.data, choice, engagement, family, HSCIC, leadership, leaflet, privacy

Patient questions on care.data – an open letter

Dear NHS England Patients & Information Directorate,

We’ve been very patient patients in the care.data pause. Please can we have some answers now?

I would like to call for greater transparency and openness about the promises made to the public, project processes & policies and your care.data communication plans.

In 2013, in the Health Service Journal Mr. Kelsey wrote:

“When patients are ignored, they are most at risk; that was the central conclusion of the report by Robert Francis into Stafford hospital.

Don Berwick, in his safety review, said the NHS should be “engaging, empowering and hearing patients and their carers all the time.

“That has been my mission since I started as National Director for Patients and Information: to support health and care services transform transparency and participation.“

HSJ, 10th December 2013

It is time to walk-the-talk for care.data under this banner of transparency, participation and open government.

Response to the Listening exercises

The care.data listening phase, introduced by the pause announced on February 18th, has captured a mass of questions, the majority of which still remain unaddressed.

At one of these sessions, [the 1-hr session on June 17th Open House, linking ca. 100 people at each of the locations in Basingstoke, Leicester, London, and York] participants were promised that our feedback would be shared with us later in the summer, and posted online. After the NHS AGM on Sept 18th I was told it would happen ‘soon’. It is still not in the public domain.

At every meeting all the unanswered questions, on post-it notes, in table-group minutes or scribbled flipcharts, were gathered ‘to be answered at a later date’. When will that be?

To date, there has been no published information which addresses the unanswered event questions.

Transparency of Process, Policies and Approach

The care.data Programme Board has held meetings to plan the rollout process, policies and approach. The minutes and materials from which have not been published. I find this astonishing when one considers that the minutes of the care.data advisory group, NIB (new), CAG, GPES advisory or even NHS England Board itself are in the public domain. I believe the care.data Programme Board meeting materials should be too.

It was acknowledged through the Partridge Review of past use of our hospital records that this HES data is not anonymous. The extent of its sale to commercial third-parties and use by police and the Home Office was revealed. This is our medical data we gave to hospitals and in our wider medical use for our care. Why are we the last to hear it’s being accessed by all sorts of people who are not at all involved in our clinical care?

Even for commissioning purposes it is unclear how these datasharing reasons are justified when the Caldicott Review said extracting identifiable data for risk stratification or commissioning could not be assumed under some sort of ‘consent deal’?

“The Review Panel found that commissioners do not need dispensation from confidentiality, human rights and data protection law…” [The Information Governance review, ch7]

The 251 approval just got extended *again* – until 30th April 2015. If you can’t legally extract data without repeat approvals from on high, then maybe it’s time to question why?

The DoH, NHS England Patients and Information Directorate, HSCIC, and indeed many data recipients, all appear to have normalised an approach that for many is still a shock. The state centralised and passed on our medical records to others without our knowledge or permission. For years. With financial exchange. 

Amazingly, it continues to be released in this way today, still without our consent or fair processing or publicised way to opt out.

“To earn the public’s trust in future we must be able to show that our controls are meticulous, fool-proof and solid as a rock.”  said Sir Nick Partridge in his summary review.

Now you ask us to trust in care.data that the GP data, a degree more personal, will be used properly.

Yet you ask us to do this without significant changes in legislation to safeguard tightly defined purposes who can access it and why, how we control what future changes may be made without our knowledge and without a legally guaranteed opt out.

There is no information about what social care dataset is to be included in future, so how can we know what care.data scope even is yet?

Transparency cannot be a convenient watch word which applies with caveats. Quid pro quo, you want our data under an assumed consent process, then guarantee a genuinely informed public.

You can’t tell patients one approach now, then plan to change what will be said after the pilot is complete, knowingly planning a wider scope to include musculoskeletal or social care data and more.  Or knowing you plan to broaden users of data [like research and health intelligence currently under discussion at IAG ] but only communicate a smaller version in the pilot. That is like cheating on a diet. You can’t say and do one thing in public, then have your cake and eat it later when no one is looking. It still counts.

In these processes, policies and approach, I don’t feel my trust can be won back with lack of openness and transparency. I don’t yet see a system which is, ‘meticulous, fool-proof or solid as a rock’.

‘Pathfinder’ pilots

Most recently you have announced that four areas of CCGs will pilot the ‘pathfinder’ stage in the rollout of phase one. But where and when remains a  mystery. Pathfinder communications methods may vary from place to place and trial what works and what fails. One commendable method will be a written letter.

However even given that individual notice intent, we cannot ignore that many remaining questions will be hard to address in a leaflet or letter. They certainly won’t fit into an SMS text.

Why pilot communications at all which will leave the same open questions unanswered you already know, but have not answered?

For example, let’s get a few of the missing processes clarified up front:

  • How will you communicate with Gillick competent children, whose records may contain information about which their parents are not aware?
  • How will you manage this for elderly or vulnerable patients in care homes and with diminished awareness or responsibility?
  • What of  the vulnerable at risk of domestic abuse and coercion?
  • When things change in scope or use, how will we be given the choice to change our opt out decision?

I ask you not to ignore the processes which remain open. They need addressed BEFORE the pilot, unless you want people to opt out on the basis of their uncertainty and confusion.

What you do now, will set the model expectations for future communications. Patient online. Personalised medicine. If NHS health and social care is to become all about the individual, will you address all individuals equally or is reaching some less important than others?

It seems there is time and effort in talking to other professionals about big data, but not to us, whose data it is. Dear Patients & Information Directorate, you need to be talking to us, before to others about how to use us.

In March, this twelve point plan made some sensible suggestions.

Many of them remain unaddressed. You could start there. But in addition it must be clear before getting into communications tools, what is it that the pathfinders are actually piloting?

You can’t pilot communications without clearly defined contents to talk about.

Questions of substance need answers, the ten below to start with.

What determines that patients understand the programme and are genuinely informed, and how will it be measured?

Is it assumed that pilots will proceed to extraction? Or will the fair processing efforts be evaluated first and the effort vs cost be taken into account whether it is worth proceeding at all?

Given the cost involved, and legal data protection requirements, surely the latter? But the pathfinder action plan conflates the two.

Citizen engagement

Let’s see this as an opportunity to get care.data right, for us, the patients. After all, you and the rest of the NHS England Board were keen to tell us at the NHS AGM on September 18th, how valuable citizen engagement is, and to affirm that the NHS belongs to us all.

How valued is our engagement in reality, if it is ignored? How will involvement continue to be promoted in NHS Citizen and other platforms, if it is seen to be ineffective? How might this negatively affect future programmes and our willingness to get involved in clinical research if we don’t trust this basic programme today?

This is too important to get wrong. It confuses people and causes concern. It put trust and confidence in jeopardy. Not just for now, but for other future projects. care.data risks polluting across data borders, even to beyond health:

“The care.data story is a warning for us all. It is far better if the industry can be early on writing standards and protocols to protect privacy now rather than later on down the track,” he said. [David Willets, on 5G]

So please, don’t keep the feedback and this information to internal departments.

We are told it is vital to the future of our NHS. It’s our personal information.  And both belong to us.

During one Health Select Committee hearing, Mr. Kelsey claimed: “If 90 per cent opt out [of care.data], we won’t have an NHS.”

The BMA ARM voted in June for an opt in model.

ICO has ruled that an opt in model by default at practice level with due procedures for patient notification will satisfy both legal requirements and protect GPs in their role as custodians of confidentiality and data controllers. Patient Concern has called for GPs to follow that local choice opt in model.

I want to understand why he feels what the risk is, to the NHS and examine its evidence base. It’s our NHS and if it is going to fail without care.data and the Board let it come to this, then we must ask why. And we can together do something to fix it. There was a list of pre-conditions he stated at those meetings would be needed before any launch, which the public is yet to see met. Answering this question should be part of that.

It can’t afford to fail, but how do we measure at what cost?

I was one of many, including much more importantly the GPES Advisory Group, who flagged the shortcomings of the patient leaflet in October 2013, which failed to be a worthwhile communications process in January. I flagged it with comms teams, my MP, the DoH.

[Sept 2013 GPES Advisory] “The Group also had major concerns about the process for making most patients aware of the contents of the leaflets before data extraction for care.data commenced”.

No one listened. No action was taken. It went ahead as planned. It cost public money, and more importantly, public trust.

In the words of Lord Darzi,

“With more adroit handling, this is a row that might have been avoided.”

Now there is still a chance to listen and to act. This programme can’t afford to pilot another mistake. I’m sure you know this, but it would appear that with the CCG announcement, the intent is to proceed to pilot soon.  Ready or not.

If the programme is so vital to the NHS future, then let’s stop and get it right. If it’s not going to get the participation levels needed, then is it worth the cost? What are the risks and benefits of pressing ahead or at what point do we call a halt? Would it be wise to focus first on improving the quality and correct procedures around the data you already have – before increasing the volume of data you think you need? Where is the added intelligence, in adding just more information?

Is there any due diligence, a cost benefit analysis for care.data?

Suggestions

Scrap the ‘soon’ timetable. But tell us how long you need.

The complete raw feedback from all these care.data events should be made public, to ensure all the questions and concerns are debated and answers found BEFORE any pilot.

The care.data programme board minutes papers and all the planning and due diligence should be published and open to scrutiny, as any other project spending public funds should be.

A public plan of how the pathfinders fit into the big picture and timeline of future changes and content would remove the lingering uncertainty of the public and GPs: what is going on and when will I be affected?

The NHS 5 year forward view was quite clear; our purse strings have been pulled tight. The NHS belongs to all of us. And so we should say, care.data  can’t proceed at any and at all costs. It needs to be ‘meticulous, fool-proof and solid as a rock’.

We’ve been patient patients. We should now expect the respect and response, that deserves.

Thank you for your consideration.

Yours sincerely.

 

Addendum: Sample of ten significant questions still outstanding

1. Scope: What is care.data? Scope content is shifting. and requests for scope purposes are changing already, from commissioning only to now include research and health intelligence. How will we patients know what we sign up to today, stays the purposes to which data may be used tomorrow?

2. Scope changes fair processing: We cannot sign up to one thing today, and find it has become something else entirely tomorrow without our knowledge. How will we be notified of any changes in what is to be extracted or change in how what has been extracted is to be used in future – a change notification plan?

3. Purposes clarity: Who will use which parts of our medical data for what? a: Clinical care vs secondary uses:

Given the widespread confusion – demonstrated on radio and in press after the pathfinders’ announcement – between care.data  which is for ‘secondary use’ only, i.e. purposes other than the direct care of the patient – and the Summary Care Record (SCR) for direct care in medical settings, how will uses be made very clear to patients and how it will affect our existing consent settings?

3. Purposes definition: Who will use which parts of our medical data for what?  b) Commercial use  It is claimed the Care Act will rule out “solely commercial”purposes, but how when what remains is a broad definition open to interpretation? Will “the promotion of health” still permit uses such as marketing? Will HSCIC give its own interpretation, it is after all, the fact it operates within the law which prescribes what it should promote and permit.

3. Purposes exclusion: Who will use which parts of our medical data for what?  c) Commercial re-use by third parties: When will the new contracts and agreements be in place? Drafts on the HSCIC website still appear to permit commercial re-use and make no mention of changes or revoking licenses for intermediaries.

4a. Opt out: It is said that patients who opt out will have this choice respected by the Health and Social Care Information Centre (i.e. no data will be extracted from their GP record) according to the Secretary of State for Health  [col 147] – but when will the opt out – currently no more than a spoken promise – be put on a statutory basis? There seem to be no plans whatsoever for this.

Further wider consents: how patients will know what they have opted into or out from is currently almost impossible. We have the Summary Care Record, Proactive care in some local areas, different clinical GP systems, the Electronic Prescription Service and soon to be Patient Online, all using different opt in methods of asking and maintaining data and consent, means patients are unsurprisingly confused.

4b. Opt out: At what point do you determine that levels of participation are worth the investment and of value? If parts of the population are not represented, how will it be taken into account and remain valuable to have some data? What will be statistically significant?

5. Legislation around security: The Care Act 2014 is supposed to bring in new legislation for our data protection. But there are no changes to date as far as I can see – what happened to the much discussed in Parliament, one strike and out. Is any change still planned? If so, how has this been finalised and with what wording, will it be open to Parliamentary scrutiny?  The Government claim to have added legal protection is meaningless until the new Care Act Regulations are put in front of Parliament and agreed.

6. What of the Governance changes discussed?

There was some additional governance and oversight promised, but to date no public communication of changes to the data management groups through the HRA CAG or DAAG and no sight of the patient involvement promised.

The Data Guardian role remains without the legal weight that the importance of its position should command. It has been said this will be granted ‘at the earliest opportunity.’ Many seem to have come and gone.

7. Data security: The planned secure data facility (‘safe setting’) at HSCIC to hold linked GP and hospital data is not yet built for expanded volume of data and users expected according to Ciaran Devane at the 6th September event. When will it be ready for the scale of care.data?

Systems and processes on this scale need security designed, that scales up to match in size with the data and its use.

Will you proceed with a pilot which uses a different facility and procedures from the future plan? Or worse still, with extracting data into a setting you know is less secure than it should be?

8. Future content sharing: Where will NHS patients’ individual-level data go in the longer term? The current documentation says ‘in wave 1’ or phase one, which would indicate a future change is left open, and indicated identifiable ‘red’ data is to be shared in future?  “care.data will provide the longer term visions as well as […] the replacement for SUS.”

9.  Current communications:

    • How will GPs and patients in ‘pathfinder’ practices be contacted?
    • Will every patient be written to directly with a consent form?
    • What will patients who opted out earlier this year be told if things have changed since then?
    • How will NHS England contact those who have retired or moved abroad recently or temporarily, still with active GP records?
    • How will foreign pupils’ parents be informed abroad and rights respected?
    • How does opt out work for sealed envelopes?
    • All the minorities with language needs or accessibility needs – how will you cater for foreign language, dialect or disability?
    • The homeless, the nomadic,  children-in-care
    • How can we separate these uses clearly from clinical care in the public’s mind to achieve a genuinely informed opinion?
    • How will genuine mistakes in records be deleted – wrong data on wrong record, especially if we only get Patient Online access second and then spot mistakes?
    • How long will data be retained for so that it is relevant and not excessive – Data Protection principle 3?
    • How will the communications cater for both GP records and HES plus other data collection and sharing?
    • If the plan is to have opt out effective for all secondary uses, communications must cater for new babies to give parents an informed choice from Day One. How and when will this begin?

No wonder you wanted first no opt out, then an assumed consent via opt out junk mail leaflet. This is hard stuff to do well. Harder still, how will you measure effectiveness of what you may have missed?

10. Pathfinder fixes: Since NHS England doesn’t know what will be effective communications tools, what principles will be followed to correct any failures in communications for any particular trial run and how will that be measured?

How will patients be asked if they heard about it and how will any survey, or follow up ensure the right segmentation does not miss measuring the hard to reach groups – precisely those who may have been missed?  i.e. If you only inform 10% of the population, then ask that same 10% if they heard of care.data, you would expect a close to 100% yes. That’s not reflective that the whole population was well informed about the programme.

If it is shown to have been ineffective, at what point do you say Fair Processing failed and you cannot legally proceed to extraction?

> This list doesn’t yet touch on the hundreds of questions generated from public events, on post-its and minutes. But it would be a start.

*******

References for remaining questions:

17th June Open House: Q&A

17th June Open House: Unanswered public Questions

Twelve point plan [March 2014] positive suggestions by Jeremy Taylor, National Voices

6th September care.data meeting in London

image quote: Winnie The Pooh, A.A. Milne

activism, engagement, leadership, politics

Human Rights proposals – stripping away the Spirit of the Human Rights Act (1998)

News today confirms what has been on simmer for some time in England:

“A majority Conservative Government will scrap Labour’s Human Rights Act, and will end the ability of the European Court of Human Rights to order changes to British laws.” [Jack of Kent, October 2nd]

The Rt Hon Lord Howard of Lympne, CH, QC said:

“The argument is not about human rights, to which we all subscribe […] the way in which the Convention on Human Rights has been interpreted is far removed from its founders’ intentions.

“We are simply restoring parliamentary sovereignty, and some much needed common sense, to our human rights laws.”

If it is truly only about common sense, everyone with common sense must support it. So why the wide press and social media uproar, and statements by other parties they would vote against such a proposal in Parliament?

“No, the argument today is whether arrangements such as the European Court of Human Rights and the Human Rights Act actually help to protect such rights or, by the way in which they have operated, bring the concept into disrepute.”

The argument appears to suggest, that there should be no need to be concerned about the removal of laws which ‘protect such rights’, that there is nothing to hide, nothing to fear. That in fact, we will do better by removing the framework which supports the common sense process. Common sense will operate and prevail without legislation.

If we believe the policy statement that under these changes, in effect, little would change for many people, why are the changes needed? By many accounts, many good results of the 1998 Act affect many of us.

Those much better informed than me, are debating this in the media and online, and is worth following. But I think we should be careful we don’t get so caught up in looking ahead, that we miss changes going on now.

The debate makes me ask myself, what is the purpose of a law, and whom should it serve?

If we are convinced change is needed, we assume a belief that the current process is flawed.  This comes in part from myths and misrepresentations in isolated cases. We should in discussion see past the UKIP defection, knee-jerk reaction which conflates everything ‘Europe’, into something from which which the UK could ‘opt out’ and what risks and benefit it would actually bring for whom.

Even if these changes were simply a case of choosing to ‘opt-out’ from the protections of the European Court for UK Citizens (which it is not) and even if one were to agree common sense can make better decisions without legal protection, one must consider that by removing the UK Human Rights Act [which had cross party support in 1998], and the European aspect of the laws, and by suggesting amendments to the 1951 European convention on human rights, changes would remove a layer of external protection and last support channel outside the UK system, for us as citizens.

Stripping away a spirit of Governance

Does this affect the opportunity for citizens and courts to benefit from external objectivity?

The 1998 Act was intended to reduce the number of cases going to the European Court. You can still take a case to the European Court, but the Human Rights Act meant a case has to go through the UK courts first. Whilst Scotland (and Wales to a lesser extent) has some devolved and historically founded independent law making processes, the 1998 Human Rights Act covers the whole of the UK. As does the ability to go to the European Courts as an extra layer of legal protection, guidance and enlightenment if exhausted at home. 

Will we no longer be able as legitimately, to call on bodies with cross-border, external best practices to learn from which has any accepted weight? Or cases to set precedence? But does the European Court have these powers anyway or do these policy statements just cause confusion?

Former Attorney General Dominic Grieve said the plans were flawed. The Tory MP said they would be “difficult to implement” and risked “undermining” the UK’s – and his own party’s – tradition of upholding human rights.
Proposals state: ‘In future ‘Britain’s courts would no longer be required to take into account rulings from the Court in Strasbourg. This would make our Supreme Court the ultimate arbiter of human rights matters in the UK.’

The statement gives the strong impression that the UK will regain a lost level of independence as a deal for giving up a layer of objectivity and governance.

In fact, we would not do so by repealing the 1998 Human Rights Act, the European Court would keep its role in the UK in practice.

Liberty clarified: “The Human Rights Act did not make Strasbourg a precedent-setting Court, as the proposals claim. This proposal will not increase the Supreme Court’s constitutional standing. It is already the ultimate arbiter of human rights cases in the UK but, if we remain part of the Convention, British people will still be able to take claims to Strasbourg once domestic litigation is exhausted. The dilution of Convention rights proposed makes it more likely that Strasbourg will find against the UK. The Court has no ability to require the UK to change British laws. Parliamentary sovereignty is intact, as made clear by the non-implementation of the prisoner voting judgment. But the British Government has ratified the Convention and so undertaken to comply with its international law obligations to respect the decisions of the Court.” [Liberty]

However the side comments on the 1951 Convention are of much more concern to me.

Are the Conservative proposal really going so far as to say it would remove that Convention undertaking, and no longer respect international law? Surely not in practice, but in spirit, it seems to suggest just that.

They would seek to: “Clarify the Convention rights, to reflect a proper balance between rights and responsibilities.”

that would be a huge change with respect for our position towards international law.

It seems to suggest that there would be a trade off giving up the universally applicable nature in the 1951  convention on Human Rights, to enable selective decisions which and when, rights would apply.

 

Stripping away the rights which apply to all

The basic principles of universality, inalienability and indivisibility, [outlined here by Liberty] are under threat through these changes:

 

“Human rights are universal. They apply to all people simply on the basis of being human.

Human rights are inalienable. They cannot be taken away simply because we do not like the person seeking to exercise their rights. They can only be limited in certain tightly-defined circumstances and some rights, such as the prohibition on torture and slavery, can never be limited.

Human rights are indivisible. You cannot pick and choose which rights you want to honour. Many rights depend on each other to be meaningful – so, for example, the right to fair trial would be meaningless without the prohibition on discrimination, and the right to free speech must go hand in hand with the right to assemble peacefully.”

Isabella Sankey, Director of Policy has taken apart some of the implications here. Her post is worth a thorough read.

Stripping away rights of access

 

It appears that we are moving towards a state in which the suggestion is that laws from the top down to control citizens’ rights will be applied universally, whilst at the same time, the rights of those who may feel unfairly treated by them are becoming restricted, through policy and in practical terms.

 

If British citizens would still be able to take claims to Strasbourg once domestic litigation is exhausted, they have to be able to not just in theory, but practice.

Courts which exist as channels to a fair appeal are only applicable to all as a right effectively, if they can be accessed by all. In the UK the  judicial review practices have changed on charging, which make universal access to judicial review harder. Recent changes to legal aid funding mean fewer people can afford access to representation.

 

This report from the International Council on Human Rights Policy may be ten years old, but is still I feel, relevant.

“…individuals, particularly those who are vulnerable because of exclusion, poverty and discrimination, unable to obtain benefits and rights to which they are entitled in law? This report examines the impediments that obstruct large numbers of people from accessing the full range of human rights. It analyses the performance and responsibilities of governments and other institutions, and identifies new forms of action that official and human rights organisations might need to undertake if access is to be improved.”

If Human Rights law is not accessible to all, and does not apply equally to all, it is not universal. Either not all are humans or they are not rights. Either way, the law is flawed.

 

I believe being universally applicable must also ensure universal access in order to be meaningful.

 

Stripping the Spirit of accepted Human Rights

Whilst the Acts  and declarations have legal weight which are of intrinsic importance and value, I believe it is also of importance to value the philosophy of the principles. It is this loss which worries me as much as the thought of losing concrete governance. We risk losing not only the protections of the law, but the Spirit of the law.

The spirit acts as an additional layer of conscience accompanying lawmakers and politicians in their decision making process.

I fear that he spirit of the values the state places on human rights,has been injured in recent times.

 I fear an ‘accepted’ element of barbarism has crept into our own humanity in the treatment of our ‘prisoners of war’.

 

The right not to be tortured or treated in an inhuman or degrading way is an absolute right. It should never be limited and it is a commonly held belief that there are no circumstances where this type of treatment of people can be justified.

 

However torture has become apparently justifiable recently. Justified by the highest authority in the US, some may see as the highest ‘western world power’. “We tortured some folks” was justified with the near flippant tone of a bumper sticker. Little official repercussion  appears to follow.

 

In doing so, the affiliated powers revealed how far we have fallen from our ideals of humanity embodied in the Universal Declaration of Human Rights.

Our values and self created global ethic in which some human rights are absolute.

It appears we have allowed through our government’s use of torture, an absolute boundary to be broken. So should we be surprised if that was only a first step? What is perceived as acceptable in how our government treats others, can only lead to a contagion in perception of what is right and acceptable in how others will treat our people abroad.

Crucially, I believe it also affects our own public perception of acceptance and ‘the norm’ in how we treat our own people.

Yet again, at home in human rights law, perception may be that this will not affect us. Not ‘our own’ kind of people. It will only affect ‘others’.

But the others in the case of human rights in the UK, may be our own gender or racial discrimination case at work. It may be how our friend or family member is treated by the authorities in sexual discrimination or in disability claims process.  Those in prison, the poor, minorities – these groups suit some agendas to portray as ‘other’. To thrive, I believe we must strive to remember our togetherness as a society which looks after one another, not treats ‘others’ as outside our realm of protections. As somehow, less ‘entitled’.  Less entitled to welfare. Less entitled to vote. Less entitled to universal rights.

If you think, no not me, then let’s consider closely our own reaction to the arrival of travellers in a local field. Or news of immigrants awaiting asylum rulings being housed in bed-and-breakfast accommodation.

It seems that to whom our human rights should apply, would become discretionary.

Are some Human Rights Claims more Trivial than Others? What about the same Human Rights for all?

If the majority of rights are non-absolute and can be limited or restricted in certain circumstances, we should not be surprised if these too are now trampled on if found to be ‘trivial’. The circumstances in which there is a need to take into account the rights of other individuals or wider society would become  discretionary.  How would that be defined and by whom?

“Limit the use of Human Rights laws to the most serious cases.”

There will be a threshold below which Convention rights will not be engaged, ensuring UK courts strike out trivial cases.

It appears that which subjects and in which circumstances individuals should be entitled access to human rights protection would become discretionary.

By saying some ‘trivial’ cases would not be relevant for consideration, you throw out the spirit of the universal applicability of Human Rights’ legislation.

Where does this leave the Spirit of our Human Rights in practice?

Politicians may say that in practice, any change will continue to ensure that:
“We promote the values of individual human dignity, equal treatment and fairness as the foundations of a democratic society.”

But current reality is that changes have already made universal access to judicial review harder. Reality is that the changes to legal aid funding already means fewer people can afford access to representation. Minority groups find access a challenge. Mothers without means are representing themselves in divorce cases. People are facing abusers in court.

If now we further undermine both access and applicability, the reality is under the law some will be more equal than others.

So what of our basic principles?

Human rights are universal. They apply to all people simply on the basis of being human.

Human rights are inalienable. They cannot be taken away simply because we do not like the person seeking to exercise their rights.

Human rights are indivisible. You cannot pick and choose which rights you want to honour.

Whether this policy ever becomes reality or not, it harms the perception of the value we place on human rights, at home and abroad.

Universality of application and universal access are already under real threat, creating inequality for which humans, these laws offer support.

These proposals normalise what is in fact nonsense.

Whilst at least for now, it makes no difference in legal practice, I think the Spirit of Human Rights in the UK under this proposal, just had her wings stripped off.

 

***

Chris Grayling’s eight-page strategy paper http://s3.documentcloud.org/documents/1308660/protecting-human-rights-in-the-uk.txt

[Liberty useful listing of what the Human Rights Act covers.]

#caredata, care.data, communications, empowerment, engagement, HSCIC, leadership, NHS, research, scope

The care.data engagement – is it going to jilt citizens after all? A six month summary in twenty-five posts.

[Note update Sept 19th: after the NHS England AGM in the evening of Sept 18th – after this care.data engagement post published 18hrs earlier – I managed to ask Mr.Kelsey, National Director for Patients and Information, in person what was happening with all the engagement feedback and asked why it had not been made publicly available.

He said that the events’ feedback will be published before the pathfinder rollout begins, so that all questions and concerns can be responded to and that they will be taken into account before the pathfinders launch.

When might that be, I asked? ‘Soon’.

Good news? I look forward to seeing that happen. My open questions on commercial uses and more, and those of many others I have heard, have been captured in previous posts, in particular the most recent at the end of this post. – end of update.]

Medical data has huge power to do good, but it presents risks too. When leaked, it cannot be unleaked. When lost, public trust cannot be easily regained. That’s what broken-hearted Ben Goldacre wrote about care.data on February 28th of this year, ten days after the the pause was announced on February 18th [The Guardian] .

Fears and opinions, facts and analysis, with lots and lots of open questions. That’s what I’ve written up in the following posts related to care.data since then, including my own point-of-view and feedback from other citizens, events and discussions. All my care.data posts are listed here below, in one post, to give an overview of the whole story, and any progress in the six months ‘listening’ and ‘engagement’.

So what of that engagement? If there really have been all these events and listening, why has there been not one jot of public feedback published? This is from September 2014, I find it terrifyingly empty of anything but discussing change in communications of the status quo programme.

I was at that workshop, hosted by Mencap on communicating

with vulnerable and excluded groups the article mentions. It was carefully managed, with little open room discussion to share opinions cross groups (as the Senior Policy Adviser at Signature pointed out.) Whilst we got the NHS England compilation of the group feedback afterwards, it was not published. Maybe I should do that and ask how each concern will be addressed? I didn’t want to stand on the NHS England national comms. toes, assuming it would be, but you know, what? If the raw feedback says from all these meetings, these are our concerns and we want these changes, and none are forthcoming, then the public should justifiably question the whole engagement process.

It’s public money, and the public’s data. How both are used and why, is not to be hidden away in some civil service spreadsheet. Publish the business case. Publish the concerns. Publish how they are to be addressed.

From that meeting and the others I have been to, many intelligent questions from the public remain unanswered. The most recent care.data advisory workshop summarised many from the last year, and brought out some minority voices as well.

 

On the day of NHS Citizen, the new flagship of public involvement, people like me who attended the NHS England Open Day on June 17th, or care.data listening events, may be understandably frustrated that there is no publicly available feedback or plan of any next steps.
care.data didn’t make it into the NHS Citizen agenda for discussion for the 18th. [Many equally other worthy subjects did, check them out here if not attending or watch it online.] So from where will we get any answers? Almost all the comment, question and feedback I have heard at events has been constructively critical, and worthy of response. None is forthcoming.

 

Instead, the article above, this reported speech by Mr.Kelsey and its arguments, make me think engagement is going nowhere. No concerns are addressed. PR is repeated. More facts and figures which are a conflation of data use for clinical treatment and all sorts of other uses, are presented as an argument for gathering more data.

Citizens do not need told of the benefits. We need concrete steps taken in policy, process and practice, to demonstrate why we can now trust the new  system.

Only then is it worthwhile to come back to communications.

How valued is patient engagement in reality, if it is ignored?

How will involvement continue to be promoted in NHS Citizen and other platforms, if it is seen to be ineffective?

How might this affect future programmes and our willingness to get involved in clinical research?

I sincerely hope to see the raw feedback published very soon, which NHS England has gathered in their listening events. How that will be incorporated into any programme changes, as well as  communications, will go a long way to assuring the quantity in numbers and quality of cross-population participation.

The current care.data status is in limbo, as we await to see if and when any ‘pathfinder’ CCGs will be announced that will guinea pig the patient records from the GP practices in a trial rollout, in whatever form that may take. The latest official statements from Mr.Kelsey have been on 100-500 practices, but without any indicator of where or when. He suggests ‘shortly’.

What next for care.data? I’ll keep asking the questions and hope we hear some answers from the NHS England Patients and Information Directorate. Otherwise, what was the [&88!@xY!] point of a six month pause and all these efforts and listening?

Publish the business case. Publish the concerns. Publish how they are to be addressed.

What is there to hide?

After this six-month engagement, will there be a happy ending? I feel patients are about to be left jilted at the eleventh hour.
******

You’ll find my more recent posts [last] have more depth and linked document articles if you are looking for more detailed information.

******

March 31st: A mother’s journey – intro

March 31st: Transparency

April 3rd: Communication & Choice

April 4th: Fears & Facts

April 7th: What is care.data? Defined Scope is vital for Trust

April 10th: Raw Highlights from the Health Select Committee

April 12th: care.data Transparency & Truth, Remit & Responsibility

April 15th: No Security Blanket : why consent packages fail our kids

April 18th: care.data : Getting the Ducks in a Row

April 23rd: an Ode to care.data (on Shakespeare’s anniversary)

May 3rd: care.data, riding the curve: Change Management

May 15th: care.data the 4th circle: Empowerment

May 24th: Flagship care.data – commercial uses in theory [1]

June 6th: Reality must take Precedence over Public Relations

June 14th: Flagship care.data – commercial use with brokers [2]

June 20th: The Impact of the Partridge Review on care.data

June 24th: On Trying Again – Project Lessons Learned

July 1st: Communications & Core Concepts [1] Ten Things Learned at the Open House on care.data and part two: Communications and Core Concepts [2] – Open House 17th June Others’ Questions

July 12th: Flagship care.data – commercial use in Practice [3]

July 25th: care.data should be like playing Chopin – review after the HSCIC Data Sharing review ‘Driving Positive Change’ meeting

July 25th: Care.data should be like playing Chopin – but will it be all the right notes, in the wrong order? Looking forwards.

August 9th: care.data and genomics : launching lifeboats [Part One] the press, public reaction and genomics & care.data interaction

August 9th: care.data and genomics : launching lifeboats [Part Two] Where is the Engagement?

September 3rd: care.data – a Six Month Pause, Anniversary round up [Part one] Open questions: What and Who?

September 3rd: care.data – a Six Month Pause, Anniversary round up [Part two] Open questions: How, Why, When?

September 16th: care.data cutouts – Listening to Minority Voices Includes questions from those groups.

September 16th: care.data – “Anticipating Things to Come” means Confidence by Design

October 30th: patient questions on care.data – an open letter

November 19th: questions remain unanswered: what do patients do now?

December 9th: Rebuilding trust in care.data

December 24th: A care.data wish list for 2015

2015 (updated after this post was published, throughout the year)

January 5th 2015: care.data news you may have missed

January 21st 2015: care.data communications – all change or the end of the line?

February 25th 2015: care.data – one of our Business Cases is Missing.

March 14th 2015: The future of care.data in recent discussions

March 26th 2015: Wearables: patients will ‘essentially manage their data as they wish’. What will this mean for diagnostics, treatment and research and why should we care? [#NHSWDP 3]

May 10th 2015: The Economic Value of Data vs the Public Good? [1] care.data, Concerns and the cost of Consent

The Economic Value of Data vs the Public Good? [2] Pay-for-privacy, defining purposes

The Economic Value of Data vs the Public Good? [3] The value of public voice.

May 14th 2015: Public data in private hands – should we know who manages our data?

June 20th 2015: Reputational risk. Is NHS England playing a game of public confidence?

June 25th 2015: Digital revolution by design: building for change and people (1)

July 13th 2015: The nhs.uk digital platform: a personalised gateway to a new NHS?

July 27th 2015: care.data : the economic value of data versus the public interest? (First published in StatsLife)

August 4th 2015: Building Public Trust in care.data sharing [1]: Seven step summary to a new approach

August 5th, 2015: Building Public Trust [2]: a detailed approach to understanding Public Trust in data sharing

August 6th 2015: Building Public Trust in care.data datasharing [3]: three steps to begin to build trust

August 12th 2015: Building Public Trust [4]: “Communicate the Benefits” won’t work for care.data

August 17th 2015: Building Public Trust [5]: Future solutions for health data sharing in care.data

September 12th 2015: care.data: delayed or not delayed? The train wreck that is always on time

****

Questions, ideas, info & other opinions continue to be all welcome. I’ll do my best to provide answers, or point to source sites.

For your reference and to their credit, I’ve found the following three websites useful and kept up to date with news and information:

Dr. Bhatia, GP in Hampshire’s care.data info site

HSCIC’s care.data site

medConfidential – campaign for confidentiality and consent in health and social care – seeking to ensure that every flow of data into, across and out of the NHS and care system is consensual, safe and transparent

 

 

 

#caredata, care.data, change management, commercial, engagement, genomics, health, HES, leadership, NHSEngland, politics, privacy, research, trust

Launching genomics, lifeboats, & care.data [part 2]

“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].”

[Part one of this post is in this link, and includes thinking about care.data & genomics interaction].

Part two:

What is the expectation beyond 2017?

The investment to date may seem vast if, like me, you are unfamiliar with the amounts of money that are spent in research [in 2011 an £800M announcement, last summer £90M in Oxford as just two examples], and Friday revealed yet more money, a new £300M research package.  It is complex how it all adds up, and from mixed sourcing. But the stated aim of the investment is relatively simple: the whole genomes of 75,000 people [40K patients and 35K healthy relatives] are to be mapped by 2017.

Where the boundary lies between participation for clinical care and for research is less clear in the media presentation. If indeed participants’ results will be fed back into their NHS care pathway,  then both aims seem to be the intent of the current wave of participants.

It remains therefore perhaps unclear, how this new offering interacts with the existing NHS genetic services for direct clinical care, or the other research projects such as the UK Biobank for example, particularly when aims appear to overlap:.

“The ultimate aim is to make genomic testing a routine part of clinical practice – but only if patients and clinicians want it.” [Genomics England, how we work]

The infrastructure of equipment is enormous to have these sequences running 24/7 as was indicated in media TV coverage. I’m no maths whizz, but it appears to me they’re building Titantic at Genomics England and the numbers of actual people planned to take part (75K) would fit on the lifeboats. So with what, from whom, are they expecting to fill the sequencing labs after 2017?  At Genomics England events it has been stated that the infrastructure will then be embedded in the NHS. How is unclear, if commercial funding has been used to establish it. But at its most basic, there will be  no point building the infrastructure and finding no volunteers want to take part. You don’t build the ship and sail without passengers. What happens, if the English don’t volunteer in the desired numbers?

What research has been done to demonstrate the need or want for this new WGS project going forwards at scale, compared with a) present direct care or b) existing research facilities?

I cannot help but think of the line in the film, Field of Dreams. If you build it they will come. So who will come to be tested? Who will come to exploit the research uses for public good? Who will come in vast numbers in our aging population to exploit the resulting knowledge for their personal benefit vs companies who seek commercial profit? How will the commercial and charity investors, make it worth their while? Is the cost/benefit to society worth it?

All the various investors in addition to the taxpayer; Wellcome Trust, the MRC, Illumina, and others, will want to guarantee they are not left with an empty shell. There is huge existing and promised investment. Wellcome for example, has already “invested more than £1 billion in genomic research and has agreed to spend £27 million on a world class sequencing hub at its Genome Campus near Cambridge. This will house Genomics England’s operations alongside those of the internationally respected Sanger Institute.”

Whilst the commercial exploitation by third parties is explicit, there may also be another possibility to consider: would the Government want:

a) some cost participation by the participants? and

b) will want to sell the incidental findings’ results to the participants?

[ref: http://www.phgfoundation.org/file/10363 ref. #13]

“Regier et al. 345 have estimated the willingness-to-pay (WTP) for a diagnostic test to find the genetic cause of idiopathic developmental disability from families with an affected child. They used a discrete choice experiment to obtain WTP values and found that these families were willing to pay CDN$1118 (95% CI CDN$498-1788) for the expected benefit of twice as many diagnoses using aCGH and a reduction in waiting time of 1 week when compared to conventional cytogenetic analysis.”

“Moreover, it is advisable to minimise incidental findings where possible; health care professionals should not have an obligation to feedback findings that do not relate to the clinical question, except in cases where they are unavoidably discovered and have high predictive value. It follows that the NHS does not have an obligation to provide patients with their raw genome sequence data for further analysis outside of the NHS. We make no judgement here about whether the individual should be able to purchase and analyse their genome sequence independently; however, if this course of action is pursued, the NHS should provide follow-up advice and care only when additional findings are considered to be of significant clinical relevance in that individual…” [13]

How much is that cost, per person to be mapped? What is the expected return on the investment?

What are the questions which are not being asked of this huge state investment, particularly at a time when we are told he NHS is in such financial dire straits?

Are we measuring the costs and benefits?

Patient and medical staff support is fundamental to the programme, not an optional extra. It should not be forgotten that the NHS is a National Service owned by all of us. We should know how it runs. We should know what is spends. Ultimately, it is we who pay for it.

So let’s see on paper, what are the actual costs vs benefits? Where is the overall and long term cost benefit business case covering the multi-year investment, both of tangible and intangible benefits? In my personal research, I’m yet to find one. There is however, some discussion in this document:

“The problem for NGS is that very little ‘real’ information is available on the actual costs for NGS from the NHS perspective and the NHS Department of Health Reference Costs Database and PSSRU, where standard NHS costings are listed, are generally not helpful.” [13 – PHG, 2011]

Where are the questions being asked if this is really what we should be doing for the public good and for the future of the NHS?

Research under good ethics and bona fide transparent purposes is a public asset. This rollout, has potential to become a liability.

To me, yet again it seems, politics has the potential to wreck serious research aims and the public good.

Perhaps more importantly, the unrestrained media hype carries the very real risk of creating unfounded hope for an immediate diagnosis or treatment, for vulnerable individuals and families who in reality will see no personal benefit. This is not to undermine what may be possible in future. It is simply a plea to rein in hype to reality.

Politicians and civil servants in NHS England appear to use both research and the notion of the broad ‘public good’, broadly in speeches to appear to be doing ‘the right thing to do’, but without measurable substance. Without a clear cost-benefit analysis, I admit, I am skeptical. I would like to see more information in the public domain.

Has the documentation of the balance of patient/public good and  expected “major contribution to make to wealth creation and economic growth in this country” been examined?

Is society prepared for this?

I question whether the propositions of the initiative have been grasped by Parliament and society as a whole, although I understand this is not a ‘new’ subject as such. This execution however, does appear at least, massive in its practical implications, not least for GPs if it is to become so mainstream, as quickly as plans predict. It raises a huge number of ethical questions. Not least of which will be around incidental findings, as the Radio 4 interview raised.

The first I have is consideration of pre-natal testing plans:

“Aside from WGS of individuals, other applications using NGS could potentially be more successful in the DTC market. For example, the use of NGS for non-invasive prenatal testing would doubtless be very popular if it became available DTC prior to being offered by the NHS, particularly for relatively common conditions such as Down syndrome…” [

and then the whole question of consent, particularly from children:

“…it may be almost impossible to mitigate the risk that individuals may have their genome sequenced without their consent. Some genome scan companies (e.g. 23andMe) have argued that the risks of covert testing are reduced by their sample collection method, which requires 2ml of saliva; in addition, individuals are asked to sign to confirm that the sample belongs to them (or that they have gained consent from the individual to whom it belongs). However, neither of these methods will have any effect on the possibility of sequencing DNA from children, which is a particularly contentious issue within DTC genomics.” [13]

“two issues have emerged as being particularly pressing: first is the paradox that individuals cannot be asked to consent to the discovery of risks the importance of which is impossible to assess. Thus from a legal perspective, there is no ‘meeting of minds’ and contractually the contract between researcher and participant might be void. It is also unclear whether informed consent is sufficient to deal with the feedback of incidental findings which are not pertinent to the initial research or clinical question but that may have either clinical or personal significance…” [PHG page 94]

And thirdly, we should not forget the elderly. In February 2014 the Department of Health proposed that a patient’s economic value should be taken into account when deciding on healthcare. Sir Andrew Dillon, head of the National Institute for Healthcare and Excellence (NICE, who set national healthcare budgets and priorities), disagreed saying:
“What we don’t want to say is those 10 years you have between 70 and 80, although clearly you are not going to be working, are not going to be valuable to somebody.

Clearly they are. You might be doing all sorts of very useful things for your family or local society. That’s what we are worried about and that’s the problem with the Department of Health’s calculation.

There are lots of people who adopt the fair-innings approach; ‘you’ve had 70 years of life you’ve got to accept that society is going to bias its investments in younger people.”

[14 – see Channel 4] Yet our population is ageing and we need to find a balance of where roles, rules and expectations meet. And question, how do we measure human value, should we, and on what basis are we making cost-based care decisions?

The Department of Health proposed that a patient’s economic value should be taken into account when deciding on healthcare. What is their thinking on genomics for the care of the elderly?

Clinical environment changes make engagement and understanding harder to achieve

All this, is sitting on shifting, fundamental questions on how decision making and accountability will be set, in a world of ever fragmenting NHS structure:

“More problematic will be the use of specific genomic technologies such as NGS in patient pathways for inherited disorders that are delivered outside the clinical genetics services (such as services for FH, haemophilia and sickle cell disease) and NGS that is used for non-inherited disease conditions. These will be commissioned by GP consortia within established care pathways. Such commissioning of companion diagnostics would, in theory be evaluated first by NICE. However, it is not clear what capacity NICE will have across a broad range of uses. In practice it seems likely that GP consortia may make a variety of different decisions influenced by local experts and pressure, funding and different priorities. Particular questions for NGS will include: How will commissioners be provided with the necessary evidence for decision-making and can this be developed and coordinated at a national level? How will commissioners prioritise particularly when it may be necessary to invest early in order to achieve savings later? What (if any) influence may commissioners be able to exert over the configuration of test providers (for example the rationalisation of laboratories or the use of private testing companies)? [13]
Today (August 8th) the public row between Roche and the Government through NICE became apparant on cancer treatment. And again I found myself asking, what are we not funding, whilst we spend on genomics?  If you did not you hear Sir Andrew Dillon & the discussion, you can listen again on BBC Radio 2 iPlayer here. [It’s in the middle of the programme, and begins at 01:09.06.]

Questions, in search of an answer
Where has the population indicated that this is the direction of travel we wish our National Health Service to take? What preparation has been made for the significant changes in society it will bring? When was Parliament asked before this next step in policy and huge public spend were signed off and where is the periodic check against progress and public sign off, of the next step? Who is preparing the people and processes for this explosive change, announced with sparklers, at arms length and a long taper? Are the challenges being shared honestly between policy, politicians and scientists, being shared with patients and public: as discussed at the stakeholder meeting at St.Barts London, 3rd October 2013 (a key panel presentation: 45 minute video with slides)? When will that be shared with the public and NHS staff in full? Why does NHS England feel this is so fundamental to the future of the NHS? Must we abandon a scuppered and sinking NHS for personalised medicine on personal budgets and expectations of increased use of private health insurance?

Is genomics really the lifeboat to which the NHS is inextricably bound?

The Patients and Information Directorate nor wider NHS England Board does not discuss these questions in public.  At the July 3rd 2014 Board Meeting, in the discussion of the genomics programme I understood the discussion as starting to address the inevitable future loss of equity of access because of genomic stratification, dividing the population into risk pool classifications [10.42] . To my mind, that is the end of the free-to-all NHS as we know it. And IF it is so, through planned policy. More people paying for their own care under ‘personalisation;  is in line with ISCG expectations set out  earlier in 2014: “there will be increasing numbers of people funding their own care and caring for others.”

Not everyone may have understood it that way, but if not, I’d like to know what was meant.

I would like to understand what is meant when Genomics England spokespeople  say the future holds:

“Increasingly to select most appropriate treatment strategy. In the longer term, potential shift to prevention based on risk-based information.”
or
“Review the role of sequencing in antenatal and adult screening.”

I would welcome the opportunity to fully understand what was suggested at that Board meeting as a result of our shared risk pool, and readers should view it and make up their own mind. Even better, a frank public and/or press board meeting with Q&A could be rewarding.

The ethical questions that are thrown up by this seem yet to have little public media attention.

Not least, incidental findings: if by sequencing someone’s DNA, you establish there is something for their health that they ought to be doing soon, will you go to that patient and say look, you should be doing this…. these are incidental findings, and may be quite unexpected and separate from the original illness under investigation in say, a family member, and may also only suggest risk indicators, not clear facts.

If this is expected to be mainstream by 2018, what training plans are in place as indicated needed as a “requirement for professionals across the NHS to be trained in genetics and its implications”? [presentation by Mark Bale, DoH, July 2014]

When will we get answers to these questions, and more?

Because there is so much people like me don’t know, but should, if this is our future NHS under such fundamental change as is hyped.

Because even the most esteemed in our land can get things wrong. One of them at the St.Bart’s events quotes on of my favourite myths attributed wrongly to Goethe. It cannot be attributed to him, that he said, ” “Whatever you can do or dream you can, begin it. Boldness has genius, power and magic in it.” You see, we just hear something which sounds plausible, from someone who seems to know what they are talking about. It isn’t always right.

Because patients of rare disease in search of clinical care answers should be entitled to have expectations set appropriately, and participants in research know to what they, and possibly family members indirectly, are committed.

Because if the NHS belongs to all of us, we should be able to ask questions and expect answers about its planning,  how we choose to spend its budget and how it will look in future.

These are all questions we should be asking as society

Fundamentally, in what kind of society will my children grow up?

With the questions of pre-natal intervention, how will we shape our attitudes towards our disabled and those who are sick, or vulnerable or elderly? Are we moving towards the research vision Mr.Hunt, Cameron and Freeman appear to share, only for good, or are we indeed to look further head to a Gattacan vision of perfection?

As we become the first country in the world to permit so called ‘three parent children’ how far will we go down the path of ‘fixing’ pre-natal genetic changes, here or in PGD?

How may this look in a society where ‘some cornflakes get to the top‘ and genetic advantage seen as a natural right over those without that ability? In a state where genetics could be considered as part of education planning? [16]

For those with lifelong conditions, how may genetic screening affect their life insurance when the Moratorium expires*  in 2017 (*any shift in date TBC pending discussion) ? How will it affect their health care, if the NHS England Board sees a potential effect on equity of access? How will it affect those of us who choose not to have screening – will we be penalised for that?

And whilst risk factors may include genomic factors, lifestyle factors some argue are even more important, but these change over time. How would those, who may have had past genetic screening be affected in future requirements?

After the August 1st announcement, [11] The Wellcome Trust‘s reporting was much more balanced and sensible than the political championing had been. It grasps the challenges ahead:

“Genomics England has ambitious plans to sequence 100,000 genomes from 75,000 people, some of whom will also have cancer cells sequenced. The sheer scale of the plans is pretty daunting. The genetic information arising from this project will be immense and a huge challenge for computational analysis as well as clinical interpretation. It will also raise a number of issues regarding privacy of patient data. Ensuring that these genetic data can be used maximally for patient benefit whilst protecting the rights of the individual participant must be at the heart of this project.

At the beginning of the Human Genome Project, scientists and funders like the Wellcome Trust knew they were on a journey that would be fraught with difficulties and challenges, but the long-term vision was clear. And so it is with the plans for Genomics England, it will most certainly not be easy…”

Managing change

Reality is that yet again, Change Management and Communications have been relegated to the bottom of the boarding priorities list.

This is not only a research technology or health programme. Bigger than all of that is the change it may bring. Not only in NHS practice, should the everyday vision of black boxes in GP surgeries become reality, but for the whole of society. For the shape of society, in age and diversity. Indeed if we are to be world leaders, we have potential to start to sling the world on a dangerous orbit if the edges of scope are ill defined. Discussing only with interested parties, those who have specific personal or business interests in genomic research and data sharing, whilst at Board meetings not clearly discussing the potential effects of risk stratification and personalisation on a free at the point of delivery health service is in my opinion, not transparent, and requires more public discussion.

After all, there are patients who are desperate for answers, who are part of the NHS and need our fair treatment and equity of access for rare disease. There is the majority who may not have those needs but knows someone who does. And we all fund and support the structure and staff in our world class service, we know and love. We want this to work well.

Future research participation depends on current experience and expectations. It is the latter I fear are being currently mishandled in public and the media.

Less than a month ago, at the NHS England Board Meeting on July 3rd,  Lord Adebowale very sensibly asked, “how do we lead people from where we are, and how we take the public with us? We need to be a world leader in engaging all the public”

Engagement is not rocket science. But don’t forget the ethics.

If this project is meant to be, according to MP George Freeman [George 2], akin to Kennedy launching the Space Race, then, by Fenyman [12], why can they not get their public involvement at big launches sorted out?

Is it because there are such large gaps and unknowns that questioning will not stand up to scrutiny? Is it because suggesting a programme will end the NHS as we know it, would be fatal for any politician or party who supports that programme in the coming year? Or do the leading organisations possibly paternalistically believe the public is too dim or uninterested or simply working to make ends meet to care [perhaps part of the 42% of the population who expected to struggle as a result of universal welfare changes,  one in three main claimants (34 per cent) said in 2012 they ‘run out of money before the end of the week/month always or most of the time’] ? But why bother will the big press splash, if it should not make waves?

In the words of Richard Feynman after the Challenger launch disaster in 1986:

“Let us make recommendations to ensure that NASA officials deal in a world of reality in understanding technological weaknesses and imperfections well enough to be actively trying to eliminate them. They must live in reality in comparing the costs and utility of the Shuttle to other methods of entering space. And they must be realistic in making contracts, in estimating costs, and the difficulty of the projects.

Only realistic flight schedules should be proposed, schedules that have a reasonable chance of being met.

If in this way the government would not support them, then so be it. NASA owes it to the citizens from whom it asks support to be frank, honest, and informative, so that these citizens can make the wisest decisions for the use of their limited resources. For a successful technology, reality must take precedence over public relations… [June 6th 1986. Six months after the disaster, the Report to the Presidential Commission (Appendix F)]

Just like the Rosetta spacecraft is getting ever closer to actually landing on the comet, its goal, [15 – BBC Newsround has an excellent little summary] after over ten years, so too is genomics close to the goal of many. It is within grasp that the long-planned mainstreaming of genomic intervention, will touch down in the NHS. My hope is that in its ever closer passes, we get hard factual evidence and understand exactly where we have come from, and where we intend going. What will who do with the information once collected?

The key is not the landing, it’s understanding why we launched in the first place.

Space may not be the most significant final frontier out there in the coming months that we should be looking at up close. Both in health and science.  Our focus in England must surely be to examine these plans with a microscope, and ask what frontiers have we reached in genomics, health data sharing and ethics in the NHS?

******  image source: ESA via Nature

[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 https://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] BBC Newsround: Rosetta spacecraft and the comet chasing

[16] Education committee, December 4th 2013 including Prof. Plomin From 11.09:30 education and social planning  http://www.parliamentlive.tv/Main/Player.aspx?meetingId=14379

*****

For avoidance of confusion [especially for foreign readership and considering one position is so new], there are two different Ministers mentioned here, both called George:

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]

 

*****

#caredata, care.data, communications, engagement, genomics, leadership, NHS, NHSEngland, politics, trust

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 https://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]

*****

#caredata, care.data, HES, HSCIC, leadership, privacy, research, scope, transparency, trust

care.data should be like playing Chopin – or will it be all the right notes, but in the wrong order? [Part one]

Five months after the most recent delay to the care.data launch, I’ve come to the conclusion that we must seek long-term excellence in its performance, not content ourselves with a second-rate dress rehearsal.

“Sharing our medical records, is like playing Chopin. Done well, it has the potential to demonstrate brilliance. It separates the good, the bad and the ugly, from the world-class players.  But will we get it right, or will we look back at repeat dire performances and can say, we knew all the right notes, but got them all in the wrong order?”

Around 100 interested individuals filled a conference room at the King’s Fund, on Cavendish Square in London last Monday, July 21st, where the Health and Social Care Information Centre (HSCIC) [1] held a meeting to publicly discuss the Partridge Review [2] and HSCIC data sharing policies, practices and stakeholder expectations going forward.  Driving Positive Change.[3]

The vast majority were from organisations which are data users, some names familiar from the care.data press coverage in spring, [Beacon Consulting, Harvey Walsh] plus many university and charity driven researchers.

Sir Kingsley Manning, Sir Nick Partridge and Andy Williams [The  CEO since April 2014] all representing HSCIC, spoke about the outcomes of the PWC audit, which sampled 10% of the releases of identifiable or pseudonymous data sharing agreements for closer review, and what is termed ‘Back Office’ access (by the police, Home Office, court orders) in the eight years as the NHS IC prior to the HSCIC rebrand and changes on April 1st, 2013.

“The standard PwC methodology was adopted for sample testing data releases with the prevailing governance arrangements. Samples were selected for each of the functional areas under review. Of the total number of data releases identified (3,059); approximately a 10% sample was tested in total.” (Report, Data Release Review June 2014)

I believe it is of value to understand how we got here as well as the direction in which the HSCIC is moving. This is what the meeting sought to do, to first look back and then look forward. They are Data Controller and Processor of our health records and personal identifiable data. As care.data pathfinder pilots approach at a pace, set for ‘autumn’, the changes in the current processes and procedures for data handling will not only effect records which are already held, from our hospital care and other health settings‘, but they will have a direct effect on how our medical records extracted from GP practices will be treated, for care [dot] data in the future.

Data Management thus far has failed to meet the standards of world class delivery; in collection, governance and release

After the event, walking back to the train home, I passed the house from which Chopin left, to play his last concert. [4]

It made me think, that sharing our medical records, is like playing Chopin. Done well, it has potential for brilliance. It separates the good, the bad and the ugly, from the world-class players. Even more so, when played as part of suite, where standards are understood and interoperable . Data sharing demands technical precision, experience and discipline. Equally, gone wrong, we can look back at past performances and say, we had world class potential and knew all the right notes, but got them all in the wrong order. Where did we fail? Will we learn, or let it repeat?

The 2.5 hour event, focused more on the attendees’ main interest, how they will be affected by any changes in the release process. Some had last received data before the care.data debacle in February put a temporary halt on releases.

As a result of planned changes, will some current data customers find, that they have already received data for the last time, I wonder?

After the initial review of the critical findings in the Partridge report, the discussion centred on listening to suggestions what may be done in England to prevent future fails. But in fact, I think we should be going further. We should be looking at what we are doing in England to be the world-class player that the Prime Minister said he wants.[5]

We are focused on making the best of a bad job, when we could be looking at how to be brilliant.

To me, the meeting missed a fundamental point. Before they decide the finer points of release, they need to ensure there will be data to collect. There was not one mention of the public’s surprise that our data was collected and had been sold or shared with each of them until last spring. So now that the public in part knows about it, the recipients should also consider we are watching them closely.

Data users are being judged as one, by their group performance

What the data recipients may or may not be conscious of, is that they too each are helping to shape the orchestra and will determine the overall sound that is heard outside.

They may not realise that as data recipients, we citizens, the data providers, will see and hear their actions and respond to them all collectively, in terms of what impact it may have on our opt in/out decision.

I heard on Monday one or two shriller voices from global data intermediaries claiming that others had been receiving data whilst their own requests had been overlooked. As of last Friday, HSCIC said 627 requests were on standby, waiting for review and to know whether or not they would receive data. Currently HSCIC is getting 70 new requests a month. Bearing in mind the attendees were mostly data users, they can be forgiven that they were mostly concerned about data release and use, but they did in part also raise the importance of correct communication, governance and consent of extraction. They realise without future public trust, there is no future data store.

One consultancy however, seemed to want to blame all the other players for their own past mistakes, though there was no talk of any blame in any discussion otherwise. They asked, what about the approvals process for SUS (Secondary Uses Service data), how are those being audited and approved, is it like HES? How about HSCIC getting their act together on opt out, putting power back in the hands of patients, they asked. What about the National Cancer Registries, ONS (Office of National Statistics), all the data which is not HES, will there be one entrance point to access all these data stores for all requests? And as for insurance concerns by patients, the same said, people were foolish to be concerned. Why, “if they don’t get our health data then all the premiums will go up.”

My my, it did feel a little like a Diva having a tantrum at the rest of the performers for messing up her part. And she would darn well pull the rest of them into the pit with her if she was going to get cancelled. In true diva style, I’m sure that company didn’t even realise it.

But all those data recipients are in the same show now – if one of them screws up badly, the critics will slam them all. And with it, their providers of data, we patients, will not share our data. Consent and confidentiality are golden tickets and will not be given up lightly. If  all the data-using players perform well, abide by the expected standards, and treat both critics, audience and each other with proper etiquette, then they will get their pay, and get to stay in the show. But it won’t be a one time deal. They will need to learn continuously, do whatever the show conductor asks, and listen and learn from the critics as they perform in future, not slacking off or getting complacent.

Whilst the meeting discussed past failings in the NHS IC, I hope the organisations will consider what has truly shocked the public is some of the uses to which data has been put. How the recipients used it. They need to examine their own practices as much as HSCICs.

The majority of the attendees were playing from the same score, asking future questions which I will address in detail in part two.

The vast majority asked, how will the data lab work? And other Research users asked many similar and related questions. [This from medConfidential [6] whilst on the similar environment for accredited safe havens, goes some way to explaining the principle of a health research remote data lab (HRRDL).]

Governance questions were raised. Penalties were an oft recurring theme and local patient representative group and charity representatives, asked how the new DAAG lay person appointments process would work and be transparent.

Other questions on past data use, were concerned with the volume of Back Office data uses. The volume of police tracing for example. How person tracing by the border agency, particularly with reference to HIV and migrant health, which may reveal data to border agencies which would not normally be shared by the patients’ doctors. “If people are going to have confidence in HSCIC, this was a matter of policy which needed looking at in detail. ” The HSCIC panel noted that they also understood there were serious concerns on the quantity of intra-government departments sharing, the HMRC, Home and Cabinet Offices getting mentions.  “There was debate to be had”, he said.

And  what do you think of the show so far? [7]

They’re collectively recovering from unexpected and catastrophic criticism at the start of the year. It is still having a critical effect on many organisations because they don’t have access to the data exactly as they used to, with a backlog built up after a temporary stop on the flow which was restarted after a couple of months. HSCIC has reviewed themselves, in part, and any smart attendees on Monday will know how each of their organisations have fared. The audit has found some of their weaknesses and sought to address them. There is a huge number of changes, definitions and open considerations under discussion and not yet ready to introduce. They realise there is a great amount of work still to be done, to bring the theory into practice, test it out, edit and get to a point where they are truly ready for a new public performance.

But none of the truly dodgy sounding instruments have been kicked out yet. I would suggest there are simply organisations which are not themselves of the same standards of ethics and physical best practices which deserve to manage our data. They will bring down the whole, and need rejected – the commercial re-use licenses of commercial intermediaries. And the playing habits of the data intermediaries need some careful attention, drawing the line between their clinical support work and their purely commercial purposes. The pace may have slowed down, but data is still flowing out, and there was no recognition that this may be without data protection permission or best practice, if individuals aren’t aware of their data being used in this way. The panel conducted a well organised and orderly discussion, but there were by far more open questions, than answers ready to be given.

What we do now, sets the future stage of all data sharing, in the UK and beyond – to be brilliant, will take time to get right

How HSCIC puts into action and implements the safeguards, processes and their verbal plans to manage data in the short and medium term, will determine much for the future of data governance in England, and the wider world. Not only in terms of the storage and release of data – its technical capability and process governance, but in the approach to data extraction, fair processing, consent, communication and ongoing management.

This is all too important to rush, and I hope that the feedback and suggestions captured on the day will be incorporated into the production. To do so well, will need time and there is no point in some half-ready dress rehearsal when so much is yet to be done.

The next Big Thing – care.data

When it came to care.data, Andy Williams said it had been a serious failing to not recognise that patients view their GP records quite, totally differently, from the records held at a hospital. Sharing their HES data.

“And it is their data, at the end of the day,” he recognised.

So to conclude looking back, I believe where data sharing has reached, is leaps and bounds ahead of where it was six months ago. The Partridge Review and its recommendations recognises there are problems and makes 9 recommendations. There is lots more the workshop suggested for consideration. If HSCIC wants to achieve brilliance, it needs to practise before going out on a public stage again. The excellence of Chopin’s music does not happen by chance, or through passion alone. To achieve brilliance we cannot follow some romantic notion of ‘it will all be alright on the night’. Hard edged, technical experience knows world-class delivery demands more.

So rolling out care.data as a pathfinder model in autumn before so much good preparation can possibly be done, is in my opinion, utterly pointless. In fact, it would be damaging. It will be like pushing  a grade 5 school boy who’s not ready into the limelight, and just wishing him luck, while you wait whistling in the wings. But what will those in charge say?

Will our health data sharing be a virtuoso performance [8]? Or will we end up with a second rate show, where we will look back and say, we had all the right notes, but played them all in the wrong order [9]?

{Update August 6th, official meeting notes courtesy of HSCIC}

I look forward to the future and address this more, as we did in the second part of the meeting, in my post Part Two. [10]

*****

[1] The Health and Social Care Information Centre – HSCIC

[2] The Partridge Review – links to blog post and all report files

[3] HSCIC Driving Positive Change http://www.hscic.gov.uk/article/4824/Driving-positive-change

[4] Chopin’s Last concert in London http://www.chopin-society.org.uk/articles/chopin-last-concert.htm

[5] What are we doing in England to be the world-class player that the Prime Minister said he wants? https://www.gov.uk/government/news/record-800-million-for-groundbreaking-research-to-benefit-patients

[6] A Health Research Remote Data Lab (HRRDL) concept for the ASH consultation – https://medconfidential.org/2014/hrrdls-for-commissioning/

[7] “What do you think of the show so far?” A classic Waldorf and Statler line from the Muppet Show. https://www.youtube.com/watch?v=jJNxj1FdKuo&list=PL1BCB0B838EBE07C6&index=12

[8] Chopin Rubenstein Piano Concerto no.2 with Andre Previn https://www.youtube.com/watch?v=T_GecdMywPw&index=1&list=RDT_GecdMywPw

[9] Classic comedy Morecambe & Wise, with Andre Previn – all the right notes, but not necessarily in the right order https://www.youtube.com/watch?v=-zHBN45fbo8

[10] Blog post part two: care.data is like playing Chopin – or will it be all the right notes, but in the wrong order? [Part two – future]

**** In case care.data is news for you, here is a simple guide via Wired  and a website from GP and Caldicott Guardian Dr. Bhatia > the official NHS England page is here   ****

####

Fun facts: From The Telegraph, 2010: Prince of The Romantics by Adam Zamoyski

“That November farewell, given in aid of a Polish charity, came at the end of a difficult six-month British sojourn, which had included concerts in Manchester (one of the largest audiences he ever faced), Glasgow and Edinburgh, where the non-religious Chopin had unwillingly endured Bible readings by a pious patroness anxious to convert him to the Church of Scotland. Finally back in London, the composer-pianist spent three weeks preparing for what turned out to be his final recital by sitting wrapped in his coat in front of the fire at St James’s Place, attended by London’s leading homeopath and the Royal Physician, a specialist in tuberculosis. A week after the concert, he was on his way home to Parisian exile and death the following year.”

Born Zelazowa Wola, Poland of a French emigrant father and Polish mother, he left Poland aged 20, never to return. Well known and by some controversially for his long romantic liaison with novelist George Sand (Aurore Dudevant) after they separated his health failed and in 1848 he paid a long visit to Britain where he gave his last public performance at the Guildhall. He died in Paris.