Tag Archives: Genomics England

care.data listening events and consultation: The same notes again?

If lots of things get said in a programme of events, and nothing is left around to read about it, did they happen?

The care.data programme 2014-15 listening exercise and action plan has become impossible to find online. That’s OK, you might think, the programme has been scrapped. Not quite.

You can give your views online until September 7th on the new consultation, “New data security standards and opt-out models for health and social care”  and/or attend the new listening events, September 26th in London, October 3rd in Southampton and October 10th in Leeds.

The Ministerial statement on July 6, announced that NHS England had taken the decision to close the care.data programme after the review of data security and consent by Dame Fiona Caldicott, the National Data Guardian for Health and Care.

But the same questions are being asked again around consent and use of your medical data, from primary and secondary care. What a very long questionnaire asks is in effect,  do you want to keep your medical history private? You can answer only Q 15 if you want.

Ambiguity again surrounds what constitutes “de-identified” patient information.

What is clear is that public voice seems to have been deleted or lost from the care.data programme along with the feedback and brand.

People spoke up in 2014, and acted. The opt out that 1 in 45 people chose between January and March 2014 was put into effect by the HSCIC in April 2016. Now it seems, that might be revoked.

We’ve been here before.  There is no way that primary care data can be extracted without consent without it causing further disruption and damage to public trust and public interest research.  The future plans for linkage between all primary care data and secondary data and genomics for secondary uses, is untenable without consent.

Upcoming events cost time and money and will almost certainly go over the same ground that hours and hours were spent on in 2014. However if they do achieve a meaningful response rate, then I hope the results will not be lost and will be combined with those already captured under the ‘care.data listening events’ responses.  Will they have any impact on what consent model there may be in future?

So what we gonna do? I don’t know, whatcha wanna do? Let’s do something.

Let’s have accredited access and security fixed. While there may now be a higher transparency and process around release, there are still problems about who gets data and what they do with it.

Let’s have clear future scope and control. There is still no plan to give the public rights to control or delete data if we change our minds who can have it or for what purposes. And that is very uncertain. After all, they might decide to privatise or outsource the whole thing as was planned for the CSUs. 

Let’s have answers to everything already asked but unknown. The questions in the previous Caldicott review have still to be answered.

We have the possibility to  see health data used wisely, safely, and with public trust. But we seem stuck with the same notes again. And the public seem to be the last to be invited to participate and views once gathered, seem to be disregarded. I hope to be proved wrong.

Might, perhaps, the consultation deliver the nuanced consent model discussed at public listening exercises that many asked for?

Will the care.data listening events feedback summary be found, and will its 2014 conclusions and the enacted opt out be ignored? Will the new listening event view make more difference than in 2014?

Is public engagement, engagement, if nobody hears what was said?

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

This wraps up my series of thoughts on ‘Building Public Trust’ since the NIB Bristol meeting on July 24th.

It has looked at how to stop chasing public trust and instead the need to become organisations that can be trustworthy [part 1]. What behaviours make an organisation trustworthy [part 2]. Why fixing the Type 2 opt out is a vital first step [part 3], and why being blinded by ‘the benefits’ is not the answer [part 4], but giving balanced and fair explanations of programme purposes, commissioning and research, is beneficial to communicate.

So I want to wrap up by suggesting how communications can be improved in content and delivery. Some ideas will challenge the current approach.

Here in part five: Future solutions, I suggest why aiming to “Build Public Trust” through a new communications approach may work better for the public than the past. I’ll propose communications on care.data:

  • Review content:  what would ethical, accurate content look like
  • Strengthen relationships for delivery: don’t attempt to rebuild trust where there is now none, but strengthen the channels that are already viewed by the public to be trustworthy
  • Rethink why you communicate and the plan for when: All communications need delivered through a conversation with real listening and action based upon it. Equal priority must be given to both a communications plan for today and for the future. It must set out a mechanism for future change communications now,  before the pathfinders begin
  • Since writing this, the Leeds area CCGs have released their ‘data sharing’ comms leaflet. I have reviewed this in detail and give my opinions as a case study.

NIB workstream 4, underpins the NHS digital future,  and aims to build and sustain public trust, delivering plans for consent based information sharing and assurance of safeguards. It focuses on 4 areas: governance and oversight, project risks, consent and genomics:

“The work will begin in 2015 and is expected to include deliberative groups to discuss complex issues and engagement events, as well as use of existing organisations and ways to listen. There will also be a need to listen to professional audiences.”  [NIB work stream 4] [ref 1]

Today’s starting point in trust, trust that enables two-way communication, could hardly be worse, with professionals and public audiences. Communications are packaged in mistrust:

“Relations between the doctors’ union and Health Secretary Jeremy Hunt hit a new low following his announcement in July that he was prepared to impose seven-day working on hospital doctors in England.” [BBC news, Aug 15, 2015]

There appears to be divided opinion between politicians and civil servants.

Right now, the Department of Health seems to be sabotaging its own plans for success at every turn.

What reason can there be for denying debate in the public domain of the very plans it says are the life blood of the savings central to the NHS future?

Has the Department learned nothing from the loss of public and professional trust in 2014?

And as regards the public in engagement work, Hetan Shah, executive director of the Royal Statistical Society said in 2014, “Our research shows a “data trust deficit”. In this data rich world, companies and government have to earn citizens’ trust in how they manage and use data – and those that get it wrong will pay the price.’ [RSS Data Trust Deficit, lessons for policymakers, 2014] [2]

Where do the NIB work stream discussions want to reach by 2020?

“The emergence of genomics requires a conversation about what kind of consent is appropriate by 2020. The work stream will investigate a strand of work to be led by an ethicist.” [NIB work stream 4]

Why is genomics here in workstream 4, when datasharing for genomics is with active consent from volunteers? Why will a strand of work be led by an ethicist for this, and not other work strands? Is there a gap in how their consent is managed today or in how consent is to be handled for genomics for the future? It seems to me there is a gap in what is planned and what the public is being told here. It is high time for an overdue public debate on what future today’s population-wide data sharing programme is building. Good communication must ensure there are no surprises.

The words I underlined from the work stream 4 paper, highlight the importance of communication; to listen and to have a conversation. Despite all the engagement work of 2014 I feel that is still to happen. As one participant summed up later, “They seem hell bent on going ahead. I know they listened, but what did they hear?” [3]

care.data pathfinder practices are apparently ready to roll out communications materials: “Extraction is likely to take place between September and November depending on how fair processing testing communications was conducted” [Blackburn and Darwen HW]

So what will patient facing materials look like in content? How will they be rolled out?

Are pathfinder communications more robust than 2014 materials?

I hope the creatives will also think carefully, what is the intent of communications to be delivered.  Is it to fully and ethically inform patients about their choice whether to accept or opt out from changes in their data access, management, use and oversight? Or is the programme guidance to minimise the opt out numbers?

The participants are not signing up to a one time, single use marketing campaign, but to a lifetime of data use by third parties. Third parties who remain in role and purposes, loosely defined.

It is important when balancing this decision not to forget that data  that is available and not used wisely could fail to mitigate risk; for example in identifying pharmaceutical harms.

At the same time to collect all data for all purposes under that ‘patient safety and quality’ umbrella theme is simplistic, and lends itself in some ways, to lazy communications.

Patients must also feel free and able to make an informed decision without coercion, that includes not making opting out feel guilty.

The wording used in the past was weighted towards the organisation’s preference.  The very concept of “data sharing” is weighted positively towards the organisation. Even though in reality the default is for data to be taken by the organisation, not donated by the citizen. In other areas of life, this is recognised as an unwilling position for the citizen to be in.

At the moment I feel that the scope of purposes both today and future are not clearly defined enough in communications or plans for me personally to be able to trust them. Withholding information about how digital plans will fit into the broader NHS landscape and what data sharing will mean beyond 2020 appears rightly or wrongly,  suspicious. Department of Health, what are you thinking?

What the organisation says it will do, it must do and be seen to do, to be demonstrably trustworthy.

This workstream carries two important strands of governance and oversight which now need to be seen to happen. Implementing the statutory footing of the National Data Guardian, which has been talked about since October 2014 and ‘at the earliest opportunity’ seems to have been rather long in coming, and ‘a whole system’ that respects patient choice. What will this look like and how will it take into account the granular level of choices asked for at care.data listening events through 2014?

“By April 2016 NIB will publish, in partnership with civil society and patient leaders, a roadmap for moving to a whole-system, consent-based approach, which respects citizens’ preferences and objections about how their personal and confidential data is used, with the goal of implementing that approach by December 2020.”

‘By December 2020’ is still some time away, yet the pathfinders for care.data rolls on now regardless. The proof that will demonstrate what was said about data use actually is what happens to data, that what is communicated is trustworthy, is part of a system that can communicate this by recording and sharing consent decisions, “and can provide information on the use to which an individual’s data has been put. Over the longer term, digital solutions will be developed that automate as far as possible these processes.”

Until then what will underpin trust to show that what is communicated is done, in the short term?

Future proofing Communications must start now

Since 2013 the NHS England care.data approach appeared to want a quick data grab without long term future-proofed plans. Like the hook-up app approach to dating.

To enable the NIB 2020 plans and beyond, to safeguard research in the public interest, all communications must shape a trusted long term relationship.

To ensure public trust, communications content and delivery can only come after changes. Which is again why focusing only on communicate the benefits without discussing balance of risk does not work.  That’s what 2014 patient facing communications tried.

In 2014 there were challenges on communications that were asked but not answered, on reaching those who are digitally excluded, on reaching those for whom reading text was a challenge, and deciding who the target audience will be, considering people with delegated authority young and old, as well as those who go in and out of GP care throughout their lives, such as some military. Has that changed?

In February 2014 Health Select Committee member Sarah Wollaston, now Chair, said: “There are very serious underlying problems here that need to be addressed.”

If you change nothing, you can expect nothing to change in public and professional feeling about the programme. Communications cannot in 2015 simply revamp the layout and pacakging. There must be a change in content and in the support given in its delivery. Change means that you need to stop doing some things and start doing others.

In summary for future communications to support trust, I suggest:

1. STOP: delivering content that is biased towards what the organsation wants to achieve often with a focus on fair processing requirement, under a coercive veil of patient safety and research

START: communicating with an entirely ethical based approach reconsidering all patient data held at HSCIC and whether omission of  ‘commercial use’, balanced risks as identified in the privacy impact assessment and stating ‘your name is not included’ is right.  

2. STOP: Consider all the releases of health data held by HSCIC again and decide for each type if they are going to deliver public confidence that your organisations are trustworthy. 

START: communicate publicly which commercial companies, re-users and back office would no longer be legally eligible to receive data and why. Demonstrate organisations who received data in the past that will not in future.  

3. STOP: the Department of Health and NHS England must stop undermining trust in its own leadership, through public communications that voice opposition to medical professional bodies. Doctors are trusted much more than politicians.

START: strengthen the public-GP relationship that is already well trusted. Strengthen the GP position that will in turn support the organisational-trust-chain that you need to sustain public support. 

4. STOP: stop delaying the legislative changes needed on Data Guardian and penalties for data misuse 

START: implement them and clearly explain them in Parliament and press

5. STOP: don’t rush through short term short-cuts  to get ‘some’ data but ignore the listening from the public that asked for choice.

START: design a thorough granular consent model fit for the 21stC and beyond and explain to the public what it will offer, the buy in for bona fide research will be much greater (be prepared to define ‘research’!

6. STOP: saying that future practices have been changed and that security and uses are now more trustworthy than in the past. Don’t rush to extract data until you can prove you are trustworthy.

START: Demonstrate in future who receives data to individuals through a data use report. Who future users are in practice can only be shown through a demonstrable tool to see your word can be relied upon in practice. This will I am convinced, lower the opt out rate.

 Point 6 is apparently work-in-progress. [p58]
NIB2015

7. STOP: rolling out the current communications approach without any public position on what changes will mean they are notified before a new purpose and user in future of our data

START: design a thorough change communications model fit for the 21stC and beyond and tell the public in THIS round of communications what changes of user or purposes will trigger a notification to enable them to opt out in future BEFORE a future change i.e. in a fictional future – if the government decided that the population wide database should be further commercialised ‘for the purposes of health’, linked to the NHSBT blood donor registry and sold to genomic research companies, how would I as a donor be told, BEFORE the event?

There are still unknowns in content and future scope that mean communications are difficult. If you don’t know what you’re saying how to say it is hard. But what is certain is that there are future changes in the programme planned, and how to communicate these these with the public and professionals must be designed for now, so that what we are signed up for today, stays what we signed up for.

Delivering messages about data sharing and the broader NHS, the DH/NHS England should consider carefully their relationships and behaviours, all communication becomes relevant to trust.

Solutions cannot only be thought of in terms tools, not of what can be imposed on people, but of what can be achieved with people.

That’s people from the public and professionals and the programme working with the same understanding of the plans together, in a trusted long term relationship.

For more detail including my case study comments on the Leeds area CCGs comms leaflet, continue reading below.

Thanks for sharing in discussions of ideas in my five part post on Building public trust – a New Approach. Comments welcome.

Continue reading “Building Public Trust [5]: Future solutions for health data sharing in care.data” »

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

 

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

Differentiation. Telling customers apart and grouping them by similarities is what commercial data managers want.

It enables them to target customers with advertising and sales promotion most effectively. They segment the market into chunks and treat one group differently from another.

They use market research data, our loyalty card data, to get that detailed information about customers, and decide how to target each group for what purposes.

As the EU states debate how research data should be used and how individuals should be both enabled and protected through it, they might consider separating research purposes by type.

While people are happy for the state to use their data without active consent for bona fide research, they are not for commercial consumer research purposes. [ref part 1].

Separating consumer and commercial market research from the definition of research purposes for the public good by the state, could be key to rebuilding people’s trust in government data use.

Having separate purposes would permit separate consent and control procedures to govern them.

But what role will profit make in the state’s definition of ‘in the public interest’ – is it in the public interest if the UK plc makes money from its citizens? and how far along any gauge of public feeling will a government be prepared to go to push making money for the UK plc at our own personal cost?

Pay-for-privacy?

In January this year, the Executive Vice President at Dunnhumby, Nishat Mehta, wrote in this article [7], about how he sees the future of data sharing between consumers and commercial traders:

“Imagine a world where data and services that are currently free had a price tag. You could choose to use Google or Facebook freely if you allowed them to monetize your expressed data through third-party advertisers […]. Alternatively, you could choose to pay a fair price for these services, but use of the data would be forbidden or limited to internal purposes.”

He too, talked about health data. Specifically about its value when accurate expressed and consensual:

“As consumers create and own even more data from health and fitness wearables, connected devices and offline social interactions, market dynamics would set the fair price that would compel customers to share that data. The data is more accurate, and therefore valuable, because it is expressed, rather than inferred, unable to be collected any other way and comes with clear permission from the user for its use.”

What his pay-for-privacy model appears to have forgotten, is that this future consensual sharing is based on the understanding that privacy has a monetary value. And that depends on understanding the status quo.

It is based on the individual realising that there is money made from their personal data by third parties today, and that there is a choice.

The extent of this commercial sharing and re-selling will be a surprise to most loyalty card holders.

“For years, market research firms and retailers have used loyalty cards to offer money back schemes or discounts in return for customer data.”

However despite being signed up for years, I believe most in the public are unaware of the implied deal. It may be in the small print. But everyone knows that few read it, in the rush to sign up to save money.

Most shoppers believe the supermarket is buying our loyalty. We return to spend more cash because of the points. Points mean prizes, petrol coupons, or pounds off.

We don’t realise our personal identity and habits are being invisibly analysed to the nth degree and sold by supermarkets as part of those sweet deals.

But is pay-for-privacy discriminatory? By creating the freedom to choose privacy as a pay-for option, it excludes those who cannot afford it.

Privacy should be seen as a human right, not as a pay-only privilege.

Today we use free services online but our data is used behind the scenes to target sales and ads often with no choice and without our awareness.

Today we can choose to opt in to loyalty schemes and trade our personal data for points and with it we accept marketing emails, and flyers through the door, and unwanted calls in our private time.

The free option is to never sign up at all, but by doing so customers pay a premium by not getting the vouchers and discounts.  Or trading convenience of online shopping.

There is a personal cost in all three cases, albeit in a rather opaque trade off.

 

Does the consumer really benefit in any of these scenarios or does the commercial company get a better deal?

In the sustainable future, only a consensual system based on understanding and trust will work well. That’s assuming by well, we mean organisations wish to prevent PR disasters and practical disruption as resulted for example to NHS data in the last year, through care.data.

For some people the personal cost to the infringement of privacy by commercial firms is great. Others care less. But once informed, there is a choice on offer even today to pay for privacy from commercial business, whether one pays the price by paying a premium for goods if not signed up for loyalty schemes or paying with our privacy.

In future we may see a more direct pay-for-privacy offering along  the lines of Nishat Mehta.

And if so, citizens will be asking ever more about how their data is used in all sorts of places beyond the supermarket.

So how can the state profit from the economic value of our data but not exploit citizens?

‘Every little bit of data’ may help consumer marketing companies.  Gaining it or using it in ways which are unethical and knowingly continue bad practices won’t win back consumers and citizens’ trust.

And whether it is a commercial consumer company or the state, people feel exploited when their information is used to make money without their knowledge and for purposes with which they disagree.

Consumer commercial use and use in bona fide research are separate in the average citizen’s mind and understood in theory.

Achieving differentiation in practice in the definition of research purposes could be key to rebuilding consumers’ trust.

And that would be valid for all their data, not only what data protection labels as ‘personal’. For the average citizen, all data about them is personal.

Separating in practice how consumer businesses are using data about customers to the benefit of company profits, how the benefits are shared on an individual basis in terms of a trade in our privacy, and how bona fide public research benefits us all, would be beneficial to win continued access to our data.

Citizens need and want to be offered paths to see how our data are used in ways which are transparent and easy to access.

Cutting away purposes which appear exploitative from purposes in the public interest could benefit commerce, industry and science.

By reducing the private cost to individuals of the loss of control and privacy of our data, citizens will be more willing to share.

That will create more opportunity for data to be used in the public interest, which will increase the public good; both economic and social which the government hopes to see expand.

And that could mean a happy ending for everyone.

The Economic Value of Data vs the Public Good?  They need not be mutually exclusive. But if one exploits the other, it has the potential to continue be corrosive. The UK plc cannot continue to assume its subjects are willing creators and repositories of information to be used for making money. [ref 1] To do so has lost trust in all uses, not only those in which citizens felt exploited.[6]

The economic value of data used in science and health, whether to individual app creators, big business or the commissioning state in planning and purchasing is clear. Perhaps not quantified or often discussed in the public domain perhaps, but it clearly exists.

Those uses can co-exist with good practices to help people understand what they are signed up to.

By defining ‘research purposes’, by making how data are used transparent, and by giving real choice in practice to consent to differentiated data for secondary uses, both commercial and state will secure their long term access to data.

Privacy, consent and separation of purposes will be wise investments for its growth across commercial and state sectors.

Let’s hope they are part of the coming ‘long-term economic plan’.

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Related to this:

Part one: The Economic Value of Data vs the Public Good? [1] Concerns and the cost of Consent

Part two: The Economic Value of Data vs the Public Good? [2] Pay-for-privacy and Defining Purposes.

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

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image via Tesco media

[6] Ipsos MORI research with the Royal Statistical Society into the Trust deficit with lessons for policy makers https://www.ipsos-mori.com/researchpublications/researcharchive/3422/New-research-finds-data-trust-deficit-with-lessons-for-policymakers.aspx

[7] AdExchanger Janaury 2015 http://adexchanger.com/data-driven-thinking/the-newest-asset-class-data/

[8] Tesco clubcard data sale http://jenpersson.com/public_data_in_private_hands/  / Computing 14.01.2015 – article by Sooraj Shah: http://www.computing.co.uk/ctg/feature/2390197/what-does-tescos-sale-of-dunnhumby-mean-for-its-data-strategy

[9] Direct Marketing 2013 http://www.dmnews.com/tesco-every-little-bit-of-customer-data-helps/article/317823/

 

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]

 

Consent to data sharing appears to be a new choice firmly available on the NHS England patient menu if patient ownership of our own records, is clearly acknowledged as ‘the operating principle legally’.

Simon Stevens, had just said in his keynote speech:

“..smartphones; […] the single most important health treatment and diagnostic tool at our disposal over the coming decade and beyond ” Simon Stevens, March 18 2015.

Tim Kelsey, Director Patients and Information, NHS England, then talked about consent in the Q&A:

“We now acknowledge the patient’s ownership of the record […] essentially, it’s always been implied, it’s still not absolutely explicit but it is the operating principle now legally for the NHS.

“So, let’s get back to consent and what it means for clinical professionals, because we are going to move to a place where people will make those decisions as they currently do with wearable devices, and other kinds of mobile, and we need to get to a point where people can plug their wearable device into their medical record, and essentially manage their data as they wish.

“It is essentially, their data.”

How this principle has been applied in the past, is being now, and how it may change matters, as it will affect many other areas.

Our personal health data is the business intelligence of the health industry’s future.

Some parts of that industry will say we don’t share enough data. Or don’t use it in the right way.  For wearables designed as medical devices, it will be vital to do so.

But before some launch into polemics on the rights and wrongs of blanket ‘data sharing’ we should be careful what types of data we mean, and for what purposes it is extracted.It matters when discussing consent and sharing.

We should be clear to separate consent to data sharing for direct treatment from consent for secondary purposes other than care (although Mr Kelsey hinted at a conflation of the two in a later comment). The promised opt-out from sharing for secondary uses is pending legal change. At least that’s what we’ve been told.

Given that patient data from hospital and range of NHS health settings today, are used for secondary purposes without consent – despite the political acknowledgement that patients have an opt out – this sounded a bold new statement, and contrasted with his past stance.

Primary care data extraction for secondary uses, in the care.data programme, was not intended to be consensual. Will it become so?

Its plan so far has an assumed opt-in model, despite professional calls from some, such as at the the BMA ARM to move to an opt-in model, and the acknowledged risk of harm that it will do to patient trust.

The NHS England Privacy Assessment said: ‘The extraction of personal confidential data from providers without consent carries the risk that patients may lose trust in the confidential nature of the health service.’

A year into the launch, Jan 2014, a national communications plan should have solved the need for fair processing, but another year on, March 2015, there is postcode lottery, pilot approach.

If in principle, datasharing is to be decided by consensual active choice,  as it “is the operating principle now legally for the NHS” then why not now, for care.data, and for all?

When will the promised choice be enacted to withhold data from secondary uses and sharing with third parties beyond the HSCIC?

“we are going to move to a place where people will make those decisions as they currently do with wearable devices” [Widening digital participation, at the King’s Fund March 2015]

So when will we see this ‘move’ and what will it mean?

Why plan to continue to extract more data under the ‘old’ assumption principle, if ownership of data is now with the individual?

And who is to make the move first – NHS patients or NHS patriarchy – if patients use wearables before the NHS is geared up to them?

Looking back or forward thinking?

Last year’s programme has become outdated not only in principle, but digital best practice if top down dictatorship is out, and the individual is now to “manage their data as they wish.”

What might happen in the next two years, in the scope of the Five Year Forward Plan or indeed by 2020?

This shift in data creation, sharing and acknowledged ownership may mean epic change for expectations and access.

It will mean that people’s choice around data sharing; from patients and healthy controls, need considered early on in research & projects. Engagement, communication and involvement will be all about trust.

For the ‘worried well’, wearables could ‘provide digital “nudges” that will empower us to live healthier and better lives‘ or perhaps not.

What understanding have we yet, of the big picture of what this may mean and where apps fit into the wider digital NHS application and beyond?

Patients right to choose

The rights to information and decision making responsibility is shifting towards the patient in other applied areas of care.

But what data will patients truly choose to apply and what to share, manipulate or delete? Who will use wearables and who will not, and how will that affect the access to and delivery of care?

What data will citizens choose to share in future and how will it affect the decision making by their clinician, the NHS as an organisation, research, public health, the state, and the individual?

Selective deletion could change a clinical history and clinician’s view.

Selective accuracy in terms of false measurements [think diabetes], or in medication, could kill people quickly.

How are apps to be regulated? Will only NHS ‘approved’ apps be licensed for use in the NHS and made available to choose from and what happens to patients’ data who use a non-approved app?

How will any of their data be accessed and applied in primary care?

Knowledge is used to make choices and inform decisions. Individuals make choices about their own lives, clinicians make decisions for and with their patients in their service provision, organisations make choices about their business model which may include where to profit.

Our personal health data is the business intelligence of the health industry’s future.

Who holds the balance of power in that future delivery model for healthcare in England, is going to be an ongoing debate of epic proportions but it will likely change in drips rather than a flood.

It has already begun. Lobbyists and companies who want access to data are apparently asking for significant changes to be made in the access to micro data held at the ONS. EU laws are changing.

The players who hold data, will hold knowledge, will hold power.

If the NHS were a monopoly board game, data intermediaries would be some of the wealthiest sites, but the value they create from publicly funded NHS data, should belong in the community chest.

If consent is to be with the individual for all purposes other than direct care, then all data sharing bodies and users had best set their expectations accordingly. Patients will need to make wise decisions, for themselves and in the public interest.

Projects for research and sharing must design trust and security into plans from the start or risk failure through lack of participants.

It’s enormously exciting.  I suspect some apps will be rather well hyped and deflate quickly if not effective. Others might be truly useful. Others may kill us.

As twitter might say, what a time to be alive.

Digital opportunities for engaging citizens as far as apps and data sharing goes, is not only not about how the NHS will engage citizens, but how citizens will engage with what NHS offering.

Consent it seems will one day be king.
Will there or won’t there be a wearables revolution?
Will we be offered or choose digital ‘wellness tools’ or medically approved apps? Will we trust them for diagnostics and treatment? Or will few become more than a fad for the worried well?
Control for the individual over their own data and choice to make their own decisions of what to store, share or deny may rule in practice, as well as theory.
That practice will need to differentiate between purposes for direct clinical care and secondary uses as it does today, and be supported and protected in legislation, protecting patient trust.
“We are going to move to a place where people will make those decisions as they currently do with wearable devices, and other kinds of mobile, and we need to get to a point where people can plug their wearable device into their medical record, and essentially manage their data as they wish.”
However as ‘choice’ was the buzzword for NHS care in recent years – conflated with increasing the use of private providers – will consent be abused to mean a shift of responsibility from the state to the individual, with caveats for how it could affect care?
With that shift in responsibility for decision making, as with personalized budgets, will we also see a shift in responsibility for payment choices from state to citizen?
Will our lifestyle choices in one area exclude choice in another?
Could app data of unhealthy purchases from the supermarket or refusal to share our health data, one day be seen as refusal of care and a reason to decline it? Mr Kelsey hinted at this last question in the meeting.
Add a population stratified by risk groups into the mix, and we have lots of legitimate questions to ask on the future vision of the NHS.
He went on to say:
“we have got some very significant challenges to explore in our minds, and we need to do, quite urgently from a legal and ethical perspective, around the advent of machine learning, and …artificial intelligence capable of handling data at a scale which we don’t currently do […] .
“I happen to be the person responsible in the NHS for the 100K genomes programme[…]. We are on the edge of a new kind of medicine, where we can also look at the interaction of all your molecules, as they bounce around your DNA. […]
“The point is, the principle is, it’s the patient’s data and they must make decisions about who uses it and what they mash it up with.”
How well that is managed will determine who citizens will choose to engage and share data with, inside and outside our future NHS.
Simon Stevens earlier at the event, had acknowledged a fundamental power shift he sees as necessary:
“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.”

That could affect everyone in the NHS, with or without a wearables revolution.

These are challenges the public is not yet discussing and we’re already late to the party.

We’re all invited. What will you be wearing?

********
[Previous: part one here #NHSWDP 1  – From the event “Digital Participation and Health Literacy: Opportunities for engaging citizens” held at the King’s Fund, London, March 18, 2015]

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

********

Apple ResearchKit: http://techcrunch.com/2015/03/09/apple-introduces-researchkit-turning-iphones-into-medical-diagnostic-devices/#lZOCiR:UwOp
Digital nudges – the Tyranny of the Should by Maneesha Juneja http://maneeshjuneja.com/blog/2015/3/2/the-tyranny-of-the-should

You may use these HTML tags and attributes: <blockquote cite="">

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 http://jenpersson.com/successful-technology-reality-precedence-public-relations/

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

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

[15] 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]

 

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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}

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

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

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

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

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

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

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

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

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

[10] November 2013 ISCG – political pressure on genomics schedule http://www.england.nhs.uk/iscg/wp-content/uploads/sites/4/2014/01/ISCG-Paper-Ref-ISCG-009-001-ISCG-Meeting-Minutes-and-Actions-26-November-2013-v1.1.pdf

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

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

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

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

[15] The Royal Statistical Society identifies a Trust Deficit

 [16] The Whitehead Institute for Biomedical Research in Cambridge, Mass in the WSJ, Jan 2013: “”It only takes one male,” said Yaniv Erlich, a Whitehead fellow, who led the research team. “With one male, we can find even distant relatives.”
[17] Adult Social care ISCG,  2014 http://www.england.nhs.uk/iscg/wp-content/uploads/sites/4/2014/01/ISCG-Paper-Ref-ISCG-009-002-Adult-Social-Care-Informatics.pdf  “Personalisation – citizens should increasingly be empowered to have choice and control over their care; and there will be increasing numbers of people funding their own care and caring for others”

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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]

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