Tag Archives: #caredata

#caredata, care.data, NHS England

A care.data Christmas carol

“Marley was dead: to begin with. There is no doubt whatever about that.” [A Christmas Carol, Charles Dickens, 1843]

“Is care.data dead?” I was asked after our children’s nativity today, “what happened to that GP record sharing project?”  The local priest, you may think of all people, wondered what had become of the news stories we had discussed at Easter.

Not dead, I assured him, though it was suggested recently that the Caldicott led Independent Information Governance Oversight Panel (IIGOP) report [1], would be the final nail in the coffin of the past approach [2], and would spell doom ahead in any care.data future were the programme not to follow its recommendations.

I told him the story of the care.data year.

So, are you sitting comfortably? For Christmas is a time of storytelling. At its heart, the story of a birth, which has been handed down through generations.

But here, I borrow from the most famous of all English Christmas stories, a Christmas Carol, by Charles Dickens from 1843. Let us begin.

“Come in!” exclaimed the Ghost. “Come in! and know me better, man!”

The ghost of care.data past rattled its chains and brought no joy in 2014, haunting the current programme with news of past data sharing practices.  At the start of the year, much was made of the 25 years of past use of our health records with third parties about which the public had never been told nor asked for permission, we were told there had never been breaches [3], and there was surprise expressed by NHS England leadership at why care.data, the plan to extract GP records now in addition, should have struck such a nerve in the public. Then they actually ran an audit that told the full story.

Various reports have since tried to vanquish those ghosts which have haunted the rollout of care.data in the past year. Sir Nick Partridge in May led the Review of Data Releases by the NHS IC which looked back at health data sharing of the existing HSCIC held data, and in November, he examined the progress up to the present.[4]  The extent of third party releases including actuarial firms, organisations in the US and China, and commercial re-use was a complete surprise to the public and, his report appeared to suggest to many like him in management as well.

The IIGOP Report published last week on the care.data Programme Board looks to the future. It sets out a thorough set of specific recommendations, questions and tests to meet before it could be reasonable to proceed to a data extraction in the care.data pilot.

The first independent report on care.data, prepared and released under the oversight of the new Data Guardian, Dame Fiona Caldicott, it also captures many sensible and practical questions raised by patients at events all year.

In some ways, whilst sad to see what so many have said was needed has only come to be addressed by an independent body rather than NHS England, recognising the current weaknesses can only be seen as positive to bring about changes. It may have a hope of restoring public and professional trust.

What next steps will come from this for a care.data relaunch by NHS England, and when in future, remain to be seen. [Updates may be here, or here or sometimes here].

Perhaps if the current course of actions is averted, we may not ‘see a vacant seat’ if it all falls apart in 2015 after all.

The CCGs have been given a huge responsibility which is not of their making, if NHS England continues to pilot under CCG-steered rollouts.[5]

One would hope that given the right amount of time needed to manage this change process, and  with the right supporting skills and tools for the practicalities, the care.data programme will take a changed form in the year ahead. It may yet be saved.

But it does seem often that timing is of the essence, and we move from one artificial deadline to the next. The public and GPs wait without the security and confidence of a realistic schedule.  Waiting we wonder if we will reach the next chime due, or the next ghost to haunt the programme will arrive and cause new fright.

It’s no cure all, but it appears the IIGOP has given the programme the gift of one last wonderful opportunity to get this right. It’s requirements are sizeable and will take time to execute sensibly. The report illuminates a future path for progress and shows what must be altered today, to avoid the future it predicts otherwise.

The outcome of care.data rests in the hands of the DH and NHS England. Dependent on the public and professions seeing change.

As Scrooge learns:

“But if the courses be departed from, the ends will change.” [A Christmas Carol, Charles Dickens, 1843]

Ignore the wisdom of the ghosts at your peril. For a changed future outcome,  the actions of the present must change first.

So, humour me awhile, and let’s consider some of the bigger themes in the care.data Christmas carol that CCGs may wish to consider as it deals with preparing for pathfinder pilots…

Chapter 1. “This boy is Ignorance. This girl is Want. Beware them both, and all of their degree, but most of all beware this boy, for on his brow I see that written which is Doom, unless the writing be erased…” [A Christmas Carol, Charles Dickens, 1843]”

What information is getting through from listening events? [6]

There should be no excuse for poverty in the world today, and whilst in my bigger picture wish list, to deal with want would come first, in my care.data Christmas carol list, it is ignorance which cannot be tolerated.

There is no excuse for ignorance, for lack of information, or wondering what questions needed answers to date at the care.data programme board of NHS England.

“How do we explain care.data vs SCR”, “Can you tell me exactly who will access my data?”, “If future purposes change and I want the opportunity to withdraw & opt out, how will I get told?”

The IIGOP report states clearly the current gaps in knowledge and what must be done to fill them, for various parties.

Together with two other major reports this year on health data sharing and care.data: Partridge, and the November 2014 APPG report [7], professional bodies have provided plenty of information and asked plenty of questions which no one now can ignore.

Misplaced statements that there have been no breaches do nothing for public confidence, when later reports show that is ignorant or inaccurate. Big Brother Watch published its report into NHS Data Breaches in November. It found that data security is an ongoing problem, and that over the last four years patient confidentiality had been breached at least 7,255 times.[8]

Facts and answers now need to address the IIGOP report in depth, and meet patients’ past questions, to lay to rest some of the issues which have haunted the programme in the press; unexpected commercial uses, and re-use of data through commercial data licenses, for example.

Adequate time must be given to the CCGs, GPs and patients to be fully informed of the programme and the choice(s) on offer. This is not an IT rollout, but a series of process changes, which need human understanding and acceptance. “What’s in it for me?” versus “What risks may harm me?” need thinking time to be fairly presented and the patient choice collected.

To avoid potential doom whether it be significant opt out or failure to meet fair processing leaving GPs at risk [9], to adequately communicate through effective education, will take effort.

Chapter 2. “Every one of them wore chains like Marley’s Ghost; some few (they might be guilty governments) were linked together; none were free.” [A Christmas Carol, Charles Dickens, 1843]

Understand the links of who, why and what, of data sharing: 

The decision making, the process steps, how patients are told of changes in the programme today and will be in future, how the public perceives their data is exploited, are all linked together by very simply: who stores and uses the data, and for what purposes.

For the programme, it would be wise to understand the importance of the interaction of these parts of the process. Linked appropriately together, and working well, trust will keep the system together.  It fails, and no matter how good the technology is, without trust, the system will fail to deliver its expectations. If too many may opt out, or opt out disproportionately in certain population segments it would harm data quality.

When at the HSCIC data sharing discussion in July it was clear some data recipients were yet to grasp this interdependency, and the effect their attitudes to data use have on each other.

If one [class of] data recipient in future receives or uses data inappropriately, it will harm public faith in all users.

For patients, to have true transparency I believe care.data should be explaining exactly how the data linkage system [10] works, and all the other silos of data it already holds. The personal demographics service, stores a whole set of personal data of which the public maybe unaware, and yet may find used to link data collected from all sorts of parts of health and social care. If NHS data sharing is to be explained, do it all. To avoid doing this, will merely store up a future risk of yet more surprises for patients and damage trust further.

Chapter 3: “I have seen your nobler aspirations fall off one by one, until the master-passion, Gain, engrosses you.” [A Christmas Carol, Charles Dickens, 1843]

Commercial use of data will be detrimental to public confidence.

By looking ahead to see what the ghost of care.data future might bring, the forecast doom of the present course, may yet be avoided.

As patients told NHS England at the Open House event [11], we’re fed up with commercial data mining, and the same was reflected by a representative group of citizens in various polls this year.[12]

How is the non-NHS data world changing? What of the upcoming EU data legislation?  How does commercial data industry itself perceive legislation in the UK?

In the 2013 Experian keynote address the Nectar Head of Customer Marketing noted, “legislation has not kept up to speed with where we are going’ [16:57] [13]

Perhaps it is opportune to reflect on one of the oldest Biblical themes at Christmas, choose which master you serve.

Back at NHS England and the IC, discussions in April 2013 seek to ‘create a vibrant market of data intermediaries , for example.

Which purposes should this serve? The health of the nation, or the wealth of the nation? Can one justly serve both equally?

“You fear the world too much,” she answered, gently. “All your other hopes have merged into the hope of being beyond the chance of its sordid reproach. I have seen your nobler aspirations fall off one by one, until the master-passion, Gain, engrosses you.” [A Christmas Carol, Charles Dickens, 1843]

It would appear to patients that by  mixing commercial purposes in with legitimate health, and health research purposes,  the data commissioning system has created its own downfall.[14]

The purposes whilst amended in the Care Act 2014, are so broad as to leave too much commercial use open under ‘purposes of health’. How would that rule out pharmaceutical marketing for example?

For many patients, use outside their own healthcare and its provision and planning is a real hot chestnut.

If patients are in disagreement over commercial uses for example, they have no choice but to opt out of research uses as well. This multi-option choice, or the removal of commercial use needs addressed.

If research wants more data, we would do well to define and restrict commercial use in legislation, much more specifically.

Chapter 4 : “You wish to be anonymous?” [a Christmas Carol, 1843]

There has been much disagreement and misunderstanding of how data will be used, anonymous or what non-identifiable really means.

Media reporting at the start of the year frequently focused on the collection of care.data as ‘anonymous data.’  Bah, humbug! that is factually incorrect.

CCGs need to make sure that their own staff understanding is correct, as well as passing on information if they are to be intermediaries on behalf of NHS England. At CCG meetings I attended, many staff confused care.data with direct care/SCR.

The default position if patients do nothing is the sharing of date of birth, full postcode, gender and ethnicity, and the NHS number is a unique identifier. Plus all the other codes and conditions.

It is still unclear how the data which has already been extracted without consent or fair processing, can be controlled by patients who may not wish to share identifiable data from their hospital visits, mental or community health.

bbc_notdentifiable

If patients can’t control data already held at HSCIC, why will they want to share more additional data, from primary care?

Learning from looking back on 2014

My own looking back on my care.data journey in 2014 is here.

medConfidential has a rather good summary of the year here. [15]

“Spirit,” said Scrooge submissively, “conduct me where you will. I went forth last night on compulsion, and I learnt a lesson which is working now. To-night, if you have aught to teach me, let me profit by it.” [A Christmas Carol, Charles Dickens, 1843]

From past lessons learned in 2014, one would hope the future rollout will profit from them and take the time, and use the tools it needs, to get to a brighter future.

Looking ahead: news for 2015 came at the end of the year.

Sir Partridge in the Telegraph, November 27 he said:

“We must make sure there are no surprises for the public about how their information is being used, that they have a choice in this and that we are honest about the balance of risk. Every single one of us has a part to play in making sure we get this right…

“The HSCIC is still improving its practices. It is also endeavouring to increase its transparency.”

The November 2014 APPG report said, what everyone appears to agree on:

“the public had been inadequately consulted in the early stages of the Care.data programme and that it was therefore correct to halt the programme to allow further public consultation.” [APPG report]

It goes on to say, “Organisations providing health or social care services must succeed in both respects [examining the Public Interest] if they are not to fail the people that they exist to serve,” and with that in mind a Public Benefits Plan should be drawn up, to support public transparency.

Public transparency would be improved by publishing the public’s questions from multiple listening events at which attendees were promised answers and follow up. The conversations did not always ask easy questions, but all the more reason to address them publicly for all; it will make the programme better.

So, if the care.data programme learns from that which has haunted care.data in the past year, and NHS England now grapples with all the questions and criteria of the IIGOP report, and increases its public transparency, stakeholders can look to the future with a renewed hope. But only if there is change made to the present course of actions.

“Scrooge was at first inclined to be surprised that the Spirit should attach importance to conversations apparently so trivial; feeling assured that they must have some hidden purpose.” [A Christmas Carol]

 What must surely happen now, is to use the IIGOP report as a basis of lessons learned. To see gaps in knowledge, and to build processes and procedures which set up the future. Some of these must be at national level, such as ‘How patients will be informed of future scope change’ so CCGs will need answers from NHS England even if pilots should be ‘co-produced’.
Quite frankly, only muppets would not want to wait and do all this in all the appropriate time needed. The coming General Election is perhaps seen as a key reason to artificially rush it through. But at what cost? Who is the programme for, party politics or the public good?

“What do you think of the show so far?”

Clearly the National Data Guardian and IIGOP, the APPG and others making many wise recommendations, find the approach so far lacking. To carry on as is, will bring predictable doom. But by using the IIGOP report insights, there is the hope that the outcomes of the current path may yet be avoided.

Which version of the care.data future will the NHS England Patients and Information Directorate choose to follow, and invite the CCGs to join them on, writing the next chapter of the care.data story in 2015?

“No space of regret can make amends for one life’s opportunity misused.” [A Christmas Carol, Charles Dickens, 1843]

***

Let’s hope 2015 is a good year, that the wish list of questions finds answers, and let’s hope there are no more care.data surprises.

Thank you for all the kind blog comments and questions I’ve received over the last year. I hope it helps keep patients’ voice heard. For all those or their representatives I have met and spoken with in the last year who have no voice at the table; the homeless, the travellers, the women and children in refuges, those concerned with public stigma, we must continue to challenge so their datasharing is, in the words of others; safe, consensual and transparent.

“I HAVE endeavoured in this Ghostly little book, to raise the Ghost of an Idea, which shall not put my readers out of humour with themselves, with each other, with the season, or with me. May it haunt their houses pleasantly, and no one wish to lay it.
Their faithful Friend and Servant,
C. D.“

Now; let’s get back to the present today:

“What’s to-day, my fine fellow?” said Scrooge.

“To-day!” replied the boy. “Why, Christmas Day.”

“Merry Christmas,  and so, as Tiny Tim observed, God bless Us, Every One!”

  [A Christmas Carol, Charles Dickens, 1843]

***

Image from a Muppets Christmas Carol, 1992

References:

[1] The IIGOP report https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/389219/IIGOP_care.data.pdf

[2] EHI ‘Care.data Review Raises Questions‘ http://www.ehi.co.uk/news/ehi/9808/care.data-review-raises-questions

[3] BBC Radio 4, February 4 2014 http://www.bbc.co.uk/programmes/p01rmpdy

[4] Nov 2014, Progress of HSCIC data sharing review by Sir Nick Partridge https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/380042/HSCIC_Report_Summary_of_progress_261114_FINAL.pdf

[5] 7 Oct 2014, CCGs to help deliver care.data pilots http://www.england.nhs.uk/2014/10/07/ccgs-care-data-programme/

[6] What information is being heard at Listening events? https://jenpersson.com/pathfinder/

[7]The APPG Report – Nov 2014 – http://www.patients-association.com/Portals/0/APPG%20Report%20on%20Care%20data.pdf

[8] Report into NHS Data breaches http://www.bigbrotherwatch.org.uk/wp-content/uploads/2014/11/EMBARGO-0001-FRIDAY-14-NOVEMBER-BBW-NHS-Data-Breaches-Report.pdf

[9] on GP indemnity: care.data MPS advice to members http://www.medicalprotection.org/uk/membership-indemnity-updates/care.data

[10] The data linkage service http://www.hscic.gov.uk/media/12443/data-linkage-service-charges-2013-2014-updated/pdf/dles_service_charges__2013_14_V10_050913.pdf

[11] The Open House June 2014, public questions https://jenpersson.com/care-data-communications-core-concepts-part-two/

[12] Privacy and Personal Data IPSOS Mori poll https://www.ipsos-mori.com/researchpublications/researcharchive/3407/Privacy-and-personal-data.aspx

[13] 2013 Experian keynote address the Nectar Head of Customer Marketing

[14] care.data downfall parody http://paulbernal.wordpress.com/2014/02/25/tim-kelsey-discovers-care-data-is-in-trouble/

[15] medConfidential bulletin https://medconfidential.org/2014/medconfidential-bulletin-19-december-2014/

 

#caredata, care.data, engagement, HES, NHS England, trust

Rebuilding trust in care.data

In response to a care.data feature in the November Pharma Times Magazine,  I wrote a brief reader letter which was published, slightly abbreviated, on p.13 in the December issue.[1]

The November article had given me the impression that legislation in the Care Act from July was considered to have ironed out most patient concerns.

And it said that GPs opting patients out at practice level ‘would be illegal’.

I suggested three things.

1. The importance that legislation would be seen and enacted before the pathfinders to:

a) shore up trust of the broad definition of purposes to rule out commercial [re]use

b) enact an opt out

c) lend any legal weight to the role of National Data Guardian

Public and professional scrutiny and consultation on these changes will be required to ensure much talked of transparency is seen to be meaningful

2. Pathfinders must not only as the article stated intend to “test all aspects of communication and extraction”  in the pilot, but have a watertight plan for managing the planned broadening of both scope and access [2]

after all, how can communications be tested and considered effective which tell patients only part of the story how their data is planned to be used in future? Its merger with social care data, just one example.

and

3. a clarification was worth noting on the GP position regards opt out; that with certain conditions, the ICO had said that GPs opting out patients at practice level would be lawful regards their Data Protection obligations.

Data protection laws do not prevent doctors from adopting the approach recommended by the group Patient Concern, practice-wide opt out and offering opt-in at local level, the Information Commissioner’s Office (ICO) had said, providing certain conditions are met.

“If GPs choose to opt out all of their patients, then that is an issue for them and NHS England – the Data Protection Act does not prevent it,” said strategic liaison group manager at the ICO, Dawn Monaghan, according to a report in GP Online and Pulse. [3]

“However, the Data Protection Act would still require patients to be given a full explanation of the options open to them, and why the GP has chosen to opt them out.”

The Health and Social Care Act however requires GPs to release data to the HSCIC so would practices be in non-compliance with the Health and Social Care Act by doing so?

NHS England threatened one practice in November 2013 with penalties for doing just that a year ago. In fact, it was that position and article [4] which first prompted me to join the twitter social media debate, and my very first tweet on care.data.

caredata twitter

 

A full year on, and here we are, still unclear on opt out.

A full year on and our HES and other data is still being released without our consent, or fair processing.

Whilst the GPs may remain unclear if they would be sanctioned for practice wide opt out of care.data even if they maintain data protection compliance, it seems the penalty for data misuse after release is unchanged.

Whilst there was talk of new penalties for data misuse by companies and organisations, no ‘one strike and out’ ever materialised.

Whilst legislation by the Secretary of State promised patients a statutory right to opt out, it hasn’t happened.

On February 25th 2014, he said in Parliament:

“people should be able to opt out from having their anonymised data used for the purposes of scientific research.” [col 148]

“When they extended the programme to out-patient data in 2003 and to A and E data in 2008, at no point did they give people the right to opt out. We have introduced that right, which is why we are having the debate.” [5]

However until that opt out for our GP care.data and our A and E, HES, and other data for secondary purposes is on a legal footing, the opt out has no value for patients compared with the weight of the Health and Social Care Act.

When will the Secretary of State follow through on his word?

Right now, our HES/other secondary data is being released even if we have indicated our opt out to GPs for secondary uses, 9nu4. [6]

It appears to date, we lack both legislation and the technical tool to operate the opt out.

This position seems to be in urgent need of clarification for patients to have our opt out rights confirmed for both GP held data and the existing data held by HSCIC. As well as needing clarified for the GPs and HSCIC as data controllers to be clear on their responsibilities.

When the system has proven so flawed in the past we need change to show why it is different now.

It’s not enough to tell patients things will be different. We want to see that they are.

We can only trust a system which is underpinned in law particularly at a time when, ahead of a General Election, many promises may have been made and will be made. Ministers move roles. Their word alone is frankly, going to be of little value to many. Experience tells us, promises may not always turn out as expected in practice.

I asked one of my local community leaders what he thought of the current position on the programme and what his reaction would be if in fact the opt out came to naught and health data was to be extracted and used for research without consent. “We’d be out on the streets,” [in protest] was his prompt reply. Whilst many are happy for data to be used in research, the majority want to know about it first; who will access it and for what purpose. Not everyone is happy for their data to be used in research. And over half were happy only with active consent or not at all, according to a survey carried out by Ipsos MORI in June 2014.[7]

The Data Guardian role [8] too, should be a positive addition to underpin the importance of ethical practice in data management but again, can only be truly meaningful with legislative weight behind it.

The recent DH November announcement said this would happen, ‘at the earliest opportunity.’

How much longer will it be before that opportunity?

When can we expect to see the rules around uses, opt out and the oversight role of the Data Guardian published for public and professional consultation and scrutiny?

If we are to rebuild trust in the programme, it must first offer a foundation for doing so.

*

In the same Pharma Times December issue [2] there is also a feature on George Freeman MP and on EU Data sharing. Well worth a read.

My submitted reader letter:

Your November article ‘Taking care of our data’ states proposed changes to the Care Act 2014 will be laid before Parliament in the new year.

It is imperative this is done before the care.data pilots’ launch. Only meaningful changes underpinned in law will provide patients the basis on which to rebuild their trust in the programme.

Data use purposes remain overly broad, the newly appointed role of National Data Guardian has no legal teeth, and the Health Secretary’s word that a patient’s objection will be respected, is not enough.

The rules around access, oversight and opt out must be pinned down.

And parliamentary scrutiny of these changes, open to professional and public consultation, will be fundamental to public confidence.

Pathfinders must not only ‘‘test all aspects of the communication and extraction process” ready for an imminent rollout. New communications must present real improvements and a watertight plan for managing the planned broadening of the future scope and access.

And finally, one clarification worth noting; under certain conditions, the ICO ruled that GPs opting out patients at practice level would be lawful regards their Data Protection obligations.

Refs:

[1] December Pharma Times p 13

[2] care.data expansion roadmap

[3] GP Online October 22, 2014

[4] Pulse, November 2013

[5] Hansard, February 25th 2014

[6] HSCIC DARS releases

[7] Ipsos MORI poll of almost 2000

[8] National Data Guardian appointed  November 13, 2014

#caredata, care.data, confidentiality, engagement, NHS, NHS England

care.data programme questions remain unanswered – what should patients do now?

care.data programme questions remain unanswered [1] and opportunities to demonstrate better transparency have to date, been turned down.

For anyone interested in the care.data rollout, professionals, patients and public alike, it is worrying to see the continued secrecy which shrouds the programme. We’ve been told online (but most in the public will still not know) an initial rollout in 4 CCG areas is now planned [2], but at which GP practices remains unclear.

On October 12th I asked that the care.data programme board minutes should be made public. The request is still open.[3]

“They seem hell bent on going ahead. I know they listened, but what did they hear?”

Questions asked by hundreds of people at multiple listening events remain unpublished and unanswered. Risks need resolved.

It is ironic that for a programme whose stated aim is to gather patient information in order to answer open questions about care,  it is so unwilling to give information back to answer the questions we, the ‘data subjects’ have about the programme.

I believe it is important to ensure that the questions are transparent, criticisms addressed and clarified, open issues solved and questions answered ahead of the pathfinder rollout to ensure the greatest success of the programme.

If the programme proceeds on an opt out basis, the risk is increased that it will not meet Data Protection regulation[4], which requires informed use of personal data. This puts GPs at risk. [5]

All the people who made the effort to attend these events for the benefit of the programme and the public good deserve answers. This would minimise the risks the public raised, which remain unresolved.

It is also important for maintaining trust in the integrity and value of user participation and engagement at other NHS events, and in this programme in particular.

Public and Transparent Feedback was Promised

I wrote to Mr. Tim Kelsey, Director, at the Patients and Information Directorate, NHS England today to ask, once again, for the release of public feedback.

Now two months ago, when I spoke with him after the NHS AGM in London on September 18th about care.data, the public questions have still not been put into the public domain.

He agreed that the raw feedback from all the care.data listening events, which included all the open questions asked by participants, would be published, “Shortly.”

This feedback includes questions from the NHS Open Days on June 17th  (4 locations), the stand-alone care.data events since, and those from the care.data advisory sessions hosted in Peterborough and Coin Street, London [6].

NHS England claims there have been hundreds of events. The website says some took place in my county, though I haven’t heard of any and neither has my CCG. Those of which I am aware and six attended, all generated a huge number of participant questions on paper, post-its and electronically, which participants were told would be published and answered, including put on the Open Day website ‘later in the summer'[7]:

“Feedback from this session is being incorporated into the overall report from the care.data listening phase which will be published later in the summer and linked to from this site.”

This is still to happen, and now nearing the end of November, is somewhat overdue.

My own questions at four events were on process and I believe it is important to get these clarified BEFORE the pathfinder:

  • How will you communicate with Gillick competent children [8], whose records may contain information about which their parents are not aware? [note also RCGP online roadmap p.15][9]
  • How will you manage this for elderly or vulnerable patients in care homes and with diminished awareness or responsibility?
  • When things change in scope or use, how will we be informed of changing plans for use or users, on an ongoing basis? [Data protection principle 2] [10]
  • For any future changes, how will we be given the choice to change our opt out or opt in? Consent is not a one-time agreement  but needs managed on a continual, rolling basis – how will this be achieved?

Campaigners have also raised remaining, unresolved issues.

Key legal questions remain, including on Opt Out

I am starting to become concerned that the opt out is STILL not on a statutory footing. Will the Secretary of State make good his verbal agreement in law?

What legal changes will be made that back up the verbal guarantees given since February? If none are forthcoming, then were the statements made to Parliament untrue? [11]

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

I am yet to see this legal change and to date, the only publicly stated choice is only for identifiable data [12], not all data, as stated by the Minister.

So too the promised extra governance on a legal basis has not yet happened.

It is worth a note that although the Health and Social Care Act 2012 may have steamrollered the legal position of the patient and GP, and that confidentiality no longer comes first, informed consent even if assumed, is still in other circumstances to be obtained fairly:

“Consent obtained under duress or on the basis of misleading information does not adequately satisfy the condition for processing.” [ICO]

Should this principle not also apply even if GPs are legally obliged to release data without patient consent? [I feel that needs more discussion, so will write about consent in my next post.]

There is much made of ‘new legal protection’ of our data but in fact it is impossible to see it provides any such thing, and yes, I have read it. The Care Act 2014 did not get amended with any binding or truly clear provisions to make data more confidential or secure.

Concerns of many people centre on commercial use, and re-use of data, and these are not addressed by the loose terms for the benefit of adult health and social care’ or the ‘promotion of health’. [part 4 p.120] Data sold all year may have met this criteria, but is this how we expect our health records to be used without our express permission?

“We will use Mosiac, appended to the ICD10 code diagnoses, to create national Mosaic profiles. These estimates and propensities will be sold to public and commercial organisations to enable them to target resources more effectively and efficiently…Other data characteristics that are also linked to Mosiac can then be used to understand broader lifestyle characteristics of those most at risk to ensure that messages and communications are appropriate and well targeted.” [July register]

“Question from Leicester: “Are we saying there will be only clinical use of the data – no marketing, no insurance, no profit making? This is our data.”[13]

So I hope it is clear, that these concerns are not only mine, but remain unanswered for the broader participants of listening events, gathered throughout the last year.

Questions from others

I’m publishing here the filtered and NHS England written, summary response of the 26th June event [14], I received as an attendee. (40 people, of whom ca 10 NHS England and HSCIC staff).

I disagreed with one of the statements made at our table at the meeting, and pointed out it was not factual. History as I understand, and has been stated by HSCIC in FOIs, will not be deleted. Yet this was allowed to be included in the notes sent to all:

“communicate that identifiable information can be deleted.”

The workshop was about how to access ‘hard-to-reach’ groups, so focused on communications methods. You will see that many statements are about how to market the programme, and do not clarify questions of substance, although many were asked on the day about scope definition, and future data changes.

Questions have not yet been addressed, such as Gillick, on children in care, young offenders, the forces, avoiding ‘propaganda-ish’ sounding and bias in the materials, to ensure the ‘adequate requirements’ for data processing.

You can see from this, that although the listening events may be deemed to have been a success, the answering part is still missing.

How are NHS England measuring success? What does good look like? I guarantee from a public perspective, it’s not there yet.

Long term benefit must not be harmed in the rush for a pilot tick-box

Since the programme is heralded as so vital for the NHS, I believe we should not be making the best of a bad job, but shaping process, security and communications to be world class, worthy of our NHS.[15]

We also need to see a long-term cost benefit plan – if we don’t know how some of these future processes are to be managed, how will we know what they will cost, and are they worth it?

The project should not aim for a quick and dirty pilot rollout. Perhaps there is a need to tick the ‘on time’ box for an NHS England target or meet a job description appraisal, as I would have had when I was responsible for project implementations in my past commercial industry role?

As it stands it is not NHS England/DoH who has the most to lose if this goes ahead as is. They must look at the big picture and accept their responsibility for this project, decide not to rush it and not expect the public and GPs to carry its risk.

At the weekend, in a speech about TTIP I heard the phrase, it’s “a classic case of socialising the risk and privatising the profit.”

So too it feels for me on care.data. NHS England wants all the benefit of our information, including from its sale, but it is we, individual patients and GPs who will be harmed if its security, commercial use [16], or everyday trust & confidentiality are compromised.

The Department of Health must look beyond party political aims pre-election. This is for the good of the NHS, which belongs to us all.

We must see open questions on process and content openly answered, for professionals and public alike.

Only then, can we trust that the infrastructure and promises made behind the scenes have set the foundation for this scheme to be worthy of our most intimate and confidential data.[17]

What can Patients do now?

“The policy and practical answers we need to ensure success, will not fit on a flyer or SMS.”

I have spoken with some of my fellow attendees since these events, including for example Stan Burridge, the Research Lead on Service User Involvement at Pathway London. (A charity providing healthcare to the homeless and which works with others on policy and best-practice approach sharing. Their recent work on dentistry outreach achieved a 0% no-show rate – getting the vital care needed for their clients and saving ££ for NHS dentist provision.)

His comments are a good summary of what has happened since:

“In the events, opinions could be expressed, questions asked, and I was made to feel they were valid questions, but they’re doing very little to answer them so that it makes a difference.

“I feel I was engaged with the process, but it’s doing nothing for the people on the margins.

“They should be given an informed choice to opt in, an uninformed choice not to opt out is not the same.

It is unclear what patients can now do, to get the answers we have asked for. We want to make a positive difference to make the project better.

The listening events seem to have been a one way process, and participation for PR purposes, rather than real engagement. The policy and practical answers we need to ensure success, will not fit on a flyer or SMS. They can’t be communicated as part of the pilot rollout. We need them published, addressed and ironed out up front.

Stan summed up exactly what I feel and what I have heard from many others:

“They seem hell bent on going ahead. I know they listened, but what did they hear?”

 

****

[1] A patient’s open letter to NHS England

[2] CCG pathfinder announcement

[3] care.data programme board minutes and materials FOI

[4] ICO Guide to Data Protection

[5] Medical Protection and care.data concern

[6] Coin Street care.data advisory group public event, Sept 6th

[7] NHS England Open House event 17th June

[8] Gillick and data protection for children

[9] RCGP Online Roadmap, includes concern on accessing data by those at risk of domestic abuse and children

[10] ICO Data Protection guidelines

[11] Hansard, Parliament 25th February 2014

[12] Parliamentary briefing note on care.data

[13] Questions from the Open House, incl. Leicester

[14] NHS England summary of feedback and statements from public event at Mencap, June 26th 2014

[15] Post from July 21st HSCIC roadmap event, future data use

[16] Commercial use of data with brokers – call for consumer data transparency

[17] Code list prepared by medConfidential and open issues

#caredata, activism, care.data, empowerment, engagement, health, NHSEngland, politics, privacy, transparency, trust

On Being Human – moral and material values

The long running rumours of change afoot on human rights political policy were confirmed recently, and have been in the media and on my mind since.

Has human value become not just politically acceptable, but politically valuable?

Paul Bernal in his blog addressed the subject which has been on my mind, ‘Valuing the Human’ and explored the idea, ‘Many people seem to think that there isn’t any value in the human, just in certain kinds of human.’

Indeed, in recent months there appears to be the creation of a virtual commodity, making this concept of human value “not just politically acceptable, but politically valuable.” The concept of the commodity of human value, was starkly highlighted by Lord Freud’s recent comments, on human worth. How much a disabled person should earn was the focus of the remarks, but conflated the price of labour and human value.

European Rights undermined

Given the party policy announcements and the response by others in government or lack of it, it is therefore unsurprising that those familiar with human rights feel they will be undermined in the event that the policy proposals should ever take effect. As the nation gears up into full electioneering mode for May 2015, we have heard much after party speeches, about rights and responsibilities in our dealings with European partners, on what Europe contributes to, or takes away from our sovereignty in terms of UK law. There has been some inevitable back-slapping and generalisation in some quarters that everything ‘Europe’ is bad.

Whether or not our state remains politically within the EU may be up for debate, but our tectonic plates are not for turning. So I find it frustrating when politicians speak of or we hear of in the media, ‘pulling out of Europe’ or similar.

This conflation of language is careless,  but I fear it is also dangerous in a time when the right wing fringe is taking mainstream votes and politicians in by-elections. Both here in the UK and in other European countries this year, far right groups have taken significant votes.

Poor language on what is ‘Europe’ colours our common understanding of what ‘Europe’ means, the nuances of the roles organisational bodies have, for example the differences between the European Court of Human Rights and the European Court of Justice, and their purposes are lost entirely.

The values imposed in the debate are therefore misaligned with the organisations’ duties, and all things ‘European’ and organisations  are tarred with the same ‘interfering’ brush and devalued.

Human Rights were not at their heart created by ‘Europe’ nor are they only some sort of treaty to be opted out from, [whilst many are enshrined in treaties and Acts which were, and are] but their values risk being conflated with the structures which support them.

“A withdrawal from the convention could jeopardise Britain’s membership of the EU, which is separate to the Council of Europe whose members are drawn from across the continent and include Russia and Ukraine. Membership of the Council of Europe is a requirement for EU member states.” [Guardian, October 3rd – in a clearly defined article]

The participation in the infrastructure of ‘Brussels’ however, is convenient to conflate with values; a loss of sovereignty, loss of autonomy, frivoulous legislation. Opting out of a convention should not mean changing our values. However it does seem the party attitude now on show, is seeking to withdraw from the convention. This would mean withdrawing the protections the structure offers. Would it mean withdrawing rights offered to all citizens equally as well?

Ethical values undermined

Although it varies culturally and with few exceptions, I think we do have in England a collective sense of what is fair, and how we wish to treat each others as human beings. Increasingly however, it feels as though through loose or abuse of language in political debate we may be giving ground on our ethics. We are being forced to bring the commodity of human value to the podium, and declare on which side we stand in party politics. In a time of austerity, there is a broad range of ideas how.

Welfare has become branded ‘benefits’. Migrant workers, ‘foreigners’ over here for ‘benefit tourism’. The disabled labeled ‘fit for work’ regardless of medical fact. It appears, increasingly in the UK, some citizens are being measured by their economic material value to contribute or take away from ‘the system’.

I’ve been struck by the contrast coming from 12 years abroad, to find England a place where the emphasis is on living to work, not working to live. If we’re not careful, we see our personal output in work as a measure of our value. Are humans to be measured only in terms of our output, by our productivity, by our ‘doing’ or by our intrinsic value as an individual life? Or simply by our ‘being’? If indeed we go along with the concept, that we are here to serve some sort of productive goal in society on an economic basis, our measurement of value of our ‘doing’, is measured on a material basis.

“We hear political speeches talking about ‘decent, hardworking people’ – which implies that there are some people who are not as valuable.”

I strongly agree with this in Paul’s blog. And as he does, disagree with its value statement.

Minority Rights undermined

There are minorities and segments of society whose voice is being either ignored, or actively quietened. Those on the outer edge of the umbrella ‘society’ offers us, in our collective living, are perhaps least easily afforded its protections. Travelers, those deemed to lack capacity, whether ill, old or young, single parents, or ‘foreign’ workers, to take just some examples.

I was told this week that the UK has achieved a  first. It was said, we are the first ‘first-world’ country under review by the CPRD for human rights abuse of the disabled. Which cannot be confirmed nor denied by the UN but a recent video indicated.

This is appalling in 21st century Britain.

Recently on Radio 4 news I heard of thousands of ESA claimants assigned to work, although their medical records clearly state they are long term unfit.

The group at risk highlighted on October 15th in the Lords, in debate on electoral records’ changes [col 206]  is women in refuges, women who feel at risk. As yet I still see nothing to assure me that measures have been taken to look after this group, here or for care.data.{*}

These are just simplified sample groups others have flagged at risk. I feel these groups’ basic rights are being ignored, because they can be for these minorities. Are they viewed as of less value than the majority of ‘decent, hardworking people’ perhaps, as having less economic worth to the state?

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

But I simply don’t see it done fairly for all.

I see society being quite deliberately segmented into different population groups, weak and strong. Some groups need more looking after than others, and I am attentive when I hear of groups portrayed as burdens to society, the rest who are economically ‘productive’.

Indeed we seem to have reached a position in which the default position undermines the rights of the vulnerable, far from offering additional responsibilities to those who should protect them.

This stance features often in the media discussion and in political debate, on health and social care. DWP workfare, JSA, ‘bedroom tax’ to name but a few.


How undermining Rights undermines access

So, as the NHS England five year forward plan was announced recently, I wonder how the plan for the NHS and the visions for the coming 5 year parliamentary terms will soon align?

There is a lot of talking about plans, but more important is what happens as a result not of what we say, but of what we do, or don’t do. Not only for future, but what is already, today.

Politically, socially and economically we do not exist in silos. So too, our human rights which overlap in these areas, should be considered together.

Recent years has seen a steady reduction of rights to access for the most vulnerable in society. Access to a lawyer or judicial review has been made more difficult through charging for it.  The Ministry of Justice is currently pushing for, but losing it seems their quest in the Lords, for changes to the judicial review law.

If you are a working-age council or housing association tenant, the council limits your housing benefit claim if it decides you have ‘spare’ bedrooms. Changes have hit the disabled and their families hardest. These segments of the population are being denied or given reduced access to health, social and legal support.

Ethical Values need Championed

Whilst it appears the state increasingly measures everything in economic value, I believe the public must not lose sight of our ethical values, and continue to challenge and champion their importance.

How we manage our ethics today is shaping our children. What do we want their future to be like? It will also be our old age. Will we by then be measured by our success in achievement, by what we ‘do’, by what we financially achieved in life, by our health, or by who we each are? Or more intrinsically, values judged even, based on our DNA?

Will it ever be decided by dint of our genes, what level of education we can access?

Old age brings its own challenges of care and health, and we are an aging population. Changes today are sometimes packaged as shaping our healthcare fit for the 21st century.

I’d suggest that current changes in medical research and the drivers behind parts of the NHS 5YP vision will shape society well beyond that.

  • We have a universal human right to healthcare  for all
  • We have a free-at-the-point-of-provision National Health Service in England, how will the plan maintain that and at the same time,
  • We expect science and technology in medicine to drive forward improvements in life quality, care and treatments.

What restrictions do we place on value and how are moral and material values to play out together? Are they compatible or in competition?

Because there is another human right we should remember in healthcare, that of striving to benefit from scientific improvement.

This is an area in which the rights of the vulnerable and the responsibilities to uphold them must be clearer than clear.

In research if Rights are undermined, it may impact Responsibilities for research

I would like to understand how the boundary is set of science and technology and who sets them on what value basis in ethics committees and more. How does it control or support the decision making processes which runs in the background of NHS England which has shaped this coming 5 year policy?

It appears there are many decisions on rare disease, on commissioning,  for example, which despite their terms of reference, see limited or no public minutes, which hinders a transparency of their decision making.

The PSSAG has nothing at all. Yet they advise on strategy and hugely significant parts of the NHS budget.

Already we see fundamental changes of approach which appear to have economic rather than ethical reasons behind them. This in stem-cell banking, is a significant shift for the state away from the absolute belief in the non-commercialisation of human tissue, and yet little public debate has been encouraged.

There is a concerted effort from research bodies, and from those responsible for our phenotype data {*}, to undermine the coming-in-2015, stronger, European data protection and regulation, with attempt to amend EU legislation in line with [less stringent] UK policy. Policy which is questioned by data experts on the use of pseudonymisation for example.

How will striving to benefit from scientific improvement overlap with material values of ‘economic function’ is clear when we hear often that UK Life Sciences are the jewel in the crown of the UK economy? Less spoken of, is how this function overlaps with our moral values.

“We’ve got to change the way we innovate, the way that we collaborate, and the way that we open up the NHS.” [David Cameron, 2011]

In this five year period ahead, in which the coming parliamentary and NHS Forward Plan will coexist, the Genomics England Ltd. plan mentioned in the 5YP is due to conclude in 2017 having mapped 100,000 genomes, of about 35K patients and 40K of their relatives.

We should be both optimistic and ambitious for the further advances that lie within our reach. Medicine is becoming more tailored to the individual.”

These medical advances will demand we make wise ethical decisions, and to do that we must be informed. I’ll consider this more in another post, On Being Human : Part Two.

Consider the current changes in Rights underway and changes in UK regulation together, and factor in what change any further changes in European legislation may mean.

In the mean time, I ask that you consider the changing political landscape in which current changes to legislation are affecting the market, the commercialisation of different areas of activity and the desirability of ‘the promotion of economic growth.’

What moral rights citizens rights will have, may be about to come into direct conflict with material values, and the balance weighted in favour of the material, strengthened a statutory footing.

Today, I suggest whilst we hear so often of material values, we must also consider our own moral values and those of the collective decision making parliamentary and regulatory bodies. We must pay attention to how language is presenting and packaging the discussion, whether in health, politics and economics.

How are certain individuals treated or their needs catered for as a certain part of society, and are all to be treated equally, with access to their rights? If not, where do you draw the line?

What value do we place on being human?

We must find our own moral compass to find a State standpoint on whether we see human worth as a commodity, or whether it should be.

Where will the future balance lie between material and moral rights?

Because the current direction of travel is clear. Everything has a price.

But at what cost?

**** Relevant for research background {*}:

The last six months of  my blog ‘thinking to some purpose’ has been spent doing my best to raise concerns from the public on care.data, in the hope of making a positive difference.

For anyone less familiar with it, this is the initiative to extract and use our confidential GP records for purposes other than direct care. Those concerns remain unanswered, so for my summary,  see here, my six month round up.

Whilst care.data announced that the CCGs had been selected in which GP practices will pilot care.data, but further facts remain unclear what exactly what they will pilot [communications or going also to extraction] or when. For both the public in those locations and elsewhere, we can only wait and see, how long, is an unknown.

#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

care.data, politics, privacy, surveillance, trust

Human Rights – real threats today vs theories of tomorrow

Theories on Thursday, furore on Friday. By Saturday the social media had hit the fan.

What we must remember whilst caught up in the recent Human Rights fuss, is that this is discussing a future theory. In practice, we are at risk of missing three* current and upcoming human rights threats, which are very real.

Whilst future policy change may already be doing harm to the spirit of the human rights law and those ideals today, current policies are having effect today in practice.

The Deregulation Bill, and other current policies and projects.

Regular readers will know, I have followed closely the care.data plans [see past posts] to extract our confidential GP medical records and centrally store, sell and share the information.

I hadn’t realised until recently why I care so strongly about doing this the right way. It simply felt wrong that the original plan was not to inform patients at all, and not ask for consent to remove the foundation stone of our confidentiality. The delayed plan, had a terrible junk-mail leaflet drop.

The current extraction plan is pending [roadmap end of page], but details unknown.

I have concerns about how it will harm the trust in the patient-GP relationship, potentially discriminate and segment certain groups and  I’m still unhappy how open the records will be for use by third parties, not for clinical care. There needs work done to make it done well, and to be transparent and trustworthy for patients.

But I’ve realised now, it feels wrong, simply because it impinges on one of our basic human rights. Our right to privacy.

This post is not about care.data per se, but the recent Bill of Rights debate made me take a closer look at the bigger picture.

There are many discussing this, far better informed on human rights than me. But perhaps it’s time the ordinary public pay more attention to our rights, and where they fit into our lives in the UK. Rights which are easily eroded if we don’t pay attention.

I’ve had a look at the current Bill proposal [my notes & comment at the end], but at least for now, I’m more concerned about the actual plans already underway, which will in  practice,  affect the application of our human rights today, and we may not know it.

There are at least three real changes in legislation right now which I believe should command our attention.

First, the Deregulation Bill.

This Bill will go to the Lords Committee stage on October 21st.

This is a real and present threat to human rights, as stated in the Joint Committee Report on Human Rights, June 14th 2014:

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

 

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.
Sections of the Deregulation Act currently passing through Parliament suggest the removal of any regulation that conflicts with the interests of a profit-maker. There are other domestic and regulatory bodies for which we should carefully consider this implication, not least from my perspective, in the NHS.

 

The Deregulation Bill creates a conflict when a law must consider commercial gain above human rights.

Further;

“The Bill would remove the power conferred on employment tribunals by the Equality Act to make wider recommendations in discrimination cases.”

 

The EHRC regards the power [conferred on employment tribunals] as useful, both for the employer to whom the recommendation is made and to the Commission itself for following up tribunal decisions, and it does not consider that sufficient evidence has been gathered to make out the case for abolition. We therefore recommend that the power of employment tribunals to make wider recommendations in discrimination cases should be retained.”

 

 

 

The Deregulation Bill also poses some concern for those interested in the requisition process for information, and press representation groups spoke out, worried it offers a back-door for seizing journalists’ material.

 

Seen all together, aspects of the Bill which is a mish-mash of all sorts of subjects, which was derided in some reports as being about knitting yarn, means it may well be a wolf in sheep’s clothing when it comes to human rights.

 

Second and Third, the recent changes in legislation & access

Other real threats to our universal human rights in the UK, I consider as points two and three, are already having an effect.

Recent legal changes to both a) the legal aid and b) the judicial review processes mean it is harder for many people to use the available processes due to cost.

(current consultation closing October 15th here and anyone can write to their MP for support, guidance at end of page.)

This results in inequality to use rights, which should be human rights for all by creating:

1. restrictions of individual access  (who can get a fair trial, the ability to appeal)

 

and

 

2. reducing the universality of application to human rights law (limiting the circumstances and reasons ‘the how and when’ under which rights may be applied)

 

 

These are the changes in progress right now. So what of the actual projects underway or recently effected?

 

Current threats in practice to our UK Human Rights

Mr. Grayling said this week that any future policy change will continue to ensure to promote the values of individual human dignity, equal treatment and fairness as the foundations of a democratic society. Many disagree.

The whole debate of this future policy change may already be doing real harm to the spirit of the law and those ideals today.

In my opinion, current actions are having real effect today in practice which risk undermining rather than strengthening our position towards universal human rights.

Current government policies and projects sign-post current thinking on the value of universal human rights and future direction.

Consider three things:

1. the recent changes which undermine access to use our rights, [access and universal applicability for all]
2. what value rights are given within current policies and practices,
3. the direction of travel in recent legislation, such as in surveillance, affecting universal rights for all.

It should come as no surprise then to hear of a more wholesale move towards the removal of rights in the proposal to repeal the Human Rights Act, and more. Steps have been taken on this path for some time.

A current sample of some areas with flaws in their approach to human rights include from my lay perspective:

If we in the ordinary public, in response to the proposals this week, are now concerned about about the theoretical threats to human rights by a potential future government, and care about getting it right, I’d suggest we:

don’t wait to worry about what might be in June next year. Encourage those who can, such as our MPs, to look at these real and practical human rights’ threats today. Support MPs & others who are.

Start the list, with the Deregulation Bill.  (Unless NHS England Patient & Information Directorate decide to begin care.data extractions before October 21st.) Watch this space.

************************
*there is clearly more of significance in this area, with which those better informed and active than me would say is missing, but with which I’ve not taken as close an interest. The Deregulation Bill will potentially affect NHS bodies, and I’ve looked at it before on care.data.

Notes on the proposals, and my references below:

************************

Reference sites:

The Deregulation Bill was introduced in the House of Commons on 23 January 2014. It received its Second Reading in the Commons on 4 February 2014, completed its Committee Stage on 25 March and began its Report Stage on 14 May. The Bill has been carried over to the next Session of Parliament. The Bill was preceded by a draft Deregulation Bill which was subject to pre-legislative scrutiny by the ad hoc Joint Committee on the Draft Deregulation Bill.

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

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

HSCIC 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

******************

On Legal Aid – consultation responses or write to your MP: http://www.lawsociety.org.uk/news/stories/moj-consultation-on-duty-crime-contracts-support-pack-for-member-responses/

******************

For reference – background Bil of Rights / scrapping the HRA

The theory

The outline future proposal this week suggested, “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]

Some of these plans were discussed here> on the Daily Politics. From 32.30 minutes in.

The plans have been met with widespread criticism in the press and by campaigners showing where the plans are flawed.

Myths abound how human rights are applied inappropriately to whom, and how they lack common sense.

In contrast, real examples have been presented of when the Human Rights Act and ECHR have been used to enhance and protect UK citizens, not least in the Mirror.

Looking to the future, individuals have further pointed out the fundamental flaw if limits of application were to be brought in which would for example, not use the law for ‘trivial cases’.

Tim Hancock, campaigns director of Amnesty UK, said in the International Business Times of this week’s announcement: “This is electioneering on the backs of Europe’s most vulnerable.

“Under these plans human rights would be reserved for only those people the Government decides should get them.”

Whilst we may each have our own political opinions, it is valuable to stay outside them and see changes objectively.

We must also see past the UKIP defection, knee-jerk reaction which conflates everything ‘Europe’, into something from which which the UK could ‘opt out’. As long as Britain remains a signatory to the ECHR, UK citizens could still directly petition the European Court of Human Rights in Strasburg to hear their case. In fact, could be more likely to, rather than go through the British courts first. These proposals conflate the 1951 Convention on Human Rights, the UK 1998 Human Rights Act and our rights under current European law, and more.

If next May, a Conservative majority were to be elected, this proposal might form a basis of proposed legislative changes.

It is highly unlikely to be as is, or without debate. It is a partisan approach which ignores the fact that cross parliamentary support would likely be needed, as was the case when Parliament voted in favour of the introduction of the UK Human Rights Act in 1998.

But that is an if, and thus far, actually moving towards this legislative change is theoretical.

 

 

#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, communications, confidentiality, NHS, NHSEngland, privacy, transparency, trust, women

care.data – the cut-outs: questions from minority voices

“By creating these coloured paper cut-outs, it seems to me that I am happily anticipating things to come…I know that it will only be much later that people will realise to what extent the work I am doing today is in step with the future.” Henri Matisse (1869-1954) [1]

My thoughts on the care.data advisory event Saturday September 6th.  “Minority voices, the need for confidentiality and anticipating the future.”

[Video in full > here. Well worth a viewing.]

After taking part in the care.data advisory group public workshop 10.30-1pm on Saturday Sept 6th in London, I took advantage of a recent, generous gift; membership of the Tate. I went to ‘Matisse – the cut outs’ art exhibition.  Whilst looking around it was hard to switch off the questions from the morning, and it struck me that we still have so many voices not heard in the discussion of benefits, risk and background to the care.data programme. So many ‘cut out’ of any decision making.

Most impressive of the morning, had been the depth and granularity of questions which were asked.  I have heard varying aspects of questions at public events, and the subject can differ a little based on the variety of organisations involved. However, increasingly, there are not new questions, rather I hear deeper versions of the questions which have already been asked, over the last eighteen months. Questions which have been asked intensely in the last 6 months pause, since February 2014 [2] and which remain unanswered. Those from the care.data advisory committee and hosting the event, said the same thing based on a previous care.data advisory event also.

What stood out, were a number of minority group voices.

A representative for the group Friends, Families and Travellers (FFT) raised a number of excellent questions, including that of communications and ‘home’ GP practices for the Traveller community. How will they be informed about care.data and know where their ‘home’ practice is and how to contact them? Whose responsibility will that be?

I spoke with a small group a few weeks ago simply about NHS use in general. One said they feared being tracked down through a government system [which was used for anything other than clinical care]. They register with new names if they need to access A&E. That tells you already how much they trust ‘the system’. For the most part, he said, they would avoid NHS care unless they were really desperately in need and beyond the capability of their own traveller community ‘nurse’. The exception was childbirth when this group said they would encourage expectant mums to go into hospital for delivery. They must continue to do so when they need to and must feel safe to do so. Whether in general they may use primary care or not, many travellers are registered at GPs, and unless their names have been inadvertently cleansed recently, they should be contacted before any data extraction as much as anyone else.

Our NHS is constitutionally there for all. That includes groups who may be cut off from mainstream inclusion in society, through their actions, inaction or others’ prejudice. Is the reality in this national programm actively inclusive? Does it demonstrate an exemplary model in practice of what we hear said the NHS aims to promote?

Transgender and other issues

The question was posed on twitter to the event, whether trans issues would be addressed by care.data. The person suggested, that the data to be extracted would “out us as probably being trans people.” As a result,  she said “I’d want to see all trans ppl excluded from care.data.”

Someone who addressed ‘her complex gender identity’ through her art, was another artist I respect, Fiore de Henriquez. She was ‘shy of publicity.’ One of her former studios is filled with work based on two faces or symbiotic heads, aside from practice pieces for her more famous commissioned work.For her biography she insisted that nothing be concealed. “Put in everything you can find out about me, darling. I am proud to be hermaphrodite, I think I am very lucky, actually.” However, in her lifetime she acknowledged the need for a private retreat and was shy until old age, despite her flamboyant appearance and behaviour. You can see why the tweet suggested excluding any transgender data or people.

‘Transgender issues’ is an upcoming topic to be addressed at the NHS Citizen even on 18th September as well. How are we making sure these groups and the ‘other’ conditions, are not forgotten by care.data and other initiatives? Minorities included by design will be better catered for, and likely to participate if they are not simply tacked on as an afterthought, in tick-box participation

However, another aspect of risk is to be considered – missing minorities 

Any groups who opt themselves out completely, may find that they and their issues are under represented in decision making about them by commissioners and budget planning for example.  If authorities or researchers choose to base decisions only on care.data these discrepancies will need taken into account.

Ciarán Devane highlighted this two-sided coin of discrimination for some people. There are conditions which are excluded from care.data scope. For example HIV. It is included in HARS reporting, but not in care.data. Will the conditions which are excluded from data, be discriminated against somehow? Why are they included in one place, not in another, or where data is duplicated in different collections, where is it necessary, where is the benefit? How can you make sure the system is safe and transparent for minorities’ data to be included,  and not find their trust undermined by taking part in a system, in which they may have fears about being identified?

Missing voices

These are just two examples of groups from whom there had been little involvement or at least public questions asked, until now. The traveller and transgender community. But there are many, notably BME, and many many others not represented at any public meetings I have been at. If they have been well represented elsewhere, any raw feedback, with issues addressed, is yet to be shared publicly.

Missing voices – youth

A further voice from which we hear little at meetings, because these meetings have been attended as far as I have seen so far, mainly by older people, is the voice of our youth.

They are left out of the care.data discussion in my opinion, but should be directly involved. It is after all, for them that we need to think most how consent should work, as once in, our data is never deleted.

Whilst consent is in law overridden by the Health and Social Care Act, it is still the age old and accepted ethical best practice. If care.data is to be used in research in future, it must design best practices now, fit for their future purposes.

How will our under-18s future lives be affected by choices others make now on their behalf?

Both for them as the future society and as individuals. Decisions which will affect research, public health planning and delivering the NHS service provision as well as decisions which will affect the risk of individual discrimination or harm, or simply that others have knowledge about their health and lifestyle which they did not choose to share themselves.

Some people assume that due to social networks, young people don’t care about privacy. This is just not true. In fact, studies show that younger people are more conscious of the potential harm to their reputation, than we may want to give them credit for.

This Royal Academy of Engineering report, [3]” Privacy and Prejudice – Young People’s views on the Development of Electronic Patient Records” produced in conjunction with Wellcome from 2010, examines in some depth, youth opinions of 14-18 year olds.  It tackles questions on medical data use: consent, control and commercialism. The hairy questions are asked about teen access to records, so when does Gillick become applied in practice and who decides?

The summary is a collection of their central questions and its discussion towards the end, which are just as valid for care.data today, as well as for considering in the Patient Online discussion for direct care access. I hope you’ll take time to read it, it’s worth it.

And what about the Children?

Some of our most vulnerable, will have their data and records held at the HSCIC. There are plans for expansion rapidly into social care data management, aligned with the transformation of health and social services. Where’s the discussion of this? Does HSCIC even have the legal capacity to handle children’s social care data?

How will at-risk groups be safer using this system in which their identities are less protected? How will the information gathered be used intelligently in practice to make a difference and bring benefit? What safeguards are in place?

“Future releases of new functionality are planned over the next 12 months, including the introduction of the Child Protection – Information Sharing application which will help to improve the protection of children who have previously been identified as vulnerable by social services.” (ref: HSCIC Spine transition)

“Domestic violence can affect anyone, but women,
transgender people and people from BME groups are at higher risk than the general population.”
(Ref: Islington’s JSNA Executive Summary – 9 – August 2014)

 

We must ask these questions about data sharing and its protection on behalf of others, because these under represented groups and minorities cannot themselves, if they are not in the room.

Where’s the Benefit?

We should also be asking the question raised at the event, about the benefits compared with the data already shared today. “Where’s the benefit?”, asked another blogger some time ago, raising his concerns for those with disabilities. We should be asking this about new dating sharing vs the many existing research databases and registries we already have, with years of history. Ciarán Devane wisely asked this on the 6th, succinctly asking what attendees had expressed.

“It will be interesting to know if they can demonstrate benefits. Not just: ‘Can we technically do this?’ but: ‘If we see primary care data next to HES data, can we see something we didn’t see before’?”

An attendee at the Healthwatch run care.data event in Oxford last week, asked the same thing. NHS England and IT providers would, one would think, be falling over themselves to demonstrate the cost/benefit, to show why this care.data programme is well managed compared with past failures. There is form on having expensive top down programmes go awry at huge public expense and time and effort. On NpfIT “the NAO also noted that “…it was not demonstrated that the financial value of the benefits exceeds the cost of the Programme.”

Where is the benefits case for care.data, to weigh against the risks? I have yet to see a publicly available business case.

The public donation

Like my museum membership, the donation of our data will be a gift. It deserves to be treated with the respect that each individual should deserve if you were to meet them face-to-face in the park.

As I enjoyed early evening sun  leaving the exhibition, the grassy area outside was packed with people. There were families, friends, children, and adults on their own. A woman rested heavily pregnant, her bump against her partner. Children chased wasps and stamped on empty cans. One man came and sold me a copy of the Big Issue, I glimpsed a hearing aid tucked into a young woman’s beehive hair, one amputee, a child with Down Syndrome giggling with a sister. Those glimpses of people gave me images I could label without a second glance. Disabled. Deaf. Downs. There were potentially conditions I could not see in others. Cancer. Crohn’s. Chlamydia. Some were drinking wine, some smoking. A small group possibly high. I know nothing about any of those individuals. I knew no names, no addresses. Yet I could see some familial relationships. Some connections were obvious. It struck me, that they represented part of a care.data population, whom buyers and researchers  may perceive as only data. I hope that we remember them as people. People from whom this programme wants to extract knowledge of their lifestyles and lives, and who have rights to express if, and how they want to share that knowledge. How will that process work?

Pathfinders – the rollout challenges that remain?

At the advisory group led meeting it was confirmed that pathfinders, would be chosen shortly.

[CCGs were subsequently announced here,  see related links, end of page for detail, note added Oct 7th]

But  the care.data programme is “still delivering without a business case”.  Despite this, “between two and four clinical commissioning groups will be selected, “in the coming weeks” to begin the pathfinder stage of the care.data programme, ” reports NIB meeting[8]

It reports what was discussed at the meeting.

“The pathfinders will test different communication strategies before moving forward with the data extraction part of the project.”

I for one would be extremely  disappointed if pathfinders go ahead in the ‘as is’ mode.  It’s not communications which is the underlying issue still. It’s not communications that most people ask about. It’s questions of substance, to which, there appear to be still insufficient information to give sound answers.

Answers would acknowledge the trust in confidentiality owed to the individual men, women, and children whose data this is. The people represented by those in the park. Or by the fifty who gave up their time on a sunny Saturday to come and ask their questions. Many without pay or travel expenses just giving up their time. Bringing their questions in search of some answers.

The pathfinder communications cannot be meaningfully trialled to meet the needs of today and the future design, when the substance of key parts of the message is uncertain. Like scope.

The care.data advisory group and the Health and Social Care Information Centre , based on the open discussion at the workshop both appear to be working, “anticipating things to come…” and to be doing their best to put processes and change in place today, which will be “in step with the future.”

To what extent that is given the right tools, time and support to be successful with all of the public, including our minorities, I don’t know. It will depend largely now on the answers to all the open questions, which need to come from the Patients and Information Directorate at the Commissioning Board, NHS England.

After all, as Mr.Kelsey himself says,

“The NHS should be engaging, empowering and hearing patients and their carers throughout the whole system all the time. The goal is not for patients to be the passive recipients of increased engagement, but rather to achieve a pervasive culture that welcomes authentic patient participation.”

What could be less empowering than to dismiss patient rights?

The challenge is: how will the Directorate at NHS England ensure to meet all these technical, governance and security needs, and yet put the most important factors first in the design; confidentiality and the voice of the empowered patient: the voice of Consent?

*****

This post captured my thoughts on the care.data advisory event Saturday September 6th.  “Minority voices, the need for confidentiality and anticipating the future.” This was about the people side of things. Part two, focuses on the system part of that.

*****

Immediate information and support for women experiencing domestic violence: National Domestic Violence, Freephone Helpline 0808 2000 247

*****

[1] Interested in a glimpse into the Matisse exhibition which has now closed? Check out this film.

[2] Previous post: My six month pause round up [part one] https://jenpersson.com/care-data-pause-six-months-on/

[3] Privacy and Prejudice: http://www.raeng.org.uk/publications/reports/privacy-and-prejudice-views This study was conducted by The Royal Academy of Engineering (the Academy) and Laura Grant Associates and was made possible by a partnership with the YTouring Theatre Company, support from Central YMCA, and funding from the Wellcome Trust and three of the Research Councils (Engineering and Physical and Sciences Research Council; Economic and Social Research Council and Medical Research Council).

[4]  Barbara Hepworth – Pelagos – in Prospect Magazine

[5] Questions remain open on how opt out works with identifiable vs pseudonymous data sharing requirement and what the objection really offers. [ref: Article by Tim Kelsey in Prospect Magazine 2009 “Long Live the Database State.”]
[6] HSCIC current actions published with Board minutes
[8] NIB https://app.box.com/s/aq33ejw29tp34i99moam/1/2236557895/19347602687/1

 

*****

More information about the Advisory Group is here: http://www.england.nhs.uk/ourwork/tsd/ad-grp/

More about the care.data programme here at HSCIC – there is an NHS England site too, but I think the HSCIC is cleaner and more useful: http://www.hscic.gov.uk/article/3525/Caredata

 

#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]

 

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#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}

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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 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”

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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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