All posts by jenpersson

change, choice, politics, words

O my Luve’s like a red, red rose #indyref

“O my Luve’s like a red, red rose, that’s newly sprung in June:       O my Luve’s like the melodie, That’s sweetly play’d in tune.

As fair art thou, my bonnie lass, so deep in luve am I;                 And I will luve thee still, my dear, Till a’ the seas gang dry. […]”

Robert Burns, 1759-1796 [aged 37]

You can listen to the full poem sung by Suzy Bogguss

Friends and I hold a Burns Supper every year. What began as a one off, was repeated in a different home, with the same dozen guests a year later. So a tradition was born to celebrate the life and works of  Scotland’s most famous export.

“His national pride, fierce egalitarianism, and quick wit have become synonymous with the Scottish character itself.”      Robert Burns Birthplace Museum, Dumfries

Burns was famous for his belief in equality, and his poem “Is There for Honest Poverty“, commonly known as “A Man’s a Man for A’ That” of 1795 declared a stance in society, seen today as the rise of a liberalism, which is declared the world over today still. It is often used by the Freemasons as Burns was at the time of his death. It is the fierce pride in humanity of man that infuses Burns’ work and which has transcended time. His love poetry, and rural recordings, being ‘ahead of his time’ made him memorable. But I feel it was his awareness and discussion of identity and social-economic politics which still inspires and what makes his work contemporary.

The Burns Night Declaration

Perhaps it is some of that inspiration that Westminster hoped to capture by naming the latest political deal, granting Scotland more rights which Mr. Brown pledged this week, “The Burns Night Declaration.”

Scots have been promised “modern home rule within the United Kingdom” on a breakneck timetable on Monday if they rejected independence next week.”

From a personal perspective

I think there is a real chance of a yes vote. If Scotland were to vote for independence next week, I will celebrate the freedom, with a divided allegiance. The Scottish ‘heart’ in me will stir with a rallying cry and remember my ancestors who died on the fields of Bannockburn. My English ‘head’ will be disappointed, as I worry for the country downsizing to the size of Denmark will be a shock, and not fully thought out change, without a leader who can bring the whole country together.  I foresee a future in which the Celts are ruled still rather than greater independence for Scotland, with more dominant powers from Brussels instead of London as they seek strength and support as they once did with France in the Auld Alliance, rallying against English oppression. Should there be a yes vote, I will be dispirited, whilst clinging to optimism of change.

I have concerns about the economy, research investment, about its potential effect on the NHS and education provision, arguably better for the people than in England today. But in the end, my concerns don’t count, it is for the Scots in Scotland to decide.

As a Scot living in England, I have no vote. For my part, that is quite alright. For another Scot I know who fully intends moving back ‘up North’ and going ‘home’ in some years time, she is devastated at the thought of Scotland going solo, and that she has no say. Her sister still in Scotland, who can vote, was among those who received a letter in which she felt that it hinted that her employer, the Job Centre, may be put in jeopardy from a yes vote. [She may be right if DWP would need to be significantly ‘disentangled’ according to this report.] She’s considering voting yes anyway. Why?

Because at local level she thinks their jobs are in jeopardy of potential outsourcing regardless of the vote.

Because she’s lived through years of ‘better together’ and has seen only a decline in standards of living and no one has seemed to really seek to change that. She may not realise, Scotland is not alone in this, but with little elected power in Westminster, they may see independence as their only hope of change.

Because she feels democratically disempowered. No matter who she votes for today, it still results in not getting who they want in charge of government, and no way to oust them if a few areas of England vote that person in. The overall budget control for Scottish spending comes from Westminster. And lastly, in terms of governance, whilst necessary, adding experience and a system of ‘check and balance’ on legislation, the unelected House of Lords sits only in London and can appear accountable to no one, never mind the Scots.

How may politics be affected by the outcome?

I hear many people have had enough of imposed rule as they see it and disconnected leaders. One may think through devolution, more powers for Holyrood would have satisfied the desire for autonomy, but in fact people are fed up with the rhetoric  of the political rule from both Westminster and Edinburgh.

Many dislike the leadership choices on offer [latest FullFact poll stats here Sept 11th]. Women in particular appear to consider this important in their decision. Should the yes vote win, it will not necessarily be a win for Mr. Salmond, but a win for independence.

Key is, what will that independence really look like? It will be interesting to see. Would it be what Mr. Salmond expects? What scenarios have been thought out [1], debated, and what may have been missed?

The red rose of Labour has become faded in Scotland.  This has and  will continue to have an impact on future General Elections. I believe however, it must be encouraged to continue to grow, come back and actively thrive in Scotland regardless of this vote outcome. All mainstream parties would do well consider this, above party politics. There is a risk that the disenchantment with mainstream politics will give rise to more extreme factions. A sense of identity is a good thing, but at its extreme can be twisted into a damaging minority view of nationalism which is based on one group view over another, the real-world diversity of a nation excluded. Should mainstream parties leave a vacuum in the garden of Scottish politics, others will be quick to fill it, and it is often ugly weeds which take root fastest.

How has the People’s involvement in politics been affected?

Perhaps the best thing about this campaign has been an awakening. An awakening of people’s role in the democratic process, exemplified by the planned march on voting day in one area of Glasgow.  Where low turnout is typical organisers aim to stir people and carry them with them, to the polls, [which may or may not be legal electoral practice]. There has been an unprecedented number of electoral registrations.  But also an awakening of the big parties that your action and inaction matters. It has been forgotten in recent apathy. This awakening will not be restricted to Scotland, and politicians across Europe should learn from these experiences quickly, as calls for independence in other places are bound to come.

The Scots are inspirational to many.  Whilst fiction, the spirited speech of William Wallace in Braveheart calls to the basic instinct in us all, for freedom. We Scots have a strong sense of history as part of our identity. Entwined in that is the relationship between the wealthy landed Scots and the English nobility, and the complex succession of the throne and in-fighting of Scots lairds.  Who sided with whom, when and how trust was won and lost became glorified legend in Rob Roy and Braveheart, but it’s not all based on fiction, but historical fact.

What has been perhaps unfairly represented by some media headlines and survey statistics, is the image of how “the English” feel about “the Scots” and how the two countries would be after a yes vote. One survey showed well over 66% in favour of the Union, but the survey chose to represent a subjective statement on currency as its headline, for example. Poll upon poll state conflicting measures as ‘fact’. It is hard to separate fact from feeling in an emotive debate.

A Troubled Relationship

If you are not Scottish, you may or may not be familiar with the Scot’s spirit of the everyday, not celebrities nor stereotypes. If you have time, listen to this speech, a Burns night reply from the lassies. It gives the ladies a chance to ‘get their neb in’. (4.28) It’s meant to be tongue in cheek and irreverent, and not to take the subject too seriously, and this hits the spot. But mainly because it hints at something of what matters to Scots  in a speech about Burns.  In particular it’s worth considering this one snippet. With humour she tells us what matters above politics and above class, is relationships and communication. It is the relationship and communication that has broken down between Westminster and the people in Scotland which may be the Union’s  downfall. The Scottish People feeling neglected, had stopped talking to Westminster a long time ago, and Westminster didn’t notice.

Robert Burns understood People

Burns was a poet, a man of love and passion. A man of the heart. A man popular with women, a philanderer, yet perhaps one of the first feminists? Not a warrior, not a career politician, he was a man for the people. He recognised women’s rights above and amongst politics, and spoke up on our behalf:

“While Europe’s eye is fix’d on mighty things,
The fate of empires and the fall of kings;
While quacks of State must each produce his plan,
And even children lisp the Rights of Man;
Amid this mighty fuss just let me mention,
The Rights of Woman merit some attention.”

Visiting politicians would do well to appeal to the rights of women as Burns did. I believe that it is not a romantic notion of freedom, which will lead to a majority of the yes vote. It is another practical aspect of life exemplified in Burns’s poetry which matters to people today, and how we live. It can affect all, but disproportionally affects women, it is poverty:

Visiting Scotland I have seen an increase in poverty and hardship in recent years, and experienced the Scots’ spirit which has refused to give in and tries to resiliently ride above it. Scotland has found life economically tough in the last twenty years. Bit by bit, it has seen its shipbuilding, steel making and coal mining weaned away with few jobs to replace those hard industries. Farming and fishing on small scale has become harder to compete worldwide. Scots believe in society and living well together. They’ve seen the right to a pursuit of happiness undermined at every turn, in the ideology focused on the economic wealth development of the individual. Westminster may have woken up too late to the effects that has had over years of neglect and apparent blinkered ignorance “down South”.
Politicians could learn from Burns

These last minute efforts of visiting politicians may or may not be planned in the campaign.  But as Burns said,

“The best laid schemes o’ mice an’ men gang aft agley.”

The politicians may visit all they like, for a day or a week, better late than never. It will not make or break the majority of voters, voting with their head based on practical matters, but it may influence the ‘don’t noes’ the ‘vote for freedom’ who vote only with the heart at the last minute, and influence enough to swing the outcome. The majority of people will decide based not on last ditch efforts and promises, but on how they want to live, and what kind of society they want to see. Will speeches and promises made in a week, override experiences of many years? Or will they swing an influential minority?

The question is how convinced will voters be of the need for a complete break from the United Kingdom and true independence with its associated risk, versus the offering in the Burns Night Declaration? How much will heart rule the head or vice versa?

Whichever way the vote may go, how will mainstream political parties react and cultivate the long term relationship between Scotland and England? There will be a period between the vote and enactment. How will uncertainty be handled in that interim? How will the yes and no factions keep talking to one another, and grow as one nation, whether in a united, devolved or separate states?

O my Luve’s like a red, red rose

Scotland whichever path you choose to take, I will follow your decision closely.  Whatever happens next week, some will be broken hearted. I hope I won’t be among them. And I hope that for those who are disappointed with the outcome, we will all be kind, encouraging and not seek to blame, as we go about restoring our trust, our relationships and grow together in a positive, new direction. Society cannot afford a political vacuum which will provide space for the weeds of extremism to grow between us.

Wherever we are born, it is not unexpected to continue to have positive feelings for that country, as our birthplace. I may have left over thirty years ago, but my heart is still in the Highlands. I still love Scotland and hope she still loves us enough to stay together.

But I’ll understand if not.

“But to see her was to love her,
Love but her, and love forever.
Had we never lou’d sae kindly,
Had we never lou’d sae blindly,
Never met – or never parted –
We had ne’er been broken hearted”

Robert Burns, 1759-1796

***

[1] Governing after the Referendum – by the Institute for Government  http://www.instituteforgovernment.org.uk/sites/default/files/publications/Scenarios%20paper%20-%20final%20APJR.pdf 

 

#caredata, care.data, communications, confidentiality, NHSEngland, scope, scope creep

Care.data – my six month pause, anniversary round up [Part 1]

On the 18th February 2014, a six month pause in the rollout of care.data was announced. [1] It’s now September. Six months is up.

When will we find out what concrete improvements have been made? There are open questions on plans for the WHAT of care.data Scope and its future change management, the WHO of Data Access and Sharing and its Opt out management, the HOW of Governance & Oversight, Legislation, and the WHY – Communication of the care.data programme as a whole. And WHEN will any of this happen?

What can happen in six months?

Based on Mo Farah‘s average running speed of 21.8km/hour over The Olympic Games 10,000m gold medal winning performance, and on 12 hours a day, he could have covered about 47,000 km in that time. Once around the world, in those 180 days. With some kilometres spare margin, into the bargain.

That’s perhaps unrealistic in 180 days, but last February promises made to the public, to the Health Select Committee and Parliament were given about data sharing as both realistic, and achievable.

So what about the publicly communicated changes to the care.data rollout in the six month time frame?

The letter from Mr.Kelsey on April 14th, said they would use the six months to listen and act on the views of patients, public, GPs and stakeholders.

I’d like to address some of those views and see how they have been acted on. Here’s the best I have been able to put together of promises made, and the questions I still have, six months on.

Scope. What part of our records is included in care.data?

The truth is this should be the simplest question, but seems the hardest to answer. Scope is elusive, and shifting.

A simple description would help us understand what data will be extracted, shared and for what purpose. The public needs an at-a-glance chart to be properly informed, to distinguish between care.data, the Summary Care Record, HES/SUS and how patient data is used, by whom for what purposes.  This will help patients distinguish between direct and indirect care uses. What doctors would use in the GP practice, versus researchers in a lab. It will help set expectations for Patient Online.  It could help explain data use in Risk Stratification.  [see care.data-info by Dr.Neil Bhatia for high level items in scope, or field name detail here p22 onwards] [11]. This lack of clarity was already identified in April 2013, point 3.3, but nothing done.

Mid-August to further complicate matters, it became apparant from published care.data advisory group minutes, that the content scope is under review and may now include sensitive data. This was met with serious concern in many quarters, not least HIV support groups, on broadening the scope of care.data extraction and access.  I realised I wasn’t in the least surprised, but continue to be shocked by the disconnect between project leadership and the public.

Are the listening exercises a complete waste of time?

If people aren’t comfortable sharing basic health records, how will suggesting they share anything more sensitive be likely to encourage participation?

[The scope of how our GP part of care.data will be used is also under consideration for expansion to research – more in part two, on that.]

Scope is undefined. It will continue to ever expand as the replacement for SUS. In April, I wrote down my concerns at that time. Most of which remain unchanged.

Stephen Dorrell, MP on the 11th March in Parliament summed up nicely, why this move now to shift scope is ludicrous. If we do not have stability of scope, we cannot know to what we are consenting. This is the foundation of our patient trust.

Mr Dorrell: I am not going to comment on whether the free text data should or should not be part of the system, or on whether the safeguards are adequate. However, I agree with the hon. Lady absolutely that the one sure way of undermining public confidence in safeguards is to change those safeguards every five minutes according to whichever witness we are listening to.

If the Patients & Information Directorate at NHS England is serious about transparency, then we should be clear about all our patient data, where it comes from, where it goes to, who accesses it and why.

Data protection principle 3 requires that the minimum possible data required is extracted, not excessive. Is this being simply ignored, as inconvenient in a project which intends scope to ever accumulate as SUS replacement?

“Will NHS England prepare an at-a-glance of differences between SCR and care.data, and HES/SUS extractions and users?”

scrcdoverview

 

Conclusion on Scope & its Communications:

This scope clarification alone would be I believe, if well done, one of the most effective communications tools for patients to make an informed choice.

1. We need to know what parts of our personal, confidential records, sensitive or otherwise are to be extracted now. 

2. How will we be informed if that scope changes in future?

3. What do we do, if we object to any of those items being included?

Before any launch of pilot or otherwise, a proper plan to ensure informed communication and choice, today and looking to future scope changes, must be clear for everyone.

What’s happened since February to the verbal agreements and promises that were made back then?

Whether in Parliament by Dan Poulter and the Secretary of State Mr.Hunt, in Select Committee Hearings, by the Patients & Information Directorate at NHS England and in patient facing hour at the mixed-subject Open Day, promises have been made, but what evidence has the public, that they are real? There has been little public communication since then.

I have read, watched or attended NHS England Board meetings, Health Select committee meetings, and read the press, media releases and social media. I’ve been to a general NHS Open Day, listened in to NHS England online events, the first HSCIC Partridge Review follow up event, and spoken to patients, public and charity groups. Had I not, I would know nothing more than I did in February which was, that something had been put on hold, about which I should have, but hadn’t, received a doordrop leaflet.

Pilot practices ‘pathfinders’ we were told will trial the extraction, in six months, then in autumn, or October 1st according to Mr.Kelsey at the Health Select Committee (extract below).

reply

I’ve not seen anywhere yet, where these practices will be, nor that patients have been informed.  The latest status I read was on EHI. In response to this lack of information, medConfidential wrote to Healthwatches and CCGs with important questions and ideas. [Well worth a read].

Scope of Access – Who will get our records and for what?

Where and to whom may our data be transferred?

As part of the what of scope, we also need clarification on the who will be in scope in which countries to access data.

“Can I confirm now, that the data connected to care.data will not be allowed outside the United Kingdom? Let me confirm that before we have further hares running.” Tim Kelsey, said at the Health Select Committee.

Since GP care.data is to be connected with HES data, and data may be linked via the Data Access Request Service (the recently renamed former HSCIC Data Linkage Service DLES) on demand;

Q.  How will I know in future that there are no plans to release my data outside the UK and EU, as HES has been in the past?

As far as I have read, geographical scope is not legislated for. I would like to be pointed to this if it is.

From the Health Select Committee: Committee Room 15 : Meeting started on Tuesday 25 February at 2.29pm – Ended at 5.20pm

Mr. Tim Kelsey, National Director for Patients and Information stated: The pause was announced, precisely to address the issues.

“People are concerned about the purpose to what their data is being put.”

It’s not yet been addressed. Neither for the now, nor the future.

We need to have a robust mechanism in place for all future scope of use changes. If today I agree to have some of my data extracted used for public health research for the public good, I don’t want to find that I’ve had all my personal details including my genomic records [which personally are somewhere in my record already] spliced with Dolly the sheep research, in the hunt for a cure for arthritis five years down the line, and there’s another me living at the Roslin Institute. [I jest to exaggerate the point, not all research definitions are equal].  A yes today, cannot mean a yes for anything and everything.

The opt out term at present only allows a later ‘opt out’ to mean that data is made less identifying ‘pseudonymous’ from that request date, nothing deleted. ‘Opt out’, is not ‘get out’.

The records from before that request date, will remain clear and fully identifying for all time. So if a company requests an historical report, will our identifiable data still be included in it?

Opt out is not as simple as it sounds.

OPT OUT

The whole issue of opt out was at best an inaccurately communicated process. I believe it was misleading.

What is still wrong to my mind with this mechanism, is that there appears to be the assumption that all data may be matched and de-identified before release. That corresponds to the September 2013 NHS England Directions led by Mr. Kelsey to HSCIC saying there is “ “no need” to take into account individual objection to pseudonymous data sharing “. [2] And the patient leaflet, which was produced before any opt out changes, which stated we could object to ‘identifiable’ data sharing. That ‘identifiable’ doesn’t include all our data.

I’d like to see that clarified. Because Mr.Hunt has promised an opt out in entirety:

25th February in Parliament:

Mr.Hunt: …”we said that if we are going to use anonymised data for the benefit of scientific discovery in the NHS, people should have the right to opt out. We introduced that right and sent a leaflet to every house in the country, and it is important that we have the debate..”

“the reason why we are having the debate is that this Government decided that people should be able to opt out from having their anonymised data used for the purposes of scientific research”

Dr Julian Huppert (Cambridge) (LD): There are of course huge benefits from using properly anonymised data for research, but it is difficult to anonymise the data properly and, given how the scheme has progressed so far, there is a huge risk to public confidence. Will the Secretary of State use the current pause to work with the Information Commissioner to ensure that the data are properly anonymised and that people can have confidence in how their data will be used and how they can opt out?

Hunt: “I will do that, and NHS England was absolutely right to have a pause so that we ensure that we give people such reassurance…”

Status: the public still has no communication about any opt outs on offer or a consistent, effectively communicated method by which to request it.

Our data continues to be released regardless.

What I want to understand on opt out:

1. Can I choose to have my data used for only care, or for bona fide public health research, but not, for example, other types, such as commercial pharma marketing or data intermediaries?

2. Can I restrict the use of all my children’s data, to include all of it, including fully ‘anonymous’ data as the Secretary of State stated? Not only restricting red and amber, but all data sharing?

3. How will patients know that all of their medical data is covered by these options, not only our GP records? (For other data held see > http://www.hscic.gov.uk/datasets)

4. Will NHS staff be given the right to opt out to prevent their personal confidential data or employment data being shared as part of the workforce data set?

5. Does opt out really mean opt out – when will we see the revised definition?

6. How will objection management (storing our opt out decision) be implemented with other data sharing? (SCR, Electronic Prescription Service, OOH access, Proactive care at local level.)

7. How will objection be effectively communicated and measured?

8. Will the BMA vote [3] be ignored by the Patients & Information Directorate at NHS England? They called for an opt in system? And also for it to have the option to be used only for improving care, not commercial exploitation. They appreciate the risks of losing patient confidentiality and trust.

9. Will the views of Dr. Mike Bewick, deputy medical director at NHS England, also be ignored, who said parts (referring to commercial use) should be ‘opt-in’ only? [Pulse, June 2014]

10. What will ensure opt out remains more than just Mr.Hunt’s word, if it has no legislative backing?

The opt out on offer at Christmas was to restrict identifiable data sharing. There was “no need” to take into account individual objection to pseudonymous data sharing said the September 13th NHS England directions. Those NHS England Board directions from September and December 2013 are now possibly out of date, but I’d like to see new ones which replaced them, to reassure me that an opt out that we are offered,  works the way I would expect.

Most importantly for me, will the opt out be given more legislative weight, Q.10? Today I have only the Secretary of State’s word that any “objection will be respected.”  And as we all know, post holders come and go, a spoken agreement by one person, may not be respected by another.

**********

ACCESS

Many of the concerns around which organisations will have access to our medical records, and which were somewhat dismissed on Newsnight then, have been shown to have been legitimate concerns since:

“Access by police, sold to insurance companies, sold for commercial purposes” Newsnight, February 19th 2014
… all shown to be users of existing medical records held by the HSCIC through the Partridge Review.
police

Which other concerns over access were raised and have they been addressed?

Dr. Sarah Wollaston MP, then member, now Chair, of the Health Select Committee raised the concerns of many when she asked whether other Government Departments may share care.data. Specifically she asked Mr.Kelsey,

“are you going to have a clear concrete offer to the public at the end of the six-month delay as to how these requests will be handled […] see if their data is going to be accessed by DWP […]?”

dwp_wollaston

I believe this is still more than a very valid and open question, particularly with reference to the December 2013  Admin Data Task Force which was exploring a ‘proof of concept’ to link DWP [6] and Department of Health data:

“Primary and Secondary Care interventions with DWP over a six year period.”

DWP_strategy

 

HSCAct

 

At the Health Select Committee evidence session, Mr. Kelsey and Mr. Jones did not give a straight yes/no answer to the question.

Personally I believe it would be clearly possible that DWP administering social care or welfare payments will make a case under ‘health and social care’. Unless I see it in legislation that DWP will not have access care.data or other HSCIC held data, I personally will assume that it is going to, and may have already especially given the ‘primary and secondary linking’ pilot listed above.

What about other government departments access to health data?

A group met for the event ‘Sharing Government Administrative Data: new research opportunities’: strategic meeting on 14 July 2014, at the Wellcome Trust, London [4]  – at which both care.data and DWP data had their own agenda slots.

The DWP holds other departments’ data and is “open to acting a hub.” July 2014 [7]

The Cabinet Office presenter included suggestions UK legislation [9] may change to enable all departments (excluding NHS) to share data, and the ADT recommended that new ‘Data Sharing” legislation should be put forward in the next [Parliamentary] term.

1. Since HSCIC is an ALB and not NHS, are they included in this plan to broaden sharing across government departments?

2. Will the care.data addendum of September 2013 be amended to show the public that those listed then, are no longer considered appropriate users?

3. Will Mr.Kelsey now be able to answer Dr.Wollaston MP’s question regards DWP with a yes / no answer?

Think tanks, intermediaries and for the purposes of actuarial refinement were included in documents at the time, which suggested that DAAG alone in future, would review applications.

The DAAG is still called the DAAG and appears to have gone from 4 to 6 members. The Data Access Advisory Group (DAAG), hosted by the Health and Social Care Information Centre (HSCIC), considers applications for sensitive data made to the HSCIC’s Data Access Request Service.

Three key issues remain unclear to me on recent Data Release governance at DAAG:

1. Free text access and 2. Commercial use 3. Third Party use

The July 2014 DAAG approved free text release of data for CSUs on a conditional cleansed basis, and for Civil Eyes with a caveat letter to say it shouldn’t be used for any ‘additional commercial use.’ It either is or isn’t commercial I think this is fudging the edges of purpose and commercial use, and precisely why the lack of defined scope use undermines trust that data will be used only for proper purposes and in the definition of the Care Act.

Free text is a concern raised on a number of occasions in Parliament and Health Select Committee.  On the HSCIC website it says, none will be collected in future for care.data. How is it now approved for release, if it has not already been collected in the past – in HES?  So it would appear, free text has already been extracted and is being released. How are we to trust it will not be the case for care.data?

****

In summary: after six months pause, it remains unclear what exactly is in scope, to whom will it be released. We are still not entirely clear who will have access to what data, and why.

In part two I’ll look in brief at what legislative changes, both in the UK and wider EU may influence care.data and wider health data sharing.  Plus some status updates on Research seeking approval, Changes to Oversight & Governance and Communications.

That commercial use, the concept that you are exploiting the knowledge of our vulnerability or illness, in commercial data mining, is still the largest open question, and largest barrier to public support I foresee. ‘Will the Care Act really help us with that?’ I ask in my next post.

MedConfidential have released their technical recommendations on safe settings access to data. Their analogy struck me again, as to how important it is that the use of data is seen by the users, as a collective.

Any pollution in the collective pool, will contaminate the data flow for all.

I believe the HSCIC, NHS England Patients & Information Directorate, the Department of Health need to accept that the continued access to patient data by commercial data intermediaries is going to do that. Either those users, some of whom are young and inexperienced commercial companies, need to be excluded, or to be permitted very stringent uses of data without commercial re-use licenses.

The commercial intermediaries still need to be told, don’t pee in the pool. It spoils it, for everyone else.

I’ll leave you with a thought on that, from Martin Collignon, Industry Analyst at Google.

**********

For part two, follow link >>here>>  I share my thoughts on current status of the HOW of Governance & Oversight, Legislation, and the WHY – addressing Communication of the care.data programme as a whole.  And WHEN will any of this happen?

Key refs:

[1]. Second delay to care.data rollout announced – The Guardian February 18th 2014: http://www.theguardian.com/society/2014/feb/18/nhs-delays-sharing-medical-records-care-data

[2] NHS England directions to HSCIC September 13th 2013: http://www.england.nhs.uk/wp-content/uploads/2013/09/item_5.pdf

[3] BMA vote for opt In system: http://www.bmj.com/content/348/bmj.g4284

[4] July 14th at Wellcome Trust event ‘Sharing Government Administrative Data: new research opportunities’: 

[5] EU Data Legislation http://www.esrc.ac.uk/_images/presentation%208_Beth%20Thompson%20Wellcome%20Trust_tcm8-31281.pdf

[6] DWP data linkage proof of concept trial 6 year period of primary and secondary data, December 2013

[7] Developments in Access to DWP data 2014

[8] NHS data sharing – Dr.Lewis care.data July 2014 presentation

[9] Possible UK Legislation http://www.esrc.ac.uk/_images/Presentation_7_Rufus_Rottenberg_tcm8-31280.pdf

[10] Progress of the changes to be made at HSCIC recommendations of the Partridge Review https://medconfidential.org/wp-content/uploads/hscic/20140903-board/HSCIC140604di_Progress_on_Partridge_review.pdf

[11] Scope list p22 onwards: http://www.england.nhs.uk/wp-content/uploads/2013/08/cd-ces-tech-spec.pdf

[12] Health and Social Care Transparency Panel April 2013 minutes https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/259828/HSCTP_13-1-mins_23_Apr_13__NewTemp_.pdf

#caredata, care.data

Care.data – my six month pause, anniversary round up [Part 2]

In part one, I looked at the status of what data care.data extracts – examining scope, the role of management of scope creep in trust, opt out management, and the who, of accessing our data and for what purposes.

Here in part two, I want to give a six-month status update of my opinion of where the public is on understanding the HOW of Governance & Oversight, Legislation, changes to the scope governance to include Research, examine work-in-progress and look to explaining the WHY of care.data, the Communications of the programme as a whole.  Leading to ask, WHEN will any of this happen?

To go back to part one of this post > click here.

Care.data – a six month pause, anniversary round up – Part 2

What legislative changes may influence care.data sharing?

In July, at an ADT meeting Dr.Geraint Lewis was billed in the agenda to be speaking on care.data. [8] At the same meeting, the item on European Data directive, where the Wellcome Trust presenter [5] noted that the new EU legislation would require informed consent for identifiable data sharing, and limit pseudonymous data sharing without consent deserves a special mention, and question all of its own.

Mr.Kelsey pointed out in January, at the ISCG meeting that his colleague was over in Brussels to discuss the new EU law. So they are clearly well aware there are implications.

Now a theoretical question. If you were designing a process upon which new legislation were going to have a big effect, would you a) try and design your process accordingly to take the new law and best practice into account to be ‘ahead of the game’ or b) rush to get the project finished before the change of law affected it, and hope it is not retroactive?

Q. Is this coming change in EU Data Protection one reason for the big rush to get care.data extracted?

In terms of UK legislation, what has changed since the pause? The Care Bill became the Care Act in May.

Senior figures in the Lords, in public health as well as MedConfidential raised concerns and proposed amendments.

Considerations included defining:

1. Purposes to exclude commercial exploitation

2. Oversight & Governance

3. Opt out on statutory basis

In the preceding Care Bill debate, Jamie Reed outlined the amendment to wording and how the public may interpret its effect. I agree with what he said:

“the new clause provides for entirely elastic definitions that, in practice, will have a limitless application.”

clause
Unless there are plans to sub-define the clause and to legislate to support that,  I await to see how that ‘purposes ‘ definition can do anything to help support our trust that actuaries & insurance firms, health or pharmaceutical marketing researchers or other third parties we cannot imagine, will be legally entitled to request to buy data. The HSCIC can only measure requests against the law under which it is given to operate after all.

a) the promotion of health – interpret that how you will.

“The DARS process has three stages – Application, Approval, and Access.”

I fear this kind of sets the tone for the expectation of applicants, you ask you get – and there’s no mention of rejection in there. But then, I’m probably being too cynical. A list of the number and type of rejected applications by organisation, would improve my trust here. CAG publishes it, where is the same transparency for DAAG? How many applicants are rejected vs accepted each month?

How will DARS interpret “the promotion of health?” I’d like for them to give case scenarios of the problematic past releases, and judge now, whether they would be accepted again or not.

Mr. Kelsey identified that this definition of purposes was vital to the public in February, but I don’t think it has been clearly addressed since.

first

 

I look forward to hearing more about what clear and specific guidance there will be to the Data Access Group,  and what protections there will be for corrective action on data mismanagement, the so called ‘one strike and out’, which must encourage breach transparency, not drive reporting underground.

The second big ticket  item the Care Act is to have brought in, is a change to oversight.

Changes to Oversight and Governance?

Again, I am yet to see any documented organisational mapping of how Data Access will be reviewed and regulated going forward, taking this new legislative amendment into account. There was some mention of CAG and IIGOP at the HSCIC stakeholders’ meeting, but nothing documented to view how recommendations may become enacted. Progress is somewhat unclear, but awaiting monitoring in the pause.

Mr. Kelsey has said the the IIGOP has been asked to advise, but I understand it has no statutory footing, nothing to make its recommendations effective, should the Patients & Information Directorate at NHS England disagree. [We do well to remember past form here. The Caldicott 2 recommendations on data sharing, which stated they ‘the Review Panel does not support such a proposition’ [7.2] that there should be dated shared for commissioning in an assumed ‘consent deal’ without clear legal basis and patient communication. It goes so far as to say it is not aligned to the rights and commitments in the NHS Constitution. This was chaired by Dame Caldicott, who also chairs IIGOP.]

When the Patients & Information Directorate /NHS England and the BMA vote also disagree, and NHS England seems to have ignored the BMA ARM call for opt in – at least I have seen no public facing statement which even acknowledged it had happened at all – which strikes me as being just plain rude to your most significant stakeholder – it gives me little hope that the Patients & Information Directorate at NHS England is going to take another group’s perspective into account. I hope I am proved wrong.

But there is no outside oversight or governance which can impose action, or intervene with any legal weight in disputed decision making like this.

GPs as Data Controllers are between a rock and a hard place still. Legally bound to release data by the Health and Social Care Act 2012 if the Patient & Information Directorate at NHS England directs them to do so, professionally bound to maintain confidentiality.second

In February at the HS Committee, Dr. Nagpaul said they were,

“looking forward to the next six months enabling our patients to be properly informed so …they can make an informed choice.

Since the Care Act and scope have changed since then, the opt out mechanism is unclear, and nothing has come from national level to acknowledge their call for opt out, I for one am not surprised patients have still not been informed in these six months. It would be hard to pin down what we could have been informed of precisely.

gps_controller

The Secretary of State wrote on April 25th, asking to ensure current practices are up to the task, but as polite as it is, a letter is no form of governance.  It rather feels like a distant wave at a drowning swimmer, acknowledging an issue, but staying well clear from actually having to go into the water.

Currently it is IAG which reviews the requests for changes to the scope of the GPES extraction tool. It has direct governance and independence. Where it fits ongoing between CAG and DAAG is unclear to me.

And what about research?

This is possibly the latest *new* development, that the care.data advisory minutes hints at. That research purposes will now be put forward to the IAG in a formal request for the GP part of care.data to be accessible for research. (Because yes, despite all the campaigning and everyone and their kittens saying how good care.data would be ‘for research’ it’s still, to date, only approved for commissioning purposes. NOT for research.) HES, SUS other  data which HSCIC already has is used in research already. Whilst some primary care data may used in research today where practices have otped in to other research databases, such as CPRD, I believe that is only in an anonymous format. Now, how this works today with linkage via HSCIC and how much we know about it, may be unclear to the public. But it’s not the same as GP primary data in identifiable format being extracted and stored and linked with every other part of your health and social care records and more, for research and sale, as is the care.data intent.

I would like to see this instead considered, a layered approach to opt in.  This enables some personal level of data governance as well as consent. Saying yes to public research, but no to commercial marketing research or re-use. Personally, I’d also want to split out genomics from other research. This supports patient choice, so oft touted as core to the new NHS. The current set up is diametrically opposed to everything NHS England purports to stand for. How can patients trust a system, which says one thing, and acts entirely against it?

Well, if the proposers can define ‘research’, I’m happy to consider signing up to opt in for its use. If it’s a blank cheque to use the knowledge of my children for just anything, unlimited in scope and time – forget it. And why? Because I am concerned that the pseudonymous use of data and use of pseudonymous tissue are too loosely governed. Who is auditing today the ethical combining of genomic mapping and pseudonymous data use? Who is using it, and for what? Where is it information that may be sold, and to whom? I don’t want their future choices limited by something I didn’t pay attention to on their behalf, today.

Why does the NHS England Patient and Information Directorate want to extract care.data? Have we lost sight of the most valuable purposes of data, and how to use it well, through the commercial drive for UK plc – purposes put ahead of research? Commissioning purposes and commercial mining are taking precedence over care and confidentiality.

Stephen Dorrell MP,  in Parliament on March 11th (Col. 198) focused rightly on defining the purposes of care.data.  In fact the IAG has not approved research for care.data (GP extracted) to be used in research:

Mr Dorrell: First, we must concentrate the rationale for the programme on to patients. Looking back at how NHS England has got itself into this position over the past few weeks and months, I have lost count of the number of times I have been told how important the programme is for research. I absolutely agree that it is important for research, but the health and care system does not exist to support research; it exists to treat and care for patients. The logic of allowing commissioners to develop joined-up services that respond to individual people’s needs—and the pattern of need based on multi-morbidity to which the right hon. Member for Sutton and Cheam (Paul Burstow) has referred—must be placed centre stage in the justification for the improved handling of data in the health and care system.

I go back to the point that this must be about treating people, not conditions. We cannot achieve that if we do not have the information to allow us to connect up the experience of the patient between one part of the system and another. In regard to the logic behind NHS England’s plans, yes there is a research argument, but—with apologies to the research scientists—it is a secondary argument. The primary argument is that we must improve the services delivered to patients and service users.

Which is why it was odd at the time, to see the Wellcome Trust driven ‘Peter’ campaign supported by the 40 research charities, championing the need to have our data. It was data (in HES/SUS) they already had access to.  At the same time care.data [wave one, primary care GP extraction] was collapsing under the weight of the press and public shock that our hospital records had been shared with third parties for years without consent.

What has practically been done by the bodies involved in data sharing?

From an NHS England point of view, I’ve seen little. HSCIC on the other hand has seemed proactive and productive. [10]

The most significant undertaking was the Partridge Review, which analysed in depth 10% of the data sharing agreements of the last eight years.

The HSCIC has undertaken to continue complete logging of registered approved data releases on a  quarterly basis.

There is also an audit function in development. “These audits will check that our customers are adhering to the obligations documented in the Data Sharing Contract and Data Sharing Agreements.”  Whether or not that will mean that HSCIC auditors will go onsite at data recipients in FDA manufacturing audit-style, is probably another matter.

The access mechanism is under review, and at the open HSCIC meeting in July Kingsley Manning stated that a secure access lab will be part of their offering next year. How that will affect who has what access to what data, remains unknown. But it appears there may be work-in-progress:

On 1st September, Ciaran Devane posted on twitter that, “With care.data advisory group chair hat on, well done to hscic team who listened very well at session on proposed secure data facility.”

Today in contrast, there are currently two ways in which data can be accessed:

  1. Data are released to you using a Secure File Transfer Mechanism.
  2. You may access Hospital Episode Statistics (HES) data using the HES Data Interrogation System.

The HSCIC Data Access Policy has been updated on their website and now states it is supported by the following principles which includes:

  1. share information to support the provision of health and social care and the promotion of health; not for solely commercial purposes;

{my italics} Solely, does not exclude enough in my opinion. This is where the care.data will meet resistance still, if it cannot see the wisdom of giving up its use for commercial purposes.

Their stakeholder meeting “Driving Positive Change” hosted at The King’s Fund was minuted here.

My own opinions on attending the meeting, are in these past blogs posts. Part one and Part two.

HSCIC also updated their Freedom of Information Disclosure Log which had been out of date by well over 6 months.

Lots going on at HSCIC.

What else has happened in between then and now? What were the expectations of the pause?

npickles6months

 

The HSCIC did have a Code of Confidentiality consultation, which was most recently published.

The Department of Health issued their Annual Assessment of the NHS Commissioning Board (Brand name NHS England), which made a passing reference to care.data on page 10.

There was a rather obtuse and confusing ASH consultation on data sharing which stressed it ‘wasn’t care.data’ yet included many of the same items, and were for purposes which included commissioning and risk stratification, ostensibly purposes of care.data. The whole thing was rather a mess. Aside from the data sharing aspects, it included whether the organisations would be State or commercially owned, and changes to consent and data sharing for people with learning disabilities.  It was really, far too wide ranging, and had a very short consultation period. Personally, I feel concerned other less defined organisations may now be made legally entitled to access our primary care records, ostensibly not under ‘care.data’ but for similar yet even more obtuse purposes.

[addition Sept 2nd after publishing – medConfidential has released an in-depth set of documents regarding secure data access design and the ASH on their blog > here]

Communications

Communications was and is repeated over and over, as the key flaw in the roll out. The doordrop junk mail was widely cited as a misjudged marketing campaign. I hope, through the above, to dispel that myth. Communications is the ‘how’ you tell people – in care.data it’s the ‘what, why, who and when’ which is missing as well. The Communications process cannot clearly inform if the substance of the message is in flux or unclear.

Have there been any national direct communications to citizens and patients from the Patients & Information Directorate at NHS England? Some online letters? Yes, from Mr. Kelsey here and here. “This is the first in a series of updates on care.data. I hope you will help shape it by giving your views on the care.data programme,” said his letter. None since then. The care.data advisory group notes are somewhat internal minutes for the public, but give us some idea of direction.

Local activities? Perhaps. There have been a couple of events posted online, such as was held via Healthwatch in Essex, but nothing in my own area. Some more accessible versions of the communications leaflet were released.

Have there been events open to the public to hear about care.data? Yes, but not widely promoted to individuals. The second hosted by the care.data advisory committee is coming up in London on September 6th: “This event is for health bodies and organisations representing a wider constituency perspective and will take place on Saturday 6 September in London from 10am to 2pm.”

The NHS England website states that,  “at the beginning of August, we have taken part in over 150 local and regional events.” I know that I actively look out for any mention of events online, and I’ve been aware of about half a dozen, none of which has been in my county although it is included in the published list. I’ve asked at my local CCG, and neither they nor the NHS England Area Team are aware of any having been in West Sussex either. So, if these 150 events are taking place, it is not widely publicly communicated.

I attended the June 17th NHSE Open Day which included one hour on care.data.  I’ve not yet seen any follow up of the questions which were asked by others then, and I blogged about then, here. The feedback from that Open Day has yet to be published > here. The site states that all the care.data listening event feedback will be published ”later in the summer.” School’s back, summer’s over. Time for some of that feedback to be shared? I hope it’s soon, so that there is time for proper digestion, consultation and adaption before the pilot rollouts.

I’ve been to one public event which was primarily intended for charity group representatives,  and the HSCIC stakeholder event, which was not about care.data, but the review after the Partridge audit. All three of these events were advertised online as open to the public. I’ve asked my CCG about it at two meetings, and had no follow up and nothing from my GP practice at all.

The NHS England Board in July didn’t mention care.data at all.

If I’m actively looking to find out what is happening, and that’s all I find, what does the general public know?

I proposed two topics for NHS Citizen consideration: care.data [as did someone else as well] and genomics. Neither made the cut for public discussion. Where can these issues which will shape the NHS so fundamentally and touch every patient and citizen, get into mainstream discussion?

So far, because any gathered listening on care.data has been kept to the Patients & Information Directorate and not made public, we don’t know what has been actioned. But from my event attendance and online discussions, I think feedback is fairly consistent.  Summed up by what Mr.Kelsey asked the Open Day by a show of hands, how many feel confident they even know what care.data is? The answer was clearly, not enough.

The July care.data advisory group minutes state that a communications consultancy was about to be hired to review materials.

What will be interesting to see is how the communications materials are relaunched with new information. Simply repackaging what was there before won’t do. If there have been significant changes in content and process, as has been suggested are the successful results of the Partridge Review and Care Act, then they must be reflected in communications content. Just as the real concerns and questions received in the listening events over the last 6 months must also be addressed.

No one seems keen to tell us. The same questions have been batted about, for a year and a half now. From April 2013, the minutes are really worth reading again. The sharing for commercial cash flow was omitted in potential uses, but did flag concerns sharing ONS data with commercial intermediaries. The Partridge Review April 2014 since showed part of the extent to which the data mining of our health records was happening in the background. The desire to get access across to all health and social care data hints in 2013 at the unbound scope they still struggle to define today. Fast forward a year, and the project was put on pause.

Six months later, when will we find out what concrete improvements have been made in this pause? What are plans for the WHAT of Scope and its future change management, the WHO of Data Access and Sharing, the HOW of Governance & Oversight, Opt out management, Legislation, and the WHY Communication of the programme as a whole? And WHEN will any of this happen?

“This purpose is broad, and poorly defined. It needs to be better specified through the core values of the NHS to ensure that care.data makes the contribution that it is capable of to the future of the NHS.”

James Wilson, Discover Society, June 2014

Has the commercial exploitation of HES poisoned the care.data pool of data uses for everyone else who wants access to our NHS world leading data?

Have we lost sight of the most valuable purposes of data, and how to use it well, through the commercial drive for UK plc – purposes put ahead of research? Commissioning purposes and commercial mining are taking precedence over care and confidentiality.

Is the Patients & Information Directorate NHS England still going for gold in a world class model, is it sneaking up the back straight for a sprint finish, or is pulling out from the race?

**********

[1] Second delay to care.data rollout announced – The Guardian February 18th 2014: http://www.theguardian.com/society/2014/feb/18/nhs-delays-sharing-medical-records-care-data

[2] NHS England directions to HSCIC September 13th 2013: http://www.england.nhs.uk/wp-content/uploads/2013/09/item_5.pdf

[3] BMA vote for opt In system: http://www.bmj.com/content/348/bmj.g4284

[4] July 14th at Wellcome Trust event ‘Sharing Government Administrative Data: new research opportunities’: 

[5] EU Data Legislation http://www.esrc.ac.uk/_images/presentation%208_Beth%20Thompson%20Wellcome%20Trust_tcm8-31281.pdf

[6] DWP data linkage prrof of concept trial 6 year period of primary and secondary data, December 2013

[7] Developments in Access to DWP data 2014

[8] NHS data sharing – Dr.Lewis care.data July 2014 presentation

[9] Possible UK Legislation http://www.esrc.ac.uk/_images/Presentation_7_Rufus_Rottenberg_tcm8-31280.pdf

[10] Progress of the changes to be made at HSCIC recommendations of the Partridge Review https://medconfidential.org/wp-content/uploads/hscic/20140903-board/HSCIC140604di_Progress_on_Partridge_review.pdf

[11] Scope list p22 onwards: http://www.england.nhs.uk/wp-content/uploads/2013/08/cd-ces-tech-spec.pdf

[12] Health and Social Care Transparency Panel April 2013 minutes https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/259828/HSCTP_13-1-mins_23_Apr_13__NewTemp_.pdf

art, change, politics, privacy, sport, surveillance, Tech

Non-human authors wanted. Drones, robots, and our relationship with technology.

“My relationship with the drone is like playing a video game: I feel out a composition and the drone will agree or challenge me. Eventually, though, the drone will develop a creative mind of its own.”  [KATSU, in interview with Mandi Keighran and N magazine, summer 2014].

KATSU, the New York City based artist/vandal/hacker depending on your point of view, raises the question in that interview for Norwegian Airlines’ magazine, of the relationship of “technology to graffiti,” or more broadly, of technology to art as a whole.

This, combined with another seemingly unrelated recent story, the David Salter macaque photo, made me wonder about drones, robots, and the role of the (non-)human author – our relationship with technology in art and beyond.

Ownership and Responsibility – Human or non-Human?

I wondered in both stories, how it may affect ownership and copyright. Rights, which led me to consider the boundaries of responsibility.

I should preface this by saying I know little about copyright and less about drones. But I’m thinking my lay thoughts, out loud.

In the first instance, if drones are used for creating something as in this story, is it as simple as ‘he who owns the drone owns or is responsible for the art it creates’? I wonder, because I don’t know, and while it may be clear today, I wonder if it is changing?

As regards the second story, when the monkey-selfie went around the world focus was sharper on copyright law, than it was in the majority of the photos the macaque had taken.  “Can a monkey own a picture?” asked many, including Metro at the time.

”Wikimedia, the non-profit organisation behind Wikipedia, has refused a photographer’s repeated requests to stop distributing his most famous shot for free – because a monkey pressed the shutter button and should own the copyright,” said the Telegraph.

But whilst most on social media and the press I read, focused on the outcome for this individual photographer, I wondered, what is the impact for the future of photography?

I’ve come to the conclusion, in this particular case I think it is more important we consider it less about the monkey having taken the photo, and more important that it was decided that a human, did not.

This decision was not (yet) decided by a UK court,  but was reached in Wikimedia’s own report.

Since then, the LA Times reported on August 21st, that:

“the public draft of the Compendium of U.S. Copyright Office Practices, Third Edition —was released this week[1], and, after final review, is to take effect in mid-December [2] — says the office will register only works that were created by human beings.”

This is the first major revision in over twenty years and is an internal manual, so it does not have the force of law.  But it’s still significant.

Copyright suitability is dependent on that the work “was created by a human being,” and only protects “…the fruits of intellectual labor” which are “founded in the creative powers of the mind.” Animal ownership is expressly excluded. (Section 306 – The Human Authorship Requirement). Pantomimes performed by a machine or robot are similarly, expressly non-copyrightable. (p.527) and continues:

“Similarly the Office will not register works produced by a machine or mere mechanical process that operates randomly, or automatically without any creative input or intervention from a human author.” (p 55)

The Telegraph article {August 6th} by Matthew Sparkes, said:

‘In its report Wikimedia said that it “does not agree” that the photographer owns the copyright, but also that US law means that “non-human authors” do not have the right to automatic copyright of any photographs that they take.

“To claim copyright, the photographer would have had to make substantial contributions to the final image, and even then, they’d only have copyright for those alterations, not the underlying image. This means that there was no one on whom to bestow copyright, so the image falls into the public domain,” it said.’

One would think common sense would mean that without the work by British photographer David Slater, there would have been no photograph. That his travel, equipment preparations and interaction with the animals was ‘substantial contribution’.

I wonder, could this become a significant argument in the future of copyright and access to material in the public domain?  Because the argument came down NOT to whether a monkey can own copyright, but whether there was any human in which copyright was vested.

copyright

 

Photography is changing. Increasingly technology is being used to take pictures. If photographic copyright depends on human ownership, I wonder if the way is opened for claims to creative images produced by drone or other forms of AI? I don’t know, and copyright law, is best left to experts but I’d like to ask the questions I have. I’ve read UK and US legislation, around ownership, and around use of computers, but it could appear to an ordinary lay eye, that technology is evolving faster than the laws to govern it. Users and uses growing in hobby and commercial markets perhaps even more so.

In UK legislation:

“In this Part “author”, in relation to a work, means the person who creates it.”

“In the case of a literary, dramatic, musical or artistic work which is computer-generated, the author shall be taken to be the person by whom the arrangements necessary for the creation of the work are undertaken.” [Copyright, Designs and Patents Act 1988, Section 9]

It is easy to see how the macaque can slip through in UK law here, as it is not computer generated. And in the US non-human is clearly defined and excluded. But my question is  how do you define computer-generated? At what point does copyright depend on autonomy or on arrangements by human-intervention?

Remember, in the US, the Office will not register works produced by a machine or mere mechanical process that operates randomly, or automatically without any creative input or intervention from a human author.” (p 55)

“Katsu pilots the drone remotely, but every movement is translated through the machine’s need to keep itself aloft and it adapts his directions.”

Where do you draw the line?

Why does it matter today at all?

It matters because copyright law is a gatekeeper and gateway. It makes it commercially viable for creators to produce and make work available to others. It defines responsibilities. One question I ask, is that if it’s no longer worth it, will we be worse off for not having the work they may have otherwise produced?

The market for work produced by or via drone,  is just becoming to hint at becoming mainstream.

The use of drones in photography, for example in hard to reach situations in useful functions like flood mapping will be of great service. Other uses in sports such as alpine skiing, canoeing, or extreme sports is only likely to increase by amateur, professional and commercial users. Stick a go-pro on the drone and it can get footage from places without the need for an accompanying person.

What questions might it raise for artists & creators today?

Specifically on art and copyright:  will this ruling affect what types of images are worth taking? Will it make some work non-commercially viable, or their value determined by the channels of distribution rather than creator? Will this Wikimedia ruling affect the balance of power between creator and  commercial channel providers, in terms of ownership and distribution? I believe it rather serves to highlight where the balance is already.

Have we lessons learned from the music and book industry that apply here? (Clue: they both start with vowels and control distribution.)

Will the decision now go to a UK court and become a clarified legal position?

David Slater reportedly faces an estimated £10,000 legal bill to take the matter to court, said the Telegraph. At very best, this situation  is disrespectful to him and leaves a bitter aftermath, in the question of the power between artist and distributor.

At worst, we could be on the cusp of being left behind in a brave new world of ownership and control of art and knowledge. A world in which actions may be taken through our technology, the product of which no human is deemed to have ownership.

So how does that affect responsibility?

If it has been legally defined, that there is no human copyright ownership for the product of the action by something non-human, where do you draw the line for human responsibility? Am I not responsible for the actions of anything non-human I own? If an animal I own, creates a road traffic accident, am I responsible for its actions? If so, then why not for artwork it creates? If there are differences, why are there differences, and where does the line of responsibility get defined and by whom?

Where are the boundaries of responsibility if we start to distinguish in law between ownership of the result of a task a human set up, but did not carry out? David Slater enabled everything for the photograph to be taken, but did not press the shutter.

I ask: “is the boundary of responsibility undermined by weakening the boundaries of ownership and definition of autonomy of action?”

I believe copyright, ownership, responsibility and non-human authorship is about more than this man vs macaque debate. Will we leave it at that and learn no more from this? If so, then the real monkey is definitely not the one in the picture.

What about considering wider impacts?

In broader context, I believe the public should be asking questions to stay ahead of the game in terms of all legal rulings, and consider carefully the idea of non-human creation and ownership. We should  ensure that both State and commercial uses of drone are not set in place, from which we need to play catch up later. We should be driving the thinking to help shape the society we want to see, and shape the expectations of commercial and State use of drone technology.

What of the drones we cannot see, never hear and yet seem to be supported by our Governments? State surveillance piggybacks commercial infrastructures and tools in other fields, such as communications and social media. We should stay ahead of how drones are increasingly used commercially (as in Amazon pilot news) and we should demand much greater transparency of the existing drone use in our name, in security, surveillance and weaponry. [ added 29 Aug 2014 > also see BT case in CW investigation].

Who controls government decisions and the ethics of drone or robot use? In all of these questions, it comes down to – who’s in a position of power? With power, comes responsibility.

The ethics in use in war zones and in other military action, seen and unseen, is also something we should be asking to understand. To date, much of the public dismisses drone use as something which happens somewhere else and nothing to do with us.

But these decisions do affect what is done in the name of our country and that does indirectly, reflect on us, as its citizens.  These decisions will shape the future commercial uses which will affect us as direct consumers, or as indirect recipients of their impacts on wider society.

There’s lots to think about, as drones develop into tools of art and applications in daily life. I know little of the legal aspects, what has been done already or is being considered today, or what will be in future. I just know, I have lots of questions as an everyday parent, considering what kind of society I hope my children, our future adult citizens, will inherit.  Where do I ask to find out?

My questions are not so much about the technology or law of it, at all. They come down to its ethics, fairness & how this will shape the future.  As a mother, that is the responsibility I bear for my children.

Will we see drones soon in ordinary life or in an everyday future?

In this Wired article, Karl VanHemert states part of Katsu’s aim with the drone is simply to raise questions about the transformative effect the machines might have on art. He plans for it to be Open Source soon. Some argue that tagging is not art, but vandalism. You can see it in action via Motherboard’s video on YouTube here. Suggesting property marking will become a blight on society, you can ask what purpose does it serve? Others suggest drones could be used precisely to paint over graffiti and be of practical uses.

In Scotland it is a well known joke,  that once the painters have finished repainting from one side of the Forth Road Bridge to the other, it’s time for them to start again. Perhaps, those days are over?

Will we see them soon in everyday occupations, and will it make a difference to the average citizen? In commercial service, the mundane estate agent [no offence to those who are, you may be 007 or M in your spare time I know] is reported to be one of the commercial market sectors looking at applications of the photographic potential. It could replace cameras on long poles.

“Unmanned drones can be used for a range of tasks including surveying repairs and capturing particularly good views from unusual angles. ” [Skip Walker, stroudnewsandjournal.co.uk]

These uses are regulated in the UK and must have permission from the CAA.

So far though, I wonder if anyone I’ve met flying a hobby drone with camera over our heads (veering wildly between tent pitches, and enthralling us all, watching it watching us) has requested permission as in point 2?

Regulation will no doubt become widely argued for and against in the public security and privacy debate, rightly or wrongly. With associated risks and benefits, they have the potential to be of public service, entertainment and have uses which we have not yet seen.  How far off is the jedi training remote game? How far off is the security training remote, which is not a game? How is it to be governed?

I have a niggling feeling that as long as State use of drones is less than fully transparent, the Government will not be in a rush to open the debate on the private and commercial uses.

Where does that leave my questions for my kids’ future?

Where is the future boundary in their use and who will set it?

The ethics of this ‘thinking’ technology in these everyday places must be considered today, because tomorrow you may walk into a retirement home and find a robot playing chess with your relative. How would you feel about the same robot, running their bath?

Have you met Bob – the G4S robot in Birmingham – yet?

“While ‘Bob’ carries out his duties, he will also be gathering information about his surroundings and learning about how the environment changes over time”

“A similar robot, called ‘Werner’, will be deployed in a care home environment in Austria.”

How about robots in the home, which can read and ‘learn’ from your emotions?

I think this seemingly silly monkey-selfie case, though clearly anything but for the livelihood of David Slater, should raise a whole raft of questions, that ordinary folk like me should be asking of our experts and politicians.  Perhaps I am wrong, and the non-human author as animal and non-human author as machine are clearly distinct and laid out already in legislation. But as the Compendium of U.S. Copyright Office Practices [open for comment see footnote 2] decision shows, at minimum the macaque-selfie shoot, is not yet done in its repercussions. It goes beyond authorship.

Who decides what is creative input and intervention vs automatic or autonomous action? Where do you draw the line at non-human? Does Bob – the G4S robot in Birmingham – count?

We may be far off yet, from AI that is legally considered ‘making its own decisions’, but when we get to the point where the owner of the equipment used has no influence, no intervention, of what, when or where an image is shot, will we be at the point where there is, no human author? Will we be at the point where there is no owner responsible for the action?

Especially, if in the words of Katsu,

“Eventually…the drone will develop a creative mind of its own.”

What may that mean for the responsibilities of drones & robots as security patrols, or as care workers? Is the boundary of responsibility undermined by weakening the boundaries of copyright, of ownership and autonomy of action?

If so, photographs being shot, without a legally responsible owner, is the least of my worries.

****

[1] Significant files ref: http://infojustice.org/archives/33164  Compendium of US Copyright Office practices – 3rd edition > full version: http://copyright.gov/comp3/docs/compendium-full.pdf

[2] Members of the public may provide feedback on the Compendium at any time before or after the Third Edition goes into effect. See www.copyright.gov/comp3/ for more information.

 

 

art, women, words

“You just put your lips together and blow.” RIP Lauren Bacall

Film fans around the world will feel another loss today, as the death of Lauren Bacall was announced.

The Huffington Post:

“Lauren Bacall, one of the last stars of Hollywood’s Golden Age, has died. [..}

… it was for her four films alongside Humphrey Bogart for which she will be best remembered.

“Bacall married Bogart in 1945, the couple going on to have two children, a son and a daughter. The pair remained together until his death in 1957. After Bogart’s death, Bacall married actor Jason Robards Jr, to whom she had a further son.”

Anyone who knows me, knows how much I love classic films. I enjoy their pace, artistry and use of language which is often so different in contemporary film making. I am a fan of the forties style. I also love the audacity and spirit of fun which is portrayed in that era of Hollywood leading ladies.

Lauren Bacall’s screen glamour and quintessential attitude will forever be immortalised in lines from To Have and Have Not, the film in which she met Bogart.

“You know how to whistle, don’t you, Steve? You just put your lips together and blow.”

The idea of a woman capable of something a man was not or that she could be his equal, was slightly tongue in cheek, but in fact a critical component of the development in society at the time. In the Second World War, notions of what women could and could not do were tossed aside, as women whether in the workplace in manufacturing or agriculture, replaced their men at war. Clothes and looks, and attitudes to sexuality and marriage, were changing. Post-war there was turmoil as roles were realigned. Some of this was reflected in film of the era, women were often dutiful housewives or dangerous femmes fatales. Bacall straddled both in real life and on screen.

Attitudes to women’s role in society and post-suffragism politics were changing. Bacall played an active role here. During the late 1940s, together with Bogart and others, she set up the Committee for the First Amendment. Though widely noted as naive, it was an attempt to stand up to the attacks on Hollywood by the House of Un-American Activities Committee (HUAC), to defend free speech and political rights.  Much as one would see the Blacklist thirty years later portrayed in The Way We Were [1973] by Barbra Streisand.

Lauren Bacall saw much change in views towards women in society in her lifetime. But that passing line, in her breakthrough film points to one small, insignificant thing which does not seem that much changed, then or now. I find it can still be seen as mildly inappropriate or surprising by some today. A woman whistling in public. Not a wolf whistle, diet-soda-would-be-proud-at-that-misfired-act-of-equality style whistle. But a tune. A rip roaring rousing melody.

Some of the most simple things in life, bring the most pleasure.

Today it is rare that I meet another women who likes to whistle, at all, never mind as much as I do. When in towns in pedestrian underpasses, in deserted London Underground tunnels or in the car. Wherever I can get a good acoustic. But occasionally I’ll forget to stop if someone should unexpectedly stumble into the soundwaves. And quizzical glances, little smiles, half comments reveal, it’s maybe a little less usual. But perhaps we should celebrate simplicity more often. It’s fun to whistle, as it is to sing. And perhaps it’s OK to be a little different, a characteristic Director Howard Hawkes who discovered Bacall, sought out and strove to preserve.

It was her film acting which made her name and found her leading man in all senses. For Lauren Bacall, Bogart was the love of her life. My favourite of their films, The Big Sleep, will no doubt be the source of headlines today.

She worked on Broadway in musicals, gaining Tony Awards for Applause in 1970 and Woman of the Year in 1981 but it was her performance in the film, the The Mirror Has Two Faces which earned her a Golden Globe Award and an Academy Award nomination. In 2009 she received an Honorary Oscar “in recognition of her central place in the Golden Age of motion pictures.”

Amongst her own achievements, it may be she will be best remembered for what she shared together in the classic black and white era with Bogart, part of the glamorous couple. She hoped that she would be remembered more for herself.  For me,  she was unique, distinct and different in film noir. It’s her independent, grown up sassiness for which I’ll remember her on screen, and the glimpses into her strength of character I admired in real life.
“You know how to whistle, don’t you, Steve? You just put your lips together and blow.”
art, communications, not health, words

I won’t be unoriginal – RIP Robin Williams

Good-Will-Hunting-Rowboat-Painting-facsimile-davesgeekyideas
The boat painting in the film Good Will Hunting, by the Director, Gus Van Sant

 

 

 

 

 

 

 

From The Huffington Post:

“Beloved actor Robin Williams was found dead on Monday, police reported. He was 63.

According to his publicist, Williams had been battling severe depression.” (Huffington Post, August 11th)

As a teen, we’d all seen Dead Poet’s Society in which he played inspirational teacher, John Keating. We didn’t just watch it. We felt it. “Oh Captain, my Captain.” It was a film which allowed us as teens to discuss suicide. He taught us something of self expression, through fiction. He inspired us to indeed, seize the day. Carpe Diem. We felt his awkward authenticity. Or perhaps, his real-life authentic awkwardness. He had to manage his mental health publicly. There were occasions when you could see through the exterior, and see how hard that was.

One of my favourite of his films, is Good Will Hunting. Whilst cliched fiction, I have always enjoyed the park scene, in response to the boat painting discussion in which Will (Matt Damon) disrespectfully hits raw notes in Sean’s (the role played by Williams ) life. Matt Damon’s character hits out at criticism of his chosen path in life and avoiding the expectations of others. He counters, “At least I won’t be unoriginal.”  That is perhaps a comic’s greatest fear.

Whilst playing a psychologist, and asking his client to open up, Williams manages to do the same for himself on the screen. He somehow touches a genuineness in that role, perhaps revealing an ability for self-examination which not all of us possess. Whilst playing a character, I believe in that role we see much of what it meant to him being authentic as an actor and as a human being. He discusses the value and need we have of revealing who we really are. The importance of being oneself. And the grit of authentic experience. Comics are famous for being less than happy on the inside. Extrovert exteriors can be used to mask the inner storms and insecure introvert.

We, Joe Public outsiders, will never know the real Robin Williams, but I believe this WTF radio interview with Marc Maron captured some of the authentic him, from 2010.

It comes with a ‘bad language’ warning if the title doesn’t give it away (mainly at the start): WTF interview April 26, 2010.

Mark gets Robin talking about playing the early days Mork, stand up clubs in the seventies and fellow comedians and experiences, learning his art. He talks about fears and authenticity, plagiarism and ‘the celebrity’.

The art of being a comic seems to have been fraught with fear of failure and fear of feelings, but a need to use them to engage with an audience. “What do you do with the anger? What do you do with the fear? ” He openly agrees with the interviewer, ”Big Time”. But he also shares how he deals with them. He shares his optimism on second chances, on alcoholism and heart surgery. He talks about divorce and living ‘in a different game as two units’, and how well his family manages it. They talk about sharing insecurities with the audience, and where they draw the line between sentiment and overstepping the mark, looking for approval from the audience. Effectively wanting to know from them, the universal question which makes the world go round, “do you love me?”

Talking about therapy they close by talking with humour, he puts the whole subject of dying over in the WTF category. He reveals through comic interpretation, discussion with his conscience. There is a fine boundary between his comedy humour and revealing his innermost thoughts. There may be many wondering about that interview today.

He was loved, popular with close colleagues and the wider worldwide audience. He will be missed. Most of all by his family, friends and those he knew, who should grieve in privacy. Let’s hope curiosity in the celebrity will permit them that.

His acting has been part of my life since I can remember watching films, and he touched the lives of many he will never know. My kids have laughed raucously watching him as Professor Brainard in Flubber only this week, in the summer holidays.

He was the deep Sean McGuire. He was the humorous DJ, Adrian Cronauer. He was the desperate & committed parent in Mrs. Doubtfire. He was engaged John Keating. He was the Fisher King. He enjoyed exploring dark traits in characters such as in the role of photo shop technician-turned-stalker in One Hour Photo. At the heart of each one was a glimpse into a conflicted character.

He was so much more. He was original. He was it seems, the very complex, Robin Williams.

Thank you, and Good Night.

****

Added Aug 13th: I believe there is a need for society to be able to talk about suicide, as there was when it was raised through Dead Poet’s Society. But how we do it, still needs sensitivity and adjustment.  

The Samaritans called for extra care of reporting after news stories on August 13th breached guidelines. Their number: 08457 90 90 90

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

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

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

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

Part two:

What is the expectation beyond 2017?

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

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

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

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

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

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

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

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

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

a) some cost participation by the participants? and

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

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

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

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

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

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

Are we measuring the costs and benefits?

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

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

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

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

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

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

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

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

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

Is society prepared for this?

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

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

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

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

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

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

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

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

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

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

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

Clinical environment changes make engagement and understanding harder to achieve

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

These are all questions we should be asking as society

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

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

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

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

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

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

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

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

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

Managing change

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

******  image source: ESA via Nature

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[15] BBC Newsround: Rosetta spacecraft and the comet chasing

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

*****

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

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

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

 

*****

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

Launching genomics, lifeboats, & care.data

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

“The UK is set to become the world leader in ground-breaking genetic research into cancer and rare diseases, which will transform how diseases are diagnosed and treated, thanks to a package of investment worth more than £300 million.” [DH press release, August 1 2014. [2] ]

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

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

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

George Freeman_ 100K

This was the next step in the programme, hailed as an historic moment, a giant leap forward for genomics.

The photo call for the symbolic signing included Jay Flatley President, Chief Executive Officer and a member of the Board of Directors of Illumina, Inc, Sir John Chisholm Executive Chair of Genomics England & Chair of Nesta, together with Dame Sally Davies Chief Medical Officer and Mr. George Freeman [George 2] MP for mid-Norfolk, and the newly appointed Life Sciences Minister.

Fewer than twelve months before an election the Government has decided to commit commercially to a US based company, in a programme which Mr.Cameron himself said,  has had controversy. That c-word is one the Conservatives will want to avoid in the coming election campaign.

This Channel 4 [4] film from almost 2 years ago, (December 2012) raises many questions as valid today as then. At that time, in contrast with today’s approach, the programme suggests that consent for research and data use would be assumed for all.

The inestimable Jon Snow asked then, why is the Business Department announcing this [the launch of the pilot programme, when focused then first in rare cancers]? The public may understand that commercial pharma, charities and the State work hand-in-glove (as Mr.Cameron’s 2011 vision stated), but as Jon Snow asks, not yet understand how this commercial venture will benefit the NHS long term as well as individual patients and the public as a whole? Is it concrete on benefits to patients vs benefits to UK plc?

So what was the key press message which came over?

The coverage of the week since August 1st, expounded the belief that through Genomics England Ltd we will do away with  chemotherapy in the future. I believe this should be the source of a raging debate, but it passed by with little more than a few waves.

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

The original review given last summer to Genomics England including listing the rare diseases which may affect the 6% of the population, suggests one consideration, targeting those with very high likelihood of familial links and therefore success.[6] or Patients selected with a high probability of a single gene disorder. There are obviously great challenges in turnaround time for the genetic processing to be useful in clinical decision making. Considering whether or not it is timely or accurate enough to be of clinical benefit in acute cancer care clinical decision making will be vital. It is also what is being promised to patients who sign up, a faster, more efficient, improved offering on what is available already in the NHS genetic services today.

The interested population and profession would do well to get an independent medical update on the status of this, to understand it better if this is now established and its reliability, so what participants sign up for, is what they get on the tin:

“Results are provided for patients in a timely fashion (e.g. within 8 weeks) and with sufficient clinical accuracy (not yet established for WGS) [whole genome sequencing].” [page 3 of 8]

And what was the press result and public reaction to the news?

As one example, look at lunchtime on Friday August 1st, Radio 2 callers to the Jeremy Vine show. They included two undergoing chemo who felt they had to call  in, to tell others, chemo is not always as bad as it sounds and make sure you don’t give up on it, refuse treatment or wait for this new genetic solution.

The impression was given, there is a new wonder solution within grasp on the horizon. This seemed to me rather reckless and unfairly manipulative on the ill and vulnerable to give them a blanket hope, that their cancer treatment may become so much better, soon. These are real people’s lives, not guinea pigs with which one can feel free to trial hypothesis and hype. If anyone now refuses chemo as a result of the Friday fantasy projections, their health may have been directly impacted. I would like to have heard a DH or Genomics England press manager speaking, not allowing such public free rein, to ensure it was factually accurate. But I’m guessing that Genomics England as an ALB is not really ready for press yet [their public engagement and education programme isn’t ready yet they confirmed when asked in July in an FOI],  and the DH perhaps at arms length, thinks, it’s not their responsibility and outside their remit. Stuck in the middle, we have the commissioning body, NHS England.

How might this involve all of us, our NHS and cross into care.data?

In most recent memory, NHS England tried and so far failed in February 2014, to engage the public and clinicians in the extraction of our GP stored health records, in the care.data initiative. Care.data languishes in some sort of unknown black hole at the moment, with little public engagement and pilots promised ‘for autumn’. Both programmes are run under the auspices of Mr. Kelsey at NHS England Patients and Information Department, and arms length from the Department of Health. Last summer, Tim Kelsey and Sir Bruce Keogh presented a paper to the Board on Genomics and its interaction with NHS patient records. [7]

Given that the Genomics paper indicated that care.data and NHS held patient records were of paramount importance to NHS England I would like to have seen more transparency over this, including informed public and parliamentary debate:

“Issues of data ownership and transparency are of paramount importance to NHS England as set out in the Mandate and given the hugely positive developments in Care.Data. Geraint  Lewis is leading this work, and has begun work to consider how the sequencing data might be held, connected to patient records and subsequently be exploited. It will also look at the connections between this work and the establishment of care data in the NHS. The NHS England data and informatics team will retain oversight of the informatics and data work and discussions continue on how it can best inform and support the implementation of business plan of Genomics England Limited.”

NHS England Board paper, July 2013 [7]

There has been almost no public statement from NHS England on genomics and our data management in the same discussion, until now. George Freeman MP [2] said on BBC Radio 4 (Starting from 2:46.30 in interview with Sarah Montague:

“It’s absolutely not the care.data initiative discussed earlier in the year. This is 100K patients, all volunteering and all providing their consent. It’s completely anonymised data in the data set, the only person who would be able to come back to the patient and make a link with the genomics and the diagnosis, is their doctor. We’re creating a database so that NHS researchers and industry researchers, can look at the broad patterns. 90% of patients with that variation, get that disease, this drug works in 50% of patients…It’s completely anonymised, there is no basis on which you could make the link. The only person who can make the link is the NHS clinician.”

Whilst this is NOT the same initiative, it intends to use some of the same data for those people who actively consent to participate in the 100K Genome Project.

The data will be extracted from care.data [which ‘assumes consent’ or requires active opt OUT, depending how you view it] to include longitudinal, phenotype data across a person’s lifetime. I spoke to the Genomics England media team last autumn, 2013, which confirmed this intent at that time.

The trouble is for Mr. Freeman [2] and these statements, that the public knows ‘anonymous’ in care.data turned out to not be anonymous at all.  ICO and HSCIC [8] are still working this out. [HSCIC has just published its first review of pseudonymisation review 9] It was discovered that far from being released only to clinicians and researchers, our hospital data has been shared with all sort of unexpected third parties, without consent. [see the Partridge Review]. This surprised and shocked many, to public outcry and the resultant loss of trust [15] in the programme has yet to be rebuilt. So some listeners may well and understandably have had concerns that their data may be used for purposes to which they have not agreed.

Some say that genetic data by its very nature, despite stripping data identifiers, cannot be non-identifying, or stay that way:[16]

“It only takes one male,” said Yaniv Erlich, a Whitehead fellow, who led the research team. “With one male, we can find even distant relatives.” [Jan 2013]

“If they choose to share that’s a very admirable thing because by sharing freely, progress for everyone is accelerated, and if someone is not comfortable we should respect that too and find ways for them to still participate in research,” he said.

What are the next steps – or should we expect, one giant leap?

As regards care.data from all,  it is I believe reasonable,  that we should we ask: how we should expect our care.data to be used, and trust for what restricted purposes it will be extracted and stored for the future?  What mechanisms will separate consent for care.data commissioning from this kind of research? How will citizens trust this data sharing now as the Department for Patients and transformation care.data proposals seem still open ended in scope in particular for social care [17], and alongside other ever widening government data sharing? [18] How will the public know where the future boundaries of care.data scope creep lie?

If anything has been learned from care.data to date it must be this: We should  continue to ask for more public involvement in policy and planning,  not just the post-event PR if the state wishes to ensure success and prevent surprises. What happens next for this data programme, and for our national programme of genomics, 100K?

{Part two continues here}

******

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[15] The Royal Statistical Society identifies a Trust Deficit

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

*****

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

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

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

*****

words

That their sighs should not blow there. My hope in haiku.

No sanctuary
but for a stone of stumbling
a rock of offence.

Houses of Israel
mercy from a gin and snare.
All your peoples

broken bodies strewn
bloodied ashen dust blows hot
bomb blasted towers

children, children lost.
Images. Lives left ruins
ragdolls photographs.

And after these things
I saw four angels standing
on the four corners of Earth:

no more dirt tunnels
no din of drone nor ambulance
no burial wail

holding the four winds
that their sighs should not blow there.
In peace, revelation.

 

(AFP Photo / Mohammed Abed)

Refs: Isaiah 8:14 / Revelations 7:1

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The next Big Thing – care.data

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

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

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

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

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

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

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

*****

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

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

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

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

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

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

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

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

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

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

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

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

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

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