Care.data - Getting the ducks in a row

Good Friday has different meanings and traditions across the cultures. For some the most sombre day of their church calendar. For others, another Bank Holiday and start of the long weekend in spring. For Mr.Cameron this year, getting stung by a jelly fish abroad.

For me, visiting family in a small nordic village, it's the day of the annual duck race fundraiser.

2,000 numbered plastic ducks are thrown into fast moving water high upstream, and the public waits and watches anxiously as the toys approach the central village bridge and race beyond. The first to hit the finish line net at the weir after an arduous course, is the winner.

There are lots of obstacles along the route and some ducks get stuck. Children are allowed to pick up those off-track in side eddies and hurl them back into the main channel. As a parent, you inevitably lose your child at some point in the crowd, fret they may have joined the ducks for a swim, and the whole race always takes longer than we expect.

So, it feels, as a citizen and patient, is the current progress of care.data.

There was a misjudged start. There's lots of obstacles still to overcome. It looks like the finish line is getting clearer. And some believe it might take longer than first thought.

Whilst on holiday I've taken time to read over the recent letter, to colleagues, from Tim Kelsey & NHS England. It's addressed to colleagues, which I'm not, so perhaps it feels a little like looking over someone's shoulder on the train, but hey, It's the only update we've got.

Looks like some positive acknowledgements and steps are in progress:

• We will work with stakeholders to produce support materials, such as an optional template letter for patients and ways of making opting-out more straightforward
• We need to do more to ensure that patients and the public have a clear understanding of the care.data programme
• This work is continuing and we will update you on these changes separately 
  
• We want to hear your views and suggestions so we can take action to improve and build confidence in the care.data programme. We will also be engaging with patient groups, GPs and other stakeholders through local and regional engagement events

Notably, it's the first time NHS England has said opt out. In the past it has only ever been an objection. As a linguist, language is important to me. And the two are not synonymous no matter how often I may be told by NHS England that they are to be used interchangeably.

It's the first time there really feels like more give, and less we'll take without asking you first.

And it's the first mention towards offering local and regional engagement.

There are some new hints which need explanation, such as a change towards who may use the data - described always as for secondary uses, clinicians and patients using it is new:

"Care.data is an initiative to ensure more joined-up data is made available to clinicians, commissioners, researchers, charities and patients."

And there are some ideas which are making progress, but seem a little stuck.

"In addition, steps have already been taken in making changes to the law"...

Whilst changes have been put into the Care Bill, other rather sensible ones, such as legal penalties for data misuse were rejected. And the purposes are still so loose as to be possible to give data for a wide range of 'health purposed' clients. That was the day in which it appeared fewer than 50 MPs were in the chamber to hear the Care Bill debate in which nearly 500 came in to vote. (How they can reasonably and effectively vote on something in which they did not hear the debate, I don't understand.) These are legal changes I believe which need hurled back to Parliament to get them on track again.

Experts much wiser than me, have made a proposal of comprehensive amendments, and seem, from my lay understanding, both really positive and practical.

The "optional template letter for patients" may be something GP practices could consider using to contact individuals where they know that leaflets were not delivered. Even Dame Fiona Caldicott did not receive hers. (BBC PM listen from 33:30)

If centrally, it is known where they did not reach patients, it would be helpful for GP practices to then be able to evaluate if there is an additional need to contact their patients. For example, in my area, no one I have spoken to received a leaflet.

Perhaps that might seem trivial now, and in the past, but for trusting the scheme I believe it is really important to know why that was. Because since no opt out was originally planned I want to know that the intention was truly to tell us all. Did they print enough? Distribute enough? Follow up at all? I've asked to find out.  After all, it was our state money that paid for it. A previous Freedom of Information request, on the status of its distribution with Royal Mail, from Phil Booth of MedConfidential appears to contradict ministerial mutterings that said an exception was invoked. I know that for myself, I had not opted out of junk mail, yet I still didn't get one. I knew to look out for it and inspected my pizza flyers and dog walking leaflets in every post in January. No leaflet and all of my friends were the same.

If the experts such as Dame Fiona, the GPES advisory group which in September had:

"major concerns about the process for making most patients aware of the contents of the leaflets before data extraction for care.data commenced" 

and ICO felt the leaflet went out with the wrong content and was rushed then I want to know why, so that the same people are not making the same decisions, and will cost us time and trust again. Why it went ahead against every expert's better advice is important to understand. "Regrettable that you are not now able to take any of our comments into account" was ICOs comment and the sentiment seems echoed by Dame Fiona on today's radio broadcast.

Even a lay person like me, could see it was a disaster about to happen.

My suggestion, was that role-based patient communication would be much more understandable. Take some stereotypical sample citizens, map their 'day-in-the-life' using HSCIC data systems, show how these interactions send data to HSCIC and map them to show what data is extracted and where it goes, is stored and may be viewed and distributed by whom. There are an awful lot of individual scenarios so no model may match any real patient experience, but looking at it backwards, take all the HSCIC systems and extract a situation which would send the data up. A&E, School nurse, Electronic Prescription Service, Choose&Book, GP screening. Mental health call centre. It would be possible.

People should know what data, is extracted when, why and who will use it. Visuals are better than words. The leaflet failed in the case of care.data, but would an individual letter have achieved more, in just a few sentences?

More has been achieved to raise our awareness of the Health and Social Care Information Centre and Government uses of our health data, through all the hoo-ha in the press, and the re-tweet by David Nicholson of the care.data downfall parody, than by the original leaflet. Perhaps the leaflet's measure of success was not intended to be a 100% reach at all. I hope we'll understand more soon.

(** for updated thought 19th April see note below.) Should we presume an 'optional template' means that no paid letter will be provided from NHS England to all? GP practices may decide to use the 'optional' template to send out letters now. Professor Mathers had called for one. But I wonder if GPs themselves will be expected to bear the cost, of an imposed central initiative for which there is no choice to participate and yet the GPs are legally liable Data Controllers for complaints? If no funding is offered, and GP practices decide not to send letters out, it would seem a risk trade off. The risk of a patient complaining or indeed legal action, if they did not know their data was going to be extracted and and potential risk for harm ensued. Yet fair processing should be a Data Protection Act requirement. But is it for care.data?

This week also saw the list of number of patients published by GP practice. Helpfully with postcode. So if my practice were to want to post a letter to every patient in my area, at 53p second class, it would cost around four thousand pounds. I don't know if they get any bulk discounts and one per household might reduce numbers. But that's a lot of money - but perhaps (**) it may be covered centrally after all, though the letter does not indicate that? (I now also know how few over 90 yr old men are registered, if interested).

It seems like there is much positive going on in the undercurrents of the care.data developments, which the general public cannot see, such as the care.data advisory group work-in-progress.

There would seem much which needs work in a very short space of time for relaunch in autumn. But if Dame Fiona Caldicott, Chair of the panel set up to advise NHS and Ministers on the use and governance of patient information, said she thinks we need longer, then I am sure she is right. To take as long as is needed to get it right would seem sensible. To rush and fail a second time, would be irretrievable. Surely, her advice would not be ignored again?

The HSCIC this week also released the Framework Agreement between the Department of Health and HSCIC. 

It will be interesting to see if this affects and changes the HSCIC roadmap. In my opinion, it should. The care.data addendum to widen commercial uses was pushed back but is still to resurface. There is still no clarity around commercial re-use licenses. These commercial drivers should come out if Mr.Hunt's rock solid assurance is to be believed which, "puts beyond any doubt that the HSCIC cannot release identifiable, or potentially identifiable, patient data for commercial insurance or other purely commercial purposes."

At the moment I would hope the HSCIC roadmap would change in its commercial focus:

"especially in relation to the potential sale of data". 

"Help stimulate the market through dynamic relationships with commercial organisations, especially those who expect to use its data and outputs to design new information-based services."

It remains to see if it does.

That framework is a good read with a hot coffee (and a short snaps if you are where I am). What's missing for me, is any reassurance at all that the HSCIC will remain public. There is a large chapter on what process would need to be followed if it were to change structure or be merged. And therefore does not rule out a private owner of the single central repository for our health, social care, research and recipient of integrated ONS data in future.

"Any change to its core functions or duties, including mergers, significant restructuring or abolition would therefore require further primary legislation. If this were to happen, the Department would then be responsible for putting in place arrangements to ensure a smooth and orderly transition, with the protection of patients being paramount."

It would appear to me, that a future intent to privatise the ownership of care.data and more could remain open. Certain aspects of the day-to-day functions were potentially to be outsourced in a past ISCG roadmap. I would hope the core will remain firmly State owned.

Bizarrely, duck races are not treated equally across the globe. Wisconsin recently repealed their ban. It seems almost as bizarre, as the idea of selling our taxpayer financial and VAT data. Or our school pupils personal details. I wish I could say, one of these stories were not true.

What the duck is going on with Government's attitude to our personal data?  The Cabinet Office seems to be failing to give out legally required Freedom of Information responses, and yet happily selling the knowledge of our health, wealth and our children?

"These regulations also allow the department to disclose individual pupil information, subject to the Data Protection Act 1998, to named bodies and persons who, for the purpose of promoting the education or well-being of children in England are conducting research or analysis; producing statistics; or providing information, advice or guidance. The department may decide to share pupil and children’s information with third parties on a case by case basis where it is satisfied that to do so would be in accordance with the law and the Data Protection Act, and where it considers that such disclosure would promote the education or well-being of children."

So if McDonalds wants to run a healthy eating campaign, would they qualify?

Open Data does not equate (must read) with being open with all of our data. Tables and summaries at aggregated level of statistics are nothing to do with individual level data. Before any Government body considers if they should enable private and other organisations to use data more freely and effectively, and their stance on charging and profit from use of data, they should think twice.

Remember the daft Deregulation Bill 162? It revokes the need to sell pre-packed knitting yarn by net weight and other nonsense. Perhaps it is the 'Exercise of regulatory functions' which is the root cause of much of these  issues on the monetisation of our data:

Clause 63 provides a power for a Minister of the Crown to issue guidance on: how regulatory functions can be exercised so as to promote economic growth;

Sections 60-67 of the Deregulation Act currently passing through Parliament allow the removal of any regulation that conflicts with the interests of a profit-maker. If your body manages data, there's really only going to be one way to meet the obligations of Bill 162. Sell it.

Someone needs to tell all the departments, if you have any chance at all of getting care.data through to the finish line, stop giving away or selling any of our personal data which we trusted you with for an entirely different original purpose.

Whilst there are many people working on many manoeuvres to get all the ducks ready to relaunch for care.data, the Government has to pay attention to the whole race. If we lose faith in the Government to make wise decisions on what will be done with all data we share for a given purpose and find later it is given to others without our knowledge, we won't trust it with our health data. If the data warehouse may one day be sold off, then all the gameplanning and rules in between will appear to have been pointless.

This is not a race to the finish with the least bad option. Care.data needs to be exemplary if it is to have any chance of reaching the podium as the world leader in patient data-sharing management. It's got one second chance to get a relaunch.

Without public trust it will flounder. Without GPs to patient communications thoroughly thought out it and funded, it is destined for a rough ride. Without further legislative changes, it's not going far enough to be convincing of real commitment to change.  Without these three, it will not reach the finish line.

The best summary of why we need still much work and how to respect so many of these under good governance, came out this week, from the Chair of CAG. "However, we cannot expect to have all of the answers in six months time. The commitment must be an ongoing one to continue to consult with people, to continue to work to optimally protect both privacy and the public interest in the uses of health data."

So between Dr. Taylor and Dame Caldicott the wise seem to indicate more than 6 months is needed.

There are encouraging signs, but many issues don't seem to be addressed yet at all, from the recent NHS England letter nor Framework Agreement. Above all, in common with the tax data sharing, pseudonymous is not equal to anonymous. It's not only what HSCIC currently determines as identifiable, which we need vital improved governance to protect.

In any upcoming public communications, I pray don't patronise the public saying that 'name and address will not be extracted' as the last FAQs and poster did. Explain instead what the Personal Demographics Service stores already, educate us how the PDS and linkage works and why. Details like this must not get lost in any rushed relaunch.

And other departments' decisions must not put it in jeopardy.

Whilst care.data is getting its ducks in a row, the wider Government approach to data management seems to have gone, I can't help but say, absolutely quackers.

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** 19th April Update: Reliable comment says if GPs get patient letters made available they only have to address them to send to their patient list. Will this happen in this case? Good news for informed communications? Let's hope so. 

What is Care.data? Defined scope is vital for trust.

It seems impossible to date, to get an official simple line drawn around 'what is care.data'. And therefore scope creep is inevitable and fair processing almost impossible. There is much misunderstanding, seeing it as exclusively this one-time GP load to merge with HES. Or even confusion with the Summary Care Record and its overlap, if it will be used in read-only environments such as Proactive care and Out-of-hours, or by 111 and A&E services.  The best unofficial summary is here from a Hampshire GP, Dr. Bhatia.

Care.data is an umbrella initiative, which is planned over many years.

Care.data seems to be a vision. An ethereal concept of how all Secondary Uses (ref.p28) health and social care data will be extracted and made available to share in the cloud for all manner of customers. A global standard allowing extract, query and reporting for top down control by the men behind the curtains, with intangible benefits for England's inhabitants whose data it is. Each data set puts another brick in the path towards a perfect, all-knowing, care.data dream. And the data sets continue to be added to and plans made for evermore future flows. Pseudonymous, it can be traded around the globe without consent. The key to making the jewel-in-the-crown, biomedical research, earn the UK ill-defined, unknown rewards.

Whilst offering insight opportunity for top down cost control, planning, and 'quality' measures, right down to the low level basics of invoice validation, it will not offer clinicians on the ground access to use data between hospitals for direct care. HES data is too clunky, or too detailed with the wrong kinds of data, or incomplete and inaccurate to benefit patients in care of their individual consultants. Prof Jonathan Kay at the Westminster Health Forum on 1st April telling hospitals, to do their own thing and go away and make local hospital IT systems work. Totally at odds with the mantra of Beverley Bryant, NHS England of, 'interoperability' earlier the same day. An audience question asked, how can we ensure patients can transfer successfully between hospitals without a set of standards? It is impossible to see good value for patients here.

Without a controlled scope I do not wish to release my children's personal data for research purposes. But at the moment we have no choice. Our data is used in pseudonymous format and we have no known publicly communicated way to restrict that use. The patient leaflet, "better data means better care" certainly gives no indication that pseudonymous data is obligatory nor states clearly that only the identifiable data would be restricted if one objected.

Data extracted now, offers no possibility to time limit its use. I hope my children will have a long and happy lifetime, and can choose themselves if they are 'a willing research patient' as David Cameron stated in 2010 he would change the NHS Constitution for. We just don't know to what use those purposes will be put in their lifetime.

The scope of an opt-in assumption should surely be reasonably expected only to be used for our care and nothing else, unless there is a proven patient need & benefit for otherwise? All other secondary uses cannot be assumed without any sort of fair processing, but they already are.

The general public can now see for the first time, the scope of how the HSCIC quango and its predecessors have been giving away our hospital records at arms-length, with commercial re-use licenses.

The scope of sharing and its security is clearly dependent on whether it is fully identifiable (red),  truly anonymous and aggregated (green, Open data) or so-called amber. This  pseudonymous data is re-identifiable if you know what you're doing, according to anyone who knows about these things, and is easy when paired with other data. It's illegal? Well so was phone hacking, and we know that didn't happen either of course.  Knowledge once leaked, is lost. The bigger the data, the bigger the possible loss, as Target will testify. So for those who fear it falling into the wrong hands, it's a risk which we just have to trust is well secured. This scope of what can be legitimately shared for what purposes must be reined in.

If we need different data for real uses of commissioning, various aspects of research and the commercial 'health purposes,' why then are they conflated in the one cauldron? Parents should be able to support research without that meaning our kids' health data is given freely for every kind of research, for eternity, and to commercial intermediaries or other government departments. Whilst I have no qualms about Public Health research, I do about pushing today's boundaries of predictive medicine. Our NHS belongs to us all, free-at-the-point-of-service for all, not as some sort of patient-care trade deal.

Where is the clear definition of scope and purposes for either the existing HES data or future care.data? Data extractions demand fair processing.

Data is not just a set of statistics. It is the knowledge of our bodies, minds and lifestyle choices. Sometimes it will provide knowledge to others, we don't even yet have ourselves.

Who am I to assume today, a choice which determines my children have none forevermore? Why does the Government make that choice on our behalf and had originally decided not to even tell us at all?  It is very uncomfortable feeling like it is Mother vs Big Brother on this, but that is how it feels. You have taken my children's hospital health records and are using them without my permission for purposes I cannot control. That is not fair processing. It was not in the past and it continues not to be now.  You want to do the same with their GP records, and planned not to ask us. And still have not explained why many had no communications leaflet. Where is my trust now?

We need to be very careful to ensure that all the right steps are put in place to safeguard patient data for the vital places which need it, public health, ethical and approved research purposes, planning and delivery of care. NHS England must surely step up publicly soon and explain what is going on. And ideally, that they will take as long as necessary to get all the right steps in the right order. Autumn is awfully close, if nothing is yet changed. The longer trust is eroded, the greater chance there is long term damage to data quality and its flawed use by those who need it. But it would be fatal to rush and fail again.

We cannot get into this mess again. If we set the right framework now, we should build a method that all future changes to scope ensure communication and future fair processing.

We need to be told transparently, to what purposes our data is being used today, so we can trust those who want to use it tomorrow.

How have we got here? Secondary Uses (SUS) is the big data cloud from which Hospital Episode Statistics (HES) is a subset. HES was originally extracted and managed as an admin tool. From the early days of the Open Exeter system GP patient data was used for our clinical care and its management. When did that change? Scope seems not so much to have crept, but skipped along a path to being OK to share the data, linked on demand even with Personal Demographics or from QOF data too, with pharma, all manner of research institutions and third party commercial intermediaries, but no one thought to tell the public. Oops says ICO.

Without scope definition, there can be no fair processing. We don't know who will access which data for what purposes. Future trust can only be built if we know what we have been signed up to, stays what we were signed up to, across all purposes, across all classes of data. Scope creep must be addressed for all patient data handling and will be vital if we are to trust care.data extraction.