Last September, a company which helps institutions understand data started a new project. What their client wanted, was to tell whether one category of videos could be distinguished from some others. The project was successful on a test dataset, and they produced a demo. The very happy client forwarded this to their boss, who sent it to their boss, and so on, until then the Home Secretary went on TV to say that the Home Office had better technology than Google for blocking ISIS videos. At no point, was there a need to test or explain whether the demo worked beyond the test data. That seems to be the standard for AI – is data processing a place where the rule of law doesn’t matter?

The Department of Health also launched guidance on “decision making” AIs for use in the NHS. Innovations have always come to healthcare and spread based on understanding – there is no need to throw all past lessons out because a PR budget gets spent. Separately, the “Malicious AI report” is worth reading – but already feels dated as the risks are both real and timely, and political imperatives are rarely spun as malicious.

Given the option for a quick headline and a cheap political point, politicians will choose to score it. With digital systems of any kind, there is a temptation to take a shortcut and claim victory.  The Home Office claimed to have an AI which did what it wanted – by ignoring any real world requirements that made things harder. This is not the greatest of precedents for public bodies using AI tools to make decisions, especially on groups who do not command easy political support.

“Explainability” is just putting in the extra time to test models and understand how they work – rather than selling the first thing that seems to meet the goal. That faster approach may have short term financial benefits, but it can be more widely toxic as an outcome generally best avoided. The Home Office can make this claim for this AI, as it as the first Department to do so; the next claim will be treated with the greater scepticism that it deserves. We’ve put the Home Office statements into the Government’s ethics framework – which again shows the failures of that framework.

‘Trustworthy technology’ needs to address systemic harms. The first mover advantage on AI will go to those with the least moral concerns about real world effectiveness, until there is a clear reputational harm for continuing to work on systems which are known to be damaging. This is why the ‘most successful’ public sector AI project in the UK is from the Home Office – harms to others are something they have never bothered to avoid.

What started out as a legitimate technology project – can AI help identify ISIS videos? –  demonstrating potential, was spun as something else. Had explainability been a prerequisite of that project as being considered a success as it was claimed, (rather than simply a stage of a trial). Where an entity refuses to follow such processes, as in the drug discovery arena, reputable actors should simply refuse to deal with them as that should be one of the requirements of being seen as a reputable actor.  The Partnership on AI was supposed to consider how to address such issues – but companies outside the partnership aren’t bound by their rules… But many of the staff of those outside would not wish to be barred from working there due to other associations (there, of course, must be a way to demonstrate lessons have been learnt)…

The AI guidance from the NHS contains a checklist, written by “industry” and the Wellcome Trust, which is so vague it barely addresses previous problems, let alone handling future questions. There are no considerations of the principles of ‘trustworthy technology’ by developers, nor any references to equivalent protocols for decision making AIs as we have for determining doctors are trained or new medicines are safe. Claiming you have a phase 0 success is one thing (whether a drug or AI), claiming you have a phase 3 success is quite another – and so it should be with machine learning tools that need to be explained.

Many of the greatest failures of the Home Office are due to technical ineptitude. While their policy can not correctly distinguish an arse from an elbow, technology has moved on sufficiently to do it for them, letting Marsham Street ignore the details while delivering the opposite of human flourishing.

Does HMG wish to be permanently excluded from buying from working with partnership members because it chased a cheap headline?  Does the partnership have the willingness to ensure members deliver “responsible” AI? It is the public headlines and narrative that matters, and the biggest headline about AI in Government is that of the Home Office wanting to choose content purely based on a single suprious claim. Government acts as a single customer to their suppliers; and the reverse must be true for AI & ethics.

Data Protection and Datasets of National Significance

Second reading of the Data Protection Bill is in a week – and Government has still not explained the effects of their proposals to centralise data policy in the periphery of Whitehall. As DCMS struggle with a politically led centre for AI data and ethics, announcements like the one from the Home Office will grow. Not because they have solved any problems, but they have done something which redefines the problem as sufficient for the box to get ticked, political claims to be made, and someone else to pick up the pieces. The Home Office does not care about DCMS politics or policy, but which way will Google DeepMind be lobbying DCMS on this?

Lord Mitchell amended the Data Protection Bill to require public bodies estimate the worth of their “datasets of national significance”. Lord Darzi is thinking along similar lines about a new deal with patients. While both good and worthy initiatives that are deserving of time, there is a risk other policies will make them irrelevant.

Lord Mitchell’s amendment mandates an assessment that should be written down, but under current rules, what NHS England or any public body will be forced to write by HM Treasury is that giving data to private companies that employ UK staff, will create new tax revenues from those staff (since company profits go offshore). One NHS trust working with Google might create a nice deal for themselves from some data – but the rest of the NHS will still have to pay a much higher rate.

What will happen when the public understand that this is how their data gets used, and where the money goes?

Even if the Government take the clause out of the Data Protection Bill, whether UK data should be flowing to tax havens is likely an increasingly important question for public debate.  This question is not going away – NHS Digital already do some checks that they’re not dealing with an empty shell company (PHE’s only meaningful step is to check that the fees are in their bank account). Does Government wish to ignore an issue that will resonate with the public on data, or leave in place the small and sensible steps Lord Mitchell added to the Bill?

Enclosed:

• Home Office Data Science Ethics Framework form for their project
• Google DeepMind / RFH and the Wellcome Trust AI checklist
• Other comments on the AI guidance

NHS Digital has published some information on the new “National Data Opt Out Programme”. The information for patients is still missing entirely, and everything else is subject to change.

The new model

The new consent model has the opportunity to do good – and it appears far clearer than the old. But if the loopholes and failures of the past continue to be included in the new model, it will fail in terms of public confidence, just like care.data.

We continue to be promised that every patient who has opted out will get a letter describing the new arrangements, although patients who didn’t opt out may be left in the dark about how their data will be used.

As Dame Fiona Caldicott was asked to create, the new opt out will be a simple question:

“You have the right to opt out of your personal confidential information being used for [these other] purposes beyond your direct care” (Deck A)

While we feared there may be new non-statutory ‘special purposes’ that override the opt out created, there seem to be none. While NHS England, and Public Health England wanted their desire to use data to be more important than any patient’s ability to dissent – the slides currently say that the Department of Health disagrees with them. This is good.

Data ‘anonymised in line with the ICO’s anonymisation Code of Practice’ will be excluded from the opt out, but we’ll come onto that later. The embedding of the list of exclusions in the Deck A list (as above) is probably just going to cause problems for all sides in future years – the language has to work irrespective of how the NHS reorganises next week, and we hope the words in square brackets above are not in the language that patients see.

It was the interactions and nuances between what the public were told, and what public bodies wanted to actually do in practice, which led to the collapses and repeated failure to restart care.data, and which led to its ultimate demise. DH hopes that avoiding sharing details too early will mean no one spots problems until it is too late. That is a theory unlikely to survive contact with the real world – which it has not yet attempted.

A trustworthiness question from medConfidential

What should the response be when a public authority is found to have misled the public about how it used data? What happens when the release register is agreed to be wrong, in a way which is demonstrably misleading? What should a trustworthy organisation do?

The remainder of this blog post is a slightly technical look at various specifics. When the patient information is published, we will write a patient perspective on where things are.

NHS England has started by issuing a tender for suppliers to ACOs and STPs. That doesn’t seem like the ideal place to start.

The loophole that remains

Data that is “anonymised in line with the ICO code” remains outside the dissent from ‘information being used for purposes beyond direct care’.

This is purely a political choice by the Department – while they may feel they have no requirement to cover it, the opt out is a gift of the Secretary of State, and he may decide what it covers, and it is only a minor implementation change to go from one to the other.

Previously, the formulation for the opt out was ‘dissent from data leaving the HSCIC” (or GP) – the focus was on data as it left an institution. And in that, it was possible to argue that it was no longer personal data when it was moving (emphasis on possible).

Now, the formulation is about “use” of data for “purposes beyond direct care”, and is undoubtedly clearer in many ways, but it looks at ‘use’. But someone is going to have to justify to the public how ‘anonymisation’ is a direct care purpose. Less than a week after DH told the Health Select Committee that it believes patients have no privacy right over non-clinical data held by NHS Digital, this looks to be a fundamental flaw, resulting from a fundamental change.

Moving to the formulation to be about use also reduces the scope for the purposes of the “promotion of health”. DH has likely missed (again) the opportunity to explain to patients whether or not “promotion of health” can include promoting McDonald’s salads or alternate tobacco products.

There are clearly cases where 100% of data is needed; but the vast majority of research projects would come to exactly the same answer if they used data for which dissent had been honoured. The Confidentiality Advisory Group was placed on a statutory footing and was deliberately given the ability to give advice to NHS Digital on these questions – but the Government has never got around to even starting that process.

No data recipient is currently asked to justify why receiving 98% of patient data is insufficient – data recipients are not asked whether they wish to receive data on people who dissent from their data being used for purposes beyond direct care. Many academic research projects outsource some of their ethical obligations to the data provider – who in this case, will be ignoring them. Again, the obligations change because of a new focus on ‘use’, and it is unlikely that NHS Digital (and PHE) not asking that question will simply allow ethical researchers to ignore it.

The Department of Health ignoring a problem just means everyone else has to deal with it. That has also not gone well elsewhere (for everyone else, DH may disagree).

The Disease Registries (including cancer)

According to the slide decks, the new opt out will not apply to the cancer registry or other data held by PHE (although after last week, it is expected that this should change – and that has consequences for the system).

If the new opt out model does cover PHE datasets like the cancer registry, this will need to be clearly explained in the letter that goes to patients.

Either way, the ‘cancer charities’ should explain (in a fair way) both the benefits of the new consent model, and the choices that it offers cancer patients (and also what those choices will not protect their community against).

Unlike some other health conditions, those who fundraise for the cancer charities often end up being encouraged to publish sensitive personal data about their diagnosis (such as the type, and date), when fundraising for charities. Where those fields are released unprotected, (whether opt outs are disregarded or not), that may change the institutional conceit around inadequate protection. (But this probably won’t happen until after something goes very badly for a someone to whom they owe a duty of care…).

If the text in the slide decks remains accurate, and there are two divergent dissent systems, it is unlikely that the cancer registry could ever integrate into the NHS and remain a backwater of unlinked and idiosyncratic data sources. That is not a good outcome for those who wish to see a cure for cancer.

We have no information that isn’t public or above – so it may be we’ve misunderstood things. This has happened before. Feel free to get in touch if your reading is different to ours ..

Update (16/1): PHE consider tobacco companies to be doing ‘medical research’

The Daily Telegraph reports today (15/1/2018) that Public Health England gave the medical histories of many cancer patients to a company for a “trends in … lung cancer” study – a company that works for a tobacco company, while that tobacco company was taking the Department of Health to court over “plain packaging”.

PHE believe NHS rules should not apply to them – this includes other opt outs or rules on data handling.

We expect more details to emerge in coming days, as the entries in the PHE release register are scrutinised, and many more companies that don’t appear on the register come to light. (if you’d like to help/watch, there’s a communal google doc for the PHE register here, plus a second one for all NHS data releases)

Press quote: Sam Smith, a coordinator at medConfidential said:

“This is a system that relies on public trust; a system so flawed that it’s not yet clear whether PHE broke any rules.

“The release of this data relies upon loopholes in the Data Protection Act – and unless Public Health England satisfied each technicality they’re arguing about, then they may have breached 3 different laws by giving sensitive personal data on the treatment of cancer patients to a US company that works for a tobacco firm.

“But even if tighter NHS rules had been followed, the Department of Health still argue any patient opt outs wouldn’t have applied in this case. What are patients supposed to do?

“It is vital for public trust that uses of patient level data for purposes beyond direct are covered by the new opt out.

medConfidential supports an NHS cancer registry that follows all NHS data rules, and where the new opt out model applies to all patient level data for purposes beyond direct care. Every data flow in the NHS should be consensual, safe, and transparent, and that includes a well run cancer registry inside the NHS.

If you may be affected, what can you do?

If you are a patient with cancer do not make any treatment changes based on this news; but if you have any questions, talk to your nurses or support structures.

If you may be affected (ie you have had a cancer diagnosis), a request to the cancer registry to opt out will result in your data being deleted, which they admit will potentially harm your direct care in the future. We can not recommend you do this, but it is the only current option. Given the situation, we suggest you write to your MP, and ask them to ask the Department of Health what they are doing to fix this. 

You may wish to:

• Say why/how this affects you or your family – in as much/little detail as you wish.
• Ask your MP to, on your behalf, ask the Department of Health why your only choices are to have your cancer diagnosis given to companies working for tobacco firms, or to have your treatment history be deleted affecting the future care of you or your family. No part of that choice is appropriate.
• In short, why does data taken from the NHS not have to follow NHS rules?

PHE’s past failures are what they are – there are limited things that can be done to fix them. However, they can be brought in line with the NHS, and catch up to all the improvements that the HSCIC/NHSDigital has made since 2014 (although this failure could still have happened to them, and opt outs would still not have been respected)

Please also join our mailing list for additional information as this evolves over the next few weeks:

As the House of Lords Select Committee on AI looks at health data, it is only 2 weeks shy of the 20th anniversary the 1997 ‘Caldicott Review’. In retrospect, it understood the world that was coming then, and the review still holds up well for the future that is still coming now. It said:

“Increasing adherence to the principles will reassure patients and those treating them that confidentiality is safeguarded. Such progress should be monitored and appropriately identified, and individuals held to account wherever patient-identifiable data is present in the Service. We believe that the principles outlined here should also be applied to information identifiable to individual patients concerned with their clinical care, and medical research. It is clear that patients expect nothing less.”

20 years on, patients still expect nothing less.

The Review could have said one other thing – that data hygiene should have been treated as a part of clinical hygiene, and thereby integrating information into clinical governance. It would have avoided a great deal of problems over the last few years, but may also have made the the original creation of Caldicott Guardians effectively impossible. It is a step operationalised by Caldicott 3. While it could have led to a very much more Digital NHS today, it is all too easy to forget that hospital hygiene, under the oversight of clinical governance, has had problems from failed incentives around outsourcing, infected by the profit motive.

Today, the demand from profit seeking technical startups is even greater, the desire to skirt the rules intense, and modern startups push a “lobbyist viable product” onto a cash strapped NHS – selling patients’ data as an asset when a parent company the patient may not have heard of inevitably gets bought.

Whatsapp’s sharing of phone numbers to facebook would breach the rules around patient confidentiality; but then lobbyists went to see NHS England, who changed the rules and put the burden on each clinician to choose…

Whatsapp still shares its data to facebook to offer it’s “patients you may know” feature, and shadow profiles, and the other creepiness. Any officially sanctioned messenger could never do this, but NHS England doesn’t care – it has taken a problem off its desk for free, and dumped it onto every clinician in the country.

As NHS Digital takes egregious actions in the name of “burden reduction”, NHS England increases a burden yet further, because it’s reduces the burden on them from lobbyists wanting a change.

Messaging in the NHS remains a problem unsolved at scale – so the lobbyists now swarm offering their solutions to similar but different problems. NHS England, not running any hospitals, caved. Pagers work because they are used only for one thing – when they go ding, the doctor is needed for something at a level of urgency that has been triaged; but also the doctor can ignore it while dealing with something else. Doctor judgement is supreme over the tools – the pager is a busy doctor’s bullshit blocker – ignore that feature at your peril.  End-to-end properly encrypted messaging is not hard, but the easiest of the tasks.

If NHS England commissioned a messaging system, institutionally it would abuse it the same way it does email, and destroy any benefits due to its own worst institutional micromanaging impulses – a problem non-existent in the pager world. But those who would change the system would include changes that distract clinicians, so the status quo continues. Such perverse incentives were well understood by Dame Fiona Caldicott when she was writing 20 years ago.

As a result, Caldicott Reviews 1, 2 and 3, are all still relevant. The history is still relevant for designing consent, and designing out unethical and harmful behaviours. That NHSE abdicates any political responsibility does not mean NHS Digital may do so when designing technical systems.

For example, the “GP at hand” service, a rebadged “Babylon Health” product invested in by DeepMind’s founders, says it has the right to sell the medical records it holds as an asset of the company when babylon get bought (which it must in order to pay back the investors). This is a model that Caldicott 1 and GMC/BMA guidance has previously made clear is not appropriate. But as with the dodgy deal with the Royal Free, it is the NHS institutions left holding the bag as the company takes what it wants. Why did NHS England approve that service with those conditions?

Companies will change their rules for profit, and use their public relations machines to argue the NHS “harms patients” by walking away from a disturbing deal the companies only offer on a take it or leave it basis.

Such a business model may be fine for a profit focussed business with no sense of public purpose or accountability to anything beyond their bottom line, but the AI companies claim a higher standard… but also, they don’t:

Q52 Lord Swinfen: In your view, do investors have a duty to ensure that artificial intelligence is developed in an ethical and responsible way? If so, how should they do this? Should such development be regulated?

Eileen Burbidge: I thought this was an incredibly insightful question when I saw it on the papers for the session. The stark and objective answer, strictly speaking, is that I do not think investors have a duty to ensure ethical and moral behaviour. Most investors sign up to a code of conduct and are authorised persons by the FCA because they have fiduciary responsibilities as a first and foremost point. That is simply the objective current situation.
…
To be quite clear, our obligation to our investors is to generate as strong a financial difference as possible.
…
It will be more social pressure and market pressure.

If the companies also refuse any social or market pressure from the NHS, then they have learnt no lessons at all.

It was with that insight that Caldicott 1 laid down strong and sustainable guidance for handling of patient data. Every failure of the last 20 years has come because that guidance was ignored.

Dame Fiona Caldicott was precient in her first report. That first report from 1997 can be applied to AI and genomics – 2 ideas that would have been almost inconceivable when it was written – and we are confident it will apply to whatever comes after AI and genomics.

Let us also hope that there doesn’t need to be a fourth part in this trilogy…

We still haven’t seen the proposed new opt out language (or the loopholes hiding in caveats).

It’s due to be discussed publicly this month, and is supposed to deliver on what Dame Fiona was originally asked to do:

“Develop a single question consent model which makes it absolutely clear to patients and users of care when health and care information about them will be used, and in what circumstances they can opt out.” (Annex A)

The question has already been tested in an opinion poll by the Government. This means 12,500 of the public have seen the question; but we have not…

It’ll be interesting to see what those 12,500 people weren’t told about when health and care information about them will be used:

1. What patient level data doesn’t the opt out cover?
   1. For recipients outside the NHS: is it all patient level data that originated in the NHS? Or just some? If some, what about the rest?
   2. For recipients inside the NHS: All secondary uses, or just some?
      1. Will the separation between direct care and secondary uses be maintained? How is paragraph 125 of the data lake document accounted for?
   3. Where do PHE and other DH ALBs sit – in or out?
      
2. What will patients who have opted out already have to do, to receive the maximum protection available under the law when this new choice comes in? (which, by then, will be GDPR/DPA2018).
   1. The care.data opt outs did not cover everything possible under the DPA1998 – will that failure be repeated?

3. What will patients be told who do want their records used? What are the exceptions? Where patients wish their records used, will they be able to see every way they were used, and what any benefits of those uses were?

4. Will companies continue to be able to access data on patients who haven’t opted out, in secret, without the patient being able to see who used it for what? (which includes such as commercial re-use licenses or information intermediaries)

Another way to look at it is will all the crosses in our scorecard become ticks?

Commercial re-use licenses (aka “information intermediaries”) are akin to telling an academic department that it can use data for any project by any funder. For good reason, that is unthinkable for academia – it should not be allowed for companies

The research community is building an impressive maginot line of justifications for research – a set of case studies that epitomise the best of british medical science. However, the problem with care.data was not the research uses, but all the other things being hiding behind a fig leaf of research.

Will that happen again?

A key metric for care, especially complex care, is how patients feel about it. An extremely expensive drug may delay an outcome, but that measures only money and time – not quality of life, which is difficult to quantify. The way the NHS usually does that is via a “Patient Reported Outcome Measure” – how did the treatment make you feel afterwards?  Do the patients who had the treatment, feel it was worth the side effects? As a key metric, we would have expected some movement towards a digital “100% PROMs” (as covered here in point 3). A treatment may be possible, and easy for hospitals, but does it help patient outcomes?

As a result of NHS England’s neglect, its Data Lake will do nothing to improve patient measures (and some issues only appear in PROMS); it’s all accounting measures from NHS England’s accountants and Whitehall micromanagers. Their idea of a consultant is not someone in a white coat, but someone with a calculator. When NHS England talks about improving care, it’s clear its idea of engaging with patients has not improved since care.data was abandoned due to its failure.

The ‘Target Architecture’ document shows NHS England has learnt nothing.  As always suspected (and denied) for care.data, NHS England now admits that it wants “near real time” access to medical records: letting its accountants and expensive management consultants in an office somewhere second-guess your nurse and your doctor, who listen to you.

• NHS England’s approach is still driven by its desire to do “near real time” monitoring of doctor and nurse performance – there will be no opt out of accountants looking at your records.
  • 125. Sensitive personal and confidential data (which is fully identifiable) will almost certainly be required to achieve interoperability and to facilitate precision medicine and case finding. The NDG Review opt out will not apply.”

• NHS England clearly considers its micromanaging more important than either Accountable Care or CCG/STP access…  See the middle box in Figure 2 (p14) and para 40 (p10); more on the fundamental problems with the use of ‘secondary datasets’ for operational purposes in this paper.

• The only reason reason to make this “near real time” (figure 2 – i.e. at least daily) is to force organisations to hand over operational data to those who have no operational role – ‘secret micromanaging of hospitals from afar’

• According to NHS England, patients will have to opt out again in May next year, given the GDPR, if they do not want their data used. (This suggests medConfidential will have to run an opt out process since NHS England say it will not be otherwise available to you.)
  • It does acknowledge two GDPR opt-outs will have to be respected, but in the process it breaks the existing opt-out choice for patients.

• “125… The NDG Review opt out will not apply. However the GDPR Right to object and the GDPR right to restrict processing will apply should a data subject wish to exercise that right and certain criteria are met.”
  • Clause 15 of the Data Protection Bill (as laid) gives the Government the ability, by Regulation, to remove those rights. Either way, the Caldicott Opt-Out should be extended to cover the opt-outs possible under GDPR. Since every patient is being written to, that can be made clear to everyone involved, and they can update their choices according to their wishes in the new environment

Fundamentally, paragraph 125 is entirely in conflict with what the Department of Health implied in its response to Caldicott 3. However, it is NHS England which is expected to organise and fund the individual letters to patients, which will have NHS England’s logo on them; possibly not a DH logo. Will DH put its logo on this?

• The mishandling of the NHS internal market:
  • While section 4.3 in the Annex tries to muddy the waters, stating patient information will be “anonymised or is provided in aggregate views sometimes linked with wider information sources”, in practice these activities are consistently done using identifiable patient data under perpetually-renewed Section 251 ‘support’.
• Lessons from care.data and Caldicott 3 have simply been ignored:
  • The document is dated 13 July – just one day after the Government’s response to Caldicott 3, on 12 July…
  • NHSE CIO Will Smart said, also on 13 July: “Let’s get away from this distinction between primary and secondary uses of data – it’s just data, let’s start using it”. Source: https://twitter.com/thatdavidmiller/status/885427094464999424
• While nods towards “transparency” and “trust” are scattered throughout the document, with one whole section devoted to the notion of a “diameter of trust”, NHS England provides no indication of how it intends to deliver the Government’s commitments on transparency of access to patients; nothing appears in any of the ‘architecture’ diagrams, or in the text.
  • The model relies heavily on the use of “de-identified” data to avoid answering difficult questions that care.data ignored. Such data would clearly be linkable to the individual – how else “personalised care”? – so, unless NHS England proposes to also ignore the Government’s transparency commitments, patients will have to be told.
  • This also ignores the critical point that de-identification will never be direct care.

• “… To promote Better Health for all”, para 6 (p3). While prevention must clearly involve ‘behavioural change through information’, a failure to be honest (and transparent) about the two meanings inherent in “promotion” – as in that has contributed to this mess. That they lead off with this phrase may be good – the NHS needs to take a more preventative approach – but it provides cover still for those with more commercial / corrupting agendas.
  
• Commercial reuse will continue, and expand. As NHS England has failed to convince anyone else that it should get a new data collection, it will instead expand the dataset collected under HES (which it has powers to do unilaterally).
  • These new datasets will flow into the “Interoperable regional data hubs” (July), aka “regional data ponds” aka “national data lake” (January), and from there, can be drained by anyone who wants to some data.
  • “Information Brokers” (which NHS Digital calls “information intermediaries”) have also expanded beyond NHS, and now include selling access to the cancer registry.

The Department of Health has confirmed that it will write to every patient who has opted out about the new arrangements. NHS England’s long standing refusal to match that for patients who are in the dark risks creating a perverse incentive for those who gave Jeremy Hunt the benefit of the doubt.

One of the changes since 2014 is that there should be a Doctor in charge of Information at NHS England – when the new Chief Clinical Information Officer is appointed, they should not inherit a toxic programme. Care.data contained catastrophic failures as a result of being designed by someone who had never spent a day at medical school.

As they plan the data lake (“regional data ponds” or “interoperable regional data hubs”) has the institutional disregard for patients mean that they’ve forgotten every lesson? Using the language of business, forgetting that no one benefits if the NHS just charges money to itself. There are alternatives.

‘data lake’ is not a clinical term, nor a clinical tool. It’s an IT term, for IT people to talk about large technology projects, and to sell the tools for those projects. The benefits to the NHS are entirely tangential from making a small number of techies in suits feel good about what they’re doing without the “burden” of talking to doctors or patients. Paddling in a data lake, they’re able to talk with confidence – despite their talk being irrelevant to solving problems that front line clinicians and their patients face. The data lake is a solution in search of a problem.

Care.data wanted to link all data and sell it in secret without consent; it’s new data lake links all data and sells it in secret without consent.  What changed in the intervening 4 years?

Those who want to read your medical records have had weekly updates on this document since January; we saw it via a leak in August, despite being lied to repeatedly by a co-author about being shown a copy. It is very clear why. No one from NHS England was willing to put their name on the document (Will Smart’s name was on the January version). Who on NHS England’s Board will be expected to sign off on this mandate to STPs?

Despite the rhetoric from the Department of Health, it’s pretty clear none of the details in NHS England have changed. Even the Wellcome Trust – who saw weekly updates – expect the same problems from 2014 all over again.

We will be here…

What’s happening?

By next summer, we will have a new Data Protection law, and a new NHS opt out model.

We should have a good idea by the end of November what the details all look like. The Department of Health are still playing coy – as until everything is final, then nothing is final.

Decisions in recent weeks have moved from a “big bang” launch next March, into a more gradual rolling start, which can deliver when things are ready. This is a great improvement.

Whatever happens, as things continue to change, we’ll update our scorecard of loopholes to keep you informed. It was first published as part of our recent “annual report”, but things will move on as the process rolls on.

NHS data: The rolling start has begun

As the rules stand today, any existing opt out will be upheld automatically within the new system. You can go to your GP receptionist, with our existing form, and they will make the change on their system which takes effect. As a patient, how it works – which system is in use – shouldn’t matter to you.

Shortly, the NHS Digital website will appear to give patients the information on how any data is used, and later a service to tell them how your data is used.

At some point next year, hopefully after you can see how your current wishes have been respected, you can express new wishes (as you can now). But the rolling start added by the last Direction to NHS Digital makes this better and simpler: There is no big bang launch, but a steady rollout as things start. If one thing is delayed, the consequences are fewer.

Your consent choice should follow your data, and when/why your wishes were honoured, or not. There are legitimate exceptions, but there are no legitimate secret exemptions.

As progress rolls forward, our scorecard can keep you up to date on where things are.

What else might happen next?

Any future Direction from either the Secretary of State or NHS England, must either leave the effects of your existing opt out in place, or explicitly take an action to remove it. Will the Department of Health or the National Data Guardian going to allow the removal of opting out that NHS Digital has already begun?

That would be a dramatic and novel change to public trust in a new system – undermining the point somewhat.

There is potential for a good outcome :

• Single tick box, online, covering all secondary data uses in and outside the NHS
  • This includes commercial reuse of cancer data by Public Health England. The ICO is investigating our complaint on this topic, which boils down to a simple question: does PHE tell the truth? (evidence says no)
• Existing care.data opt outs merged into the new one giving a clear path forwards
• Letters to every patient about the new arrangements.

Any of these would undermine any other good work:

• Undoing opting out that is already in place
• Multiple forms being needed
• Letters not going to every patient who did not opt out
• Multiple steps (and digital dark patterns – paragraph 2) in the opt out process.

We do not yet know all the details – and we’ll tell you when there’s evidence in practice. But there is progress.

While the NHS is moving towards a rolling start, the road they’re on is akin to an ambulance going down a busy high street with lights flashing – there’s a good idea how long it should take, but if someone does something unwise in the belief that thinking their goal is more important, it might take a little longer while an obstacle is removed. It’s been nearly 4 years since care.data collapsed. If it takes another few months, that’s ok.

But if the NHS data environment is like a normal street, the rest of Government is more like the Wacky Races.

What’s next?

In a couple of weeks, we’ll have an update on the National Data Guardian Bill, which is currently queued up in the House of Commons, and the Data Protection Bill, which is currently in the House of Lords.

While our main focus is on medical data, in our free time, we look at the rest of Government – both central and local.

They are themselves doing some thinking about how data is used, and while views are variable, it mostly reflects the initial reactions to care.data in the NHS. That it couldn’t happen there, and why do they need to change anything.

The lesson from the last 4 years, is that doing this properly takes time. We have taught the NHS this once, and will remain here to make every data flow in the NHS consensual, safe, and transparent.

It would be a surprise if the Government chooses to have worse data handling than the NHS. They will have only themselves to blame.