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.

The Government has launched its life sciences strategy.

The operative line which underlies all of this from an NHS perspective is:

“This may require some trade-off between trials infrastructure for nursing and for digital,”

Business want such trade offs, but the NHS and patients will likely have something to say about that. Did DH agree to it?

medConfidential coordinator Phil Booth said:

“The missing piece in here is patient consent. While the strategy mentions Dame Fiona’s Review, it doesn’t actually say whether the human tissue they want to buy will be consented or not” (top of page 8)

“Until we see what the NHS itself is planning, there’s nothing in here that wasn’t on the life sciences wishlist 4 years ago from the flawed care.data scheme; and nothing to suggest they’ve learnt any lessons.

“The Government has confirmed that patients who have opted out will be contacted about the new arrangements; but what will those who trusted the NHS to do the right thing be told?

We’ve previously published an overview entitled “Governance of a Digital Economy in the medium term: AI, blockchain, genomics, and beyond” and a detailed answer to three questions we get asked. We now add this fourth on current questions around research and statistics (and NHS England).

Those questions are:

1. Should the UK sequence the full genome of the entire population? (pg 1) (no)
2. Can there be innovative, speculative analysis of individual-level sensitive data in a way that is Consensual, Safe, and Transparent? (pg 2) (yes)
3. Is there a need for “AI exceptionalism” in data handling and administrative data? (pg 3) (no)
4. Implications for research and statistics on extending Secondary Uses to facilitate third party time-sensitive micromanagement of Direct Care.

Also related, is the medConfidential response to the Code of Practice on Statistics consultation from the UK Statistics Authority.

Care Episode Histories: There will be a new dataset that replaces HES. The question is where that dataset will be copied, who will access it and on what terms, and whether dissent will be honoured for secondary uses.

The Government’s response to Caldicott 3 has made very clear: Patients will know about every access to their records, whether for direct care or secondary uses.

NHS England’s non-clinical staff look at it purely in terms of data protection; what about the medical profession’s obligation to confidentiality?

For PHE/CPRD, there remain copying loopholes that may remain in theory, and it’s unclear whether they wish their activities to be consensual, safe, or transparent.

The NHS has said that it will use digital tools to tell individuals how data about them is used, and have a public register of data sharing – both are necessary for trustworthiness. Whereas the Government still hasn’t committed to a Register of where it copies any data, including your medical information, under the Digital Economy Act; let alone mandating that its many digital services tell you how your data gets used.

Given the GDS/DCMS claims of digital leadership, being this far behind the NHS has got to get embarrassing. Given Government manifesto commitments, and the unknown hopes of a “Digital Charter”, we’ll see if anything is implemented…