Ahead of a Comprehensive Spending Review, the Government has decided that a large percentage of discretionary government spending will go on health and social care by the end of the next spending period. That is probably a better choice than the US, which spends about that amount on their military.

In light of that decision being made, there are rational consequences which require thought to avoid perverse incentives:

• Data available to life sciences and research: For there to be public confidence in data use, every patient should be able to know how the NHS and others use data about them, and how their wishes are respected. The NHS has established clear processes for the use of data for legitimate research – these do not need to be changed. However, the implementation of the National Data Opt-out remains hamstrung by legacy data disseminations. This, the first spending review since the 2018 Data Protection Act, allows for a clearer formulation when communicating with the public: “If you want your data to be used for research and for other purposes beyond your care, it will be; if you don’t, it won’t.” (Any exceptions being solely decided by the explicit approval of the Confidentiality Advisory Group – which was placed on a statutory footing in 2014, yet still has no Regulations governing its work.) Past and current heavy reliance on (DPA98) ‘anonymous’ data as the basis for dissemination both undermines public confidence and limits the data available to research. The spending review offers an opportunity to reconsider that failed approach, improving public confidence and making more high quality data available to researchers and the life sciences – both underpinned by a commitment that whatever a patient wishes, they will be able to see how their wishes were respected. Any suggestion of ‘data trusts’ for NHS patients’ data requires as a prerequisite the admission that the NHS itself will never get data dissemination right in patient’s interests. Public confidence in data for life sciences and research would be higher if the message was clear, simple, and accurate: If you want us to use your data in legitimate projects, we will; if you don’t, we won’t.
  
• Technology in the NHS: Clinicians will use technology when it helps them with patients; when it doesn’t, they don’t – no matter how hard NHS England may push it. The FHIR (Fast Healthcare Interoperability Resources) standard is now internationally recognised as the standard for interoperability between health systems – yet the first version was only published after the last spending round. Treasury / DH / NHSE should ensure that companies cannot use contracts to limit or prohibit interoperability, or to require bulk data copying from core hospital systems into commercial companies. Where they are proposing new national programmes, chopped up into parts, what happens at the boundaries between parts? 
• Prevention is cheaper than cure: In advance of the spending review, HMT should commission an independent assessment of the ‘DH vision’ on prevention to answer two critical questions: will it do what it claims to do? And if not, how and where does it fall short? (Page 14 of the vision shows the disconnects.) The assessment should be published alongside the DH green paper, and show what questions must be considered across Whitehall to avoid any other department causing what DH seek to prevent. 
• New forms of Transport: Will DfT allow self-driving cars to operate in a way where their stopping distance is greater than their effective sensor range? Will equivalent assessments be made for other technologies; and if not, what will the consequent effects be on the health of the nation? 
• Procurement incentives for competitive markets: Where an NHS body, wishes to procure an AI to assist in diagnosis, it should be required to procure 3 – effectively requiring 3 diverse analyses rather than one, replicating the medical norm of a ‘second opinion’ from a human doctor. That may be extensible to other public bodies. 
• AI and algorithms in the public sector: For all bodies subject to judicial review, any AI or algorithm involved in input to that decision must satisfy the explainability requirements of judicial review. Should there be a clear public sector mandate that algorithms will only be used if they satisfy existing legal obligations, and that technology tools will need to be procured to satisfy those tools, that will create a market in which the UK is possibly uniquely placed to lead.

The first two points have strong equivalents across all departments.

 

Tests for the spending review: Balancing mental health, parity of esteem, and Public Health

The spending review is the primary administrative mechanism for cross-government prioritisation. 

The largest public health concerns are different in different local areas – will the spending review (and MHCLG priorities) reduce or exacerbate those differences?

Will (tech) companies assessed to be causing mental health issues be required to take steps to reduce the harms they cause in future, and mitigate harms already caused? If they are not, these costs will have to come from the NHS budget, and are effectively a commercial subsidy paid by the public purse. By comparison, for each of alcohol, tobacco, other substances with consequences for human health, and digital companies – does each contribute in tax revenue what they create in direct and indirect costs?

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Some areas of this post were elaborated in our submission to the Digital Competition Expert Panel.

This page has been superseded by a 2021 page

Below is left here for historical purposes

medConfidential’s opt-out form for GP data continues to allow you to protect the information held by your family GP as it has always done – but the only way to protect your data collected by hospitals and in other care contexts is now via NHS Digital.

NHS Digital does not (yet) have direct access to your GP record, so its opt-out process requires you to take several steps – and officials have decided that people who have children must make a third.

Additional steps forced on those who care for children

If you have children, or other dependents, and wish to express a choice about the use of their medical records for purposes beyond their direct care, the process is needlessly complex.

NHS Digital provides no online process for families with children – even those who are registered with the NHS at the same home address as their parent or carer – so you must use its online process for yourself alone, and then use a separate postal process for any children under 13.

(Children aged 13 or over can express their own choice about their medical records for themselves online.)

So, instead of the single form you could use to express your choice for yourself and your family back in 2014, you must now do THREE things:

1) For your own hospital and other non-GP data: opt out (or opt back in) online

2) For your dependents’ hospital and other non-GP data: post this form to NHS Digital

3) For your and your dependents’ GP data: give this form to your GP

If you don’t have access to a working printer, e-mail children@medConfidential.org with your postal address and we will post you copies of the paper forms, for free, no questions asked. If you don’t have e-mail, you can text your address to 07980 210 746.

If you can afford to make a small donation to support us in offering this service to others, we have a donation page.

registered with the ICO to process personal data in this way.)

Why?

It appears the “most digital” Secretary of State the NHS has ever had would rather place the burden of understanding and action onto individual patients – especially those with families – than solve the problem his officials have created.

And the fix is simple: NHS Digital’s online process confirms who you are to the extent that you are able to express your choice online, yet it chooses not to ask if you have any children – who could then be confirmed in exactly the same way the process confirms that you are who you say you are. The move to ‘digitise’ the National Data Opt-out left YOU with more work to do…

This extra work for you is a deliberate choice; it didn’t have to be this way.

Once you have expressed your wishes about your and your family’s data, you may also wish to write to your MP and ask them to ask the Department of Health why you are being forced to jump through these hoops.

Because while healthy, young, and particularly male protagonists commonly have little understanding or insight into the types of sensitive information they will one day have to divulge to their doctor – and the consequences of confidentiality not being respected – others do not have the luxury of such ignorance.

Update: longer response.

The current Westminster penchant for speeches with applause lines but without details has reached DH… 

Update: NHS Digital has now published some details – which are utterly underwhelming when compared with the Secretary of State’s hyperbole. “Use the NHS number” and “upgrade from ICD-10 to ICD-11” is not the radical changes Secretary of State appeared to suggest. Although with the promise of registers, we might dust off the amendment we suggested to the Lefroy Bill (which mandated NHS numbers by law) in 2014. We will update this document when NHS Digital published the document that should have appeared at the same time.

Notes:

• Data: “We are supportive of … Data Trusts” – does the SofS/DH have so little confidence in the NHS getting data right that he/it is supportive of stripping the NHS of that governance role?
• DH blindspots: “We will know we have achieved our goals when”… does not mention patients other than suggesting they use apps for self-care…
• Privacy: There is no reference to the duty of confidence every clinician is under to their patients (it instead points at the Data Protection Act)
• Google: The obligation on all systems to use FHIR interoperability removes the figleaf behind which DeepMind insisted on data for all patients in the Royal Free for 5 years.
• Google: It also proposes outlawing the monopoly line in Google’s standard contract that forces users of the Streams app to only connect to DeepMind’s servers. It is unclear whether that line will survive the lobbying it is about to receive.
• Amazon: Case study 7 is as true as leaving a note on the fridge, but there are other effects of giving Amazon/Alexa such information. Facebook’s new Portal offers the same functionality, and will explicitly be used to target ads at users.

 

Below quotes can be attributed to Sam Smith, coordinator of medConfidential, which works to improve uses of data and technology in the NHS.

The NHS knows what good working technology like, but to get there, you can’t just turn A&E off and on again and see if helps.

Mr Hancock says “we are supportive” of stripping the NHS of its role in oversight of commercial exploitation of data. That should be a cause for widespread concern. If Matt thinks the NHS will never get data right, what does he know that the public don’t?

The widely criticised National Programme for IT also started out with similar lofty vision. This is yet another political piece saying what “good looks like”, but none of the success criteria are about patients getting better care from the NHS. For that, better technology has to be delivered on a ward, and in a GP surgery, and the many other places that the NHS and social care touch. Reforming procurement and standards do matter, and will help, but it helps in the same way a good accountant helps – and that’s not by having a vision of better accounting.

There’s not much detail in here. It’s not so much ‘jam tomorrow’, as ‘jam… sometime’ – there’s no timeline, and jam gets pretty rancid after not very long. He says “these are standards”, but they’re just a vision for standards – all the hard work is left to be done.

-ends-

The Australian ‘care.data’ isn’t going well. Taking its lead from the English plan, the Australian ‘My Health Record’ programme claims to be about direct care and creates a new repository of patients’ data hiding behind a badly-run opt-out process, with minimal publicity that’s all about direct care; those who support it don’t actually understand it, and in the small print, the data can be copied for purposes that aren’t direct care at all. None of the lessons of care.data have been learnt there at all.

Meanwhile, in the UK, NHS England has announced a set of pilots for ‘Local Health and Care Record’ schemes – 3 in May, 2 more in June – which claim to be about direct care, which may or may not create a new repository of data without an opt-out process, and about which all the publicity is only about direct care; those who support it seem not to articulate fully what it is, and in the small print, the data can be copied for purposes that aren’t direct care at all.

‘Just in time’ or ‘Eventually in case’?

There is clear value in the principal public goal of Local Health and Care Records (LHCR): when a patient arrives at a new care setting, doctors should be able to see care provided only hours before – especially when it’s that which may have put the patient there. An obvious example would be a hospital doctor being able to see new medicines, prescribed that morning. This has obvious clinical value, assuming the data is up to date enough – showing data that is as current as the patient’s arrival, not yesterday.

In practice, this would mean looking up records across the system as needed, rather than building yet another pile of outdated data – most of which would never be touched for care purposes, and which could be dangerously out of date if it were. The ‘glue’ required for interoperability is to simplify ‘just in time’ interoperability, rather than to copy data from everywhere ‘just in case’ it’s needed somewhere else.

The driving principle must be the provision of relevant, necessary, up-to-date information. Which, as any serious technologist will tell you, means using APIs – not making and passing around endless copies of data. (‘Paperless’ shouldn’t mean promiscuous…) Building yet another set of out-of-date databases only works for the people who sell and run databases.

The local areas offered as pilots apparently get to choose their own technology for their own needs. But before the ink on the LHCR announcements was dry, there were other announcements about projects that want to copy the data that the ‘pilots’ apparently haven’t yet decided upon. The money is already flowing as if they will.

Clearly they all know something that NHS England isn’t telling the public. Where data is made available to ‘research’, NHS England (as data controller) will also want to use the GP data it copies for its own purposes – clinical performance management and ‘developments’ that skirt the line between research and micromanaging. The National Data Opt Out should apply to these uses – whether it will or not remains to be seen – but even so, the creation of another copy of patients’ medical records, under the control of NHS England rather than doctors, has apparently been mandated without public debate, discussion, or basic honesty.

Will patients be sold the figleaf of ‘direct care’, with other uses hidden behind, in a very Australian way?

However a local care record system is implemented, every patient needs to be able to have clear and specific answers to their questions: who is looking at my data? Why? And what are my choices?

The advocates of dangerous data copying will continue to push for it – while the ‘spawn of care.data’ resurfaces in Australia, the toxic causes of care.data are now reappearing across this country, in the form of ‘data trusts’. Until there is a binding commitment to transparency over all data access, those who wish to copy patients’ information for secret reasons will continue to publicly claim patient ‘benefits’ for activities that are far more sordid.

 

We have also done a deep dive into the systems, which is possibly far more than you ever wanted to know about local health and care record systems.

A serious error affecting 150,000 NHS patients has been reported in the media in recent days, after it was uncovered last week. We understand the error affects patients who set an opt-out between March 2015 and June 2018 and whose GP practices use TPP’s SystmOne software – their opt-out codes were not sent to NHS Digital until last week.

As a consequence of this error, from April 2016 until 26 June this year, those patients’ confidential, identifiable data was sold to a range of organisations, including private companies. This will obviously be of concern to a great many people.

Both TPP and NHS Digital are taking remedial action; the coding error has been corrected to ensure opt-outs will be uploaded properly from now on, affected GP practices were written to on Monday 2 July, and the individual patients affected should be written to by the end of the month.

Until then, based on current information, this is what you can do:

If you have recently received a letter from NHS Digital about the conversion of your Type-2 opt-out to the National Data Opt-out then you weren’t affected by this incident. (These letters were sent out during June.)

If however you haven’t received a letter, and you are over 16, and you remember opting out any time from March 2015 onwards, then either:

1. a) you are affected by the TPP incident, or
2. b) separately, your opt-out was never applied to your GP record.

Anyone over the age of 13 should be able to check their current opt-out status by using NHS Digital’s new online National Data Opt-out process:

If the light blue status box does not appear when you check and you do not wish your confidential, identifiable medical information to be used for any purposes beyond your own direct care, then you need to set the option on this screen to “No”.

This new online process only works, however, for individuals over 13 years old – and not for families with children or adult dependants. medConfidential’s (now improved!) GP opt-out form continues to work, as it has done since late 2013. It also lets you prevent confidential, identifiable information leaving your GP record, which the National Data Opt-out does not cover.

But – given this incident, and every previous breach of public trust – why can’t every patient see their data, so they can know what has happened?

Everyone agrees how bad the situation created by TPP’s error, with consequences for patients from their data being used against their wishes, really is:

Professor Helen Stokes-Lampard, Chair of the Royal College of GPs, said:

Patient data held by the National Health Service should only ever be used morally, safely and responsibly, and we must all work together to ensure mistakes of this nature are never repeated. We need to be able to reassure patients that their wishes concerning their data are being respected.

Understanding Patient Data said in response (their emphasis):

This incident highlights the critical need for transparency – to ensure that it is clear where data is going and how choices are honoured. It also demonstrates that a trustworthy system must not just say the right things but also do the right things in practice as well: if opt-outs are claimed to be honoured, they absolutely must be. If these standards are not upheld, there has be clear accountability in the system, with sanctions if necessary to demonstrate that these issues are taken seriously, or public confidence will again suffer.

Dr Natalie Banner, who now leads the ‘Understanding Patient Data’ project, tweeted:

Astonishing and appalling failure to uphold patient objections: but what sanctions to ensure providers uphold the standards we expect of them? New opt-out, which is patient-registered rather than GP-registered, *should* be less liable to such errors though.

Mr Harry Evans, from the Kings Fund policy team, said:

We are all agreed on the importance of the public not being surprised by how NHS uses data, so this is just remarkable.

These are fine words, but when will they speak out about the people NHS Digital disregarded in its new ‘digital’ process – a process that Ministers signed off – which separates processing for parents and children? (Not every American policy approach should be replicated in the NHS…)

In a recent explanation for OurNHS, we showed the ‘proxy’ form itself says:

…if your family has children under the age of 13, or if you look after a dependent older relative, then things are even more complicated. Rather than giving a simple instruction to your doctor, those who would prefer their children’s data wasn’t sold to third parties for unknown purposes, will be required to send to NHS Digital, by post, four pieces of ID documentation along with a seven-page form. So much for Jeremy Hunt’s much-vaunted commitment to a ‘paperless’ NHS.

Given the significant effect this will have on people far wider than the 150,000 currently affected, you might want to ask (a) Understanding Patient Data, or (b) your MP, what they are doing to ensure the broken process for families making a decision together is fixed.

…we’ve updated our scorecard.

One of the existing patient opt-outs has been renamed as the new National Data Opt-out, but a whole swathe of issues that have festered, unaddressed, for years still remain.

We consider these issues below, framed by questions of – and glaring omissions to – the ‘Your NHS Data Matters’ communications campaign, launched on GDPR Day.

Overview

“Your health and adult social care information supports your individual care. It also helps us to research, plan and improve health and care services in England.”

The word “us” appears to be doing a lot of work here; would patients expect “us” to include, for example, commercial information intermediaries such as Harvey Walsh Ltd?

“You can choose whether or not your confidential patient information is used for research and planning.”

All well and good, if true – but what about all other ongoing (and future) uses of patient information besides “research and planning”? Why does the new National Data Opt-out not use the far clearer, more accurate, and comprehensive Caldicott 3 definition of “purposes beyond direct care”?

If the new National Data Opt-out does cover the use of patients’ information for all purposes beyond their direct or ‘individual’ care, then why not say so? If it does not, then how does the ‘new’ opt-out meet the requirements of Caldicott 3, the recommendations of which the Government accepted in full?

medConfidential recommends: Be accurate! All public communications must in the first instance use the proper Caldicott 3 formulation, “purposes beyond direct care”.

These purposes may be further explained in terms of “research” and “planning”, but public explanations must be clear that uses are not limited to only these two purposes. To do otherwise would both mislead patients and undermine the effectiveness of the opt-out, and could lead to further collapses in public trust when people become aware of uses that do not clearly fall into either category.

“Information that only identifies you like your name and address is not confidential patient information and may still be used.”

This is utterly muddle-headed, and goes against what many (if not most) people reasonably understand is meant by the word “confidential”. While the example given is relatively benign it is precisely this loophole that, not coincidentally, led to the scandal of the Home Office MoU.

“Your confidential patient information is used in two different ways:”

This is not even close to true! We consider other uses, such as commissioning and commercial re-use in more detail below, but this statement is demonstrably untrue: take, for example, the HRA Confidentiality Advisory Group’s Non-Research Register, which contains ongoing uses such as invoice reconciliation, risk stratification, commissioning and projects that explicitly mix direct care and secondary uses.

medConfidential recommends: Don’t mislead patients! Be more clear and explicit about the range of uses to which patients’ information are put.

While public communications must be as clear and as understandable as possible, they must also be accurate – and true. The split between “your individual care” and “research and planning” (a description that we note above is itself too narrow and misleading) is far too simplistic, especially when patients are being asked to make an informed consent choice.

“Most of the time, we use anonymised data for research and planning. So your confidential patient information isn’t always needed.”

No definition of “anonymised” is provided. Using this word without explaining what it means is misleading; the natural (i.e. many patients’) assumption is that “anonymised data” is anonymous, which is not the case. GDPR and guidance from the ICO now makes it clear that what NHS Digital has been disseminating “most of the time” is identifiable data.

That only some identifiers are being removed, or pseudonyms substituted, must be explained – and linking to a third party, non-NHS information source to do this will hardly be reassuring to many patients. Hiding behind narrow legalistic reasoning and jargon never has and (especially post-GDPR) never will solve major long-standing issues.

medConfidential recommends: Follow the law! Stop implying that ‘anonymised’ is the same as anonymous, and respect people’s opt-outs for all identifiable data – don’t keep trying to find loopholes and excuses.

Benefits of data sharing

We are not aware that this is, or ever has been, in dispute. Clearly there are benefits to lawful, ethical, consensual, safe, and transparent data sharing.

Problems come when, as with the care.data programme and previous attempts at public communication, the NHS tries exclusively ‘selling the benefits’ without even mentioning any of the risks. Addressing these directly helps people make sense of the mitigations used – and such measures are no longer just arbitrary claims or assertions – and enables a more informed choice on that basis.

Who uses your data

As we note above, the narrow definition “research and planning” does not even come close to defining the full range of uses, for purposes beyond their direct care, to which patients’ information is put.

These omissions aside, and while ‘Your NHS Data Matters’ lists some types of organisations that may do “research” and acknowledges the use of patients’ information “to support the delivery of health and social care” (conflating both direct care and “planning”) it makes no mention of the types of organisations that may be involved in “planning”, and all of the activities that term is supposed to encompass.

Given that it is precisely those people and organisations that may have access to their information that matters to most patients who have concerns, this is another serious omission. Without it, how are patients supposed to make an informed choice?

medConfidential recommends: Be honest and upfront about who will have access to patients’ information; patients should not be assumed (or required) to understand the inner workings of the health and care system in order to make choices.

It may be argued that NHS Digital’s Data Release Register performs this function. However, linking to a massive Excel spreadsheet, containing literally thousands of individual entries, puts too much of a burden on any normal individual and – given the disparity between this and the level of detail provided elsewhere – begins to look like obfuscation.

We understand NHS Digital is working on a more clearly-formatted HTML publication of its Data Release Register but, in its absence, medConfidential has provided a more readable version that – unlike the current Register – contains links to NHS Digital’s audit reports, for those organisations that have been audited.

medConfidential recommends: Continue improving the transparency of data use.

For example, besides audits (and actions taken) future Registers should link to the relevant DARS and/or IGARD documentation; showing there is a process, and that the process is being applied competently and consistently is an important way to build and maintain trust.

It is unfortunate that the “NIC numbers” given in current Registers are entirely self-referential to anyone performing, e.g. a Google search; concealing or obscuring relevant parts of the process raises and persists doubts.

“Research bodies and organisations include:
– university researchers
– hospital researchers
– medical royal colleges
– pharmaceutical companies researching new treatments”

Why are “pharmaceutical companies” the only ones on this list whose use of patients’ information is qualified? Is the claim that pharmaceutical companies only receive patients’ data for the specific purpose of researching new treatments? This is patently untrue, and leads onto the further spurious claim that patients’ information will not be sold for “marketing or insurance” purposes.

While this claim may be narrowly true, at least for “commercial insurance purposes”, it omits to mention that at least some information intermediaries (i.e. commercial re-users, now sometimes referred to as “health and care analysis companies”) which regularly receive data from NHS Digital still service pharmaceutical marketers.

NHS Digital cannot state definitively who does or does not reuse patients’ medical records, as it specifically chooses not to know.

medConfidential recommends: Stop misleading patients as to the ultimate uses of their data, and stop sending out copies of everyone’s hospital histories to companies which (also) profit from servicing non-NHS commercial interests.

How data is protected

‘Your NHS Data Matters’ makes quite a few assertions about what will and will not be done with your data – though, and especially given the tendency to use jargon and narrow legalistic terms, it would be good to provide evidence and to clearly define key phrases. For example, we presume “confidential patient information” and “data” are two different things.

In addition, as noted above, linking to a third party, non-NHS information source to achieve some of this – however good the explanation – will hardly be reassuring to patients with concerns.

Another glaring omission, given the significant number organisations that do not provide health and care services, but that do use patients’ information for purposes beyond their direct care, is the list of the steps those organisations are supposed (required?) to take to protect patients’ data.

The list of steps for such organisations clearly cannot be the same as those for NHS bodies, in that some of these organisations do not “make it clear why and how data is being used”, and others hide behind the information intermediaries’ commercial reuse contracts to, e.g. measure the efficacy of pharma sales, and to market their products to NHS doctors and commissioners.

medConfidential recommends: Make it a requirement to report to NHS Digital (and thence to patients) how data is used by everyone; stop relying on commercial reuse contracts and the “promotion of  health” loophole in the Care Act 2014 to persist what are self-evidently marketing uses.

Manage your choice

The new ‘digital’ National Data Opt-out process cannot cope with dependant children, and assumes that all 13 year olds have mobile phones or e-mail accounts which can be accessed safely without duress. It appears as if, when the process was signed off under the Government’s Digital Service Standard, Ministers did not spare a thought for their families at all…

The entire process is overly bureaucratic and intimidating, especially when compared with the existing ‘Type-2’ opt-out process: rather than simply instructing your own GP, who already knows you, you must identify yourself to officials at a remote call centre – and may even have to send in up to four pieces of ID and documentation with a form. (Check pages 2-3 of NHS Digital’s 7-page ‘Non-Digital Proxy Opt-Out Form’ for a list of requirements.)

This feels more like an inquisition than a ‘choice’.

Given how fundamentally broken NHS Digital’s new ‘Beta’ opt-out process is, medConfidential recommends patients who have concerns use the opt-out form we’ve provided since late 2013.

We updated our form in line with recent changes and it still works for you, your dependant children and others for whom you are responsible – it also protects your GP data from uses beyond your direct care, not just your data supplied to NHS Digital.

With all that is and will be changing, medConfidential also strongly recommends you get yourself a Patient Online account, if you don’t already have one.

We provide more information about this on the ‘For patients’ section of our website.

Though it will still be some time until you can see how all of your data has been used, by which organisations and for what purposes, a Patient Online login to your GP’s online system should already allow you to see how your GP data is being used.

Where an opt out doesn’t apply

One critical question is whether patients’ opt-outs will now be honoured in the dissemination of ‘Hospital Episode Statistics’. HES comprises two-thirds of data releases from NHS Digital, most of those to commercial companies – including all of the commercial reusers. Until now, over 1.4 million patients’ wishes in this regard have been ignored.

Apparently officials believe IGARD, a body of NHS Digital’s own creation, can decide to override patients’ dissent when, in fact, the only body with a statutory basis to approve such exceptions is the Confidentiality Advisory Group (CAG) at the HRA.

Both GDPR and the UK’s new Data Protection Act clarify and extend the definition of identifiable data such that – the day before GDPR came into effect – staff at NHS Digital were ordered not to disseminate any “anonymised” patient data. Data releases were resumed the following day, but NHS Digital is still in discussions with the Information Commissioner’s Office as to what patient information can now be considered “anonymous”.

Under GDPR, this is unlikely to include HES in its current form: individual-level, lifelong hospital medical histories, where every event is dated and linked by a pseudonym.

Given a mother with two children is over 99% likely to be identifiable from her children’s birth dates alone, and given the enhanced GDPR ‘right of access’ to any data received by any customer of NHS Digital to which opt-outs have not been applied, it would seem not only unlawful but highly irresponsible for NHS Digital to keep selling what GDPR now defines as the identifiable patient data of those who have opted out.

If you – or any patient – would like to see how your data is used, and where your choices are being ignored, medConfidential recommends you visit TheySoldItAnyway.com

We talk a lot about NHS Digital, and its data releases that continue to ignore opt-outs. But 4 years ago today, Royal Assent of the Care Act 2014 gave NHS Digital a “general duty” to “respect and promote the privacy of recipients of health services and of adult social care in England” – which clearly hasn’t been honoured in some areas of its work. The Act also changed the law specifically so that the Confidentiality Advisory Group (CAG) of the Health Research Authority has the power to advise NHS Digital; advice to which NHS Digital must listen.

Caldicott 3 itself does not require dissent to be honoured when data is disseminated in line with the ICO’s Code of Practice on Anonymisation. (The National Data Guardian – who has been given no enforcement powers – is very careful not to ‘cross wires’ with the UK’s data regulator, who does have such powers.) And, despite well over a million patients clearly indicating their wishes to the contrary, NHS Digital continues to argue its dissemination of pseudonymised data is “anonymised” to the satisfaction of the 1998 Data Protection Act.

The UK is about to get a new Data Protection Act, aligned with and based on the EU General Data Protection Regulation, which says:

(26) … Personal data which have undergone pseudonymisation, which could be attributed to a natural person by the use of additional information should be considered to be information on an identifiable natural person.

The UK’s Information Commissioner will update the Code of Practice on Anonymisation in due course –  she’s just a little busy right now, and the new Data Protection Act is not yet on the statute book – but the Irish Commissioner has already said: (emphasis added)

“Although pseudonymisation has many uses, it should be distinguished from anonymisation, as it only provides a limited protection for the identity of data subjects in many cases as it still allows identification using indirect means. Where a pseudonym is used, it is often possible to identify the data subject by analysing the underlying or related data.”

Current practice will have to change.

While IGARD may be the appropriate body to advise whether a request meets NHS Digital’s standards for dissemination, it is not an appropriate body to advise on releasing data which does not honour patients’ objections. The adjudication of the principles of those decisions, by statute, belongs to CAG.

There are legitimate instances where patients’ dissent may be be overridden – but IGARD is not, and never should have been, the body to decide that.

The opt-out is there to protect patients who decide that the safeguard the NHS currently relies upon – pieces of paper, which include for example commercial re-use contracts with commercial companies that service other commercial companies, including pharmaceutical companies that use the data for promoting their products (i.e. marketing) to doctors – is not sufficient for their situation. As is their right.

Another example: in 2014, the Health Select Committee asked for a safe setting for researchers. Only in April 2018 did a remote safe setting begin to be piloted for researchers – that work not only needs to be completed, but it should become the standard means of access.

NHS Digital continues to insist that a piece of paper is sufficient safeguard under which to release copies of the entire nation’s lifelong, linked medical histories to hundreds of organisations. Its own published records show that two-thirds of NHS Digital’s data releases do not respect patient dissent.

It should be CAG which makes such decisions, whenever and wherever it is necessary. The CAG Regulations will make that clear, when they exist. Assurances to patients are less than meaningful when the Regulations to which they relate do not yet exist.

If someone applying for patients’ data cannot do what they need with only 98% of people’s data, they should simply explain to a responsible body why this is the case. Public Health England’s cancer registry already takes this approach with the choice of protections if offers for event dates. NHS Digital simply releases data on every patient, with the medical event dates completely unprotected.

The National Data Guardian was asked to determine a single choice by which patients could express their dissent from their data being used for purposes beyond their direct care. When that choice is disregarded, it must be on a basis clearly and specifically defined in statute, and approved by CAG.

As it is doing around the world, the introduction of the GDPR will force a change, and that change should protect patients’ data that under the new Data Protection Act will be considered identifiable. Those who still need everyone’s data will have to explain why to a competent body – which really isn’t too much to ask.

Given the clear promises given as a consequence of the care.data and HES data scandals – promises much repeated, but yet to be delivered – we’ve been waiting a long time for this to be fixed.