The care.data coach ride: communications – all change or the end of the line?

Eleven months ago, care.data was put on hold and promises made to listen to professional and public opinion, which would shape programme improvement.

Today, Sir Bruce Keogh of NHS England said: “an unprecedented shift of resources and care into GP surgeries was necessary to help the NHS withstand the twin pressures of rising demand and tight budgets.”
[The Guardian, 19 Jan 2015]

care.data right now, seems like the straw on the camel’s back that GPs do not need, and that in its current format, many patients do not want.

Why the rush to get it implemented and will the costs of doing so, – to patients, to professionals and to the programme – be worth it?

What has NHS England heard from these listening events?

The high level ‘you said, we did’ document, sharing some of the public concerns raised with care.data, has been published by NHS England.

It is an aggregated, high level presentation, but I wonder if it really offers much more insight than everyone knew a year ago? It’s a good start, but does it suggest any real changes have taken place as a result of listening and public feedback?

Where are we now, what does it tell us, and how will it help?

Some in the media argue, like this article, that a:

“massive privacy campaign effectively put a halt to it last year.”

In reality it was the combination of the flaws in the care.data plans for the GP  data extraction and sharing programme, and past NHS data sharing practices, which was its own downfall.

Campaigners merely pointed these flaws out.

Once they were more apparant, many bodies involved in good data sharing and those with concerns for confidentiality, came together with suggestions to make improvements.

But to date and a year after patients first became aware of the issues, even this collaboration has not yet solved patients’ greatest concern, that data is being given, without the individuals’ knowledge or consent, to third parties for non-clinical care, without oversight once they receive it.

The HSCIC 2013-15 Roadmap outlined HSCIC  would ‘agree a plan for addressing the barriers to entry into the market for new commercial ventures’ using our data provided by the HSCIC and:

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

 

Working with care.data was first promised, to ‘innovators of all kinds’  just as HES was delivered to commercial businesses, [including reportedly Google, and PA Consulting getting 15 years of NHS data], all with unclear and  unproven patient benefit or UK plc economic development and gain.

Patients are concerned about this.

They have asked about the assurance given that the purposes are more defined but still don’t rule out commercial users, re-use licences have not been categorically ruled out, and patients have asked further, detailed questions, which are still open.

View some of them for yourself here:  including coercion, disability inclusion, and time and time again concerns over the accuracy and quality of records, which may be uploaded, and mistakes never deleted upon which judgments are made, from records which the patient may never have seen.

care.data events have been hosted by and held for a group of charities, other care.data listening events held by the care.data advisory group, [include Peterborough and Coin Street, London]  [you can view the 26th November Manchester event with questions from 33 minutes in] and those held as part of the NHS Open House event in June [from 01:13.06 in the NHS Open House video], all asked sensible detailed questions on process and practice which are still to be addressed, which are not in the high level ‘you said, we did.’

Technical and practical processes of oversight have been changed to improve the way in which data was shared, but what about data use that has been the crux of patient concern?

How will the questions that remain unanswered be addressed? – because it seems the patient letter, posters and flyers won’t do it.

What now?

Communications are rolling out in pathfinders

All year the message has been the same: communication was poor.

“We have heard, loud and clear, that we need to be clearer about the care.data programme and that we need to provide more support to GPs to communicate the benefits and the risks of data sharing with their patients, including their right to opt out.” [October 2014, Mr. Kelsey, NHS England]

The IIGOP report on care.data outlined in December 2014 what still remains to be done and the measures required for a success.

These go far beyond communications issues.

But if pathfinders are being asked to spend time and money now, it must be analysed now, what will new communications materials look like, compared with those from a year ago.

Whilst I would agree that communications were poor, the question that remains to be asked is why? Why was communication poor? Why did a leaflet that was criticised by ICO, criticised by the GPES advisory group, criticised by many more and glaringly a failed piece of communication to outsiders, why was all that advice and criticism ignored and it got sent [or not sent] to patients across England?

[Sept 2013 GPES Advisory] “The Group also had major concerns about the process for making most patients aware of the contents of the leaflets before data extraction for care.data commenced”.

We could say it doesn’t matter. However it is indicative of the same issues now, as then, and throughout the year. There has been lots of positive advice given, shared, and asked for at patient listening events. If this is the extent of “you said, we did”, feedback is still being ignored. That matters.

Because if it continues to be, any new communications will have the same failure-to-launch that they did a year ago.

In the last year we have heard repeatedly, that the pause will enable the reshaping of communications materials.

Sadly, the bell hasn’t rung yet, on what really needs done. It looks to me as though the communications people have done their best, dealing with glaring gaps in content.

Communications materials are not ready, because it’s not clear where care.data is going, or what’s the point of the trip.

bellbroken

 

All change?

It has failed to address the programme as a change issue.

That is what it is at its core, and it is this failure which explains why it has met so much resistance.

If the 26th November Manchester questions are anything to go by the reason for the change as to why our data is needed at all, remains very unclear, for professionals and patients.

How patients will be empowered to manage its ongoing changes into the future, is also undefined.

In addition, there has been little obvious, measurable change in the substance of the programme communication in the last 12 months.

New materials suggest no real changes have taken place as a direct result of listening to public feedback at all. They may have from feedback that was given before the pause, but what impact has the pause had?

If you disagree, look over the GP care.data leaflet from 2013 and see what changes you would make now. Look at the 2013 patient leaflet and see what substantial improvement there is. Look at the basic principles of data protection and see if the care.data programme communications clearly and simply address them any better now.

What are the new plans for new communications, and how do they pick up on the feedback given at ‘hundreds’ of listening events?

The communications documents are a good start at addressing a complex set of questions.

However, whilst they probably meet their spec it doesn’t meet their stated objective: to show clear ‘we did’ nor a clear future action plan.

The listening feedback may have been absorbed, but hasn’t generated any meaningful new communications output.

It shows as far as listening goes, real communications in this one-way format, may have reached the end of the line.

How can patients make a decision on an unknown?

The new communications in posters and the ‘you said, we did’, state that access to the information collected will be limited in the pathfinder – but it does not address the question in the longer term.

This is a key question for patients.

It should be simple. Who will have access to my data and why?

No caveats, no doubts, no lack of clarity.

Patients should be properly informed how ALL their data is being used that is held by HSCIC. The opt out talked in February 2014 of two options; for data to be extracted under care.data at GPs and all the other data already stored at the HSCIC from hospitals and elsewhere. To explain those two different options patients first need told about all the data which is stored, and how it is used.

Talk about the linkage with other datasets, the future extraction and use of social care data, the access given via the back office to police and other non-health government departments.

Being cagey does not  build trust. Incomplete explanation of uses would surely not meet the ICO data protection requirements of fair processing either.

For care.data this is the unknown.

NHS England is yet to publish any defined future use and scope change process, though its plan is mapped:

caredatatimeline

 

There must be a process of how to notify patients either of what will be extracted, or who will be given access to use it > a change process. A basic building block for fair processing.

It needs to address: how is a change identified, who will be notified within what time frame before the extraction, how will the training and access changes be given, and how will patients be informed of the change in what may be extracted or who may be using it and be given the right to change their opt in / out selection.

They should also be made aware what impact this choice has on data already extracted, and that nothing will be deleted from their history.

Communication is impossible whilst the content & scope is moving.

I’ve been banging on, quite frankly,  about scope, since March.

This is what needs done. Pull over, and get the fixes done.

> Don’t roll out any comms in a pathfinder yet. They’re not ready.

> First sort out the remaining substance so you know what it is that materials are communicating.  What, who, why, when, how?

The IIGOP report lists clearly all that needs done and how to measure their success: it’s not communications, it’s content.

The final technical, security and purposes pieces still need resolved; practical questions on opt out,  legislation needed to make sure the  opt out really is robust, that the so-called ‘one strike and out’ isn’t just a verbal assurance but actually happens, and that future access is defined beyond the pathfinder – who will have access at and outside the new secure lab – not only for the pilot, but future.

Get the definition of scope limited so as to meet fair processing, and get the future scope change communication process ironed out.

How will patients be communicated to not only now, not in a pathfinder, but for every change that happens in the future which has a fair processing requirement?

Only then can the programme start to truly address change and communications with meaningful messages. Until then, it’s PR.

Once you know what you’re saying, how to say it becomes easy.

If it’s not proving easy to do well, we need to ask why.

change>>>References>>>

 1. You said, we did NHS England presentation

2. IIGOP report into care.data

3. Pharmacists to access DWP data – example of scope change who accesses data and why, which fails fair processing without a change process in place to communicate

>>>>>>>>>

For anyone interested in considering the current materials in detail, see below: this doesn’t address the posters shared in the Manchester event or what is missing, but many of the messages are the same as in the ‘you said, we did’ and it’s a start.

>>>>>>>>>

Addendum:

1. The “co-production” approach to materials

2. Why a scope change management process is vital to trust for care.data.

3. Some feedback on the high level ‘you said, we did’ document

4. What do communications require to improve from those before?
5. Hard questions

 

1. The “co-production” approach to materials

The IIGOP report on care.data outlined in December 2014 asked a very sound question on page 8:

“What are the implications of using locally developed communications material (“co-production”) for subsequent national rollout ?”
The Programme is developing a “co-production” approach to initial GP and patient-facing material, based on feedback from the care.data “listening period” and from local events and formal research.
“The intent is to ensure that there is local ownership of material used to communicate with professionals and patients in the Pathfinder stage.”
To ask a basic tenet of change management: what’s in it for them?
It’s unclear to what level of detail the national materials will go, and how much local sites will create.

 

If I were at CCG or GP level and responsible for ‘local ownership’ of communications from this national programme, I’d be asking myself why I am expected to reinvent the wheel? I’d want to use national standards as far as possible.

Why should local organisations have to produce or design materials which should be communicating the intent of a programme whose purpose is to be identical for every one of the 62 million in England registered with a GP? Let’s hope the materials are national.

What benefit will a local level site see, by designing their own materials – it will cost time and money – where’s the benefit for the patients in each practice, for the GPs and the programme?
Is it too cynical to ask, has NHS England not got the resources to do this well and deliver ready-done?
If so, I should urge a rethink at national level, because in terms of time and people’s effort this multiple duplication will be a costly alternative.
It also runs the risk of costly mistakes in accuracy and inconsistency.
There appears to date to be no plan yet how future changes will be communicated. This must be addressed before the pathfinder and in any current communication, and all local sites need the same answer because the new decisions on extraction, will be at national level.

 

2. Some feedback on the high level ‘you said, we did’ document:

page 9: “present the benefits” – this fails to do so  – this is however not a failing of this presentation – there is simply still no adequate cost benefit document available in the public domain.

page 11: “keep data safe” – the secure lab is mentioned – a great forwards step compared with HES access – and it states analysts will only access it there in the pathfinder – but what about after that?

page 13: “explain the opt out clearly”: “You can opt out at any time. Just talk to your GP Practice.” > I have, but as far as I know my data is still released by the HSCIC from HES and wider secondary collections of data, which I did not know were extracted and did not consent to being used for secondary purposes. Opt out doesn’t appear to actually work. Please let me know if that’s a misunderstanding on my part. I’d be delighted to hear it is functional.

page 15: “legislative changes” - the biggest concern patients raise over and over again, is sharing data beyond their direct care with commercial companies and for non-NHS purposes. This has not been excluded. No way round that. No matter how you word it and made harder by the fact that data was released from HES in July to Experian for use in mosaic. If that makes the definition, then it’s loose.

The one-strike-and-out is not mentioned in materials, although it was discussed on Nov 26th in Manchester. When is the legislation to actually happen?

Both this and the opt out are still not on a robust legal basis – much verbal assurance has been given on “legislative changes” but they are meaningless if not enacted.

page 17: “access safeguards” – the new audit trail is an excellent step. But doesn’t help patients know if OUR data was used, it’s generic. We need some sort of personal audit trail of our consent, and show how it is respected in what data is released, to who, when, and why. The over emphasis of ‘only with legal access’ is overdone as 251 has been used to approve data access for years without patient knowledge or consent. If it is to be reassuring, it is somewhat misleading; data is shared much more widely than patients know. If it is to answer questions asked in the listening feedback events, there needs to be an explanation of how the loop will be closed to feed the information back and how it will be of concrete benefit.

And in general:

Either “this will not affect the care you receive”  or it will. Both sentences cannot be true.  Either way, there should be no coercion of participation:

“If you decide to opt out it won’t affect the care and treatment you receive. However, if significant amounts of people do opt out, we won’t be able to collect enough information to help us improve NHS services across the nation.”
Agreement must in usual medical environments, be given voluntarily and freely, without pressure or undue influence being exerted on the person either to accept or refuse.

 

 

3. What do communications require to improve from those before?

a. Lessons Learned for improvement:

The point of the pause was in order to facilitate the changes and improvement needed in the programme, whose flaws were the reason to stop in February. All the questions need shared so that all the CCGs can benefit from all the learning. If all the flaws are not discussed openly, how can they be fixed? Not only being fixed, but being seen to be fixed would be productive and useful for the programme. [The IIGOP report on care.data outlined in December 2014 covers these.]

b. Consistency:

Raw feedback will be vital for CCGs and GP practices to have. It has not been released and the ‘you said, we did’ is a very high level aggregate of what was clear last February. Since then, the detailed questions are what should be given to give all involved the information to able to understand, and to have the answers for consistently.

This way they will be properly prepared for the questions they may get in any pilot rollout. If questions have already been asked in one place, the exact same answer should be reproduced in another.

c. Time-saving:

If the same question has already been asked at a national or regional event, why make the local level search for the same answer again?  This could be costly and pointless multiplied many times over.

d. Accuracy:

Communications aren’t always delivered correctly. They can be open to misinterpretation or that the comms team simply gets facts wrong.  That would fail data protection requirements and fail to protect GPs. How will this accuracy be measured if done at local level and how will it be measured and by whom?

IIGOP asked: “What are the success criteria for the Pathfinders? How will we know what has worked and what has not? “

I know from my own experience that either the communications team or consultants can misunderstand the facts, or something can easily become lost in translation, from the technical theory to the tangible explanation.

4. Future change: Control of scope change for linkage and  access

Current communications may address the current pathfinder extraction, but they are not fit for purpose for a rollout which is intended to be long term and ever changing.

So what exactly is it piloting? – a “mini” approach? – if so, to what purpose? or is it just hoping to get X amount of data in, done and dusted, as ‘a start.’

If the pathfinder patients are only told a sub-set of information in a pilot rollout, we should ask:

a. why? Is this in order to make the idea sound more appealing?

b. how will it be ensured that their consent, or lack of objection, is fully informed and therefore meets Data Protection requirements?

and finally

c. how will future changes be communicated? This must be addressed before the pathfinder and in any current communication.

For example; who gets access to data may change so you can’t say only “” access to the information collected will only be given to a limited number of approved analysts who will have to travel to a new secure data facility that the HSCIC is setting up.”

Pharmacists who have access to this data for direct care, may also now be getting access to DWP data.

“the Royal Pharmaceutical Society has already said that the new measures could affect trust between patients and pharmacists.” [EHI Dec 30th 2014]

When patients signed up for the SCR at a GP practice they may not realise it is shared with pharmacies. When data is shared with the Department of Work and Pensions, citizens may not realise it could be shared with pharmacies.  Neither told the other when signing up that future access would allow this cross referencing and additional access.

This is a real life scenario that should not be glossed over in a brochure. A hoped for ‘quick-fix’ now, will simply cause later problems, and if data is used inappropriately, there may not be another opportunity for winning back trust again.

Here’s why it would be better to do no more communications now:

5. Hard questions can’t be avoided

Currently, comms still avoid the hard questions, and those are the ones people want answers for. Open questions remain unaddressed.

Raw questions asked in July at a charities’ event are, with some post-event reshaping and responses here. Note how many are unknowns.

Changes have been suggested to be constructive.

One attendee of a public listening event commented online in October 2014, on the NHS England CCG announcement:

“I am one of those that has tried hard to engage with you to try and make sure that people can be assured that their personal and private information will not be exploited, I feel that you have already made the decision to press ahead regardless and feel very let down.

“Please publish the findings of your listening exercise and tell people how you intend to respond to their concerns before proceeding with this.”

People have engaged and want to be involved in making this programme work better, if it has to work at all like this.

The actual raw questions have been kept unpublished for no clear purpose. It could look like avoiding answering the hard questions.

The IIGOP report captures many of them; for example on process of competence, capacity and processes – and the report shows there is still a need to “demonstrate that what goes on ‘under the bonnet’ of Pathfinder practice systems operates in the same way that patients are being told it does.”

When is the promised legislative change to actually happen? The opt out is still not on a robust legal basis – much verbal assurance has been given on “legislative changes” but they are meaningless if not enacted.

It’s all about trust and that relationship, like the communication and feedback responses, has to be two-way.

The Deregulation Bill – Episode III : Regulate, what with?

Regulation, the use of regulatory powers and the authority to oversee them, are in flux in England.

Some will have lesser discussed, but long term, wide ranging effects such as the regulatory framework and requirement for profit in almost all public bodies.

A significant amendment [1] appears to have been proposed by Lord Hunt of Kings Heath on 9th Jan, 2015 in the Deregulation Bill [2]. The next discussion date of which seems to be provisionally scheduled for February 3rd and 5th.

The amendment proposes the removal of ten regulatory functions in health and care, from the requirement to exercise the clause of considerable concern, renamed from clause 83 to clause 88: the statutory duty towards a desirability to promote economic growth.

My last post in November on this clause was after the debate in which Lord Tunnicliffe concluded:

”if our fears comes to pass, these three clauses could wreak havoc in a regulatory regime within this country.”

Later  he asked:

“are these new clauses a licence for regulators to approve regulations that kill people to save money?”

Clause 88: background on the clause to ‘promote economic growth.’

Almost a year ago, in February 2014, [3] MPs had discussed this same clause in its passage in the House of Commons.

MPs were asked to support a reasoned amendment tabled by Caroline Lucas, Jonathan Edwards, John McDonnell and Jeremy Corbyn MPs.

They proposed the removal of the clause, requiring the desirability for economic growth, and they had concerns:

…”that this Bill represents a race to the bottom and an obsession with GDP growth at any cost which is not in the public interest.”

(my underlining):

[…]”the Health and Safety Executive, which is irresponsible and risks undermining their core roles; further considers that this Bill is another illustration of a Government which is embarking on a deregulatory path without due consideration of warnings, including from businesses, that effective regulation is essential to create jobs and innovation and that ripping up vital green legislation risks locking the UK into polluting industrial processes for decades to come, jeopardising future competitiveness, damaging the UK’s attractiveness for green investment, and undermining new industries.”

This clause must be reviewed thoroughly and transparently from scratch. If indeed these ten bodies are to be considered for exclusion from the clause there must be a detailed case of why. This leads automatically to ask for the benefits to justify the inclusion of others. If this has not been made transparent to the Lords debating the clause by now, then the bill should not pass as is without reasonable justification.

Is there an MP or Lord who will gladly take the responsibility to say:

“I agreed to a new law, the consequences of which I was not clear, but I did not ask the questions I should have done. I ignored that Lord Tunnicliffe asked: “are these new clauses a licence for regulators to approve regulations that kill people to save money?” And I did not examine why this might be for each and every function of regulation it affects.”

Based on what decision criteria and based on what measures or public interest test has this department area been selected for exclusion and others, such as the environment, been omitted?

Considering the reported opinion of the Bill’s proponent Oliver Letwin MP to the NHS it sould seem wise to ask, what kind of National Health Service do our MPs expect to see in future under this new model of statutory requirement to seek profit.

In conclusion:

Is the bill designed to future-proof regulatory common sense or set it up for widespread failure from the start?

In the words of Lord Tunnicliffe:

“The problem is the clauses themselves. Clause 83(2) states that:

‘the person must … consider the importance for the promotion of economic growth of exercising the regulatory function in a way which ensures that … regulatory action is taken only when it is needed, and … any action is proportionate”.

“Those words by themselves seem a pretty high test for a regulator. As I tried to illustrate, our lives are made acceptable and benign by regulators acting pretty well as they do at the moment to protect us. So are these new clauses a licence for regulators to approve regulations that kill people to save money?”

It should be made very transparent what bodies will be affected, why, how the decision making in each function will be carried out and what with? At national or local level ruling authority?

Clearly there is still work to be done to ensure that the implications in the public interest. That ethic seems to have been lost at the back of the vast cupboard of all that the deregulation bill has in store.

Alongside the changes to the sale of liqueur chocolates and weights and measures for knitting yarn we have lost something much greater in the Deregulation Bill.

However this amendment suggests there is new hope coming for the proposed change to regulatory powers and their profit making; that in fact, some significant bodies may be made exempt of this duty on a statutory footing.

Now the case should be made why any public bodies should not be.

Simply, the wider Public Interest must come first, above profit.

Perhaps when one hears calls to ignore criticism of these proposals of deregulation in this bill and in TTIP one would do well to ask why.

Anything else could be as disastrous for society, as the Poll Tax is now accepted to have been for Margaret Thatcher.

But perhaps, some would maintain, there is still no such thing?

*********

For those with more in depth interest:

Further detail; below I continue and review the amendment,  wider implications at local authority level, changes in the future landscape of health and social care and why it could be of significant negative impact on political and social trust.

This is my update on two previous posts; Part one: October 4th, Deregulation Bill Clause 47 and the back door access to journalist sources and Part two: the Deregulation Bill Clause 83 from 6th Nov with additional notes on Nov 21st.

It continues with Part four to follow: The Deregulation Bill: Part IV New Hope for Regulatory powers?

*****

The amendment

Here is what it looks like:

 Page 70, line 29, at end insert—“( )     This section does not apply to the following—
 

(a)   Care Quality Commission,

(b)   Human Tissue Authority,

(c)   Medicines and Healthcare Products Regulatory Agency,

(d)   Professional Standards Authority,

(e)   General Medical Council,

(f)   Nursing and Midwifery Council,

(g)   Health and Care Professions Council,

(h)   General Chiropractic Council,

(i)   General Dental Council,

(j)   General Pharmaceutical Council,

(k)   Human Fertilisation and Embryology Authority, and

(l)   any persons exercising a regulatory function with respect to health and care service that the Secretary of State specifies by order.

( )     An order under this section must be made by statutory instrument.

( )     A statutory instrument containing an order under this section may not be  made unless a draft has been laid before, and approved by a resolution of,  each House of Parliament.”

What would the amendment change, if they become law?

These exceptions are specific to healthcare and, it remains to be seen if they will be adopted.

There is also some provision, to make further special cases for the health and care service more broadly, that the Secretary of State specifies by order.

This addresses some organisations in the regulation of health and care.

But it opens up the question more clearly why should other bodies be included? Where is the benefit – and where is the cost and risk analysis?

That would be a most welcome discussion in the public interest. Some professionals and professional bodies have already flagged their concern.

The Equality and Human Rights Commission is one example, that was discussed in the last debate andthe ECHR response to it. [4]

Nov 21st update:  see Column GC229 < and whilst verbal assurances were made, it appears nothing changed in the Bill, and that the EHRC said in response:

“While we welcome this undertaking we understand that this doesn’t mean that we’ll be removed on the face of the Bill”.

The ECHR clearly sees it as detrimental and asks for change. Will the government ride roughshod over professional opinion without transparent and thorough justifications of the need for this?

If so, it seems an extraordinary dismissal of democracy.

Other bodies should take the lead from the EHRC and make their positions clear in the public domain now, or risk future backlash once the impacts become clear.

What wider impact will this amendment have?

At first the effect appears to be that a significant number of health related bodies could be freed from the duty to make a profit.

At national level this seems a welcome and sensible step.

To decide which bodies should and which bodies should not be exempt it must be very clear exactly what impact these changes will have.

 

For each body involved, an impact assessment table should be drawn up – what do they regulate, how, why and what would change under the deregulation bill and the effects of its clauses, especially 88. Risks and benefits.

 

That would help understand today’s position.

 

The next step is to understand the future implications. Identify which bodies will be deregulated by it in future, why and how they will be affected by other aspects of the bill.

However it’s not the whole story.

How these bodies perform their tasks at national level and how far down their powers reach will affect the organisations below them.

These lower branches of organisational structure also need to be understood for any regulatory implications. How that function is carried out under what powers needs to be clear at what point the removal of the requirement would have an effect.

These ten bodies are in health and social care. The future of health seems to be bound to social care and in Simon Stevens’ vision, with ever more physical, as well as financial mergers.

 

In an interview with the Financial Times: he predicted ‘a blurring of the [lines] that exist between different public services’.He said:

Basing my understanding on CCG meeting attendance, reading ADASS minutes and general media news. it appears pooled budgetary responsibility will call for a shift in more responsibility to local authorities.

 

Is it therefore logical to assume that will include the responsibility for regulatory functions?

 

Any changes therefore at national level in terms of organisational structure or regulatory responsibility will have an affect at lower levels.

 

So for an organisation of the amendment ten, taking the Care Quality Commission for example, it is not unthinkable that change is inevitable regardless whether they are in or out of this clause.

 

The CQC has come in for some criticism in recent months with media stories repeating failings. Mistakes were made, with significant media coverage, on the calculations of quality ratings of GP practices.

Questions were raised in November as to the extent of the reach of the CQC surveillance powers at practice level, reviewing individual patient medical records ‘to assess the quality of care provided by the practice’ without individual consent. Professionals on social media raised their electronic eyebrows and lamented the breach of confidentiality.

What deeper impact will this have?

What happens should the CQC powers be broken up at national level and carried out at local level instead needs to be examined.

The body having been made exempt at national level from this commercially driven clause, may find that the regulatory functions would be required to comply with it again at Local Authority level.

The reasons why the CQC should be made exempt, would therefore be lost in the transition, unless the special orders and special provision were made before any organisational restructure.

The timing therefore of new regulations would need to become integral to any departmental organisational change at any and every level of regulatory governance.

Instead of removing ‘red tape’ and bureaucracy in this bill, I foresee it adding a burden of analysis and requirement to assess and document responsibilities; determining whether or not the clause to promote economic growth should apply or not.

Its definition is so vague and its responsibility to be ‘proportionate’ so open, that in fact it is not assigned to anybody; which everybody knows,  means it ends up being done, by nobody.

Every time some any reorganisation is planned, the impact of this regulatory clause may need considered and not only in health and social care but in every aspect of regulatory function across government.

Every action a regulatory body takes, is by default ‘regulatory action.’ So any time the function should do its job, each and every time, every decision, every ruling, would need to consider the need for economic growth and if they need to act at all.

(a) regulatory action is taken only when it is needed,

and

(b) any action taken is proportionate.

Surely this is what they do already in every decision, and therefore why make it a statutory requirement at all – for any regulatory body?

If we don’t need it, why write it in. And if we do need it, what precisely is it intended to do, how and why?

I would encourage anyone who has not yet done so, to have a good look over the contents of the bill. It’s like an end of year sale and there is definitely something in there for everyone. The likelihood is high that some unforeseen damage will be done to the public interest in the rush to get it through in this term by government, akin to a Black Friday panic. The bills lined up to rush through the  last minute doors of parliament, seem to be queueing in droves.

For bodies which have regulatory functions today in health and social care at Local Authority level already, the hoped for reduction in harm through this amendment affecting their national level body, could fail to materialise.

The high-level  health and social care bodies may get “let off” the duty in explicit terms in the bill, but if the function is performed at another level, “on the ground”,  the requirement of the function will in effect still happen under-the-radar.
  
Here is at least a starting point to go deeper into who regulates what at local authority level. [6] Imagine each and every regulatory function trying to consider the importance for the promotion of economic growth of exercising  the regulatory function in a way which ensures that —

(a) regulatory action is taken only when it is needed,

and

(b) any action taken is proportionate.

How will as another example, the local government ombudsman make a profit but not put that before the people it serves?
In this case their role is managing complaints about councils and some other authorities and organisations, including education admissions appeal panels and adult social care providers. How does one justify exploiting that, for profit?

 

With purdah and the general election drawing near,  this may be a question with an unpredictable answer for many organisations if their future structural model is uncertain.

 

The backdrop

 

There are various other bills in progress to do with regulation, which involve communications and data, and by implication, potentially journalists’ sources. They are also affected by clause 47 in the deregulation bill which the NUJ protested in 2014. [more in my next post].
A press free from political control and undue regulation is something to be held dear, and indeed Guido Fawkes has experienced this week. attempts to control it, by the Electoral Commission:

 

“Guido has no intention of registering with the Electoral Commission or reporting a penny of spending or anything else to them. This authoritarian law is a nonsense. If you read the guidance it should apply to newspapers. We haven’t just rejected statutory control of the printed press by one regulator for political control of digital media by another.”

Here we arrive at the nub of the issue: what is to be deregulated and why and by whom are fundamental to understand what effects these changes will require, and the demands the duty for economic growth will create.

I question: “Can this dramatic change, really be a wise and throroughly thought out course of action, when the only certainty in the affected organisations’ governance duties is that in fewer than five months, it may all change?”
Had all the background and assessments been done already, one would think it could be understandable to press on and complete. But the fact that this significant amendment has been proposed now, surely shows that an adequate cost benefit and risk assessment does not exist. Does it not exist only for these ten, or for all?

 

All sorts of areas of public interest are affected, with questions being asked on private tenancy changes to the very Electoral Commission itself.

 

In the run up to the election, will it be asked to become a profit driven  entity? – instead of prioritising its key focus, the regulation of our democratic processes:

 

“These roles and responsibilities outline much of the work we do in order to meet our objectives of:

  • well-run elections, referendums and electoral registration
  • transparency in party and election finance, with high levels of compliance”

How will the Electoral Commission  maintain neutrality if profit must drive the function as the regulator of political funding and spending?

That decision could have almighty and lasting effect on public confidence and our trust in the wake of the MP expenses scandals.

Without a publicly available clear cost benefit analysis, the overwhelming drive for profit in every sector of UK regulatory reach remains at best unclear.  The intended benefits or whether they will even create any efficiencies, never mind public gain, lacking.

At worst, “are these new clauses a licence for regulators to approve regulations that kill people to save money?”

****

Key references:

[1] Proposed amendment by Lord Hunt of Kings Heath in the Deregulation bill.

[2] The Deregulation Bill

[3] Hansard, February 3 2014, MPs propose removal of clause

[4] Hansard, November 20th 2014, ECHR comments included in Lords’ debate

[5] Public Health functions under Local Authority

[6]  Local Authority regulatory functions

********

List of The National Regulators – the ten bodies  above are those explicitly mentioned in Lord Hunt of King’s Heath’s amendment:

Animal Health and Veterinary Laboratories Agency (AHVLA)

Animals in Science Regulation Unit

Architects Registration Board (ARB)

British Hallmarking Council (BHC)

Care Quality Commission (CQC)

Charity Commission for England and Wales

Civil Aviation Authority (CAA)

Claims Management Regulation Unit

Coal Authority

Companies House

Competition Commission

Professional Standards for Health and Social Care (PSA)

Disclosure and Barring Service (DBS)

Drinking Water Inspectorate (DWI)

Driver and Vehicle Licensing Agency (DVLA)

Driving Standards Agency (DSA)

Employment Agency Standards Inspectorate (EAS)

English Heritage (EH)

Environment Agency

Equality and Human Rights Commission

Financial Reporting Council (FRC)

Fish Health Inspectorate (FHI), Centre for Environment, Fisheries and Aquaculture Science (Cefas)

Food and environment research agency (plant and bee health) and (Plant Variety and Seeds)

Food Standards Agency (FSA)

Forestry Commission

Gambling Commission

Gangmasters Licensing Authority (GLA)

General Medical Council

General Chiropractic Council

General Dental Council

General Pharmaceutical Council

Health and Safety Executive (HSE)

Higher Education Funding Council for England (HEFCE)

Highways Agency (HA)

HM Revenue and Customs (Money Laundering Regulations and National Minimum Wage)

Homes & Communities Agency (HCA)

Human Fertilisation and Embryology Association (HFEA)

Human Tissue Authority (HTA)

Information Commissioner’s Office (ICO)

Insolvency Service including Insolvency Practitioner Unit

Intellectual Property Office (IPO)

Legal Services Board (LSB)

Marine Management Organisaton (MMO)

Maritime and Coastguard Agency (MCA)

Medicines and Healthcare Products Regulatory Agency (MHRA)

Monitor

National Measurement Office (NMO)

Natural England

Nursing and Midwifery Council

Office of Communications

Office for Fair Access (OFFA)

Office for Nuclear Regulation (ONR)

Office for Standards in Education, Children’s Services and Skills (OFSTED)

Office of Fair Trading

OFQUAL

Office of Rail Regulation (ORR)

Office of the Regulator of Community Interest Companies

OFGEM

Pensions Regulator

Rural Payments Agency (RPA)

Security Industry Authority (SIA)

Senior Traffic Commissioner

Sports Grounds Safety Authority (SGSA)

Trinity House Lighthouse Service (THLS)

UK Anti-Doping (UKAD)

Vehicle and Operator Services Agency (VOSA)

Vehicle Certification Agency (VCA)

Veterinary Medicines Directorate (VMD)

***

Please feel free to comment below or find me on twitter @TheABB

care.data related December news you may have missed in the holiday

January looks like it’s going to be a busy NHS news month and December set out a very information rich programme.

Do you need a catch up from the holidays time? I know I could do with going back to September really, I blinked and missed the last quarter. But lots of news came in at the end of year, in typical holiday time, which is relevant to care.data, health data sharing and its backdrop:

[1] December 18th:  The Independent Information Governance Oversight Panel report raises questions about the preparation for a pilot stage of the care.data programme.

A very thorough and  most significant report. I considered this is more detail here.

[2] December 22nd: The Primary Care Support (PCS) Services procurement. Launched in November 2014 interested suppliers were asked to respond to a Pre-Qualification Questionnaire (PQQ).

“Members of our Stakeholder Group, staff from the PCS Service and experts in the procurement team have been evaluating the responses received from the PQQ. We have now produced a short list of suppliers to invite to the next stage of the procurement. We will be announcing the shortlisted suppliers in January 2015.”

How will this affect primary care records’ management and is that unknown being factored into current decision making?

[3] December 28th The Guardian reported the delayed Rose Report would be out in January and say the NHS is hampered by poor management structure.

[4] December 30th Poulter announces DWP prescription check “The government is planning to give High Street pharmacists access to Department of Work and Pensions IT systems to check whether patients in England are entitled to free prescriptions.”

This raises a raft of questions on data protection with implications for patient confidentiality, expected purposes, informed consent and data linkage.

[5] December: a New HSCIC Code of Confidentiality

A longer read and leaves not everyone content it addresses all the needed questions. Opt outs and technical solutions on anonymisation remain two areas of undefined detail relevant for care.data.

[6] January 2nd: IIGOP annual report How health and social care organisations are implementing recommendations about sharing information.

This is a key publication on data sharing as a whole [not only care.data] – snuck in on one of the quietest days of the year perhaps? Some points of particular mention are those which set expectations for legislation change:

“During a debate in the House of Lords in May 2014, in the face of criticism of the care.data programme, the Government said it was sympathetic to calls for IIGOP to be placed on a statutory footing.”

One can only expect then it is a question of when, not if, the IIGOP role will become enshrined in law. Before the next major data sharing step for care.data, the planned pathfinders perhaps?

The second piece of law needing defined and actioned goes back almost a year to February 2014 and Mr. Hunt’s promise of a statutory opt out, which would seem fundamental to any next step step and pilots.

On opt out IIGOP said:

“It is the view of IIGOP that progress at a nationwide level in achieving appropriate sharing of information for direct care will not be satisfactory until core building blocks are in place, including agreement on terminology, clarity on consent and consistency of arrangements for objection and “opt out.”

That opt out refers to all medical data sharing, not only that for care.data, which comes in for criticism but notes some positive side effects:

“The unintended consequence of care.data was a positive cycle of change.”

Most positively, the report notes the changed attitude to public awareness and expectations around personal data management:

“Over the past year, the subject of information governance has moved from the backwaters of organisational management into the mainstream of public discussion. Debate about when it is right to share people’s care data is no longer restricted to policymakers, technical experts and medical ethicists.”

[7] January 5th: The Health and Social Care Information Centre will launch a secure data lab for viewing sensitive patient data in March, allowing it to support the pathfinder stage of NHS England’s controversial care.data programme.

What about opt out – technical feasibility and the Ministers promises to put it into legislation, still not done yet?

[8] Public health commissioning in the NHS 2015 to 2016 plan

Everything connected to everything in the market matters in the bigger picture. See [2], [4] and consider commercial data uses.

[9] Predictions from professionals for 2015 via EHI Insider: A clear direction for NHS IT was set in 2014; but could be disrupted by the general election due on 7 May, according to experts asked for their predictions for healthcare IT in 2015.

So, this quarter is getting off to an information-rich start with the December releases of reports and news having laid an interesting foundation for the coming quarter. And election purdah at the end of March…

[10] My own care.data wish list - no more surprises please  – what will care.data plans hold for 2015?

 

****

References:

[1] IIGOP care.data report https://www.gov.uk/government/publications/iigop-report-on-caredata

[2] Primary Care support services outsourcing / transformation http://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2014/12/Final_Stakeholder_Update_December_2014-.pdf

[3] The Rose Report http://www.theguardian.com/society/2014/dec/28/nhs-management-system-complex-rose-report

[4] www.ehi.co.uk/news/EHI/9813/poulter-announces-dwp-prescription-check

[5] HSCIC code of confidentiality http://systems.hscic.gov.uk/infogov/codes/cop/code.pdf

[6] IIGOP Annual Report: https://www.gov.uk/government/publications/iigop-annual-report-2014

[7] HSCIC secure data lab news: http://www.ehi.co.uk/news/primary-care/9815/hscic-data-lab-to-launch-in-march

[8] Commissioning plans: https://www.gov.uk/government/publications/public-health-commissioning-in-the-nhs-2015-to-2016

[9] 2015 Predictions: http://www.ehi.co.uk/news/primary-care/9800/coming-up-in-2015

[10] My own wish list fior care.data in 2015:  http://jenpersson.com/care-data-2015-list/

Oh, and my New Year’s Resolution, I’m cutting my posts in half. Nothing over 1000 words.

A review of NHS news in 2014, from ‘the Spirit of the NHS Future’.

Respectful of all the serious, current news and that of the past year, this is a lighthearted look back at some of the stories of 2014. ‘The Spirit of the NHS Future’ looks forwards into 2015 & at what may still be changed.

***

The Spirit of the NHS Future  visits the Powers-at-be
(To the tune of The 12 Days of Christmas)

[click to open music in another window]

On the first day of Christmas
the Spirit said to me:
I’m the ghost of the family GP.

On the second day of Christmas
the Spirit said to me: a
two-tiered system,
in the future I foresee.

On the third day of Christmas
the Spirit said to me:
You told GPs,
merge or hand in keys,
feder-ate or salaried please.

On the fourth day of Christmas
the Spirit said, I hear:
“Save our surgeries”,
MPIG freeze,
partners on their knees,
blame commissioning on local CCGs.

On the fifth day of Christmas
the Spirit said to me:
Five Ye-ar Plan!
Call it Forward View,
digital or screwed.
Let’s have a new review,
keep ‘em happy at PWC.

On the sixth day of Christmas
the Spirit said to me:
Ill patients making,
out-of-Ho-urs-rings!
Callbacks all delayed,
six hours wait,
one one one mistakes.
But must tell them not to visit A&E.

On the seventh day of Christmas
the Spirit said, GPs:
see your service contract,
with the QOF they’re trimming,
what-will-this-bring?
Open Christmas Eve,
New Year’s no reprieve,
please don’t cheat our Steve,
or a breach notice will you see.

On the eighth day of Christmas
the Spirit said to me:
Population’s ageing,
social care is straining,
want is pro-creating,
obe-si-ty’s the thing!
Cash to diagnose,
statins no one knows,
indicator woes,
and Doc Foster staff employed at CQC.

On the ninth day of Christmas
the Spirit said to me:
Cash for transforming,
seven days of working.
Think of emigrating,
ten grand re-registration.
Four-teen hour stints!
DES and LES are fixed.
Called to heal the sick,
still they love the gig,
being skilled, conscientious GPs.

On the tenth day of Christmas
the Spirit said to me:
Many Lords a-leaping,
Owen’s not been sleeping,
private contracts creeping,
Circle’s ever growing.
Care home sales not slowing.
Merge-eve-ry-thing!
New bidding wars,
tenders are on course
top nine billion, more,
still you claim to run it nation-al-ly.

On the eleventh day of Christmas
the Spirit said to me:
Patient groups are griping,
records you’ve been swiping,
listening while sharing,
data firms are buying,
selling it for mining,
opt-out needs defining,
block Gold-acre tweets!
The care dot data* board
minutes we shall hoard,
troubled pilots loom.
Hi-de Partridge’s report behind a tree?

On the twelfth day of Christmas
the Spirit said to me:
disabled are protesting
sanctions, need arresting,
mental health is failing,
genomes we are trading,**
staff all need more paying,
boundaries set for changing,
top-down re-arranging,
All-this-to-come!
New hires, no absurd,
targets rule the world,
regulation first.
What’s the plan to save our service, Jeremy?

– – – – – –

Thanks to the NHS staff, whose hard work, grit and humour, continues to offer the service we know. You keep us and our loved ones healthy and whole whenever possible, and deal with us & our human frailty, when it is not.

Dear GPs & other NHS staff who’ve had a Dickens of a year. Please, don’t let the system get you down.

You are appreciated, & not just at Xmas. Happy New Year everyone.

“It is a fair, even-handed, noble adjustment of things, that while there is infection in disease and sorrow, there is nothing in the world so irresistibly contagious as laughter and good humour.”
Charles Dickens,   A Christmas Carol, 1843

– – – – –

*New Statesman, Dr Phil Whitaker’s Health Matters column, 20th March 2014, ‘Hunt should be frank about the economic imperative behind the urgency to establish the [care.data] database and should engage in a sensible discussion about what might be compromised by undue haste.’

**Genomics England Kickstarting a Genomics Industry

A care.data Christmas carol

“Marley was dead: to begin with. There is no doubt whatever about that.” [A Christmas Carol, Charles Dickens, 1843]

“Is care.data dead?” I was asked after our children’s nativity today, “what happened to that GP record sharing project?”  The local priest, you may think of all people, wondered what had become of the news stories we had discussed at Easter.

Not dead, I assured him, though it was suggested recently that the Caldicott led Independent Information Governance Oversight Panel (IIGOP) report [1], would be the final nail in the coffin of the past approach [2], and would spell doom ahead in any care.data future were the programme not to follow its recommendations.

I told him the story of the care.data year.

So, are you sitting comfortably? For Christmas is a time of storytelling. At its heart, the story of a birth, which has been handed down through generations.

But here, I borrow from the most famous of all English Christmas stories, a Christmas Carol, by Charles Dickens from 1843. Let us begin.

“Come in!” exclaimed the Ghost. “Come in! and know me better, man!”

The ghost of care.data past rattled its chains and brought no joy in 2014, haunting the current programme with news of past data sharing practices.  At the start of the year, much was made of the 25 years of past use of data, we were told there had never been breaches [3], and there was surprise expressed by NHS England leadership at why care.data, the plan to extract GP records now in addition, should have struck such a nerve in the public.

Various reports have since tried to vanquish those ghosts which have haunted the rollout of care.data in the past year. Sir Nick Partridge in May led the Review of Data Releases by the NHS IC which looked back at health data sharing of the existing HSCIC held data, and in November, he examined the progress up to the present.[4]

The IIGOP Report published last week on the care.data Programme Board looks to the future. It sets out a thorough set of specific recommendations, questions and tests to meet before it could be reasonable to proceed to a data extraction in the care.data pilot.

The first independent report on care.data, prepared and released under the oversight of the new Data Guardian, Dame Fiona Caldicott, it also captures many sensible and practical questions raised by patients at events all year.

In some ways, whilst sad to see what so many have said, has only come to be addressed by an independent body rather than NHS England, recognising the current weaknesses can only be seen as positive to bring about changes.

What next steps will come from this for a care.data relaunch by NHS England, and when in future, remain to be seen. [Updates may be here, or here or sometimes here].

Perhaps if the current course of actions is averted, we may not ‘see a vacant seat’ if it all falls apart in 2015 after all.

The CCGs have been given a huge responsibility which is not of their making, if NHS England continues to pilot under CCG-steered rollouts.[5]

One would hope that given the right amount of time needed to manage this change process, and  with the right supporting skills and tools for the practicalities, the care.data programme will take a changed form in the year ahead. It may yet be saved.

But it does seem often that timing is of the essence, and we move from one artificial deadline to the next. The public and GPs wait without the security and confidence of a realistic schedule.  Waiting we wonder if we will reach the next chime due, or the next ghost to haunt the programme will arrive and cause new fright.

It’s no cure all, but it appears the IIGOP has given the programme the gift of one last wonderful opportunity to get this right. It’s requirements are sizeable and will take time to execute sensibly. The report illuminates a future path for progress and shows what must be altered today, to avoid the future it predicts otherwise.

As Scrooge learns:

“But if the courses be departed from, the ends will change.” [A Christmas Carol, Charles Dickens, 1843]

Ignore the wisdom of the ghosts at your peril. For a changed future outcome,  the actions of the present must change first.

So, humour me awhile, and let’s consider some of the bigger themes in the care.data Christmas carol that CCGs may wish to consider as it deals with preparing for pathfinder pilots…

Chapter 1. “This boy is Ignorance. This girl is Want. Beware them both, and all of their degree, but most of all beware this boy, for on his brow I see that written which is Doom, unless the writing be erased…” [A Christmas Carol, Charles Dickens, 1843]”

What information is getting through from and at listening events? [6]

There should be no excuse for poverty in the world today, and whilst in my bigger picture wish list, to deal with want would come first, in my care.data Christmas carol list, it is ignorance which cannot be tolerated.

There is no excuse for ignorance, for lack of information, or wondering what questions needed answers to date at the care.data programme board of NHS England.

“How do we explain care.data vs SCR”, “Can you tell me exactly who will access my data?”, “If future purposes change and I want the opportunity to withdraw & opt out, how will I get told?”

The IIGOP report states clearly the current gaps in knowledge and what must be done to fill them, for various parties.

Together with two other major reports this year on health data sharing and care.data: Partridge, and the November 2014 APPG report [7], professional bodies have provided plenty of information and asked plenty of questions which no one now can ignore.

Misplaced statements that there have been no breaches do nothing for public confidence, when later reports show that is ignorant or inaccurate. Big Brother Watch published its report into NHS Data Breaches in November. It found that data security is an ongoing problem, and that over the last four years patient confidentiality had been breached at least 7,255 times.[8]

Facts and answers now need to address the IIGOP report in depth, and meet patients’ past questions, to lay to rest some of the issues which have haunted the programme in the press; unexpected commercial uses, and re-use of data through commercial data licenses, for example.

Adequate time must be given to the CCGs, GPs and patients to be fully informed of the programme and the choice(s) on offer. This is not an IT rollout, but a series of process changes, which need human understanding and acceptance. “What’s in it for me?” versus “What risks may harm me?” need thinking time to be fairly presented and the patient choice collected.

To avoid potential doom whether it be significant opt out or failure to meet fair processing leaving GPs at risk [9], to adequately communicate through effective education, will take effort.

Chapter 2. “Every one of them wore chains like Marley’s Ghost; some few (they might be guilty governments) were linked together; none were free.” [A Christmas Carol, Charles Dickens, 1843]

Understand the links of who, why and what, of data sharing: 

The decision making, the process steps, how patients are told of changes in the programme today and will be in future, how the public perceives their data is exploited, are all linked together by very simply: who stores and uses the data, and for what purposes.

For the programme, it would be wise to understand the importance of the interaction of these parts of the process. Linked appropriately together, and working well, trust will keep the system together.  It fails, and no matter how good the technology is, without trust, the system will fail to deliver its expectations. If too many may opt out, or opt out disproportionately in certain population segments it would harm data quality.

When at the HSCIC data sharing discussion in July it was clear some data recipients were yet to grasp this interdependency, and the effect their attitudes to data use have on each other.

If one [class of] data recipient in future receives or uses data inappropriately, it will harm public faith in all users.

For patients, to have true transparency I believe care.data should be explaining exactly how the data linkage system [10] works, and all the other silos of data it already holds. The personal demographics service, stores a whole set of personal data of which the public maybe unaware, and yet may find used to link data collected from all sorts of parts of health and social care. If NHS data sharing is to be explained, do it all. To avoid doing this, will merely store up a future risk of yet more surprises for patients and damage trust further.

Chapter 3: “I have seen your nobler aspirations fall off one by one, until the master-passion, Gain, engrosses you. [A Christmas Carol, Charles Dickens, 1843]

Commercial use of data will be detrimental to public confidence.

By looking ahead to see what the ghost of care.data future might bring, the forecast doom of the present course, may yet be avoided.

As patients told NHS England at the Open House event [11], we’re fed up with commercial data mining, and the same was reflected by a representative group of citizens in various polls this year.[12]

How is the non-NHS data world changing? What of the upcoming EU data legislation?  How does commercial data industry itself perceive legislation in the UK?

In the 2013 Experian keynote address the Nectar Head of Customer Marketing noted, “legislation has not kept up to speed with where we are going’ [16:57] [13]

Perhaps it is opportune to reflect on one of the oldest Biblical themes at Christmas, choose which master you serve.

Back at NHS England and the IC, discussions in April 2013 seek to ‘create a vibrant market of data intermediaries , for example.

Which purposes should this serve? The health of the nation, or the wealth of the nation? Can one justly serve both equally?

“You fear the world too much,” she answered, gently. “All your other hopes have merged into the hope of being beyond the chance of its sordid reproach. I have seen your nobler aspirations fall off one by one, until the master-passion, Gain, engrosses you.” [A Christmas Carol, Charles Dickens, 1843]

It would appear to patients that by  mixing commercial purposes in with legitimate health, and health research purposes,  the data commissioning system has created its own downfall.[14]

The purposes whilst amended in the Care Act 2014, are so broad as to leave too much commercial use open under ‘purposes of health’. How would that rule out pharmaceutical marketing for example?

For many patients, use outside their own healthcare and its provision and planning is a real hot chestnut.

If patients are in disagreement over commercial uses for example, they have no choice but to opt out of research uses as well. This multi-option choice, or the removal of commercial use needs addressed.

If research wants more data, we would do well to define and restrict commercial use in legislation, much more specifically.

Chapter 4 : “You wish to be anonymous?” [a Christmas Carol, 1843]

There has been much disagreement and misunderstanding of how data will be used, anonymous or what non-identifiable really means.

Media reporting at the start of the year frequently focused on the collection of care.data as ‘anonymous data.’  Bah, humbug! that is factually incorrect.

CCGs need to make sure that their own staff understanding is correct, as well as passing on information if they are to be intermediaries on behalf of NHS England. At CCG meetings I attended, many staff confused care.data with direct care/SCR.

The default position if patients do nothing is the sharing of date of birth, full postcode, gender and ethnicity, and the NHS number is a unique identifier. Plus all the other codes and conditions.

It is still unclear how the data which has already been extracted without consent or fair processing, can be controlled by patients who may not wish to share identifiable data from their hospital visits, mental or community health.

bbc_notdentifiable

If patients can’t control data already held at HSCIC, why will they want to share more additional data, from primary care?

Learning from looking back on 2014

My own looking back on my care.data journey in 2014 is here.

medConfidential has a rather good summary of the year here. [15]

“Spirit,” said Scrooge submissively, “conduct me where you will. I went forth last night on compulsion, and I learnt a lesson which is working now. To-night, if you have aught to teach me, let me profit by it.” [A Christmas Carol, Charles Dickens, 1843]

From past lessons learned in 2014, one would hope the future rollout will profit from them and take the time, and use the tools it needs, to get to a brighter future.

Looking ahead: news for 2015 came at the end of the year.

Sir Partridge in the Telegraph, November 27 he said:

“We must make sure there are no surprises for the public about how their information is being used, that they have a choice in this and that we are honest about the balance of risk. Every single one of us has a part to play in making sure we get this right…

“The HSCIC is still improving its practices. It is also endeavouring to increase its transparency.”

The November 2014 APPG report said, what everyone appears to agree on:

“the public had been inadequately consulted in the early stages of the Care.data programme and that it was therefore correct to halt the programme to allow further public consultation.” [APPG report]

It goes on to say, “Organisations providing health or social care services must succeed in both respects [examining the Public Interest] if they are not to fail the people that they exist to serve,” and with that in mind a Public Benefits Plan should be drawn up, to support public transparency.

Public transparency would be improved by publishing the public’s questions from multiple listening events at which attendees were promised answers and follow up. The conversations did not always ask easy questions, but all the more reason to address them publicly for all; it will make the programme better.

So, if the care.data programme learns from that which has haunted care.data in the past year, and NHS England now grapples with all the questions and criteria of the IIGOP report, and increases its public transparency, stakeholders can look to the future with a renewed hope. But only if there is change made to the present course of actions.

“Scrooge was at first inclined to be surprised that the Spirit should attach importance to conversations apparently so trivial; feeling assured that they must have some hidden purpose.” [A Christmas Carol]

 What must surely happen now, is to use the IIGOP report as a basis of lessons learned. To see gaps in knowledge, and to build processes and procedures which set up the future. Some of these must be at national level, such as ‘How patients will be informed of future scope change’ so CCGs will need answers from NHS England even if pilots should be ‘co-produced’.

Quite frankly, only muppets would not want to wait and do all this in all the appropriate time needed. The coming General Election is perhaps seen as a key reason to artificially rush it through. But at what cost? Who is the programme for, party politics or the public good?

“What do you think of the show so far?”

Clearly the National Data Guardian and IIGOP, the APPG and others making many wise recommendations, find the approach so far lacking. To carry on as is, will bring predictable doom. But by using the IIGOP report insights, there is the hope that the outcomes of the current path may yet be avoided.

Which version of the care.data future will the NHS England Patients and Information Directorate choose to follow, and invite the CCGs to join them on, writing the next chapter of the care.data story in 2015?

“No space of regret can make amends for one life’s opportunity misused.” [A Christmas Carol, Charles Dickens, 1843]

***

Let’s hope 2015 is a good year, that the wish list of questions finds answers, and let’s hope there are no more care.data surprises.

Thank you for all the kind blog comments and questions I’ve received over the last year. I hope it helps keep patients’ voice heard.

“I HAVE endeavoured in this Ghostly little book, to raise the Ghost of an Idea, which shall not put my readers out of humour with themselves, with each other, with the season, or with me. May it haunt their houses pleasantly, and no one wish to lay it.
Their faithful Friend and Servant,
C. D.

Now; let’s get back to the present today:

“What’s to-day, my fine fellow?” said Scrooge.

“To-day!” replied the boy. “Why, Christmas Day.”

“Merry Christmas,  and so, as Tiny Tim observed, God bless Us, Every One!”

  [A Christmas Carol, Charles Dickens, 1843]

***

Image from a Muppets Christmas Carol, 1992

References:

[1] The IIGOP report https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/389219/IIGOP_care.data.pdf

[2] EHI ‘Care.data Review Raises Questions‘ http://www.ehi.co.uk/news/ehi/9808/care.data-review-raises-questions

[3] BBC Radio 4, February 4 2014 http://www.bbc.co.uk/programmes/p01rmpdy

[4] Nov 2014, Progress of HSCIC data sharing review by Sir Nick Partridge https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/380042/HSCIC_Report_Summary_of_progress_261114_FINAL.pdf

[5] 7 Oct 2014, CCGs to help deliver care.data pilots http://www.england.nhs.uk/2014/10/07/ccgs-care-data-programme/

[6] What information is being heard at Listening events? http://jenpersson.com/pathfinder/

[7]The APPG Report – Nov 2014 – http://www.patients-association.com/Portals/0/APPG%20Report%20on%20Care%20data.pdf

[8] Report into NHS Data breaches http://www.bigbrotherwatch.org.uk/wp-content/uploads/2014/11/EMBARGO-0001-FRIDAY-14-NOVEMBER-BBW-NHS-Data-Breaches-Report.pdf

[9] on GP indemnity: care.data MPS advice to members http://www.medicalprotection.org/uk/membership-indemnity-updates/care.data

[10] The data linkage service http://www.hscic.gov.uk/media/12443/data-linkage-service-charges-2013-2014-updated/pdf/dles_service_charges__2013_14_V10_050913.pdf

[11] The Open House June 2014, public questions http://jenpersson.com/care-data-communications-core-concepts-part-two/

[12] Privacy and Personal Data IPSOS Mori poll https://www.ipsos-mori.com/researchpublications/researcharchive/3407/Privacy-and-personal-data.aspx

[13] 2013 Experian keynote address the Nectar Head of Customer Marketing

[14] care.data downfall parody http://paulbernal.wordpress.com/2014/02/25/tim-kelsey-discovers-care-data-is-in-trouble/

[15] medConfidential bulletin https://medconfidential.org/2014/medconfidential-bulletin-19-december-2014/

 

a care.data 2015 wish list

“All I want for Christmas, from care.data and NHS England, is no more surprises. In 2014, there were a few too many.[1]”

 

As Christmas approaches one often hears the question, “What do you want?”

I’ve seen  a few wish lists lately. The latest and most heartfelt, from my youngest child,  written to Santa:

“Dear Father Christmas, please can I have surprises? Love,  x”

Asking for surprises may indicate we don’t know what we want. Or don’t want to restrict ourselves in case we get something better.

But although I like surprises, for care.data this year, I’m in agreement with Sir Nick Partridge’s view in the report in November, of existing data practices: as the foundation of what lies ahead. We want no more surprises.

In the Telegraph, November 27 he said:

“We must make sure there are no surprises for the public about how their information is being used.”

A most thorough wish list, published the week before Christmas, is the Caldicott led Independent Information Governance Oversight Panel (IIGOP) reportto the care.data Programme Board on the care.data Pathfinder stage.

“The report lists 27 areas of concern for the care.data Programme Board itself, containing some 52 unanswered questions, with 7 additional tests that pathfinder CCGs must meet.”

As a mother, I try to help my 5 year old with easy advice, and a little fun. In that spirit…. and with a sprinkling of seasonal reindeer dust, here’s a suggested wish list for the NHS England care.data programme in 2015.

Number 1. on my care.data wish list:  Sit down quietly, and decide what you really need and why you want it. Don’t be greedy.

ICO Data protection principle 3 on Data Minimisation suggests [2] data collectors should identify the minimum amount of personal data  needed to properly fulfill their purpose. They should hold that much information, but no more.  When you see discussed on social media or hear at events, how much data is already extracted and appears little used, we should also ask how NHS England intends to increase the quality not only quantity of data gathered.

There is also good reason to be skeptical of ever increasing wish lists when industry and government say “collect everything,” but history suggests this is a bad idea.  [3] Data collected should also be accurate. 

Being very defined about why it is needed, will make explaining the benefits of sharing it easy to explain. Having a limited scope will allow GPs to complete the fair processing required by law and enforced by the ICO, to tell patients what data is being extracted, or what purposes, and who will use it.

It must be very clearly about secondary uses, so patients know why they are being asked about records again, or they may confuse it with Summary Care Records.

Without this clear ‘what and why’, CCGs will find it hard to get the message over clearly to patients and many will opt out through doubt or confusion, or fail to make an informed choice.

Number 2. Write your own wish list of the types of conditions and data to include, and share it in full. It cannot be open ended.  

The original list [4] [p.18-22] of what is to be collected will be added to incrementally in future.

Why not design a simple and straightforward tool online to see what these codes mean, and make it easy for professionals and public alike to understand?  It could be changed real time and notice sent by messaging system to GPs easily. Spreadsheets shared via email can be out of date as soon as they are sent and version tracking an accurist’s nightmare.

The code for conditions has a short definition, and does not need fancy explanations. Communications to date about ‘your data’ have just been lots of ‘glitter’ making the data sharing sound rather abstract and somehow ‘friendly’. Instead of a generalised ‘data’, just list the items plainly.

This is the what.

So how will the changes in what will be extracted, and who uses data be shaped and communicated in future? See 3.

Number 3. Draw a nice picture of the scope change process, policy and detail its change procedure and steps.

The public needs a way to know what new things have been added to the uses for their data, and given time to change their mind if they want to withdraw participation. The care.data board shared current steps on expansion with the advisory board. [13-30] on a future process.

Number 4. Sprinkle some fairy dust on commercial re-use licenses [5], to make them disappear.

As patients said at the Open House event [6], we’re fed up with commercial data mining. As recorded by a representative group of citizens in various polls [7], data for use by data companies, such as has been done for Experian in the past, is not a use patients expect to be made by others outside the NHS of their health records.

A majority state a preference that GP records should not be sold or shared without consent, or even with government or for commercial use in any circumstances.

Number 5. Improve the handwriting for clarity (in the purposes in the Care Act, sort the wording out to tighten up the definition ‘ for the purposes of health’).

In November Big Brother Watch published NHS Data Breaches, a report into the subject (PDF). It found that data security is an ongoing problem, and that over the last four years patient confidentiality had been breached at least 7,255 times.

Commentators suggest that technology will continue to “outpace…the imagination of even the most clever law-makers.”
Legislation provides the supporting framework for the choices the HSCIC will make who may access data, it must be very clear.
 

Number 6. Too many sweets aren’t good for anyone, so no more fudge.

A citizens’ right to confidentiality and to object to data sharing is firmly embedded in the NHS Constitution. The promised opt out by Secretary of State Jeremy Hunt given last March, is not yet legally defined or enacted.

The IIGOP report also includes that the opt-out [p.4] will affect all patient confidential data leaving the practice and not just care.data. How this is to be managed technically, practically and legally all still needs shaped. No one cookie-cutter might fit all.

To avoid future tummy-ache, consult widely on the proposal in advance to get public and professional feedback on the wording of the legislation. This is more than a wish, it really is a must-have.

Number 7. Don’t be all about taking. Sharing gifts is often a two-way process. You need to consider how you are asking us what we want too.

An opt-out model has been decided, rather than an opt-in process, despite many professionals voicing concern and objecting to this method of ‘assumed consent’. That the choice was already made to remove patient-GP confidentiality without asking patients for an active approval, has upset many.

This summer 2014, the BMA voted for an opt-in model, as you may recall.

So to avoid future issues, consider already the question of datasharing in a wider, joined-up remit between health, with social care, with local authorities and what concerns or issues that may raise.

Address the issue documented in the Mental Capacity Act in 2005, for those in Local Authority care, who lack capacity for consent.

If health and social care becomes increasingly integrated and under local authority control, how will the decision-making, conflict of interest loop be reconciled, where the LA is effectively state data requester and individual guardian?

As IIGOP stated,

“Arrangements will also have been made for legal guardians, who have a right to make decisions on behalf of those without capacity, to make those decisions as regards the opt-out. In each case the CCG will be able to provide evidence.” [before pilot data extraction begins] [Report, December 2014, p.8]
In the past, for commissioning in London in 2010 in HRSS, “Members were clear that GPs could not provide consent on behalf of their patients, to transfer identifiable data.” [p.12]

Are there are some models of consent which resonate as right, and others which feel managed and moulded into an ethics package which is wrong?

Perhaps if we have the wrong kind of consent, we have no consent at all. Certainly it appears the confidentiality group felt this in the HRSS example in 2010.

That kind of recent past decision making and polls, should therefore have meant that an assumed opt in, would clearly be problematic from the start. (Perhaps why at first, no opt out was on offer at all.)

Why the care.data programme does not address this from the start has lessons to be learned for the pilot, and other research programmes.

Consent should not be used as a way to offload liability, but to ensure an engaged, informed and an ongoing contract of understanding between two or more parties.

Yet over the last ten months, consent and whether it is assumed, informed or lacking has been fundamental to the debate on the planned primary care records extraction, through care.data.

I have heard three things most frequently from professionals; medics, researchers and programme management:

1. “Consent is not a legal requirement.”

2. “But it’s the foundation of good medical practice.”

3. “So we need a broad and open consent.”

Too broad however, and it comes full circle into conflict with meeting the principles of fair processing under data protection, and patients become less happy that they understand its scope and use, and are therefore more inclined to opt out.

Here is what the NHS Choices website says on consent:

“Consent to treatment is the principle that a person must give their permission before they receive any type of medical treatment or examination. This must be done on the basis of a preliminary explanation by a clinician.

Consent is required from a patient regardless of the intervention – from a physical examination to organ donation.

The principle of consent is an important part of medical ethics and the international human rights law.”

The last sentence appears difficult to reconcile with a programme which is based on assumption. Even if it is legal, is it ethical?

The November 2014 APPG report [8] backed an opt-out scheme on the basis that opt out is needed in order to, “ensure that researchers have large enough data sets which are representative of the population as a whole – to make the scheme worthwhile”. Professor John Williams, director of the health informatics unit, RCP said that the Royal College of Physicians was strongly in favour of ‘presumed’ consent requiring patients to ‘actively opt out’ should they not wish any of their data to be shared.”

Most professionals involved in the process, seem reconciled to the opinion that in order to promote the broadest participation an opt-out model will be used.

If so, this therefore demands the highest standards of communication to ensure everyone is given a proper way to make a fully informed and active choice. NHS England appear to be passing this down the chain to CCGs for care.data pilots, who will really need to get this spot on for patients to enable their GPs to feel this will be done properly.

The IIGOP report asks many questions about this and also shows the need for supporting evidence for patients to show that their choice has been carried out. [point 3 p.9]

Number 8. If you need some help with questions, just ask. I’d be glad to help.

Ten months of listening events’ feedback remain unpublished, but must surely now be before the pathfinder rollout begins.

The CCGs must be made aware of all questions and concerns already raised, if they or their GPs are prepared to respond in future.

How will these questions will be taken into account before the pathfinders launch?

When might these be shared?, I asked on September 18th.  ‘Shortly,’ said Mr. Kelsey. I still look forward to seeing that happen [9]. If for no other reason than to salvage the impression that patient voice matters.

How this is resolved now will be a pilot model for future.

But it is vital practically, find an appropriate approach to the difficult questions asked. They need published and addressed, case by case.

Number 9. Tell us who’s been naughty or nice on a regular basis

At programme level, the quarterly data release approvals of HES/SUS data already held, have been a positive step at HSCIC in 2014.  To have them updated on a more frequent, even real time basis, would be even better.

At individual level, for the patient to have a way to know to know who accessed their data at individual level, a personal data usage report [10], and how it benefited the public good in research would be a great step forward.

Now, if we could wave a magic wand and make that technologically possible quickly, it would be wonderful. Reality, may need some time.

Number 10. No more glitter.

The communications’ materials need to become far more concrete and less ‘friendly’. Materials can be so high level as to be fairly meaningless.

The public have different levels of knowledge and interest about how their health data is used.

But what information and parts of my record is being shared, who will have access to it, and how will they use it should not be hard to communicate. If it is, go back to number 1 and 2 on this wish list.

That’s it, but I also know I tell my children:

Remember, you don’t always get everything you wish for…

What was suggested throughout the year, has in part been taken on board and implemented by HSCIC, much remains to be done to ensure patient confidentiality, world class security and system wide trust that it works.

In the Telegraph, November 27, Sir Nick Partridge wrote:

“We must make sure there are no surprises for the public about how their information is being used, that they have a choice in this and that we are honest about the balance of risk.

“Every single one of us has a part to play in making sure we get this right.”

NHS England would I’m sure wish they could get the pilots started as soon as possible and have it over with. The public reaction in February and all the unanswered questions from listening events, and in the IIGOP report, may suggest otherwise.

Let’s see how much of my personal wish list comes true in the year ahead.

These things may make all the difference to public perception. To go ahead without many of these steps in place, would I believe, effectively mean a repeat of the HES management processes until such a time as the changes are in place, for care.data.

Will NHS England want to go through all of that again, and surprises in the press stories, or slow the pace and get it right?

If only it was all so easy, as the Fairy Godmother manages to make it look when she brings in changes. That’s half the trick of course, when it works well. You hardly notice the magic dust, whilst the changes happen quietly in the background.

Season’s greetings one and all. Here’s to a magical 2015!

***

1. medConfidential’s track of media reports in 2014 : https://medconfidential.org/information/media-coverage/

2. ICO Data protection principle 3 – minimisation and 4. accuracy

3. Slate: http://www.slate.com/articles/technology/future_tense/2014/11/big_data_underground_railroad_history_says_unfettered_collection_of_data.html

4. Care.data customer benefits document - scope listing

5. Commercial re-use

6. Open House questions

7. Ipsos MORI poll

8. The APPG report

9. Public engagement: Open questions raised at listening events

10. What is a data usage report

Rebuilding trust in care.data

In response to a care.data feature in the November Pharma Times Magazine,  I wrote a brief reader letter which was published, slightly abbreviated, on p.13 in the December issue.[1]

The November article had given me the impression that legislation in the Care Act from July was considered to have ironed out most patient concerns.

And it said that GPs opting patients out at practice level ‘would be illegal’.

I suggested three things.

1. The importance that legislation would be seen and enacted before the pathfinders to:

a) shore up trust of the broad definition of purposes to rule out commercial [re]use

b) enact an opt out

c) lend any legal weight to the role of National Data Guardian

Public and professional scrutiny and consultation on these changes will be required to ensure much talked of transparency is seen to be meaningful

2. Pathfinders must not only as the article stated intend to “test all aspects of communication and extraction”  in the pilot, but have a watertight plan for managing the planned broadening of both scope and access [2]

after all, how can communications be tested and considered effective which tell patients only part of the story how their data is planned to be used in future? Its merger with social care data, just one example.

and

3. a clarification was worth noting on the GP position regards opt out; that with certain conditions, the ICO had said that GPs opting out patients at practice level would be lawful regards their Data Protection obligations.

Data protection laws do not prevent doctors from adopting the approach recommended by the group Patient Concern, practice-wide opt out and offering opt-in at local level, the Information Commissioner’s Office (ICO) had said, providing certain conditions are met.

“If GPs choose to opt out all of their patients, then that is an issue for them and NHS England – the Data Protection Act does not prevent it,” said strategic liaison group manager at the ICO, Dawn Monaghan, according to a report in GP Online and Pulse. [3]

“However, the Data Protection Act would still require patients to be given a full explanation of the options open to them, and why the GP has chosen to opt them out.”

The Health and Social Care Act however requires GPs to release data to the HSCIC so would practices be in non-compliance with the Health and Social Care Act by doing so?

NHS England threatened one practice in November 2013 with penalties for doing just that a year ago. In fact, it was that position and article [4] which first prompted me to join the twitter social media debate, and my very first tweet on care.data.

caredata twitter

 

A full year on, and here we are, still unclear on opt out.

A full year on and our HES and other data is still being released without our consent, or fair processing.

Whilst the GPs may remain unclear if they would be sanctioned for practice wide opt out of care.data even if they maintain data protection compliance, it seems the penalty for data misuse after release is unchanged.

Whilst there was talk of new penalties for data misuse by companies and organisations, no ‘one strike and out’ ever materialised.

Whilst legislation by the Secretary of State promised patients a statutory right to opt out, it hasn’t happened.

On February 25th 2014, he said in Parliament:

“people should be able to opt out from having their anonymised data used for the purposes of scientific research.” [col 148]

“When they extended the programme to out-patient data in 2003 and to A and E data in 2008, at no point did they give people the right to opt out. We have introduced that right, which is why we are having the debate.” [5]

However until that opt out for our GP care.data and our A and E, HES, and other data for secondary purposes is on a legal footing, the opt out has no value for patients compared with the weight of the Health and Social Care Act.

When will the Secretary of State follow through on his word?

Right now, our HES/other secondary data is being released even if we have indicated our opt out to GPs for secondary uses, 9nu4. [6]

It appears to date, we lack both legislation and the technical tool to operate the opt out.

This position seems to be in urgent need of clarification for patients to have our opt out rights confirmed for both GP held data and the existing data held by HSCIC. As well as needing clarified for the GPs and HSCIC as data controllers to be clear on their responsibilities.

When the system has proven so flawed in the past we need change to show why it is different now.

It’s not enough to tell patients things will be different. We want to see that they are.

We can only trust a system which is underpinned in law particularly at a time when, ahead of a General Election, many promises may have been made and will be made. Ministers move roles. Their word alone is frankly, going to be of little value to many. Experience tells us, promises may not always turn out as expected in practice.

I asked one of my local community leaders what he thought of the current position on the programme and what his reaction would be if in fact the opt out came to naught and health data was to be extracted and used for research without consent. “We’d be out on the streets,” [in protest] was his prompt reply. Whilst many are happy for data to be used in research, the majority want to know about it first; who will access it and for what purpose. Not everyone is happy for their data to be used in research. And over half were happy only with active consent or not at all, according to a survey carried out by Ipsos MORI in June 2014.[7]

The Data Guardian role [8] too, should be a positive addition to underpin the importance of ethical practice in data management but again, can only be truly meaningful with legislative weight behind it.

The recent DH November announcement said this would happen, ‘at the earliest opportunity.’

How much longer will it be before that opportunity?

When can we expect to see the rules around uses, opt out and the oversight role of the Data Guardian published for public and professional consultation and scrutiny?

If we are to rebuild trust in the programme, it must first offer a foundation for doing so.

*

In the same Pharma Times December issue [2] there is also a feature on George Freeman MP and on EU Data sharing. Well worth a read.

My submitted reader letter:

Your November article ‘Taking care of our data’ states proposed changes to the Care Act 2014 will be laid before Parliament in the new year.

It is imperative this is done before the care.data pilots’ launch. Only meaningful changes underpinned in law will provide patients the basis on which to rebuild their trust in the programme.

Data use purposes remain overly broad, the newly appointed role of National Data Guardian has no legal teeth, and the Health Secretary’s word that a patient’s objection will be respected, is not enough.

The rules around access, oversight and opt out must be pinned down.

And parliamentary scrutiny of these changes, open to professional and public consultation, will be fundamental to public confidence.

Pathfinders must not only ‘‘test all aspects of the communication and extraction process” ready for an imminent rollout. New communications must present real improvements and a watertight plan for managing the planned broadening of the future scope and access.

And finally, one clarification worth noting; under certain conditions, the ICO ruled that GPs opting out patients at practice level would be lawful regards their Data Protection obligations.

Refs:

[1] December Pharma Times p 13

[2] care.data expansion roadmap

[3] GP Online October 22, 2014

[4] Pulse, November 2013

[5] Hansard, February 25th 2014

[6] HSCIC DARS releases

[7] Ipsos MORI poll of almost 2000

[8] National Data Guardian appointed  November 13, 2014

care.data programme questions remain unanswered – what should patients do now?

care.data programme questions remain unanswered [1] and opportunities to demonstrate better transparency have to date, been turned down.

For anyone interested in the care.data rollout, professionals, patients and public alike, it is worrying to see the continued secrecy which shrouds the programme. We’ve been told online (but most in the public will still not know) an initial rollout in 4 CCG areas is now planned [2], but at which GP practices remains unclear.

On October 12th I asked that the care.data programme board minutes should be made public. The request is still open.[3]

“They seem hell bent on going ahead. I know they listened, but what did they hear?”

Questions asked by hundreds of people at multiple listening events remain unpublished and unanswered. Risks need resolved.

It is ironic that for a programme whose stated aim is to gather patient information in order to answer open questions about care,  it is so unwilling to give information back to answer the questions we, the ‘data subjects’ have about the programme.

I believe it is important to ensure that the questions are transparent, criticisms addressed and clarified, open issues solved and questions answered ahead of the pathfinder rollout to ensure the greatest success of the programme.

If the programme proceeds on an opt out basis, the risk is increased that it will not meet Data Protection regulation[4], which requires informed use of personal data. This puts GPs at risk. [5]

All the people who made the effort to attend these events for the benefit of the programme and the public good deserve answers. This would minimise the risks the public raised, which remain unresolved.

It is also important for maintaining trust in the integrity and value of user participation and engagement at other NHS events, and in this programme in particular.

Public and Transparent Feedback was Promised

I wrote to Mr. Tim Kelsey, Director, at the Patients and Information Directorate, NHS England today to ask, once again, for the release of public feedback.

Now two months ago, when I spoke with him after the NHS AGM in London on September 18th about care.data, the public questions have still not been put into the public domain.

He agreed that the raw feedback from all the care.data listening events, which included all the open questions asked by participants, would be published, “Shortly.”

This feedback includes questions from the NHS Open Days on June 17th  (4 locations), the stand-alone care.data events since, and those from the care.data advisory sessions hosted in Peterborough and Coin Street, London [6].

NHS England claims there have been hundreds of events. The website says some took place in my county, though I haven’t heard of any and neither has my CCG. Those of which I am aware and six attended, all generated a huge number of participant questions on paper, post-its and electronically, which participants were told would be published and answered, including put on the Open Day website ‘later in the summer'[7]:

“Feedback from this session is being incorporated into the overall report from the care.data listening phase which will be published later in the summer and linked to from this site.”

This is still to happen, and now nearing the end of November, is somewhat overdue.

My own questions at four events were on process and I believe it is important to get these clarified BEFORE the pathfinder:

  • How will you communicate with Gillick competent children [8], whose records may contain information about which their parents are not aware? [note also RCGP online roadmap p.15][9]
  • How will you manage this for elderly or vulnerable patients in care homes and with diminished awareness or responsibility?
  • When things change in scope or use, how will we be informed of changing plans for use or users, on an ongoing basis? [Data protection principle 2] [10]
  • For any future changes, how will we be given the choice to change our opt out or opt in? Consent is not a one-time agreement  but needs managed on a continual, rolling basis – how will this be achieved?

Campaigners have also raised remaining, unresolved issues.

Key legal questions remain, including on Opt Out

I am starting to become concerned that the opt out is STILL not on a statutory footing. Will the Secretary of State make good his verbal agreement in law?

What legal changes will be made that back up the verbal guarantees given since February? If none are forthcoming, then were the statements made to Parliament untrue? [11]

“people should be able to opt out from having their anonymised data used for the purposes of scientific research.”

I am yet to see this legal change and to date, the only publicly stated choice is only for identifiable data [12], not all data, as stated by the Minister.

So too the promised extra governance on a legal basis has not yet happened.

It is worth a note that although the Health and Social Care Act 2012 may have steamrollered the legal position of the patient and GP, and that confidentiality no longer comes first, informed consent even if assumed, is still in other circumstances to be obtained fairly:

“Consent obtained under duress or on the basis of misleading information does not adequately satisfy the condition for processing.” [ICO]

Should this principle not also apply even if GPs are legally obliged to release data without patient consent? [I feel that needs more discussion, so will write about consent in my next post.]

There is much made of ‘new legal protection’ of our data but in fact it is impossible to see it provides any such thing, and yes, I have read it. The Care Act 2014 did not get amended with any binding or truly clear provisions to make data more confidential or secure.

Concerns of many people centre on commercial use, and re-use of data, and these are not addressed by the loose terms for the benefit of adult health and social care’ or the ‘promotion of health’. [part 4 p.120] Data sold all year may have met this criteria, but is this how we expect our health records to be used without our express permission?

“We will use Mosiac, appended to the ICD10 code diagnoses, to create national Mosaic profiles. These estimates and propensities will be sold to public and commercial organisations to enable them to target resources more effectively and efficiently…Other data characteristics that are also linked to Mosiac can then be used to understand broader lifestyle characteristics of those most at risk to ensure that messages and communications are appropriate and well targeted.” [July register]

Question from Leicester: “Are we saying there will be only clinical use of the data – no marketing, no insurance, no profit making? This is our data.”[13]

So I hope it is clear, that these concerns are not only mine, but remain unanswered for the broader participants of listening events.

Questions from others

I’m publishing here the filtered and NHS England written, summary response of the 26th June event [14], I received as an attendee. (40 people, of whom ca 10 NHS England and HSCIC staff).

I disagreed with one of the statements made at our table at the meeting, and pointed out it was not factual. History as I understand, and has been stated by HSCIC in FOIs, will not be deleted. Yet this was allowed to be included in the notes sent to all:

“communicate that identifiable information can be deleted.”

The workshop was about how to access ‘hard-to-reach’ groups, so focused on communications methods. You will see that many statements are about how to market the programme, and do not clarify questions of substance, although many were asked on the day about scope definition, and future data changes.

Questions have not yet been addressed, such as Gillick, on children in care, young offenders, the forces, avoiding ‘propaganda-ish’ sounding and bias in the materials, to ensure the ‘adequate requirements’ for data processing.

You can see from this, that although the listening events may be deemed to have been a success, the answering part is still missing.

How are NHS England measuring success? What does good look like? I guarantee from a public perspective, it’s not there yet.

Long term benefit must not be harmed in the rush for a pilot tick-box

Since the programme is heralded as so vital for the NHS, I believe we should not be making the best of a bad job, but shaping process, security and communications to be world class, worthy of our NHS.[15]

We also need to see a long-term cost benefit plan – if we don’t know how some of these future processes are to be managed, how will we know what they will cost, and are they worth it?

The project should not aim for a quick and dirty pilot rollout. Perhaps there is a need to tick the ‘on time’ box for an NHS England target or meet a job description appraisal, as I would have had when I was responsible for project implementations in my past commercial industry role?

As it stands it is not NHS England/DoH who has the most to lose if this goes ahead as is. They must look at the big picture and accept their responsibility for this project, decide not to rush it and not expect the public and GPs to carry its risk.

At the weekend, in a speech about TTIP I heard the phrase, it’s “a classic case of socialising the risk and privatising the profit.”

So too it feels for me on care.data. NHS England wants all the benefit of our information, including from its sale, but it is we, individual patients and GPs who will be harmed if its security, commercial use [16], or everyday trust & confidentiality are compromised.

The Department of Health must look beyond party political aims pre-election. This is for the good of the NHS, which belongs to us all.

We must see open questions on process and content openly answered, for professionals and public alike.

Only then, can we trust that the infrastructure and promises made behind the scenes have set the foundation for this scheme to be worthy of our most intimate and confidential data.[17]

What can Patients do now?

“The policy and practical answers we need to ensure success, will not fit on a flyer or SMS.”

I have spoken with some of my fellow attendees since these events, including for example Stan Burridge, the Research Lead on Service User Involvement at Pathway London. (A charity providing healthcare to the homeless and which works with others on policy and best-practice approach sharing. Their recent work on dentistry outreach achieved a 0% no-show rate – getting the vital care needed for their clients and saving ££ for NHS dentist provision.)

His comments are a good summary of what has happened since:

“In the events, opinions could be expressed, questions asked, and I was made to feel they were valid questions, but they’re doing very little to answer them so that it makes a difference.

“I feel I was engaged with the process, but it’s doing nothing for the people on the margins.

“They should be given an informed choice to opt in, an uninformed choice not to opt out is not the same.

It is unclear what patients can now do, to get the answers we have asked for. We want to make a positive difference to make the project better.

The listening events seem to have been a one way process, and participation for PR purposes, rather than real engagement. The policy and practical answers we need to ensure success, will not fit on a flyer or SMS. They can’t be communicated as part of the pilot rollout. We need them published, addressed and ironed out up front.

Stan summed up exactly what I feel and what I have heard from many others:

“They seem hell bent on going ahead. I know they listened, but what did they hear?”

 

****

[1] A patient’s open letter to NHS England

[2] CCG pathfinder announcement

[3] care.data programme board minutes and materials FOI

[4] ICO Guide to Data Protection

[5] Medical Protection and care.data concern

[6] Coin Street care.data advisory group public event, Sept 6th

[7] NHS England Open House event 17th June

[8] Gillick and data protection for children

[9] RCGP Online Roadmap, includes concern on accessing data by those at risk of domestic abuse and children

[10] ICO Data Protection guidelines

[11] Hansard, Parliament 25th February 2014

[12] Parliamentary briefing note on care.data

[13] Questions from the Open House, incl. Leicester

[14] NHS England summary of feedback and statements from public event at Mencap, June 26th 2014

[15] Post from July 21st HSCIC roadmap event, future data use

[16] Commercial use of data with brokers – call for consumer data transparency

[17] Code list prepared by medConfidential and open issues

On Being Human – moral and material values

The long running rumours of change afoot on human rights political policy were confirmed recently, and have been in the media and on my mind since.

Has human value become not just politically acceptable, but politically valuable?

Paul Bernal in his blog addressed the subject which has been on my mind, ‘Valuing the Human’ and explored the idea, ‘Many people seem to think that there isn’t any value in the human, just in certain kinds of human.’ Indeed, in recent months there appears to be the creation of a virtual commodity, making this concept of human value “not just politically acceptable, but politically valuable.” The concept of the commodity of human value, was starkly highlighted by Lord Freud’s recent comments, on human worth. How much a disabled person should earn was the focus of the remarks, but conflated the price of labour and human value.

European Rights undermined

Given the party policy announcements and the response by others in government or lack of it, it is therefore unsurprising that those familiar with human rights feel they will be undermined in the event that the policy proposals should ever take effect. As the nation gears up into full electioneering mode for May 2015, we have heard much after party speeches, about rights and responsibilities in our dealings with European partners, on what Europe contributes to, or takes away from our sovereignty in terms of UK law. There has been some inevitable back-slapping and generalisation in some quarters that everything ‘Europe’ is bad.

Whether or not our state remains politically within the EU may be up for debate, but our tectonic plates are not for turning. So I find it frustrating when politicians or in the media, we hear ofpulling out of Europe’ or similar.

This conflation of language is careless,  but I fear it is also dangerous in a time when the right wing fringe is taking mainstream votes and politicians in by-elections. Both here in the UK and in other European countries this year, far right groups have taken significant votes. Poor language on what is ‘Europe’ colours our common understanding of what ‘Europe’ means, the nuances of the roles organisational bodies have, for example the differences between the European Court of Human Rights and the European Court of Justice, and their purposes are lost entirely.

The values imposed in the debate are therefore misaligned with the organisations’ duties, and all things ‘European’ and organisations  are tarred with the same ‘interfering’ brush and devalued.

Human Rights were not at their heart created by ‘Europe’ nor are they only some sort of treaty to be opted out from, [whilst many are enshrined in treaties and Acts which were, and are] but their values risk being conflated with the structures which support them.

“A withdrawal from the convention could jeopardise Britain’s membership of the EU, which is separate to the Council of Europe whose members are drawn from across the continent and include Russia and Ukraine. Membership of the Council of Europe is a requirement for EU member states.” [Guardian, October 3rd – in a clearly defined article]

The participation in the infrastructure of ‘Brussels’ however, is convenient to conflate with values; a loss of sovereignty, loss of autonomy, frivoulous legislation. Opting out of a convention should not mean changing our values. However it does seem the party attitude now on show, is seeking to withdraw from the convention. This would mean withdrawing the protections the structure offers. Would it mean withdrawing rights offered to all citizens equally as well?

Ethical values undermined

Although it varies culturally and with few exceptions, I think we do have in England a collective sense of what is fair, and how we wish to treat each others as human beings. Increasingly however, it feels as though through loose or abuse of language in political debate we may be giving ground on our ethics. We are being forced to bring the commodity of human value to the podium, and declare on which side we stand in party politics. In a time of austerity, there is a broad range of ideas how.

Welfare has become branded ‘benefits’. Migrant workers, ‘foreigners’ over here for ‘benefit tourism’. The disabled labeled ‘fit for work’ regardless of medical fact. It appears, increasingly in the UK, some citizens are being measured by their economic material value to contribute or take away from ‘the system’.

I’ve been struck by the contrast coming from 12 years abroad, to find England a place where the emphasis is on living to work, not working to live. If we’re not careful, we see our personal output in work as a measure of our value. Are humans to be measured only in terms of our output, by our productivity, by our ‘doing’ or by our intrinsic value as an individual life? Or simply by our ‘being’? If indeed we go along with the concept, that we are here to serve some sort of productive goal in society on an economic basis, our measurement of value of our ‘doing’, is measured on a material basis.

“We hear political speeches talking about ‘decent, hardworking people’ – which implies that there are some people who are not as valuable.”

I strongly agree with this in Paul’s blog. And as he does, disagree with its value statement.

Minority Rights undermined

There are minorities and segments of society whose voice is being either ignored, or actively quietened. Those on the outer edge of the umbrella ‘society’ offers us, in our collective living, are perhaps least easily afforded its protections. Travelers, those deemed to lack capacity, whether ill, old or young, single parents, or ‘foreign’ workers, to take just some examples.
I was told this week that the UK has achieved a  first. It was said, we are the first ‘first-world’ country under review by the CPRD for human rights abuse of the disabled. Which cannot be confirmed nor denied by the UN but a recent video indicated. This is appalling in 21st century Britain.

Recently on Radio 4 news I heard of thousands of ESA claimants assigned to work, although their medical records clearly state they are long term unfit.

The group at risk highlighted on October 15th in the Lords, in debate on electoral records’ changes [col 206]  is women in refuges, women who feel at risk. As yet I still see nothing to assure me that measures have been taken to look after this group, here or for care.data.{*}

These are just simplified sample groups others have flagged at risk. I feel these groups’ basic rights are being ignored, because they can be for these minorities. Are they viewed as of less value than the majority of ‘decent, hardworking people’ perhaps, as having less economic worth to the state?

Politicians may say that any change will continue to ensure:

Politically, socially and economically we do not exist in silos. So too, our human rights which overlap in these areas, should be considered together.

Recent years has seen a steady reduction of rights to access for the most vulnerable in society. Access to a lawyer or judicial review has been made more difficult through charging for it.  The Ministry of Justice is currently pushing for, but losing it seems their quest in the Lords, for changes to the judicial review law.

If you are a working-age council or housing association tenant, the council limits your housing benefit claim if it decides you have ‘spare’ bedrooms. Changes have hit the disabled and their families hardest. These segments of the population are being denied or given reduced access to health, social and legal support.

Ethical Values need Championed

What restrictions do we place on value and how are moral and material values to play out together? Are they compatible or in competition?

“We’ve got to change the way we innovate, the way that we collaborate, and the way that we open up the NHS.” [David Cameron, 2011]

“We should be both optimistic and ambitious for the further advances that lie within our reach. Medicine is becoming more tailored to the individual.”

What value do we place on being human?

We must find our own moral compass to find a State standpoint on whether we see human worth as a commodity, or whether it should be.

Where will the future balance lie between material and moral rights?

Because the current direction of travel is clear. Everything has a price.

But at what cost?

 

**** Relevant for research background {*}:

The last six months of  my blog ‘thinking to some purpose’ has been spent doing my best to raise concerns from the public on care.data, in the hope of making a positive difference.

For anyone less familiar with it, this is the initiative to extract and use our confidential GP records for purposes other than direct care. Those concerns remain unanswered, so for my summary,  see here, my six month round up.

Whilst care.data announced that the CCGs had been selected in which GP practices will pilot care.data, but further facts remain unclear what exactly what they will pilot [communications or going also to extraction] or when. For both the public in those locations and elsewhere, we can only wait and see, how long, is an unknown.

Deregulation – the UK Bill and the Titanic TTIP

The Deregulation Bill will go to the Lords Committee stage on 6th November. [For ongoing progress, see here.]

Deregulation Bill

 [graphic added Nov 21st: This was the concluding statement by Lord Tunnicliffe on November 20th.]

I write this in follow up to a previous post of because it’s a big bill with one very important little clause, amongst much detail which needs careful review in the public interest:

What is it? Clause 83: Exercise of regulatory functions, economic growth:

(1) A person exercising a regulatory function to which this section applies must,  in the exercise of the function, have regard to the desirability of promoting  economic growth.

(2) In performing the duty under subsection (1), the person must, in particular,  consider the importance for the promotion of economic growth of exercising  the regulatory function in a way which ensures that—

(a) regulatory action is taken only when it is needed,

and

(b) any action taken is proportionate.

This section of the Deregulation Act which is currently passing through Parliament, suggests the removal of any regulation that conflicts with the interests of a profit-maker.

 

There are domestic and regulatory bodies for which we should carefully consider this implication.

The Deregulation Bill surely creates an ethical conflict or at least challenge, when in law it must consider commercial gain on a statutory footing above other factors?

The clause is openly worded, that regulatory action should be taken only when it is needed and that any action taken should be ‘proportionate’.

That suggests that regulatory interventions should be reduced. Who and how will it be decided when and what is proportionate?

The Bill provides that a person exercising a regulatory function specified by the Minister:

In detail, what does that mean? If it’s not important why include it at all? If it is important, why have we heard so little about it?

That Lord Tunnicliffe would make such a forceful statement should not be taken lightly: …”if our fears comes to pass, these three clauses could wreak havoc in a regulatory regime within this country.”

Which bodies will this affect?

Functions to which section 83 applies:

There is a long list of regulatory organisations at the end of this post.
Click on the organisation’s name below to read about each one.

The implications for them are unclear but should be examined for public bodies whose function today is not for profit.

For one area in particular, and close to my heart, we should understand its impact on  regulation of the NHS; Monitor and CQC, the MHRA and HFEA (Fertility and Embryology) and how about the Human Tissue Authority? A body whose purpose is to:

“manage the interests of the public and those we regulate at the centre of our work. It aims to maintain confidence by ensuring that human tissue is used safely and ethically, and with proper consent.” [Ref: HTA]

It is unclear how this profit aim will be helpful for these bodies in healthcare, especially considering some of the issues in state social care .

A different body where others share a concern about the impact of clause 83 is for the EHRC.

 

The Joint Committee Reported on Human Rights, June 14th 2014 has concerns about the impact of this, listed in this report:

The Government intends this economic growth duty to apply to the EHRC. We believe that applying this growth duty to the EHRC poses a significant risk to the EHRC’s independence, and therefore to its compliance with the Paris Principles and the Equal Treatment Directives as implemented by the Equality Act 2010. The Government is therefore risking the possibility of the EHRC’s accredited “A” status being downgraded and of putting the UK in breach of its obligations under EU equality law. Unless the continuing discussions between the Government and the Commission satisfy the Commission that the growth duty will not in any way impact upon its independence, we recommend that this duty not be applied to the EHRC.

[Nov 21st update: this clause was specifically debated >  see Column GC229 < and whilst verbal assurances were made, it appears nothing has changed in the Bill, and that the EHRC said in response:

“While we welcome this undertaking we understand that this doesn’t mean that we’ll be removed on the face of the Bill”.

So what value the assurances from  the Minister who will have left his post long before the Bill may be in effect?]

A large number of organisations play a part in securing compliance with the law. They include national regulators, local authorities, and bodies independent of Government, some of which have statutory regulatory functions.  The list below of the main national regulators is not exhaustive, but long. Clause 83 will have a very wide reach.

We should understand just how wide ranging this apparently small function in the Bill may turn out to be.

I believe this clause will serve to mop up the real or imagined economic leakage that the government seeks to collect from all these bodies. Resources that are as yet, untapped.

How will these regulatory bodies promote economic growth?

I wonder how, in the best public interest at all times, economic interest should come first in bodies responsible for oversight?

Will they be compelled to consider [further] cost cutting, selling assets, or charging for services?  Or how about entering into commercial partnerships?

Will the Drinking Water Inspectorate under DEFRA stay entirely independent?

What about the Gambling Commission – in its remit is ‘to protect children and vulnerable people from being harmed or exploited by gambling’?

How will the Office for Nuclear Regulation (ONR) hope to promote economic growth? Or the Forestry commission?

The consequences of such widespread promotion of deregulation and the requirement to actively promote profit seems ill-thought through and given little public attention.

Could it be that under austerity, and desperate to squeeze every drop of monetary gain from our state bodies, that this clause will open the gateway to increased fees, or the start of fees for some current non-charging access by the public to services?

Or will they be encouraged as schools were once, to sell off land and assets? Many of these bodies hold little land. The assets they both produce and hold, is data. It is clear from current practice and the direction of travel across government departments, that information is seen as a commodity and an untapped resource for sale. Perhaps this is an area each body will look at selling?

What about authorities which charge the public fees for services or could do so – the CAA for airspace regulation, the DVLA or the ICO? Will we see an increase in service charges – it is perhaps almost inevitable if the desirability  to promote economic growth is to be given statutory footing.

In addition to looking at what may actively promote commercial growth by direct sale or raising fees, rather than imaginary direct marketing concepts, in order to promote economic growth, will we simply find it more likely that indirect growth is encouraged through change in regulatory practices?

Most importantly perhaps, will we see regulations slackened which cost money to oversee?

Will the organisations which are to be regulated, permitted to do more which promotes commercial interest over other policies, or ethics?

I wonder if a future state aims to deregulate the market in almost every field of activity to enable profits for private commercial businesses, and if the intent is not desirable economic growth for the state directly, but indirectly?

If so, will the ideology that once deregulated, somehow private business interests will contribute more to the economy than they do today, be realised in practice? How has the deregulation of trains, postal services, water and utilities benefited the public interest over economic growth?

If the benefit is to be state economic growth,  whether through revenue direct or indirect, and whether or not it is achieved in the way it may be hoped, there will be other consequences.

Have we learned lessons from other areas in which oversight of regulation has been slackened in recent times, such as banking?

What happened since Banking was deregulated?

Anyone who can look back at the deregulation of the financial markets and say it was all, without any doubt a good thing, should say subprime mortgage deregulation and wash their mouth out.

“Regulation did not keep pace and became mismatched with the risks building in the economy. The Financial Crisis Inquiry Commission (FCIC) tasked with investigating the causes of the crisis reported in January 2011 that: “We had a 21st-century financial system with 19th-century safeguards.” [FCIC report]

“It found widespread failures in financial regulation; dramatic breakdowns in corporate governance; excessive borrowing and risk-taking by households and Wall Street; policy makers who were ill prepared for the crisis; and systemic breaches in accountability and ethics at all levels.” **[FCIC]

In summary,  has any cost risk benefit analysis has been done on the impact of what this widespread cross-market promotion of deregulation and the desirability of economic growth in a regulatory function will mean?

Why may this be seen as a desirable course of action?

Deregulation is tacking its way to its destination through the Lords in the UK. Whether it will reach it before the end of this parliamentary term is perhaps unclear.  But let’s not forget deregulation is the course on which we are set globally, at full steam ahead.

This UK Bill is simply a sponge on the deck of the Titanic of deregulation, the TTIP.

The purpose of the Transatlantic Trade and Investment Partnership is to remove the regulatory differences between the US and European nations. Its plan to cross the Atlantic at break neck speed has been somewhat slowed. But its purpose remains steadfast. There are effectively no tariff restrictions in place any more, so the barriers left to lift are those of regulatory intervention:

“The US and the European commission, both of which have been captured by the corporations they are supposed to regulate, are pressing for investor-state dispute resolution to be included in the agreement.” [The Guardian, Nov 4 2014]

This peer-reviewed  paper looks at the imagined trade and its consequences, “leaving the investment component of TTIP on the sidelines. Going forward, valuable insights could be drawn by further extending the analysis of TTIP’s financial effects.”

[Update Nov 13, letter today in the FT: quotes the same research paper and notes, “Even the most vocal proponents of free trade admit that there’s nothing irrational about opposing such big issues of public policy being traded off behind closed doors.” Nick Dearden, Director, World Development Movement]

Whilst much is made, with some confusion, around the potential for impact on the NHS, TTIP is indisputably very real for the rest of industry and wider market. And any deregulation as a whole touches many NHS bodies.

Despite wide professional and public criticism the TTIP discussions continue with little transparency. Deregulation appears to have become the UK government’s mantra for achieving economic growth, though in coalition not everyone may agree it is right.

In conclusion:

There should be detailed analysis and an impact assessment made for this Deregulation Bill clause 83 as it stands alone.

It must also be seen in conjunction with proposals for deregulation under TTIP,  and the impact analysed for the vast number of regulatory bodies and functions we have under the State wing, for the public good.

I sincerely hope our legislators in the Lords are taking this into account and not as a stand-alone Bill, but in the wider picture of current TTIP trade negotiations, and that the failures created in part through deregulation twenty years ago in banking, are not recycled now across the board.

Can society afford “dramatic breakdowns in governance, risk taking, learning by mistakes, or systemic breaches in accountability and ethics?” ** as we saw as a consequence in banking?

Oversight serves an important purpose.

It is often to ensure a balance between the needs of people, and search for profit. Whilst it is an accepted practice in our market economy, to seek to  make a profit,  oversight and regulation can ensure it’s not at the expense of the greater good.

Some of these public services that the regulatory bodies oversee in England will be harmed if they are not free to all at the point of their delivery. The independence of their ethical decision making will be challenged if it competes with promoting economic growth.

Who will help the public understand what this Deregulation Bill clause really will mean and complete proper and transparent public analysis of its impact for each regulatory authority?

I hope that those responsible for scrutiny of the Bill see value in maintaining first and foremost, independent oversight and ethics, in the Public Interest.

Or will the band continue to play as TTIP sails on? And will the Deregulation Bill pass as is, to promote the desirability of economic growth at all costs?

———

[Update November 21st:

Significant concerns raised in yesterday’s discussion by Lord Tunnicliffe and others on this Clause 83: The promotion of Economic Growth for Regulatory Bodies.

Social Care:
On a previous day of debate (Nov 18th) it appears regulation of Social Care staff is to be scrapped without proper consultation or scrutiny, in Clause 71.

Column GC116: “This is despite the fact that there was no clear support for removing regulation in the original consultation responses.

“The Government did not consult on this issue as part of the consultation in April 2014 on extending outsourcing in children’s social work. During the debate in Committee in the House of Commons on whether the clause should stand part of the Bill, the Deputy Leader of the Commons, Tom Brake MP, acknowledged that there had been no clear support for removing the registration requirement.”

“The Office of the Children’s Commissioner for England raised concerns and stated: “We consider all delegated social care services should be required to have formal registration with Ofsted in addition to an expectation that they will be held to account by rigorous and expert inspection, just as local authorities currently are”.

Scrutiny and Bill quality and clarity:
In particular concerns are raised in the Lords on lack of proper documentation and new legislation included which has not had scrutiny by the HoC or Scrutiny Committee.

Column GC142 “it is inefficient for Parliament to try to scrutinise line by line material which is obscure and possibly not very well expressed in terms of the material we are given and the notes.”
“One is that without a Keeling schedule relating to the particularities of the Bills being amended, it is almost impossible to work out what they are.”

Column GC144 “… that we are discussing now was not discussed in the Commons. It was not discussed by the Pre-Legislative Scrutiny Committee, as we have heard, and there has been no real opportunity to call those who drafted it to account. A blow for better government.”

Lord Tunnicliffe concluded on November 20th:

“We are all on the same side, but if our fears comes to pass, these three clauses could wreak havoc in a regulatory regime within this country that, generally speaking, is doing pretty well.” [Hansard]

My concerns seem founded, supported by many of these comments in recent debate in the Lords. I feel this Bill is a disaster lying in the future path of the Public Interest.  “Iceberg, right ahead!”

End Nov 21st update.]

Please feel free to comment below or find me on twitter @TheABB

*********

List of The National Regulators

Animal Health and Veterinary Laboratories Agency (AHVLA)

Animals in Science Regulation Unit

Architects Registration Board (ARB)

British Hallmarking Council (BHC)

Care Quality Commission (CQC)

Charity Commission for England and Wales

Civil Aviation Authority (CAA)

Claims Management Regulation Unit

Coal Authority

Companies House

Competition Commission

Professional Standards for Health and Social Care (PSA)

Disclosure and Barring Service (DBS)

Drinking Water Inspectorate (DWI)

Driver and Vehicle Licensing Agency (DVLA)

Driving Standards Agency (DSA)

Employment Agency Standards Inspectorate (EAS)

English Heritage (EH)

Environment Agency

Equality and Human Rights Commission

Financial Reporting Council (FRC)

Fish Health Inspectorate (FHI), Centre for Environment, Fisheries and Aquaculture Science (Cefas)

Food and environment research agency (plant and bee health) and (Plant Variety and Seeds)

Food Standards Agency (FSA)

Forestry Commission

Gambling Commission

Gangmasters Licensing Authority (GLA)

Health and Safety Executive (HSE)

Higher Education Funding Council for England (HEFCE)

Highways Agency (HA)

HM Revenue and Customs (Money Laundering Regulations and National Minimum Wage)

Homes & Communities Agency (HCA)

Human Fertilisation and Embryology Association (HFEA)

Human Tissue Authority (HTA)

Information Commissioner’s Office (ICO)

Insolvency Service including Insolvency Practitioner Unit

Intellectual Property Office (IPO)

Legal Services Board (LSB)

Marine Management Organisaton (MMO)

Maritime and Coastguard Agency (MCA)

Medicines and Healthcare Products Regulatory Agency (MHRA)

Monitor

National Measurement Office (NMO)

Natural England

Office of Communications

Office for Fair Access (OFFA)

Office for Nuclear Regulation (ONR)

Office for Standards in Education, Children’s Services and Skills (OFSTED)

Office of Fair Trading

OFQUAL

Office of Rail Regulation (ORR)

Office of the Regulator of Community Interest Companies

OFGEM

Pensions Regulator

Rural Payments Agency (RPA)

Security Industry Authority (SIA)

Senior Traffic Commissioner

Sports Grounds Safety Authority (SGSA)

Trinity House Lighthouse Service (THLS)

UK Anti-Doping (UKAD)

Vehicle and Operator Services Agency (VOSA)

Vehicle Certification Agency (VCA)

Veterinary Medicines Directorate (VMD)

Water Services Regulation Authority (OFWAT)

Thinking to some purpose