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. Stop using ‘your name will not be used’ in materials like the original patient leaflet – It may be factual for care.data per se, but is misleading on what of our personal data is extracted and used without our consent or awareness – most of us don’t know the PDS extracts name at all.

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

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 clearly 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. Not a back door.

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. The law requires fair processing BEFORE the change happens.

We patients should also be made aware what impact this choice has on data already extracted, and that nothing will be deleted from our history. Even if its clearly a mistake. How does that affect reports?

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?

The IIGOP report 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.

To get it legally wrong now, would be inexcusable.

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.

Q: Where is the simple, clear public business case for cost and benefits?

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.