Tag Archives: NHS patient data

care.data, change management, datasharing, engagement, ethics, HSCIC, human rights, NHS England, politics, privacy

A vanquished ghost returns as details of distress required in NHS opt out

It seems the ugly ghosts of care.data past were alive and well at NHS Digital this Christmas.

Old style thinking, the top-down patriarchal ‘no one who uses a public service should be allowed to opt out of sharing their records. Nor can people rely on their record being anonymised,‘ that you thought was vanquished, has returned with a vengeance.

The Secretary of State for Health, Jeremy Hunt, has reportedly  done a U-turn on opt out of the transfer of our medical records to third parties without consent.

That backtracks on what he said in Parliament on January 25th, 2014 on opt out of anonymous data transfers, despite the right to object in the NHS constitution [1].

So what’s the solution? If the new opt out methods aren’t working, then back to the old ones and making Section 10 requests? But it seems the Information Centre isn’t keen on making that work either.

All the data the HSCIC holds is sensitive and as such, its release risks patients’ significant harm or distress [2] so it shouldn’t be difficult to tell them to cease and desist, when it comes to data about you.

But how is NHS Digital responding to people who make the effort to write directly?

Someone who “got a very unhelpful reply” is being made to jump through hoops.

If anyone asks that their hospital data should not be used in any format and passed to third parties, that’s surely for them to decide.

Let’s take the case study of a woman who spoke to me during the whole care.data debacle who had been let down by the records system after rape. Her NHS records subsequently about her mental health care were inaccurate, and had led to her being denied the benefit of private health insurance at a new job.

Would she have to detail why selling her medical records would cause her distress? What level of detail is fair and who decides? The whole point is, you want to keep info confidential.

Should you have to state what you fear? “I have future distress, what you might do to me?” Once you lose control of data, it’s gone. Based on past planning secrecy and ideas for the future, like mashing up health data with retail loyalty cards as suggested at Strata in November 2013 [from 16:00] [2] no wonder people are sceptical. 

Given the long list of commercial companies,  charities, think tanks and others that passing out our sensitive data puts at risk and given the Information Centre’s past record, HSCIC might be grateful they have only opt out requests to deal with, and not millions of medical ethics court summonses. So far.

HSCIC / NHS Digital has extracted our identifiable records and has given them away, including for commercial product use, and continues give them away, without informing us. We’ve accepted Ministers’ statements and that a solution would be found. Two years on, patience wears thin.

“Without that external trust, we risk losing our public mandate and then cannot offer the vital insights that quality healthcare requires.”

— Sir Nick Partridge on publication of the audit report of 10% of 3,059 releases by the HSCIC between 2005-13

— Andy WIlliams said, “We want people to be certain their choices will be followed.”

Jeremy Hunt said everyone should be able to opt out of having their anonymised data used. David Cameron did too when the plan was  announced in 2012.

In 2014 the public was told there should be no more surprises. This latest response is not only a surprise but enormously disrespectful.

When you’re trying to rebuild trust, assuming that we accept that ‘is’ the aim, you can’t say one thing, and do another.  Perhaps the Department for Health doesn’t like the public answer to what the public wants from opt out, but that doesn’t make the DH view right.

Perhaps NHS Digital doesn’t want to deal with lots of individual opt out requests, that doesn’t make their refusal right.

Kingsley Manning recognised in July 2014, that the Information Centre “had made big mistakes over the last 10 years.” And there was “a once-in-a-generation chance to get it right.”

I didn’t think I’d have to move into the next one before they fix it.

The recent round of 2016 public feedback was the same as care.data 1.0. Respect nuanced opt outs and you will have all the identifiable public interest research data you want. Solutions must be better for other uses, opt out requests must be respected without distressing patients further in the process, and anonymous must mean  anonymous.

“Pseudonymised data requests that go through the DARS process so that a Data Sharing Framework Contract and Data Sharing Agreement are in place are considered to be compliant with the ICO code of practice“ – fine, but they are not anonymous. If DARS is still giving my family’s data to Experian, Harvey Walsh, and co, despite opt out, I’ll be furious.

The [Caldicott 2] Review Panel found “that commissioners do not need dispensation from confidentiality, human rights & data protection law.”

Neither do our politicians, their policies or ALBs.

[1] https://www.england.nhs.uk/ourwork/tsd/ig/ig-fair-process/further-info-gps/

“A patient can object to their confidential personal information from being disclosed out of the GP Practice and/or from being shared onwards by the HSCIC for non-direct care purposes (secondary purposes).”

[2] Minimum Mandatory Measures http://www.nationalarchives.gov.uk/documents/information-management/cross-govt-actions.pdf p7

#caredata, care.data, NHS England

Building Public Trust in care.data datasharing [3]: three steps to begin to build trust

Let’s assume the question of public trust is as important to those behind data sharing plans in the NHS [1] as they say it is. That the success of the care.data programme today and as a result, the very future of the NHS depends upon it.

“Without the care.data programme, the health service will not have a future, said Tim Kelsey, national director for patients and information, NHS England.” [12]

And let’s assume we accept that public trust is not about the public, but about the organisation being trustworthy.[2]

The next step is to ask, how trustworthy is the programme and organisation behind care.data? And where and how do they start to build?

The table discussion on  [3] “Building Public Trust in Data Sharing”  considered  “what is the current situation?” and “why?”

What’s the current situation? On trust public opinion is measurable. The Royal Statistical Society Data Trust Deficit shows that the starting points are low with the state and government, but higher for GPs. It is therefore important that the medical profession themselves trust the programme in principle and practice. They are after all the care.data point of contact for patients.

The current status on the rollout, according to news reports, is that pathfinder  practices are preparing to rollout [4]  communications in the next few weeks. Engagement is reportedly being undertaken ‘over the summer months’. 

Understanding both public trust and the current starting point matters as the rollout is moving forwards and as leading charity and research organisation experts said: “Above all, patients, public and healthcare professionals must understand and trust the system. Building that trust is fundamental. We believe information from patient records has huge potential to save and improve lives but privacy concerns must be taken seriously. The stakes are too high to risk any further mistakes.” [The Guardian Letters, July 27, 2015]

Here’s three steps I feel could be addressed in the short term, to start to demonstrate why the public and professionals should trust  both organisation and process.

What is missing?

1. Opt out: The type 2 opt out does not work. [5]  

2 a. Professional voices called for answers and change: As mentioned in my previous summary various bodies called for change. Including the BMA whose policy [6] remains that care.data should be on a patient opt-in basis.

2b. Public voices called for answers and change: care.data’s own listening event feedback [7] concluded there was much more than ‘communicate the benefits’ that needed done. There is much missing. Such as questions on confusing SCR and care.data, legislation and concern over controlling its future change, GP concerns of their ethical stance, the Data Guardian’s statutory footing, correction of mistakes, future funding and more.
How are open questions being addressed? If at all?

3. A single clear point of ownership on data sharing and public trust communications> Is this now NIB, NHS England Patients and Information Directorate, the DH  who owns care.data now? It’s hard to ask questions if you don’t know where to go and the boards seem to have stopped any public communications. Why? The public needs clarity of organisational oversight.

What’s the Solution? 

1. Opt out: The type 2 opt out does not work. See the post graphic, the public wanted more clarity over opt out in 2014, so this needs explained clearly >>Solution: follows below from a detailed conversation with Mr. Kelsey.

2. Answers to professional opinions: The Caldicott panel,  raised 27 questions in areas of concern in their report. [8] There has not yet been any response to address them made available in the public domain by NHS England. Ditto APPG report, BMA LMC vote, and others >> Solution: publish the responses to these concerns and demonstrate what actions are being done to address them.

2b. Fill in the lack of transparency: There is no visibility of any care.data programme board meeting minutes or materials from 2015. In eight months, nothing has been published. Their 2014 proposal for transparency, appears to have come to nothing. Why?  The minutes from June-October 2014 are also missing entirely and the October-December 2014 materials published were heavily redacted. There is a care.data advisory board, which seems to have had little public visibility recently either. >> Solution: the care.data programme business case must be detailed and open to debate in the public domain by professionals and public. Scrutiny of its associated current costs and time requirements, and ongoing future financial implications at all levels should be welcomed by national, regional (CCG) and local level providers (GPs). Proactively publishing creates demonstrable reasons why both the organisation, and the plans are both trustworthy. Refusing this without clear justifications, seems counter productive, which is why I have challenged this in the public interest. [10]

3. Address public and professional confusion of ownership: Since data sharing and public trust are two key components of the care.data programme, it seems to come under the NIB umbrella, but there is a care.data programme board [9] of its own with a care.data Senior Responsible Owner and Programme Director. >> Solution: an overview of where all the different nationally driven NHS initiatives fit together and their owners would be helpful.

[Anyone got an interactive Gantt chart for all national level driven NHS initiatives?]

This would also help public and professionals see how and why different initiatives have co-dependencies. This could also be a tool to reduce the ‘them and us’ mentality. Also useful for modelling what if scenarios and reality checks on 5YFV roadmaps for example, if care.data pushes back six months, what else is delayed?

If the public can understand how things fit together it is more likely to invite questions, and an engaged public is more likely to be a supportive public. Criticism can be quashed if it’s incorrect. If it is justified criticism, then act on it.

Yes, these are hard decisions. Yes, to delay again would be awkward. If it were the right decision, would it be worse to ignore it and carry on regardless? Yes.

The most important of the three steps in detail: a conversation with Mr. Kelsey on Type 2 opt out. What’s the Solution?

We’re told “it’s complicated.” I’d say “it’s simple.” Here’s why.

At the table of about fifteen participants at the Bristol NIB event, Mr. Kelsey spoke very candidly and in detail about consent and the opt out.

On the differences between consent in direct care and other uses he first explained the assumption in direct care. Doctors and nurses are allowed to assume that you are happy to have your data shared, without asking you specifically. But he said, “beyond that boundary, for any other purpose, that is not a medical purpose in law, they have to ask you first.”

He went on to explain that what’s changed the whole dynamic of the conversation, is the fact that the current Secretary of State, decided that when your data is being shared for purposes other than your direct care, you not only have the right to be asked, but actually if you said you didn’t want it to be shared, that decision has to be respected, by your clinician.

He said: “So one of the reasons we’re in this rather complex situation now, is because if it’s for analysis, not only should you be asked, but also when you say no, it means no.”

Therefore, I asked him where the public stands with that now. Because at the moment there are ca. 700,000 people who we know said no in spring 2014.

Simply: They opted out of data used for secondary purposes, and HSCIC continues to share their data.

“Is anything more fundamentally damaging to trust, than feeling lied to?”

Mr. Kelsey told the table there is a future solution, but asked us not to tweet when. I’m not sure why, it was mid conversation and I didn’t want to interrupt:

“we haven’t yet been able to respect that preference, because technically the Information Centre doesn’t have the digital capability to actually respect it.”

He went on to say that they have hundreds of different databases and at the moment, it takes 24 hrs for a single person’s opt out to be respected across all those hundreds of databases. He explained a person manually has to enter a field on each database, to say a person’s opted out. He asked the hoped-for timing not be tweeted but explained that all those current historic objections which have been registered will be respected at a future date.

One of the other attendees expressed surprise that GP practices hadn’t been informed of that, having gathered consent choices in 2014 and suggested the dissent code could be extracted now.

The table discussion then took a different turn with other attendee questions, so I’m going to ask here what I would have asked next in response to his statement, “if it’s for analysis, not only should you be asked, but also when you say no, it means no.”

Where is the logic to proceed with pathfinder communications?

What was said has not been done and you therefore appear untrustworthy.

If there will be a future solution it will need communicated (again)?

“Trust is not about the public. Public trust is about the organisation being trustworthy.”

There needs to be demonstrable action that what the org said it would do, the org did. Respecting patient choice is not an optional extra. It is central in all current communications. It must therefore be genuine.

Knowing that what was promised was not respected, might mean millions of people choose to opt out who would not otherwise do so if the process worked when you communicate it.

Before then any public communications in Blackburn and Darwen, and Somerset, Hampshire and Leeds surely doesn’t make sense.

Either the pathfinders will test the same communications that are to be rolled out as a test for a national rollout, or they will not. Either those communications will explain the secondary uses opt out, or they will not. Either they will explain the opt out as is [type 2 not working] or as they hope it might be in future. [will be working] Not all of these can be true.

People who opt out on the basis of a broken process simply due to a technical flaw, are unlikely to ever opt back in again. If it works to starts with, they might choose to stay in.

Or will the communications roll out in pathfinders with a forward looking promise, repeating what was promised but has not yet been done? We will respect your promise (and this time we really mean it)? Would public trust survive that level of uncertainty? In my opinion, I don’t think so.

There needs to be demonstrable action in future as well, that what the org said it would do, the org did. So the use audit report and how any future changes will be communicated both seem basic principles to clarify for the current rollout as well.

So what’s missing and what’s the solution on opt out?

We’re told “it’s complicated.” I say “it’s simple.” The promised opt out must work before moving forward with anything else. If I’m wrong, then let’s get the communications materials out for broad review to see how they accommodate this and the future re-communication of  second process.

There must be a budgeted and planned future change communication process.

So how trustworthy is the programme and organisation behind care.data?

Public opinion on trust levels is measurable. The Royal Statistical Society Data Trust Deficit shows that the starting points are clear. The current position must address the opt out issue before anything else. Don’t say one thing, and do another.

To score more highly on the ‘truthworthy scale’ there must be demonstrable action, not simply more communications.

Behaviours need change and modelled in practice, to focus on people, not  tools and tech solutions, which make patients feel as if they are less important to the organisations than their desire to ‘enable data sharing’.

Actions need to demonstrate they are ethical and robust for a 21stC solution.

Policies, practical steps and behaviours all play vital roles in demonstrating that the organisations and people behind care.data are trustworthy.

These three suggestions are short term, by that I mean six months. Beyond that further steps need to be taken to be demonstrably trustworthy in the longer term and on an ongoing basis.

Right now, do I trust that the physical security of HSCIC is robust? Yes.

Do I trust that the policies in the programme would not to pass my data in the future to third party commercial pharma companies? No.
Do I believe that for enabling commissioning my fully identifiable confidential health records should be stored indefinitely with a third party? No.
Do I trust that the programme would not potentially pass my data to non-health organisations, such as police or Home Office? No.
Do I trust that the programme to tell me if they potentially change the purposes from those which they outline now ? No.

I am open to being convinced.

*****

What is missing from any communications to date and looks unlikely to be included in the current round and why that matters I address in my next post Building Public Trust [4]: Communicate the Benefits won’t work for care.data and then why a future change management model of consent needs approached now, and not after the pilot, I wrap up in [5]: Future solutions.

Continue reading Building Public Trust in care.data datasharing [3]: three steps to begin to build trust →

#caredata, care.data, engagement, HES, HSCIC, NHS England

Public data in private hands – should we know who manages our data?

When Tesco reportedly planned to sell off its data arm Dunnhumby [1] in January this year, it was a big deal.

Clubcard and the data which deliver customer insights – telling the company who we are, what we buy and how and when we shop using ‘billions of lines of code’ – will clearly continue to play a vital role in the supermarket customer relations strategy, whether its further processing and analysis is in-house or outsourced.

Assuming the business is sold,  clubcard shoppers might wonder who will then own their personal data, if not the shoppers themselves? Who is the data controller and processor? Who will inform customers of any change in its management?

“Dunnhumby has functioned as a standalone outfit in the past few years, offering customer information services to other retailers around the world, and could operate in a similar way for Tesco post-acquisition.”

I haven’t seen in the same media that the Dunnhumby speculation turned into a sale. At least not yet.

In contrast to the commercial company managing customer data for those who choose to take part, the company which manages the public’s data for many state owned services, was sold in December.

For an undisclosed value, Northgate Public Services [2] part of NIS was sold in Dec 2014 to Cinven, a European private equity firm.

What value I wondered does the company have of itself, or what value is viewed intrinsic to the data it works with – health screening, the National Joint Registry and more? It formerly managed HES data. What was part of the deal? Are the data part of the package?

Does the public have transparency of who manages our data?

Northgate has, according to their website, worked with public data, national and local government administrative data since 1969, including the development and management of the NNADC, “the mission critical solution providing continuous surveillance of the UK’s road network. The NADC is integrated with other databases, including the Police National Computer, and supports more than 3 million reads a day across the country.”

Northgate manages welfare support payments for many local authorities and the Welsh Assembly Government.

Data are entrusted to these third parties by the commercial or public body, largely without informing the public.

One could argue that a ‘named owner and processor’ is irrelevant to the public, which is probably true when things are done well.

But when things go wrong or are changed, should ‘the supplier’ of the data, or rather the public whose data it is, not be told?

If so, citizens would be informed and know who now accesses or even owns our public data that Northgate had in the past. Different firms will have different levels of experience, security measures and oversight of their practices than others. To understand how this works could be an opportunity for transparency to create trust.

Trust which is badly needed to ensure consensual data sharing continues.

So what will the future hold for these systems now owned by a private equity firm?

The buyer of Northgate Public Services, Cinven, has experience making a profit in healthcare.

We hear few details of plans available in the public domain about the NHS vision for data management and its future in public research.

We generally hear even less about the current management of the public’s data unless it is in a crisis, as front page stories will testify to over the last year. care.data has been in good company generating anger, with HMRC, the electoral register and other stories of legal, but unexpected data use of citizens’ data.

As a result we don’t know what of our public data is held by whom.

The latest news reported by the DM [3] will not be popular either given that 2/3rds of people asked in research into public trust over the governance of data [4] have concerns about public data in the hands of private firms:

“Controversial plans to give private companies such as Google responsibility for storing people’s private personal health data could be revived, a minister has suggested.”

Could there ever be privatisation plans afoot for HSCIC?

It’s going to be interesting to see what happens next, whoever is making these decisions on our behalf after May 7th.

Certainly the roadmap, business plan, SIAM goals, and framework agreement [5] have given me cause to consider this before. The framework agreement specifically says change to its core functions or duties would require further primary legislation.”
[HSCIC DH framework agreement]

hscic_DH_framework

 

Changes to the HSCIC core remit, such as privatising the service, would require a change in legislation which would by default inform parliament.

Should there not be the same onus to inform the public whose data they are? Especially with “protection of patients being paramount”.  One could say protections should apply to our consumer data too.

Regardless of whether data are managed in-house or by another third party, by the state or commercial enterprise, if third parties can be outsourced or even sold, should consumers not always know who owns our data and of any changes in that guardianship?

Taking into account the public mistrust of commercial companies’ data management I would like to think so.

Further privatising the workings of our state data without involving the public in the process would certainly be a roadmap to driving public confidence on data sharing into the ground.

So too, when it comes to public trust, we might find when the commercial sale of consumer Clubcard data goes ahead, every little does not help.

****

Refs:

[1] Computing 14.01.2015 – article by Sooraj Shah: http://www.computing.co.uk/ctg/feature/2390197/what-does-tescos-sale-of-dunnhumby-mean-for-its-data-strategy

[2] Northgate sale to Cinven http://www.northgate-is.com/press-release-nps.html / http://www.northgatepublicservices.co.uk/

[3]  On the future of data handling http://www.dailymail.co.uk/news/article-3066758/Could-Google-look-NHS-data-Controversial-plans-revived-minister-says-technology-firms-best-placed-look-information-securely.html

[4] Ipsos MORI research with the Royal Statistical Society into the Trust deficit with lessons for policy makers https://www.ipsos-mori.com/researchpublications/researcharchive/3422/New-research-finds-data-trust-deficit-with-lessons-for-policymakers.aspx

[5] HSCIC DH Framework agreement http://www.hscic.gov.uk/media/13866/Framework-Agreement-between-the-Department-of-Health-and-the-HSCIC/pdf/Framework_Agreement_between_the_Department_of_Health_and_the_Health_and_Social_Care_Information_Cent.pdf

#caredata, care.data, choice, empowerment, engagement, genomics, NHS England

smartphones: the single most important health treatment & diagnostic tool at our disposal [#NHSWDP 2]

After Simon Stevens big statement on smartphones at the #NHSWDP event, I’d asked what sort of assessment had the NHS done on how wearables’ data would affect research.

#digitalinclusion is clearly less about a narrow focus on apps than applied skills and online access.

But I came away wondering how apps will work in practice, affect research and our care in the NHS in the UK, and much more.

What about their practical applications and management?

NHS England announced a raft of regulated apps for mental health this week, though it’s not the first approved.  

This one doesn’t appear to have worked too well.

The question needs an answer before many more are launched: how will these be catalogued, indexed and stored ? Will it be just a simple webpage? I’m sure we can do better to make this page user friendly and intuitive.

This British NHS military mental health app is on iTunes. Will iTunes carry a complete NHS approved library and if so, where are the others?

We don’t have a robust regulation model for digital technology, it was said at a recent WHF event, and while medical apps are sold as wellness or fitness or just for fun, patients could be at risk.

In fact, I’m convinced that while medical apps are being used by consumers as medical devices, for example as tests, or tools which make recommendations, and they are not thoroughly regulated, we *are* at risk.

If Simon Stevens sees smartphones as: “going to be the single most important health treatment and diagnostic tool at our disposal over the coming decade and beyond,” then we’d best demand the tools that work on them, work safely. [speech in full]

And if his statement on their importance is true, then when will our care providers be geared up to accepting extracts of data held on a personal device into the local health record at a provider – how will interoperability, testing and security work?

And who’s paying for them? those on the library right now, have price tags. The public should be getting lots of answers to lots of questions.

“Over the coming decade”  has already started.

What about Research?: I know the Apple ResearchKit had a big reaction, and I’m sure there’s plenty of work already done on expectations of how data sharing in wearables affect research participation. (I just haven’t read it yet, but am interested to do so,  feel free to point any my way).

I was interested in the last line in this article: “ResearchKit is a valiant effort by Apple, and if its a hit with scientists, it could make mass medical research easier than ever.”

How do we define ‘easier’? Has Apple hit on a mainstream research app? How is ‘mass medical research’ in public health for example, done today and how may it change?

Will more people be able to participate in remote trials?

Will more people choose to share their well-being data and share ‘control’ phenotype data more in depth than in the past?

Are some groups under- or not-at-all represented?

How will we separate control of datasharing for direct care and for other secondary uses like research?

Quality: Will all data be good data or do we risk research projects drowning in a data tsunami of quantity not quality? Or will apps be able to target very specific trial data better than before?

How: One size will not fit all. How will data stored in wearables affect research in the UK? Will those effects differ between the UK and the US, and will app designs need different approaches due to the NHS long history and take into account single standards and be open? How will research take historical data into account if apps are all ‘now’? How will research based on that data be peer reviewed?

Where: And as we seek to close the digital divide here at home, what gulf may be opening up in the research done in public health, the hard to reach, and even between ‘the west’ and ‘developing’ countries?

In the UK will the digital postcode lottery affect care? Even with a wish for wifi in every part of the NHS estate, the digital differences are vast. Take a look at Salford – whose digital plans are worlds apart from my own Trust which has barely got rid of Lloyd George folders on trolleys.

Who: Or will in fact the divide not be by geography, but by accessibility based on wealth?  While NHS England talks about digital exclusion, you would hope they would be doing all they can to reduce it. However, the mental health apps announced just this week each have a price tag if ‘not available’ to you on the NHS.

Why: on what basis will decisions be made on who gets them prescribed and who pays for the,  where apps are to be made available for which area of diagnosis or treatment, or at all if the instructions are “to find out if it’s available in your area email xxx or call 020 xxx. Or you could ask your GP or healthcare professional.”

The highest intensity users of the NHS provision, are unlikely to be the greatest users of growing digital trends.

Rather the “worried well” would seem the ideal group who will be encouraged to stay away from professionals, self-care with self-paid support from high street pharmacies. How much could or will this measurably benefit the NHS, the individual and make lives better? As increasingly the population is risk stratified and grouped into manageable portions, will some be denied care based on data?

Or will the app providers be encouraged to promote their own products, make profits, benefit the UK plc regardless of actual cost and measurable benefits to patients?

In 2013, IMS Health reported that more than 43,000 health-related apps were available for download from the Apple iTunes app store. Of those, the IMS Institute found that only 16,275 apps are directly related to patient health and treatment, and there was much to be done to move health apps from novelty to mainstream.

Reactionary or Realistic – and where’s the Risks Assessment before NHS England launches even more approved apps?

At the same time as being exciting,  with this tempting smörgåsbord of shiny new apps comes a set of new risks which cannot responsibly be ignored. In patient safety, cyber security, and on what and who will be left out.

Given that basic data cannot in some places be shared between GP and hospital due for direct care to local lack of tech and the goal is another five years away, how real is the hype of the enormous impact of wearables going to be for the majority or at scale?

On digital participation projects: “Some of the work that has already been done by the Tinder Foundation, you take some of the examples here, with the Sikh community in  Leicester around diabetes, and parenting in other parts of the country, you can see that this is an agenda which can potentially get real quite quickly and can have quite a big impact.”
(Simon Stevens)

These statements, while each on different aspects of digital inclusion, by Simon Stevens on smartphones, and scale, and on consent by Tim Kelsey, are fundamentally bound together.

What will wearables mean for diagnostics, treatment and research in the NHS? For those who have and those who have not?

How will sharing data be managed for direct care and for other purposes?

What control will the patriarchy of the NHS reasonably expect to have over patients choice of app by any provider? Do most patients know at all, what effect their choice may have for their NHS care?

How will funding be divided into digital and non-digital, and be fair?

How will we maintain the principles and practice of a ‘free at the point of access’ digital service available to all in the NHS?

Will there really be a wearables revolution? Or has the NHS leadership just jumped on a bandwagon as yet without any direction?

****

[Next: part three  – on consent – #NHSWDP 3: Wearables: patients will ‘essentially manage their data as they wish’. What will this mean for diagnostics, treatment and research and why should we care?] 

[Previous: part one – #NHSWDP 1: Thoughts on Digital Participation and Health Literacy: Opportunities for engaging citizens in the NHS – including Simon Stevens full keynote speech]

#caredata, care.data, communications, HES, HSCIC, NHS, NHSEngland

Hear no evil, see no evil, speak no evil – the impact of the Partridge Review on care.data

3wisemonkeysThe Partridge Review came out on Tuesday 17th and everyone should read it. But not just the summary. Both the full version and [1] summary are here.

So what is positive about these massive revelations? At long last it appears that the hands have come off the ears and the real issues are being listened to.

My summary: “NHS England cannot now put a hand over its eyes & hope care.data issues are only about communications.”

I feel somewhat relieved that the issues many have been concerned about for the last ten months, have now been officially recognised.

Amongst them,  it has confirmed the utter lack of clear, publicly transparent and some quite basic, governance procedures.

It’s no surprise then, that our medical records, on at least two occasions in this sample 10% review of the releases, have gone to undocumented destinations. (Let’s ignore the fact of the other 90%!? of which we have no visibility yet).

At least eight insurers or re-insurers were in this 10% sample, so how many times did such companies get it, in the other 90% which has not been reviewed and we haven’t heard about?

How will ‘promotion of health’ purposes exclude them in future? In my opinion, it won’t.

Why would an insurance company be excluded if it requests data in order to provide health care coverage?

This is the wording of the Act, not ‘for the benefits of the NHS’ or any other more ‘friendly’ patient facing framing.

Care Act 2014At the NHS Open Day on Tuesday, the same day as the release, a panel spokesperson stated that commercial information intermediaries [2]  will continue to be approved recipients. Gah – why this is such a bad idea, I wrote about here. [3]

The Partridge review said there had been no complaints.  [4] MedConfidential pointed out an example of those of which they know. Kingsley Manning told the Health Select Committee [5] on 8th April, there had been seventeen opt outs of Hospital Episode Statistics, ever.  Fourteen in 2013 and three prior to 2013.

“Q377Chair: There is not an opt-out rate for care.data yet, presumably.

Kingsley Manning: No, not on that, but in terms of the number of people who have acted to opt out, it is 3 opt-outs up until April 2013 and a further 14 opt outs since 1 April 2013.”

Would I be wrong to suspect each was accompanied by a  complaint? You don’t usually opt out of something you are happy with.

The reason for these low numbers of both complaints and opt out in the wider public? WE DID NOT KNOW. The public didn’t know we had anything to be unhappy about. Many still do not.

As soon as I fully understood the commercial selling of my family’s patient records, this below is the query for advice / complaint I made in January to ICO, before the launch was postponed.

I wanted some guidance from an outside body, because I was being told the law permitted this extraction, so what good would a further complaint to HSCIC do? I had already written to my MP and had a response from the Secretary of State / Department of Health (which tried to tell me patient identifiable data was not shared with third parties), as well as feedback to my concerns raised by email with HSCIC, all of which only tried to reassure me. I had no one to otherwise raise concerns with. The ICO advisor I spoke to told me at that time, that they had had many similar complaints.

I’ll be blunt and say now, especially since the Open Day [more on that later, especially on the content of care.data FAQs we received], I think it’s fair to say I am far better informed about care.data than most in the public. When Mr. Kelsey asked for a show of hands, how many had heard of care.data, all put their hands up. Bearing in mind the rooms were full of highly involved people, NHS England staff, CCG and PPG leaders, and few ‘ordinary patients’ like me, and the agenda contained a section on care.data, it’s unsurprising we had heard of it. When Mr.Kelsey asked, “how many of you understand what it is?” the response was around 50%. I’d dispute also, that all of those 50% truly do.

Some of the comms material we were given is factually incorrect, for example, around research. Currently, GP held data planned for care.data extraction and its merger with HES, into Care Episode Statistics (CES), is approved for commissioning purposes but not for research by the GPES group. It’s not approved for research purposes, so its no good telling us how good it is to have it for the benefit of research. What has already been released for research, and continues to be so, is what was already extracted in the past, with or without consent, and informing patients.

Records will not be deleted which raises all sorts of historical reporting concerns if mistakes are identified in retrosepct.

I have spoken with several NHSE Communications people who genuinely asked me, or left me asking the question for them in my own mind, “If I don’t understand it, then how is the public expected to?”

The concerns I had now almost five months ago, seem vindicated by the report. The actions taken since, the loose wording of the Care Act 2014, and little evidence of intention to make any change which is binding i.e. the opt out is only granted at the whim of the Secretary of State, it’s not statutory and that there is no independent governance to be put in place , have done nothing to bolster my confidence these gaps have been filled.

Simon Denegri, Chair of INVOLVE – the UK’s national advisory group on public involvement – and NIHR National Director for Public Participation and Engagement in Research, wrote a response on his blog [6]. I agree with the spirit of his post, and positivity, [he also writes excellent haiku] but where I disagree I outline below. There is room for positive hope for care.data, but first, let’s properly address the past.

“I am sure that many better informed people than I will pore over the detail. Others will use it to strengthen their case that we should put a stop to any manner of data sharing.”

Perhaps most key, I disagree with his fears the report could be used by ‘others.’ I don’t know anyone who wants to see a stop to ‘any manner’ of data sharing, including me. It’s the *how* and *why*  and *with whom*  that still needs work. Some of us may not want it without active consent, but that is part of the how, not if.  It’s not *any* manner that I object to, it’s *this* manner specifically.

I have read the Review in detail and whilst there is much positive in attitude in the Review, the reality of what difference this will make with any real bite, is hard to find.

For example, “The HSCIC will plan a new ‘data laboratory’ service which will protect the public’s information by allowing access to it in a safe environment with HSCIC managed networks and facilities.”  But this is with caveats, as it’s the “default,” Tim Kelsey said on Tuesday to the NHSE Open House. It does not mean *all* and if global third party intermediaries and business intelligence companies are still to receive data, then I can’t imagine the  global likes of IMS Health, or Experian, or Harvey Walsh will send someone along to Leeds every time they want to extract data. Who will  be given special permissions and how will they be decided and recorded, how will it be documented what data they access, if they get a free pass?

Unknown others have direct access to the HES system now through HDIS. Public Health should rightly use our health data, but a  transparent list of all approved organisations here too, would be a positive step.

Simon’s post continues,

“As you would expect from a previous Chair of INVOLVE, Nick Partridge, has secured fundamental changes in the governance of HSCIC and data releases going forward.  These include patients and the public sitting on the main committees reviewing data releases, open publication of data releases and a programme of ‘active communication’ with the public”.

Patients and public on the DAAG committee. If they are informed about data governance law and good practices, yes, if it’s just ‘representative’, not so useful. But DAAG is HSCIC staffed, and HSCIC has a legal and policy remit from the Department of Health and in its roadmap to distribute data, and will create ‘a vibrant market of data intermediaries’, as it would be wrong to exclude private companies simply on ideological grounds.  So the concept of ‘independent’ is flawed. Where are the teeth needed to reject an application, if it’s in the interest of the reviewing body, to accept it?

“It’s my view that the Partridge review, its recommendations, and the swift response from the Health and Social Care Information Centre (HSCIC), offers us the opportunity of a fresh start with the public on this issue.” [S.D.]

This could be used as an opportunity to brush the past aside and say time for a fresh start, but it can only be so if there is confidence of change.

NHS England cannot now put a hand over its eyes and hope the issues go away or that it’s only about communications.

The past needs fisking, issue by issue, to avoid they happen again. And the real risks need addressed, not glossed over. Why?

Because let’s assume the public all thinks it’s fine, and none of us opt out. Then through these still flawed process holes, a huge data leak. The public loses trust all over again, and the opportunity for the care.data benefits is lost forever.

Get it right now, and you build a trustworthy and seaworthy future, for the future public good.

There are other more detailed questions I would raise, [I previously worked in functional database design amongst other things] and I will believe these recommendations will have an effect, if and when I see the words become actions. The Review by PwC and Sir Nick Partridge is a positive listening and speaking exercise, but the plans must become reality with actions, some under legislation, in my view.

And perhaps the simplest, unspoken point seems to being deliberately ignored as if just not seen, unmentioned, except by data protection gurus [7]. There is legal obligation to provide information to citizens before their data is released, in a transparent way, to whom and for what purpose. What happened to Fair Processing? [8] Past and present?

Sir Kingsley Manning, Chair of HSCIC, asked in the Guardian on 22nd January [9] that we have ‘intelligent, grown up debate’ about data sharing. Well my hand is certainly off my mouth. I wrote a feature in my local paper and I’m still speaking to anyone I can to promote fact-based informed decision making.  But wider Public Debate is still sorely lacking [BBC Question Time anyone?] Through it, I’d like to encourage wider knowledge of the why, who and what of secondary purposes of data sharing and to ensure we can get it done transparently and safely.

Why?

To ensure we, as patients, continue to trust telling our GPs and hospital consultants all the information that we need to, and have no fear it will be held against us by an insurer or others.

We need to trust we will not be penalised whether through disclosure, by stigma and exclusion from policy or care; or whether by opting out, we could be penalised for not participating and not get ‘advantages’ offered to others, just like store loyalty cards.

We may think the insurance debate is irrelevant, if like me, we are not ‘self-payers’ or don’t use a private insurer. With a £30bn gap in planned budget and needed spend over the next five years, someone is still going to be paying for our healthcare.

If it’s not the State, then who? The risk more of us will pay for our own care in future is real. If not for us, for our kids, and their privacy will be a whole different ball game if genomics gets involved.

Meanwhile, we are told for care.data identifiable personal data is crucial for patient safety tracking. In my opinion, patient safety will be harmed if confidence in confidentiality fails. The relationship between clinician and patient will be harmed. And no number of Dr. Foster Intelligence reports by tracking quality or safety, will be able to fix those failures which it has helped create.

Perhaps most tellingly, NHS England is still to make a statement on the Review. There is no news yet here.

It still seems to me the NHS England leadership and its data sharing policy carried out through IC past and present, wants to continue without grown up debate under the PR motto ‘it’s all going jolly well’, and to act with the attitude of a teenager, who with a shrug of the shoulders will tell you:

‘It’s easier to ask for forgiveness than permission.’

***********

January 25th, 2014 – my ICO complaint / guidance request

{abbreviated only to show  issues I feel still need addressed}

Dear ICO
I would like to ask for your urgent advice.

I am a mother of X children under 12. […] Our confidential patient data is being extracted via care.data to the HSCIC. Until my recent research to understand what this was all about, I did not know that HSCIC stored all our patient confidential health data from all sorts of health providers: Hospitals, Mental Health, National Child Measurement Programme, [10] Immunisations and Health visitors.

I have not knowingly given my permission for our data to be stored or transmitted to or from HSCIC in any format in the past. If by signing a consent form for treatment I also signed consent for sharing with this central body, it was without my knowledge and therefore without informed consent.

I have significant concerns over its use, now that I understand how widely our patient data may be used and now even shared abroad. [11] […]

There is no public information on :

1. How long our data will be stored for  – data retention and data deletion and cross border governance
2. There is no opportunity for health record deletion of anything which was simply a mistake i.e.: recorded on the wrong record, or a misinformed opinion on lifestyle entered by the GP, not fact
3. How will future governance be assured that it will not be slackened to allow less strict pseudonymisation, and identifiable releases; for example to US firms who establish themselves in the NHS England healthcare market?

I do not believe that the legal rights created through the Health and Social Care Act are sufficient justification to overrule the Common Law of Confidentiality, and the Data Protection Act 1998. [And the data shared before 2012 was not covered by the Act which did not exist and was not retrospective.] Even if the dissent codes are applied, patient data has been or will be extracted to the HSCIC (without my permission) and it will contain identifiable items such as clinician name, practice and CCG locations, and referral dates which may be used as identifiers to connect with HES data stored at HSCIC – since HSCIC also holds data in the Personal Demographics Service [PDS], [12] I believe they may also link the data [13] then to my personal demographic identifiers. Just an undefined or internal  governance procedure to suggest that they would not, when it is technically possible, is not sufficient oversight. […]

I do not consent for the use of our [hospital HES or other] data in health research – because it has not been explained to me, what that term means and the implications of this assumed consent.

I cannot know what the other future uses will be for our health information stored today. I do not feel that I can apply any fair processing to their health records due to the lack of publicly available information and scope of the full uses of their data today and in future. […]

Sincerely,
Jen Persson
XXXXXXX

———————————

[1] The Partridge Review Summary and Full report http://www.hscic.gov.uk/datareview

[2] On selling data to Intermediaries and the governance which permits it  https://medconfidential.org/category/press-releases/

[3] Commercial users of NHS patient data – third party use – my blog https://jenpersson.com/flagship-care-data-2-commercial-practice/

[4] Complaints and why confidence needs restored https://medconfidential.org/2014/press-release-partridge-review-patients-need-proof-to-restore-confidence/

[5] Health Select Committee 8th April 2014 http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/health-committee/handling-of-nhs-patient-data/oral/8416.html

[6] Simon Denegri’s blog response to the Partridge Review http://simondenegri.com/2014/06/17/partridge-reviews-elegant-demolition-of-past-practice-on-personal-data-offers-opportunity-for-fresh-start-with-the-public/

[7] Information Rights and Wrongs – Jon Baines’ blog http://informationrightsandwrongs.com/2014/06/18/the-partridge-review-reveals-apparently-huge-data-protection-breaches/

[8] ICO Processing Data Fairly and Lawfully http://ico.org.uk/for_organisations/data_protection/the_guide/principle_1

[9] The Guardian, January 22nd 2014 ‘Lack of Debate on the Sale of Patient Information‘ http://www.theguardian.com/society/2014/jan/22/debate-sale-patient-information?CMP=twt_gu

[10] National Child Measurement Programme data managed by HSCIC http://www.hscic.gov.uk/ncmp

[11] Data use in the USA Memorandum between DH, HSCIC and the US  Dept of Health and Human Services to include exploring secondary stores http://www.healthit.gov/sites/default/files/hhsnhs_mou_final_jan_21.pdf

[12] Personal Demographics Service http://systems.hscic.gov.uk/demographics/pds/contents data already stored at HSCIC

[13] Data Linkage Service at HSCIC to manage the requests for data which is stored in different silos and brought together on request http://www.hscic.gov.uk/dles

Image courtesy of an interesting post on the history of the featured monkeys: http://frontiersofzoology.blogspot.co.uk/2013/04/why-are-three-wise-monkeys-usually-apes.html

#caredata, care.data, commercial, HES, HSCIC, NHSEngland, scope, trust

Flagship care.data – precious cargo [1] & commercial uses in theory

“The challenge is that if many users of data are intermediaries with re-use licences and even the HSCIC doesn’t know who all the end users are, how on earth can anyone judge how they will be for purposes of ‘improving NHS care’?”

Commercial and third party use is one of the most damaging aspects of the rollout which is wrecking the care.data programme.

I’ve cut my opinion on this care.data topic into two parts, theory and practice, to address the outcomes of the LMC conf of yesterday from a patient POV. From my lay perspective, the result of the debate and votes was partly due to the failure to shore up the policy theory around commercial uses to make any perceivable improvement to trust for the future. And partly based on proven failures in practice to protect our data in the past. Failures around commercial use of care.data in theory and practice.

The theme of making money, is a recurring topic for women in literature, and graced or should I say, grubbied  our screens in recent weeks in the adaptation of Dame Daphne Du Maurier’s Jamaica Inn.

Mary Yellan, orphaned and without means, seeks the only family she has and lands among the smugglers and muddy marsh of the Cornish moors. It’s not only set against a backdrop  of smuggling, but wrecking. The heroine struggles between moral conflict and practical necessity, whether to join in their activities, against her ethical principles.  She gets used to it but ultimately can’t live with it.

Given that the real inn is in the middle of a very bleak moor, with no outlook except the rough shorn grass, you need to really see unmet potential to want to be its new owner. For that, you need to see strong commercial opportunities or be a committed hard core Du Maurier fan. Or both.

So it can appear, from a patient point of view on care.data. Either the driving parties promoting the release of patient data see unmet potential [1] which needs commercial harnessing [1b], have direct commercial interests[1c], or they have another personal interest in its extraction and access. Or perhaps they are just hard core fans of data sharing, to the point that we should support mashing our health data up with commercial retail loyalty cards as Mr. Tim Kelsey suggested in November 2013 at Strata [from 16:00] [2].

Are the same people and organisations driving the programme and calling for ‘data for patients’ not also the same who will benefit most from having access to the data? The measurable benefits to us patients remain unclear, at best. The cost, our confidentiality and GP trust, is however clearly non-refundable. Consent, the age old pillar of medical ethics is to be waived aside. The LMC Conf obviously see value in protecting confidentiality at source if it cannot be guaranteed by others, whether the HSCIC or the data users.

Who will all the end users of our data be? They remain somewhat undefined, because the care.data addendum including Think Tanks, commercial companies and information intermediaries was not approved [3] and because future users are undefined in social care, for example. Future scope will entail additional future users. But then perhaps this should not surprise us that NHS England and the HSCIC expect us to acquiesce to this fair processing failure although we don’t yet know all the future end users, because Sir Kingsley Manning admitted that HSCIC does not know who all the current end users are either (Q272) [4a] at the  Health Select Committee hearing. So, were the GPs at LMC Conf just expected to trust ‘on spec’ to whom their approval of care.data would entitle its sharing?

Information intermediaries in particular, seem to still be on the key stakeholders list[5] in January 2014. But only a year ago, in April 2013, The ‘Health and Social Care Transparency Panel’ discussion on sharing patient data with information intermediaries clearly stated there was no legitimate or statutory basis to share at least ONS data with them. [6]

“The issues of finding a legitimate basis for sharing ONS death data with information intermediaries for commercial purposes had been a long running problem. A number of possible approaches had been considered but advice from the relevant Government legal teams was that there did not appear to be a statutory basis for doing so. The panel identified this as a significant barrier to developing a vibrant market of information intermediaries (IIs). It also limited the ability of IIs to support NHS organisations with business intelligence to evaluate and benchmark the quality of their services.

It was agreed that this issue needed to be resolved, and if necessary changes to the relevant legislation should be considered. ” 

I would love to know whether the law changed in the last year, how was the issue resolved, or has HSCIC and have we just through use, acknowledged that this sharing with intermediaries is acceptable and legal? The meeting later in July should have given clarity, but I can’t see minutes beyond April. They are no doubt somewhere, and someone cleverer than me, can help find them and clarify how the decision was reached I expect. I did find notes in the recent HSCIC audit of past data releases [4b], that ONS data was granted under existing law after all:

“The ONS data are supplied under the Statistics and Registration Service Act 2007 section 42(4) as amended by s287 of the Health and Social Care Act 2012, for the purpose of assisting the Secretary of State for Health, or the Welsh Ministers, in the performance of his, or their functions in relation to the health service.”

Since the Health and Social Care Act revoked the Secretary of State’s duty of care to provide a national health service, I wonder what functions it relates to as pertains to third party intermediaries? The ONS application form is detailed but no more enlightening for commercial intermediary use. I can’t help feeling we’re seeking justifications rather than good cause as the starting point for widening data releases. That we are starting to accept that our hospital records have been shared without our consent and sold. (Let’s give up the recouping costs word play, call a spade a spade. Data and cash change hands.). ‘What can we do about it anyway? we may well ask. As time has gone on in the care.data debacle, and in the three months since the delay, it appears from the leadership comments of NHS England from Mr. Kelsey in Pulse that, we’re not to worry, “now we are working to make care.data safe.” [free registration required] Still no one has said, we made a mistake of its handling in the past.

This acknowledgement however that work needs done to make the data safe, underlines exactly what so many saw months ago including the GPES advisory group which had concerns [17] in Sept 2013 on commercial uses and its communication, governance and patient trust. Care.data was launched regardless. Now it’s grounded.  What has improved since then? What remains to fix?

How well exactly did HES storage and sharing work so far, with breaches identified as well as the basic legal fair processing failing to inform us of its extraction? What has been done to prevent it happening again? I have seen no concrete steps which give me faith the past flaws have been fixed enough to now trust it in future.

In February, before the pause Jeremy Taylor of National Voices wrote a very sound 12 point plan of what needed to change.  Since then, what has actually  changed [7] as far as I can see, is only the introduction of a delay, and that his words were listened to, that there should be no artificial deadline:

‘”the timescale for launching Care.Data was entirely artificial, as is the six month “pause”.

Three months into the delay, nothing of substance other than agreeing there is no artificial deadline, appears to have changed.

The most significant past let downs have all been commercial or third party uses. OmegaSolver, Beacon Dodsworth, PA Consulting,  Earthware.

The Care Bill amendment touted as a change in the legal protection of our care.data, does not block commercial Third party intermediaries sharing care.datauses of our data, only stating that it should be used ‘for the promotion of health’ which is open to all sorts of interpretation. Not least I imagine, those similar to ‘fight against obesity’ campaigns by marketing masters of commercialism.

So with little transparent change on policy, since we have become aware of data breaches, misuse and patient anger about commercial use, it should come therefore as no surprise that the BMA Local Medical Committees (LMCs) yesterday voted to state a preference for opt in not opt out, pseudo or anonymisation at source and insists that care.data should only be used for its stated purpose of improving health care delivery, and not sold for profit.

Simply: the public don’t trust that our identifiable data is protected and we object to all our data being traded commercially.

This is in direct conflict with HSCICs stated purpose in the HSCIC 2013-15 roadmap [8]:

“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.”

And in statements by both Sir Manning at the Health Select Committee and Dr. Geraint Lewis [9]:

…”we think it would be wrong to exclude private companies simply on ideological grounds; instead, the test should be how the company wants to use the data to improve NHS care. And, as Polly Toynbee put it, if “it aids economic growth too, that’s to the good.”

The challenge is that if many users of data are intermediaries with re-use licences and we don’t even know who all the end users are, how on earth can the HSCIC judge how they will benefit ‘improving NHS care’?

As regards economic growth, if the aim is to give away data for free, as Mr. Kelsey told the September 13th NHS England board (from 26:10)[10], how is the NHS to make profit from it? It’s not. Commercial companies are to buy at prices only to help HSCIC recoup costs [11], so that is not technically opposed in wording to ‘ not making a profit.’ Citizens, GPs and others can be aligned with that on paper. But not in spirit. For now commercial companies profit from our state funded records, paid for by NHS DoH money.  They profit intermediaries with re-use licences beyond which we have no visibility or control of where our data goes or why. And the fact that the wider profiting third parties from the whole scheme,  ATOS paid zero tax in the UK in 2012,[12] really grates. How does the cash given to ATOS benefit economic growth in the country?

Therefore, for the LMCs to have voted now any differently, would have expected them be soothsayers, knowing that the care.data work-in-progress and any future changes will make both the future scope purposes and future users clearly defined, in order to fulfil their duty as data controller, ensuring patients have a reasonable expectation of how their data will be used. It asks GPs to betray their age old fundamental principle of medicine, to betray patient confidentiality, for commissioning. They are being told to betray the good ethics of consent.  They are being asked to betray patients’ trust and even to use that trust to ‘sell’ the idea in which they may not believe.

And care.data current processes betray the best practices of data collection – seek to collect the minimum data required, for a specific purpose and delete it when that is completed.

“Personal data processed for any purpose or purposes shall not be kept for longer than is necessary for that purpose or those purposes’ consistent with the Data Protection Act principle 5. [13]

Instead HSCIC’s remit over the coming years of care.data is to fill in all the remaining gaps with any health and social care information not already collected [14], and keep it linkable from cradle to grave – or even from “germ to worm” for everyone with an NHS number in England. Purposes are non-specific and unlimited because they’ll change over time and the end users are not all defined for it plans to be opened up increasingly widely for use in social care and we don’t know what else.

caredatatimeline

 

In my lay view, the BMA LCs had no choice in the interests of their patients but to call for a rejection of assumed consent and commercial uses. The two do not go together. Opt out for uses of our data purely for NHS care and its planning would be much more palatable. But add in commercial uses, which is what has both been the main source of patient objection and data breaches, and it’s a deal breaker.

They can’t stake their support and reputation on a best guess of what might be. They can only base their judgement on what they know now. And no one supports care.data exactly as she is right now, which is why it is postponed and work in progress. Shore up trust, governance and axe these commercial uses and perhaps an assumed consent would seem more palatable. For example, Cross border governance needs documented when the application form gives non UK options. Scope and users need defined to ensure proper fair processing to meet DPA ICO requirements [16]. But so far, nothing has visibly changed.

It’s no different from when Ben Goldacre was telling us public trust cannot be easily regained and it broke his heart [15]. I know why, there are expected benefits to public research amongst others to access primary care data more than they already have in CPRD or pseudonymous data in QResearch and others, but we need to act based on today’s approved uses for care.data, not what might be remain in an undefined future. Right now, we’ve seen no changes of substance since the delay was announced.

NHS England can’t therefore genuinely expect to see a shift in trust in citizens or GPs based on nothing more than lines in the sand.

I believe GPs at the LMC Conf took the best decisions they could with the programme in its current form, with knowledge of past problems and lack of future clarity over scope and users.

They voted for how they feel best protects, respects and empowers their patients.

If our current Data Controllers and  guardians of confidentiality don’t stand up for patients to get the build of the infrastructure right before they agree to release our data to fill it, who will? The question will be whether the Secretary of State and NHS England will force their legal right of extraction through regardless, or will respect the medical profession’s representatives and the rights of citizens they care for?

There is an opportunity to fix things. The LMC Conf after all have no legal efficacy, they stated their opinion and stance which commands respect and attention. Flagship care.data is not washed up, yet. But it can’t sail without addressing governance and professional support. Commercial exploitation and assumed opt in are not going to work comfortably together. Transparency of who has access to what data for what purposes and how it is released needs sharpened up. And regardless of whether opt in ever comes onto the table or not, if care.data keeps her strongly  commercial heading many, many more will jump ship to opt out. The damage of bias will be done, either way.

She needs some new directions, helmsmanship that we trust and sound repairs.

********

If you have missed the background to this saga, I’d recommend the Julia Powles article in WIRED – what to save when the care.data ship goes down.

I’m going to look at some more of the commercial uses of care.data in practice another time. And clarify the communication of the opt out codes and why research purposes is a misnomer in the GP patient record sharing part of care.data purposes – it’s not (yet at least) an approved use.

********

[1] MOU between AstraZeneca and the HSCIC, December 2012

[1b]  ABPI Vision for harnessing Real World Data 2011

[1c] Hansard, Nov 2010 George Freeman ‘I know from my own experience that we are sitting on billions of pounds-worth of patient data. Let us think about how we can unlock the value of those data around the world.’

[2] Strata November 2013, Tim Kelsey keynote ‘mash it up with other data sources to get their local retailers to tell them about their purchasing habits so they can mash that up with their health data’

[3] care.data addendum Sept 2013

[4] Written Hansard of the Health Select Committee , 8th April

[4b] The HSCIC data release register issued on April 3rd 2013

[5] Oversight panel with input from Dame Fiona Caldicott, January 2014, with stakeholders’ list

[6] Health and Social Care Transparency Overview Panel April 2013

[7] National Voices – Jeremy Taylor, an excellent overview of 12 points which needed fixed from February 2014

[8] HSCIC 2013-15 Roadmap

[9] NHS England comments by Dr.Lewis on commercial principle

[10] September 13th 2013, care.data directions approved by the NHS England Board – care.data from 25:40 – 39:00 – note identifiable, not anonymous data is extracted and stored with the DLES at HSCIC, and GP objections to date on care.data opt-in seem not to have been respected in contrast to the claim ‘GPs make a decision’ from 31:00. There is to date, no communicated way to prevent HES data extraction and its sharing in pseudonymous form.

[11] The HSCIC Data Linkage price list

[12] The Independent, November 2013 Atos & G4 pay no corporation tax in 2012, National Audit Office stats via Adam Withnall, The Independent

[13] Data Protection Standards – retention, principle 5

[14] care.data programme overview April 2013

[15] the Guardian, 28th February 2014 – care.data is in chaos – Ben Goldacre

[16] Blog from the Information Commissioner’s Office on care.data Data Protection and Fair processing

[17]The GPES Advisory Group meeting minutes Sept 12th 2013

{updated 28th May – looks like past uses of our health data are now also under scrutiny by ICO which is investigating claims that insurers have accessed full medical records using subject access requests.}

By [email protected]