Category Archives: News

What else will burn in the Bonfire of the faxes?

“Digital services so good that people prefer to use them”, claim the Government.

“The NHS should go paperless”, says Jeremy Hunt.

But what replaces the fax machine when NHS England builds a ‘Bonfire of the faxes’?

It won’t be e-mail.

Clinicians are very familiar with email; they know how it works, and how it fails, when sending patient details between organisations. Even within NHS.net, what works in theory doesn’t necessarily work with how clinicians treat patients. If “NHSmail” is NHS England’s suggestion to clinicians as they ban fax machines, doctors may just use stamps.

Don’t subvert the Summary Care Record

A different option, being advocated by pharmacists – not just outfits like Pharmacy2U, but bodies such as the Royal Pharmaceutical Society – is that many different types of organisations should have the ability to edit a patient’s Summary Care Record.

Not only would this immediately exclude all patients who don’t have a Summary Care Record, it would simultaneously destroy any confidence in the integrity of SCR data, which may then be out of sync with clinical systems – fundamentally undermining the data quality in both, and making them untrustworthy for any purpose. As currently designed, multi-party writable SCR is a terrible idea.

What is Slack for the NHS?

If we look at what pharmacists actually need to do, they need to tell the custodian of the patient’s medical record (their GP) what they did. Maybe it was a prescription change, maybe it was a recommendation, maybe it’s other information. This doesn’t require write access to the SCR. It simply requires a reliable mechanism, knowing a patient’s NHS number (which they have), to send a message to the GP or relevant care provider, with the confidence that it has been delivered.

The NHS knows who the care provider is, so the pharmacist doesn’t actually need to. On delivery, it is up to the care provider to act on that information – or, e.g. to make a clinical decision not to act – and to update their records, which then flow through to SCR. So when the pharmacist next looks at the patient’s SCR, the relevant information should all be there. This is not therefore a matter of creating a new system, or breaking a process that works, but about using existing systems better.

Properly designed messaging can be better than fax for clinicians.

We’ve written a draft paper considering how this might be done, in the spirit of building “Digital services so good people choose to use them”. Comments and feedback welcome.

medConfidential Bulletin, 23 October 2015

Quite a lot has happened over the past week. Events are still unfolding, but there has been progress in three key areas.

What just happened?

This week saw the UK’s largest online pharmacy, Pharmacy2U, fined £130,000 for concealing its sale of names and addresses of NHS patients to quacks and charlatans. Quite literally – the companies who bought patients details were selling “alternative” treatments and lottery scams.

Not only did they sell the data; Pharmacy2U has been unable to confirm whether the company kept, or can reconstruct, any records as to whose data they sold. Clearly, the private sector has joined NHS England in ignoring HSCIC’s lessons about data releases, following our work over the past two years.

A blanket, criminal ban on marketing to patients is the only way to prevent these predators, quacks and charlatans buying patients’ names and addresses for 8p a time, and scamming them out of money – or health. For, as the ICO’s Penalty Notice points out:

49. It is possible that some customers, who received marketing material from Woods Supplements, after being prescribed medication by a doctor, may have stopped taking their prescribed medication and spent money on products that were subject to the ASA adjudication in relation to misleading advertising and unauthorised health claims.

In light of the ICO’s determination, in regard of serious breaches of the Data Protection Act, medConfidential has written to the relevant medical regulators and professional bodies, asking for them to consider appropriate action within their various remits.

Given the number of patients who contact medConfidential having been marketed about specific conditions and diagnoses, this is clearly not an isolated incident but a systemic problem – and one that must be addressed at all levels.

We believe this underlines the need for all releases of patient data to be covered by personal Data Usage Reports (each and every secondary use being recorded by HSCIC), and highlights the need for a Data Incident Protocol (so that doctors and medical staff can provide the necessary assurance to patients), grounded in medical ethics not mere DPA compliance.

Apps Library

Last week, NHS England announced that its much-vaunted ‘Health Apps Library’ was being shut down, describing it as “a pilot programme”. Since 2013, it has been endorsing hundreds of apps to patients, now replaced by a set of pages on the NHS Choices website which promote a total of seven “online mental health services”.

Not quite what Jeremy Hunt was saying 6 weeks ago when “the Health Secretary stated his ambition to get a quarter of smartphone users – 15% of all NHS patients – routinely accessing NHS advice, services and medical records through apps by the end of the next financial year.”

Serious concerns have been raised over the past year by medConfidential and others with regard to the security, safety and suitability of dozens of apps which were endorsed in the now withdrawn Apps Library.

While we welcome the closure of this sprawling, unaccredited mess of apps and internet quackery, NHS England must now demonstrate how radically it has changed its approach to innovation if it wants to avoid destroying patient trust. Again.

A ban on marketing to patients

Last Friday saw the Second Reading of Chris Heaton-Harris MP’s Access to Medical Treatments (Innovation) Bill – substantively the same Bill as that previously introduced by marketing magnate Lord Saatchi. Alongside many other issues, the question of marketing to patients was raised. When asked: “Will [the database] be used for marketing to patients?” the Minister for Life Sciences, George Freeman answered: “The Government would oppose this being used as a marketing tool.”

Opposing it doesn’t prevent it happening. The ‘McDonald’s amendment’ in the Care Act last year created a loophole allowing data to be used for the purpose of “the promotion of health”, which clearly includes marketing.

medConfidential will continue to ask for a blanket, criminal ban on marketing to patients: explicit, informed prior consent (i.e. opt in) must be the only acceptable consent mechanism, for those who wish to receive marketing – with criminal penalties for those who refuse to comply.

The Government says it opposes marketing to patients, the Saatchi / Heaton-Harris ‘Medical Innovation’ Bill provides the legislative opportunity to implement this, and Pharmacy2U has shown why it is necessary; the remaining question is, will Jeremy Hunt act?

What’s next?

The Saatchi / Heaton-Harris Bill moves now to Committee stage, which we shall of course continue to monitor closely, revisiting as necessary the amendments we proposed prior to Second Reading.

Companies hiding behind the fig leaf of research regularly complain that “slow and costly access to anonymised patient data impedes academic research”. Quite aside from the continued abuse of the term “anonymised”, medConfidential believes that for privileged access to NHS patients’ medical data, filling in a form honestly shouldn’t be too high a bar.

And finally

We remain a tiny organisation, with minimal funding. If you can help us, please do – every penny received will be used on work you’ve just read about in this newsletter.

Please, if you can, make a donation via our PayPal page so that in future every flow of patient data into, within and out of the NHS and social care system can be consensual, safe and transparent.

Phil Booth and Sam Smith
medConfidential

23rd October 2015

medconfidential’s BMJ rapid response to “Slow and costly access to anonymised patient data impedes academic research”

Research is vital, and it is always unfortunate when any research project fails to deliver the promise in the funding proposal, irrespective of the reason. But railing against the custodian of the nation’s medical histories (BMJ 2015;351:h5087), the HSCIC, seems an odd choice if given any consideration.

The author’s institution was unable to give the assurances required that they were capable of looking after the data to the standard that the public expects. The standards have barely changed; what’s changed is that HSCIC has started checking the assurances more carefully – something it should have been doing all along.

Those necessary assurances are steered and delivered by institutions and supervisors on behalf of their students, not individual students themselves. It is not the students’ fault if their institution refuses to assure that it will take due care of 1 billion health events. And it is precisely the lack of verification of such assurances that sent 25 years of medical records to insurers, to marketers, and elsewhere.

Academia emerged with its reputation pretty much unscathed from the data debacles of 2014 and 2015. The high standards legitimate institutions expect of their researchers are one of the factors that justify the access to sensitive medical data, sometimes without consent, that academia is in a position to receive. Complaining that the standards are too high for your institution to agree to meet says more about the institution than the standards.

All research is important, but no single project – and no one institution – is more important than public confidence in all research. That is why a wide range of organisations support the “one strike” principle for abuse or misuse of medical records. With the Hospital Episode Statistics, i.e. linked, longitudinal medical records of the population for the past 30 years, every woman with 3 children is uniquely identifiable – and with 2 children that’s about 90% likely (quite literally, a birthday attack).

In the last week, the ICO has fined the UK’s largest internet pharmacy for selling NHS patient and customer details to spammers, quacks and charlatans, pushing “innovative treatments” and lottery scams (paragraphs 49, 51, 52). Those participating in the abuse of these records stand to make a great deal of money, and until there is a ban on marketing to patients that leads to jail time for these predators, there will continue to have to be deep scrutiny of every project, and every release.

The “promotion of health”, as undefined in the Care Act 2014, is a loophole so broad you could slip a Saatchi advertising hoarding through it, quacking.

The author’s experience is unfortunate. Both the researcher and their funder deserve a clear answer as to why their institution doesn’t provide them the infrastructure necessary for modern data-driven health research. But corners cannot be cut if patient confidence is to be maintained.

The care.data debacle includes lessons for many. While BMJ readers would always uphold the highest standards of Information Governance, readers may consider (former) colleagues who might – in similar or related circumstances – find themselves with a highly-cited paper, for all the wrong reasons?

HSCIC is the custodian of the nation’s medical histories. In making it available for legitimate research, it simply requires you fill in a form honestly. That shouldn’t be too high a bar*.

* Paragraph 62

-ENDS-

Excerpt from our last newsletter on the Saatchi/CHH bill:

medConfidential had some questions for Mr Heaton-Harris on the content of the draft Bill, and had a meeting with him last week. Our comments and suggestions arising from that meeting covered a ban on marketing to patients, Data Usage Reports (including our example of what one might look like) and an alternative approach that might deliver the policy intent of the Bill without creating another new database, or giving DH duplicates of powers it already has.

 

Pharmacy2U kept no records of whose data they sold

Addendum to press release

Pharmacy2U kept no records or audit trail of whose data they sold, stating “we are unable to contact individual patients.”  EMIS Group, a minority shareholder in Pharmacy2U Ltd, stated yesterday, “The decision to sell data was made by the executive day-to-day management team at Pharmacy2U”, while claiming the “highest standards of patient confidentiality and data security”.

The ICO’s judgement states:

49. It is possible that some customers, who received marketing material from Woods Supplements, after being prescribed medication by a doctor, may have stopped taking their prescribed medication and spent money on products that were subject to the ASA adjudication in relation to misleading advertising and unauthorised health claims.

The choice of Pharmacy2U to sell names and addresses of patients to quacks and charlatans must be addressed. “As a responsible company, we undertook due diligence to check that the organisations intending to use the data were reputable”, say Pharmacy2U, but they still sold data to “spammy” companies that may have encouraged patients not to take medicines prescribed to them (and which they had paid Pharmacy2U for).

medConfidential received the following statement from Pharmacy2U’s media and PR representatives, ‘Intelligent Conversation’ – the new name for the same PR firm that contacted us previously, see the Update from April this year.

We publish Pharmacy2U’s statement in full:

Daniel Lee, Managing Director of Pharmacy2U, said: “This is a regrettable incident for which we sincerely apologise.  

“While we are grateful that the ICO recognise that our breach was not deliberate, we appreciate this was a serious matter. As soon as the issue was brought to our attention, we stopped the trial selling of customer data and made sure that the information that had been passed on was securely destroyed.

“We have also confirmed that we will no longer sell customer data.

“We take our responsibilities to the public very seriously and want to reassure our customers that no medical information, email addresses or telephone numbers were sold. Only names and postal addresses were given, for one-time use.

“As a responsible company, we undertook due diligence to check that the organisations intending to use the data were reputable. There was no publicly available information at the time to suggest that the lottery company was suspected of any wrongdoing and we have confirmed with the relevant authorities that they were validly licensed.  There was no publicly available information at the time that there had been a complaint to the ASA about Healthy Marketing Ltd.

“Following this incident, we have changed our privacy policy to highlight that we will no longer sell customer data and have implemented a prior consent model for our own marketing. We have also worked with the Plain English Campaign to make our policies as clear as possible to our customers.

“We hope that this substantial remedial action will reassure our customers that we have learned from this incident and will continue to do all we can to ensure that their data is protected to the highest level.”

The ICO’s judgement shows, while the data transferred may have been a list of names and addresses, the information received by the companies and charity was far more than that. For example, in the case of the Australian lottery scammers, they would have known that each name and address on that list was of a man (i.e. gender), aged 70 or over (i.e. age), who had made a purchase (financially active) from an online pharmacy in the past 6 months (with certain conditions)

Pharmacy2U’s “substantial remedial action” does not include informing any of the 21,500 patients and customers whose names and address was sold – as for example, the Government did when it lost two CDs containing HMRC Child Benefit data.

So we asked them about it.

This was the response:

A Pharmacy2u spokesman said: “As soon as the issue was brought to our attention, we ordered the certificated destruction of all the names and addresses that had been sold. [Our emphasis] For that reason, we are unable to contact individual patients.

“Anyone with concerns should contact us on 0113 265 0222 or via email, director@pharmacy2u.co.uk“

We are pleased that Pharmacy2U has (finally) provided contact details for patients and customers who may have been affected by them selling their details, though these seem not to have been published in a way concerned members of the public can easily find them. We got them in an email, and P2U’s online statement directs people to their standard customer feedback form.

However, we are astonished to hear that the company retained no record of the people whose details were sold, and is incapable of regenerating those lists from the records it is supposed to keep according to Pharmaceutical Regulators.

This is a serious failure of information governance, which only compounds their original decision to sell people’s details. Pharmacy2U have not confirmed that all the recipients of the data destroyed all of the details.

Once again, predatory quacks and charlatans have targeted those who are most vulnerable. Pharmacies and charities are likely to know who is most at risk, and selling their names and addresses is complicity in the sort of abuse that has cost lives.

Only a criminal ban on marketing to patients will prevent crooks preying on patients.

 

[PRESS RELEASE] UK’s largest online pharmacy fined £130,000 for selling patients’ data to scammers

The Information Commissioner’s Office will this morning issue a £130,000 fine [1] to the UK’s largest NHS-approved online pharmacy, Pharmacy2U, [2] whose senior executives approved the sale of NHS patients’ and P2U customers’ personal data by direct marketers.

The ICO determined that, through a direct marketing company called Alchemy Direct Media (UK) Ltd, Pharmacy2U executives unlawfully and unfairly sold the personal data of over 21,000 NHS patients and P2U customers either directly, or through intermediaries, to:

  • Australian Lottery fraudsters [3] targeting male pensioners who were more likely to have chronic health conditions, or cognitive impairments;
  • a Jersey-based ‘healthcare supplement’ company [4] which the Advertising Standards Authority ruled against for “misleading advertising” and “unauthorised health claims”;
  • and a UK charity which used the details to solicit donations [5] for people with learning disabilities.

The ICO determined that the sale of personal data was “likely to cause substantial damage or substantial distress to the affected individuals”, [6] that the incidents were neither “one-off events or attributable to mere human error” [7] and that Pharmacy2U executives were negligent [8].

Phil Booth, coordinator of medConfidential said:

“When medConfidential made a complaint to the Information Commissioner on behalf of patients who were being marketed, we’d no idea the trade in their data was as murky as this.

“Vulnerable people shouldn’t be exposed to this sort of harm and distress, but what’s doubly appalling is that this was done by the largest NHS-approved online pharmacy in the country, which is part-owned by the company that provides a majority of GPs with their medical records systems.

“The Government has to act decisively. Six-figure fines alone won’t stamp out this poisonous trade; not when there’s so much profit to be made. There must now be a blanket, statutory ban on all marketing to patients.


“Those who profiteer from patients’ data are predators and should face prison when they are caught.”

—

Notes for editors:

  1. The fine is a ‘Monetary Penalty Notice’; the ICO’s full judgement is published here: https://ico.org.uk/action-weve-taken/enforcement/pharmacy2u-ltd/
  2. Following a Daily Mail investigation, first reported on 31 March 2015: http://www.dailymail.co.uk/news/article-3020480/Your-secrets-sale-NHS-dock-s-revealed-details-patients-bought-prescriptions-online-sold-off.html Pharmacy2U is 20% owned by EMIS, the single largest provider of GP IT systems across England, see p80: https://www.emisgroupplc.com/media/1084/emis-group-plc-annual-report-and-accounts-2014.pdf and EMIS’ current Chief Executive is also a Director of Pharmacy2U: https://www.companiesintheuk.co.uk/director/11692582/christopher-spencer
  3. See paragraphs 24-28 of the ICO’s judgement, which includes: “The National Trading Standards Scams Team has also informed the Commissioner’s office that the lottery company is the subject of an ongoing international criminal investigation into fraud and money laundering, although this wouldn’t have been known to Pharmacy2U.”
  4. See paragraphs 20-23, which includes: “In February 2015, the Advertising Standards Authority (“ASA”) issued an adjudication on Healthy Marketing Ltd in relation to breaches of the CAP Code, although this wouldn’t have been known to Pharmacy2U at the time the order was approved. The breaches related to a press advert which was found to contain misleading advertising and unauthorised health claims.”
  5. Paragraph 29 of the ICO’s judgement.
  6. Paragraph 65 of the ICO’s judgement.
  7. Paragraph 72 of the ICO’s judgement.
  8. Paragraph 63:  “The senior executive of Pharmacy2U must have known that there was a risk that people may object to the sale of data to the lottery company because, when he was asked to approve the order, he replied “OK but let’s use the less spammy creative please, and if we get any complaints I would like to stop this immediately”. However, he still approved the order.”

medConfidential campaigns for confidentiality and consent in health and social care, seeking to ensure that every flow of data into, across and out of the NHS and care system is consensual, safe and transparent. Founded in January 2013, medConfidential is an independent, non-partisan organisation working with patients and medics, service users and care professionals.

For further information or for immediate or future interview, please contact Phil Booth, coordinator of medConfidential, on 07974 230 839 or phil@medconfidential.org

– ends –

[PRESS RELEASE] There’s an app for that? NHS Health Apps Library “pilot” is shut down, but will “medical innovation” include marketing to patients?

This morning, the NHS Health Apps Library – a “pilot programme” that has been endorsing hundreds of apps to patients since 2013 – was finally shut down. It is replaced by a set of pages on the NHS Choices website which promote a total of seven “online mental health services”. [1]

Serious concerns have been raised over the past year by researchers at Imperial College London and Ecole Polytechnique CNRS, France [2] and by medConfidential [3] with regard to the security, safety and suitability of dozens of apps which were endorsed in the Apps Library.

A handful of apps – including Kvetch, Doctoralia and My Sex Doctor [4] – were silently withdrawn following complaints, but it is unclear how NHS England intends to notify patients left hanging now that “innovative” apps it has been promoting for up to two years have had their approval pulled.

The closure of the Apps Library coincides with the Second Reading of the Access to Medical Treatments (Innovation) Bill – a Private Members’ Bill by Chris Heaton-Harris MP, a version of which was introduced previously in the Lords by advertising magnate Lord Saatchi.

Apps fall within the Bill’s definition of “innovative treatments”, opening far wider questions as to the use of the database [5] that would be created under Section 2 of the Bill. Minister for Life Sciences, George Freeman MP, tweeted during the debate [6] that he did not intend for the database to be used for marketing to patients, but the Bill itself and existing legislation [7] provide no legal bar.

All of which further calls into question the stated ambition of Secretary of State for Health, Jeremy Hunt, “to get a quarter of smartphone users – 15% of all NHS patients – routinely accessing NHS advice, services and medical records through apps by the end of the next financial year.” [8]

Phil Booth, coordinator of medConfidential said:

“While we welcome the closure of this sprawling, unaccredited mess of apps and internet quackery, NHS England must now demonstrate how radically it has changed its approach to innovation if it wants to avoid destroying patient trust.

“Promoting predatory ‘bait and switch’ apps targeting teenagers, like My Sex Doctor, was certainly an “innovation” for the NHS. Real doctors would have laughed the charlatans out of the surgery and got back to helping patients, but it seems Tim Kelsey’s team welcomed them with open arms.

“Jeremy Hunt and George Freeman may not intend for any of this to be used for marketing to patients, but there’s no legal bar. And as NHS England’s abortive attempt with apps has shown, not thinking this through properly puts patients at risk.”

—

Notes for editors:

  1. Just three of these “services” are available as apps: http://www.nhs.uk/conditions/online-mental-health-services/Pages/introduction.aspx
  2. http://www.theguardian.com/society/2015/sep/25/nhs-accredited-health-apps-putting-users-privacy-at-risk-study-finds which led to the removal of My Sex Doctor and other apps. Full study published here: http://www.biomedcentral.com/1741-7015/13/214
  3. http://www.computing.co.uk/ctg/news/2415698/caredata-nhs-choices-and-now-apps-could-it-be-three-failures-in-a-row-for-tim-kelsey
  4. Kvetch app was a self-described “experiment” that proposed to “make sickness social”, with a communally-visible “alcoholism” group it encouraged individuals to “check your friends in for a laugh”. Barcelona-based Doctoralia (still available in UK apps stores) failed to correctly list GPs working in UK practices, listing at least one GP who had died tragically, and had complex DPA issues that failed to meet the Apps Library’s own criteria for inclusion. My Sex Doctor (also still available in commercial apps stores, and still claiming NHS endorsement) targets teenagers with sex advice, with a stated business model: “Once gained their trust we can leverage it for commercial purposes” – see slide 11, http://www.slideshare.net/FabrizioDolfi/my-sexdoctor-pitch-deck-43296908
  5. Which Chair of the Health Select Committee, Dr Sarah Wollaston MP, described as “a vast sprawling database of anecdotal treatment for male pattern baldness”. Debate transcript: http://www.parliament.uk/business/publications/hansard/commons/todays-commons-debates/read/unknown/12/
  6. https://twitter.com/Freeman_George/status/654976202810269696
  7. See medConfidential’s briefing, following a meeting with Chris Heaton-Harris on 30 Sept: https://medconfidential.org/wp-content/uploads/2015/10/medconfidential-1-Marketingtopatients.pdf
  8. Official report of Jeremy Hunt’s speech, 2 September 2015: https://www.gov.uk/government/news/health-secretary-outlines-vision-for-use-of-technology-across-nhs – updated on 18 September following the announcement of the consultation on the role and remit of the statutory National Data Guardian, who will produce “clear guidelines for the protection of personal data against which every NHS and care organisation will be held to account.”

medConfidential campaigns for confidentiality and consent in health and social care, seeking to ensure that every flow of data into, across and out of the NHS and care system is consensual, safe and transparent. Founded in January 2013, medConfidential is an independent, non-partisan organisation working with patients and medics, service users and care professionals.

– ends –

medConfidential Bulletin, 11 October 2015

We hope you had a good summer. Ours was interesting, to say the least.

Parliament begins sitting again on Monday, and people will wake up to the stack of things we’ve got ready for them. But in the meanwhile, quite a lot has happened:

care.data “paused” yet again

Despite NHS England’s announcement in June that the care.data pathfinders would be starting at “the beginning of September”, the Secretary of State on 2 September effectively pushed back the restart to at least the end of January 2016.

The announcement (originally) said:

The National Data Guardian for health and care, Dame Fiona Caldicott, will… provide advice on the wording for a new model of consents and opt-outs to be used by the care.data programme that is so vital for the future of the NHS. The work will be completed in January…

A later “clarification” omits to mention care.data, but confirms that the National Data Guardian will develop “clear guidelines for the protection of personal data against which every NHS and care organisation will be held to account. She will provide advice on the wording for a new model of consents and opt-outs, to enable patients to make an informed decision about how their data will be shared.”

This work – a task NHS England singularly failed to complete in 3 years! – is to be completed in January, “…with recommendations on how the new guidelines can be assured through CQC inspections and NHS England commissioning processes.”  Apparently “no arbitrary deadlines” only applies to NHS England.

Where does this leave the care.data programme itself? Well, for starters…

Tim Kelsey ‘opts out’ of care.data

On 17 September, care.data mastermind Tim Kelsey announced his resignation as National Director for Patients and Information at NHS England. He has taken a job as commercial director for Telstra Health, a division of Australian telecomms provider Telstra Corp, to which in March this year DH sold Dr Foster Intelligence, the company Kelsey co-founded in 2000.

Tim Kelsey leaves the UK for Australia in December – an antipodean departure emulating that of the former NHS Director General of Information and head of Connecting for Health, Richard Granger, some years back – but his departure leaves a number of important issues unresolved.

As we learned from care.data Programme Board papers that were finally published in August, and from subsequent Board meetings of both NHS England (video) and HSCIC (cf. minutes on p10), the care.data Directions still aren’t finalised. Indeed, in responding to the Directions sent by NHS England, HSCIC’s Board identified five key unaddressed issues in addition to matters medConfidential had raised.

There’s also no sign of the CAG Regulations, due since the passage of the Care Act 2014 last summer. This means that promised safeguards such as “one strike and you’re out” sanctions for data abuse or misuse and, crucially, the closure of the commercial re-use loophole – persisted by the over-broad definition, “the promotion of health” – have still not been enacted.

What next?

Dame Fiona Caldicott is rewriting the language on consent for patients, which NHS England previously said was ‘ready to go’; HSCIC appears close to being able to ‘fix’ the 9Nu4 opt-out problem, currently affecting over a million patients, that NHS England dumped on it; and DH is finally drafting the Directions on Patient Objections, required to deliver on the Secretary of State’s 2013 promise to respect patient opt-outs.

Assuming the decision is to replace him, whoever replaces Mr Kelsey has a tough task and problems much wider than just care.data to resolve – the digital public health disaster that is the NHS Health Apps Library, to mention but one.

Patients and Registered Medical Professionals must be fairly represented throughout these processes and on all relevant bodies (the care.data Programme Board, for example, still has no public and patient representative) and both NHS England and DH must ensure that the new ‘worldview’ – drawing on lessons learned the hard way – is consistently applied across the health and care system.

medConfidential believes it is still possible to preserve confidentiality and consent in health and social care, and will continue to work to ensure that every flow of data into, across and out of the NHS and care system is consensual, safe and transparent. If they want to regain public confidence, it is up to the Government, DH and its arm’s-length bodies to now show they can do so, in a trustworthy way.

Statutory National Data Guardian

The Government has now published its consultation on the remit and functions of the National Data Guardian – the role currently fulfilled by Dame Fiona Caldicott. medConfidential welcomes this consultation, available here, which should lead to legislation that will ensure the strength and the remit of the National Data Guardian into the future.

medConfidential will be responding formally in due course, and we have published some initial observations on some of the significant questions raised.  We strongly encourage anyone with views on this vital statutory reinstatement of overarching, independent governance oversight to make a submission of their own before the 17 December deadline.

Another new database?

The ‘Medical Innovation Bill’, first proposed by advertising magnate Lord Saatchi, will shortly return in the form of a Private Members’ Bill by Chris Heaton-Harris MP, entitled the ‘Access to Medical Treatments (Innovation) Bill 2015-16’ (draft Bill here). The new Bill has its Second Reading in the Commons on 16 October.

medConfidential had some questions for Mr Heaton-Harris on the content of the draft Bill, and had a meeting with him last week. Our comments and suggestions arising from that meeting covered a ban on marketing to patients, Data Usage Reports (including our example of what one might look like) and an alternative approach that might deliver the policy intent of the Bill without creating another new database, or giving DH duplicates of powers it already has.

We shall watch the progress of the Bill with interest.

In other news…

medConfidential continues to draw attention to matters of importance to patients and – in our continued membership of the up-to-now somewhat ignored care.data Advisory Group and engagement with other groups, Boards, panels and processes – providing robust but constructive criticism to those who need it.

However, issues sometimes come up that have a wider impact than in just health and care. (You may remember All But Names, a few months back.) One such issue is Freedom of Information; a vital tool for all those who seek to hold the powerful to account. Sam and Phil have joined with others in the FOI community, including journalists, campaigners and citizens across the country in a project to #saveFOI.

The purpose of #saveFOI is to defend against threatened restrictions to Freedom of Information, proposed in the Terms of Reference for the FOI Commission – and by fees proposed in an earlier consultation affecting FOI appeals, that could mean charges of up to £600 to get information released.

The FOI Commission, already half-way through its appointed time scale, has only just put out a public call for evidence – and #saveFOI needs your help:

  • If you have used FOI to help change the world for better, let us know. #saveFOI is assembling a dossier of FOI requests which led to improvements in the world (precisely which of these is the Government seeking to prevent?) and also examples of the broad and/or eccentric interpretation of the exemptions currently in the Freedom of Information Act. We need YOUR stories.
  • Spread the word – on Twitter, on Facebook, on your blog and wherever else you can; the hashtag is in the name, #saveFOI, and the more people who speak up on the positive effects of FOI the harder it will be for the Government to restrict the transparency that is so vital to public trust.

—

Apologies for the length of this Bulletin. As we said at the top, a great deal has happened since our last newsletter – keeping us very busy.

We remain hugely grateful for the continuing support you and our other supporters provide, most especially the actions you take when we need you.

Phil Booth and Sam Smith
medConfidential

11th October 2015

“Fair Processing” and the ICO

In practice, the ICO has a very simple test for fair processing:

Do data subjects know (i.e. have they been they fairly informed) what (processing of their data) you’re intending to do?

That’s it – is the organisation being completely honest?

If yes, that’s fair processing.

If no, that’s not “fair processing”.

It’s that simple. It’s not a high bar, and it’s not a complex bar.

If you end up in trouble, it’s because of surprises – you weren’t completely honest with the data subjects about what you were going to do.

With regard to fair processing, the ICO doesn’t make a distinction as to whether or not you should do something; it solely looks at whether you said you would. The ICO is often seen as facilitating data flows, because this test isn’t what people often seem to think it is.

The ICO considers itself to have one job in this regard, defined by the Data Protection Act, and that human rights are the remit of a Court. If someone is honest and informs you about using your data to breach your human rights, the ICO believes this is not a consideration for the data protection authorities. This may be an incomplete or incorrect reading of the law, but the current ICO has made its consideration.

In many controversial cases, organisations themselves – including the Government, Ministers, the NHS – all add additional requirements. These are not data protection constraints, they are moral constraints, they’re other legal constraints or they’re ‘ministerial gifts’ (e.g. the care.data opt out).

Remember, it’s only fair processing so long as what you tell people you’ll do matches what you actually do. (You can tell them you’ll do something and not do it – that’s still fair processing.)

When you want to do something new with data, if that wasn’t in the old rules, you need to tell people about the new rules. It is here that NHS England’s various data grabs have run into trouble, mainly because they don’t want to tell people quite what it is they want to do.

So in short, be completely honest.

No wonder the political machinations in the Department of Health and NHS England keep screwing it up…

P.S. Complaints about “fair processing” basically boil down to, “we don’t want to be honest with you”. Any fines simply show that you weren’t honest; one reason organisations get fined for losing data is because they’ve said that they won’t. If they didn’t say that, then losing your data mightn’t be a breach in those terms – but then no-one would do business with them. Which is why such promises get made in the first place.

A first look at the National Data Guardian Consultation

Late last week, the Government published its consultation on the remit of the National Data Guardian. The consultation is available here and closes on the 17th December, just days before Tim Kelsey departs (NHS) England.

We welcome this consultation, which we believe is intended to ensure the strength and the remit of the National Data Guardian into the future, as NHS England reconsiders its failed approach to data, privacy and information governance.

medConfidential will provide a substantive response to the consultation in future weeks, but on first reading, we would make a few initial observations:

1) This is a consultation on the nature of the teeth the NDG will have

It is not consulting on the existence of those teeth, but their shape and constitution, and how they relate to other bodies.

2) There is a question about how the National Data Guardian relates to Non-Medical Professionals

Medical Professionals are regulated by the General Medical Council; however, many decision-makers in the NHS are not Medical Professionals, and hence not subject to GMC rules and sanctions.

care.data and the Prime Minister’s Challenge Fund fiascos, for example, were both conceived and implemented by individuals who are not (Registered Medical) Professionals. There is currently no effective regulation of those individuals. The details of this will matter, and are likely to need multiple diverse discussions which we look forward to having in the coming weeks and months.

3) Covering the use of Health and Social Care Data about Children

Children are a large and vulnerable constituency of the NHS. For the National Data Guardian to lack effective powers in this area would be perverse.

However, Children’s Social Care is entirely separate to Adult Social Care, and so in practice powers will have to be significantly different – if only because the other public bodies are different bodies with different remits.

We greatly welcome the inclusion of this question in the consultation, though we suspect the Government’s response to the consultation will be limited to the principle of whether the NDG should be able to cover all Social Care, with the details of implementing coverage in Child Social Care being covered by a future consultation on that topic.

Since November 2014, the National Data Guardian has interacted with other regulators on the basis of an agreement of standing and respect for overlapping remits. Until the details of similar interactions can be worked out for Children’s Social Care, that is likely to be the way forwards. Any future consultation on this particular matter need not slow down primary legislation to put NDG onto a statutory basis “at the earliest opportunity” – subject to appropriate provision being made for, e.g. (super-)affirmative resolutions mandating the interactions between bodies in an agreed manner.

We will draft and publish a more comprehensive response in due course.

PLEASE NOTE: This consultation is entirely separate and unrelated to the announcement earlier this month that Dame Fiona Caldicott, the National Data Guardian, will review the language around consent for secondary uses of patient data in the NHS. It was that announcement by the Secretary of State that led, yet again, to another suspension of care.data.

NHS England failed to satisfactorily resolve the question of what “opt-out” actually means and does for nearly 3 years – so, as the scheme’s architect and main proponent himself opts out of care.data by leaving the country, those left behind will have to clean up the mess he’s left.

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Our press release on the NDG consultation follows:

[PRESS RELEASE] Consultation on National Data Guardian: “no public confidence without Caldicott”

medConfidential today welcomed the long-anticipated consultation on the role of the National Data Guardian [1] as a step in the right direction. medConfidential and others have been pushing for the reinstatement of statutory independent oversight on the use of personal data across the health and care system since late spring 2014 [2].

With care.data put on “pause” yet again [3], Jeremy Hunt has asked Dame Fiona Caldicott to sort out the “fiasco” that Tim Kelsey and NHS England have failed to address for the past two years. Given the tight timing of this consultation, medConfidential hopes the Government will publish its response before Dame Fiona is required to offer her suggestions on resolving NHS England’s incompetence.

Issued by the Department of Health hours after NHS England announced Mr Kelsey’s resignation, the consultation is a positive step towards restoring public trust in the NHS’ handling and use of patient data.

As many, including leading research charities [5], have emphasised, “Patient data must be safeguarded… The stakes are too high to risk any further mistakes.”

Responding to the launch of the consultation, Phil Booth, coordinator of medConfidential said:

“We welcome putting the National Data Guardian role, currently held by Dame Fiona Caldicott, onto a statutory footing as a sensible and necessary step towards restoring public confidence.

“As we have pointed out time and again, there can be little public confidence in the handling of sensitive patient information without overarching, independent oversight – with teeth – of every single body involved.

“NHS England’s continued screw-ups and missteps are toxic to trust. They must improve, but that must be overseen by an independent body that can inspire confidence.”

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Notes for editors:

  1. The consultation was published on the evening of 17 September, just hours after care.data SRO, Tim Kelsey, announced his resignation [6]: https://www.gov.uk/government/consultations/the-role-of-the-national-data-guardian-for-health-and-social-care
  2. See, e.g. medConfidential’s briefing and proposed amendments to the Care Bill 2014: https://medconfidential.org/wp-content/uploads/2014/05/medConfidential-briefing-for-Care-Bill-ping-pong_07May.pdf
  3. See announcement by Somerset CCG (one of the care.data ‘pathfinder’ areas), published by Somerset LMC, 4/9/15: https://www.somersetlmc.co.uk/caredatapaused
  4. “Caldicott to oversee care.data pilot”, EHI, 2/7/14: http://www.digitalhealth.net/news/29382/
  5. Research charities’ letter to the Guardian following PM’s Challenge Fund debacle, 27/7/15: http://www.theguardian.com/society/2015/jul/27/patient-data-must-be-safeguarded
  6. medConfidential Press Release,17/9/15, on Tim Kelsey’s resignation: https://medconfidential.org/2015/press-release-kelsey-leaves-england-for-down-under/

medConfidential campaigns for confidentiality and consent in health and social care, seeking to ensure that every flow of data into, across and out of the NHS and care system is consensual, safe and transparent. Founded in January 2013, medConfidential is an independent, non-partisan organisation working with patients and medics, service users and care professionals.

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[PRESS RELEASE] Kelsey leaves England for down under

medConfidential joins others in recognising the effect Tim Kelsey – Director for Patients and Information at NHS England, Chair of DH’s National Information Board, SRO for care.data and Chair of the care.data Programme Board – has had on the NHS.

Mr Kelsey announced today [1] that he will be resigning from NHS England and leaving the UK for Australia, to work as a commercial director for Telstra Health, a division of Australian telecommunications provider Telstra Corp – which in March this year acquired Dr Foster Intelligence [2], the company Mr Kelsey co-founded in 2000.

Tim’s commitment to the NHS is exemplified by serving his full notice period of 6 months. Earlier this morning, the HSCIC published its Board’s rejection of the Directions for the care.data pathfinders [3], a decision made in July.

Phil Booth, privacy advocate and long-standing scrutineer of Tim’s work, said:

“Tim’s gone back to his old job in the private sector, but serious questions of consent and transparency in NHS England remain unresolved. At the beginning of September Jeremy Hunt announced that responsibility for effective patient consent, long ignored by NHS England under Tim’s rule, had been handed to Dame Fiona Caldicott for resolution.

“We look forward to seeing how public confidence in the handling of NHS patient data will recover under new leadership. NHS England’s strident insistence on commercial re-use of medical records must now be reconsidered.

“Lord Saatchi’s Medical Database Bill, due to be re-published in the Commons the week after Conservative Party Conference, may provide some sign whether Jeremy Hunt has learnt the lessons of care.data for the entire NHS.”

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Notes to editors:

1) NHS England announcement of Tim Kelsey’s resignation, 17/9/15: http://www.england.nhs.uk/2015/09/17/tim-kelsey-to-leave/

2) Telstra Health acquires Dr Foster Intelligence, 26/1/15: http://www.drfoster.com/updates/news/dr-foster-acquired-by-telstra-health/
Dr Foster Intelligence was formed when the Department of Health a 50% stake in Dr Foster in 2006, in a deal that was later criticised by the National Audit Office: http://www.nao.org.uk/report/dr-foster-intelligence-a-joint-venture-between-the-information-centre-and-dr-foster-llp/

3) Minutes of HSCIC Board meeting on 15/7/15, published on 17 September 2015, as part of papers for upcoming HSCIC Board meeting on 23/9/15. HSCIC reject the care.data Directions (previously approved by the care.data Programme Board and NHS England Board) for reasons listed on p10 of 300:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/461371/20150923_HSCICBoardpapers_Part1.pdf

medConfidential campaigns for confidentiality and consent in health and social care, seeking to ensure that every flow of data into, across and out of the NHS and care system is consensual, safe and transparent. Founded in January 2013, medConfidential is an independent, non-partisan organisation working with patients and medics, service users and care professionals.

For further information or for immediate or future interview, please contact Phil Booth, coordinator of medConfidential, on phil@medconfidential.org

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