Driving digital health, revolution by design

This follows on from: 1. Digital revolution by design: building for change and people.

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Talking about the future of digital health in the NHS, Andy Williams went on to ask, what makes the Internet work?

In my head I answered him, freedom.

Freedom from geographical boundaries. Freedom of speech to share ideas and knowledge in real time with people around the world.  The freedom to fair and equal use. Cooperation, creativity, generosity…

Where these freedoms do not exist or are regulated the Internet may not work well for its citizens and its potential is restricted, as well as its risks.

But the answer he gave, was standards.

And of course he was right.  Agreed standards are needed when sharing a global system so that users, their content and how it works behind the screen cooperate and function as intended.

I came away wondering what the digital future embodied in the NHS NIB plans will look like, who has their say in its content and design and who will control  it?

What freedoms and what standards will be agreed upon for the NHS ‘digital future’ to function and to what purpose?

Citizens help shape the digital future as we help define the framework of how our data are to be collected and used, through what public feeling suggests is acceptable and people actually use.

What are some of the expectations the public have and what potential barriers exist to block achieving its benefits?

It’s all too easy when discussing the digital future of the NHS to see it as a destination. Perhaps we could shift the conversation focus to people, and consider what tools digital will offer the public on their life journey, and how those tools will be driven and guided.

Expectations

One key public expectation will be of trust, if something digital is offered under the NHS brand, it must be of the rigorous standard we expect.

Is every app a safe, useful tool or fun experiment and how will users [especially for mental health apps where the outcomes may be less tangibly measured than say, blood glucose] know the difference?

A second expectation must be around universal equality of access.

A third expectation must be that people know once the app is downloaded or enrolment done, what they have signed up to.

Will the NHS England / NIB digital plans underway create or enable these barriers and expectations?

What barriers exist to the NHS digital vision and why?

Is safety regulation a barrier to innovation?

The ability to broadly share innovation at speed is one of the greatest strengths of digital development, but can also risk spreading harm quickly. Risk management needs to be upfront.

We  assume that digital designs will put at their heart the core principles in the spirit of the NHS.  But if apps are not available on prescription and are essentially a commercial product with no proven benefit, does that exploit the NHS brand trust?

Regulation of quality and safety must be paramount, or they risk doing harm as any other treatment could to the person and regulation must further consider reputational risk to the NHS and the app providers.

Regulation shouldn’t be seen as a barrier, but as an enabler to protect and benefit both user and producer, and indirectly the NHS and state.

Once safety regulation is achieved, I hope that spreading benefits will not be undermined by creating artificial boundaries that restrict access to the tools by affordability, in a postcode lottery,  or in language.

But are barriers being built by design in the NHS digital future?

Cost: commercial digital exploitation or digital exclusion?

There appear to be barriers being built by design into the current NHS apps digital framework. The first being cost.

For the poorest even in the UK today in maternity care, exclusion is already measurable in those who can and cannot afford the data allowance it costs on a smart phone for e-red book access, attendees were told by its founder at #kfdigital15.

Is digital participation and its resultant knowledge or benefit to become a privilege reserved for those who can afford it? No longer free at the point of service?

I find it disappointing that for all the talk of digital equality, apps are for sale on the NHS England website and many state they may not be available in your area – a two-tier NHS by design. If it’s an NHS app, surely it should be available on prescription and/or be free at the point of use and for all like any other treatment? Or is yet another example of  NHS postcode lottery care?

There are tonnes of health apps on the market which may not have much proven health benefit, but they may sell well anyway.

I hope that decision makers shaping these frameworks and social contracts in health today are also looking beyond the worried well, who may be the wealthiest and can afford apps leaving the needs of those who can’t afford to pay for them behind.

At home, it is some of the least wealthy who need the most intervention and from whom there may be little profit to be made There is little in 2020 plans I can see that focuses on the most vulnerable, those in prison and IRCs, and those with disabilities.

Regulation in addition to striving for quality and safety by design, can ensure there is no commercial exploitation of purchasers.  However it is a  question of principle that will decide for or against exclusion for users based on affordability.

Geography: crossing language, culture and country barriers

And what about our place in the wider community, the world wide web, as Andy Williams talked about: what makes the Internet work?

I’d like to think that governance and any “kite marking” of digital tools such as apps, will consider this and look beyond our bubble.

What we create and post online will be on the world wide web.  That has great potential benefits and has risks.

I feel that in the navel gazing focus on our Treasury deficit, the ‘European question’ and refusing refugees, the UK government’s own insularity is a barrier to our wider economic and social growth.

At the King’s Fund event and at the NIB meeting the UK NHS leadership did not discuss one of the greatest strengths of online.

Online can cross geographical boundaries.

How are NHS England approved apps going to account for geography and language and cross country regulation?

What geographical and cultural barriers to access are being built by design just through lack of thought into the new digital framework?

Barriers that will restrict access and benefits both in certain communities within the UK, and to the UK.

One of the three questions asked at the end of the NIB session, was how the UK Sikh community can be better digitally catered for.

In other parts of the world both traditional and digital access to knowledge are denied to those who cannot afford it.

school

This photo reportedly from Indonesia, is great [via Banksy on Twitter, and apologies I cannot credit the photographer] two boys on the way to school, pass their peers on their way to work.

I wonder if one of these boys has the capability to find the cure for cancer?
What if he is one of the five, not one of the two?

Will we enable the digital infrastructure we build today to help global citizens access knowledge and benefits, or restrict access?

Will we enable broad digital inclusion by design?

And what of  data sharing restrictions: Barrier or Enabler?

Organisations that talk only of legal, ethical or consent ‘barriers’ to datasharing don’t understand human behaviour well enough.

One of the greatest risks to achieving the potential benefits from data is the damage done to it by organisations that are paternalistic and controlling. They exploit a relationship rather than nurturing it.

The data trust deficit from the Royal Statistical Society has lessons for policymakers. Including finding that: “Health records being sold to private healthcare companies to make money for government prompted the greatest opposition (84%).”

Data are not an abstract to be exploited, but personal information. Unless otherwise informed, people expect that information offered for one purpose, will not be used for another. Commercial misuse is the greatest threat to public trust.

Organisations that believe behavioural barriers to data sharing are an obstacle,  have forgotten that trust is not something to be overcome, but to be won and continuously reviewed and protected.

The known barrier without a solution is the lack of engagement that is fostered where there is a lack of respect for the citizen behind the data. A consensual data charter could help to enable a way forward.

Where is the wisdom we have lost in knowledge?

Once an app is [prescribed[, used, data exchanged with the NHS health provider and/or app designer, how will users know that what they agreed to in an in-store app, does not change over time?

How will ethical guidance be built into the purposes of any digital offerings we see approved and promoted in the NHS digital future?

When the recent social media experiment by Facebook only mentioned the use of data for research after the experiment, it caused outcry.

It crossed the line between what people felt acceptable and intrusive, analysing the change in behaviour that Facebook’s intervention caused.

That this manipulation is not only possible but could go unseen, are both a risk and cause for concern in a digital world.

Large digital platforms, even small apps have the power to drive not only consumer, but potentially social and political decision making.

“Where is the knowledge we have lost in information?” asks the words of T S Elliott in Choruses, from the Rock. “However you disguise it, this thing does not change: The perpetual struggle of Good and Evil.”

Knowledge can be applied to make a change to current behaviour, and offer or restrict choices through algorithmic selection. It can be used for good or for evil.

‘Don’t be evil’ Google’s adoptive mantra is not just some silly slogan.

Knowledge is power. How that power is shared or withheld from citizens matters not only today’s projects, but for the whole future digital is helping create. Online and offline. At home and abroad.

What freedoms and what standards will be agreed upon for it to function and to what purpose? What barriers can we avoid?

When designing for the future I’d like to see discussion consider not only the patient need, and potential benefits, but also the potential risk for exploitation and behavioural change the digital solution may offer. Plus, ethical solutions to be found for equality of access.

Regulation and principles can be designed to enable success and benefits, not viewed as barriers to be overcome

There must be an ethical compass built into the steering of the digital roadmap that the NHS is so set on, towards its digital future.

An ethical compass guiding app consumer regulation,  to enable fairness of access and to know when apps are downloaded or digital programmes begun, that users know to what they are signed up.

Fundamental to this the NIB speakers all recognised at #kfdigital15 is the ethical and trustworthy extraction, storage and use of data.

There is opportunity to consider when designing the NHS digital future [as the NIB develops its roadmaps for NHS England]:

i making principled decisions on barriers
ii. pro-actively designing ethics and change into ongoing projects, and,
iii. ensuring engagement is genuine collaboration and co-production.

The barriers do not need got around, but solutions built by design.

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Part 1. Digital revolution by design: building for change and people
Part 3. Digital revolution by design: building infrastructures

NIB roadmaps: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/384650/NIB_Report.pdf

Digital revolution by design: building for change and people (1)

Andy Williams said* that he wants not evolution, but a revolution in digital health.

It strikes me that few revolutions have been led top down.

We expect revolution from grass roots dissent, after a growing consensus in the population that the status quo is no longer acceptable.

As the public discourse over the last 18 months about the NHS use of patient data has proven, we lack a consensual agreement between state, organisations and the public how the data in our digital lives should be collected, used and shared.

The 1789 Declaration of the Rights of Man and Citizen as part of the French Revolution set out a charter for citizens, an ethical and fair framework of law in which they trusted their rights would be respected by fellow men.

That is something we need in this digital revolution.

We are told hand by government that it is necessary to share all our individual level data in health from all sorts of sources.

And that bulk data collection is vital in the public interest to find surveillance knowledge that government agencies want.

At the same time other government departments plan to restrict citizens’ freedom of access to knowledge that could be used to hold the same government  and civil servants to account.

On the consumer side, there is public concern about the way we are followed around on the web by companies including global platforms like Google and Facebook, that track our digital footprint to deliver advertising.

There is growing objection to the ways in which companies scoop up data to build profiles of individuals and groups and personalising how they get treated. Recent objection was to marketing misuse by charities.

There is little broad understanding yet of the power of insight that organisations can now have to track and profile due to the power of algorithms and processing capability.

Technology progress that has left legislation behind.

But whenever you talk to people about data there are two common threads.

The first, is that although the public is not happy with the status quo of how paternalistic organisations or consumer companies ‘we can’t live without’ manage our data, there is a feeling of powerlessness that it can’t change.

The second, is frustration with organisations that show little regard for public opinion.

What happens when these feelings both reach tipping point?

If Marie Antoinette were involved in today’s debate about the digital revolution I suspect she may be the one saying: “let them eat cookies.”

And we all know how that ended.

If there is to be a digital revolution in the NHS where will it start?

There were marvelous projects going on at grassroots discussed over the two days: bringing the elderly online and connected and in housing and deprivation. Young patients with rare diseases are designing apps and materials to help consultants improve communications with patients.

The NIB meeting didn’t have real public interaction and or any discussion of those projects ‘in the room’ in the 10 minutes offered. Considering the wealth of hands-on digital health and care experience in the audience it was a missed opportunity for the NIB to hear common issues and listen to suggestions for co-designed solutions.

While white middle class men (for the most part) tell people of their grand plans from the top down, the revolutionaries of all kinds are quietly getting on with action on the ground.

If a digital revolution is core to the NHS future, then we need to ask to understand the intended change and outcome much more simply and precisely.

We should all understand why the NHS England leadership wants to drive change, and be given proper opportunity to question it, if we are to collaborate in its achievement.

It’s about the people, stoopid

Passive participation will not be enough from the general public if the revolution is to be as dramatic as it is painted.

Consensual co-design of plans and co-writing policy are proven ways to increase commitment to change.

Evidence suggests citizen involvement in planning is more likely to deliver success. Change done with, not to.

When constructive solutions have been offered what impact has engagement if no change is made to any  plans?

If that’s engagement, you’re doing it wrong.

Struggling with getting themselves together on the current design for now, it may be hard to invite public feedback on the future.

But it’s only made hard if what the public wants is ignored.  If those issues were resolved in the way the public asked for at listening events it could be quite simple to solve.

The NIB leadership clearly felt nervous to have debate, giving only 10 minutes of three hours for public involvement, yet that is what it needs. Questions and criticism are not something to be scared of, but opportunities to make things better.

The NHS top-down digital plans need public debate and dissected by the clinical professions to see if it fits the current and future model of healthcare, because if not involved in the change, the ride will be awfully bumpy to get there.

For data about us, to be used without us, is certainly an outdated model incompatible with a digital future.

The public needs to fight for citizen rights in a new social charter that demands change along lines we want, change that doesn’t just talk of co-design but that actually means it.

If unhappy about today’s data use, then the general public has to stop being content to be passive cash cows as we are data mined.

If we want data used only for public benefit research and not market segmentation, then we need to speak up. To the Information Commissioner’s Office if the organisation itself will not help.

“As Nicole Wong, who was one of President Obama’s top technology advisors, recently wrote, “[t]here is no future in which less data is collected and used.”

“The challenge lies in taking full advantage of the benefits that the Internet of Things promises while appropriately protecting consumers’ privacy, and ensuring that consumers are treated fairly.” Julie Brill, FTC, May 4 2015, Berlin

In the rush to embrace the ‘Internet of Things’ it can feel as though the reason for creating them has been forgotten. If the Internet serves things, it serves consumerism. AI must tread an enlightened path here. If the things are designed to serve people, then we would hope they offer methods of enhancing our life experience.

In the dream of turning a “tsunami of data” into a “tsunami of actionable business intelligence,” it seems all too often the person providing the data is forgotten.

While the Patient and Information Directorate, NHS England or NIB speakers may say these projects are complex and hard to communicate the benefits, I’d say if you can’t communicate the benefits, its not the fault of the audience.

People shouldn’t have to either a) spend immeasurable hours of their personal time, understanding how these projects work that want their personal data, or b) put up with being ignorant.

We should be able to fully question why it is needed and get a transparent and complete explanation. We should have fully accountable business plans and scrutiny of tangible and intangible benefits in public, before projects launch based on public buy-in which may misplaced. We should expect  plans to be accessible to everyone and make documents straightforward enough to be so.

Even after listening to a number of these meetings and board meetings, I am  not sure many would be able to put succinctly: what is the NHS digital forward view really? How is it to be funded?

On the one hand new plans are to bring salvation, while the other stops funding what works already today.

Although the volume of activity planned is vast, what it boils down to, is what is visionary and achievable, and not just a vision.

Digital revolution by design: building for change and people

We have opportunity to build well now, avoiding barriers-by-design, pro-actively designing ethics and change into projects, and to ensure it is collaborative.

Change projects must map out their planned effects on people before implementing technology. For the NHS that’s staff and public.

The digital revolution must ensure the fair and ethical use of the big data that will flow for direct care and secondary uses if it is to succeed.

It must also look beyond its own bubble of development as they shape their plans in the ever changing infrastructures in which data, digital, AI and ethics will become important to discuss together.

That includes in medicine.

Design for the ethics of the future, and enable change mechanisms in today’s projects that will cope with shifting public acceptance, because that shift has already begun.

Projects whose ethics and infrastructures of governance were designed years ago, have been overtaken in the digital revolution.

Projects with an old style understanding of engagement are not fit-for-the-future. As Simon Denegri wrote, we could have 5 years to get a new social charter and engagement revolutionised.

Tim Berners-Lee when he called for a Magna Carta on the Internet asked for help to achieve the web he wants:

“do me a favour. Fight for it for me.”

The charter as part of the French Revolution set out a clear, understandable, ethical and fair framework of law in which they trusted their rights would be respected by fellow citizens.

We need one for data in this digital age. The NHS could be a good place to start.

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It’s exciting hearing about the great things happening at grassroots. And incredibly frustrating to then see barriers to them being built top down. More on that shortly, on the barriers of cost, culture and geography.

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* at the NIB meeting held on the final afternoon of the Digital Conference on Health & Social Care at the King’s Fund, June 16-17.

NEXT>>
2. Driving Digital Health: revolution by design
3. Digital revolution by design: building infrastructure

Refs:
Apps for sale on the NHS website
Whose smart city? Resident involvement
Data Protection and the Internet of Things, Julie Brill FTC
A Magna Carta for the web

Reputational risk. Is NHS England playing a game of public confidence?

“By when will NHS England commit to respect the 700,000 objections  [1] to secondary data sharing already logged* but not enacted?” [gathered from objections to secondary uses in the care.data rollout, Feb 2014*]

Until then, can organisations continue to use health data held by HSCIC for secondary purposes, ethically and legally, or are they placing themselves at reputational risk?

If HSCIC continues to share, what harm may it do to public confidence in data sharing in the NHS?

I should have asked this explicitly of the National Information Board (NIB) June 17th board meeting [2], that rode in for the last 3 hours of the two day Digital Health and Care Congress at the King’s Fund.

But I chose to mention it only in passing, since I assumed it is already being worked on and a public communication will follow very soon. I had lots of other constructive things I wanted to hear in the time planned for ‘public discussion’.

Since then it’s been niggling at me that I should have asked more directly, as it dawned on me watching the meeting recording and more importantly when reading the NIB papers [3], it’s not otherwise mentioned. And there was no group discussion anyway.

Mark Davies. Director at UK Department of Health talked in fairly jargon-free language about transparency. [01:00] I could have asked him when we will see more of it in practice?

Importantly, he said on building and sustaining public trust, “if we do not secure public trust in the way that we collect store and use their personal confidential data, then pretty much everything we do today will not be a success.”

So why does the talk of securing trust seem at odds with the reality?

Evidence of Public Voice on Opt Out

Is the lack of action based on uncertainty over what to do?

Mark Davies also said “we have only a sense” and we don’t have “a really solid evidence base” of what the public want. He said, “people feel slightly uncomfortable about data being used for commercial gain.” Which he felt was “awkward” as commercial companies included pharma working for public good.

If he has not done so already, though I am sure he will have, he could read the NHS England own care.data listening feedback. People were strongly against commercial exploitation of data. Many were livid about its use. [see other care.data events] Not ‘slightly uncomfortable.’  And they were able to make a clear distinction between uses by commercial companies they felt in the public interest, such as bona fide pharma research and the differences with consumer market research, even if by the same company.  Risk stratification and commissioning does not need, and should not have according to the Caldicott Review [8], fully identifiable individual level data sharing.

Uses are actually not so hard to differentiate. In fact, it’s exactly what people want. To have the choice to have their data used only for direct care  or to choose to permit sharing between different users, permitting say, bona fide research.  Or at minimum, possible to exclude commercially exploitative uses and reuse. To enable this would enable more data sharing with confidence.

I’d also suggest there is a significant evidence base gathered in the data trust deficit work from the Royal Statistical Society, a poll on privacy for the Joseph Rowntree Foundation, and work done for the ADRN/ESRC. I’m sure he and the NIB are aware of these projects, and Mark Davies said himself more is currently being done with the Nuffield Trust.

Work with almost 3,000 young for the Royal Academy of Engineering people confirmed what those interested in privacy know, but is the opposite of what is often said about young people and privacy – they care and want control:

youngpeople_privacy

NHS England has itself further said it has held ‘over 180’ listening events in 2014 and feedback was consistent with public letters to papers, radio phone-ins and news reports in spring 2014.

Don’t give raw data out, exclude access to commercial companies not working in the public interest, exclude non-bona fide research use and re-use licenses, define the future purposes, improve legal protection including the opt out and provide transparency to trust.

How much more evidence does anyone need to have of public understanding and feeling, or is it simply that NHS England and the DH don’t like the answers given? Listening does not equal heard.

Here’s some of NHS England’s own slides – [4] points included a common demand from the public to give the opt out legal status:

legal

 

Opt out needs legal status

Paul Bate talked about missing pieces of understanding on secondary uses, for [56:00] [3] “Commissioners, researchers, all the different regulators.” He gave an update, which assumed secondary use of data as the norm.

But he missed out any mention of the perceived cost of loss of confidentiality, and loss of confidence since the failure to respect the 9nu4 objections made in the 2014 aborted care.data rollout. That’s not even mentioning that so many did not even recall getting a leaflet, so those 700,00K came from the most informed.

When the public sees their opt out is not respected they lose trust in the whole system of data sharing. Whether for direct care, for use by an NHS organisation, or by any one of the many organisations vying to manage their digital health interaction and interventions. If someone has been told data will not be shared with third parties and it is, why would they trust any other governance will be honoured?

By looking back on the leadership pre- care.data flawed thinking ‘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’ and its resulting disastrous attempt to rollout without communication and then a second at fair processing, lessons learned should inform future projects. That includes care.data mark 2. This < is simply daft.

You can object and your data will not be extracted and you can make no contribution to society, Mr. Kelsey answered a critic on twitter in 2014 and revealed that his thinking really hasn’t changed very much, even if he has been forced to make concessions. I should have said at #kfdigital15, ignoring what the public wants is not your call to make.

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

“people should be able to opt out from having their anonymised data used for the purposes of scientific research.” [Hunt, 2014]

We are yet to see this legal change and to date, the only publicly stated choice is only for identifiable data, not all data for secondary purposes including anonymous, as offered by the Minister in February 2014, and David Cameron in 2010.

If Mark Davies is being honest about how important he feels trust is to data sharing, implementing the objection should be a) prioritised and b) given legal footing.optout_ppt

 

Risks and benefits : need for a new social contract on Data

Simon Denegri recently wrote [5] he believes there are “probably five years to sort out a new social contract on data in the UK.”

I’d suggest less, if high profile data based projects or breaches irreparably damage public trust first, whether in the NHS or consumer world. The public will choose to share increasingly less.

But the public cannot afford to lose the social benefits that those projects may bring to the people who need them.

Big projects, such as care.data, cannot afford for everyone’s sake to continue to repeatedly set off and crash.

Smaller projects, those planned and in progress by each organisation and attendee at the King’s Fund event, cannot afford for those national mistakes to damage the trust the public may otherwise hold in the projects at local level.

I heard care.data mentioned five different times over the two-day event  in different projects as having harmed the project through trust or delays. We even heard examples of companies in Scotland going bust due to rollouts with slowed data access and austerity.

Individuals cannot afford for their reputation to be harmed through association, or by using data in ways the public finds unreasonable and get splashed across the front page of the Telegraph.

Clarity is needed for everyone using data well whether for direct care with implied consent, or secondary uses without it, and it is in the public interest to safeguard access to that data.

A new social contract on data would be good all round.

Reputational Risk

The June 6th story of the 700,000 unrespected opt outs has been and gone. But the issue has not.

Can organisations continue to use that data ethically and legally knowing it is explicitly without consent?

“When will those objections be implemented?” should be a question that organisations across the country are asking – if reputational risk is a factor in any datasharing decision making – in addition to the fundamental ethical principle: can we continue to use the data from an individual from whom we know consent was not freely given and was actively withheld?

What of projects that use HES or hospital secondary care sites’ submitted data and rely on the HSCIC POM mechanisms? How do those audits or other projects take HES secondary objections into account?

Sir Nick Partridge said in the April 2014 HSCIC HES/SUS audit there should be ‘no surprises’ in future.

That future is now. What has NHS England done since to improve?

“Consumer confidence appears to be fragile and there are concerns that future changes in how data may be collected and used (such as more passive collection via the Internet of Things) could test how far consumers are willing to continue to provide data.” [CMA Consumer report] [6]

The problem exists across both state and consumer data sharing. It is not a matter of if, but when, these surprises are revealed to the public with unpredictable degrees of surprise and revulsion, resulting in more objection to sharing for any purposes at all.

The solutions exist: meaningful transparency, excluding commercial purposes which appear exploitative, consensual choices, and no surprises. Shape communications processes by building-in future change to today’s programmes to future proof trust.

Future-proofing does not mean making a purpose and use of data so vague as to be all encompassing – exactly what the public has said at care.data listening events they do not want and will not find sufficient to trust nor I would argue, would it meet legally adequate fair processing – it must build and budget for mechanisms into every plan today, to inform patients of the future changes to use or users of data already gathered, and offer them a new choice to object or consent. And they should have a way to know who used what.

The GP who asked the first of the only three questions that were possible in 10 minutes Q&A from the room, had taken away the same as I had: the year 2020 is far too late as a public engagement goal. There must be much stronger emphasis on it now. And it is actually very simple. Do what the public has already asked for.

The overriding lesson must be, the person behind the data must come first. If they object to data being used, that must be respected.

It starts with fixing the opt outs. That must happen. And now.

Public confidence is not a game [7]. Reputational risk is not something organisations should be forced to gamble with to continue their use of data and potential benefits of data sharing.

If NHS England, the NIB or Department of Health know how and when it will be fixed they should say so. If they don’t, they better have a darn good reason why and tell us that too.

‘No surprises’, said Nick Partridge.

The question decision makers must address for data management is, do they continue to be part of the problem or offer part of the solution?

******

References:

[1]The Telegraph, June 6th 2015 http://www.telegraph.co.uk/news/health/news/11655777/Nearly-1million-patients-could-be-having-confidential-data-shared-against-their-wishes.html

[2]  June 17th NIB meeting http://www.dh-national-information-board.public-i.tv/core/portal/webcast_interactive/180408

[3] NIB papers / workstream documentation https://www.gov.uk/government/publications/plans-to-improve-digital-services-for-the-health-and-care-sector

[4] care.data listening feedback http://www.england.nhs.uk/wp-content/uploads/2015/01/care-data-presentation.pdf

[5] Simon Denegri’s blog http://simondenegri.com/2015/06/18/is-public-involvement-in-uk-health-research-a-danger-to-itself/

[6] CMA findings on commercial use of consumer data https://www.gov.uk/government/news/cma-publishes-findings-on-the-commercial-use-of-consumer-data

[7] Data trust deficit New research finds data trust deficit with lessons for policymakers: http://www.statslife.org.uk/news/1672-new-rss-research-finds-data-trust-deficit-with-lessons-for-policymakers

[8] Caldicott review: information governance in the health and care system

Off the record – a case study in NHS patient data access

Patient online medical records’ access in England was promised by April 2015.

HSCIC_statsJust last month headlines abounded “GPs ensure 97% of patients can access summary record online“. Speeches carried the same statistics.  So what did that actually mean? The HSCIC figures released in May 2015 showed that while around 57 million patients can potentially access something of their care record only 2.5 million or 4.5% of patients had actively signed up for the service.

In that gap lies a gulf of a difference. You cannot access the patient record unless you have signed up for it, so to give the impression that 97% of patients can access a summary record online is untrue.  Only 4.5% can, and have done so. While yes, this states patients must request access, the impression is somewhat misrepresentative.

Here’s my look at what that involved and once signed up, what ‘access your medical records’ actually may mean in practice.

The process to getting access

First I wrote a note to the practice manager about a month ago, and received a phone call a few days later to pop in any time. A week later, I called to check before I would ‘pop in’ and found that the practice manager was not in every day, and it would actually have to be when she was.

I offered to call back and arrange a suitable date and time. Next call, we usefully agreed the potential date I could go in, but I’d have to wait to be sure that the paper records had first been retrieved from the external store (since another practice closed down ours had become more busy than ever and run out of space.) I was asked whether I had already received permission from the practice manager and to confirm that I knew there would be a £10 charge.

So, one letter, four phone calls and ten pounds in hard cash later, I signed a disclosure form this morning to say I was me and I had asked to see my records, and sat in a corner of the lovely practice manager’s office with a small thinly stuffed Lloyd George envelope, and a few photocopied or printed-out A4 pages  (so I didn’t get to actually look at my own on-screen record the GP uses) and a receipt.

What did my paper records look like?

My oldest notes on paper went back as far as 1998 and were for the most part handwritten. Having lived abroad since there was then a ten year gap until my new registration and notes moved onto paper prints of electronic notes.

These included referral for secondary care, correspondence between consultants and my GP and/or to and from me.

The practice manager was very supportive and tolerant of me taking up a corner of her office for half an hour. Clutching a page with my new log-in for the EMIS web for patient records access, I put the papers back, said my thank yous and set off home.

Next step: online

I logged on at home to the patient access system. Having first had it in 2009 when I registered, I hadn’t used the system since as it had very limited functionality, and I had had good health. Now I took the opportunity to try it again.

By asking the GP practice reception, I had been assigned a PIN, given the Practice ID, an Access ID and confirmation of my NHS number all needed entry in Step 1:

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Step 2: After these on screen 2, I was asked for my name, DOB, and to create a password.

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Step 3: the system generated a long number user ID which I noted down.

Step 4: I looked for the data sharing and privacy policy. Didn’t spot with whom data entered would be shared or for what purposes and any retention or restrictions of purposes. I’d like to see that added.

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Success:

Logged on using my new long user ID and password, I could see an overview page with personal contact details, which were all accurate.  Sections for current meds, allergies, appointments, medical record, personal health record and repeats prescriptions. There was space for overview of height, BMI and basic lifestyle (alcohol and smoking) there too.

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A note from 2010 read: “refused consent to upload national. sharing. electronic record.” Appropriately some may perhaps think, this was recorded in the “problems” section, which was otherwise empty.

Drilling down to view the medication record,  the only data held was the single most recent top line prescription without any history.

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And the only other section to view was allergies, similarly and correctly empty:

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The only error I noted was a line to say I was due an MMR immunization in June 2015. [I will follow up to check whether one of my children should be due for it, rather than me.]

What else was possible?

Order repeat prescription: If your practice offers this service there is a link called Make a request in the Repeat Prescriptions section of the home page after you have signed in. This was possible. Our practice already does it direct with the pharmacy.

Book an appointment: with your own GP from dates in a drop down.

Apple Health app integration: The most interesting part of the online access was this part that suggested it could upload a patient’s Apple health app data, and with active patient consent, that would be shared with the GP.

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It claims: “You can consent to the following health data types being shared to Patient Access and added to your Personal Health Record (PHR):”

  • Height
  • Weight
  • BMI
  • Blood Glucose
  • Blood Pressure (Diastolic & Systolic)
  • Distance (walked per day)
  • Forced expired volume
  • Forced Vital capacity
  • Heart Rate
  • Oxygen Saturation
  • Peak Expiratory Flow
  • Respiratory rate
  • Steps (taken per day)

“This new feature is only available to users of IOS8 who are using the Apple Health app and the Patient Access app.”

 

With the important caveat for some: IOS 8.1 has removed the ability to manually enter Blood Glucose data via the Health app. Health will continue to support Blood Glucose measurements added via 3rd party apps such as MySugr and iHealth.

Patient Access will still be able to collect any data entered and we recommend entering Blood Glucose data via one of those free apps until Apple reinstate the capability within Health.

What was not possible:

To update contact details: The practice configures which details you are allowed to change. It may be their policy to restrict access to change some details only in person at the practice.

Viewing my primary care record: other than a current medication there was nothing of my current records in the online record. Things like test results were not in my online record at all, only on paper. Pulse noted sensible concerns about this area in 2013.

Make a correction: clearly the MMR jab note is wrong, but I’ll need to ask for help to remove it.

“Currently the Patient Access app only supports the addition of new information; however, we envisage quickly extending this functionality to delete information via the Patient Access service.” How this will ensure accuracy and avoid self editing I am unsure.

Questions: Who can access this data?

While the system stated that “the information is stored securely in our accredited data centre that deals solely with clinical data. ” there is no indication of where, who manages it and who may access it and why.

In 2014 it was announced that pharmacies would begin to have access to the summary care record.

“A total of 100 pharmacies across Somerset, Northampton, North Derbyshire, Sheffield and West Yorkshire will be able to view a patient’s summary care record (SCR), which contains information such as a patient’s current medications and allergies.”

Yet clearly in the Summary Care Record consent process in 2010 from my record, pharmacists were not mentioned.

Does the patient online access also use the Summary Care Record or not? If so, did I by asking for online access, just create a SCR without asking for one? Or is it a different subset of data? If they are different, which is the definitive record?

Overall:

From stories we read it could appear that there are broad discrepancies between what is possible in one area of the country from another, and between one practice and another.

Clearly to give the impression that 97% of patients can access summary records online is untrue to date if only 4.5% actually can get onto an electronic system, and see any part of their records, on demand today.

How much value is added to patients and practitioners in that 4.5% may vary enormously depending upon what functionality they have chosen to enable at different locations.

For me as a rare user of the practice, there is no obvious benefit right now. I can book appointments during the day by telephone and meds are ordered through the chemist. It contained no other information.

I don’t know what evidence base came from patients to decide that Patient Online should be a priority.

How many really want and need real time, online access to their records? Would patients not far rather the priority in these times of austerity, the cash and time and IT expertise be focused on IT in direct care and visible by their medics? So that when they visit hospital their records would be available to different departments within the hospital?

I know which I would rather have.

What would be good to see?

I’d like to get much clearer distinction between the data purposes we have of what data we share for direct and indirect purposes, and on what legal basis.

Not least because it needs to be understandable within the context of data protection legislation. There is often confusion in discussions of what consent can be implied for direct care and where to draw its limit.

The consultation launched in June 2014 is still to be published since it ended in August 2014, and it too blurred the lines between direct care and secondary purposes.  (https://www.gov.uk/government/consultations/protecting-personal-health-and-care-data).

Secondly, if patients start to generate potentially huge quantities of data in the Apple link and upload it to GP electronic records, we need to get this approach correct from the start. Will that data be onwardly shared by GPs through care.data for example?

But first, let’s start with tighter use of language on communications. Not only for the sake of increased accuracy, but so that as a result expectations are properly set for policy makers, practitioners and patients making future decisions.

There are many impressive visions and great ideas how data are to be used for the benefit of individuals and the public good.

We need an established,  easy to understand, legal and ethical framework about our datasharing in the NHS to build on to turn benefits into an achievable reality.

Are care.data pilots heading for a breech delivery?

Call the midwife [if you can find one free, the underpaid overworked miracle workers that they are], the care.data ‘pathfinder’ pilots are on their way! [This is under a five minute read, so there should be time to get the hot water on – and make a cup of tea.]

I’d like to be able to say I’m looking forward to a happy new arrival, but I worry care.data is set for a breech birth. Is there still time to have it turned around? I’d like to say yes, but it might need help.

The pause appears to be over as the NHS England board delegated the final approval of directions to their Chair, Sir Malcolm Grant and Chief Executive, Simon Stevens, on Thursday May 28.

Directions from NHS England which will enable the HSCIC to proceed with their pathfinder pilots’ next stage of delivery.

“this is a programme in which we have invested a great deal, of time and thought in its development.” [Sir Malcolm Grant, May 28, 2015, NHS England Board meeting]

And yet. After years of work and planning, and a 16 month pause, as long as it takes for the gestation of a walrus, it appears the directions had flaws. Technical fixes are also needed before the plan could proceed to extract GP care.data and merge it with our hospital data at HSCIC.

And there’s lots of unknowns what this will deliver.**

Groundhog Day?

The public and MPs were surprised in 2014. They may be even more surprised if 2015 sees a repeat of the same again.

We have yet to hear case studies of who received data in the past and would now be no longer eligible. Commercial data intermediaries? Can still get data, the NHS Open Day was told. And they do, as the HSCIC DARS meeting minutes in 2015 confirm.

By the time the pilots launch, the objection must actually work, communications must include an opt out form and must clearly give the programme a name.

I hope that those lessons have been learned, but I fear they have not been. There is still lack of transparency. NHS England’s communications materials and May-Oct 2014 and any 2015 programme board minutes have not been published.

We have been here before.

Back to September 2013: the GPES Advisory Committee, the ICO and Dame Fiona Caldicott, as well as campaigners and individuals could see the issues in the patient leaflet and asked for fixes.The programme went ahead anyway in February 2014 and although foreseen, failed to deliver. [For some, quite literally.]

These voices aren’t critical for fun, they call for fixes to get it right.

I would suggest that all of the issues raised since April 2014, were broadly known in February 2014 before the pause began. From the public listening exercise,  the high level summary captures some issues raised by patients, but doesn’t address their range or depth.

Some of the difficult and unwanted  issues, are still there, still the same and still being ignored, at least in the public domain. [4]

A Healthy New Arrival?

How is the approach better now and what happens next to proceed?

“It seems a shame,” the Walrus said, “To play them such a trick, After we’ve brought them out so far, And made them trot so quick!” [Lewis Carroll]

When asked by a board member: What is it we seek to learn from the pathfinder approach that will guide us in the decision later if this will become a national approach? it wasn’t very clear. [full detail end of post]

First they must pass the tests asked of them by Dame Fiona [her criteria and 27 questions from before Christmas.] At least that was what the verbal background given at the board meeting explained.

If the pilots should be a dip in the water of how national rollouts will proceed, then they need to test not just for today, but at least for the known future of changing content scope and expanding users – who will pay for the communication materials’ costs each time?

If policy keeps pressing forward, will it not make these complications worse under pressure? There may be external pressure ahead as potential changes to EU data protection are expected this year as well, for which the pilot must be prepared and design in advance for the expectations of best practice.

Pushing out the pathfinder directions, before knowing the answers to these practical things and patient questions open for over 16 months, is surely backwards. A breech birth, with predictable complications.

If in Sir Malcolm Grant’s words:

“we would only do this  if we believed it was absolutely critical in the interests of patients.” [Malcom Grant, May 28, 2015, NHS England Board meeting]

then I’d like to see the critical interest of patients put first. Address the full range of patient questions from the ‘listening pause’.

In the rush to just fix the best of a bad job, we’ve not even asked are we even doing the right thing? Is the system designed to best support doctor patient needs especially with the integration “blurring the lines” that Simon Stevens seems set on.

If  focus is on the success of the programme and not the patient, consider this: there’s a real risk too many opt out due to these unknowns. And lack of real choice on how their data gets used. It could be done better to reduce that risk.

What’s the percentage of opt out that the programme deems a success to make it worthwhile?

In March 2014, at a London event, a GP told me all her patients who were opting out were the newspaper reading informed, white, middle class. She was worried that the data that would be included, would be misleading and unrepresentative of her practice in CCG decision making.

medConfidential has written a current status for pathfinder areas that make great sense to focus first on fixing care.data’s big post-election question the opt out that hasn’t been put into effect. Of course in February 2014 we had to choose between two opt outs -so how will that work for pathfinders?

In the public interest we need collectively to see this done well. Another mis-delivery will be fatal. “No artificial timelines?”

Right now, my expectations are that the result won’t be as cute as a baby walrus.

******

Notes from the NHS England Board Meeting, May 28, 2015:

TK said:  “These directions [1] relate only to the pathfinder programme and specify for the HSCIC what data we want to be extracted in the event that Dame Fiona, this board and the Secretary of State have given their approval for the extraction to proceed.

“We will be testing in this process a public opt out, a citizen’s right to opt out, which means that, and to be absolutely clear if someone does exercise their right to opt out, no clinical data will be extracted from their general practice,  just to make that point absolutely clearly.

“We have limited access to the data, should it be extracted at the end of the pathfinder phase, in the pathfinder context to just four organisations: NHS England, Public Health England, the HSCIC and CQC.”

“Those four organisations will only be able to access it for analytic purposes in a safe, a secure environment developed by the Information Centre [HSCIC], so there will be no third party hosting of the data that flows from the extraction.

“In the event that Dame Fiona, this board, the Secretary of State, the board of the Information Centre, are persuaded that there is merit in the data analysis that proceeds from the extraction, and that we’ve achieved an appropriate standard of what’s called fair processing, essentially have explained to people their rights, it may well be that we proceed to a programme of national rollout, in that case this board will have to agree a separate set of directions.”

“This is not signing off anything other than a process to test communications, and for a conditional approval on extracting data subject to the conditions I’ve just described.”

CD said: “This is new territory, precedent, this is something we have to get right, not only for the pathfinders but generically as well.”

“One of the consequences of having a pathfinder approach, is as Tim was describing, is that directions will change in the future. So if we are going to have a truly fair process , one of the things we have to get right, is that for the pathfinders, people understand that the set of data that is extracted and who can use it in the pathfinders, will both be a subset of, the data that is extracted and who can use it in the future. If we are going to be true to this fair process, we have to make sure in the pathfinders that we do that.

“For example, at the advisory group last week, is that in the communication going forward we have to make sure that we flag the fact there will be further directions, and they will be changed, that we are overt in saying, subject to what Fiona Caldicott decides, that process itself will be transparent.”

Questions from Board members:
Q: What is it we seek to learn from the pathfinder approach that will guide us in the decision later if this will become a national approach?
What are the top three objectives we seek to achieve?

TK: So, Dame Fiona has set a series of standards she expects the pathfinders to demonstrate, in supporting GPs to be able to discharge this rather complex communication responsibility, that they have under the law  in any case.

“On another level how we can demonstrate that people have adequately understood their right to opt out [..]

“and how do we make sure that populations who are relatively hard to reach, although listed with GPs, are also made aware of their opportunity to opt out.

Perhaps it may help if I forward this to the board, It is in the public domain. But I will forward the letter to the board.”

“So that lays out quite a number of specific tangible objectives that we then have to evaluate in light of the pathfinder experience. “

Chair: “this is a programme in which we have invested a great deal, of time and thought in its development, we would only do this  if we believed it was absolutely critical in the interests of patients, it was something that would give us the information the intelligence that we need to more finely attune our commissioning practice, but also to get real time intelligence about how patients lives are lived, how treatments work and how we can better provide for their care.

“I don’t think this is any longer a matter of huge controversy, but how do we sensitively attune ourselves to patient confidentiality.”

“I propose that […] you will approve in principle the directions before you and also delegate to the Chief Executive and to myself to do final approval on behalf of the board, once we have taken into account the comments from medConfidential and any other issues, but the substance will remain unchanged.”

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[4] request for the release of June 2014 Open House feedback still to be published in the hope that the range and depth of public questions can be addressed.

care.data comms letter

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“The time has come,” the walrus said, “to talk of many things.”
[From ‘The Walrus* and the Carpenter’ in Through the Looking-Glass by Lewis Carroll]

*A walrus has a gestation period of about 16 months.
The same amount of time which the pause in the care.data programme has taken to give birth to the pathfinder sites.

references:
[1] NHS England Directions to HSCIC: May 28 2015 – http://www.england.nhs.uk/wp-content/uploads/2015/05/item6-board-280515.pdf
[2] Notes from care.data advisory group meeting on 27th February 2015
[3] Patient questions: http://jenpersson.com/pathfinder/
[4] Letter from NHS England in response to request from September, and November 2014 to request that public questions be released and addressed