Category Archives: Innovation

Open Digital Platform Challenge Fund

Many  will be aware of the proposal that Tony Shannon and I have been promoting to persuade the NHS to allocate 1% of the money they plan to spend on digital health to an “Open Digital  Platform Challenge Fund” to stimulate the development of an open digital ecosystem based on open standards.

We have had a positive response so far and will shortly be presenting out plans to the NHS CIO and CCIO. We want to be able tell them that there are enough people and projects committed to an Open Digital Ecosystems to make good use of the money we are asking for and give then a good idea of the projects that might come forward if they take up our suggestion.

To this end we have been asking people for expressions of interest via this link . We are looking for expressions of interests from people who support the approach and the specific standards laid out in our document. In not onerous to fill in the form which does not imply a fixed commitment just a general indication of interest.

If you have not already done so I’d urge you to let us have your ideas

Full details below

 

Globe (1)

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1) Executive Summary

An NHS open digital platform challenge fund will stimulate the development of an open platform in the NHS. Open digital platforms are independently forecast by McKinsey and Co to reduce the delivery of care costs across the NHS by 11%. They will support widescale entry and growth of suppliers into the market, injecting innovation at all levels of service delivery to support improved care outcomes for our patients.

In the context of an NHS struggling through a perpetual winter, open digital platforms present a realisable opportunity to massively stimulate new ways of working, process innovation and a new digital health and care market, based around services. This is independently forecast by McKinsey and Co who predict a positive financial impact in excess of 11% across the whole of health and social care.

By creating an open digital platform and a move towards a services market, the NHS opens up the market to innovative commercial and social enterprises who presently have great difficulty breaching the significant barriers to entry. At the same time it creates an environment where health and care professionals can readily create, contribute and share new digital tools to support transformational new models of care, radically improving the care outcomes of our patients and building a sustainable care ecosystem that is fit for the future.

There is little disagreement that platforms represent the future for digital health. Rather the present debate is about who should own them, and how and when they will emerge. The “status quo” retains the closed platform frameworks, introducing open interfaces for exchange of information. This provides a short term stimulus, supporting improvements in patient care and operational efficiencies. However in the longer term, by seeking to control the rules of engagement and restricting the mobility of data, the retention of closed platform frameworks will stifle competition, impede innovation, and continue to drive-up costs.

Open digital platforms are a radical alternative that overcome the serious shortcomings of closed platforms.
They present the most assured approach to achieve consistent, long term and affordable growth in innovation-led service transformation across the complexities of health and social care. They will enable the full competitive aspects of market supply to be exploited, with associated benefits of the injection of innovations on a massive scale. For this reason, open digital platforms are manifestly in the interest of both the NHS and its patients.

The purpose of the proposed Open Digital Platform Challenge Fund is to stimulate the development of an open platform ecosystem through kick-starting the creation of open platforms, building on work already well underway, and the development of exemplar applications to exploit them.

We propose that the fund is created through diverting 1% of the investment each year in NHS digitisation into the challenge fund. This fund would be made available via an annual open competition in the form of relatively small awards to innovative organisations (public, private and third sector). The selection of projects will be balanced to stimulate and develop an open ecosystem of shareable and reusable applications to service across health and social care. We are inviting submissions of expressions of interest into this Open Platform Fund. In so doing, we will gauge the wider interest in this Open Platform fund proposal to then quickly bring these related responses to the attention of both NHS Digital and NHS England by the end of February 2017 and seek the related funding.

2) Current Situation

To introduce this bid for funding we need to review the current situation with important context on the bigger picture issues that are at play. We need to acknowledge and understand the current mediocre state of health IT, as an immature and problematic market with mixed/relatively poor value for money and results seen from billions of £ and $ of investment from the UK to the US and elsewhere.

We also need to recognise the related digitisation of the NHS has been over promised and under delivered for some considerable time. Compounding this people/process/technology problem is the ongoing and perpetual winter faced by the frontline in the NHS that is in the news.

We restate the need to continue the critical push towards more personalised, integrated care at home and in the community to meet the 2020 vision. This clearly requires an underpinning patient centred infrastructure to do so. Last February Jeremy Hunt announced £4.2 billion for NHS Health IT. In the last 18-24 months while there have been plans in the form of Integration Pioneers, Vanguards, Local Digital Roadmaps (LDRs), Sustainability Transformation Plans (STPs), there has been little/no allocated funding to date to make these happen.

In Autumn 2016 we were able to read and digest the latest review of the NHS IT, authored by US physician Dr Bob Wachter. Dr Wachter built his reputation as establishing the hospitalist as a medical specialty in the US. In recent years he has become a fearless and honest critic of the state of Healthcare IT in the US, with his book “Digital Doctor : Hope, Hype & Harm at the Dawn of Medicines Computer Age” (2015) exposing the real mediocre state of the health IT market in the US. The book and related opinion pieces on the state of health IT industry he explains some of the real problems with the current supplier market is clear. In a New York Times Op Ed piece on “Why Health Care Tech Is Still So Bad” (2015) he highlights that

“In today’s digital era, a modern hospital deemed the absence of an electronic medical record system to be a premier selling point…That hospital is not alone. A 2013 RAND survey of physicians found mixed reactions to electronic health record systems, including widespread dissatisfaction. Many respondents cited poor usability, time-consuming data entry, needless alerts and poor work flows”.

However in the NHS, Dr Wachter’s recent review led to funding being provided to “digital exemplars” all of which are a small group of hospital trusts in the NHS who will invest in those very same health IT monoliths. While understandable as a means to “do something”, rather than nothing, given the state of affairs is understood, it is sadly limited in its thinking and perpetuates the usual tactics that we have seen in the NHS IT for years, i.e. investing in the same 20th Century monoliths of old. We know that doing the same thing over and over and expecting different results is futile.

Simply put, if a small elite are getting the focus of funding for investments in 20th Century health IT monoliths over the next years then inequity within the system will increase, while original ideas in the sector to bring care into the modern era will decrease.

We have been left asking where has the requirement for integrated person centred care gone, that is ingrained in the other plans that NHS and local authorities have been working towards with STPs and LDRs etc.

What is sorely missing is the open patient centric platform that Dr Wachter looks forward to and that healthcare awaits. As this is a glaring omission, our paper recommends a focussed investment towards that end as part of a bimodal strategy for NHS IT at this challenging time.

3) What can be done

The changes required are radical, if we are to simply survive, yet alone thrive in the years ahead. We know we need a mix of people + process + technology changes. We know too that the leaders of the NHS understand and value the role of innovation and the crucial role of information technology in achieving same.

3.1) The role of an open platform

For some time now leading thinkers on both sides of the Atlantic, in the NHS and indeed the US has been calling for a move towards a more open platform approach. From within the US market, the establishment of Healthcare Services Platform Consortium aims to address the mediocrity of the “big 6” monoliths and the concurrent problem of the thousands of small unrelated vendors.

“EHRs are becoming commodity platforms. The winner will be the EHR vendor that provides the best platform for innovation – the most open and most extensible platform.”

In this we wholeheartedly agree and concur with our US colleagues.

We believe there is now a compelling case for a small but useful investment in Health IT from the bottom up, to the princely sum of 1% of the planned £4 Billion NHS IT expenditure, aimed deliberately at the integrated, patient centred care vision of Personalised Care 2020, based on the principle that all projects should aim to leverage elements of a common open platform.

4) 1% Case for an open platform

We are making a case for an investment of just 1% of available NHS IT funds to offer a way forward to improve the care of 99% of the population. To do so we have highlighted Dr Watchers analysis and writings to focus on the key problems and issues we seek to address;

Usability

“This principle of user-centered design is part of aviation’s DNA, yet has been woefully lacking in health care software design.

Interoperability

“[There are] Political obstacles to overcome, put in place mostly by vendors and healthcare systems that remain reluctant to share.”

Vision for patient centred care

“In essence, there will no longer be an EHR in the traditional sense, an institution-centric record whose patient portal is a small tip of the hat to patient-centeredness. Rather, there will be one digital patient-centered health record that combines clinician-generated notes and data with patient-generated information and preferences. Its locus of control will be, unambiguously, with the patient.”

So in order to address these real issues and support the national ambitions – usability, interoperability and patient centred care we will use the investment fund available to benefit the broader public. We wish to draw attention to that part of the population who could be better served by the NHS with an improved patient centric platform today. We are also mindful of the need to support;

  • Prevention, Self care and management
  • GP patients
  • Community Care Patients
  • Mental Health Patients
  • Social Care

We look to the leadership provided by the Gov UK Digital Service standard to highlight the principles to underpin the approach we commend.

Pursue User Centred Design & Agile Development

Leverage Open Source & Open Standards

In our work to date (on the Ripple programme and Code4Health platform based on openEHR) we have deliberately pursued these principles to useful effect and recommend them to others who wish to transform healthcare with information technology. We welcome wider scrutiny of our open platform work to date. Our work and the leading work of others (such as the Endeavour Foundation and the INTEROPen CareConnect API Collaborative) in this field, leads us to believe there is now a real, significant appetite for wider and deeper moves towards an open digital platform in the NHS.

By creating an open digital platform ecosystem, the NHS opens up the market to innovative commercial and social enterprises who presently have great difficulty breaching the significant barriers to entry. At the same time it creates an environment where health and care professionals can readily create, contribute and share new digital tools to support innovative new models of care.

We firmly believe that a small but focussed 1% investment can deliver against some of the key challenges in Personalised Health and Care 2020 on an open service oriented platform- to stimulate the public & private sector. An open healthcare platform fit for the 21st Century.

 

5) What is an Open Platform?

Platform based architectures power the internet, with the platform providing the plumbing (the infrastructure, data and services) that applications need, freeing the application developer to focus their efforts on their application without the need to build the infrastructure it needs to operate. Platform approaches speed development, make applications more robust and interoperable and open up a new services market in healthcare IT, where suppliers compete on services and the value they add rather than on the proprietary nature of their software.

An Open Platform is based on freely available open standards, so that anyone can play. As no one party can control the platform – they must collaborate – just like the Internet.

An Open Platform has the following characteristics:

  • Open Standards Based – The implementation should be based on wholly open standards. Any willing party should be able to use these standards without charge to build an independent, compliant instance of the complete platform;
  • Share Common Information Models – There should be a set of common information models in use by all instances of the open platform, independent of any given technical implementation;
  • Support Application Portability – Applications written to run on one platform implementation should be able to run with either trivial or no change on another, independently developed;
  • Federatable – It should be possible to connect any implementation of the open platform to all others independently developed, in a federated structure to allow the sharing of appropriate information and workflows between them;
  • Vendor and Technology Neutral – The standards should not depend on particular technologies or require components from particular vendors. Anyone building an implementation of the open platform may elect to use any available technology and may choose to include or exclude proprietary components;
  • Support Open Data – Data should be exposed as needed (subject to good information governance practice) in an open, shareable, computable format in near to real-time. Implementors may choose to use this format natively in their persistence (storage) layer of the open platform itself or meet this requirement by using mappings and transformations from some other open or proprietary format;
  • Provision of Open APIs – The full specification of the APIs (the means by which applications connected to the platform a should be freely available.

The key to an open platform is the definition of a set of standard interfaces (APIs) to the range of services that might be provided on a platform defined by an open process that all interested parties can participate in (like Internet standards) and that are freely available for all to use.

While it may be encouraged, not all elements in an open platform need to be open sourced. We believe that “infrastructural” components that are generic, reusable and utility like (e.g see Appendix 1 below) should be open sourced, while the overlying applications do not necessarily need to be open sourced, as long as they leverage open data models and offer open APIs.

6) Why an open digital platform?

We have seen across all sectors how platforms are changing the way people lead their everyday lives, from how we communicate and interact, how we travel and where we stay, how we manage our finances to how we shop, to name but a few. Platforms transform. An open digital platform supports:

  • Unconstrained innovation – ideas and ambitions can be shared by people across the office, street or globe
  • Collaboration – clinicians and care professionals inherently want want to share their good work with the rest of the medical world.
  • Alignment to medical science progression, been based on the spread of ideas – health IT can do the same.
  • “Publish or perish” culture of modern medicine demands that healthcare advances are laid open for scrutiny by our peers
  • Grassroots progress – Complex adaptive systems require decentralized control so people can locally innovate. Amendments and improvement can come from the grassroots and bottom up, without the bureaucracy that innovators often face.
  • A shift in the market towards a healthy, commercially sustainable, services oriented marketplace.

7) Open Platform Fund mechanism

The main aim of this Open Platform bid is;

Support the development of services towards Personalised Care 2020 –

support the development of an NHS ecosystem around an open digital platform

To be clear, while we do not currently have any secured funding for an open platform fund, our aim is to gauge interest in this approach and make the evidence based case to NHS Digital.

The fund is intended to support innovative projects that stimulate the creation of an open digital ecosystem and as such aims to support a large number of small projects that are unlikely to be supported as part of “business as usual” investment by health and care organisations. The aims are to driving innovation and transformation that is scalable, shared, flexible and adaptable and ultimately improve health IT for clinicians and improve care outcomes for patients. Winners will show that they will concentrate their efforts on usability, interoperability, patient centred care that meet the vision. To do so we suggest;

7.1) Request for Expressions of Interest

We initially invite the submission of expressions of interest into this Open Platform Fund. In so doing, we wish to gauge the wider interest in this Open Platform fund proposal to then quickly bring these related responses to the attention of both NHS Digital and NHS England by the end of February 2017 and seek the related funding .

Please submit a brief expression of interest (1-3 page) via this Google forms link; https://goo.gl/forms/4SaNvAgkAe2AfLZ82 by Friday 10th February 2017.


We will acknowledge expressions of interest, collate and feedback the results of our findings, pass on related submissions and summary findings to the Apperta Foundation CIC which we believe is ideally placed to independently oversee this process and support the case for funding from NHS Digital and NHS England. The Apperta Foundation is a not-for-profit community interest company supported by NHS England and NHS Digital led by clinicians to promote open systems and standards for digital health and social care.

While the focus of this paper relates to the NHS in England, we know that colleagues in the health systems of Scotland, Wales, Northern Ireland and indeed the Republic of Ireland are facing the same challenges at the frontline, while aware of the same opportunity on offer from an open platform from a 1% investment, particularly if done openly and collaboratively. Therefore we invite related submissions towards an open platform fund on an All Islands basis – which we also will pass onto the Apperta Foundation and the UK and Ireland CCIO Networks.

7.2) Outline of Proposed Allocation

A) Infrastructural component projects

45% of £40m = £18m over 3 years (until 2020)
Open source tooling & infrastructure components – underpinning standards and compliant components that provides services useful in an open ecosystem (See Appendix 1 examples)

B) Personalised Care: Innovation Incubation and Exemplar Implementations

50% of £40m = £20m over 3 years (until 2020)

Open APIs & open data models based projects as showcases of an open platform in action. (e.g. may include open APIs (e.g. INTEROPen CareConnect FHIR based APIs) + open data models +/- open source data repository (e.g. openEHR based). Examples may include Person Held Records/Electronic Patient Record/Integrated Digital Care Record etc. related projects.

C) Oversight/Custodian of process by an independent CIC such as the Apperta Foundation

Along with the CCIO Network and INTEROPen Collaborative to oversee clinical merit and technical connectathons.

5% of £40m = £2m over 3 years (until 2020)

7.3) Eligibility

We suggest that this open platform fund is open to:

  • UK Registered for-profit commercial entities (Companies and LLPs) and
  • UK Registered not-for-profit entities (CICs,Trusts,Companies limited by guarantee and other recognised forms) meeting UK definition of an SME (In the UK a company is defined as being an SME if it meets two out of three criteria: it has a turnover of less than £25m, it has fewer than 250 employees, it has gross assets of less than £12.5m)
  • UK Public Sector bodies (NHS Bodies, Government agencies and local authorities etc.) irrespective of size.

7.4) Match funding obligations

We suggest that applicants will be required to match fund any award from the fund as follows

  • Social or commercial micro-enterprises 1
    No match funding obligation
  • Social or commercial SMEs 2
    Match funding equal to 50% of the award
  • Public sector bodiesMatch funding equal to 100% of the award

 

1 A business with less than 10 employees and (a turnover < £2 million euro or a balance sheet total of less than £2 million euro)
2 A business with less than 250 employees and (a turnover < £50 million euro or a balance sheet total of less than £43 million euro)
These are the current official definitions applying in the UK

8) Criteria

We suggest that an Open Platform fund is open to projects that stimulate and support both the creation and adoption of an open digital ecosystem which meet the definition in section 5 of What is an Open Platform.

While the main aim of all projects will be to improve NHS services towards personalised health and care 2020, the criteria by which the funding from this fund will be allocated will depend on the concurrent creation of value add in the form of;

  • Collaborative – all projects must establish open channels of communication and means of engagement with other parties in the bid at the time of their application (e.g. INTEROPen Ryver etc).
  • Transparent – all projects must be willing and evidence how they will partake in regular clinical and technical reviews. We suggest these should be in the form of bi-annual CCIO Network led review along with INTEROPen led Connectathons with a minimum of 3 out of 6 Connectathons undertaken.
  • Share Ideas, Knowledge, Experience – i.e. willing and able to openly collaborate with others in this initiative (e.g via online community building via tools such as the Open Health Hub, Ryver etc) and partake in Open Data connectathon against INTEROPen FHIR APIs

9) Judging process

Initial Bid and Review Point Principles

We suggest the related submissions into this fund will need to evidence the following as part of their bids and progress at agreed review points:

  • Clinical merit – against the Personalised Health and Care 2020 Vision
  • Technical merit – against the open platform principles outlined
  • Clinical gap / need / demand
  • Clinical Leadership – all projects need nominated clinical lead
  • User Centred Design – include/demonstrate a commitment to open publish UX design
  • Alignment with Agile Development methodologies
  • Business readiness (preparatory work, governance etc in place)
  • Collaboration with other parties in the open platform bid
  • Open Source track record

10) Conclusion

If public monies are for one purpose, they should be for the common good. Our proposal aims to ensure the efficient and effective allocation of public monies to projects that can impact the health and care of millions of citizens in England, supporting local NHS & Social Care organisations in their hour of need, while leveraging Britain’s long held reputation for industry and innovation to enable a new global open platform fit for the 21st Century.

Our proposal for an open platform technology fund aims to offer a means towards the integrated care vision of Personalised Care 2020 that is in the best interests of the NHS. In aligning patient, clinical and care needs with the investment potential offered by open platforms in healthcare, we believe there is a clear win-win on offer here.

At times of challenge and change the natural instinct may be to withdraw from risk or novel action, yet all our instinct is telling us that now is very time to embrace this challenge and seek the opportunity – which is why we are taking a public lead in getting this Open Digital Platform for Healthcare into action and welcome your interest and support in this effort.

Dr Tony Shannon, Ewan Davis
14th January 2017

Questions or Comments?
Email us at 1percentfund@ripple.foundation or tweet @rippleosi with #1percentfund

11) Declarations of Interest

Both of the authors are unashamedly proponents of an open platform in healthcare for some time. One might argue that this constituents a conflict of interest with the proposed approach. Rather we would suggest that our track record in leading the effort to disrupt the market towards an open platform, equates to a confluence of interest with the approach now required.

Dr Tony Shannon, Director – Ripple Foundation C.I.C
Director – Frectal Ltd

Ewan Davis, Director – Synapta C.I.C
Director – Handi Health C.I.C
Director – Open Health Hub C.I.C
Director – Operon Ltd
Director – Woodcote Consulting Ltd

12) Related Links

Ripple Foundation Community Interest Company http://rippleosi.org/
HANDI Health Community Interest Company http://handihealth.org/
Synapta Community Interest Company http://synapta.org.uk/
Endeavour Health Charitable Trust http://www.endeavourhealth.org/
Apperta Foundation Community Interest Company http://www.apperta.org/
INTEROPen Collaborative http://www.interopen.org/
openEHR Foundation http://openehr.org/
HL7 FHIR https://www.hl7.org/fhir

Appendix 1 – Open Platform Infrastructural Component Candidates

The aim here is to initially outline examples/suggestions of a “top 10” set of federated service components in a Service Oriented Architectural world that would be useful to in healthcare. In doing so we welcome further suggestions and related expressions of interest that would aim to provide open source solutions to plug gaps / provide enhancements towards the open digital platform movement. The fund may support the open sourcing of existing components or their development.

Identification & Authorisation
Master Patient Index
User Interface framework
Integration technologies
Clinical Data Repository
Terminology services
Workflow services
Rules engine
Scheduling
Business intelligence
Clinical content collaboration/authoring tools (i.e. openEHR/FHIR etc)

Applications for these open source infrastructure projects are encouraged to state their preferred OS license (weighting towards non copyleft (Apache 2/MIT/BSD) or AGPL licensing)

 



 

Hiding the Onions – Interop and Open Platforms


With McKinsey telling us that open platforms can save more that 11% of total health care costs, we really have to sweep away the barriers and make it happen. This means moving to an open platform architecure meeting the principles I described in my last blog, which require open standards, open data and open APIs. While most in the vendor community understand this and some actively promote it for others asking them to open up their systems and data and adopt open standards is like asking the turkey’s to help make the stuffing – They might help you find the sage, but they are  going to hide the onions.

Many existing vendors recognise the need to move open standards, open data and open interfaces (APIs) but while some are moving in the right direction, they are not there yet Others drag their feet knowing their current success relies on existing proprietary solutions, customer lock and their pseudo-ownership of customer data. Getting to the tipping point at which open platforms can really take off is going to require new players challenging the status qou and a willingness from the health and care community to help them successfully engage.

The objective is to move towards what is now being described as a Post Modern EHR  this is an architecture that separates data (describing both record content and work-flows) from the applications that create and process it storing it in an open computable format available to all authorised applications.

There are almost certainly no vendors who think interoperability is a bad thing and this is exemplified by the techUK Interoperabity Charter, to which many vendors have signed up . While some have described this as “Motherhood and Apple Pie” in nonetheless contains some specific commitments and there is certainly no justification for any health or care organisation to do business with companies that are not signatories (it is not necessary to be a member of techUK to sign up to the charter). Having  signed the Charter should be a mandatory condition in the PQQ of any IT procurement in Health and Care.

However, vendors commitment to interoperability is not always what it seems and varies between companies and within companies depending on what particular aspect of interoperability at issue.

Most vendors are keen to facilitate interoperability that enhances the range and quality of data in their systems or which adds functionality that they don’t and and have no desire or ability to provide. Vendors are less keen to support interoperability that allows competitors products more easily to replace some or all of their system or which loosens their peusdo-ownership of their customers data – True interoperability does both of these things.

For a system to be fully interoperable the following needs to be true:

  • It should be possible to access all of the data in a system in an open, shareable and computable format, either for an individual patient or any cohort of patients (include all patients). Interfaces should be provided to efficiently access data and where the customer wishes to maintain a near real-time replica of the data in a parallel system.
  • It should be possible to upload to a system any data that could otherwise be manually entered into a system, subject to relevant  user defined work-flows and quality assurance.
  • All business functions that can be executed using a system should be exposed via an appropriate API to allow them to be executed by an authorised external application.

Looking at the API’s than vendors are now providing, few come close to meeting the criteria above. For some systems and to some extent there are real technical barriers to opening up systems and making the data they hold available in an open format, but there can also be pressing commercial reason for not opening up systems and it can be very difficult for customers to determine the extent to which vendors have genuine technical challenges to overcome or are simple looking for excuses to hang on the commercial benefits of limiting what can be done through their APIs.

Customers need to push vendors towards open platform architectures, open standards, open data and open APIs, but need to recognise that this transition cannot be achieved overnight and will require investment by vendors that will ultimately need to be paid for by customers. The trick is to link new business to an evolution to open standards without making unrealistic demands, that in the end you will have to allow vendors to ignore.

Vendors need to appreciate the value of open platforms and the commercial opportunities they bring. The increasing complexity of digital health means that I can foresee only two future options:

  • The first based on open platforms creates opportunities for vendors, particularly innovative SMEs, to enter the market and compete with the larger players on a level playing field and forces vendors to compete on quality, performance, support and value rather than relying on customer lock-in and pseudo-ownership of customer data.
  • The second is increasing market consolidation with a few very large  vendors owning competing proprietary platforms, that allow access to other vendors on their terms with customers locked into their platform

The first option drives innovation and value, creating a competitive market  for both the provision of  federatable open platforms and the applications that run it. The second will result poor value and reduces both the opportunity and motivation for innovation and gives the platform provider too much influence in the way health and care services are provided.

There is a great future for vendors of all sizes in an open platform environment, which by delivering value to the health and care system, will result in market growth delivering greater revenue opportunities for those that can adapt their business models to take advantage – For those that can’t there always the cranberry sauce.

Stuffed Turkey
By No machine-readable author provided. Chensiyuan assumed (based on copyright claims). – No machine-readable source provided. Own work assumed (based on copyright claims)., CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=1491125

Sticking to the Knitting


I’ve written about this before, but have become increasing concerned that the pressure on NHS organisation to generate revenue outside of their core business is a dangerous distraction, acts as a barrier to the diffusion of innovation within the NHS and acts against the best interest of patients and taxpayers.

A distraction because NHS management has challenges enough without targets to generate revenues, trivial in comparison to the budgets of the services they manage, form activities which are peripheral to their core business.

A barrier to to the diffusion on innovation because NHS organisations hang on to intellectual property, in the hope of selling it, rather than making freely available to other NHS organisations and the broader UK health and care sector.

Against the best interests of patients, because it distracts people from doing their day-job and denies patients the benefits of innovation from elsewhere in the NHS.

Against the best interest of tax payers, because in many cases the target customers are just other NHS or public sector bodies which at the very best in a zero-sum game but in reality much, much worse because of the cost of sale and the massive opportunity cost from the slowed diffusion of innovation.

Those involved in the system understand and resent the situation, but politicians and policy makers don’t and have created incentives and penalties in the system that force rational people to behave in what are a sub-optimal ways.

I’m all in favour of exploiting public sector IPR to taxpayer benefit and while there are examples of such opportunities at significant scale (most often in pharmaceuticals and biotech) in many more cases the small scale of the opportunity and the disbenefits to patients and taxpayers mean we really should think again.

openEHR a Game Changer Comes of Age


I’ve been watching openEHR over more than fifteen years, and although I have always been impressed by its potential to enable us to do things differently, I must admit it has been a slow burn, and take up has been limited, particularly in the UK where it was invented. However, due to some recent developments, I think this is about to change, and that openEHR is going to take off in a big way. This is going to revolutionise how we think about and do digital health, and it should increase the speed at which we can do it by at least two orders of magnitude. Why do I say this, and what evidence is there to support my assertion?

openEHR has come of age with a large number of successful small implementations, and a few much larger ones (1) which have proven the approach works at scale. We have also seen the use of openEHR by governments and major health providers across the globe, including the NHS (2), as the mechanism for the creation and curation of clinical content standards in their territories. In addition, changes to the openEHR Foundation have made it unarguably an open source organisation with a global user community; a growing vendor community has developed offering both open source and proprietary tools and components supporting the standard; and there is serious interest from major system integrators. These changes make openEHR look like a much better alternative to the hegemony of the big US megasuite providers, who still want to shape health and care systems in their image and who own the platforms on which these providers will increasingly depend.

UPDATE (12 April 16)

Possibly the best explanation of openEHR I’ve seen “openEHR technical basics for HL7 and FHIR users” Well worth reading.

UPDATE (15 March 16)

Some great videos here which provide an easy way to understand various aspects of openEHR.

In particular:

Clinician-led e-health records – An introduction to openEHR for clinicians

National governance of openEHR archetypes in Norway – A national approach to building information models with openEHR. Many lessons here for HSCIC who have just started doing something similar here.

UPDATE (13 July 15)

In their PQQ which kicks of the procurement for the Datawell to support Devo Manch,  Manchester have mandated openEHR along with other established standards including IHE-XDS. This could potentially lead to the largest implementation of openEHR in the UK with Manchester building on pioneering work in Moscow and Leeds

UPDATE  (24 Apr 15) Further information and news about the growing interest in openEHR will be found here

Firstly, everything I read and all of the people I talk to across the globe about digital health agree on a couple of things.

  • Firstly, we need to move towards a platform architecture into which we can plug the thousands of apps and hundreds of traditional systems that we currently use in health and care; an architecture which will enable all of these to interoperate and work together.

  • Secondly, we need to separate content (the data, information and knowledge that applications consume and update) from the applications that process it; and that content needs to be expressed in a modular, computable and reusable format.

Beyond this, agreement breaks down – people do argue about business models (who should own and control the platform), and also the details of the particular standards and technology to be used – but on the core principles, everyone with any credibility agrees.

When it comes to business models, some would like to own the platform, because doing so would create a massive commercial opportunity. And while some still pursue this goal, most significantly Apple, others have decided, as I have, that ownership of the platform is neither achievable (competitive and customer pressures mean even the mighty Apple can’t win this battle) nor is it desirable from the perspective of citizens, health and care providers and payers – none of whom wish to be locked in or to pay the ‘fruit tax’ or its equivalent.

Others, including me, and more significantly some big players, have come to the view that while it might be great to own the platform, that isn’t going to happen and so we need to move to an open platform which nobody owns (in the sense that nobody owns the Internet). As for commercial opportunities, they will still exist higher up the value chain, and the existence of the platform will create such opportunities by the spadeful. Surely it’s more fruitful to concentrate on these, rather than waste time and resource on a battle no one can win.

On the details of implementation, disagreement is less significant. The two major contenders, openEHR and the Healthcare Consortium, both have similar approaches, and they are already converging through the Clinical Information Modeling Initiative (CIMI) to reduce their differences to the point where they really don’t matter and can be dealt with at a purely technical level, with their components being easily interchangeable.

So, if we want to create an open platform, what do we need? We need openEHR or something like it – and frankly there is nothing else as mature or as well supported as openEHR.

OpenEHR is not software, nor is it a particular technology. It’s an open specification or standard for the representation of a key bit of content – the health and care record. The specification is open source (insofar as you can apply this term to something that is not software), and it’s curated by the openEHR Foundation, which is a not-for-profit company democratically controlled by those who choose to be part of the global openEHR community (and anybody can). The community is truly global and growing, and consists of both users and developers; and is supported by a number of vendors who can offer tools, components and services supporting the standard.

openEHR provides a simple, robust and stable over-arching reference model (3) which defines a formalism for the representation of the modular components of a health and care record. openEHR calls these ‘archetypes’ and they define the elements of a record, their properties, and how they are represented (including bindings to terminologies and classifications). Archetypes are intended to represent a superset of all those properties that might be associated with the concept they represent (at a high level these will be either an observation, an evaluation, an instruction or an action). Archetypes can then be constrained and/or combined in a ‘template’ to provide practical interoperable components for use in a particular context or system.

The tools available for the creation of archetypes and templates are open source (as are the vast majority of the archetypes and templates created with them), and this makes openEHR easily accessible to clinicians and other domain experts while also providing system developers with robust components to handle many of the technical complexities. openEHR enables clinicians to concentrate of the clinical stuff, and developers to concentrate on the technical stuff, without needed to understand more about the other domain than they want to.

By building systems using openEHR, system development work shifts from the technical level to the domain level. A repository that has been built to store an openEHR health and care record does not need to take account of the particular content of a given archetype. Whatever that archetype might represent, the repository will be able to store it, and you will be able to query that repository about its content. This feature of openEHR is the key enabler of much faster application development, because the addition of new features will not require changes to database schemas (with all the associated testing and data migration that entails). Instead, all that is needed is the addition of some archetypes and/or templates – and these may already be available as the result of work by others in the community, or else they can be created rapidly by a relevant domain expert – plus the creation of some new user interface components, and these can often be generated automatically from the underlying templates. In this way changes can be made by end users, or by people close to them. This will reduce the time to add new features from months to hours, and the time to build new systems from years to weeks.

openEHR is also technology independent. Applications don’t need to concern themselves with the technology of a particular implementation of an openEHR repository – that’s purely a matter for the implementer, who can chose whatever technology works best for them at a particular time and in a particular context. The applications that use it will not be affected, so long as they remain compliant with the standard. We can see this happening in the dozen or so existing implementations of openEHR repositories: they use different operating systems, different databases (SQL and NOSQL) and various development tools to create both open source and proprietary implementations of the standard. Compliant implementations of the standard from different vendors are interchangeable, and a single query can be executed across multiple implementations. openEHR is vendor independent, and it eliminates vendor lock-in.

Suppliers of openEHR repositories will have to compete on performance, security, robustness, value and service – they cannot rely on customer lock-in, as the vendors of many traditional EHR systems have in the past. From the perspective of health and care providers, openEHR puts them back in charge of their own destiny. This contrasts with most of the current successful approaches to the delivery of enterprise-wide EHR, where customer institutions have adopted one of the four big US megasuites, and then have had to adapt internal processes and organisation to fit with the chosen system – in effect, you become an EPIC, Cerner, Allscripts or Meditech institution, rather than a customer who calls the shots.

The ‘megasuite model’ has worked spectacularly well (if expensively) in a number of big US hospitals, particularly for EPIC, but that model starts to break down when you seek to extend the scope of a system from an institution to an integrated health and care community. It also fits badly with UK and other European models of health and care, which are not so close to the US model as the megasuite vendors might hope them to be.

Of course European health and care providers don’t want to remodel their processes along American lines – why would relatively successful European providers want to adopt systems designed primarily for the inequitable and unsustainable US system? According to the well respected US Commonwealth Foundation the United States ranks last among eleven leading developed countries on measures of access, equity, quality, efficiency, and healthy lives (and, by the way, the UK’s NHS takes the number one spot).

Much of my conviction about openEHR comes from work I’ve been involved in with HANDI, in building HANDI-HOPD – the HANDI Open Platform Demonstrator, which has now been adopted by NHS England as the NHS England Code4Health Platform. This platform provides a simulation environment for any system or service that wants to expose an API (interface) within an open ecosystem, and it includes an openEHR repository loaded with test data from the Leeds Lab Project.

We have exposed SMART and FHIR APIs, as well as the native openEHR service API, on top of the repository; we have used this to build a number of apps, and also demonstrated how you can simply plug in apps that were developed elsewhere using the SMART API. We have also used this platform to prototype a UK localisation of an open source ePrescribing product (www.openep.org), and the speed at which we have been able to carry out the localisation and meet some special mental health requirements has been impressive – indeed so impressive that we will shortly be announcing the first NHS Trusts who will be taking the system live.

Work is currently being completed to re-brand the HANDI platform as the NHS Code4Health Platform, and this will shortly be available for those who want to learn more and experiment with this and other open technologies.

openEHR has come of age – If you don’t believe, me give it a try.

Notes:

This is a slightly updated version of the original with a few minor changes to make it more readable to the general reader and correct some typos my thanks for this to my friend and colleague Conrad Taylor.

1) Large scale implementations of openEHR include:

Moscow – Integrated health and social care 12 million population 

Slovenia – Country wide 2 million population

Brazil – Unimed Medical cooperative

2) Health systems using openEHR to create curate and publish clinical content.

NHS HSCIC

NHS Scotland

Australia

Norway

Slovenia

Brazil

openEHR Foundation 

Applications built on openEHR platform

OPENeP EPMA product www.openep.org

Marand Think!Med Clinical, Ljubljana Children’s Hospital http://www.marand-thinkmed.com

Ocean Multiprac Infection control, Queensland Health, Australia http://www.multiprac.com/?portfolio_4=infection-control-2

Ocean LinkedEHR, Western Sydney, Australia  http://openehr.org/news_events/industry_news.php?id=121

DIPS Arena, Norway http://openehr.org/news_events/industry_news.php?id=97

mConsole, Mental Health patient portal, Code24, Netherlands

Clinical Decision Support, Cambio, Sweden http://www.cambio.lk/News-and-facts/Produktnytt/COSMIC-Clinical-Decision-Support1/

See also http://www.openehr.org/who_is_using_openehr/healthcare_providers_and_authorities

3 Some key documents on OpenEHR

OpenEHR Architecture Overview

OpenEHR Reference Model

Farewell to “Ruthless Standardisation”


“Ruthless Standardisation” was the failed mantra of the NHS National Programme for IT. The Programme is dead, but in some places this view still persist but it is time to consign it to history as something else that “seemed a good idea at the time”

In a previous blog I said “Standards are a Barrier to Innovation” and I have taken to repeating this statement which tends to get a strong reaction often supportive but sometimes not.

This statement is of course deliberately provocative and those who read beyond the headline will find that I not saying that standards are a bad thing, indeed I believe that applied appropriately that they are probably a good and necessary thing.

It seems I’m not alone in these concerns and I was recently introduced to  a blog from Prof. Enrico Coiera from last November which asks “Are standards necessary?”  This is essential reading and provides a more erudite and evidenced perspective than my own in which he proposes a  new ‘Malthus’ law of standards “That the fraction of standards produced that are actually complied with, will with time asymptote toward zero”

I’ve also been much influenced by discussion with my friend and colleague Dr Ian McNicoll who has spent more time in the standards swamp than me and who introduced me to the idea of a “Distributed Doocracies” as a new approach to developing clinical content standards.

I conclude that to make progress we have to.

  • End (or at least ignore) the religious wars amongst the Standards Tribes  for the one true way and adopt a more polytheistic and pragmatic approach
  • Learn from the processes that have allowed us to create the Internet, the Web and Wikipedia and apply them to health informatics.
  • Apply the “Four Freedoms” of open source to the standards making process to create a “Shared Commons” of clinical content.
  • Promote new ways of creating the accommodations we need to deliver interoperable digital health systems, based on distributed doocracies, which are accessible to and driven by frontline clinicians, supported by techies and informaticians.

In this blog I want to talk about the process of standards development and how I’m led to the conclusions above.

I’ve become increasingly convinced that the process as currently applied to digital health and care is not fit for purpose and it is this rather the process that standards themselves that are a barrier to innovation.

There are two problems with the process. Firstly, it’s too slow, changes are not possible in a responsive way forcing people to “do their own thing” to meet operational needs. Secondly, it opaque and inaccessible both to clinicians and innovative SMEs.

Before considering these two points I want to differentiate between the technical and contents aspects of standards. The technical aspects deal with the format of data and might use representations like CSV, XML, JSON, etc. These are generally not a problem. If the content is equivalent it is usually easy to write mappings or transformations between them. The content aspects are where the problems lie, what do we mean by a blood pressure, an allergy, a diagnosis, a prescription? What elements make up these things and how do we represent them in ways that are unambiguous and computable. The domain expertise to answer these questions lies with experts in the clinical domain to which these concepts relate i.e. clinicians. Specialist clinical informaticians can support this process but even if they are clinically qualified they are rarely the domain expert. If you want expert input on, say, visual acuity you need to ask an ophthalmologist specialising in visual acuity.

The problem is that the current process for standard settings and many of the tools that support it are not likely to engage the required domain expertise as those best able to provide it are generally more interested in clinical practice than learning the technicalities of things like UML, HL7 or RDF or sitting in interminable standards meetings waiting for the few minutes where they can make a valuable contribution.

So the first problem is that we have to make the process accessible to frontline clinical experts. This means managing the process so they can engage only on those matters of specific interests to them and supporting them by tools that feel intuitive to a clinician with minimal training in their use.

The second problem is that we have to make the process agile so that required enhancements to content standards can be made available in hours-days, rather than months-years. This requires two things: A move from top down control and a shift to a continuous process (rather than one based on review and publication cycles) this is analogous to what is known as continuous integration in the software development world.

The third problem is that we have to make the process open, too many standards making bodies operate behind closed doors or raise barriers to participation by way of the cost of participating in the process or obtaining outputs. It is a scandal that formal standards from the likes of BSI, CEN and ISO which are funded by taxpayers are not freely available on the web and I was appalled to be asked to sign a NDA by BSI before joining a committee to develop standards for apps (I declined). The fact that it costs £232 to buy a copy of CEN 13606 from BSI is hardly going to encourage a microenterprise to find out if it might to be helpful to them (even if they can get it at half price by joining BSI for £189 pa at the microenterprise rate) –   Standards development needs to be like open source software and licensed in a similar way to grant the “Four Freedoms”

So how do we address these issues? Well the answer as ever is to follow the Internet which provides us with two great  open, distributed models for reaching accommodations.

The first is the way core Internet standards are developed, which is by way of RFCs. The clue to the approach is in the name “Request for Comment” Internet standards are those things, which for the moment, nobody is moved to make any comments about. RFCs cover “many aspects of computer networking, including protocols, procedures, programs, and concepts, as well as meeting notes, opinions, and sometimes humor(sic)” – The last is essential when trying to set standards. – Read the page my link points to it’s short and stuffed with wisdom.

The second is the Wikipeadia editorial model and it’s a simplified version of this we need for clinical content and this is illustrated in the diagram below created by Dr Ian McNicoll.

Distributed Doocracy

This specifically relates to proposals for the creation and curation of clinical content models in the form of OpenEHR archetypes, but is equally applicable to any similar process.  It has a number of key features.

Archetype development is an open process that anyone minded to can watch and/or participate in.

  • Archetypes can be used at any point a user considers them stable enough and fit for their purposes, but become standard at the point of “publication” at which point they become subject to strict version control and configuration management.
  • The work and decision making is delegated to Editors working with a small number of reviewers and is fine grained operating at the level of a single archetype or small group of related archetypes. While anyone who wants to participate can at this level there would typically be a small number of active participants (<10 often fewer) who have  specific expertise and interest
  • Publication is a decision of the Editor who operates as a “benign dictator” subject only to the risk of a coup if they fail to satisfy the needs of users.
  • There can be competing archetypes and archetypes can fork if users feel a need, but the aim of the Editor should be to create an “accommodation” that allows a rough consensus (the maximal data set + restraining template approach of OpenEHR makes this relatively easy to achieve)
  • There is some loose overarching governance to enforce general principles and deal with dictators who cease to be benevolent, but there is no central body controlling the publication and approval of archetypes.
  • Professional bodies and standards organisations are encouraged to provide guidance, nominate appropriately expert and interested individuals as editors and reviewers and to provide formal secondary endorsement of published archetypes but are not required to approve publication.
  • There is a high level of vendor engagement, as these are the people that need to make archetypes work in the real world.
  • Archetype and project Editors are supported and coordinated by a team of expert informaticains acting as Clinical Knowledge Administrators.

This general approach is proven as successful both in the very diverse world of Wikipeadia and the specific world of OpenEHR.

Making this work requires the existence of an engaged community, appropriate governance and supporting tools. Here again OpenEHR provides a great model. Available tools like the Clinical Knowledge Manager are easy for clinicians to learn and use and provide an online community that can engage global clinical expertise and allow debate and discussion to support archetype development. The online approach removes the need for costly and time-consuming meetings and allows individuals just to engage in those things in which they have a specific interest. The OpenEHR tools as provide the facilities that the Techies need in a way accessible to them without the need for detailed clinical knowledge, provides the technical artefacts they need and supports good software engineering practice in relation to version control, configuration management and backward compatibility.

So we know what needs to be done and have some proven examples of how to do it. So lets just do it.

 

 

 

 

 

 

 

 

PHRs – An important but limited role

There is a lot of interest around PHRs at the moment at senior levels within the NHS, but there seems to be a lack of clarity the role PHRs might play in the UK

If we are to make progress we have to develop a shared understanding of what we are hoping to achieve, what we mean by a PHRs and what role they might play in meeting our objectives?

For many, including me,  the key feature that separates a PHR from other forms of health records is that it is controlled by the person to whom it relates – i.e. they decide if it exists, what form it takes, where it is held, what it contains, who has access to it and if and when it might be destroyed.

It seems to me that in the UK context PHRs have a limited, but important, role to play as a driver of innovation and change, but that many of the benefits they might bring would be better archived through patient access to existing records, particular GP records, and by a step-by-step evolution from siloed institutional records to a single logical record under share curation and governance.

In this long blog:

  • I provide some background about the purposes of EHRs and the Rights and Responsibilities of both record subjects and record users, an understanding of which I think is essential to understanding the limitations of PHRs and where they fit in the bigger picture.

  • Some thoughts about what I think are seen of the benefits of PHRs. I believe it is important to start with a shared view of what we are trying to achieve rather than jumping to the conclusion that the answer is PHRs

  • Finally, I lay out what steps I think we should take to move towards a shared record and what this is (which is definitely NOT a single physical record) and how patient record access to existing systems fit into this journey.

I conclude:

PHR are not the solution to the problem of sharing Electronic Health Records, but an intermediate step on a journey to a single shared logical record for every patient under shared governace with the paitient as “first amongst equals”. We should encourage the further development of PHRs and in particular explore the use of a common model for data persistence across multiple PHRs based on OpenEHR. Recognising that this is a long and difficult journey we should also continue to open up patient access to existing EHR systems (particularly GP systems) which for many will provide a better solution than a PHR to support patients engagement in their own care and the relevant sharing of their  data. We don’t know the answers to some of the challenges we will face achieving  our objectives, but answers will emerge from an exploration of PHRs, Patient Record Access and Shared Governance Models.

Background

Before coming back to what we do with PHRs I want to develop three points.

  • The purpose of health and care records

  • Rights and responsibilities in relation to such records

  • What we hope to get out of PHRs?

Purpose of Health Records

Health records have a wide range of purposes and these include:

  • Directly supporting the delivery of care to individuals

This category includes both clinical and administrative activities that are necessary for the maintenance of health and wellbeing of and the delivery of care to identifiable individuals including:

    • The provision of an aide-memoire for those involved in care.

    • To facilitate the engagement of patients and their family and informal carers.

    • As a means of communication within teams responsibly for an aspect of care.

    • As a means of communication between teams responsible for the different aspects of care.

    • The provision of the data need by decision support tools design to provide automated guidance to patients, formal and informal carers

    • The provision of data to support workflows, care processes and transactions related to care.

  • Supporting the Health of Populations

The category includes all those uses that are concerned with the health of populations, the planning of care and the development of health knowledge. These uses don’t offer a direct and immediate benefit to individuals, often don’t require identifiable personal information and are often referred to as secondary uses. These uses include:

    • Healthcare planning and commissioning

    • Public health and epidemiology

    • Risk stratification and risk scoring

    • Predictive modelling

    • Drug safety surveillance and pharmacovigilance

    • Clinical audit and outcome measurement

    • Population based healthcare research

    • Identification of subjects for clinical trials

  • Providing a Medico-Legal Record

Those providing care need to be able to demonstrate that they did so with due professional care, recording relevant information appropriately and acting reasonably on the basis of the information available to them. The medical legal record needs to meet the requirements laid down by statue and common law for the admissibility of evidence in both civil and criminal proceedings (principally the “Civil Evidence Act 1995” and “Police and Criminal Evidence Act 1984”. A medico-legal record needs to:

  • Be able to reliably represent the record as it would have been at any particular point in time

  • Securely represent the provenance of information recorded

  • Ensure that information once recorded cannot be repudiated

  • Provide an audit trail of additions, changes and access to the record

The record has to support the needs of all those involved in care which includes health and care professionals, administrative personnel, family and informal carers and patients themselves.

Rights and Responsibilities

In order to understand the issue surround the use and access to health records I think it is helpful to think in terms of a set of rights and responsibilities.

Rights might include: The right to;

  • Determine where and how the record is stored

  • Determine the information stored in the record

  • Decide who has access to the record and the purposes for which they use it

  • Collect information

  • Know the provenance of information stored in the record

  • Use the information in the record for defined purposes

  • Retain/destroy the record

  • Change, clarify or comment on and challenge the veracity of information in the record

  • Disclose information to others for defined purposes

Responsibilities and obligations might include: The requirement to;

  • To ensure the accuracy of information recorded

  • To maintain the currency of information in the record

  • To protect record from inappropriate use or disclosure

  • T disclose information as required by law, regulation or overriding public interest

  • To protect information from loss or damage

  • To maintain details on the provenance of information

  • To maintain audit records of access to, disclosures of and changes to information

  • To securely destroy particular copies of information (typically in compliance with retention policies)

  • Not to disclose certain information even to the patient

Many individuals and organisations may have some of these rights and responsibilities including the patient; those who have contributed to the record or delivered care on the basis of the record; those responsible for maintaining systems on which the record is stored; those who have paid for care on the basis of information for which the record is the authorative source, third parties referenced in the record and those executing certain regulatory or statutory functions.

A PHR as defined above is a record in which the patient has all of the rights and few if any of the responsibilities and in which others have few if any rights and only those responsibilities that may flow from providing and/or hosting the record on behalf of the patient.

Those who wish to maintain records can take one of two basic approaches (and many variations at points between) to ensure the record is fit for their purposes At one extreme each stakeholder maintains their own record for their own purposes (this is broadly the current situation) and at the other extreme we try and create a single logical record under shared governance that satisfies all.

Why PHRs

What then do we hope to achieve by creating PHR? Proponents of PHRs cite many potential benefits, which include the following:

  1. Greater engagement of patients and their informal carers in their health and care.

  2. Facilitation of innovation and experimentation with new approaches to health and care records.

  3. The creation of a truly integrated life-long record which covers all aspects of wellbeing, health and care.

  4. Greater transparency so that patients and their advocates are better able to assess the cost and quality of care that they receive and if needbe challenge it.

  5. Improvements to the completeness and accuracy of health and care records by allowing patients, their digital devices and their informal careers to contribute to and validate the information recorded in the record..

  6. Provide a mechanism which allows patients to see what is recorded about them and manage informed decisions about the sharing of data for both primary and secondary purposes.

  7. To enable patients to record information about the health and care beliefs, values and preferences.

  8. To allow patients to record data about their health and care for their private use which they don’t wish to be available to others.

However, with the exception of the 5th and 8th points above all of these things could be achieved using facilities that are available now in GP systems and which have been offered to patients by pioneering practices for over 10 years. Extending systems to support the 5th and 8th points while non-trivial, is entirely doable.

So what should we do?

My answer to this question is not a simple one as I think we need to pursue multiple paths.

  • First, we need to push forward with GP record access to meet the Goverment’s commitment that all patients who wish to do so should be able to access their GP record online.

  • Secondly, we need to start to lay plans to provide a single shared record under shared governance and curation with the patient as “First Amongst Equals”

  • Thirdly, we should encourage the development of PHRs as a transitional approach for those patient groups who needs would not well met by access to GP records (these are typically those groups undergoing an extended episode of care outside of general practice e.g. renal patients) and as a vehicle to experiment and drive innovation which will inform the creation of shared record.

  • Finally, we should enforce the Open APIs policy being developed by NHS England which requires all new procurement of systems to make open APIs available and require  all systems to enable patients to obtain a machine readable download along the lines of the US “Blue Button” model

Making GP record access a reality

Given that the technical facilities to allow patient access to GP records have been available to the majority of practices for many years and that they have be used successfully by pioneering practices, Government wrongly assumed that getting wider take up would be easy. What they failed to understand is that pioneering practices had chosen to ignore the risk of the unlawful disclosure of third party information to patients, something neither the Government nor their professional bodies could advise others to do. Solving this problem retrospectively is not practical and as a result a more limited approach is now being proposed as laid out in ‘Patient Online: The Road Map’.   We should get on with this and also work to ensure systems are amended so that future recording of third party data is tagged to enable it to be easiy redacted.

Building a shared record

Building a shared record will be a slow process, but one that can be approached incrementally. It’s also important to understand that I’m not proposing a single national record, but rather that for an individual there should be a single authoritve record. Every application that needs information about the patient would get it from this record and any application that needs to persist data about that patient would write it to this record. There could (and should be) multiple providers of repositories for records and the patient should be able to choose which one they use and be able move their record to another provider should they wish. It might even be appropriate for different sections of a record for a single patient to be stored in different services? It would be the responsibility of the service provider to ensure the security and integrity of the record and to put mechanisms in place to enable all those with an interest in the record to secure their rights and responsibilities in relation to the record.

The record architecture required would need to be flexible and extensible and able to handle record dissonance and maintain multiple versions of the truth where the contributors to the record can’t agree a single version.(I will shortly publish a further blog detailing my proposed model for shared governance and the role of multiple truths) It would need to be based on a set of open standards shared (at least) across the UK to ensure interoperability. For me the only currently available viable contender for this architecture is that provided by OpenEHR, which I believe can meet these complex requirements of my proposed model. In this model record storage becomes a commodity service in the cloud and various organisations could offer such storage under a range of business models, but it the UK I would suggest that the default choice of most citizens would be to use the repository funded by their local public sector care provider.

For this approach to work other things need to be in place:

  1. A discovery service for applications to find where the record for a particular patient is – This could be most simply be provided on a centralised basis by the NHS Personal Demographic Service, but could also be achieved using a distributed directory service .

  2. A service to maintain a registry of those who have contributed to the record or have a legitimate interest in it along with the consents granted by the patient for access and particular uses. Again this might be provided centrally as a service on the NHS Spine or as a distributed service. The work of www.miconsent.org has potential to address aspects of this requirement.

  3. Governance structures (probably with a statutory underpinning) to regulate the record service providers to ensure they are irrevocable obliged to: Satisfy the rights and responsibilities of all those with a legitimate interest in the record,  transfer the record  to an alternative provider if they cease to be able to  do so or on request of the patient and ensure that records are protected from loss in the event of a technical or business failure of a provider.

This architecture is one that I have described before  and is built round an enterprise service bus (ESB) that connects back-end services (which would include record repositories) to front end applications that consume these services. An appropriately designed ESB would:

  • Provide a single interface (API) to the various record repositories and supporting services avoiding the need for applications to deal with multiple APIs with the ESB handling mappings and transformations between different APIs, technical and clinical content standards facilitating incremental progress toward common standards.

  • Protecting services from badly behaved applications and denial of service attacks.

  • Off-load many functions from application and service providers to make their lives easier, requiring these functions to be implemented just once in the ESB rather than in each principal system e.g. authentication, identity management, access control, consent management IG, load balancing (to name a few.)

  • Provide an accounting platform that could support innovative business models for apps (such as pay for use models) and a mechanism for charging the responsible party for compute resource and services consumed by applications.

  • Provide a comprehensive patient portal integrating access to existing NHS national web services; NHS Choices, NHS Direct online and NHS 111 online content with record access, and transactional services.

Migration to a Shared Record

My expectation is that, over time, existing systems would migrate to using the shared record to persist the patient information rather than their own local storage. For this migration to occur existing system vendors and users will need to be confident that the shared record can deliver a level of performance and availability to match that provided by local storage and some may wish to start by maintaining of local cache of the record to improve performance and provide resilience. Also, initially that many will continue to use their own storage simply using the ESB for messaging, interoperability and to provide access to transactional services.

Where does the PHR fit

In this model I see that existing PHRs will also migrate to using the shared record just as other ExRs will do.

Many existing PHR systems are already using the latest web technologies and the agile and innovative nature of most PHR vendors and their flexible business models mean that they should be amongst the first to migrate to the shared record.

Similarly the agile and innovative nature of the PHR sector and the much similar Information Governance issue that exist with PHRs (as the patient is in control) will combine with the emerging shared record to enable of slew of PHR developments in which the developers can concentrate on the user experience and user interface design and experimentation with novel business models free from much of the burden of managing record persistence.

For those wanting to experiment there are already facilities provided by the Leeds Health Innovation Lab Platform  which offers what a test platform that could be used to start to build exactly the sort of shared record I’m suggesting.

EhrScape also based on OpenEHR has also recently annocunced an Open Health Data Platform that could also provide a basis for experimentaion

There are also a number of Open Source PHRs that could provide a rapid route for those wanting to experiment or provide live services quickly. Including Indivo and Renal Patient View

We should encourage and facilitate such activities which will help and refine and develop the shared record and the supporting open digital health ecosystem at a pace not possible with the more complex issued raised in the migration of existing large scale EHR systems.

So, in conclusion:

PHR are not the solution to the problem of sharing Electronic Health Records, but an intermediate step on a journey to a single shared logical record for every patient under shared governace with the paitient as “first amongst equals”. We should encourage the further development of PHRs and in particular explore the use of a common model for data persistence across multiple PHRs based on OpenEHR. Recognising that this is a long and difficult journey we should also continue to open up patient access to existing EHR systems (particularly GP systems) which for many will provide a better solution than a PHR to supporting patients engagement in their own care and the sharing of data. We don’t know the answers to some of the challenges we will face achieving  our objectives, but answers will emerge from an exploration of PHRs, Patient Record Access and Shared Governance Models.

What makes an Open Source community?

There has been a lot of interest in the role of Open Source software in the UK over recent months, initially stimulated by NHS interest in the American VistA Open Source EHR, but now taking on a broader scope including some of the exciting home grown initiatives.

Included amongst these are a number of projects that started in a closed source environment, where the IPR owner has decided to shift to an Open Source model. From a narrow technical perspective making software Open Source is easy – You just make release it under a recognised Open Source licence and make it freely available for download. However, Open Source is about much more than the licensing model and much more needs to be done to achieve the benefits of Open Source than what the Open Source community disparagingly call a “Code Dump”.

Open Source is about an approach and philosophy that at its’ heart believes that by creating a community who can freely use and contribute to a product that we can create better software and release new commercial and social value not available from other approaches. Open Source enshrines some import  freedoms and principles which defined and maintained by the Open Source Initiative  that also provides guidance on licences that meet these principles.

To be effective an Open Source community has to be diverse and well supported; containing all of those stakeholders needed to ensure a sustainable business model for the products’ ongoing development and use in which no single entity has effective monopoly control and requires governance structures around a particular distribution or version of the source code (often called a “Distro” in the Open Source world) so that users can have confidence in the safety, security and quality of that Distro including changes and new contributions made to it by the community – Something that is particularly important in context of health and care software.

Stakeholders include:

  • Those that gain financial value from the existence of the Distro – These might be organisation that use the software or the data it generates (like the NHS, researchers and other health and care commissioners and providers) or organisation that sell services to community made possible by the existence of the Distro (including developers, implementers and maintainers) – It is this group of stakeholders who will be the main source of resources to sustain the development and use of the Distro.
  • End users of systems and those who they seek to serve using the software – It is only by involving end users in an agile user-centred design processes that we can build systems that truly unlock the potential of digital technology – Too often the poor design of tools that people are expected to use is a barrier to doing what’s important. In the context of health and care this means involving frontline clinicians, other health and care professionals, managers and administrators – Their needs are often not well understood by policy makers, senior management and IT departments. Most important of all it means working with patients, service users and their informal careers who are too often the victims of poor service resulting from poor design.
  • Academics and technologists who are able to educate the community with regard to those things they know that might enable the community to improve the Distro and/or the effectiveness of its deployment and help the community critically evaluate it use. This might include ensuring that the community is aware of existing and emerging standards, technology and theoretical frameworks of potential value to the community.
  • Policy makers and senior management who need to understand how the Distro can be deployed to improve services and how such use can both shape and support policy.
  • A vibrant market of individuals and organisations who can provide a range of services to support the development, implementation and use of the system as well as relevant add-on products and services. This market should ideally include individual consultants and contractors, SMEs, social enterprises and large global system integrators. It is vital for the health of the community that there is a competitive market in the products and service needed to improve, deploy and exploit the Distro so that user organisation have a choice of who they contract to provide these service.

The Distro needs a custodian, owned and controlled by the community, who will promote nurture and protect the Distro, provide mechanisms to encourage, manage and quality control changes and improvements to it by the community and commission the delivery of enhancements and other services on behalf of the community.  The custodian needs to set and maintain source code and documentation standards and ensure that documentation is available of a sufficient quality to enable a competent developer without prior knowledge of the product to work with the source code and ideally should be able to provide additional guidance and training to enable those who want to work with the software to be able to so as quickly as possible.

A key aim of the custodian is to try and keep the community together on a common Distro. Too often, short-term pragmatism results in changes to source code somewhere that breaks something somewhere else creating a “fork”in the source code tree. While some limiting forking might be healthy if too many users “fork off” the benefits of Open Source are diminished. Avoiding this requires that the custodian provides support for people to make changes to meet their needs without breaking things important to others, in a rapid agile and responsive way. However, making changes in this way will still be slower, in terms of achieving immediate local priorities, but doing so has damaging medium and long-term sequelae. The custodian has to close the gap between the two approaches and educate developers about  the benefits of doing things for longer term benefit.

Additionally , the custodian has a role in providing assurance and warranties to users that deployments based on the Distro support by organisations accredited by the custodian will be safe and secure to deploy in live health and care settings.

Enabling the custodian to deliver its’ responsibilities will require that it is funded by the community to do so. To facilitate this the custodian is probably best constituted as not-for-profit Community Interest Company (CIC) whose control is vested in the community such that no single class of stakeholder can determine its’ actions.

If we can build effective communities then the wider introductions of Open Source software in the NHS as part of a mixed economy alongside proprietary products will help drive better value and front line user engagement and commitment  across the board, just dumping source code under an open source licence (or worse some bowdlerised licence) will not.

 

 

 

“Wicked” Barriers to Innovation and Adoption

Sometimes we just have to JUST DO IT! In the NHS we have too high a tolerance for inaction and too little tolerance for honourable failure.

I’ve just come back from the Healthcare Innovation Expo in Manchester, where there was much talk about the need to encourage innovation. I’m all for that but I think it’s widely agreed that the problem is not innovation but getting innovation that works widely and rapidly adopted.

I’m trying to help NHS England do some innovative things with Open Source and we made lots of progress over the two days at Expo, but I again encountered examples of two of the wicked barrier to innovation and its’ adoption.

I call these things “wicked” because they are both things that are genuinely important and that we must properly consider, but they also represent two of the most effective spanners that those who feel threatened by the innovations of others can throw in the works to slow down adoption.

They are:

  • Clinical safety
  • Evidence

Don’t get me wrong clinical safety is important and I support the application of standards like ISB0129, which I think is actually well put together and does a good job of encouraging a proportionate approach to clinical safety. What gets my goat though is the way in which clinical safety can be used as excuse for not doing things differently. I wouldn’t mind so much if we knew that current systems and processes were safe, but the fact is that we know they are probably not and I don’t see a good case for slowing down innovation longer than is necessary to be confident that they at least marginally reduce harm. Too often “the Best is the enemy of the Good” and the paradox is that the laudable desire to ensure that responsibility for clinical safety is nailed down and hazards are properly assessed and managed makes it desirable, to some, to stick with current systems and process where the hazards are not well understood or managed, but where nobody’s head is on the block if things go wrong.

Similarly with evidence, we should of course seek evidence to support that what we plan to do will be effective in achieving whatever it is we hope to achieve, but again bleating “where’s the evidence” is a great way to throw a spanner in the work for those who lack a more cogent reason for objecting to a particular course of action. Again, I’m particularly irritated as we sometimes have little evidence that what we currently do works well and more often have evidence that it doesn’t so why not try something different. I’m also concerned when people ask for evidence for things that have not done before. Clearly, if we have not tried something before we can’t have direct evidence of its effect and the more innovative an idea is the more difficult it is to find proxies for direct evidence. Sometimes we just have to rely on professional judgment, faith or plain old gut feel and just do it. We have to take this route if we want innovation and adoption but we also have to recognise that we might be wrong, evaluate what we do and “Fail Fast”. We also have to ensure that we don’t castigate those who try and innovate when they fail, as long as they fail as fast and with as little harm as is reasonable practical; sadly in the NHS we have too high a tolerance for inaction and too little tolerance for honourable failure. Given the challenges we face we know inaction will inevitably lead to catastrophic failure and have encourage people to, at least, do something.

You can read more about barriers to innovation in my blog “What Entrepreneurs Want” over on the HANDI web sitenovation