Select Committee on Health Written Evidence


Evidence submitted by Mr Tom Banks (EPR 70)

Executive Summary

  1.  This memorandum of evidence addresses the intent and realisation to date of plans for the creation of "detailed' patient record in electronic format both locally and nationally. In particular it is intended to assist the Committee in its deliberations upon:

    —  What patient information will be held on the new local and national electronic record systems, including whether patients may prevent their personal data being placed on systems.

    —  Whether patient confidentiality can be adequately protected.

    —  Current progress on the development of the NHS Care Records Service and the National Data Spine and why delivery of the new systems is up to two years behind schedule.

as listed in the Terms of Reference for the inquiry.

  2.  This evidence statement asserts in relation to the first bullet point (electronic record systems) that:

    —  The intention to assemble patient records in electronic format nationally (on what has been termed the dataspine) was flawed from its inception and there is no evidence that it can be attained with currently available technologies.

    —  The creation of patient records in useful electronic format at the "point of care delivery" has been retarded rather than advanced by the activities of Connecting for Health.

    —  Patients would be well advised to be wary of permitting any electronic records to be deposited in a national repository, for fear that the impact of erroneous data could outweigh any potential benefits from "shared" data.

  3.  This evidence statement asserts in relation to the patient confidentiality bullet point that:

    —  Primary legislation will be required to provide a degree of patient confidentiality sufficient to avoid frequent referrals by patients to the UK and European Courts alleging breaches of European "Data Protection' directives and increasing amounts of patient litigation in relation to patient record accuracy and integrity.

  4.  This evidence statement asserts in relation to the last bullet point that the gap between delivery of service and the timetable originally published has been caused by:

    —  Failings in the original contracting process deployed by the National Programme for IT.

    —  In particular, the allocation of "monopoly" concessions (franchises) to selected commercial companies to deliver "local services" to NHS bodies.

    —  The lack of appropriate authority being contractually delegated to NHS Bodies with ultimate responsibility for implementation of franchised monopoly concessionaires' services.

    —  The decision of the then Secretary of State for Health, Mr John Reid, in 2004 to include the NHS Information Authority in his programme "winding up arms length bodies".

  5.  The opinion is expressed that there is no evidence published to indicate that the "Care Records Service" element of the National Programme could be delivered in the next decade, and there exists technical evidence that the original goals of the National Programme for IT are unattainable. This memorandum therefore supports the representation previously made to the Committee by the "Group of 23 Senior Academics in Computing and Systems" that a detailed open technical review of the Programme be commissioned, in a transparent manner that will enable the resultant recommended actions to be progressed in a climate of widespread acceptance and support.

AUTHOR DETAILS

  I am a management consultant who specialises in supporting the effective management of healthcare. I have worked with the NHS in England, Wales and Scotland and with health and social care in Hong Kong, Singapore, Norway and the USA. Between 1995 and 1997, I was seconded to the NHS Executive in Leeds where I led the NHS Number project, a successful national IT based project delivered fully in England and Wales. I have first hand experience of the national programme for IT, through supporting trusts in various parts of England to improve their NHS IT services often despite the challenges thrown up by Connecting for Health.

  I am a Fellow of the British Computer Society, and a member of the Worshipful Company of Information Technologists Medicines and Health Panel. I am also a member of the all party Parliamentary IT Committee where I serve on the programme committee assisting MPs and Peers with their liaison with healthcare bodies and organisations. However, I offer this evidence in an entirely personal capacity.

EVIDENCE STATEMENT

What patient information will be held on the new local and national electronic record systems, including whether patients may prevent their personal data being placed on systems

  6.  Creating patient records in useful electronic format at the "point of care delivery" is a substantial challenge. In England, such records have been produced in GP practices in a programme of nationally led activity that was well underway as early as 1994. However, in very many GP practices, paper records remain in common use adding detail to that held in electronic format. In the trust sector—acute, mental health primary care, etc—an even greater percentage of those delivering patient care depend upon patient detail recorded on paper.

  7.  Even in the United States, to which the Department of Health frequently looks for inspirational new ideas, the majority of clinicians utilise paper records to a greater extent than electronic ones. In the last few weeks, the "Bush" administration has again appealed to health maintenance organisations and others to increase their use of electronic recording of patient data. However, at the same time, the "Washington Post" Blogs recorded evidence that details of weaknesses in electronic patient records contributed to the Walter Reed Army Hospital scandal.

  8.  The attempt by the Department of Health in England to produce both local and national electronic record systems in the same Programme in essentially the same timescale was hugely ambitious and recognised as such. The NHS Confederation Briefing of August 2003 recorded as its opening paragraph:

    "The largest investment programme in information technology (IT) and building infrastructure in the NHS in England is under way. The next three years will see an investment of £2.3 billion in IT. The IT changes being proposed are individually technically feasible but they have not been integrated, so as to provide comprehensive solutions, anywhere else in the world."

  9.  In the view of many informatics engineers the Programme has been doomed from the start. Connecting for Health has never been able to define and publish any detailed data architecture that covered both the central patient record depository and the local records.

  10.  There is broad acceptance that patient records in electronic format should be produced and used locally. The challenge of creating patient records in useful electronic format at the "point of care delivery', although substantial, is a challenge that in the various NHS Bodies have been willing to accept.

  11.  The controversial issue has been central infrastructure item of the national patient data repository.

  12.  The Output Based Specification for the National Programme for IT (OBS) requested that a national "personal spine information service record" be produced for each patient. This would include a record of all of the patient's healthcare history in electronic format. Every NHS and social care organisation nationwide would be able to share access to the patient's details through this national record.

  13.  Perhaps the best published description of the national patient record depository is contained in the OBS in the section "Clinical Spine Application Service". Appended to this evidence statement is a simplified diagrammatical illustration of how it was envisaged that use of the Clinical Spine Application Service by a clinician during a patient presentation might work.

  14.  A calculation of the potential size of such a record structure as indicated in the OBS will have been made during the procurement process by several bidders. At least one such calculation indicated that the proposed scheme was beyond that realistically implementable on current technology. Further, a calculation of the volume of messages that would need to be supported if everyone in the NHS depended upon a central patient data depository to support their patient consultations, also suggests a performance demand well beyond the capability of current day technology.

  15.  Connecting for Health has not published any calculation details that it has made to demonstrate that the scale of the implementation is technically achievable. The NASP contract for the "spine" signed with BT is understood never to have warranted that it could handle a fully detailed central patient data depository and such volume of transaction activity as a fully detailed central patient record system might have presented to it.

  16.  The Group of 23 Senior Academics in Computing and Systems have deployed their experience and expertise to examine at a high level the technical basis for expecting the National Programme to succeed. They have expressed considerable concern that "success' may not be achievable and recommended that a detailed open technical review of the Programme be commissioned, in a transparent manner that will enable the recommended outcome to be progressed in a climate of widespread acceptance and support.

  17.  The OBS contained target milestones for the delivery and deployment of the national "Clinical Spine Application Service". The 2004 and 2006 milestones have both been missed. A revised simplified proposal for creating embryonic shareable patient records on the "spine" has been developed. This proposal is considered to be an ill-defined fudge.

  18.  The detail of what patient data items would be held on the national spine has changed frequently and only a "first step" "summary" is defined currently. Clinicians are broadly agreed that the current "first step" "summary" detail is of extremely limited value to them. No timeline pathway has been published by Connecting for Health to describe how and when these first steps will build to attain the full, or even a useable, "Clinical Spine Application Service".

  19.  One challenging question is the degree to which clinicians should rely upon the data in their local records when a patient presents or rely on the nationally held detail? Which is the more likely to be correct and which should take precedent when the details are not identical? The OBS included a few "rules' that would assist in the governance of the data and in answering some data precedence queries. But no data architecture model or comprehensive precedence rule-set has been published that would suggest that the alternatives have been carefully analysed.

  20.  In particular, the Department of Health has not published any comprehensive guidance on who is accountable, including from a litigation viewpoint, for clinical or other care errors made through reliance upon national patient electronic record data, which may be incorrect or incomplete or outdated.

  21.  Informed patients may be most reluctant to allow any data allegedly related to them to be included in a national depository for fear that misinformation could contain more damaging risks than no information at all.

  22.  There is view that Connecting for Health, by concentrating on the central infrastructure items of the "spine" and the national patient data repository, has produced the result of NHS Trusts being retarded rather than advanced in their development of local electronic record systems.

  23.  In 2002, there were many instances throughout England of NHS bodies engaged in acquiring systems to improve their local electronic record management. Several of these bodies had formed collaborative ventures to procure systems widely approved by the local clinicians and IT professionals. Among these were the Shires initiative in the South West and the Birmingham and Black Country initiative. In May 2003, Government Computing announced that both of these initiatives had been cancelled.

  24.  "Government Computing" reported Martin Carter, a spokesperson for the Shires consortium, as saying, it was "disappointing" that the Government had pulled the plug at such a late stage. "Our project has been scrapped but what we'll eventually see on the national programme will be very much like the project we were trying to introduce", he said. "It's a very big and complicated project but in the end we will see an electronic patient record that will apply to all sectors, all areas of health and social services. That is the holy grail and we will see how it progresses."

  25.  The Boards of some Trusts refused to "pull the plug on their procurement and implementation initiatives'. For example in 1999-2000 I assisted trusts in East London to develop a "Local Information Systems Strategy'. This strategy was followed up by Newham University NHS Trust and Homerton University NHS Trust. After careful consideration they decided collaboratively to procure and implementing systems independently of the National Programme. Ironically, the supplier they chose, Cerner Inc, was initially shortlisted but not selected by NPfIT to support any consortium, but has now been belatedly adopted by Connecting for Health as a key system. By acting outside of the National Programme, Newham and Homerton have the most advanced Cerner systems in the UK currently.

  26.  Another example was University College London Hospital, which successfully implemented the IDX Carecast system under a contract that was independent of Connecting for Health. This was some time before the first (and only) Connecting for Health IDX Carecast implementation in London. Plymouth Hospitals NHS Trust, although geographically in an IDX/Cerner region, installed effective versions of the iSoft products and the "Plymouth" or "Derriford" option was subsequently offered by Local Service Providers to NHS Bodies in the Northern clusters. In summary those NHS Bodies with Trust Boards resolute enough to exercise their own judgement have made the better progress.

Whether patient confidentiality can be adequately protected

  27.  The Data Protection Act 1998 gives effect in UK law to EC Directive 95/46/EC, and introduces eight data protection principles that set out standards of information handling. The term "health record' is defined by Section 68 of the Act, and means any record which:

    —  consists of information relating to the physical or mental health or condition of an individual; and

    —  has been made by or on behalf of a health professional in connection with the care of that individual.

  The term "health professional" is also defined by the Act.

  28.  There has long been tension in the NHS regarding whether the practices for ensuring patient confidentiality are complied with in a sufficiently disciplined manner to conform with the Act and often a lack of clarity about who would be accountable for any breaches. On 18 October 2001, Nigel Crisp wrote in his management letter,

    "There has been widespread concern about the need to comply with legal requirements and professional guidelines, notably the need in certain circumstances to obtain patient consent prior to disclosure and use of patient identifiable data. Whilst it is clear that current NHS practice does not always meet required standards, the NHS is dependent on information collected from and about patients and the Department of Health policy is to encourage and support the necessary improvements without disruption to important NHS and related work. The General Medical Council, the Information Commissioner, and many others, are working with the Department to ensure that reasonable and managed progress is made but it is clearly in no-one's interests for any aspect of health service provision to be impaired. The Department of Health will shortly publish a strategy document that will set out... new powers provided under section 60 of the Health and Social Care Act 2001 that can be used to support key uses of patient information where there are particular concerns".

The Health and Social Care Act 2001 requires that resulting regulations under section 60 of the Act to be laid under affirmative process. It is understood that few such regulations have been laid.

  29.  In May 2002, the then Information Commissioner, Elizabeth France, published "USE AND DISCLOSURE OF HEALTH DATA—Guidance on the Application of the Data Protection Act 1998". This 43 page document was the principal source of guidance to NHS staff for several years. It is a document that addresses practical issues related to the confidentiality of patient data in a detailed clear manner.

  30.  In 2005 the Department of Health published a "Care Record Guarantee", which it revised in 2006. This "Care Record Guarantee", which is understood to have no statutory basis, is increasingly being viewed by NHS staff as a justification for ignoring the more detailed guidance contained in USE AND DISCLOSURE OF HEALTH DATA—Guidance on the Application of the Data Protection Act 1998".

  31.  In January 2007, the current Information Commissioner published a brief paper entitled "The Information Commissioner's view of NHS Electronic Care Records". The phrases included in this "leaflet" have been interpreted by some as giving a seal of approval to whatever use Connecting for Health wishes to make of data collected from or recorded about patients. Others are confused as to the legal responsibilities that continue to reside with data controllers, with staff who created a patient record, with "Caldicott guardians", with the Secretary of State and with unincorporated bodies such as the Care Record Development Board or Connecting for Health, when data is extracted without explicit data subject consent from local depositories and then is misused subsequently.

  32.  NHS staff are aware that data often referred to as "anonymous data" is often only pseudonymised using reversible algorithms. Some staff therefore harbour concerns that personal patient subject data that they may have recorded, is subsequently used in the National Programme Secondary Uses Service or by research bodies, and may expose them to litigation if misused.

  33.  During the last 12 months, misuse of patient data in electronic format in the USA has become a major cause for concern and even prompted articles in "Readers Digest". The larger number of issues in practice have not been caused externally, such as hacking by outsiders, but rather have resulted from improper collaboration and/or malpractice by staff legitimately allowed access to the computer system and sometimes with a potential need to have access to a particular patient's records.

  34.  It is asserted that the current framework directing practice in the NHS in relation to patient confidentiality is insufficiently clearly defined and that detailed statutory regulations are needed to provide an appropriate base to enable permitted data sharing by staff to occur free from the threat of legal redress.

Current progress on the development of the NHS Care Records Service and the National Data Spine and why delivery of the new systems is up to 2 years behind schedule

  35.  In June 2002, Health Minister Lord Philip Hunt announced the publication of "Delivering 21st Century IT support across the NHS", a radical new national programme for Information and Communication Technology in the NHS. He announced improved management and implementation support including "franchise" plans with funding agreed by the national IT programme director. The concept of awarding franchises to external IT suppliers to serve a defined geographic part of the country was new to the NHS and progressed without having any good practice precedent to follow.

  36.  The inadequacy of the NPfIT franchise procurement process has been a major contributory factor causing the delay. Computer Weekly revealed in May 2004, that "only five months after the deal was signed" it had "run into contractual issues". Quoting from a leaked BT document, CW reported the issues as arising from "detailed definition of requirements and practical deployment not envisaged at the Effective Date of the Agreement".

  37.  The reason that BT (and other franchised LSPs) faced up to "detailed definition of requirements and practical deployment not envisaged" is that after the contracts were signed, the Contractors had to produce a substantial amount of detail on an "agree to agree" basis. In different contracts, post signature documents were said to be required for "Service Level Specifications", Help Desk Interworking Procedures', Detailed Annual Implementation Plans, Component System Descriptions, Quality Plans, Disaster Recovery Plans, Module testing plans and specifications, etc, etc.

  38.  The delivery details for the National Data Spine contract had to be "reorganised and replaced" as early as December 2004. The recent NAO report on the National Programme recorded that the core care records element of the Accenture contract was revised "into four releases" the last of which was "13 months later that the original target date" and that CSC customers could fare even worse with a "five release" rescheduling, the last element of which would be nearly two years late.

  39.  The delays have created the greatest impact at the Trust level. It has been stated recently in a Committee of Public Accounts Report that fourteen Trusts have asked for contributions to costs incurred as a result of delays in the implementation of the National Programme for IT.

  40.  In awarding its franchise contracts, the Department of Health approved the use of particular software products as being suitable for deployment at the Trust level, but did not contract directly with the provider of the software that was to be used. As a result, the Department has had no direct leverage available to ensure that the software offered to Trusts was suitable for use or would be delivered "on time".

  41.  In the three northern franchises, the iSoft "Lorenzo" offering was selected from paper descriptions of its intended scope and with minimal demonstrations of prototype software elements. The first Lorenzo version to be available, that may deliver certain key elements of the detail promised during the procurement process, is known as version 3.5 and is understood still not yet available from the development laboratories in India. When "version 3.5 functionality" software is ready, iSoft have indicated that they may evaluate it first in Germany and Singapore. Neither of these two countries requires solutions that closely mirror the NHS in England.

  42.  The two southern franchises proposed software from an American company, IDX. The NPfIT version of IDX has only been installed in one London hospital. Both southern franchise holders (Fujitsu and the BT consortium) have now terminated their relationship with IDX and propose to supply a product from another American company Cerner.

  43.  This decision casts shadows over the quality of analysis work undertaken by the NPfIT procurement team. During the procurement the Cerner solution, which was included in a shortlisted consortium, was examined and rejected. Apparently it was considered to be less suitable than the other computer software offerings. The once rejected Cerner is now the "great hope" of Connecting for Health.

  44.  The implementations in the southern clusters to date have confirmed what USA health organisations' implementations have demonstrated: That it is difficult to "build' and implement Cerner Millennium without very close interaction between Trust IT and clinical staff and Cerner technicians in Kansas. The LSP and Cluster team structure gets in the way of that necessary very close interaction.

  45.  Another unique aspect of the National Programme arrangements is that Trusts with the "responsibility" for local implementation have no contractual agreement with either Cerner or the franchised LSP. The original contracts between the Secretary of State and the franchised LSP made provision for a further tripartite contract to be agreed between the Secretary of State, the franchised LSP and the Trust, known as an accession contract. It does not appear that any such tripartite contracts have been signed. This raises the question about the degree of adherence to corporate governance and risk management present in the current implementation activity.

  46.  Finally, members of the Committee may wish to explore the degree to which NHS staff have been developed and trained to ensure the success of this high risk venture. As early as March 2004, Sir Christopher Bland, whose company was said to have won the biggest contracts in its history to implement key parts of the programme, said it will be a "real challenge" to get the initiative to work. He said BT was excited by the challenge but "somewhat frightened by the enormity and complexity of it". At the same conference the Minister John Hutton said it would be an "enormous challenge" to make a success of the programme and it would be "foolish to ignore the risks".

  47.  In early 2002, Lord Hunt and Prof Sir John Pattison commissioned a report entitled "Making Information Count: A Human Resources Strategy for Health Informatics Professionals". This project identified that the NHS contained some 20,000 health informatics staff and one conclusion of the report was that "high quality, credible, recognised education, training and development are essential components to ensure the NHS has an effective Health Informatics workforce now and for the future".

  48.  As a result the NHS Information Authority sought tenders to develop and deliver a range of training that would prepare NHS to work effectively with the LSP franchise staff in ensuring local delivery of the Programme and awarded contracts to three companies. The courses commissioned by the NHSIA included such topics as "Gaining clinical commitment", "Managing outsourcing contracts" "Delivering successful projects with LSPs", "Managing NHS business change" and "Developing health community cooperation". Some 500 NHS health informatics staff attended one or more of these courses during 2003 and 2004.

  49.  In 2004, the then Secretary of State for Health, Mr John Reid, included the NHS Information Authority in his programme "winding up arms length bodies". As a result the NHS Information Authority's programme of NHS staff training was terminated. Details of the NHS staff development activity are known to have been conveyed to NPfIT (as Connecting for Health was then called) senior management but no decision was made by NPfIT to continue the staff development courses. No equivalent training has been made available from any other source.

  50.  The winding up of the NHS Information Authority resulted in significant numbers of experienced NHS IT staff either resigning, being made redundant or being offered early retirement terms. NHS staff development and training was just one of a number of valuable resource areas that ceased to be available in the reorganised NPfIT.

RECOMMENDATIONS FOR ACTION

  51.  The key recommendations in this memorandum are:

    —  That the challenges presented by the National Programme are fully recognised and the probability that the original goal is unattainable is acknowledged, hence that a detailed open technical review of the Programme be commissioned, in a transparent manner that will enable the recommended outcome to be progressed in a climate of widespread acceptance and support.

    —  That the NHS concentrate upon implementing electronic record systems at the point of care to build a foundation of patient records in electronic format in care delivery institutions and that work on the national electronic record system (the dataspine) be suspended pending the completion of the recommended technical review and the concept of a national patient electronic record depository be reconsidered sometime in the next decade.

    —  That the failure of the franchise approach to implementing Information Systems in the NHS be recognised and hence that Trusts should be both permitted and encouraged to seek from outside the current franchisees, private sector partners to assist in implementing electronic record systems who fit with the Trust's ethos and possess the requisite complementary skills.

    —  That NHS Trusts should contract directly with the supplier of their IT service, or at least can adopt formal governance responsibility as the senior party to a tripartite agreement.

    —  That the substantial number of experienced informatics professionals in the NHS have their skills updated through the reintroduction of appropriate IT staff development courses.

    —  That the statutory and other rules for permitted access to, and the management of, health records be clarified through primary legislation on patient record confidentiality.

Tom Brooks

20 March 2007


 
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