Evidence submitted by the Renal Association
and the Renal Information Exchange Group (EPR 30)
Patients and health professionals
in the renal community understand the crucial role of IT in delivering
efficient, safe health care. This is based on 25 years experience
using clinical information systems in some aspects of healthcare
for renal patients.
We are therefore strongly supportive
in principle of the development and establishment of electronic
patient records, which underlies the Connecting for Health initiative
to introduce a National Care Record Service and a National Data
Connecting for Health has:
Failed to assure the renal community
that its strategy respects clinical need as well as technical
Failed to develop an understanding
of the specific IT needs of ours and other specialist health communities;
Failed to convince the health community
that its strategy of nationwide procurement and development through
large scale Local Service Providers will succeed;
Eschewed opportunities for "early
wins" by demonstrating benefit in chronic disease management
in local health communities which would have won clinical confidence
in its strategic goals and products;
Threatened the survival of specialist
clinical software suppliers who understand well the needs of the
healthcare community with which they work.
Professor Feehally is Professor of Renal Medicine
at the University of Leicester and Consultant Nephrologist at
University Hospitals of Leicester NHS Trust. Professor Feehally
is President of the Renal Association and chair of the national
Renal Information Exchange Group. The Renal Association is the
professional society of nephrologists and renal scientists in
The Renal Information Exchange Group [RIXG]
represents the whole renal community and includes representatives
from professional and patient groups. Members include the Renal
Association, British Renal Society, British Transplantation Society,
Scottish Renal Association, National Kidney Federation, and Kidney
Research UK. RIXG works to maximise opportunities for the renal
community to influence the new information and knowledge environment
in the NHS. RIXG adopted the Renal Information Strategy developed
as a companion to the National Service Framework for Renal Services
The renal community is among the most IT literate
in the NHS. For example:
Many kidney units have used
electronic clinical information systems in routine clinical care
for more than twenty five years.
There are national databases
of patients with established kidney failure treated by dialysis
or kidney transplant [Renal Association UK Renal Registry and
UK Transplant] which are of proven value for secondary uses including
audit and health planning, and these continue to be enhanced.
A renal specialist library has
been developed within the National Electronic Library for Health
The renal community through
RIXG has been innovative in developing the opportunities of electronic
systems for patient benefit. Uniquely in the NHS it has developed
RenalPatientView, which allows patients to have direct web-based
access to their personal clinical information held on their kidney
unit clinical system. This award winning initiative [supported
by Department of Health funding] has been warmly welcomed by professionals
and has strong endorsement from patients. It has been developed
independently of Connecting for Health.
The principles behind the introduction of electronic
patient records currently envisaged as the National Care Record
Service and the National Data Spine are strongly endorsed by RIXG.
In this submission we respond specifically to
the topics raised by the Health Committee.
1. What patient information will be held
on the new local and national electronic record systems?
1.1 The system for the development of National
Datasets which are to be held on the National Spine is sound,
and has good clinical engagement. Members of the renal community
have dedicated time and energy to work with the Information Centre
to produce the National Renal Dataset, which is now awaiting Information
Standards Board approval.
1.2 As we understand there is still organisational
debate about the extent of data to be held locally or nationally
on the spine.
1.3 Information held must be sufficient
for the care record to be meaningful in clinical practice throughout
care pathways which traverse traditional boundaries between primary,
secondary, and tertiary care. Datasets including the results of
all relevant laboratory investigations must be supported by clinical
information less dependent on numerical data entry, such as imaging,
clinical letters, information on past and present medication,
and data on previous major health events.
1.4 If the system is to be launched with
a minimal dataset, technical and organizational solutions must
allow for future extensive expansion of datasets, the content
of which cannot necessarily now be predicted.
1.5 Many renal centres have well-developed
decision support systems that should not be lost by the introduction
of generic less flexible systems. It is unclear whether the proposed
Lorenzo solution will be able to offer the same level of sophistication
on which we have come to rely.
2. May patients prevent their personal data
being placed on systems?
2.1 Personal autonomy in withholding data
does not make sense for individual healthcare which is likely
to be compromised. Health professionals would need to make decisions
with incomplete data, and opportunities for error would increase.
2.2 It is our experience that patients with
chronic disease such as chronic kidney disease do not wish to
withhold data about their health; they recognise from personal
experience the risks to their healthcare of incomplete availability
of data to health professionals. One local health community has
recently integrated its information systems for the care of people
with long term conditions [independently of Connecting for Health]
; no patient has chosen to opt out.
2.3 Data will also have important uses other
than direct clinical care including healthcare planning, audit
and clinical research. Such data are usually pseudonymised. Such
work will be compromised by incomplete data. The scope of "personal
autonomy" needs to be judged against a national "greater
good" which in our opinion can be achieved with appropriate
2.4 Patients should have personal access
to most aspects of their own health records. The introduction
of RenalPatientView demonstrates that this can be secure and appreciated.
3. Who will have access to locally and nationally
held information and under what circumstances?
3.1 Access should be for anyone involved
in the clinical care of a patient. By seeking healthcare, the
patient is de facto approving that the involved health
professional has access to relevant personal health information,
just as is now the case with paper records. No health professional
should restrict access to other health professionals to clinical
data they hold.
3.2 While individuals from time to time
raise concerns about inappropriate access to personal information,
this must be understood in the context of the plethora of problems
which arise when incomplete health information is available, especially
during acute illness. Such problems can be life threatening, for
example incomplete information about allergies to medications,
or inaccessibility of previous X-rays to allow informed comparisons.
3.2 Such problems arise much more commonly
for patients with chronic disease [such as kidney disease] who
are often involved with a number of specialist clinics in different
hospitals as well as their primary care team. Lack of immediate
access to records is a common cause of wasted time, substandard
care, and risk. These problems are self-evidently the issues which
NHS Care Records Service and the National Data Spine are designed
to overcome. The plan is significantly weakened if patients can
3.3 If a system is chosen which allows patient
opt out, patients must be made aware of the risks they are taking.
3.4 Access to patient identifiable data
for secondary uses is appropriately controlled by the Patient
Information Advisory Group.
4. Can patient confidentiality be adequately
4.1 We accept it may be impossible to support
a system which provides absolute guarantees of confidentiality
in every circumstancewe presume a determined hacker can
always succeed. Absolute confidentiality would probably paralyse
the system as a real time support of healthcare. But it is our
view that sufficient confidentiality can be provided in a pragmatic
4.2 It is important that the issues related
to confidentiality are clear to all NHS staff. There are examples
of informatics staff tying the hands of clinical staff by restricting
access to vital data on spurious grounds.
4.3 In RenalPatientView we have provided
web-based access to personal clinical information held by the
NHS with the level of security afforded for example in personal
on-line banking. This is workable and has satisfied the Data Protection
Act, the concerns of Caldicott Guardians, and patient groups.
5. How can and should data held on the new
systems be used for purposes other than the delivery of care eg
5.1 While the primary goal of the new systems
is improvement in the quality of direct clinical care, secondary
uses of data are of great strategic importance:
providing data for needs prediction
and healthcare planning;
enabling national comparative
audit, and using that audit as the basis for cycles of quality
enabling clinical research which
may have low cost and high product value if data are already captured
and appropriately managed.
5.2 The Renal Association's UK Renal Registry
is a powerful example of a secondary use of data which is of proven
benefit. It collects and analyses data on all patients with established
kidney failure in the UK. It produces annual audit and outcome
data which are widely used by kidney units and commissioners.
Its systems and methods are also internationally respected.
5.3 The introduction of the National Data
Spine must not compromise data flows to the Renal Registry, nor
hinder opportunities for data analysis and dissemination. The
necessary sequences of data collection and validation are yet
to be established to the satisfaction of clinical and renal informatics
5.4 Opportunities for patients to "opt
out" of data collection crucially weaken the value of such
secondary uses of data to the detriment of the whole NHS. The
coherent and comprehensive coverage of the NHS means that data
collection through the National Data Spine and its proper analysis
make the NHS uniquely placed among world health systems to inform
its own improvement, but only if datasets are complete.
5.5 In our view "the greater good"
outweighs the autonomy of the individual in this setting.
6. Why is current progress on the development
of the NHS Care Records Service and the National Data Spine and
delivery of the new systems up to two years behind schedule?
We have no insight into the internal workings
of Connecting for Health but we offer an informed outsider's observations.
6.1 Flawed model
The chosen developmental model with a small
number of Local Service Providers developing regional systems
in parallel seems to us flawed:
It has prevented learning from
It has not visibly created energy
by competition as was perhaps intended.
It has meant huge investment
without any "proof of concept".
It has provided no "quick
wins' to assure a sceptical healthcare community that the "grand
plan' would ever deliver benefit
It risks the possibility that
issues of commercial confidentiality can compromise some of the
benefits which might have been envisaged
The interactions of a number
of organisations appear necessary for progress to be made, but
their respective roles, responsibilities and lines of command
are to us opaque: as well as Connecting for Health and the LSPs,
these include the Department of Health, the Information Centre,
and the Secondary Users Service.
6.2 Changing leadership
Identified leadership of Connecting for Health
within the higher echelons of the NHS and the Department of Health
has rotated with disconcerting frequency. To the outsider this
suggests recognition of the problems, but uncertainty about the
6.3 Lack of clinical consultation
From the beginning there has been a lack of
RIXG, speaking for the whole renal community,
itself an unusually IT-literate part of the NHS, has been unable
to open any channels of communication with Connecting for Health.
Connecting for Health has never come to us to ask about the functionality
of our present systems [which must at very least be maintained
if not improved in the future] or to enquire about specific insights
we might have. This is in spite of the fact that this was highlighted
as a necessity in the Renal Information Strategy and in LSP business
6.4 Underestimate of complexity
Lacking specific interaction, the renal community
can only rely on the public stance of Connecting for Health. To
our perception this is consistently overoptimistic, assuming that
technical advances will overcome very large system-related challenges.
Our scepticism when expressed has regrettably
been cast as Luddite, or as a lack of confidence in the technical
innovations which we do not understand. The possibility that we
might have informed criticism based on 25 years of using electronic
care systems in the NHS should be taken seriously.
6.5 Existing systems
6.5.1 The renal community among others has
highly effective clinical information systems refined for our
purposes and integral to clinical care. From the beginning we
were told that the NHS Care Records Service and the National Data
Spine would replace our systems, although Connecting for Health
has never asked us what functionality it is they are replacing.
6.5.2 Specialist clinical software suppliers
have worked with clinicians over many years and understand well
the needs of the healthcare community with which they work. The
Connecting for Health strategy has appeared to threaten their
existence and this could lose much expertise of value to the health
6.5.3 Recently we are told there has been
recognition that existing systems cannot all be replaced, and
that alternative mechanisms are needed for integrating them. From
our perspective this is encouraging, but it is symptomatic of
the communication issues that the renal community has had to seek
out this change of strategy, it has not been communicated to us.
6.6 Focus on making local health communities
workNational Service Frameworks and local networks
6.6.1 Clinical computing developed in the
UK through the emergence of highly specific systems in specialist
areas, for example renal care and diabetes care. The requirement
now is for the overlapping information requirements of these disciplines
to be fully defined and extended into the community setting. But
this needs to be achieved without loss of the specific and clinically
valuable functionality which has evolved in these systems over
6.6.2 The specialist nature of clinical
provision is acknowledged in the development of the National Service
Frameworks [NSF]. In the case of renal services a separate piece
of work compiled an available Renal Information Strategy to support
and enable the main features of the Renal NSF. The Information
Strategy can serve to "ground" the informatics developments
in clinical activities, but we see no evidence that the Information
Strategy is being used as the basis of any Connecting for Health
6.6.3 The goal of nationally available clinical
information is attractiveie ensuring that wherever an individual
falls ill or has an accident their health records will be available.
But the great majority of health gain from the NHS Care Records
Service will be in local health communities. The largest early
gains will be in the care of people with chronic disease.
6.6.4 This is exemplified for patients with
chronic kidney disease [CKD], a common condition affecting 5%
of the adult population, many of whom have coincident cardiovascular
disease. In early CKD most care is delivered in the community
with a focus on cardiovascular risk management. As kidney disease
advances the input of the specialist kidney team gradually increases.
By the time there is advanced CKD requiring dialysis treatment
or a kidney transplant much of the care is based in the kidney
unit. This later stage is characterized by multiple specialist
inputs, frequent attendances at multiple healthcare settings,
and complex medicines management.
6.6.5 Care pathways are being developed
which work across traditional interfaces between primary, secondary
and tertiary care for chronic disease management. For CKD these
pathways have the potential to delay or prevent progression to
established renal failure requiring treatment by dialysis or transplant,
which is complex and high, cost [presently consuming ~2% of the
NHS budget to treat ~40,000 people]. It will also be possible
to minimize the number of patients previously unknown to kidney
units who require urgent dialysis; such patients, colloquially
known as "crash landers" have a significantly worse
outcome than those with prior care from the specialist team.
6.6.6 Information flows which break down
"barriers' and make an electronic care record available across
care pathways, will therefore provide major health gains. Seamless
IT is integral to modern delivery of chronic disease management
as patients move from primary to secondary to tertiary care. The
healthcare services which patients access may be in different
6.6.7 Clinical staff need to understand
the Connecting for Health strategy. Quicker wins, such as could
have been delivered in chronic disease management, would have
been vital in winning the confidence of the clinical community.
They can still be.
6.7 UK perspective
The limitation of Connecting for Health to England
is unhelpful. Health care occurs across the UK. Secondary purpose
data use as for example in the UK Renal Registry is based on UK
wide data allowing nationwide benchmarking. Distinct IT strategies
in different parts of the UK add complexity, consume energy, and
offer no health gain.
Professor John Feehally,
President, Renal Association and
Chair, Renal Information Exchange Group