Select Committee on Health Written Evidence


APPENDIX 6

Memorandum by Alasdair MacDonald (MT 21)

  The following report, which is a personal submission, was written by Alasdair MacDonald and circulated to a number of colleagues, who are active in the field of e-health, for their comments and contributions. The document is based on real experience and understanding of the sector, its component parts, problems and restrictions. New technologies need new ideas on how to implement and use them, which in turn demands changes not just to how we do things, but how we think about how we do things.

  Alasdair originally trained as a fast jet pilot in the Royal Air Force before becoming one of the first IBM authorised PC dealers in the UK. He is an experienced computer programmer and systems analyst and has been an innovator in the telemedicine field for the last 12 years. He is Chief Executive of TeleMedic Systems Ltd and e-Health Consultants Ltd. A promoter of low bandwidth real time solutions, Alasdair designed and built the first remote mobile medical vital signs monitor to send real time ECG, SpO2, Blood Pressure and Temperature from a commercial aircraft in flight to a doctor on the ground. With strong, practical, experience of telemedicine in the most difficult and austere environments, Alasdair has presented a number of papers at international conferences and has worked with the WHO and ITU as well as many other individuals and organisations, including the US special forces.

EXECUTIVE SUMMARY OF REPORT IN RESPONSE TO THE UK GOVERNMENT SELECT COMMITTEE ON HEALTH INQUIRY INTO—THE USE OF NEW MEDICAL TECHNOLOGIES WITHIN THE NHS

  The following report looks at the use of new medical technologies from an e-health perspective. e-health, as with e-commerce and e-government, relates to all aspects of health that utilise electronic processing, communication, storage etc. Given the prevalence of such matters in all walks of life, one would think that this would be a principle concern of any initiative concerned with new technology. Unfortunately, e-health seems to be almost an afterthought, as such, new technologies, even now, are being looked at in isolation, instead as part of an integrated and interoperable solution.

  The report begins with some recommendations in order to focus the reader with regard to the relevance of the text that follows. The report then follows with a simplistic overview, in an attempt to ensure that, as far as this report is concerned, everyone has at least the same basic information and can, hopefully, therefore, realise the reasons for the concerns expressed and recommendations given. The ultimate objective should be the smoother delivery of, and ubiquitous access to, healthcare through the use of e-health and new technology.

  The report then looks at the four areas specifically identified.

  There is a general lack of understanding of telemedicine and telecare, both key components of e-health. The report attempts to explain why there has not been greater success and uptake in this area and how important it is to establish, not only an "Innovation Centre", but a real life working centre of excellence where people can view at first hand what telemedicine is and how it is an integral part of modern, conventional, medicine.

  A key recommendation is the establishment of an "accreditation body" for e-health, which will not only accredit a specific device as being fit for purpose, but will look at all the people processes, standard operating procedures and integration issues so that potential users are clear on exactly how and where something can and should be used and for what purpose.

  While the scope of the Healthcare Industries Task Force (HITF) report goes far beyond e-health related matters, the content and recommendations are almost exactly those that the author and a number of colleagues have been trying to draw the Government's attention to for several years. This report looks at the key outputs of the HITF report with specific recommendations of how these need to be modified to elevate e-health to a more prominent and contributory position.

  The key concern relating to the speed of, and barriers to, the introduction of new technologies is the fragmentation of the health service in terms of its decision processes. If the health service were responsible for food, we would never have cakes because flour is a distinct division, which does not talk to eggs, sugar etc. In real terms, if an initiative is devised within primary care that would only really show benefits further down the line, it is impossible to obtain funding. Primary care cannot show a benefit and secondary/tertiary care will not fund something outside their own direct control!

  The primary concern with the effectiveness and cost benefits is one of measurement. How do we measure if something is a success or not? This section gives a specific example of an initiative that the participants thought was a great success, however, an external auditor deemed a failure.

  The following report has been prepared as information for the UK Government Select Committee for Health for its inquiry into the use of new medical technologies within the NHS. The report offers useful information towards the understanding of Telemedicine and e-Health, what it means and some pertinent issues around the subject. The ultimate objective should be the smoother delivery of, and ubiquitous access to, healthcare through the use of e-health and new technology. We will begin with our recommendations in order that the information that follows can be read with these in mind, which we hope will bring about a greater relevance and understanding.

RECOMMENDATIONS

  Our most important recommendation is that the Government establish a single body to coordinate all e-health activities across any and all boundaries. This body needs to be completely autonomous reporting directly to the Department of Health, it could, perhaps, be a special health authority.

  For new ideas, technologies, systems and services to be tested effectively, they must work in a real environment and integrate and interoperate with existing processes. There must, therefore, be an active medical centre using these new systems and services on a day to day basis. In this way, the clinicians with first hand experience of e-health systems would be able to evaluate and appraise new technologies based on experience and their relative value as part of a wider, overall, solution. Other clinicians would be able to come and see for themselves how things work and the benefits that can be gained.

  Systems also need proper technical evaluation and accreditation. There is, therefore, a need for high quality medical technicians and IT specialists, to evaluate the technical capabilities of new technologies and systems. That they have passed regulatory approval and are safe does not mean that they will be useful, they need to be appraised against existing systems for compatibility and interoperability. Clear and practical information needs to be produced on the capabilities and limitations of each system in different environments, how and where they could be used, possible interference with other systems and so on.

  e-health solutions also need to be regulated by some form of standardisation agency. There needs to be a separate team to look at the people and process aspects. Technologies need to be assessed in terms of their role and the manner in which they should be used. Because not all elements of an e-health solution will be under the control of any one given body, all participants in any specific area of e-health must operate to clear and specific "standard operating procedures". These standards are not those already defined and managed by any other body or agency, these are the people processes and best practice procedures that must be undertaken to ensure the seamless integration and interoperation of a specific device, system or service, irrespective of its place of use or place of service delivery.

  Finally, there is the need to inform and instruct everyone as to the relevance and value of e-health services as well as training those who will train people within their own organisation.

  We recommend that all these functions be put together in a single centre, which we have called an "Incubation Centre". This is a place where, once started, initiatives are developed and matured before fully defining, standardising and releasing into the wider healthcare market as fully developed and replicable systems and services.

  The standardisation group, although acting independently, will work within this centre with both clinicians and technicians to establish how they each see a particular device, system or service working. They will then look at appropriate models of best practice, medical efficacy and any other regulatory aspect before presenting a prospective blue print back to the clinicians and technicians. After any fine tuning, the result will be a clearly documented definition of how this specific device, system or service should be implemented.

  Furthermore, by having a clear reference document to work to, not only can other health facilities easily implement their own instance of this system or service, they also have a measure against which to be assessed for accreditation purposes. This standards group will also, therefore, have a role in the accreditation of e-health systems and services. Any accredited system or service should be able to integrate and interoperate with any other accredited system or service anywhere else in the country.

  Finally, the centre would be able to train those people responsible for training within their own organisations. Training is, after all just another service and would be subject to the same accreditation as any other service. This means that the training is consistent, irrespective of location.

  A full description of the Incubation Centre and its various functions and responsibilities is available on request.

  Before reading this report further, we would like to offer readers a common understanding of a number of key issues. In particular, where we are today and what certain expressions and phrases actually mean. In this instance, jargon is not the biggest inhibitor, however, there is such a range of understanding about different aspects that without a short overview it would be no better than trying to explain a "Stealth Fighter" to the Wright brothers. Indeed, for those "within" telemedicine circles, the term "telemedicine" has been dropped in favour of the term "e-health". People seem to be more able to relate to the "e" aspect and its broad scope while "telemedicine" is often only seen as having very limited application, usually being limited to a particular example that an individual has been exposed to in some way, such as Teleradiology.

  New technology within medicine is a subject as old as medicine itself and as in any walk of life, is always looked on with scepticism and introduced with reservation. The stethoscope being a particularly good example. It is, however, in the area of computerisation that the biggest problems arise. This is best understood by looking at the history of computers in health. Initially computers delivered little or no clinical benefit but did increase the workload on clinicians and were a long way from being "user friendly". The advent of the PC and more specifically, the Windows operating system, helped dramatically by being more useable and offering easier access to information. However, a whole plethora of dissimilar competing systems popped up with individual clinicians having personal preferences for this or that system. They did not (and still don't) integrate or interoperate with one another and they do not necessarily collect the same data. While much of this is the responsibility of the National Program for IT (NPfIT) there are important aspects that are not covered and it is these that we will look at now.

  Most measurements of physiological data by clinicians, such as blood pressure, are done manually or by stand-alone devices. Transcribing this information into a patient's record is also done manually, even when using a computerised electronic patient record system. These electronic devices are obviously more prevalent in hospitals and ambulances. Some even have a data port, which will allow them to connect to another electronic device or link them into a larger, proprietary system. There are two significant problems with this, firstly, they are designed as stand alone systems not as components of an integrated information system and secondly, there is much confusion about what they can or cannot do.

  Let us consider an illustration. The Government has recently made money available to ambulance services to purchase "telemedicine" enabled 12 lead Electrocardiograph (ECG) units (An ECG unit is a device for producing a graph of the electrical activity of the heart. The term "lead" refers to a view of the heart through a particular axis, not as most of us would think, the number of wires connected to the patient). Now, let us start by asking, what is a 12 lead ECG? Do we really need a 12 lead or would a three lead do? (A 12 lead is used routinely in hospital because (1) it is available and (2) it usually gives diagnostic details without the need for a cardiologist.) If we do need a 12 lead, do we need all 12 leads simultaneously or one at a time? If one at a time should they all be of the same time interval, sent sequentially, or a representation of the time interval over which they are being sent? How are we going to send it? Who is going to receive it and what will happen to it then? While the reader may not know what is or is not the right answer, they should at least realise that there are quite a few questions that need asking and a simple "that's how it has always been done" is insufficient.

  As we will discuss later, devices themselves are not a solution, in fact most devices on their own have little diagnostic value, there are other components necessary to ensure that they work as part of a solution that at least allows access to an appropriately qualified person to use/interpret the data received.

  It is also important to realise that because a 12 lead ECG unit has a data port and is "communications enabled" that does not make it a telemedicine unit. Telemedicine requires appropriate data communication and trained personnel. And what does "communications enabled" mean? Often it means that it can communicate with a computer, this is also potentially very misleading. Those with PC experience you will know that even if everything works correctly now, if you try and install a new program or device, while it may or may not work, other applications and systems that were previously working may now not work! This is not an acceptable outcome for a medical device! There is a serious lack of understanding, outside the regulatory bodies, about the use of computers in the medical field and about what is and what is not a medical device and where responsibility for failure lies.

  This brings us back to the first point, companies that produce these devices, sometimes also produce a range of other devices that link together to make a total "solution". While this negates the point that the device is entirely stand-alone, it does create an additional problem that you have to use their components, their terminals, their software etc. This is how the computer market was before the advent of the IBM Personal Computer (PC) 25 years ago. To fully appreciate what this means think about your PC. It doesn't matter what make it is, it has the same look and feel (through the assumed operating system, Microsoft Windows) as every other PC. You can buy any PC software and it will run, any hardware and it will connect. You can take data off your PC and run it on someone elses!

  We take this interconnectivity for granted, businesses have grown up that only make certain bits of computer hardware. Perhaps less well known but more technically interesting, is the fact that specialist programmers write pieces of code which are used by other programmers to incorporate into their own offerings. Before the "PC" this did not happen, it could not be done. Not only could you not take a floppy disk from one computer and run it on another, the disk probably wouldn't even fit. Programmers not only had to write programs for your specific computer but they had to know or restrict you to a set of known printers and other peripherals.

  Just as the PC market changed, so too must the medical market. For the PC this was brought about by an open hardware platform (the IBM Personal Computer or "PC") and a common operating system or user interface. The medical market must change in a similar way but with one important additional item, the adoption of common practices and standard clinical procedures on a national basis. This is nothing to do with clinical or regulatory standards, which are already well catered for, but a clear set of "Standard Operating Procedures" to ensure different people in separate locations know what is going on, where in a process things are and what comes next.

  Most professions have clearly defined rules and procedures, as circumstances change then the rules change. Medicine is practised by highly qualified professionals but, and this is really serious, they practice medicine in their own particular way. Imagine if this was how air traffic control was handled. With the advent of e-health, many clinical interventions will be done out of the physical presence of a clinician, or by a less qualified clinician remotely supported, for this to work smoothly there need to be clearly defined operational procedures and processes. As already stated, we are not referring to aspects already adequately covered by existing standards bodies and agencies but the specific elements that pertain to remote use and the interaction and interoperability of people and systems when connected electronically.

  Given the global economy in which we now live, these procedures and processes must be International. For example, most airlines now use a company called MedAire in Phoenix, Arizona to handle medical emergencies in the air. As new technologies, such as remote medical monitors, allow the MedAire physicians to obtain qualitative information on the patient's physiological parameters, clear international standards and procedures need to be in place to allow, or deny as appropriate, access to patient information and the forwarding of this to the next people in the process chain

THE UTILISATION OF TELEMEDICINE (INCLUDING TELECARE) AND ITS FUTURE POTENTIAL FOR IMPROVING SERVICES

  As has already been mentioned, the term "Telemedicine" now comes under the broader banner of e-health, along with Telecare. However, the intended use for this inquiry is presumed to be the use of e-health systems and services to deliver remote medical interventions (telemedicine) and ongoing remote care at home or other non-medical facilities (telecare). The key word here is "remote", which simply means that one or more elements of the solution are not at the same locality as the patient. Remote can, therefore, be as diverse as the care of an airline passenger by a doctor on the ground or a patient receiving care at home from a community nurse with remote access to patient records, hospital booking systems etc. Large distances are NOT a prerequisite!

  At the moment, instances of telemedicine and telecare tend to be looked at in isolation, a bit like looking at flour, eggs, sugar etc as the end product without looking to see how these things can be put together to make something that is more than the sum of the parts! Indeed, very little consideration is given to telemedicine despite the huge cost being incurred in building NPfIT, which will enable telemedicine and turn it into a major form of medical intervention. This could be likened to the use of aircraft by the military at the outbreak of World War One, the powers that be saw them as little more than observation platforms, by the end of the war they had their own service and now "air supremacy" is seen as a pre-requisite of any land or sea intervention!

  NHS Direct is telemedicine, the initial activity is telephone based, however, despite doing a reasonable job for many, it does a less than adequate job for most long term or repeat illness patients. In these cases the call centre operative deals with them in exactly the same way as someone who calls in with a stomach ache, these people need an enhanced system where they reach a clinician with direct access to their notes and, in the case of longer term illness, perhaps even real time medical parameters, blood pressure, ECG etc. It is not that the capability does not exist; it is that there is no high level support for such initiatives.

  Instances of telemedicine and telecare are currently run as local "pilots" where there is a clinical lead that is willing to support the initiative. Often funding for such "pilots" dries up or the clinical lead moves on. This lack of high-level support means that the same initiatives are piloted again and again all over the country, the outcomes of previous pilots being completely unknown to anyone other than those intimately involved in the project. This lack of understanding also means that people with little or no experience of telemedicine are able to pass themselves off as experts, if you are ignorant of something, someone who knows a little is, in your eyes, an expert!

  There is also a sense that telemedicine systems, because they connect to computer systems, which are getting cheaper and cheaper, should also be significantly cheaper than hospital systems. An over the counter blood pressure unit from Boots can cost you less than a hundred pounds, a hospital unit often costs ten times this. The answer is clearly one of quality, but as more and more of these systems are produced their unit cost will reduce. What we shouldn't do, but is happening, is to compare telemedicine systems based on low quality components, with the equivalent high quality hospital based system.

  Once we make this change of attitude, the potential for telemedicine far exceeds our imagination. Care homes are, by their very nature, places that tend to have a greater need for home visits and out of hours care. By putting telemedicine equipment into these locations and connecting them to a "virtual GP" system, much of this need could be addressed remotely. Community nurses should also be equipped with appropriate systems both in terms of monitoring and remote access to electronic patient records, decision support tools and so on. Once established, with the staff and patients both conversant with the systems, it will be possible for regular, routine monitoring to take place, not just knee jerk emergency intervention. Regular monitoring combined with other pieces of relevant information can be used for early intervention and ultimately prevention.

  As has already been mentioned, however, telemedicine is not simply about technology, it requires the adoption of common practices and processes. This cannot be achieved by individual "pilots" run by local enthusiasts, this must be done, first in a specific area (where it is evaluated and problems ironed out) and then systematically on a wider and wider basis until adopted nationwide. This requires support at the highest level within government and, on an international basis, through cooperation and mutual development with other countries.

  Telemedicine will also enable a strong interaction between the private sector and NHS. There is a diving company, based in Aberdeen, which provides telemedicine support for their divers, even while still in hyperbaric chambers. A doctor, also in Aberdeen, is able to monitor a diver, under pressure in a hyperbaric chamber, on board the company's diving vessels, wherever they may be, anywhere in the world. Under the NPfIT, these divers will all have an electronic patient record; the private doctor in Aberdeen should be allowed appropriate access to this record to be able to properly manage the current medical situation. Likewise, on returning to shore, the diver's GP should be able to see what action was taken by the doctor in Aberdeen and by any medic on the ship. This is just one example of how companies and even individuals will pay for medical services, the outcome of which is available to NHS doctors, thereby simplifying and streamlining the interventions and care given and ultimately reducing costs through cutting out duplication of tests etc.

  Ultimately, people will be able to receive hospital grade monitoring in their workplace, at the gym, on board an aircraft on holiday and so on. These cease to be isolated incidents but part of the complete picture of a person's long-term health.

THE RECOMMENDATIONS OF THE HEALTHCARE INDUSTRIES TASK FORCE (HITF) REPORT, PUBLISHED 17 NOVEMBER 2004

  The main recommendations of the HITF report were contained in nine key outputs; however, these are primarily concerned with medicine as we know it, not e-health, which is seen as a new technology in itself. It is our belief that, within a very short time frame, all aspects of health will, in some way, integrate with a wider "e" component, even if they are not themselves part of an overall e-health solution. To that end, this report emphasises the additional aspects needed for this to happen.

  The HITF report seeks to "inform procurement decisions and encourage the support and uptake of useful, safe, innovative products and procedures". For this to happen, there must be some system of evaluation and assessment that has also been proven in real life scenarios. Unfortunately, unless these recommendations are followed through, nothing changes. There is also the need to "train the trainers" with regard to the wider benefits of e-health. While the outputs of the HITF are being considered and the follow-on actions devised, e-health implications must be built in. Otherwise technology will only be an add-on to existing practices, not an integral part of healthcare delivery, the folly of which has been well illustrated in earlier examples.

  The report also seeks to "Stimulate more innovation and encourage a more entrepreneurial culture in industry and the NHS". The only part of this that needs serious action is that part involving the NHS and even here it is not a lack of desire on the part of those involved, simply those in decision making positions. The UK leads the world in the development of innovative medical technology; the problem is not one of innovation but one of innovative leadership. The author and a number of colleagues have been trying to bring a number of things to the attention of the "powers that be" for, in some cases, almost 10 years.

  The HITF report calls for a new Innovation Centre, while this is a good idea in principle, what we really need is an "Incubation Centre" (as recommended at the beginning of this report) where innovations are used and tested in real, working situations. Within such a centre the relevance to and capabilities of integration and interoperation with other systems can be evaluated and an appropriate blue print of how they should be used in other real world situations defined. The "Incubation Centre" would not be just a showcase but a model of how innovative technologies can be used. Nurses need to see other nurses working with something to understand the true potential and value; the same is true of all professionals, not just in healthcare. Such a centre would also fulfil a large number of other recommendations of the HITF report, with the exception of introducing an "innovation fund". However, the output of the "Incubation Centre" will do this and the need therefore is not for a "fund" but to fund the "Incubation Centre".

  One aspect looked at in the HITF report is procurement. It is not for us to make recommendations outside our sphere of expertise. However, common sense would suggest that if an "Incubation Centre" is established and it delivers clear guidelines on not only how to use a specific piece of technology for a particular function, but defines best practice procedures and processes, then healthcare agencies within the NHS should, subject to their own budgetary constraints, be able to purchase said technology for use in this manner. Those involved in the procurement process should actively work with the "Incubation Centre" to ensure that "cost effectiveness" is a major consideration and provide details of how this is evaluated.

  e-health also has a serious role to play in providing the evidence base in support of R&D activities. Regular monitoring of everyone, by using e-health tools as part of an overall e-health programme, will provide a greater understanding of factors leading to ill health. At the moment people only really enter an evidence-based program once they are already sick. e-health offers the first real chance of monitoring people, both well and sick, from before birth until death and should, therefore, be embraced as a common thread to any R&D programme.

  The author is aware of a number of initiatives involving different academic centres of excellence, which are looking to be "the recognised academic body" within a specific area or aspect of health. The problem here is one of status, rather than have one official academic centre, which will not stop other centres from trying to out-do them to show that they should have been the "official centre", the academics should work with the "Incubation Centre", as outlined above, to ensure that all are working to the same goals.

  The establishment of an "Incubation Centre" would also provide a platform from which to address communications with and between patients/the public and clinical bodies/government agencies in all aspects relating to e-health. A working centre that is open to public scrutiny and which would actively encourage the participation of patient and healthcare groups, including Royal Colleges, Unions and other interested parties, would provide an open forum that would actively encourage communication. This, in turn leads to education and training.

  "Knowledge dispels fear" is an apt phrase because the converse is also true. People are afraid of what they do not understand. When PCs were first introduced, people from all walks of life became concerned about their jobs and a myriad of other completely unrelated things. Training and education removes this barrier of fear and people move on.

  The HITF report suggests "Maximising UK influence in regulatory matters in the EU and other international forums". We agree with this wholeheartedly, the UK already leads the world in many aspects of e-health and to apply best practice and standard operating procedures to this at a time when they simply do not exist would be to secure our long-term influence. This is also a major cost factor as, if other standards are adopted in preference to ours, then in order to operate on an international basis, our systems will have to be changed or adapted to meet these different standards.

THE SPEED OF, AND BARRIERS TO, THE INTRODUCTION ON NEW TECHNOLOGIES

  It is fair to say that most e-health "pilots" have not moved beyond the initial "pilot" stage. The reasons for this have been well documented above, principally they have been driven by a single, local, sponsor with no ongoing funding and no "place" for a full blown service within the current healthcare structure.

  Healthcare is broken up into very distinct compartments and if an initiative crosses boundaries, or worse if the benefits of an initiative are seen in a different segment, there is no funding. Sources of funding also change, and even when funding has been obtained, it is not unknown for this to be used somewhere else within an organisation, not for or even by the department that applied.

  There is little to no long term planning, with short-term goals taking precedence over long term objectives that bring accumulating benefits.

  There is a lack of trust by clinicians in IT systems, which have, in the past, been purely administrative tools. There needs to be a place where people from all sectors of healthcare can go and see new technology being used in real situations by ordinary people.

THE EFFECTIVENESS AND COST BENEFIT OF NEW TECHNOLOGIES

  As new technologies, practices and processes are adopted, there will be the initial benefits for which they were intended, but there will then come additional benefits, many of which will remain unknown until they actually happen. What we have to be wary of, however, is a simplified comparison against some arbitrary factor.

  There was a dermatology pilot conducted between GPs in rural practices and a remote consultant dermatologist. When the GPs were faced with a skin problem they could not identify, an appointment would be made for the patient to return to the practice at a time when the doctor could have a live link to the remote dermatologist. The skin would be photographed using an appropriate digital camera and the image sent to the dermatologist. He would discuss this with the patient in the presence of the GP.

  At the end of the project it was reported to be a failure, not by the doctors, patients or dermatologist but by a third party auditor. The reason for the failure, after an initial period of regular use, the system was used less and less. On questioning the doctors, they deemed it a huge success. Why the drop in usage? Each time they referred a patient, they were, in effect, receiving ongoing training. Once a condition had been seen on a number of occasions, the doctors no longer needed to refer the patient but were able to deal with the situation themselves!

  Healthcare will never cost less, however, it will be possible to do more for the same amount. As new technologies emerge, when a patient is screened for one particular aspect, it will probably be possible to simultaneously screen for many other things at the same time. Medicine will start to move from only dealing with people once they are sick, to managing them while they are well and intervening at the fist sign of "preconditions" to act in a preventative manner. Once this happens, healthcare in the UK will move to a truly National HEALTH Service.





 
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