Project PANACEA

EUREKA FUNDED PROGRAMME PROJECT DESCRIPTION PANACEA Consortium August 1994 AGENDA SECTION 1 PROJECT INTRODUCTION SECTION 2 COMMUNICATING THE ELECTRONIC PATIENT RECORD SECTION 3 PATIENT DATA CARDS - ROLE AND STATUS Role of the PDC Current Status User Requirements Smartcard Technology What is a universal interface? SECTION 4 PANACEA PDC INFRASTRUCTURE Data Structures Security Interface to healthcare applications SECTION 5 PROJECT DELIVERABLES Document Summary This document describes the background to Project PANACEA and the planned deliverables. The content is designed to be used within the Project Initiation Document (PID) and as a detailed project description for external and internal communications. Version 1.0 9 July 1994 SECTION 1 PROJECT INTRODUCTION A patient held electronic medical record that is both dynamic and evolutionary, accessible wherever care is provided, has been projected as part of future healthcare services in most western countries, including the UK. For almost ten years, there have been a succession of trials of such a record based on portable electronic devices, such as smartcards or memory cards, which whilst highlighting both potential benefits and pitfalls has not yet led to any wide scale usage. The PANACEA project is not another such trial, but focuses on removing one of the major barriers to the successful use of a patient held medical record. Its principal delivery is an open software infrastructure that can integrate into individual health services information system strategies providing a seamless view of the electronic patient record, no matter where the data is held. Project PANACEA will develop this software infrastructure and then test its acceptability both from a technical and clinical (user) view in two locations: Exeter, Devon and Lisbon, Portugal. This will involve the integration of the software infrastructure with a number of existing and planned healthcare applications. Part of the piloting process will involve the use of mobile computer systems within a community healthcare environment. The advances this project will bring include: Universal/open format for communicating the complete medical record between incompatible application systems based on Read 3 clinical coding structure Use of mobile computers in a remote clinical application Greater synchronisation of medical information between different computing systems and services Providing a solution to the problems of patient record access within community care The expected success of the project is based on the experience of the PANACEA consortium that combines healthcare, academic, industry, consultancy and government backing. The prime partner is the University of Exeter that has pioneered many developments in the areas of primary care and electronic records, in addition to providing local management for one of the most successful pilots of patient held records in Europe - The Care Card. Bull Information Systems, and its sister company Bull CP8, have led the development of smartcard technology for over a decade, and has extensive experience in designing and advancing the introduction of patient held records, and in the integration of healthcare applications. Exeter and District Community Health Service NHS Trust who will trial the software infrastructure within their mental health services, backed by their application systems suppliers. Abies Medical Information Systems who have extensive experience in developing clinical based applications and integration with patient held records. F7 Consultoria em Systema of Portugal who provide consultancy services to the Portuguese health service, and who will both provide application products and services to the Lisbon trial of the infrastructure. The project is based on several man years of international design on the requirements of a portable electronic patient held record and software infrastructure, and on the experienced gained from several of the major international implementations of the technology throughout Europe. As a EUREKA funded project, the UK implementation is supported by the Department of Trade and Industry. SECTION 2 COMMUNICATING THE ELECTRONIC PATIENT RECORD In today's health service, medical information concerning the patient is scattered and uncoordinated between information systems used by the different parts of the service. Hospital systems (e.g. Patient Management, Ward Systems etc.) hold details on the patient that relate to specific inpatient or outpatient care. The Laboratory system holds details of test results, various Community agency systems hold details specific to their focus, some pharmacy systems hold details on medication dispensed and General Practitioner systems typically hold comprehensive detailed summaries pertaining to their direct knowledge of patient conditions, diagnosis and treatment programmes. The problem is that even in the most computerised environment, the electronic patient record is dispersed and uncoordinated over a wide range of incompatible systems such that no one clinician has access to all the pertinent parts of the record. Often data is incomplete or worst, out-of date. This leads to uncoordinated requests for information, and care based on partial data. To communicate medical data between two or more healthcare professionals, several communication methods are used: Post, telephone, electronic mail and facsimile. However, except for the telephone, all other communication methods are not synchronised with the movement of the patient. When a patient is referred to a hospital, or discharged from hospital, the information that is communicated between secondary and primary care is based on known data a point in time. It does not take into account any treatment or diagnosis that may take place between the communicating of the information and the next time the patient comes in contact with the carer receiving the communication. In England, the NHS plan to install a nation wide network that will allow all information systems to communicate with each other using national and international standard messages. This will certainly enhance the current environment. Unless, however, all information systems are enhanced so that they can interrogate each other's databases, or all the existing systems in use are replaced with equivalent systems that are both compatible and capable of sharing information across the network in real-time, then the information gap will continue. This is because of the potentially unpredictable movement of the patient. Acute hospitals are starting to move in this direction through the centrally co-ordinated HISS programmes. But to expand this programme to include all aspects of primary care and the many community agencies is today thought to be too big a challenge. The patient held record represents the key to both synchronisation of data and catering for patient movement. It does not replace a national network, but complements it. Each time that a patient receives care, the card is used to update the local healthcare professional's information with data collected since the last contact, and act as a communication media for new information associated with this treatment/diagnosis/ investigation. The professional does not need to predict who will next require access to the new information, but by adding it to the portable record, can be assured that it will be available at the point of patient contact. Current communication of discharge reports, laboratory test results and radiology reports between hospitals and GPs will still be required to provide the relevant healthcare professional with information in advance of the next patient contact. The card simply fills the information gap. SECTION 3 PATIENT DATA CARDS - ROLE AND STATUS 3.1 Role of the Patient Data Card The patient held record or, as it is most commonly known, the Patient Data Card (PDC) has three roles: To provide an effective identification of the patient. When the card is submitted to an information system it provides patient identification details that will allow the system to correctly match the patient with its local data. To synchronise data between incompatible and dispersed information databases. To provide mobile information systems, such as hand held computers, with access to the patient record. i.e. for domiciliary visits. It can contain the full range of patient data including: Identification and other demographic information Medication details (+ prescription and dispensing details) Emergency details Diagnosis and treatment summaries Test results and potentially images 3.2 Current status of PDCs As was indicated earlier, since 1985 when the first PDC implementation took place in the French town of Blois with Carte Santé, there have been many trials but no national implementation. Pilot implementations have typically been based on either: a dedicated application that reads and displays the data to/from the card a front end application that read the card and then passed it to a healthcare application integration of the card with a single application. Whilst each trial showed that the smartcard or memory card technology was: capable of holding the data required robust enough to be carried by the patient, and that there were benefits or potential benefits in the use of the technology The implementation method chosen limited the potential for rolling out on a wider scale. The obvious draw back in each of the above implementation methods being: If a dedicated application that simply managed the card as a separate database, it would not be either financially or operationally viable to have an additional system at each point of care just to handle the PDC. Such an environment would add to the clinician's workload without providing any long term answer. If a front end application, then the cost of having additional hardware and software combined with the integration with existing systems would make the solution on a large scale financially a non starter. If PDC support only came with a dedicated clinical application then this would need to be installed at each point of care - again, it would not make financial sense. It can easily be seen that the only practical solution to the use of PDCs would be if any existing application could easily, and at a low cost, access the card as though it was another local database. Much as in the same way most healthcare applications can support some level of data communications. In the UK there are still a number of small trials either starting up, as in Aberdeen in Scotland, or continuing as in the Care Card, but no plans for any wide scale or national use. As the cost of integration with existing systems is prohibiting individual health authorities taking local initiatives, PDCs will probably not progress any further. The only way that the PDC will start to be used is if a software infrastructure is put in place, where existing systems can be easily and at a low cost, adapted to integrate the portable record, where all the inhibitors are addressed so allowing for local implementations that can naturally progress to a national or regional scheme. This is the heart of project PANACEA. The software infrastructure being EuroCare. 3.3 User Requirements In understanding what are the barriers that have held back the introduction of PDCs, it is first important to recognise what is required for a successful implementation. The criteria for success: (1) Patients must carry them Unless the patient carries the card with them at all times, then it will provide only part information. If this becomes a common situation, then the value of the PDC will be considerably reduced. (2) Professionals must use them If the professional does not ask for the card at the start of each consultation, then once again only part information will be contained on the portable record. (3) No conflict with National Government Initiatives Any Patient Data Card system introduced must not be in conflict with the national strategies and initiatives, for example, in the UK with the Community Information System for Providers (CISP) programme. If it did, then it would be difficult for individual hospital units and other healthcare agencies to justify the required budgets for implementation. (4) Must be a cost benefit There has to be a tangible cost benefit before such as system could be introduced. Looking at each of these four criteria for success in more detail: - Patients must carry them Experiences from existing PDC systems throughout Europe show that Patients will carry the card if they perceive a benefit. High card carrying rates were identified where the patients felt that the card was actually contributing to a better service from healthcare providers. This belief most often occurred when the patients' could visibly see the card being used, and where there had been a programme of patient education. Simply stated, patients carried the cards when they believed that the healthcare professional that they come in contact with actually requires the card as part of the process of care. - Professionals must use them Experience has shown that professionals ask for and use PDCs when they perceive a benefit. Whilst it is easier to introduce a patient data card where there is only limited existing information systems in place, except for care away from the normal healthcare base, without such an infrastructure there is little purpose for the portable record in shared care. A key factor for success is, therefore, that the use of the card must not create any additional processes for the professional. So, for those General Practitioners, for example, that have implemented information systems that are patient/person focused, the PDC must be directly accessed by the existing system, appearing almost completely transparent to the user. The two separate patient records must appear as one to the user. - No conflict with National Government Initiatives The PDC needs to integrate with the existing systems and IT strategy. Within the English NHS, this means integration with the various central initiatives, whilst supporting the standards that are being introduced under the IM&T Strategy. It must also take into account the key ethical and data protection issues. Costs in developing a truly universal PDC software interface that can interact with many different healthcare systems have previously been underestimated. Because of this there has been a gap between the potential PDC off-the-shelf applications and user requirements. - Cost Benefits The most difficult criteria for success with PDCs are that they must be seen to be providing cost benefits. Most trails and initial implementations have shown potential cost savings in areas such as reduced administrative tasks, medication prescribed and investigations, however, the size of trail with limited patient coverage has meant that the findings could not be easily translated into tangible cost savings. Where the patient data cards are used by specific patient groups that require either concentrated or prolonged periods of care such as in child health, metal health, diabetic care or care of the elderly, it is easier to identify the cost benefits. 3.4 International Requirements In addition to the requirements described above for a successful implementation, there are a number of necessary additional facilities identified if a PDC infrastructure was to be country independent. Language independent The data held on the PDC should be language independent, so that when a patient travels between locations where the main communicating language changes it should be possible for the data to be transferred to the local application in that language. Supports national security/data protection/legal requirements Each country has differences in what medical information can be accessed and by whom. The infrastructure must allow for local rules/regulations to be applied in a way that when the patient travels to a different country the then local rules/regulations would apply. Coding system independent Not all countries utilise the same coding/classification standards. The data held on the card must be coding system independent so that when it is read by any one application the data is transferred from (and to) the card utilising in a form acceptable to the local system. Technology supplier independent The infrastructure must be independent of technology and supplier, i.e. Open, if it to be acceptable to any agency that wishes to utilise it. 3.5 Smartcard Technology The technology requirements for a patient data card can be summarised as: Durable, as it will be treated similarly to any other piece of plastic card; Large enough memory capacity to hold a patient medical and administrative data Is secure from unauthorised access to the medical data Quality look and feel The smartcard, or Integrated Circuit Card (ICCard), and to a lesser degree, the Memory Card can satisfy these needs. An IC Card is a single piece of silicon to ISO standards for bank cards in terms of size and flex. Into the plastic is embedded a single chip microcomputer, as the diagram shows below. With the advanced in IC Card technology, there should be no restrictions on what data can be recorded on the card. If efficiently recorded, today's cards can hold up to 50 A4 pages of information. And as most medical data held on the smartcard is typically coded (e.g. utilising the Read Clinical Classification codes in the UK), today's technology is capable of holding an average patient's history for up to 10 years. Although the plan is for the EuroCare software infrastructure to support other card technologies, the initial development will concentrate on the IC Card. The self programmable one chip microcomputer (SPOM) embedded into the ISO standard plastic card is comprised of a Read Only Memory (ROM) that contains the IC Cards operating system, a RAM which is used as working memory, an EPROM or EEPROM memory that contains the medical record and an 8 bit central processing unit. The core of the card is made from white PVC which is then covered on both sides by a thin film of transparent PVC. This allows the support of all the physical aspects of the international standards and embossing of the card. The IC Card represents an ideal medium for storing patient related information because of its inherent security architecture and design. Maximum security is provided through the physical and logical specifications of the chip and the manufacturing process. Inviolability and fraudulent copying are guarded against by the use of FAMOS technology with buried layers of non erasable memories able to withstand magnetic and electro-magnetic fields, X-rays or ultra violet rays. The operating system that is etched into the Read Only Memory during the chip manufacturing process determines the IC Card's capabilities and security controls. The only external access to the micro chip is via the central processor unit and hence the operating system. The secure operating system controls all access to the memories including the patient data, as wells as managing the structure of that data and all external behaviour. The operating system supported is based on ISO recommendations and supports a hierarchical filing system which is ideally suited for the PDC application. Each level has its own security controls based on a sophisticated access control and authentication system. IC Card Data Files To read or write to the cards data files, the card first checks that the request has come from an authorised individual by the submission of security keys. These keys also determine what data the requester has the right to access. If there is any attempt to "hack" the card it will automatically lock itself from further access and require to be unlocked by an authorised body, typically with a PDC the patient's GP. In the diagram above, one data file contains the medical record, divided into a number of sub files that contain groups of information. The "other data" is clinical based information that would only be accessible by clinicians. If there is an attempt to penetrate the cards memory through any physical attack the card will immobilise its security files, and depending on the type of attack, may become permanently inaccessible. In addition the protection from external environments, the microchip is contained within a well of resin that allows the plastic card to be bent and twisted in line with ISO standards without any damage. It is therefore well suited to being carried and stored in the same way as other plastic cards. 3.6 What is a universal interface? The software infrastructure at the heart of project PANACEA is a universal interface, known as EuroCare, designed in a number of discrete layers. Acting as the translator between the card and the application, it is designed to be linked into existing healthcare information systems whilst accessing any PDC which could be based on one or more technologies (IC Card, Memory Card, ISTN etc). It is designed in such a way that it can reside on any host utilising any operating system, the only limitations being the requirement to first have the interface ported to the particular host environment, and the external connection of an intelligent card reader using an RS232 interface. SECTION 4 PANACEA PDC INFRASTRUCTURE This section describes the EuroCare interface, the security architecture, data structures, the application interface and how it will typically be linked to healthcare applications. The main functions of EuroCare interface are: Takes data from application and writes to card in common compacted form Reads data from card decompacts, and passes to application Manages access rights and general security Translates data from card into free text or other coding Translates data from application into common codes Manages physical and logical card interfaces 4.1 EuroCare architecture The EuroCare interface is divided into four main sections, the Application Interface, the Card Driver, the Translation Layer and the Card Interface Layer. Application Interface This interfaces with the existing healthcare application by providing a series of commands which can be called to carry out specific patient data card and host functions. Validation is carried out on the command requests and data received before the command is executed by calling the relevant functions supplied by the Card Driver. Translation Layer This will be, in effect, a library of functions which can optionally translate the data and clinical codes on the card into other application specific codes. Card Driver The Card Driver will contain those functions which call the Card Interface Layer. These functions may not always be those which the application is aware of, as one command issued by the application could equate to several actual functions. Once the function(s) to be carried out is determined, the command(s) and data are sent to the Card Interface Layer. All communications with the Card Interface Layer are managed within the Card Driver. Card Interface Layer This resides on the intelligent IC Card readers, interfacing directly with the cards. An objective of implementing as much code onto the Intelligent IC card reader as possible is that the more code which can be stored on the Intelligent IC card readers, so making it easier to port the system to different host operating systems. The Card Interface Layer contains the security controls, compaction and decompaction of data, record management and physical interface with the IC Card (or other card technology). A more detailed description of the functions of the layers of the interface is included within the following subsections. 4.2 Data Structures The data storage has been designed for multilingual support, therefore all of the data on the card which can be stored using recognised coding systems uses them including ISO standards for data definitions. A brief description of the data which is stored on the cards is given below. i) General Information about the patient. ii) A subset of the patient's medical record including all historic data which would be relevant to any future treatment. iii) Medication and Emergency information. This will allow the card to be used during or for the dispensing of drugs. A doctor would write the prescription to the card, the patient would give take their card to a pharmacy who would use the card to dispense the medication. After the medication is dispensed information is written to the card to show this. The data structures used within the patient data card, and in communicating with the healthcare application, have been designed to be very flexible in order to allow the system to store further information which may be required in the future, for example costing/contract related details. As far as the application developer is concerned, there are four data files with different levels of security and each is stored in one of the four WZs (Working Zones). The contents of these different files are :- WZ 1 - Administrative Identification of the patient Registration details Notes Special Records Extension Records WZ 2 - Emergency data and medication Notes Special records Extension records WZ 3 - Other data (main clinical record, test results, observations etc) Notes Special records Extension records WZ 4 - Tables Site table Author table Deletion table Record Table The tables defined above in WZ 4 are used within the PDC to minimise space taken and to provide a form of audit trail. It is necessary to identify against each data item written to the card who was the author of the information (normally a healthcare professional), from which site and from which system the data was transferred. On the card, therefore, this information is stored in tables and indexed to the individual data items. The deletion table identified data items that have been designated as deleted and no longer valid. The record table allows data items to be linked together in the form of relationships such as a Care Plan. An author table entry is unique for an individual and each individual should usually only have a single entry in the table. However, occasionally a health professional may have more than one identifier on account of different posts in different locations, for example a GP who also attends his/her local community hospital. A site table is unique for each separate application database (e.g. a PAS). Two application databases should be defined as separate if they are not updated by each other in real time. In this context if a change made after reading a card or making a manual entry on one application is not immediately resolved with the other application, they are separate. Usually each computer will have a different identifier unless the card based functions act directly on a common file server or network. Where departments keep separate databases on the same multipurpose computer, the application itself will need a separate identifier. This way the issue of synchronisation of data can be fully addressed. The data formats used in the card are not seen by any external application and are used to provide the maximum flexibility with efficiency of storage. The data structures passed between the Interface and the healthcare application represent the external view of the card and it is therefore these that are described below. The data structure used by EuroCare have been designed to be flexible enough to interface to any general healthcare application. There are four types of data structures used in the interface - Primitive, Major, Extension and Special. The primitive data structures are component parts of the major and extension data structure and therefore will not be passed across the interface as records in their own right. Examples of these include, identity of author, date, patient name, post code in an address, and dosage on a medication request. The major data structures are the five main record typess which exist in EuroCare. Every time an update is made to the patient's card, it will consist of at least one of these records. IDENTIFICATION REGISTISTRATION NOTE EVENT* PRESCRIPTION EVENT EXTRA (general) *Examples of a Note Event record include: general clinical record, medication details, sensitivities, administrative associated with medical history, family history details, past history details, possible diagnosis, confirmed diagnosis, planned activity, carried out activity. At the time that the identification record is written to the patient card (i.e. on issue), there is some additional data which must also be written. The first site and author table entries must be written as these entries define who issued the card and where it was issued. Additionally, the site country and site region fields of the first entry in the site table define the validity of any Extra records which are specific to Country or region. This record can never be deleted. Any required change to this record would require a new card to be issued. There may be any number of NoteEvent records within the EuroCare ADF. These records may be in WZ 1, 2 or 3 according to the required level of access protection. Other records may be associated with the NoteEvent record either by physical location or by reference to the record handle of the NoteEvent (i.e. its WZ number and record number). By this means it is possible to string a number of records together as an episode of care or care plan. The NoteEvent record can be explicitly deleted and is never implicitly deleted (by a later NoteEvent). Changes cannot be made except by deleting the record and creating a new record which includes the changes details. Any extension records associated with the NoteEvent record are deleted (by the interface) when it is deleted. The Extra record forms a header identifying additional records which do not form extensions to the preceding NoteEvent record. Any number of extra records may exist in WZs 1, 2 and 3. The Extra record is followed by a number of general extensions which contain the data specified by the Extra record. There is no validation of the ordering of this data, so this allows extensions to be defined without impacting the interface software. Applications which do not recognise the Extra record will ignore its data content after a read rather than reporting any errors. The interface should refuse to pass through any Extra records on a write which are national, regional or local unless the issuing nation, region or local application of the card (as found in the first site record of the site table) matches that of the current application (as found in the Extra record) at the appropriate level. The extension data structures are used to provide a high degree of flexibility in what is written to the patients card. These records are 'appended' to one of the major records to enhance its meaning or to provide any extra information which the application feels is appropriate. Any number of extension records could be 'appended' to a major record. However, extension records only have a meaning in the context of the major record to which they are attached and therefore these records cannot be written to or read from the card on their own. When a major record is passed across the interface, all it's extension records will automatically follow it and likewise, when a major record is written to the card, any associated extension records must be written immediately afterwards. Examples of extension records are: MEDICAL AUTHORITY INTEGER DOSAGE FREE TEXT NUMERIC DATA FINANCIAL DATA AUTHOR SITE DETAILS EXTENDED NAME EXTENDED ADDRESS DATE TIME The special data structure is the end session record. This record is written automatically by the EuroCare Interface to the card in any data zones which have been changed when the Close card command is carried out. It therefore can never be written by the application but can be returned with all the other records after a read command. The nature of the data structures chosen means that it is not possible to know how many records or what type of records, will be returned by the EuroCare Interface after the execution of a "Read card" command. Therefore a dynamic list is used to pass records back from the Interface which can hold a variable number of records of diverse types. 4.3 Security Access rights for health professionals will be controlled by issuing them with keycards (IC Cards). These keycards are set up with different levels of security for the different types of health professional so that the working zones (WZs) which a health professional can access can be restricted. In order for a health professional to access a patient's card they must use their keycard in conjunction with a password. This ensures that keycards which are lost or stolen cannot be used by anyone else. All cards become 'blocked' or unusable after the entry of a pre-defined number of wrong passwords. This situation can only be reversed by someone with the necessary authority. All the security features listed above are provided by the EUROCARE INTERFACE. As far as possible these are implemented using the cards built in security mechanism, where this is not sufficient the security will be handled by the software which is burnt into the Intelligent IC card readers ROM. There are several aspects to the security of the EuroCare interface : i) Preventing access by unauthorised personnel to the information stored on the card. ii) Restricting the access of authorised personnel to only those records which they have authority to access. iii) Ensuring that all records have an associated Author and site reference, so that it is possible to track who wrote which information to the card. iv) Restricting the issue of patient cards. v) Restricting the issue of keycards (held by the Healthcare Professional). vi) Ensuring that the issue and use of keycards and patient cards allows for different versions of keycards. For example, a version 1 keycard will not be able to access version 2 patient cards. This will provide an added level of security. During the first access to the system for the day the health professional must place their card into a card reader. The application will then prompt them to enter their password. Once this has been done patient cards can be read and written to within the constraints of the security level of the health professional's card. In many countries it is important to allow the patients to view their own medical records easily. This is both to meet the Data Protection Act and to help the acceptance of the system. To allow for this all the data on the card can be read by its owner on entering their card's PIN. It is envisaged that the application developers will provide a separate system to do this, i.e. it would not normally be a function of the health professional's system. 4.4 Interface to healthcare applications The application Interface receives requests from the application. The processing here will include data validation and determining which lower level function calls are required. Commands will be implemented as a set of procedure calls which are accessible to developers using any language which allows the calling of external procedures in linked C library format. Other applications (which cannot link to C libraries) will pass commands via a pipe or files. This would work by using an application which will accept the commands and data through a pipe or file, then calling the EuroCare interface commands in the normal way with the data. This would be the responsibility of the calling application and is not a part of the EuroCare Interface. Commands include: Check for card presence Open Card Check Patient card (Patient) View card Key card Enter PIN Issue new Patient Card Read card Add record Delete record Close card Example of effect of Open Card command.. Interface will... Check if card is a patient card, unblock card if blocked (PIN), Read identification record, card version number, issue number and update number Checks that version number matches interface version, patient card authenticates keycard and visa versa, returns identity record to application. SECTION 5 PROJECT DELIVERABLES The main project deliverables will be: i) EuroCare interface ii) Interface integrated with a number of healthcare applications iii) A mobile workstation with direct access to patient record (via PDC) iv) Reports on the success of the trial. Project PANACEA Overview Version 1.0
Comments to Dr Robin Hopkins at <100340.2104@compuserve.com>