Patent Document

CROSS-REFERENCES TO RELATED APPLICATION  
       [0001]     The present invention is related in subject matter to the co-pending U.S. patent application entitled “INTEGRATED AND SECURE ARCHITECTURE FOR DELIVERY OF COMMUNICATIONS SERVICES IN A HOSPITAL” to Graves et al., filed on the same day as the present application and incorporated by reference herein in its entirety.  
       FIELD OF THE INVENTION  
       [0002]     The present invention relates generally to systems and methods for preserving the confidentiality of sensitive healthcare information (i.e., clinical data) accessible via end user devices located at the point of care.  
       BACKGROUND OF THE INVENTION  
       [0003]     The ability for a hospital information network to interact with clinicians while they are located at the point of care (POC), e.g., at a patient&#39;s bedside, is recognized as having the potential to dramatically reduce the incidence of certain medical complications. Specifically, studies estimate that significant benefits are likely to arise through the provision of “computerized physician order entry” (CPOE), which consists of allowing clinicians (e.g., doctors, nurses, orderlies) to place orders (e.g., prescription, blood test, clean towel, etc.) combined with the deployment of real-time Decision Information and Support Tools (DIST) to alert the clinician to potential issues, delivered to the clinician via a bedside location in the vicinity of the patient being treated. This simple yet elusive paradigm, dubbed “CPOE at the POC”, has the potential effect of reducing human error due to temporary memory loss and mistakes in transcription by clinicians or clerical staff, since the terminal is at the patient-clinician interaction site and human memory or scribbled notes are not needed to retain the data until entry during a subsequent data entry session at a somewhat remote location. In addition, when coupled with real-time decision information support tools (DIST), CPOE provides physicians with an additional level of assurance that their diagnosis or treatment plan is within generally accepted parameters.  
         [0004]     For background reading on the CPOE at the POC paradigm and its predicted impact, the reader is referred to the following references, incorporated by reference herein: 
         Clinical Decision Support—Finding the Right Path , by J. Metzger, D. Stablein and F. Turisco, First Consulting Group, September 2002      Computerized Physician Order Entry: Costs, Benefits and Challenges—A case Study Approach , by First Consulting Group for Advancing Health in America and the Federation of American Hospitals, January 2003      Leapfrog Patient Safety Standards—The Potential Benefits of Universal Adoption,  by J. D. Birkmeyer, The Leapfrog Group, November 2000      Computerized Physician Order Entry: A Look at the Vendor Marketplace and Getting Started , by J. Metzger, F. Turisco, First Consulting Group, December 2001      A Primer on Physician Order Entry , by First Consulting Group for the California Healthcare Foundation, Oakland, Calif., September 2000        
 
         [0010]     One effect of implementing CPOE at the POC is a proliferation of access points to the hospital information system (HIS). Whereas in a conventional hospital environment, access to the HIS may be gained through terminals strategically located in a limited number of relatively secure locations at ward nursing stations, ward corridors, operating rooms and examination rooms, under the “CPOE at the POC” paradigm there may be hundreds of access points to the HIS since access is to be provided at the point of clinician-patient interaction. It becomes quickly apparent why a major concern with implementing CPOE at the POC lies is in the area of data security and privacy. More specifically, a valid concern is raised regarding the potential availability of sensitive clinical information at a variety of access points, not all of which can be guarded simultaneously or with the same effectiveness. Not only is it apparent that the physical theft of any device containing confidential medical information may inconvenience or harm the patient but, in addition to losing a physical asset in the device itself, the healthcare facility may be faced with sanctions and/or lawsuits, should the contents of the stolen records be made public or if there are reasonable grounds to believe that they will be made public. Moreover, the potential for theft of physical devices and sensitive data, along with the consequences such theft entails, becomes even greater in the mobile version of CPOE, known as MPOE, where clinicians communicate with the HIS through portable wireless devices, whose whereabouts are clearly more difficult to track on a constant basis.  
         [0011]     Thus, there remains a need in the healthcare industry for protecting the confidential nature of clinical data in a CPOE or MPOE environment, where there is a risk of theft, or where there is a risk that the terminal will be temporarily or permanently moved outside the control of the hospital IT system or staff, whether outside or inside the hospital.  
       SUMMARY OF THE INVENTION  
       [0012]     According to a first broad aspect, the present invention seeks to provide a data processing apparatus. The data processing apparatus comprises a memory store; a data bus connected to the memory store, the data bus being adapted for transporting data to and from the memory store; a processing entity operative to release read and write commands towards the memory store, the write command being accompanied by first data intended to be written to the memory store; and an encryption module communicatively coupled to the processing entity and to the data bus. Upon the processing entity releasing a write command accompanied by said first data, the encryption module encrypts, in accordance with an encryption key, said first data and send an encrypted version of said first data onto the data bus for writing into the memory store. Upon the processing entity releasing a read command, the encryption module decrypts, in accordance with a decryption key, an encrypted version of second data received from the memory store via the data bus and provide said second data to the processing entity.  
         [0013]     According to a second broad aspect, the present invention seeks to provide an end user device for communication with a server. The end user device comprises a control entity operative to support a session with the server for an authenticated user and a memory store operative to store sensitive information during the session. The control entity is further operative to (i) determine whether confidentiality of the sensitive information stored in the memory store is to be preserved and (ii) responsive to determining that confidentiality of the sensitive information stored in the memory store is to be preserved, taking an action to preserve confidentiality of the sensitive information stored in the memory store.  
         [0014]     According to a third broad aspect, the present invention seeks to provide a method. The method comprises supporting a session with the server for an authenticated user; storing sensitive information during the session; determining whether confidentiality of the sensitive information stored in the memory store is to be preserved; and, responsive to determining that confidentiality of the sensitive information stored in the memory store is to be preserved, taking an action to preserve confidentiality of the sensitive information stored in the memory store.  
         [0015]     According to a fourth broad aspect, the present invention seeks to provide a method. The method comprises establishing a healthcare session with an end user device servicing an authenticated user; providing sensitive healthcare information to the end user device for storage thereon during the healthcare session; detecting existence of a requirement to preserve confidentiality of the sensitive healthcare information; and, responsive to the detecting, sending a message to the end user device instrumental in causing the end user device to preserve the confidentiality of the sensitive healthcare information.  
         [0016]     According to a fifth broad aspect, the present invention seeks to provide a network attachment process for an end user device. The process comprises receiving operational characteristics of the end user device; selecting operating code for use by the end user device on the basis of the operational characteristics of the end user device; and downloading the selected operating system code onto the end user device.  
         [0017]     According to a sixth broad aspect, the present invention seeks to provide a host entity for use in a network. The host entity comprises a terminal identification module adapted to receive operational characteristics of an end user device and an operating system server adapted to select operating code for use by the end user device on the basis of the operational characteristics of the end user device. The operating system server is further adapted to transmit the selected operating system code to the end user device.  
         [0018]     According to a seventh broad aspect, the present invention seeks to provide a network attachment process for an end user device. The process comprises transmitting first operating system code to the end user device to enable the end user device to transmit a message requesting authentication of a user; and, responsive to successful authentication of the user, transmitting second operating system code to enable continued use of the end user device by the user.  
         [0019]     These and other aspects and features of the present invention will now become apparent to those of ordinary skill in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0020]      FIG. 1  shows an architecture for delivering healthcare communications services to the point of care, including a detailed block diagram of a core hospital network;  
         [0021]      FIGS. 2A and 2B  show two embodiments of a host for use in the architecture of  FIG. 1 ;  
         [0022]      FIGS. 3-6  are block diagrams of an end user device in accordance with embodiments of the present invention;  
         [0023]      FIGS. 7 and 8  show policies applied in order to determine whether there is a requirement to preserve confidentiality of sensitive healthcare information stored in the end user device. 
     
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS  
       [0024]     With reference to  FIGS. 1, 2A ,  2 B and  3 A, there is shown an architecture for delivering healthcare communications services (e.g., CPOE) to the point of care (POC) for healthcare users (e.g., physicians, nurses, orderlies, etc.). The architecture comprises a host processing entity  100  (hereinafter “host”), which consists of one or multiple instantiations, based on size, capacity, physical partitioning, and other factors, disposed between a core hospital network  114  and a plurality of end user devices  104 . Examples of a POC where a fixed-wire end user device  104  may be employed include a patient bedside or a ward, an operating theater and an examination room. On the other hand, the use of a wireless end user device  104  allows the healthcare user a greater deal of flexibility, whereby the actual location of the POC will be governed by movement of the healthcare user. Both scenarios, as well as variations and combinations thereof, are within the scope of the present invention.  
         [0025]     With specific reference to  FIG. 1 , the core hospital network  114  comprises a secure healthcare information network (SHIN)  160 , as well as a general hospital information system  170 .  
         [0026]     These two networks may be physically separate or the secure hospital information network may be protected from the general hospital information system  170  by a degree of separation involving firewalls, additional security, gateway functions, dedicated VPN&#39;s and the like. The secure healthcare information network  160  is connected to the host  100  via a communication link  123 . The secure healthcare information network  160  interconnects various hospital entities, such as radiology (connected to a PACS system), diet, scheduling, pharmacy, cardiology, billing, laboratories, local electronic health records, etc. The secure healthcare information network  160  also maintains a healthcare AAA database  162 , which contains information allowing healthcare users to be authenticated. In an embodiment, the healthcare AAA database  162  comprises a collection of healthcare user identities and securely held corroborating evidence, along with an associated access profile for each healthcare user, which will include a dynamic patient access list based on the hospital&#39;s admissions database together with a specific mapping of who has what accessible data, based upon professional qualifications, status and allocation to patient treatment teams, which itself may be dynamic, especially for shift workers such as nurses. The secure healthcare information network  160  may further interconnect to other hospital information systems via a firewall.  
         [0027]     The CPOE-at-the-POC architecture of  FIGS. 1, 2A ,  2 B and  3  provides authenticated healthcare users with real-time bidirectional access to a suite of clinical tools and databases which can assist their productivity and accuracy while interacting with the patient and making decisions about the patient&#39;s condition and treatment. This is achieved by providing access to a suite of clinical services and applications in the host  100  which can interact with the secure hospital information network  160  under the direction of authenticated users in order to permit access to records of the patient, including historical records, results from recent/ongoing tests, previous/ongoing treatments and drug regimens, etc., while also allowing the authenticated healthcare user to capture his/her decision on patient condition, diagnosis, treatment orders and drug orders to the pharmacy, etc., in a direct-entry process proven to reduce the incidence of clinical errors. This approach allows the use of real-time Decision Information Support Tools (DIST) which can reside in the hospital core network  114  or which might reside as a service on an application server in the host  100 . Such tools provide validation of clinician orders, for instance by checking medical records for other drug prescriptions that are in effect which might lead to a drug interaction with the newly prescribed drug and cause an adverse drug reaction (ADR). Naturally, the healthcare user is first authenticated to be who he/she claims to be, and then the healthcare user is admitted on a limited basis to the host  100  and the core hospital network  114 , based upon his/her access profile. The healthcare user can then access the necessary clinical tools to access patient data for those patients they are authorized to access to a level of read, read/write or write access as allocated from an AAA server located in the hospital core network  114 .  
         [0028]     The host  100  communicates with each end user device  104  via a respective communications link  138 , which may be either an entirely fixed-wire link ( FIG. 2A ) or a partly fixed-wire and partly wireless link ( FIG. 2B ) or even a completely wireless link, depending on the nature of the end user device  104  and the intermediate access transmission system. The communications link  138  may be implemented as a physical end-to-end link or it may be in series with a virtual encrypted link over an interposed general purpose network. Suitable non-limiting examples of fixed-wire cabling for the communications link  138  include coaxial cable, as well as twisted pair (e.g., access-side PBX, Cat 2-3 or Cat 5). In another embodiment, the host  100  is connected via Ethernet connections (e.g., native Ethernet or Ethernet over DSL) to wireless base stations or access points to provide wireless LAN service to areas (such as examination rooms) throughout the hospital.  
         [0029]     With specific reference to  FIG. 2A , there is shown a first variant of the host  100 , which is used to communicate over fixed-wire links  138  with fixed-wire end user devices  104 . The host  100  comprises an interface (I/F)  142 , a session controller  120 , a routing entity (e.g., a router or switch)  112 , a plurality of application servers  144 A, . . . ,  144 N, a healthcare authentication entity  116 , an operating system server  180  and a second interface (I/F)  141 . The routing entity  112  interconnects the various components of the host  100 . The interface  141  connects the routing entity  112  to the secure healthcare information network  160  via link  123 . The interface  142  connects the session controller  120  to the end user devices  104 . In a specific embodiment, the interface  142  may comprise a plurality of dedicated Ethernet ports.  
         [0030]     With specific reference to  FIG. 2B , there is shown a second variant of the host  100 , which is used to communicate over partly fixed-wire, partly wireless links  138  with end user devices  104  that are mobile. In addition to the components described above in the context of the fixed-wire scenario, there are some differences in the scenario of  FIG. 2B  since the connectivity between individual ports at the interface  142  and the end user devices  104  accessing those ports is no longer static, with both mobility (different terminals attaching to the same port) and roaming (terminals moving between ports) being possible. Specifically, there is provided a network of wireless LAN access points (only one of which is shown at  192 ) that is connected to the interface  142  over a fixed-wire link and that communicates over a wireless link to one or more end user devices  104 . Since the wireless LAN access point  192  can simultaneously service multiple remote terminals, this requires that multiple concurrent but entirely separate sessions to multiple end user devices  104  (operating under different users and authentications) be accommodated on a single port into the interface  142 . The leads to the requirement that multiple concurrent and/or overlapping sessions, each with a potentially unique user access policy, be supported on a common port. It is the role of a wireless security switch (WSS)  190  (an available entity associated with the control of WLAN users and security), to meet these requirements by handling the multiple connections to various end user devices, as well as authentication at a device level. In addition, the wireless security switch  190  handles to wide variety of security threats and attacks not encountered in fixed-wire solutions.  
         [0031]     Of course, other variants of the above architectures exist and do not limit the scope of the present invention. These include, for example, scenarios where the communication links  138  are fully wireless, or where the end user devices are wireless but not necessarily portable (e.g., computer on wheels—COW), etc.  
         [0032]     The application servers  144 A, . . . ,  144 N are responsible for running and executing healthcare applications (such as CPOE services, decision information support tools—DIST, prescription drug order entry services, radiology image viewing services, etc.) and storing temporary medical data (volatile or otherwise) required by those applications under the direction of the authenticated user. One or more of the application servers  144 A, . . . ,  144 N may also be responsible for data gathering from the core hospital network  114 , which is achieved by communicating with a topology database (not shown) in the secure healthcare information network  160  via the routing entity  112  and the interface  141  or a specific server in the host  100  equipped with physician request/database mining software. This may require access to the secure healthcare information network  160  and therefore the particular healthcare application may comprise a data mining sub-function which places data requests to the secure healthcare information network  160  and receives the requested data in return.  
         [0033]     In a small hospital the application servers  144 A, . . . ,  144 N might be implemented on a single computing device. However, in a larger hospital deployment with perhaps hundreds of terminals, a single computer-based server may be inadequate. In this case, the application servers  144 A, . . . ,  144 N evolve into an application server “complex” with various specialized servers interconnected by a router or switch and with one server providing the master sequencing and data display formatting. The use of a server complex has several advantages. Firstly, multiple application servers can provide some form of protection against failure so that, in the event of a server failure, the system slows down but does not fail, with other servers picking up the traffic load of the failed server. Also, a centralized suite of servers makes application software upgrades much smoother and easier, especially relative to trying to upgrade such software if it were resident in mobile terminals, some of which are guaranteed not to be on-site at the time of upgrade, in addition to the sheer number of machines to upgrade. Additionally, an individual server can be taken out of service for an upgrade or for application suite upgrade without taking the system down, and that upgrade can be exhaustively checked before returning the server to the system.  
         [0034]     The end user devices  104  may take many forms based upon the nature of the communications link  138  (fixed-wire in  FIG. 2A , WLAN in  FIG. 2B , etc.), and whether the end user devices  104  are fixed (e.g. workstations in  FIG. 2A ) or mobile (e.g. Tablet PC&#39;s, PDA&#39;s in  FIG. 2B ). The end user devices  104  may contain their own operating systems in non-volatile storage. Alternatively, parts or all of the operating system and applications (if any) may be downloaded from the operating system server  180  into a volatile memory store on start-up or network attachment. This latter option has various advantages, one of which is that the need for a hard drive or similar non-volatile memory store is eliminated (although those skilled in the art will appreciate that the size of the downloaded operating system or the downloaded portions of the operating system should be kept relatively small in order to make the attachment time reasonable). A second advantage of having all or part of the operating system downloaded from the operating system server  180  into volatile memory is that the end user device  104  will be rendered incapable of operation in the absence of the hospital network after it is detached from the specific hospital network or has been through a detached power-down cycle. This latter reason makes the unit less valuable to a thief and the terminal can truthfully be labeled with “This Terminal Will Not Operate Outside This Hospital”.  
         [0035]     Of course, to enable the operating system to be downloaded into volatile memory of the end user device  104 , the host  100  needs to recognize that such a download is required. Accordingly, the interface  142  provides a terminal identifier functional unit (TIFU)  199 , which may be implemented as a processing unit or as an application-specific integrated circuit and whose role it is to recognize the capabilities of the end user device  104  in a variety of ways. These include the possibility of integrating a specific identifier built in to the end user device being attached, which can be interrogated by the TIFU  199  early in the terminal attachment process. For example, the terminal identifier functional unit  199  is operable to recognize whether a particular end user device  104  is of the type that requires the operating system to be downloaded from the operating system server  180  or it may be operable to identify which parts of which operating system will be required to be downloaded to the terminal in order to render it operable, based upon the identifier received from the end user device and on a look-up table map relating the terminal type code to the required download components, this table residing either in the TIFU  199  or in the operating system server  180 . Even without any or part of an operating system, the end user device  104  may run boot code from ROM which, on attachment or power-up, notifies the terminal identifier functional unit  199  of its type and basic capabilities so that the correct settings can be made within the operating system server  180 .  
         [0036]     In some embodiments, all of the operating system from may need to be downloaded from the operating system server  180  into the volatile memory of the end user device  104 , whereas in other embodiments, only part of the operating system may need to be downloaded into the volatile memory of the end user device  104 . These are examples of a “thin client” architecture, where the end user device functionality is strictly contained, where minimal (or no) autonomous processing occurs in the device so as to render it a dependent entity of the host  100 . As has been mentioned, however, the use of the operating system server  180  is not required, as where the operating system is stored in non-volatile memory on the end user devices  104 . In such cases (e.g., when the end user device  104  has full workstation capability) the terminal identifier functional unit  199  may still be used, but merely for the purposes of setting up the scope and nature of future session-related data from the application servers  144 A, . . . ,  144 N to the end user device  104 .  
         [0037]     Thus, if used, the operating system server  180  comprises operating system software for the end user devices  104  in order to allow the end user terminals to contain reduced non-volatile memory resources than standard terminals. The operating system download process is illustrated by the numeral  260  in  FIGS. 2A and 2B . Basic non-volatile boot code running on the end user devices  104  connects with the terminal identifier functional unit  199  and then with the download server  180 , to cause the appropriate operating system to be downloaded from the operating system server  180  into a volatile memory store on the end user device  104 .  
         [0038]     A further variation would be to have the operating system server  180  download to the terminal  104  just enough operating system code to allow the end user device  104  to formulate and transmit an initial “authentication request message” to the host  100 . Upon authentication (to be described later on), the user of the end user device  104  is known and it is now possible, based on the access profile of the user, to download to the end user device  104  the remainder of the appropriate operating system for that end user device  104  (and for the user associated therewith). This permits customized operating system downloads to the end user device  104 , depending on both the operational characteristics of the end user device and the customization preferences of the end user, which is advantageous from the point of view of flexibility.  
         [0039]     Other advantages of the multi-stage operating system download are apparent from the following scenario. Consider the case where a clinician, who has been operating a remote portable device that has exhausted its battery charge, places that unit into a charger and picks up a replacement charged unit. At power-up, the boot code in the new end user device  104  causes a negotiation with the TIFU  199  which allows a download of just enough operating system code to formulate and transmit an authentication request message containing the user&#39;s authentication primitives. After successful authentication of the user, the operating system server  180  downloads the same operating system and customizations as the old device, which, due to the volatile nature of its operating system store, has reverted to being a generic non-functional unit awaiting a new operating system load.  
         [0040]     It is noted that the above advantages apply particularly to the case where the end user device  104  is a mobile device, which allows a hard drive to be dispensed with, hence eliminating a source of power consumption, cost, weight, shortened battery duration and security risk (in case clinical information should be written to that hard drive). Nonetheless, certain advantages can be gained even if the end user device is equipped with a hard drive for storing part of the operating system. To achieve these advantages, the main enablers of the operating system as well as the end user device customizations could be placed into volatile memory and those elements would ideally be constrained to such a size as to allow a rapid download.  
         [0041]     In the context of 802.11a WLAN communications, and assuming no more than 25% of the WLAN access point  192  capacity is consumed in the “squirt” of a terminal load, then the maximum load that can be delivered per second would be around 6 Mbps (i.e., 25% of 25 Mbps—which is the maximum actual payload rate of “54 Mb/s” 802.11). This would allow 750 kilobytes worth of operating system or operating system customization files to be delivered per one second. It is noted that, for portable and hand-held devices, these numbers allow very large operating systems and operating system customization files to be downloaded in a relatively short period of time that would be imperceptible to a user accustomed to a ordinary “warm-up times” on the order of 1-5 seconds.  
         [0042]     The authentication process, shown by numeral  250  in  FIGS. 2A and 2B , is controlled by the session controller  120  in conjunction with the healthcare authentication entity  116 . Specifically, the session controller  120 , which can be implemented in a non-limiting way as a general purpose computing entity having a routing functionality, is operative to detect an authentication request message (i.e., a request for a new session with a particular one of the healthcare application servers  144 A, . . . ,  144 N) received from one of the end user devices  104 . The session controller  120  then performs a high-level validation of the authentication request message. For instance, the session controller  120  may ensure that the proper parts of authentication request message are present and consistent with the expected message structure, and that each part&#39;s content is properly structured, but without concern for whether the specific user is a valid or authorized user. The session controller  120  then sends the validated authentication request message to the healthcare authentication entity  116 .  
         [0043]     Since the session controller  120  only outputs validated authentication request messages to the healthcare authentication entity  116 , it may throttle message rates from specific terminals to  116 . This frees  116  from having to deal with bogus, poorly formatted or incomplete messages and prevents denial of service attacks from reaching the healthcare authentication entity  116  and hence the healthcare AAA database  162 .  
         [0044]     The healthcare authentication entity  116  communicates with the healthcare AAA database  162  in the core hospital network  114  via the routing entity  112  in an attempt to authenticate the user. The healthcare authentication entity  116 , which can be implemented as a computing entity, performs authentication of healthcare users based on a validated authentication request message received from the end user device  104  via the session controller  120 , which, as described above, detects the presence of an authentication request message in the traffic flow from the terminal  104 , and then extracts and validates the message format but not its contents. The remainder of the authentication process  250  can then take on one of many forms, including but not limited to the following two examples.  
         [0045]     Under a first possibility, on reception of a validly formatted authentication request message from  120 , the healthcare authentication entity  116  sends a query containing all the received parameters of the authentication request message to a server in the secure healthcare information network  160  where the healthcare AAA database  162  is contained, in an attempt to allow that server to authenticate the user. The server in the secure healthcare information network  160  extracts, from user credentials carried in the authentication request message, an indication of who the user is claiming to be (i.e., user identity) in addition to proof (i.e., corroborating evidence) that the user is who he or she is claiming to be. The user identity is used to index the healthcare AAA database  162  which contains stored corroborating evidence for each healthcare user. If the stored corroborating evidence stored in the healthcare AAA database  162  corresponding to the user identity matches the corroborating evidence in the authentication request message, then the authentication is said to have been successful. The server in the secure healthcare information network  160  provides the healthcare authentication entity  116  with an indication that the authentication process  250  has been successful in addition to an “access profile” which indicates, e.g., the permissions given to the user with respect to the application servers  144 A, . . . ,  144 N and/or the set of resources in the secure healthcare information network  160 . The use of an access profile permits control of the healthcare information and resources being made accessible to different healthcare users. For example, the access profile for a healthcare user who is a clinician or nurse may list the patients forming his or her case load, together with selective permissions for accessing specific levels or areas of information regarding those patients, dependent upon the user&#39;s authentication credentials and actual task assignments.  
         [0046]     Under a second possibility, the healthcare authentication entity  116  itself extracts the user identity and the corroborating evidence from the user credentials in the authentication request message. The user identity is supplied to the healthcare AAA database  162  in the secure healthcare information network  160 , which returns stored corroborating evidence corresponding to the user identity, as well as the access profile associated with the user. The healthcare authentication entity  116  then compares the returned corroborating evidence with the corroborating evidence extracted from the user credentials carried in the authentication request message. If there is a match, then the authentication process  250  is said to have been successful. These two variants described above result in different partitions of workload and therefore one approach may be preferred over the other, depending on operational requirements. Those skilled in the art will be familiar with yet other variants of the authentication process  250  that are within the scope of the invention.  
         [0047]     Upon successful authentication, the session controller  120  establishes a communication channel between the end user device  104  and the chosen one of the healthcare application servers  144 A, . . . ,  144 N, allowing the chosen healthcare application server to open a healthcare “session” with the user. At this point, the healthcare application servers  144 A, . . . ,  144 N begin configuring data for the end user device  104 , at a level dependent upon the needs of the end user device  104 . These needs may be different for a basic thin client/display emulation terminal than for a fully featured workstation, at the level of display characteristics, screen presentation, graphics, active information, input boxes, etc. The knowledge of the end user device configuration is obtained during the initial procedure  260  described above, whereby the terminal identifier functional unit  199  learns of the terminal characteristics of the end user device  104 . A page formatter is an example of an application in the application servers  144 A, . . . ,  144 N that can provide data for the end user device  104  in pages that are pre-formatted for display in the event that the terminal is a wholly dependent thin client or display emulating terminal.  
         [0048]     Now, at any time during the session and for a variety of reasons, the session controller  120  may need to instruct the end user device  104  to take action to preserve the confidentiality of sensitive healthcare information stored therein. For example, this may arise in the event of forced or voluntary session termination, or when the authenticated user is detected to have traveled far from the end user device  104  (as determined from a triangulation operation, for example, involving multiple wireless access points  192 ), or again if no user activity has been detected for a specific duration of time. Depending on the circumstances, the action to be taken by the end user device  104  may range from “mild” (e.g., causing the terminal screen to go blank or taking other reversible steps to put the session temporarily into stasis or reversibly removing various forms of access to the session) to “severe” (e.g., causing a complete and permanent end to that particular authorized session and fully removing components of the session stored in the volatile memory, by erasing the contents of the volatile memory  212 ). It is expected that various forms of “mild” and “severe” responses will be taken in response to various “at-risk” conditions during a session. For instance, and purely as an illustration, the absence of a clinician input may make the screen blank after 30 seconds. After a further minute of no input a password will be required to unblank the screen. After another five minutes the screen and keyboard will remain locked out unless the authentication primitives are re-entered. After 20 minutes or after the entry of a different authentication primitive the session is erased. Note that the data is held secure from view by anyone except the authenticated person after the first 30 seconds, but that the authenticated clinician can retrieve and continue the session at any time up to 20 minutes after the last input. Furthermore, optionally the session can be archived for retrieval by the clinician in a central location within the host  100 . More details regarding the actions taken by the end user device  104  will be provided following a description of various embodiments of the end user device  104  with reference to  FIGS. 3, 4 ,  5  and  6 .  
         [0049]     With reference first to  FIG. 3 , the end user device  104  comprises a network interface  208 , a main processor  214 , a message formulator  210 , a set of I/O devices  202 , an authentication device  204 , a volatile memory store (e.g., RAM)  212  and a session data control module  228 . Other embodiments including a non-volatile memory store, an encryption module and an RF-ID reader will be described later with specific reference to  FIGS. 4, 5  and  6 , respectively. For the purposes of this description, and by way of example only, the end user device  104  could be a fixed-wire device or a mobile wireless device.  
         [0050]     The network interface  208  is connected to the main processor  214  via a link  304 , to the session data control module  228  via a link  302  and to the message formulator  210  via a link  306 . The network interface  208  may comprise a multiplexer. In a downstream direction (host  100  to end user device  104 ), the network interface  208  recognizes messages destined for the main processor  214  as well as messages destined for the session data control module  228 . The network interface  208  has the capability to discern the various types of messages and route them to the proper functional element via link  302  or  304 , as appropriate. In the upstream direction (end user device  104  to host  100 ), the network interface  208  receives messages destined for the host  100  as received from the message formulator  210  via link  306  and from the main processor  214  via link  304 . The network interface  208  has the capability to combine these messages and transmit them to the host  100  along the communications link  138 . In a specific embodiment, the network interface  208  does not have the capability to connect outgoing messages on link  304  from the processor onto link  302 , the line to the session data control module  228 , which is required only to be accessible to/from the host  100 , in order to ensure control security, should the main processor  214  become contaminated with illicit software code by means-unknown. Furthermore, formatted messages generated in the message formulator  210  are only visible to the host  100  and it is required that the network interface  208  be incapable of making these messages visible on link  304  back into the main processor  214 , preventing the main processor  214  and its memory (some of which may be non-volatile) from reading and storing these messages, which would be a security leak if authentication request messages could be recovered by the physical theft of the terminal or from spyware downloaded into the end user device  104  by means/people unknown.  
         [0051]     The authentication device  204  may include one or more of, for example, a magnetic card reader, a bar code scanner (e.g., for reading a user&#39;s bracelet), a biometric (e.g., fingerprint, iris) scanner, etc., the operation of which may or may not be augmented by a password or PIN. The authentication device  204  receives authentication primitives input by the user. The authentication device  204  supplies these authentication primitives to the message formulator  210  via a link  314 .  
         [0052]     The I/O devices  202  may include, for example, a keyboard/mouse arrangement with a display having a built-in touch screen. The I/O devices  202  receive input (e.g., physician order entries and responses, etc.) which is provided to the main processor  214  via a link  316  for transmission to the host  100  via the network interface  208 . The I/O devices  202  also receive data from the main processor  214  via the link  316  which is to be output to the user (e.g., in the form of an image or sound). The I/O devices  202  may also receive some of the authentication primitives (e.g., user name and password or PIN) input by the user. If this is the case, the I/O devices  202  provide these authentication primitives to the message formulator  210  via a link  320 .  
         [0053]     The message formulator  210  is responsible for formulating authentication request messages based on the authentication primitives received from the authentication device  204  (via link  314 ) and possibly the I/O devices  202  (via link  320 ). The message formulator  210  is operable to send the generated authentication request messages to network interface  208  via link  306 . The message formulator  210  is also operable to detect when the user has requested to terminate or suspend the current session, either explicitly by an end-of-session command or series of commands interpreted from the keyboard inputs or from the withdrawal of an enabling element, such as an authentication device  204 , or implicitly by specifying a new set of authentication primitives. Such a message indicative of session termination or suspension is sent via link  308  to the session data control module  228 , which will take appropriate action as described herein below.  
         [0054]     The volatile memory store  212  stores data required for the main processor  214  to run a session with one of the application servers  144 A, . . . ,  144 N, for a particular user of the end user device  104 . This data may include a downloaded operating system, I/O drivers and software for human-machine interface (HMI), display formatting and data collection. In addition, the data to be stored in the volatile memory store  212  includes sensitive healthcare information (e.g., clinical data), which may be delivered in pages formatted in the host  100  for display via one of the I/O devices  202 , analogous to web pages. The portions of the data corresponding to sensitive healthcare information may be stored in a predetermined portion of the volatile memory store  212 . The data being written to and read from the volatile memory store  212  by the main processor  214  is carried along a link  322 . The volatile memory store  212  is connected to the session data control module  228  by a link  310  having the potential to carry a signal which at times causes the volatile memory store  212  to render the sensitive healthcare information inaccessible to the user of the end user device  104 . This result can be achieved in a variety of ways, including erasing, scrambling or resetting a section of the memory, etc.  
         [0055]     The main processor  214  manages the processing load presented by the operating system, and runs local applications which are primarily associated with data collection, formatting and display. For example, the main processor  214  may implement a web browser for receiving user input from the I/O devices  202  via link  316 , displaying still images and interacting with the user via input boxes for applications which have been centralized in the host  100 . The main processor  214  may also implement an MPEG decoder or media player for display of video images, and a voice codec for audio input/output. The main processor  214  accesses the volatile memory store  212  via link  322 . In addition, the main processor  214  is connected to the session data control module  228  by a link  312  having the potential to carry messages from the session data control module  228  instructing the main processor  214  to enable/disable the screen display, keyboard input functions and other I/O devices  202 .  
         [0056]     The session data control module  228  is connected to the message formulator  210  via link  308 , to the network interface  208  via link  302 , to the terminal processor  314  via link  312  and to the volatile memory store  212  via link  310 . In some embodiments, it may be advantageous to implement the session data control module  228  as a hardware or software module external to the main processor  214 , allowing a separate messaging channel to be maintained between the session controller  120  and the session data control module  228  via the network interface  208 . Such an implementation prevents the session data control module  228  from being influenced or corrupted by nefarious code arriving at the main processor  214  and also this overcomes some start-up sequencing issues, especially with the multi-stage operating system download described earlier. Moreover, actions can be taken to preserve the confidentiality of sensitive healthcare information, irrespective of the state of the main processor  214 . Still, it is within the scope of the invention to implement the session data control module  228  as a hardware or software module internal to the main processor  214 .  
         [0057]     The session data control module  228  receives stimuli from the host  100  (via the network interface  208  and link  302 ) and from the user (via the message formulator  210  and link  308 ). Examples of stimuli received from the host  100  via the network interface  208  and link  302  include but are not limited to “pilot” messages which indicate that a session is ongoing and not yet terminated, as well as messages that require the session data control module  228  to preserve confidentiality of the sensitive healthcare information. Such messages may be session termination messages, or messages indicating that the user has been detected to be a certain distance away from the end user device  104  (as determined from a triangulation operation, for example, involving multiple wireless access points  192 ). Examples of stimuli received from the user via the message formulator  210  via link  308  include messages indicative of a user request to terminate the current session (either explicitly or implicitly by specifying a new set of authentication primitives) or to suspend the current session.  
         [0058]     The purpose of the session data control module  228  is to apply a policy (either preconfigured or securely downloaded from the host  100 ) in order to assemble the stimuli received from various sources with a view to determining whether action needs to be taken to preserve the confidentiality of the sensitive healthcare information stored in the volatile memory store  212 . The actions taken by the session data control module  228  can range from severe (e.g., irreversible, which is useful when a session is terminated or a connection is lost) to mild (e.g., reversible, which is useful when a session is temporarily interrupted or suspended).  
         [0059]      FIG. 7  shows an example of a policy resulting in “severe” action to preserve confidentiality of sensitive healthcare information stored in the volatile memory  212 . Specifically, such action is taken if any of the following conditions is met: either a pilot message has not been received for a predetermined amount of time (box  702 , which represents loss of a connection with the host  100 ), or there are instructions received from the user to terminate the session (box  704 ) without contrary instructions from the host  100  (box  708 ), or there are instructions from the host  100  to terminate the session (box  706 ), regardless of there being no instructions from the user to terminate of the session. Each of these circumstances leads to box  712 , which represents the determination that severe action is required to preserve confidentiality. If, on the other hand, none of the above conditions is reached, then box  710  applies, i.e., no specific action is taken as regards preservation of confidentiality of the sensitive healthcare information stored in the volatile memory store  212 .  
         [0060]     Examples of severe action to preserve confidentiality of sensitive healthcare information stored in the volatile memory  212  include the session data control module  228  sending a signal to the volatile memory store  212  via link  310 , to which the volatile memory store  212  responds by deleting or writing over the portion of memory containing the sensitive healthcare information.  
         [0061]      FIG. 8  shows an example of a policy resulting in “mild” action to preserve confidentiality of sensitive healthcare information stored in the volatile memory  212 . Specifically, if instructions to suspend the session are received from the host  100  or the user (box  802 ), then mild action is taken (box  806 ). As mentioned above, the mild action is reversible and this is illustrated by box  804 , which represents receipt of instructions from the host  100  to unsuspend the previously suspended session, resulting in reversing the mild action at box  810 . If, on the other hand, none of the above conditions is satisfied, then box  808  applies, i.e., no specific action is taken as regards preservation of confidentiality of the sensitive healthcare information stored in the volatile memory store  212 . It is noted that in order to reverse, at box  810 , the mild action taken at box  806 , it may be useful to require that such instructions be received from the host  100  and not the user, as it would prevent hacking on the part of the user.  
         [0062]     Examples of mild action to preserve confidentiality of sensitive healthcare information stored in the volatile memory store  212  include the session data control module  228  sending a message to the main processor  214  via link  312  instructing it to disable the screen display, keyboard input functions or other I/O devices  202 , without necessarily affecting the contents of the volatile memory store  212 . This is useful in circumstances where the user has temporarily stepped away from the end user device and may soon thereafter wish to re-access the contents of the volatile memory store  212 . In order to reverse the mild action taken in box  806 , the session data control module  228  sends a similar message to the main processor  214  via link  312 , instructing it to enable the affected I/O devices  202 .  
         [0063]     Still more complex policies can be applied, in which mild action to preserve confidentiality of the sensitive healthcare information could be followed by severe action if a given condition is satisfied. For example, if a certain amount of time elapses following the mild action, then the severe action could be taken. In another example, if the distance between the user and the end user device (which can be determined by triangulation, for example) exceeds a first threshold, then the mild action could be taken and if the distance exceeds a second threshold, then the severe action could be taken. Or severe action could be taken if the distance between the user and the end user device continuously exceeds a predetermined threshold for a predetermined amount of time.  
         [0064]     A first variant of the end user device  104  of  FIG. 3  is shown in  FIG. 4 , where there is provided a non-volatile memory store  220  (such as a hard drive) in addition to the volatile memory store  212 . The use of the hard drive  220  to store sensitive healthcare information may not always be recommended, since power-off of the end user device does nothing to affect availability of the data. Nonetheless, when a hard drive  220  is used, it may be desirable to employ a mechanism such as that described above in order to preserve the confidentiality of sensitive healthcare information stored thereon.  
         [0065]     The hard disk  220  may assume some of the functionality of the previously described volatile memory store  212  and thus may be used to store data required for the main processor  214  to run a session with one of the application servers  144 A, . . . ,  144 N, for a particular user of the end user device  104 . This data may include a downloaded operating system, I/O drivers and software for human-machine interface (HMI), display formatting and data collection. The hard disk  220  may also store a clinical application processes sensitive healthcare information (e.g., clinical data). The sensitive healthcare information may be stored in a predetermined portion of the hard drive  220 . The data being written to and read from the hard drive by the main processor  214  is carried along a link  324 . The hard drive  220  is connected to the session data control module  228  by a link  410  which at times carries a signal that causes the hard drive  220  to render the sensitive healthcare information inaccessible to the user of the end user device  104 . This result can be achieved in a variety of ways, including erasing, scrambling or resetting a section of the hard drive  220 , etc.  
         [0066]     Basically the same functional description as the one above applies in respect of taking action to preserve confidentiality of sensitive healthcare information, with the additional feature that the part of the hard drive  220  comprising sensitive healthcare data is to be erased or otherwise rendered inaccessible to the user of the end user device  104 . Specifically, with reference to  FIG. 7 , if application of the policy leads to box  712 , representing the determination that severe action is required to preserve confidentiality, the session data control module  228  may, in addition to (or instead of) the signal sent to the volatile memory store  212  along link  310 , send a signal to the hard drive  220  via link  410 , to which the hard drive  220  responds in the manner described in the previous paragraph. In another embodiment, with reference to  FIG. 8 , if application of the policy leads to box  806 , representing the determination that mild action is required to preserve confidentiality, the session data control module  228  may send a message to the main processor  214  instructing it to disable the screen display, keyboard input functions or other I/O devices  202 . Again, a combination of these and other policies is also possible.  
         [0067]     A second variant of the end user device  104  of  FIG. 3  is shown in  FIG. 5 , where there is provided additional security against tampering with sensitive healthcare information stored in the volatile memory store  212  and/or the hard drive  220  (collectively “the memory  212 ,  220 ”). Specifically, the end user device  104  comprises an encryption module  224  connected to the memory  212 ,  220  via a data bus  508 . The encryption module  224  uses an encryption key to encrypt data intended to be written to the memory  212 ,  220 . The encryption key is supplied by the host  504  via a separate channel  504  established by the network interface  208 . The encryption key may be kept in a volatile or non-volatile memory store within the encryption module  224 . A decryption key, which may be the same as or different from the encryption key, is used by the encryption module  224  to decrypt data read from the memory  212 ,  220 .  
         [0068]     In order to write sensitive healthcare information into the memory  212 ,  220 , the main processor  214  releases a write command towards the memory  212 ,  220 . The write command may pass through the encryption module  224  and thus may be provided along link  322 . The write command is accompanied by sensitive healthcare information which is provided to the encryption module  224  along link  322 . The sensitive healthcare information is encrypted, using the encryption key, by the encryption module  224 . An encrypted version of the sensitive healthcare information is thus written to the memory  212 ,  220  along the data bus  508 .  
         [0069]     In order to read sensitive healthcare information from the memory  212 ,  220 , the main processor  214  releases a read command towards the memory  212 ,  220 . The read command may pass through the encryption module  224 . The memory  212 ,  220  responds to the read command by providing an encrypted version of the desired sensitive healthcare information onto the data bus  508 . The encrypted information arrives at the encryption module  224 , where it is decrypted, using the decryption key, prior to being fed to the main processor  214  along link  322 .  
         [0070]     Of course, it should be understood that a segment or portion of the memory  212 ,  220  could be reserved for storing unencrypted data, specifically data in respect of which it is not necessary to preserve confidentiality. In fact, it may be advantageous to limit the amount of data stored in the volatile memory store  212  in an encrypted manner in order to render cracking the encryption/decryption key more difficult and also to reduce the delay with which data is written to/read from the memory  212 ,  220  by the main processor  214 . To this end, the end user terminal is provided with a selection module  502  that is disposed between the main processor  214  and the encryption module  224 . The main processor  214  is equipped with the ability to control the operational state of the selection module  502  by means of a control signal, which controllably causes the selection module  502  to exchange unencrypted data either with the encryption module  224  or with the memory  212 ,  224  via a link  506  that bypasses the encryption module  224 .  
         [0071]     The gate  502  is operated by the clinical context as-seen by the clinical application, whether resident within the host  100  or the end user device  104 . One way this can be done is for all clinical data files to carry a readable field (or word or header component) that denotes the file to be one requiring encryption. This field is read by the switch element in the gate  502  which routes that particular file through to the encryption module  224 . On reading stored files, the gate  502  can read both the direct path output and the decrypted path output. If it sees the reconstruction of an “encryption required” header or flag on the decrypted path output, then the gate  502  selects that path and routes the file to the main processor  214  (and/or the processor&#39;s volatile cache memory for its working files). Otherwise, the gate  502  selects the non-encypted path from the volatile memory store  212 . Note that the gate  502  does not require knowledge of the encryption or decryption key, and thus its operation does not have to be kept secure (other than to prevent it from being disabled). This is readily accomplished by placing a watchdog on link  506 , which watches for the “encryption-required” field (or word or header) message in the data. Detection of this is an indication of a malfunction within the gate  502  which can cause an alarm or the termination of the session, or a memory wipe upon the termination of that particular session or the initiation of “spy-hunter” software to check the validity of the terminal software load as a background task.  
         [0072]     Those skilled in the art will appreciate that in some embodiments, the encryption module  224 , gate  502  may be implemented on the same application-specific integrated circuit (ASIC) as the main processor  214 , which renders the link  322  between the encryption module  224  and the main processor  214  more difficult to intercept than the data bus  508  between the encryption module  224  and the memory  212 ,  220 , as long as the main processor  214  cannot read the downloaded encryption key (i.e. has no access to link  504 ). Specifically, if a thief intercepts the data bus  508  by means of an electronic equivalent to an “extension cord” (e.g. by coupling into an empty expansion slot for additional memory modules), this will yield information of little value to the thief, as the data so accessed has been encrypted by the encryption key that remains safely stored in the encryption module  224 , and which is inaccessible due to its location on the same ASIC as the main processor  214 .  
         [0073]     In order to preserve the confidentiality of sensitive healthcare information stored in the memory  212 ,  220 , various options are possible in addition to those discussed above in respect of  FIGS. 3 and 4 . For example, because the sensitive healthcare information stored in the memory  212 ,  220  is encrypted, it is not necessary to expressly erase its contents in order to render it inaccessible to the user. Rather, the same net effect is achieved by simply changing or resetting the decryption key used by the encryption module  224 . To this end, should the session data control module  228  conclude that mild or severe action is required to preserve confidentiality of sensitive healthcare information stored in the memory  212 ,  220 , it can generate a message to the encryption module  224  along link  510 , containing a new (or blank) decryption key or containing a command to erase or change the decryption key. The effect will be that subsequent accesses to the memory  212 ,  220  will be of little value to the end user, the sensitive healthcare information stored therein having effectively been rendered inaccessible. In order to reverse the mild action (step  810  in  FIG. 8 ), the previous version of the decryption key can be restored to the encryption module  224 . This of course assumes that the previous version of the decryption key was stored before it was changed.  
         [0074]     A third variant of the end user device  104  of  FIG. 3  is shown in  FIG. 6 , where there is provided a radio frequency identification (RF-ID) reader  610 , which is capable of reading a code on a passive tag worn by a user. The RF-ID reader  610  is connected to the session data control module  228  by a link  602 . The degree of match between the code detected by the RF-ID reader  610  and a code obtained from the host  100  can be interpreted as an indication of the distance between the user and the end user device  104 . If this distance exceeds a certain threshold (or if the degree of match falls below a certain threshold), then the RF-ID reader  610  generates a message along link  602  in order to inform the session data control module  228  that the user has distanced himself/herself from the end user device  104 . Such message may also be generated as a result of a more complex condition, such as when the distance between the user and the end user device  104  continuously exceeds a predetermined threshold for a predetermined amount of time or a running integral of the distance between the user and the end user device  104  over time exceeds a predetermined threshold.  
         [0075]     In order to preserve the confidentiality of sensitive healthcare information stored in the memory  212 ,  220 , the receipt of a message along link  602  provides yet another stimulus that needs to be considered by the session data control module  228  when applying its policy to determine whether action needs to be taken to preserve the confidentiality of the sensitive healthcare information stored in the memory  212 ,  220 . In this case,  FIG. 7  would be modified to include a step of verifying whether a message was received from the RF-ID reader  610  along link  602 . If so, this should be interpreted by the session data control module  228  as there being a requirement to preserve confidentiality of sensitive healthcare information, unless it is in receipt of a pilot message from the host  100  and it has not received instructions to terminate the session. The session data control module  228  then sends a signal to the memory  212 ,  220 , which reacts in the way described above.  
         [0076]     Of course, combinations of the above embodiments could be used. For example, the use of the encryption module  224  with the RF-ID reader  610  allows a more complex policy to be applied, in which mild action to preserve confidentiality of the sensitive healthcare information could be followed by severe action if a given condition is satisfied. For example, if the distance between the user and the end user device (which can be determined by the RF-ID reader  610  based on the degree of match between a detected code and the code corresponding to the authenticated user) exceeds a first threshold, then the mild action could be taken and if the distance exceeds a second threshold, then the severe action could be taken without the possibility of reversing the mild action.  
         [0077]     While specific embodiments of the present invention have been described and illustrated, it will be apparent to those skilled in the art that numerous modifications and variations can be made without departing from the scope of the invention as defined in the appended claims.

Technology Category: 5