Controlling access to a medical monitoring system

Access to a medical monitoring system, which includes a patient-portable monitoring device and an associated monitoring service at a central unit, is controlled by inputting a set of identification data elements into a medical monitoring device, which then establishes a communication link with a central unit and communicates the set of identification data elements to the central unit. The medical monitoring device and the central unit cooperatively determine whether the medical monitoring device may be activated for rendering medical monitoring device service, by evaluating the set of identification data elements as to whether they meet a set of basic structural requirements, and obtaining financial or other authorization from a third-party source. In the event that the identification data elements meet the set of basic structural requirements and the authorization is obtained, the central unit issues an activation signal to the medical monitoring device over the communication link.

BACKGROUND

The following description relates to controlling access to a medical monitoring device and/or a service associated with the device, for example, to help ensure that access to the monitoring device and service are authorized prior to commencing usage.

Advances in sensor technology, electronics, and communications have made it possible for physiological characteristics of patients to be monitored even when the patients are ambulatory and not in continuous, direct contact with a hospital monitoring system. For example, U.S. Pat. No. 5,959,529 describes a monitoring system in which the patient carries a remote monitoring unit with associated physiological sensors. The remote monitoring unit conducts a continuous monitoring of one or more physiological characteristics of the patient according to the medical problem of the patient, such as the heartbeat and its waveform.

One potential issue associated with the use of such medical monitoring devices is establishing whether the patient's health-care-benefit payer has authorized the use of the monitoring device and service. In the absence of a proper authorization, the patient may use the medical monitoring device and incur significant charges, for example, in the form of rental value of the medical monitoring device, telephone charges, charges at the central monitoring system, and charges by medical personnel, and the providers of those goods and services may not get paid. Bad debts—an increasing concern in the medical field generally—tend to be an even greater concern in the case of a portable medical monitoring device and its service where the physical control of the device is in the hands of a third party, such as a prescribing doctor, who does not own the medical monitoring device and is not responsible for improper charges.

SUMMARY

The present inventors recognized a need for an approach to controlling access to medical monitoring devices and their associated services to help ensure that only a properly authorized patient can use the service. Controlling access to a medical monitoring system may be accomplished by a system and/or technique that includes one or more of the following features.

To control access to a medical monitoring system, a computer-based method may involve receiving information indicating that a remote monitoring device (e.g., a patient-portable device configured to monitor one or more physiological aspects of a patient) seeks access (e.g., through one or more communications links including either or both of a wired communication link and a wireless communication link) to a monitoring service hosted by a central unit, and determining whether the remote monitoring device is authorized to access the monitoring service. This determination is based at least in part on authorization data received from a third-party source. Based on a result of the determination, an activation signal is selectively issued to the remote monitoring device.

The determination of whether the remote monitoring device is authorized to access the monitoring service may be performed cooperatively between the remote device and the central unit. Further, the determination of whether the remote monitoring device is authorized to access the monitoring service may include one or both of (i) performing a format check on access data entered into the remote monitoring device and (ii) comparing the entered access data against the third-party authorization data.

The access control method may further include maintaining, at the central unit, a local database of third-party authorization data to be used in the determination of whether the remote monitoring device is authorized to access the monitoring service. The local authorization database may be updated, for example, periodically or based on a predetermined event or a combination of both.

Selectively issuing the activation signal to the remote monitoring device based on a result of the determination may include issuing the activation signal if the remote monitoring device is determined to be authorized to access the medical monitoring service and refraining from issuing an activation signal if the remote monitoring device is determined to be unauthorized to access the medical monitoring service.

In another aspect, a medical monitoring system centered at a central node includes one or more communications links configured to facilitate communications with remote monitoring devices (e.g., a patient-portable device configured to monitor one or more physiological aspects of a patient) and one or more third-party authorization sources. The medical monitoring system also includes at least one programmable processor configured to perform various operations. These operations may include hosting a medical monitoring service (e.g., implemented at least in part by one or more software processes), receiving information indicating that a remote monitoring device seeks access to the medical monitoring service hosted by a central unit, determining, based at least in part on authorization data received from a third-party authorization source, whether the remote monitoring device is authorized to access the monitoring service, and based on a result of the determination, selectively issuing an activation signal to the remote monitoring device.

The programmable processor may further be configured to maintain at the central node a local database of third-party authorization data to be used in the determination of whether the remote monitoring device is authorized to access the monitoring service. The local authorization database may be updated based on data received from the one or more third-party authorization sources. Updating may occur periodically or based on a predetermined event or a combination of both.

The programmable processor may further be configured to determine whether the remote monitoring device is authorized to access the monitoring service by one or both of (i) performing a format check on access data entered into the remote monitoring device and (ii) comparing the entered access data against the third-party authorization data.

The programmable processor may be configured to issue the activation signal to the remote monitoring device if the remote monitoring device is determined to be authorized to access the medical monitoring service and to refrain from issuing an activation signal if the remote monitoring device is determined to be unauthorized to access the medical monitoring service.

In another aspect, a portable medical monitoring device includes a transceiver for communicating with a central node, a user interface for communicating with a user of the device, and a programmable processor configured to perform various operations. These operations may include receiving user input specifying user-specific information, transmitting the received user input to the central node for third-party authorization based at least in part on the user-specific information, and selectively providing the user with access to a monitoring service hosted at the central node based on a result of the third-party authorization.

The programmable processor further may be configured to perform a format check on the received user input to determine whether the user input meets one or more predetermined criteria. If the user input is determined not to meet one or more of the predetermined criteria, the programmable processor may refrain from transmitting the received user input to the central station and/or may deny access to the monitoring service. In addition, the programmable processor may be configured to provide access to the monitoring service if the device receives an activation signal from the central node and to deny access to the monitoring service if the device fails to receive an activation signal from the central node.

Among other potential advantages, the systems and techniques described here may facilitate controlling access to medical monitoring devices and associated services. The approach may help to ensure that service is initiated and continued only for persons who are properly authorized to have the service. For example, the present approach may activate the medical monitoring device and its corresponding service only for a person who provides proper identification data and is financially and otherwise properly authorized for the service. As a result, the chances of a wrong person being monitored may tend to be reduced. The activation process, which may involve the input of proper identification data, may be quick and largely transparent to the person seeking the service.

The systems and techniques described here may help to ensure that medical monitoring device services are provided only to properly identified and authorized persons. They may also help to ensure that all persons and agencies responsible for the medical monitoring device and the services are coordinated in their approval of rendering service to the particular patient and in effect have approved the provision of service and the type of service to be provided. Potential legal and financial liability may thereby be reduced. Other features and advantages will be apparent from the following detailed description, the accompanying drawings, and the claims.

DETAILED DESCRIPTION

FIG. 1depicts a flow diagram of a method of controlling access to a medical monitoring device and/or service. A medical monitoring device and its associated system are provided (20). The medical monitoring device and medical monitoring system may be of any operable type, such as that disclosed in U.S. Pat. No. 5,959,529 (hereafter, “the '529 patent”), whose disclosure is incorporated by reference in its entirety, and/or modified as discussed herein.

FIG. 2depicts details, in block diagram form, of a medical monitoring system50that includes a medical monitoring device system52, which in turn comprises a medical monitoring device54and a base station56. The medical monitoring device54may be a portable or remote monitoring unit of the type generally described in the '529 patent. The base station56has communication access to a central unit58through a communication link such as a wireless cellular telephone transceiver link60and/or a telephone land-line62. Alternatively, or in addition, communication links can be established by other available means, among others, such as wired or wireless networks that implement communications protocols and standards such IP (Internet protocol), WiFi (IEEE 802.11x), WiMax (IEEE 802.16x), and GPRS (General Packet Radio Service). The central unit58, typically maintained at a central node or location, may in practice be composed of multiple computer systems distributed across, or even outside of, the central node.

In the implementation shown inFIG. 2, the base station56has a base station cradle64that is configured to receive the medical monitoring device54therein and establishes communication between the medical monitoring device54and an input/output device65that typically includes a microprocessor, communications controller, and communications hardware and/or software to establish the links60and/or62. The input/output device65has a keypad66for inputting information and a display68to view the input information and other information to be displayed, as well as information transmitted to the input/output device65.

The central unit58has communications access to a variety of databases71and to third-party sources72, typically by telephone land-line, network or other connection70. The databases71may include prior patient records, general records, and the like. The third-party sources72may include, for example, financial sources74, medical sources76, and other sources78. A financial source might be, for example, an insurance company, the social-security administration, or a credit-granting company. A medical source might be, for example, a specialist physician whose authorization is required before commencing the monitoring of the patient. Other third-party sources might be, for example, the company that maintains the medical monitoring device54and which is consulted to be certain that the specific medical monitoring device to be activated is approved for service.

The base station56, when not prescribed or otherwise assigned and distributed to a patient to be monitored, ordinarily is in the custody the office of the agency that is providing the medical monitoring device54to a patient for the purpose of monitoring physiological parameters of the patient. Such an agency could be, for example, the patient's physician or a hospital. When the agency undertakes to provide the medical monitoring device54to the patient, for example, to take home, the medical monitoring device54is docked with the base station56, and the procedures described in relation to subsequent portions ofFIG. 1are followed.

Returning toFIG. 1, a set of identification data elements (22) are input into the medical monitoring device system52through the keypad66of the input/output device65of the base station56in the system50ofFIG. 2. The identification data elements may include, for example, a patient name, a patient address, a patient social security number, a patient sex, and an identification of the third-party financial source. The identifier of the medical monitoring device54, such as its serial number, may be manually input in step22, but more normally the identifier is automatically made available by the medical monitoring device54to the base station56.

The base station56may perform a preliminary evaluation of the set of identification data elements, for example, such as to determine by using a software utility program whether the identification data elements meet a set of one or more format requirements. Such basic format requirements may be specified for each of the identification data elements. For example, a format requirement may specify that a patient name is to include only alphanumeric characters. If as typed into the keyboard the patient name includes other characters (e.g., a percent sign %), software running in the base station can recognize the error and provide an input diagnostic message through the display68to prompt the input of correct information. In another example, a format requirement may specify that a user's social security number must contain 9 numerical digits and may not contain letters or other characters.

After what appears from the preliminary format evaluation to be a set of correct identification data elements is input to the medical monitoring device system52, the medical monitoring device system52establishes (24) a communication link to the central unit58. The communication link is preferably through the land-line62, but may be though the cellular telephone transmission link60or another wireless or wired link if the land-line is not available.

The medical monitoring device system52and the central unit58cooperatively determine whether the medical monitoring device54may be activated for rendering medical monitoring device service (26). The final decision is typically made by the central unit58, although the medical monitoring device system52may aid in data processing or may be called upon for additional input, for example, such as when the patient name is found not to match with the social security number in other records.

The activation determination process26may include various sub-processes including evaluating the set of identification data elements as to whether they meet a set of basic structural requirements (28) and obtaining third-party authorization (30) from one or more of the third-party sources72. The sub-processes of evaluating28and obtaining30are preferably performed automatically. “Automatically” as used means herein that the steps are performed without human action or intervention, except where a discrepancy occurs. The present system is organized to perform the evaluating and obtaining steps entirely by computer procedures, to minimize costs and take advantage of data collections at a variety of locations. Alternatively, the present approach may be performed in whole or in part using manual (i.e., human-performed) sub-processes28and30. In addition, the sub-process30of obtaining third-party authorization can be performed either before or during the activation determination process26. For example, the sub-process30may involve updating a locally stored (e.g., at a central unit hosting the medical monitoring service) copy of a third party's database of authorization information, and then performing the sub-process30by accessing the local copy of the database instead of accessing the third party's system, which typically would be maintained at a remote location. Updating of the local third-party authorization database may occur based on one or both of the following criteria: (i) periodically (e.g., once a day) or (ii) based on an occurrence of a predetermined event (e.g., the third-party system determines that a certain amount of new authorization data is available and has not yet been copied to the central unit's local database and/or the central unit determines that its local database does not contain needed information).

The set of basic structural requirements to be imposed may include the format requirements evaluated by the base station56, or may include different or additional structural requirements. For example, the central unit58may check the database71to attempt to match the input patient name with a social security number that is already in the database71from prior medical contacts. If the patient name and the social security number that were input in subprocess22do not match, then further inquiry may be made back to the medical monitoring device system52. The failure to match the name and the social security number may arise from a simple inputting error, which can be corrected with revised input, or it may arise from a fraudulent attempt to obtain medical monitoring services that is detected by the procedures of sub-process28.

As noted above, obtaining third-party authorization in sub-process30may include contacting appropriate third-party sources72, e.g., either on a dynamic, as-needed basis, and/or ahead of time by periodically replicating a third party's remote database to create a local copy. The financial source74may be contacted to determine whether it authorizes the charges associated with the patient monitoring services. This authorization is particularly important for the business interests of the provider of the services, for example, to avoid unpaid billings. Unpaid billings for medical services represents a major loss for many medical service companies. The medical source76may be contacted to determine whether it authorizes the patient monitoring. For example, if the prospective patient is being treated by more than one physician, it may be important to obtain authorization from each physician who is treating the patient before medical monitoring services are commenced. In this case, “authorization” signals formal recognition by the authorizing party that monitoring information will be available. Other sources78may also be contacted to determine whether they authorize the patient monitoring. For example, it may be desirable to ensure that the company responsible for maintaining the specific medical monitoring device54to be activated authorizes its use. If a prior user had reported a problem and the specific medical monitoring device54had been taken out of service for repair, but was mistakenly to be re-activated without being repaired, the company responsible for the maintenance could prevent its activation at this stage.

Thus, the procedures in sub-process26act as a “sign off” by a number of checks and third-parties to minimize the possibility that a medical monitoring device will be wrongly issued to a patient and activated. If the sign-offs are not completed, the medical monitoring device is not activated until the reason for the non-completion may be investigated. It is expected that in the great majority of cases, the activation determination process26will be completed without incident and so rapidly that the checking will be transparent to the patient and the issuer of the medical monitoring device.

Based on results of the activation determination process, the activation decision is made (32). The final decision is typically made at the central unit58, although all or part of the final decision could be made at the base station and/or distributed or made by a system at another location. Typically, the decision is made at the central unit58because it has the access to the required information during the activation determination process26, and because the central unit58tends to be more immune to tampering than the base station56.

In the event that the identification data elements meet the set of basic structural requirements and third-party authorization is obtained, the central unit58issues an activation signal (34) to the medical monitoring device system52over the communication link60or62. The medical monitoring device54is activated and enters service (36).

The “activation signal” may be of any operable type. It may be a software “on” switch that enables the processing of data within a microprocessor in the medical monitoring device54or a hardware “on” switch that turns on particular hardware functions such as the communications links built into the medical monitoring device54. The activation signal may be complex, and may include identification of the patient and the specific medical monitoring device54that is associated with that patient. This activation signal may then be transmitted with each subsequent communication between the medical monitoring device54and the central unit58for identification purposes. In the event that the proper activation signal is not transmitted with each communication, it may be ignored. The activation may be revoked (38) at a later time if the authorization is withdrawn or for other reasons. Upon revocation38, the signals transmitted by the medical monitoring device54are not acted upon, and the patient and/or the issuing authority are notified and requested to return the medical monitoring device54. As an alternative to revocation38, the activation signal of step34may include a maximum time limit for which activation is authorized, so that a further authorization is required to extend the period of authorized use.

As shown inFIG. 3, an apparatus110for remotely monitoring and assessing the status of a subject includes a portable monitoring unit112and a central monitoring device114, which may communicate via by a wireless communication link116.

The portable monitoring unit112includes a sensor interface unit120having a microprocessor122with multiple inputs and outputs, illustrated in a bus architecture. Communication of the microprocessor122with the wireless communication link116, and thence with the central monitoring device114, is effected through a communications device interface124and a first transceiver126of the wireless communication link116. Information is gathered by one or more sensors128. It is preferred that the wireless communication link116be a digital wireless communication link, but an analog link may be used instead. The sensors128may include internal sensors128aembedded in the portable monitoring unit112and/or external sensors128bthat are connected to the portable monitoring unit through appropriate external interfaces130. (InFIG. 3, the external interface130is illustrated as part of the portable monitoring unit112, but it may be external to the portable monitoring unit.) The external sensors128bmay be any type that may be interfaced with the microprocessor122through the interface130. For example, the interface130may be a standard serial or parallel interface, a PCMCIA interface, or an Ethernet interface. An external programming device or other device may also be connected to microprocessor122through the appropriate external interface130.

An optional manual input device132communicating with the microprocessor122is accessible from the exterior of the portable monitoring unit112, to allow a user or subject of the portable monitoring unit to provide information to the microprocessor122. The manual input device132may be as simple as a switch such as a push button, or more complex such as a keypad. Optionally, a display134, such as a liquid crystal display, and an audio and/or visual communicator136, such as a tone generator, speaker, or flashing light, may be provided to signal the user of the portable monitoring unit112to take responsive action. An external port137, such as a serial or a parallel communication port, is provided to permit information or reprogramming instructions to be Input to the microprocessor122at the site of the portable monitoring unit112. (A compatible sensor may also be connected through the external port137.) The manual input device132, the display134, the audio and or visual communicator136, and external port137are each optional features that may be provided for specific applications.

The microprocessor122may be a Multi-Chip Package (MCP) such as the currently available Vadem VG330, the Advanced Micro Devices AMD Elan SC400, the NEC HHT-ASSP, or the ZF MicroSystems SMX/386. The microprocessor includes a power management unit which permits the microprocessor to be placed into an inactive state or awakened to an active state by a proper signal. The power management achieves conservation of the power of the power supply142. The microprocessor is typically provided with memory144, which may be a random access memory, a readonly memory, a mass storage device, or any combination of these types of memory. This memory may be shared with other components of the portable monitoring unit112. The first transceiver126may be a single-board digital wireless module such as a WIT915 or WIT2500M marketed by Digital Wireless Corporation, with the appropriate interface124. The first transceiver126has its own power management unit that permits the transceiver to be placed into an inactive state or awakened to an active state by a proper signal.

A location-determining device138is provided so that the location of the portable monitoring unit112may be determined. The location-determining device138is preferably a global positioning system (GPS) receiver having an antenna140shared with the antenna of the first transceiver126. The GPS receiver may be a MicroTracker LP global positioning system receiver module available from Rockwell Semiconductor Systems. Other types of location-determining devices138such as those based upon cellular cell-site position triangulations, LORAN, and the like, may also be used.

A power supply142such as a battery provides power for the components of the portable monitoring unit112requiring power, and optionally for the external sensor128band the external interface130. InFIG. 3, the power connections between the powered components and the power supply142are indicated by “PS” to avoid the need for drawing the interconnections that would obscure the data-communications paths.

The central monitoring device114includes at least a second transceiver150of the wireless communication link116, to establish communications between the first transceiver126of the portable monitoring unit112and the central monitoring device114. Typically, the central monitoring device114further includes a terminal152having a communications device interface158to the second transceiver150, and connections to a display154that may be viewed by an operator156. The terminal152may be a simple manual system, or, preferably, it may be a more complex as illustrated. In this more complex terminal152, there is a computer160that communicates with the display154and communicates with and oversees the operations of the portable monitoring unit112in the manner to be discussed subsequently. The central monitoring device114may also be provided with a location-determining device162, particularly if the central monitoring is movable or portable and its location must be determined. The location-determining device162has an antenna164shared with the antenna of the second transceiver150. The location-determining devices138and162are typically selected to be compatible. If, for example, the location-determining device138is an autonomous GPS receiver, the location-determining device162normally is also a GPS receiver. On the other hand, the location-determining technique may utilize a triangulation, time-of-flight, or other type of measurement that requires. coordination between the location-determining devices138and162, which are then chosen with that technique in mind.