Patent Application
20070180047
The present invention relates in general to external sensor authentication and, specifically, to a system and method for providing authentication of remotely collected external sensor measures.
Remote patient management has become increasingly attractive as an alternative to routine clinical follow-up in light of trending increases in healthcare costs. Remote patient management enables a clinician, such as a physician, nurse, or other healthcare provider, to follow patient well-being through homecare medical devices that can collect and forward patient data without requiring the presence or assistance of medical personnel. Advances in automation have encouraged such self-care solutions and public data communications networks, in particular, the Internet, have made ready data retrieval and patient communication viable and widely available.
To participate in remote patient management, each patient installs an at-home medical device, such as a patient management device, for collecting quantitative patient data measured by external sensors, such as a weight scale, blood pressure cuff, pulse oximeter, or glucometer, and for connecting to a centralized patient management facility, frequently implemented as a server accessible over the Internet. Other devices, such as a personal computer, can. measure and report qualitative patient data. In addition, implantable medical devices (IMDs), for example, pacemakers and implantable defibrillators, are beginning to include the capability to work with at-home medical devices.
To succeed, remote patient management must be user-friendly to encourage regular use. Difficulties in use will discourage patients and decrease the effectiveness of treatment and the benefit received. Ideally, remote patient management devices should introduce no more than minimal inconvenience, such as experienced when using a bathroom scale or thermometer, and will accommodate the needs of the infirm, elderly and physically challenged. Additionally, these devices should transparently manage spurious data, such as resulting from unauthorized use and from use by sources other than the patient, because raw patient data cannot easily be associated with a specific authorized patient. Conventional remote patient management devices assume that the patient is the only user and rely on implicit patient identification.
U.S. Pat. No. 6,168,563, to Brown, discloses a system and method that enables a healthcare provider to monitor and manage a health condition of a patient. A clearinghouse computer communicates with the patient through a data management unit, which interactively monitors the patient's health condition by asking questions and receiving answers that are supplied back to the clearinghouse computer. Patient information may also be supplied by physiological monitoring devices, such as a blood glucose monitor or peak-flow meter. Healthcare professionals can access the patient information through the clearinghouse computer, which can process, analyze, print, and display the data. However, Brown fails to disclose specific controls to ensure proper patient identification prior to accepting data from the data management unit.
U.S. Pat. No. 6,416,471, to Kumar et al. (“Kumar”), discloses a portable remote patient telemonitoring device. A disposable sensor band with electro-patches detects and transmits vital signs data to a signal transfer unit, which can be either be worn or positioned nearby the patient. The base station receives data transmissions from the signal transfer unit for transferring the collected data to a remote monitoring station. Indications are provided to a patient from a base station when threshold violations occur. However, Kumar fails to disclose authenticating the identity of the patient prior to receiving collected data from the base station.
U.S. Pat. No. 6,024,699, to Surwit et al. (“Surwit”), discloses a central data processing system configured to communicate with and receive data from patient monitoring systems, which may implement medical dosage algorithms to generate dosage recommendations. Blood from a pricked finger may be read on a chemically treated strip for review at the central data processing system. Modifications to medicine dosages, the medicine dosage algorithms, patient fixed or contingent self-monitoring schedules, and other treatment information are communicated. However, Surwit fails to disclose identifying the patient submitting the sample through each patient monitoring system.
Therefore, there is a need for providing an automated determination of patient identification associated with patient data collected by remote external and unsupervised sensors to ensure the integrity of the data received. Preferably, such an approach would provide a range of patient authentication mechanisms customizable to meet patient needs and monitoring situations.
A system and method includes passive and active authentication of patient data received or accepted from a source under remote patient management. Active authentication requires a patient to undertake a physical action, such as providing biometric, token, or code entry identifiers, which can provide identification credentials for comparison to authentication data prior to forwarding. Passive authentication utilizes credentialing indicia generally provided as an implantable device, such as an implantable medical device, implantable sensor, or implantable identification tag, to authenticate the physical proximity of a patient as the source of the patient data.
One embodiment provides a system and method for authenticating remotely collected external sensor measures. Physiological measures are collected from a source situated remotely from a repository for accumulating the physiological measures. The source of the physiological measures is identified by comparison to authentication data that uniquely identifies a specific patient. The physiological measures are forwarded to the repository upon authenticating the patient data as originating from the specific patient.
Still other embodiments of the present invention will become readily apparent to those skilled in the art from the following detailed description, wherein are described embodiments of the invention by way of illustrating the best mode contemplated for carrying out the invention. As will be realized, the invention is capable of other and different embodiments and its several details are capable of modifications in various obvious respects, all without departing from the spirit and the scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.
Automated Patient Management Environment
Automated patient management encompasses a range of activities, including remote patient management and automatic diagnosis of patient health, such as described in commonly-assigned U.S. Patent application Pub. No. US2004/0103001, published May 27, 2004, pending, the disclosure of which is incorporated by reference. Such activities can be performed proximal to a patient, such as in the patient's home or office, centrally through a centralized server, such from a hospital, clinic or physician's office, or through a remote workstation, such as a secure wireless mobile computing device.
Each patient management device 12 is uniquely assigned to a patient under treatment 14 to provide a localized and network-accessible interface to one or more medical devices 15-17, either through direct means, such as wired connectivity, or through indirect means, such as selective radio frequency or wireless telemetry based on, for example, “strong” Bluetooth or IEEE 802.11 wireless fidelity “WiFi” and “WiMax” interfacing standards. Other configurations and combinations of patient data source interfacing are possible. Medical therapy devices include implantable medical devices (IMDs) 15, such as pacemakers, implantable cardiac defibrillators (ICDs), drug pumps, and neuro-stimulators, as well as external medical devices (not shown). Medical sensors include implantable sensors 16, such as implantable heart and respiratory monitors and implantable diagnostic multi-sensor non-therapeutic devices, and external sensors 17, such as Holter monitors, weight scales, and blood pressure cuffs. Other types of medical therapy, medical sensing, and measuring devices, both implantable and external, are possible.
Patient data includes physiological measures, which can be quantitative or qualitative, parametric data regarding the status and operational characteristics of the patient data source itself, and environmental parameters, such as the temperature or time of day. In a further embodiment, patient data can also include psychological, drug dosing, medical therapy, and insurance-related information, as well as other types and forms of information, such as digital imagery or sound and patient-provided or -uploaded information. The medical devices 15-17 collect and forward the patient data either as a primary or supplemental function. The medical devices 15-17 include, by way of example, implantable and external medical therapy devices that deliver or provide therapy to the patient 14, implantable and external medical sensors that sense physiological data in relation to the patient 14, and measurement devices that measure environmental parameters and other data occurring independent of the patient 14. Other types of patient data are possible. Each medical device 15-17 can generate one or more types of patient data and can incorporate one or more components for delivering therapy, sensing physiological data, measuring environmental parameters, or a combination of functionality.
Patient data received from IMDs 15 and implantable sensors 16 is known to have originated from a particular patient 14, as implantable devices are uniquely identified by serial number or other identifying data. Accordingly, any patient data originating from an implantable device can only be from the patient 14 in which the device was implanted. Patient data received from external sensors 17, however, is not uniquely tied to a particular patient 14 and could instead originate from another person, such as a spouse or family member, or random source, such as a pet that accidentally triggers a sensor reading. To ensure the integrity of patient data, the identification of the source from which the patient data was collected is confirmed against authentication data that uniquely identifies a specific patient 14 prior to being forwarded to the centralized server 13 or other patient data repository. In one embodiment, a patient data source is associated with a specific patient in a one-to-one mapping that ensures authentication prior to receipt of the patent data at the centralized server 13, as further described below beginning with reference to
In a further embodiment, data values can be directly entered by a patient 14. For example, answers to health questions could be input into a personal computer with user interfacing means, such as a keyboard and display or microphone and speaker. Such patient-provided data values could also be collected as patient information. In one embodiment, the medical devices 15-17 collect the quantitative physiological measures on a substantially continuous or scheduled basis and also record the occurrence of events, such as therapy or irregular readings. In a further embodiment, the patient management device 12, a personal computer, or similar device record or communicate qualitative quality of life (QOL) measures that reflect the subjective impression of physical well-being perceived by the patient 14 at a particular time. Other types of patient data collection, periodicity and storage are possible.
In a further embodiment, the collected patient data can also be accessed and analyzed by one or more clients 19, either locally-configured or remotely-interconnected over the internetwork 11. The clients 19 can be used, for example, by clinicians to securely access stored patient data assembled in a database 18 and to select and prioritize patients for health care provisioning, such as respectively described in commonly-assigned U.S. patent application, Ser. No. 11/121,593, filed May 3, 2005, pending, and U.S. patent application, Ser. No. 11/121,594, filed May 3, 2005, pending, the disclosures of which are incorporated by reference. Although described herein with reference to physicians or clinicians, the entire discussion applies equally to organizations, including hospitals, clinics, and laboratories, and other individuals or interests, such as researchers, scientists, universities, and governmental agencies, seeking access to the patient data.
In a further embodiment, patient data is safeguarded against unauthorized disclosure to third parties, including during collection, assembly, evaluation, transmission, and storage, to protect patient privacy and comply with recently enacted medical information privacy laws, such as the Health Insurance Portability and Accountability Act (HIPAA) and the European Privacy Directive. At a minimum, patient health information that identifies a particular individual with health- and medical-related information is treated as protectable, although other types of sensitive information in addition to or in lieu of specific patient health information could also be protectable.
Preferably, the server 13 is a computing platform configured as a uni-, multi- or distributed processing system, and the clients 19 are general-purpose computing workstations, such as a personal desktop or notebook computer. In addition, the patient management device 12, server 13 and clients 19 are programmable computing devices that respectively execute software programs and include components conventionally found in computing device, such as, for example, a central processing unit (CPU), memory, network interface, persistent storage, and various components for interconnecting these components.
Method Overview
Patient data includes any data that originates from a patient 14 under remote management and can include physiological measures, parametric data, and environmental parameters. The patient data can either be measured or generated directly by an external sensor 17 or can be submitted as already-measured values to a patient management device 12, either directly, such as through a user interface, or indirectly, via, for instance, an external sensor 17 or other device interfaced to the patient management device 12.
By way of example, the collection 31 of patient data 37 can be performed autonomously 34, semi-autonomously 35, and through networked data collection 36. Autonomous patient data collection 34 is performed by an external sensor 17 independently from other devices and includes authentication of the source of the patient data 37, which is forwarded as a complete packet of information. Semi-autonomous data patient collection 35 is performed by an external sensor 17 in conjunction with another device, typically the patient management device 12, which uses the external sensor 17 as a measurement source and records the measurement as patient data 37. Networked data collection 36 is performed by a patient management device 12 or equivalent device, such as a Web-based personal computer, which receives the patient data 37 through a user interface, such as in response to queries presented to the patient 14. Other forms of patient data collection 31 are possible.
The delivery of the patient data 37 to the centralized server 13 and, in a further embodiment, a patient management device 12, is deferred pending the determination 32 of the identification of the source from which the patient data 37 was obtained. In one embodiment, identification determination 32 is performed passively by relying upon detectible indicia implanted physically into the patient 14, as further described below with reference to
Following successful determination of the source of the patient data 37 as being the patient 14, the patient data 37 can be forwarded 33 for accumulation at the centralized server 13 or other repository to facilitate remote patient management. In further embodiments, the patient data 37 is forwarded on an interim basis to the patient management device 12 or to an IMD 15 or implantable sensor 16 for transient staging, pending eventual forwarding to the centralized server 13. Other forms of patient identification authentication are possible, including incremental or intermediate authentication on a point-to-point basis through passive, active, or combined authentication performed by one or more devices.
Passive Authentication
Passive authentication relies upon the presence of detectable indicia implanted into the patient 14 to provide the necessary authentication data by which to confirm patient identity.
The identifying data is compared against stored authentication data that uniquely identifies a specific patient 14. Passive authentication 40 requires the least amount of effort by the patient 14 and relies upon the system 10 to perform authentication transparently to the patient 14. However, the patient 14 must be willing to receive an implantable device, which contains the uniquely identifying data. Other forms of passive authentication are possible.
Active Authentication
Active authentication requires the patient 14 to undertake a physical action to provide credentialing information by which to confirm patient identity.
Patient Identification with an External Sensor
Autonomous patient data collection 34 (shown in
Autonomous patient data collection 34 is performed by the external sensor 61 independent from the centralized server, patient management device, and other devices. The external sensor 61 defers forwarding the collected patient data to the patient management device 12 or, in a further embodiment, the centralized server 13, pending confirmation of patient identity.
Patient Identification with a Patient Management Device
Patient management devices must also include the capability to confirm patient identification when performing semi-autonomous patient data collection 35 or networked data collection 36.
Similar to the autonomous patient data collection 34 performed by an external sensor 61, each patient management device 81 defers forwarding the collected patient data to the centralized server 13 pending confirmation of patient identity.
Patient Identification with an Implantable Medical Device
Passive authentication requires detectable indicia generally available through a device implanted in the patient 14, such as an IMD, implantable sensor, or implantable identification tag.
Prior to being forwarded to the centralized server 13, the patient data can be transiently staged at either an external sensor, patient management device, or implantable medical device. Transiently staging patient data at a patient management device enables the patient data to be forwarded to the centralized server immediately upon authentication, but consumes storage on the patient management device if the authentication fails and the patient data must ultimately be discarded as spurious. Referring to
Referring next to
Transiently staging the patient data on an external sensor avoids consuming storage on a patient management device if authentication fails, but can incur a delay in forwarding the patient data to the centralized server while the patient data is forwarded from the external sensor to the patient management device. Referring next to
Referring next to
Transiently staging the patient data on an implantable medical device avoids involving a patient management device in authentication, but is expensive in terms of the resources consumed, as the implantable medical device must expend processing, storage, and power budget resources to temporarily hold the patient data pending forwarding to the patient management device. The implantable medical device must have sufficient resources to temporarily hold the patient data pending upload to the patient medical device. Referring next to
Referring next to
Patient Identification for Multiple Patients
In one embodiment, a single patient data source can be associated with a specific patient in a one-to-one mapping, which provides local authentication. In a further embodiment, a single patient data source can be associated with multiple patients in a one-to-many mapping.
Referring next to
While the invention has been particularly shown and described as referenced to the embodiments thereof, those skilled in the art will understand that the foregoing and other changes in form and detail may be made therein without departing from the spirit and scope of the invention.
