Variable encryption scheme for data transfer between medical...

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

Reexamination Certificate

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C380S045000, C128S903000

Reexamination Certificate

active

06622050

ABSTRACT:

FIELD OF THE INVENTION
The present invention generally relates to data management for medical devices. Specifically, the invention relates to an apparatus and method for variably encrypting and transferring of data transmitted between various devices. More specifically, the invention provides for dynamic encryption of patient data, program commands, physician's options and choices, and similar parameters at varying levels of security based on the content and nature of the data.
BACKGROUND OF THE INVENTION
A network of devices having data communications capabilities, that are associated with implantable medical devices (IMDs) has been provided for the administration of IMDs. On the network may be implemented a system and method of bi-directional telecommunications between an expert data center, clinicians, and an IMD programmer device, utilizing various types of network platforms and architecture to implement, in the programmer, distance-based troubleshooting, maintenance, upgrade, information and is administrative services thereby providing an economical and highly interactive system for therapy and clinical care.
The assignee of the present invention has disclosed data management, transfer and archiving schemes relating to IMDs and associated instruments such as a programmer, remote monitor and similar instruments, which are in data communications with the IMDs. The structures and methods of these schemes are generally defined in applications entitled “Medical System Having Improved Telemetry,” filed Jul. 19, 1999, Ser. No. 09/356,340 now U.S. Pat. No. 6,298,271; “System and Method for Transferring Information Relating to an Implantable Medical Device to a Remote Location,” filed on Jul. 21, 1999, Ser. No. 09/358,081 now U.S. Pat. No. 6,250,309; “Apparatus and Method for Remote Troubleshooting, Maintenance and Upgrade of Implantable Device Systems,” filed on Oct. 26, 1999, Ser. No. 09/426,741 now U.S. Pat. No. 6,442,433; “Tactile Feedback for Indicating Validity of Communication Link with an Implantable Medical Device,” filed Oct. 29, 1999, Ser. No. 09/430,708; “Apparatus and Method for Automated Invoicing of Medical Device Systems,” filed Oct. 29, 1999, Ser. No. 09/430,208 now U.S. Pat. No. 6,385,593; “Apparatus and Method for Remote Self-Identification of Components in Medical Device Systems,” filed Oct. 29, 1999, Ser. No. 09/429,956 now abandoned; “Apparatus and Method to Automate Remote Software Updates of Medical Device Systems,” filed Oct. 29, 1999, Ser. No. 09/429,960 now U.S. Pat. No. 6,363,282; “Method and Apparatus to Secure Data Transfer From Medical Device Systems,” filed Nov. 2, 1999, Ser. No. 09/431,881 “Implantable Medical Device Programming Apparatus Having An Auxiliary Component Storage Compartment,” filed Nov. 4, 1999, Ser. No. 09/433,477 now U.S. Pat. No. 6,411,851; “Remote Delivery Of Software-Based Training For Implantable Medical Device Systems,” filed Nov. 10, 1999, Ser. No. 09/437,615 now U.S. Pat. No. 6,386,882; “Apparatus and Method for Remote Therapy and Diagnosis in Medical Devices Via Interface Systems,” filed Dec. 14, 1999, Ser. No. 09/460,580 now U.S. Pat. No. 6,418,436; “Virtual Remote Monitor, Alert, Diagnostics and Programming For Implantable Medical Device Systems” filed Dec. 17, 1999, Ser. No. 09/466,284 now U.S. Pat. No. 6,497,655; “Instrumentation and Software for Remote Monitoring and Programming of Implantable Medical Devices (IMDs), filed Dec. 21, 1999, Ser. No. 60/172,937; “Application Proxy For Telecommunication-enabled Remote Medical Access Instruments,” filed Dec. 23, 1999, Ser. No. 60/173,081; “Information Network Scheme For Interrogation Of Implantable Medical Devices (IMDs),” filed Dec. 24, 1999, Ser. No. 60/173,064; “Medical Device GUI For Cardiac Electrophysiology Display And Data Communications,” filed Dec. 24, 1999, Ser. No. 60/173,065; “Integrated Software System For Implantable Medical Device Installation And Management,” filed Dec. 24, 1999, Ser. No. 60/173,082; “Dynamic Bandwidth Monitor And Adjuster For Remote Communications With A Medical Device,” filed Dec. 24, 1999, Ser. No. 60/173,083 “Large-Scale Processing Loop For Implantable Medical Devices (IMDs),” filed Dec. 24, 1999, Ser. No. 60/173,079; “Chronic Real-Time Information Management Systems For Implantable Medical Devices (IMDs),” filed Dec. 24, 1999, Ser. No. 60/173,062; “Automatic Voice and Data Recognition For Medical Device Instrument Systems,” filed Dec. 24, 1999, Ser. No. 60/173,071 “Central Switchboard to Facilitate Remote Collaboration With Medical Instruments,” filed Dec. 24, 1999, Ser. No. 60/173,080; “System Of Notification Of Recalled Components For A Medical Device” filed Dec. 29, 1999, Ser. No. 09/474,694; “A Communications System For An Implantable Device And A Drug Dispenser” Dec. 30, 1999, Ser. No. 09/475,709 now U.S. Pat. No. 6,471,645; “User Authentication In Medical Systems Device,” filed Dec. 30, 1999, Ser. No. 60/173,822; “Automated Invoicing Based On Medical System Usage,” filed Dec. 30, 1999, Ser. No. 60/173,824; “Responsive Manufacturing and Inventory Control,” filed Feb. 4, 2000, Ser. No. 60/180,289; “Information Remote Monitor (IRM) Medical Device,” filed Feb. 4, 2000, Ser. No. 60/180,285 “Follow-Up Monitor For Implantable Medical Device,” filed Feb. 23, 2000, Ser. No. 60/184,221; “Implantable Medical Device With Multi-Vector Sensing Electrodes,” filed Mar. 1, 2000, Ser. No. 60/186,235; “Stimulator For Delivery Of Molecular Therapy,” filed Mar, 7, 2000, Ser. No. 60/187,280; “Individualized, Integrated, And Informative Internet Portal For Holistic Management of Patients With Implantable Devices,” filed Mar. 15, 2000, Ser. No. 60/189,562; “Heart Failure Monitor Quick Look Summary For Patient Management Systems,” filed Mar. 17, 2000, Ser. No. 60/190,272; “A Universal Interface For Medical Device Data Management,” filed Mar. 17, 2000, Ser. No. 60/190,465; “Telepresence Apparatus And Method For Remote Implantable Medical Device Implementation And Management,” filed Mar. 24, 2000, Ser. No. 60/192,006; “A Hand-Held Surface ECG and RF Apparatus Incorporated With a Medical Device,” filed Mar. 29, 2000, Ser. No. 60/192,943,; all of which are incorporated herein by reference in their entirety.
Data encryption is a valuable tool for protecting privacy and ensuring data authenticity. Specifically, encryption technology which has wide application in the management of regulated therapy and diagnosis data, is widely used. More particularly, security relating to medical data is important to prevent tampering, modification or data corruption when data is sent over a public network that is potentially subject to eavesdropping and tampering. Even for dedicated lines and other secure data channels, it may be desirable to use encryption technology, such as digital signatures or checksums to ensure the integrity of transmitted messages. Such confirmation by means of digital signatures or checksums may be particularly indicated in patient care, where privacy, accuracy in instructions, either to a human caregiver or to a remote device, may be important. For example, the highest level of security and accuracy may be indicated for patient data on which critical therapy and diagnosis depend. On the other side of the security spectrum, data that is collected by a sensor on a real time basis, for example, an Electrocardiogram (ECG), an electroencephalogram, or an IEGM, may be sent with minimal or no protection and relatively lower accuracy. In addition, the reduction in computing overhead to which real-time data may be subject according to an embodiment of the present invention helps to ensure that no distortion of data, as a function of time, is injected into the real-time physiologic data being transmitted.
Prior art encryption systems are not dynamically adjustable. Further, prior art systems lack selectable encryption devices and methods which are based on the level of security assigned to the data to be encrypted. Additionally, various networks such as the Internet, World Wide Web, and the like do not implement dynamically variable encryption systems. Pri

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