Systems and methods to automate transfer, storage, and analysis of medical device data

Abstract

Systems and methods for automated generation of medical device communication software, cloud-based storage of medical device data, and user interface software for accessing medical device data, that meets one or more medical device standards set by government or industry regulatory bodies.

1 .- 27 . (canceled) 
     
     
         28 . A system for automated generation of interface software for data transfer between an electrical medical device (EMD) and a data storage medium, comprising:
 a medical device modeler for receiving an input defining one or more EMD properties, the medical device modeler comprising a property validator module to validate each medical device property and providing an EMD data model comprising a set of validated medical device properties and property rules, wherein the at least one property feature is selected from data type, name, size, frequency of upload, or hierarchical relationship with another property, and the at least one property rule is selected from values permitted for the data type, values within a defined range, a type or types of users permitted to access the property, a formula for a calculation to be performed on the property, and consistency of a first parameter or attribute of the property with a second parameter or attribute of the property;   an EMD interface generator module for automatically generating, based on the EMD data model, (i) code for an EMD communication interface to allow an EMD to transmit data to the system, and (ii) code for a system interface to receive data transmitted from the EMD; and   a compiler for compiling the code for the EMD communication interface into an EMD communication interface program and compiling the code for the system interface into a system interface program.   
     
     
         29 . The system of  claim 28 , further comprising a storage medium for storing data received by the system interface. 
     
     
         30 . The system of  claim 28 , wherein the EMD communication interface and the system interface comply with one or more governmental standards for EMDs set by the United States Food & Drug Administration (USFDA). 
     
     
         31 . The system of  claim 30 , wherein the EMD communication interface and the system interface comply with one or more industry standards selected from ISO 13485, IEC 82304 and ISO 14971. 
     
     
         32 . The system of  claim 28 , wherein the medical device modeler comprises
 a property input module for receiving an input defining one or more features for each medical device property, and at least one rule for each said property; and   a property validator module for validating the one or more features and the at least one rule for each medical device property.   
     
     
         33 . The system of  claim 28 , wherein the EMD interface generator module comprises
 a device property interface builder for generating a generic EMD communication interface based on the EMD data model; and   an EMD interface language adapter for automatically generating said EMD communication interface and said system interface in a desired interface language based on the generic EMD communication interface.   
     
     
         34 . The system of  claim 33 , wherein the device property interface builder generates the generic EMD communication interface based on the EMD data model and a generic communication template. 
     
     
         35 . The system of  claim 33 , wherein the EMD interface language adaptor generates the EMD communication interface and the system interface by applying programming language-specific rules to the generic EMD communication interface. 
     
     
         36 . The system of  claim 28  wherein the EMD communication interface is programmed into the EMD as one or more of software and firmware. 
     
     
         37 . A system for automated generation of interface software for a user device for obtaining electrical medical device (EMD) data from a storage medium, comprising:
 a medical device modeler for receiving an input defining one or more EMD properties, the medical device modeler comprising a property validator module to validate each medical device property and providing an EMD data model comprising a set of validated medical device properties and property rules, wherein the property rules are selected from values permitted for a data type, values within a defined range, a type or types of users permitted to access the property, a formula for a calculation to be performed on the property, and consistency of a first parameter or attribute of the property with a second parameter or attribute of the property;   a user device interface generator module for automatically generating, based on the EMD data model, code for at least one user device interface to allow a user device to access EMD data from a storage medium; and   a compiler for compiling the code for the at least one user device interface into at least one user device interface program.   
     
     
         38 . The system of  claim 37 , wherein the user device comprises a device selected from a clinician programmer for an EMD, a patient device to communicate with an EMD coupled to the patient's body, and an OEM server. 
     
     
         39 . The system of  claim 37 , wherein the medical device modeler comprises
 a property input module for receiving an input defining one or more features for each medical device property, and at least one rule for each said property; and   a property validator module for validating the one or more features and the at least one rule for each medical device property.   
     
     
         40 . The system of  claim 37 , wherein the user device interface generator module comprises
 a user interface builder module for generating a user interface data model based on the EMD data model; and   a web interface builder module for automatically generating the user device interface based on the user interface data model and a web template defining generic elements for how the user device interface will be displayed.   
     
     
         41 . The system of  claim 40 , wherein the user interface builder module generates the user interface data model based on the EMD data model and a user mode. 
     
     
         42 . The system of  claim 41 , wherein the user mode identifies a user selected from one of a clinician, a patient, and an original equipment manufacturer. 
     
     
         43 . The system of  claim 40 , wherein the web interface builder module automatically generates the user device interface in an interface language selected from HTML, CSS, and JS. 
     
     
         44 . The system of  claim 37 , wherein the user device interface is programmed into the user device as software. 
     
     
         45 . A system for automated generation of software for analyzing electrical medical device (EMD) data, comprising:
 a storage medium having stored data obtained from an EMD; and   a machine learning algorithm module for automatically analyzing stored data from an EMD using machine learning and for generating machine learning algorithm reports, wherein the machine learning algorithm module automatically performs at least one task using the stored data obtained from an EMD, the at least one task selected from identifying trends in the data, generating alerts that may be forwarded to a user, classifying disease states, identifying patient status, generating decision trees, and wherein the machine learning algorithm automatically stores the machine learning algorithm reports in the storage medium.   
     
     
         46 . The system of  claim 45 , further comprising
 a medical device modeler for receiving an input defining one or more EMD properties, the medical device modeler comprising a property validator module to validate each medical device property and providing an EMD data model comprising a set of validated medical device properties and property rules;   wherein the machine learning algorithm automatically analyzes stored data obtained from an EMD using at least one of the validated medical device properties and property rules from the EMD data model, wherein the at least one property rule is selected from values permitted for a data type, values within a defined range, a type or types of users permitted to access the property, a formula for a calculation to be performed on the property, and consistency of a first parameter or attribute of the property with a second parameter or attribute of the property.   
     
     
         47 . The system of  claim 45 , wherein the machine learning algorithm automatically forwards at least one of said reports to a user selected from a clinician, a patient, and an original equipment manufacturer on a periodic basis.