Methods and systems for managing, controlling and monitoring medical devices via one or more software applications functioning in a secure environment

A computer implemented method of operating a medical device, comprising:

• initiating establishment of a communications connection between a user device and the medical device wherein the user device includes:
• a secure environment utilizing a secure environment processor configured to continue to execute at least part of the medical application in the event of at least one of a denial of service attack, an attempt to overload processing or memory usage in the secure environment, and a reboot or shutdown of a nonsecure environment;
• a nonsecure environment processor wherein the secure environment processor is isolated from the nonsecure environment processor,
• a secure environment memory coupled to the secure processor and accessible only to the secure environment processor, the secure environment memory being included within the secure environment and including a security monitor executed by the secure environment processor wherein the security monitor is configured to:
• identify secure traffic on the user device wherein the secure traffic is associated with a function of the medical application requiring security,
• identify a security requirement associated with the function,
• manage execution of the medical application within the secure environment in accordance with the security requirement,
• identify other traffic on the user device wherein the other traffic is associated with a nonsecure function of an application,
• determine that the nonsecure function does not require security,
• allow the nonsecure function to run in the nonsecure environment,
• a nonsecure environment memory coupled to the nonsecure environment processor;
• at least one of a short range wireless radio and a wired connector for facilitating the communications connection;
• a radio configured to receive a medical application from a service platform;
• sending, from the medical application and via the communications connection, instructions for controlling or monitoring an operational function of the medical device, wherein:
• the secure environment memory is configured to store code for the medical application,
• the nonsecure environment memory is configured to store one or more nonsecure applications,
• the nonsecure functions do not interact with the secure memory segment;
• receiving, from the medical device and using the medical application, data associated with operation of the medical device;
• and
• storing the data associated with operation of the medical device in the secure environment memory.

An apparatus for a user device, comprising:

• a secure environment of the user device wherein the secure environment utilizes a secure environment processor and memory resources in the event of at least one of a denial of service attack and an attempt to overload processing or memory usage in the secure environment;
• a nonsecure environment processor wherein the secure environment processor is isolated from the nonsecure environment processor;
• a nonsecure environment memory coupled to the nonsecure environment processor wherein the nonsecure environment memory is configured to store code for one or more non-certified applications;
• a secure environment memory coupled to the secure processor and accessible only to the secure environment processor wherein the secure environment memory is configured to securely store code for a certified medical application disposed for execution on the secure environment processor to facilitate control and/or monitoring of a medical device;
• a radio for communicating with the medical device, wherein the radio is exclusively controlled by the secure environment processor when communicating with the medical device;
• at least one of a wide area network radio and a wired connector wherein the at least one of a wide area network radio and the wired connector receives the certified medical application from a service platform;
• wherein the non-certified applications do not interact with the secure environment memory.

A medical device, comprising:

• a sensor configured to monitor at least one physiological characteristic of a patient;
• a secure environment utilizing a secure environment processor coupled to the sensor, wherein the secure environment processor is configured to continue operating in the event of at least one of a denial of service attack and an attempt to overload processing or memory usage in the secure environment;
• a nonsecure environment processor wherein the secure environment processor is isolated from the nonsecure environment processor;
• a nonsecure environment memory coupled to the nonsecure environment processor wherein the nonsecure environment memory is configured to store code for one or more noncertified applications;
• a secure environment memory being coupled to the secure processor and accessible only to the secure environment processor wherein the secure environment memory is configured to securely store code for a certified medical application disposed for execution on the secure environment processor to facilitate monitoring of the physiological characteristic and wherein the secure environment memory includes a security monitor executed by the secure environment processor wherein the security monitor is configured to:
• identify secure traffic on the medical device wherein the secure traffic is associated with a function of the certified medical application requiring security,
• identify a security requirement associated with the function,
• manage execution of the certified medical application within the secure environment in accordance with the security requirement;
• a radio for communicating with a user device, wherein the radio is exclusively controlled by the secure environment processor when communicating with the user device;
• wherein the non-certified applications do not interact with the secure environment memory.