Secure Remote Care Session Manager for IMDs

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Solution Overview

Problem

Remote patient care systems face increased risks of malicious access to patient data and interference with medical devices due to the lack of secure communication channels for clinicians and implantable medical devices, especially with the adoption of longer-range telemetry capabilities.

Innovation Solution

A system and method utilizing a secure network architecture with a key infrastructure system to establish trusted relationships between clinicians, patients, and implantable medical devices, enabling secure communication credentials for remote care therapy operations through a cloud-based service architecture, including registration and validation processes for clinician and patient devices.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If longer-range telemetry capabilities are adopted for remote patient care, then access to care is increased and healthcare delivery costs are decreased, but the risk of malicious access to patient data and interference with medical devices is increased

Engineering Contradiction:
Improveaccess to careVSAvoidrisk of malicious access
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a key infrastructure system and secure communication channel as intermediaries between external devices and implantable medical devices. This mediator establishes trusted relationships through cryptographic key pairs, allowing remote access while preventing malicious interference. The secure channel acts as a buffer that enables communication without exposing the IMD directly to untrusted networks.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system performs preliminary security actions by establishing trusted relationships and generating cryptographic key pairs before remote access occurs. The bonding process between external devices and IMDs is completed in advance during in-person or in-clinic settings, creating pre-established secure channels that can be activated remotely without compromising security.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If in-person or in-clinic programming is used for implantable medical devices, then security against third-party access is maintained, but remote patient care and access are limited

Engineering Contradiction:
Improvesecurity against unauthorized accessVSAvoidremote patient care access
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent uses secure communication channels and key infrastructure systems as intermediaries to bridge the gap between in-person security requirements and remote access needs. The cryptographic authentication mechanism allows the system to maintain the security characteristics of in-person programming while enabling remote patient care operations.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system replaces the physical proximity requirement (mechanical presence of clinician and patient in same location) with cryptographic authentication mechanisms. Instead of relying on physical closeness to ensure security, the patent uses digital key pairs and secure communication protocols to authenticate and authorize remote access, substituting physical security measures with digital security infrastructure.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If short-range communication links are used for device programming, then the likelihood of third-party establishing communication sessions is minimized, but remote therapy operations are not enabled

Engineering Contradiction:
Improvecommunication securityVSAvoidremote therapy capability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The system dynamically adapts communication range based on operational context. During initial programming and bonding, short-range communication is used to ensure security. Once trusted relationships are established, the system transitions to longer-range telemetry capabilities for remote therapy operations. This dynamic adjustment allows the system to maintain security during critical setup phases while enabling remote access during therapy delivery phases.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent performs preliminary security setup using short-range communication to establish cryptographic key pairs and trusted relationships before transitioning to long-range communication. This preliminary action ensures that when remote therapy operations begin, the security framework is already in place, allowing versatile remote access without compromising communication security.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS11364386B2System, method and architecture for facilitating remote patient care
Publication Date: 2022.06.21 ADVANCED NEUROMODULATION SYSTEMS INC
  • US11364386B2 patent drawing
  • US11364386B2 patent drawing
  • US11364386B2 patent drawing

AI summary

A system, method and a network architecture for facilitating remote care therapy via secure communication channels between clinicians and patients having one or more IMDs, wherein certain unique information retrieved from an IMD is used in association with an encryption key infrastructure system for establishing trusted relationships between a clinician device, a patient's device and the patient's IMD. A cloud-based remote care session manager is provided for registering and validating the clinician and patent devices based on the IMD data used as trust indicia. In one embodiment, trusted associations between the devices are only established when the devices in close proximity of each other, e.g., in an in-person setting.