Validating Mobile Access to Regulated Content

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Solution Overview

Problem

Accessing regulated content on mobile devices poses security challenges due to the risk of tampering and integrity breaches, as mobile applications and devices are not subject to the same stringent validation and authentication as traditional systems, making it difficult to maintain the integrity of FDA-regulated documents and files.

Innovation Solution

A multi-step security process within a regulated content management system that authenticates and verifies mobile applications, devices, and user identities through certificate validation, device ID authorization, and continuous integrity checks to ensure secure access to regulated content.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If mobile devices are allowed to access regulated content, then operational efficiency and user accessibility are improved, but security risks and integrity threats increase

Engineering Contradiction:
Improveuser accessibilityVSAvoidcontent integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The validation process is segmented into multiple independent checks: application certificate validation, device authorization verification, user credential authentication, and content integrity verification. Each segment operates independently to ensure comprehensive security while maintaining accessibility.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system performs preliminary validation of application certificates, device authorizations, and user credentials before allowing access to regulated content. This preliminary action ensures that only authorized entities can access the content, preventing tampering while enabling legitimate users to access efficiently.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If multi-step validation processes are implemented, then content integrity and security are improved, but system complexity and validation time increase

Engineering Contradiction:
Improvecontent integrityVSAvoidvalidation process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The regulated content management system acts as an intermediary between mobile devices and regulated content. It centrally manages validation processes, certificates, and authorizations, simplifying the complexity by centralizing control rather than distributing it across multiple independent systems.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The validation system serves multiple functions: validating application certificates, authorizing devices, authenticating users, and verifying content integrity. By consolidating these functions into a single multi-functional system, complexity is managed more effectively than through separate specialized systems.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If strict validation rules are applied to mobile applications, then security and compliance are improved, but ease of installation and deployment decrease

Engineering Contradiction:
Improvesecurity complianceVSAvoidapplication deployment
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

Application certificates and device authorizations are validated in advance before deployment. This preliminary validation ensures compliance is built-in from the start, reducing the need for complex runtime validation and simplifying deployment processes while maintaining security standards.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS10694330B2Validating mobile applications for accessing regulated content
Publication Date: 2020.06.23 MEDIDATA SOLUTIONS INC
  • US10694330B2 patent drawing
  • US10694330B2 patent drawing
  • US10694330B2 patent drawing

AI summary

Allowing access to regulated content (e.g., FDA regulated) via mobile devices can increase operational efficiency of companies that have this type of content, and allow users to quickly interact with this content even when outside of the company office. Yet, mobile devices present security issues in ensuring that the integrity of the regulated content is maintained. A regulated content management system applies a multi-step validation and authentication process to allow mobile access to regulated content. The system validates a mobile application installed on the device for regulated content access, the mobile device itself, and the credentials of the user trying to access the content before access is granted. This thus provides users with access to regulated content in a mobile environment while maintaining the integrity of the regulated content.