XML Record Search via Segmentation and Intermediary Indexing
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Solution Overview
Problem
Existing electronic record systems face challenges in efficiently searching and securely accessing XML-based electronic records due to their flexible structure, and in managing electronic signatures required for compliance with regulations like GMPs, which are typically handled manually in paper-based systems.
Innovation Solution
A method and system for securely storing and accessing electronic records, including automatically creating electronic records, determining the need for electronic signatures, collecting and verifying signatures, and securely associating them with records, while providing an audit trail and restricting access through a common repository with security protocols.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If XML-based electronic records are stored in a common repository, then data consolidation and accessibility are improved, but searching and access control become more complex due to the flexible XML structure
Solution Approach 1:
The patent segments the flexible XML data structure into standardized hierarchical levels (e.g., patient level, visit level, procedure level) with defined schemas. This segmentation allows the system to maintain the adaptability of XML while imposing a structured framework that simplifies searching and access control by breaking down complex XML documents into manageable, queryable units.
Solution Approach 2:
The patent introduces an intermediary layer between the XML storage and the search functionality. This intermediary includes standardized schemas, templates, and indexing mechanisms that translate flexible XML structures into a format suitable for efficient searching and access control, thereby resolving the contradiction between data flexibility and search complexity.
2Reliability
If access to electronic records is restricted for security reasons, then security is improved, but physical separation of confidential documents becomes more complex
Solution Approach 1:
The patent applies local quality by implementing granular access control at different levels of the XML hierarchy. Instead of uniformly restricting access to entire documents, the system allows different users to access specific portions or elements of XML records based on their roles and permissions. This localized approach to access control enhances security while reducing the complexity of managing access to large volumes of records.
Solution Approach 2:
The patent implements self-service access control mechanisms where the system automatically manages access rights based on predefined policies, user roles, and document classifications. This automation reduces the manual complexity of access control while maintaining high security standards, as the system itself handles the complex logic of who can access what without requiring manual physical separation.
3Productivity
If electronic signatures are automated for compliance, then productivity is improved, but system complexity increases due to signature collection and verification processes
Solution Approach 1:
The patent merges the electronic signature collection, verification, and storage processes into the existing XML record management system. By integrating signature functionality with the document lifecycle management, the system automates compliance requirements without requiring separate complex infrastructure. The signature data is stored as structured elements within or associated with the XML records, simplifying the overall system architecture.
Solution Approach 2:
The patent creates a universal signature management framework that handles multiple signature types (electronic, digital, biometric) and compliance requirements through a single integrated system. This multi-functional approach allows the system to automate various signature collection and verification processes while maintaining a consistent interface and underlying architecture, thereby improving productivity without proportionally increasing complexity.
4Reliability
If an audit trail is maintained for electronic records, then reliability and compliance are improved, but data storage requirements and system complexity increase
Solution Approach 1:
The patent implements an audit trail system that creates selective copies of relevant record elements and metadata rather than duplicating entire XML documents. The audit trail captures essential information such as access events, modification timestamps, user identifiers, and key data elements in a structured, compressed format. This copying approach maintains compliance and reliability by preserving audit evidence while significantly reducing storage requirements compared to full document duplication.
Data Source
AI summary
A method of and system for searching unstructured data stored in a database. In one embodiment the method comprises storing a plurality of electronic records in a common repository of electronic records in the database that provides an audit trail that cannot be altered or disabled by users of the system where each electronic record comprises unstructured data stored in a character large-object (CLOB) format in a column of a table of the database; creating a security protocol that protects the electronic records against unauthorized access; and creating a query designed to identify electronic records in the database that meet criteria designated in the query. The method further comprises modifying the query in accordance with the security protocol to create a modified query prior to executing the query and running the modified query against the unstructured data. In one particular implementation, the unstructured data comprises a well-formed XML document stored within a column of a table stored in the database.