Machine-Assisted Medical Document Generation System

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Solution Overview

Problem

The pharmaceutical industry faces challenges in medical writing during clinical trials due to the lack of standardization and the high cost and time consumption of manual document creation, particularly in the absence of a standard corpus for training algorithms, which is compliance-driven and requires regulatory adherence.

Innovation Solution

A processor-implemented method and system for machine-assisted documentation in medical writing, which receives input documents, processes them into sections, classifies categories, generates local and global contexts, parses sentences, and validates summaries to produce compliant and concise documents, utilizing a combination of hardware processors and memory storage with communication interfaces.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual process is used for creating and updating medical documents, then document quality and compliance can be maintained, but the process becomes expensive and time consuming

Engineering Contradiction:
Improvedocument complianceVSAvoiddocument creation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces manual mechanical writing processes with an automated system that uses natural language processing, machine learning, and algorithmic generation to create medical documents. The system automatically extracts information from source documents, structures content according to regulatory templates, and generates compliant medical writing outputs without manual intervention for routine document creation tasks.

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

Solution Approach 2:

The system enables self-service document generation by automatically processing input data, applying regulatory compliance rules, and producing finished medical documents. The automated system serves itself by managing the entire document creation workflow including information extraction, structuring, validation, and output generation without requiring continuous human oversight for each document.

Inventive Principle:
Principle #25Self-service

2Reliability

If manual process is used for creating and updating medical documents, then document quality can be maintained, but the process becomes expensive

Engineering Contradiction:
Improvedocument qualityVSAvoidcost
Core Design Contradiction:
ReliabilityVSLoss of energy

Solution Approach 1:

The patent replaces expensive manual professional writing services with an automated computational system that uses natural language processing and machine learning algorithms to generate medical documents. This substitution significantly reduces labor costs while maintaining document quality through structured templates and compliance validation rules embedded in the system.

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

Solution Approach 2:

The system changes the parameters of document production by transitioning from human-intensive processes to computation-intensive processes. This parameter change allows the same or better document quality to be achieved at lower cost by leveraging automated information extraction, template-based structuring, and algorithmic content generation rather than manual writing.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If standardization is introduced in medical writing, then efficiency can be improved, but lack of standard corpus makes algorithm training difficult

Engineering Contradiction:
Improvewriting efficiencyVSAvoidcorpus preparation complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by pre-processing and structuring input documents before they are fed into the generation system. The system prepares standardized input formats, extracts relevant information in advance, and organizes data according to regulatory requirements before the actual document generation process, thereby simplifying the training corpus preparation and improving overall efficiency.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system achieves universality by creating a multi-functional platform that can handle various types of medical documents (clinical study reports, protocols, summaries) using the same underlying technology stack. This universal approach allows the system to process different document types through common information extraction and structuring mechanisms, reducing the complexity of preparing separate training corpora for each document type.

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

Data Source

PatentUS11443538B2System and method for machine assisted documentation in medical writing
Publication Date: 2022.09.13 TATA CONSULTANCY SERVICES LTD
  • US11443538B2 patent drawing
  • US11443538B2 patent drawing
  • US11443538B2 patent drawing

AI summary

In medical writing, manual process of creating, updating and maintaining documents is expensive, time consuming. This disclosure provides a method of an automatic medical document writing by receiving, a plurality of input documents as an input; processing, the inputted plurality of documents by extracting into an at least one section to generate a list of sections; classifying, at least one category corresponding to the at least one section to generate a summary set; generating, at least one of a local context and a global context based on the summary set; parsing, at least one sentence based on the generated local context and global context to generate at least one sequence of the plurality of sentences; processing, the at least one sequence of the plurality of sentence to generate a queue of the at least one sequence; validating, the queue of the at least one sequence to obtain a combined summary set.