HIPAA-Compliant Research Application Generator

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Solution Overview

Problem

Current research management tools lack the ability to dynamically create HIPAA-compliant research applications, hindering researchers' ability to gather and share protected health information and personally identifiable information, and often require hiring software developers, which is costly and time-consuming.

Innovation Solution

A method and system for generating HIPAA-compliant research study applications using a graphical user interface, allowing users to create consent, eligibility, and medical history surveys, and automatically updating applications to include HIPAA-compliant consent surveys or privacy authorization forms, enabling researchers to build and manage their own studies without software developers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If researchers use existing application-generating tools, then they can create research applications, but the tools do not meet HIPAA compliance requirements for protected health information

Engineering Contradiction:
ImproveHIPAA complianceVSAvoidapplication creation capability
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The system enables researchers to self-generate HIPAA-compliant research applications using automated templates and forms. The platform provides built-in HIPAA-compliant consent surveys, privacy authorization forms, and data collection templates that researchers can configure without external assistance, eliminating the need to hire developers while ensuring compliance

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system pre-configures HIPAA-compliant templates, consent forms, and data structures before researchers begin their study design. These pre-built components include proper privacy authorization language and data protection mechanisms, allowing researchers to simply customize rather than create from scratch, ensuring compliance is built-in from the start

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If researchers hire software developers to create custom research applications, then they can obtain customized applications, but it increases cost and time requirements

Engineering Contradiction:
Improvecustomization capabilityVSAvoidapplication development time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The system provides researchers with copyable templates and pre-configured application structures that can be rapidly replicated and customized. Researchers can copy proven HIPAA-compliant templates and adapt them to their specific study needs, avoiding the time-consuming process of building applications from scratch while maintaining compliance standards

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The platform creates universally applicable research application templates that can serve multiple study types and purposes. A single template system handles diverse research needs through configurable parameters, allowing one versatile tool to replace multiple specialized applications that would otherwise require separate development projects

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

3Reliability

If researchers manually create HIPAA-compliant consent surveys and privacy forms, then they can ensure compliance, but it increases complexity and time consumption

Engineering Contradiction:
ImproveHIPAA compliance assuranceVSAvoidapplication configuration complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system automatically generates HIPAA-compliant consent surveys and privacy authorization forms based on researcher inputs. The platform handles the complex legal and compliance language generation automatically, requiring researchers only to provide basic study information while ensuring proper HIPAA language is included without manual legal expertise

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system uses configurable parameters and dropdown selections to control the generation of compliance documentation. By changing simple parameters like study type, data collection methods, and participant demographics, the system automatically adjusts the consent forms and privacy policies to match the appropriate HIPAA requirements, reducing manual configuration complexity

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS11631041B2Methods and systems for creating and managing a research study and deploying via mobile and web utilizing a research module
Publication Date: 2023.04.18 MEDABLE INC
  • US11631041B2 patent drawing
  • US11631041B2 patent drawing
  • US11631041B2 patent drawing

AI summary

Systems and methods as disclosed herein are provided for generating a research study application. A request to generate a research study is received from a user. A plurality of task generation options are presented on a graphical user interface of an electronic device. The plurality of task generation options are selected from the group consisting of a consent survey, an eligibility survey, a medical history survey, and a medical tracking survey. Input regarding the plurality of task generation options is received from the user. Additionally, a research study application is generated based on information received from the user.