US 2026/0031202 A1Published application

Computer-implemented system and method for secure federated studies

AssigneeEvidentli Pty Ltd

InventorsGuy TSAFNAT, Dean TSAFNAT

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Abstract

A computer-implemented federated studies system and method are disclosed. The system includes: a predefined common data model associated with a study; a set of sites of origin, each associated with a set of input devices for acquiring study data from subjects and a study data device. Each study data device includes: a database for storing study data derived from input devices; a data model translator for translating study data to a common data model format; a common model database for storing, in the data model, individual participant values derived from study data; a study compute module for determining site aggregate values from individual participant values; and an aggregate database for storing site aggregate values. A site of analysis is associated with a study analysis device that includes: an analysis compute module for processing site aggregate values received from sites of origin; and a reporting module for generating study reports.

Claims20

Dependent claims

A computer-implemented federated studies system comprising:

a predefined common data model associated with a study;
a set of sites of origin, each site of origin being associated with:
(i) a set of input devices for acquiring study data from subjects, and (ii) a study data device, wherein each study data device includes:
a native database for storing study data associated with the respective site of origin and derived from said set of input devices;
a data model translator for translating stored study data to a format corresponding to said common data model;
a common model database for storing, in said common data model, individual participant values derived from said study data;
a study compute module for determining site aggregate values from said individual participant values;
and
an aggregate database for storing said site aggregate values;
and
a site of analysis coupled to each site of origin via a communications network, wherein said site of analysis is associated with a study analysis device that includes:
an analysis compute module for processing, in accordance with a predefined analysis profile, site aggregate values received from said sites of origin;
and
a reporting module for generating study reports based on said processed site aggregate values;
a central repository for storing and retrieving a set of data translation elements for managing extensions and mappings within study data sets associated with each site of origin;
and
an Identifier Issuing Service configured to interface between each site of origin and said central repository to ensure elements within data sets having the same semantic meaning have a common unique identifier.

14 more elements

A method of conducting a federated study across a plurality of Sites of Origin and using a Site of Analysis, the method comprising the steps of:

defining a common data model for the study;
defining a set of analysis instructions for the study;
at each Site of Origin:
acquiring, utilising least one input device, study data from a set of subjects;
translating said study data to generate individual participant values stored in said common data model;
processing said individual participant values to generate a set of site aggregate values;
transmitting said site aggregate values to said site of analysis;
and
processing study aggregate values received from said Site of Analysis in accordance with said defined set of analysis instructions;
and
at said Site of Analysis:
processing site aggregate values received from at least one of said Sites of Origin in accordance with said defined set of analysis instructions;
and
generating a study report based on said processed site aggregate values;
wherein the method unifies data translations across said plurality of Sites of Origin by:
storing in a central repository a set of data translation elements for managing extensions and mappings within the federated study;
on receipt of a request for a new extension, an Identifier Issuing Service communicating with said central repository to determine whether the requested extension exists;
when the requested extension exists, the Identifier Issuing Service retrieving the requested extension from the central repository and forwarding the requested extension to the requesting translation client, and
when the requested extension does not exist, the Identifier Issuing Service:
issuing a new unique identifier for the requested extension,
forwarding the new identifier for the requested extension to the requesting translation client, and
forwarding the new identifier for the requested extension to the central repository for storage.

19 more elements

Dependencies are inferred from the claim text.

Facts

Application: 19/349,962Filed 4 Oct 2025
Priority: AU 20239009945 Apr 2023
Published: 29 Jan 2026
Term ends: Not estimatedThe source records don’t support an estimate.

Classification13 codes

G06Q 50/26
Services: government or public services
G16H 10/20
ICT specially adapted for the handling or processing of patient-related medical or healthcare data: for electronic clinical trials or questionnaires
G06Q 10/101
Office automation; Time management: collaborative creation, e.g. joint development of products or services
G06Q 10/103
Office automation; Time management: workflow collaboration or project management