IP Library Granted Patent US 12694992
Granted Patent B1
US 12694992 · App. 18/429,648 · Granted Jul 28, 2026

Systems and methods for electronically collecting and linking standardized case data in a data warehouse

Inventors: Marius K. Mortensen (Burlington, CA); Zhen Tan (North York, CA); Eric Mitchell Woolven (Toronto, CA); Sandra Komadinic (Hamilton, CA); Shanul Srivastava (Brampton, CA)
Assignee: Veeva Systems Inc.
G16H50/70G06F16/215
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Quick Facts
Patent No.
US 12694992
App. No.
18/429,648
Granted
Jul 28, 2026
Kind
B1
Abstract

A method for determining a potential signal includes receiving a request for case data and a statistical value minimum. The method further includes selecting the case data from the central case warehouse based on the request and determining a statistical value based on the case data. The statistical value is at least one of: a case count, a proportional reporting ratio (PRR) value, a chi-squared value, an Empirical Bayes (EB) value, or an Interaction Singal Score (INTSS) value. The method further includes determining the potential signal associated with a specific adverse event code and a medical product identifier based on the statistical value and the statistical value minimum. The method further includes outputting the statistical value and the potential signal via the secure network.

Claims (69)

1 . A method for determining a potential signal in a central case data storage system, wherein the central case data storage system comprises a provider computing system communicably coupled to a secure network, wherein the provider computing system comprises a central case data warehouse for storing case data, the method comprising:

receiving, by a network interface of the provider computing system, a request for first case data from a user computing device via the secure network, wherein the request identifies a timeframe and a medical product;

receiving, by the network interface, a statistical value minimum from the user computing device via the secure network;

selecting, by a processing circuit of the provider computing system, the first case data from the central case data warehouse based on the request;

determining, by the processing circuit, a first statistical value based on the first case data,

wherein the first statistical value is at least one of: a case count, a proportional reporting ratio (PRR) value, a chi-squared value, an Empirical Bayes (EB) value, or an Interaction Signal Score (INTSS) value;

determining, by the processing circuit, one or more signals based on the first statistical value and the statistical value minimum, wherein each signal of the one or more signals represents an adverse event related to the medical product;

transmitting, by the network interface, the first statistical value, the first case data, and the one or more signals via the secure network to the user computing device to be displayed on a first webpage including:

an interactive statistical value chart or graph,

an interactive heat map of the adverse event of the one or more signals, and

an interactive list of the one or more signals and one or more corresponding track signal buttons;

receiving, by the network interface and in response to a selection of one of the one or more track signal buttons, a request to track a potential signal from the user computing device;

receiving, by the central case data warehouse, new case data associated with the potential signal from at least one of a health agency computing system or a trusted case repository;

selecting, by the processing circuit, the new case data associated with the potential signal from the central case data warehouse;

determining, by the processing circuit, a change to the potential signal based on the new case data;

generating, by the processing circuit and in response to determining the change to the potential signal, one or more alerts; and

transmitting, by the network interface and via the secure network, the one or more alerts to the user computing device to be displayed on a second webpage including:

a state section,

a signal details section,

a signal sources section identifying a first electronic data source associated with the health agency computing system and a second electronic data source associated with trusted case repository,

a case listing section, and

a workbench button.

2 . The method of claim 1 , wherein timeframe includes a start date and end date, wherein the first case data includes a date, and wherein selecting the first case data from the central case data warehouse based on the request comprises:

determining, by the processing circuit, the date of the first case data is between the start date and the end date of the timeframe; and

selecting, by the processing circuit and in response to determining the date of the first case data is between the start date and the end date of the timeframe, the first case data from the central case data warehouse.

3 . The method of claim 1 , wherein the request identifies a first medical product identifier of the medical product, wherein the first case data includes a second medical product identifier, and wherein selecting the first case data from the central case data warehouse based on the request comprises:

determining, by the processing circuit, the first medical product identifier of the first case data matches the second medical product identifier of the request; and

selecting, by the processing circuit and in response to determining the first medical product identifier of the first case data matches the second medical product identifier, the first case data from the central case data warehouse.

4 . The method of claim 1 , wherein the request includes a filter that is at least one of an age group, a gender, or a seriousness, and wherein the method further comprises:

filtering, by the processing circuit, the first case data based on the filter of the request,

wherein the first statistical value is determined based on the filtered first case data.

5 . The method of claim 1 , wherein the central case data warehouse comprises a central health agency case repository and one or more central PV repositories.

6 . The method of claim 1 , wherein determining the one or more signals based on the first statistical value and the statistical value minimum comprises:

determining, by the processing circuit, the first statistical value is greater than the statistical value minimum; and

determining, by the processing circuit and in response to determining the first statistical value is greater than the statistical value minimum, the one or more signals.

7 . A method for determining a potential signal in a central case data storage system, wherein the central case data storage system comprises a provider computing system communicably coupled to a secure network, wherein the provider computing system comprises a central case data warehouse for storing case data, the method comprising:

receiving, by a network interface of the provider computing system, a request for first case data from a user computing device via the secure network, wherein the request identifies a timeframe and a medical product;

receiving, by the network interface, a statistical value minimum from the user computing device via the secure network;

selecting, by a processing circuit of the provider computing system, the first case data from the central case data warehouse based on the request;

determining, by the processing circuit, a first statistical value based on the first case data, wherein the first statistical value is at least one: an Empirical Bayes Geometric Mean (EBGM) value, an EB05 value, or an EB95 value;

determining, by the processing circuit, one or more signals based on the first statistical value and the statistical value minimum, wherein each signal of the one or more signals represents an adverse event related to the medical product;

transmitting, by the network interface, the first statistical value, the first case data, and the one or more signals via the secure network to the user computing device to be displayed on a first webpage including:

an interactive statistical value chart or graph,

an interactive heat map of the adverse event of the one or more signals, and

an interactive list of the one or more signals and one or more corresponding track signal buttons;

receiving, by the network interface and in response to a selection of one of the one or more track signal buttons, a request to track a potential signal from the user computing device;

receiving, by the central case data warehouse, new case data associated with the potential signal from at least one of a health agency computing system or a trusted case repository;

selecting, by the processing circuit, the new case data associated with the potential signal from the central case data warehouse;

determining, by the processing circuit, a change to the potential signal based on the new case data;

generating, by the processing circuit and in response to determining the change to the potential signal, one or more alerts;

transmitting, by the network interface and via the secure network, the one or more alerts to the user computing device to be displayed on a second webpage including:

a state section,

a signal details section,

a signal sources section including identifying a first electronic data source associated with the health agency computing system and a second electronic data source associated with trusted case repository,

a case listing section, and

a workbench button.

8 . The method of claim 7 , wherein the timeframe includes a start date and end date, wherein the first case data includes a date, and wherein selecting the first case data from the central case data warehouse based on the request comprises:

determining, by the processing circuit, the date of the first case data is between the start date and the end date of the timeframe; and

selecting, by the processing circuit and in response to determining the date of the first case data is between the start date and the end date of the timeframe, the first case data from the central case data warehouse.

9 . The method of claim 7 , wherein the request includes a filter that is at least one of an age group, a gender, or a seriousness, and wherein the method further comprises:

filtering, by the processing circuit, the first case data based on the filter of the request,

wherein the first statistical value is determined based on the filtered first case data.

10 . The method of claim 7 , wherein the request identifies a first medical product identifier of the medical product, wherein the first case data includes a second medical product identifier, and wherein selecting the first case data from the central case data warehouse based on the request comprises:

determining, by the processing circuit, the first medical product identifier of the first case data matches the second medical product identifier of the request; and

selecting, by the processing circuit and in response to determining the first medical product identifier of the first case data matches the second medical product identifier of the request, the first case data from the central case data warehouse.

11 . The method of claim 7 , wherein the central case data warehouse comprises a central health agency case repository and one or more central PV repositories.

12 . The method of claim 7 , wherein determining the one or more signals based on the first statistical value and the statistical value minimum comprises:

determining, by the processing circuit, the first statistical value is greater than the statistical value minimum; and

determining, by the processing circuit and in response to determining the first statistical value is greater than the statistical value minimum, the one or more signals.