IP Library Granted Patent US 10,846,424
Granted Patent B2
US 10,846,424 · App. 14/478,860 · Granted Nov 24, 2020

Method for multi-tiered, rule-based data sharing and ontology mapping

Inventors: Justin Thomson (Brooklyn, NY); Evan Shore (New York, NY)
Assignee: Medidata Solutions, Inc.
G06F21/6245G16H10/60
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,846,424
App. No.
14/478,860
Granted
Nov 24, 2020
Kind
B2
Abstract

A computer-based method for creating enforced, context-specific sharing of ontologically mapped, aggregated medical data includes storing at least one data field in a database as an entity type ontology, receiving context-specific rule configurations corresponding to the entity type ontology, and identifying any conflict between the received context-specific rule and any applicable rule. The context-specific rule configurations include at least one context, one data source, and one entity type ontology data field. If a conflict is identified, the method receives resolution of the conflict and stores the context-specific rule configurations in the database.

Claims (34)

1. A computer-based method for generating a data-sharing database based on multi-tier permissioning, comprising:

storing in the database at least one rule regarding sharing of clinical trial data, wherein the rule is based on three rule tiers, a law tier, an informed consent agreement tier, and a user preference tier, wherein a rules engine is configured to calculate the precedence of rules across the three rule tiers;

generating an informed consent agreement regarding sharing of clinical trial data, wherein the informed consent agreement is obtained by a sponsor, signed by a patient, stored in the database, and converted into structured hierarchical rules that govern the sharing of the patient data obtained in the clinical trial, and supersedes user preferences;

receiving a context-specific rule configuration comprising a context, a data source, and an entity type, wherein said context-specific rule configuration comprises at least one term of said informed consent agreement;

identifying any conflict between the context-specific rule configuration by identifying any overlapping rules within the informed consent agreement tier and resolving the overlapping rules;

determining whether the identified conflict is between a term of said informed consent agreement and a user preference and, based on the determination, resolving the conflict in favor of the term of said informed consent agreement;

determining whether the identified conflict is between terms of informed consent agreements or is between user preferences and, based on the determination, receiving resolution of the conflict;

storing said context-specific rule configuration in the database;

generating a query interface comprising a plurality of filters comprising at least the context, the data source, and the entity type;

displaying on the query interface a summary of records, satisfying the filters, that are automatically accessible to a database user, accessible by request by the database user, and outside the query context; and

providing, based on the summary of records, for the database user to view the records that are automatically accessible, to submit a request for access to the records accessible by request, to view rules that govern the database user's query, and to edit or delete the rules.

2. The method of claim 1 , further comprising:

receiving a data access query from a user;

determining the context to query based on said data access query receipt; and

providing said user access to entity data based on said context-specific rule configuration.

3. The method of claim 1 , wherein receiving resolution of the conflict comprises (i) editing said context-specific rule configuration or (ii) contacting a creator of the conflicting rule.

4. The method of claim 1 , further comprising determining whether any queried data fields require access permission.

5. The method of claim 4 , wherein said determining whether any queried data fields require access permission includes issuing requests for data access.

6. The method of claim 1 , further comprising receiving at least one conditional rule selection.

7. The method of claim 1 , further comprising storing transactions in a database.

8. The method of claim 1 , wherein said context-specific rule configuration comprises a law.

9. The method of claim 1 , wherein the different levels of access comprise accessibility without an access permission request and accessibility with an access permission request.

10. The method of claim 9 , further comprising displaying the records satisfying the filters and that are accessible without an access permission request.

11. A computer-based method for generating a data-sharing database based on multi-tier permissioning, comprising:

storing in the database at least one rule regarding sharing of clinical trial data, wherein the rule is based on three rule tiers, a law tier, an informed consent agreement tier, and a user preference tier, wherein a rules engine is configured to calculate the precedence of rules across the three rule tiers;

generating an informed consent agreement regarding sharing of clinical trial data, wherein the informed consent agreement is obtained by a sponsor, signed by a patient, stored in the database, and converted into structured hierarchical rules that govern the sharing of the patient data obtained in the clinical trial, and supersedes user preferences;

receiving a context-specific rule configuration comprising a context, a data source, and an entity type, wherein said context-specific rule configuration comprises at least one term of said informed consent agreement;

identifying any conflict between the context-specific rule configuration by identifying any overlapping rules within the informed consent agreement tier and resolving the overlapping rules;

determining whether the identified conflict is between a term of said informed consent agreement and a user preference and, based on the determination, resolving the conflict in favor of the term of said informed consent agreement;

determining whether the identified conflict is between terms of informed consent agreements or is between user preferences and, based on the determination, receiving resolution of the conflict;

storing said context-specific rule configuration in the database;

generating a query interface comprising a plurality of filters comprising at least the context, the data source, and the entity type;

displaying on the query interface a summary of records, satisfying the filters, that are automatically accessible to a database user, accessible by request by the database user, and outside the query context; and

showing, based on the summary of records, the database user the records that are automatically accessible.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded Oct 30, 2019
From: HSBC BANK USA
To: MEDIDATA SOLUTIONS, INC.; CHITA INC.
Reel/Frame 050875/0776 →
SECURITY INTEREST Recorded Jan 2, 2018
From: MEDIDATA SOLUTIONS, INC.
To: HSBC BANK USA, NATIONAL ASSOCIATION
Reel/Frame 044979/0571 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 8, 2014
From: THOMSON, JUSTIN; SHORE, EVAN
To: MEDIDATA SOLUTIONS, INC.
Reel/Frame 033691/0421 →
Continuity (1)
Related Publication 20160070758A1 · Mar 10, 2016