Mark Thomas Laney

US Patent:

20210125725, Apr 29, 2021

Filed:

Oct 29, 2019

Appl. No.:

16/667358

Inventors:

- Armonk NY, US
Isaac Erickson - Mansfield TX, US
Craig A. Bennett - Woodstock GA, US
Maren Erickson - Mansfield TX, US
Justin L. Sheppard - Holly Springs NC, US
Mark A. Laney - Wake Forest NC, US

International Classification:

G16H 50/30
G16H 15/00
G16H 50/70
G16H 70/20
G16H 10/60

Abstract:

Mechanisms are provided for automated medical device regulation risk analysis (MDRRA). An automated MDRRA engine receives compliance rules for a medical device, a data dictionary for a patient data source, and medical device characteristics data for the medical device. The automated MDRRA engine automatically determines, based on the compliance rules and the data dictionary, critical fields of patient data and medical device characteristics data for demonstrating medical device efficacy according to the compliance rules. The automated MDRRA engine automatically determines, based on the critical fields, one or more patient population data subsets for a plurality of patients from a patient population data set and selects a population segment from the one or more patient population data sets to populate an electronic case report form (eCRF) study build. The automated MDRRA engine automatically populates fields of the eCRF with data from the population data sets corresponding to the selected population segment.