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Leveraging the Power of Data: The Role of Patient Consent and Efficiency

Last month, Foundation Medicine and Flatiron Health announced an initiative to assemble large genomic databases built around the electronic health records (EHRs), of 20,000 cancer patients. The purpose of this initiative would be to provide a real world data-based tool for oncology reseachers.

It’s exciting to think about the possibilities that this type of database holds, from understanding and identifying mutations that may be affected by certain types of drugs, to enrolling specific patient cohorts into clinical trials based upon genetic similarities. And this is only the tip of the iceberg. Considering that currently only 4 percent of cancer patients participate in clinical trials, there are vast amounts of data held in these health records of the other 96 percent of cancer patients that could be a treasure trove of information.

Yet the Foundation-Flatiron partnership is just one example of how health information technology companies are leveraging EHRs to accelerate research. Large numbers of health IT companies are emerging to develop diverse and powerful tools that make better use of available healthcare information, from drawing insights into treatment practices, to improving prescription practices, to understanding large populations of patients. We are at a point where the power of information is just beginning to be tapped, holding great promise for the future of medical development.

Although the Foundation-Flatiron structure will be anonymized and HIPAA-compliant, there is some concern that patients haven’t directly consented to participate. This is a point where Novaseek strongly differentiates. When we founded Novaseek, we put together a seasoned management team from both the life science research and hospital operations sides of the equation. Collectively, we have implemented clinical data programs in 600+ hospitals and launched 20+ life sciences products in the US. We understand the potential and challenges from a variety of perspectives.

Based on all of this experience, from the beginning we felt it was important to put patient consent front and center. We designed a process for patient consent and data-sharing authorizations in ways that are highly aligned to current hospital workflows.

The goal was to make it transparent and convenient for patients. We also wanted to make it easy and convenient for hospital personnel whose main focus is patient care. We designed Novaseek’s CDNR platform to interface with hospital data sources seamlessly and to scale easily.

Our consent process covers not only the patient’s medical history and prospective medical data but also the human biospecimens obtained via the regular course of patient care. This is convenient for patients, sustainable for the hospital, and provides researchers access to important longitudinal information, such as disease progression. It also allows researchers to have access to biospecimens and associated data at various points of the disease progression so that clinical phenotype can be matched to the underlying biology.

As our industry continues its path forward in leveraging technology to provide better care for patients, it’s important to streamline processes so that patients and healthcare providers can partake in research and medical advances. The results will advance the science, resulting in better treatments to patients sooner.