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Tag: Clinical data repositories


Regulatory

FDA plans to fully tap real-world data and evidence

January 30, 2019

Via: Health Data Management

The Food and Drug Administration plans to exploit claims, clinical and patient-generated data—information not captured through traditional clinical trials—for post-marketing safety surveillance. “New streams of real-world data gathered from electronic health records, lab tests, wearable devices, insurance claims and even […]


Regulatory

FDA issues 5-year plan to make its Sentinel system more robust

January 11, 2019

Via: Health Data Management

The Food and Drug Administration wants to ensure that its post-market monitoring of drugs and biologics keeps pace with changing drug development and safety ecosystems. Towards that end, the agency has developed a five-year strategy to grow the capabilities of […]


EHR & EMR, Innovation, Med Tech

Algorithm predicts patients at risk for chronic kidney disease

January 10, 2019

Via: Health Data Management

Roche and IBM have developed an algorithm based on real-word data, including electronic health records, that predicts patients with early risk of diabetes-related chronic kidney disease. The Roche-IBM predictive algorithm—trained using half a million electronic health records—outperformed published algorithms derived […]


Regulatory

FDA looks to bolster regulatory decisions using real-world data

September 4, 2018

Via: Health Data Management

The Food and Drug Administration is ramping up its efforts to leverage billing, claims, EHR and registry data to better inform the agency’s regulatory decisions regarding drugs and other medical products. This real-world evidence (RWE) could help to “answer questions […]


EHR & EMR, Regulatory

FDA looks to leverage EHR data to better evaluate medical products

July 11, 2018

Via: Health Data Management

The Food and Drug Administration wants to take advantage of the real-world data available from electronic health records to more fully evaluate medical products in the post-market setting, according to FDA Commissioner Scott Gottlieb, MD. The agency is seeking $100 […]


Innovation, Med Tech

Anthem Blue Cross to launch digital health platform

October 25, 2017

Via: Health Data Management

Anthem Blue Cross is launching an integrated digital health platform designed to create a personalized member experience by connecting healthcare plan and benefits data with individual clinical and claims data, as well as information pulled from fitness and wellness apps. […]


EHR & EMR

Healthcare stakeholders weigh value of claims and clinical data

October 11, 2017

Via: Health Data Management

In healthcare, claims data is often described as a river that is a mile wide but only an inch deep, while clinical data—the analogy goes—is a mile deep and an inch wide. Yet, with the widespread adoption of electronic health […]


Uncategorized

Why more workloads are headed for the cloud

September 13, 2016

Via: Health Data Management

Enterprise IT executives expect 60 percent of workloads will run in the cloud by 2018, according to a new report from 451 Research. The firm’s survey of more than 1,200 IT buyers worldwide conducted in May and June shows that […]


Uncategorized

Worries about data quality put pressure on IT pros

July 28, 2016

Via: Health Data Management

Data quality issues continue to plague the large majority of organizations, according to a new report from research firm TDWI. The study found that 86 percent of the 411 organizations it surveyed are not fully satisfied with the quality of […]