The FDA is looking to develop a $100mn medical data enterprise

By Catherine Sturman
Data is becoming increasingly essential for healthcare organisations. As the industry becomes further patient centered, technology will play a key role...

Data is becoming increasingly essential for healthcare organisations. As the industry becomes further patient centered, technology will play a key role in streamlining clinical development, where medical devices will provide individuals with a greater understanding of their healthcare needs. Technology will also work to support medical professionals in the prevention, diagnosis and treatment of long-term conditions.

By harnessing what the FDA has coined ‘real world data’ (RWD), described as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, including information obtained at the point of care,” RWD will also work to transform traditional clinic trials, where sophisticated data and reduced costs will lead to enhanced patient outcomes.

Whilst there will be continued investment in the FDA’s National Evaluation System for Health Technology (NEST), the organisation has a long-term ambition of creating a “natural resource,” whilst maintaining essential data security and compliance standards.

Through President Trump’s Fiscal Year 2019 Budget, the FDA has therefore submitted a $100mn medical data enterprise proposal to build a new system which would be bolstered by electronic healthcare record data of up to 10mn citizens, alongside other key RWD sources, such as insurance claims or mobile health devices.

“This is the next evolution in the Agency’s development of a comprehensive data enterprise to improve medical product regulation and better inform us on the safety and benefits of new innovations,” said Gottlieb in a recent blog.

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Through the use of clinical data from electronic health records, healthcare professionals will drive sophisticated reporting on the performance of medical devices in real time and transform complex regulations in line with modern healthcare requirements, providing individuals with essential information to enable better decision making.

It is imperative for healthcare organisations to remove barriers to communication and potential siloes, and data will remain central to this. The FDA’s budget request will therefore work to resolve any obstacles within interoperability, as well as establish essential data standards through data sharing.

It will also enable the development of effective new medical products and services.

“Most importantly, such a system will provide patients with better care and more informed treatment decisions,” Gottlieb stated.

“The wider use of real world data could decrease the cost of product development, while increasing our understanding of how, when, and in whom, to use medical products. It’ll allow us to use the post-market period to refine our understanding of medical products. And it’ll allow us to make reliable post-market information available to providers and patients to better inform their treatment decisions.”


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