The U.S. Food and Drug Administration's Center for Devices & Radiological Health has released its regulatory science priorities for fiscal year 2017, and a handful of health IT-centric items made the list.
CDRH first published its regulatory science priorities in 2015. "Regulatory science at CDRH is aimed at improving the assessment of the safety, effectiveness, performance and quality of medical devices and radiation-emitting products throughout the product life cycle thereby reducing the time to market, improving safety and making the process least burdensome," according to CDRH.
Among the health IT-focused priorities on this year's list are:
- Leveraging big data for regulatory decision-making: "Data from real-world experience, insurance, Medicare and Medicaid claims, clinical trials, imaging and next generation sequencing can help improve medical device designs, become training sets for artificial intelligence devices or be used to develop precision diagnostics," according to CDRH.
- Enhancing the performance of digital health and medical device cybersecurity: The agency suggests adopting a common vulnerability scoring system to enhance assessment of medical device vulnerability.
- Leveraging precision medicine and biomarkers for predicting device performance, disease diagnosis and progression: "An emphasis on precision medicine during the device lifecycle could be a means to obtaining better focused indications and clinical studies as well as device optimization," according to CDRH.
Click here to read CDRH's full list of priorities.
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