The Government Accountability Office (GAO) is urging the U.S. Food and Drug Administration (FDA) and the Cybersecurity and Infrastructure Security Agency (CISA) to update their five-year-old arrangement to cooperate on improving medical device cybersecurity. […]

The U.S. Food and Drug Administration (FDA) published a notice in the Federal Register today seeking comments on its draft IT strategy, with plans to publish the official strategy by Sept. 29. […]

The U.S. Food and Drug Administration (FDA) wants to begin leveraging AI and ML in its drug development and approval processes but wants to first ensure that both the opportunities and challenges of the emerging technologies are fully explored. […]

Women across the Federal IT landscape are taking the reins in their leadership roles and getting big stuff done. During GovCIO’s Women Tech Leaders Summit in Washington, D.C., this week, officials from the Department of Veterans Affairs (VA), the Food and Drug Administration (FDA), the Federal Bureau of Investigation (FBI), and the Centers for Medicare and Medicaid Services (CMS) highlighted some projects they are spearheading at their agencies to make an impact on the cyber workforce, innovation, and diversity and inclusion. […]

The Food and Drug Administration (FDA) wants to use artificial intelligence (AI) to help evaluate pharmaceutical products, the agency announced in a small business source sought notice published to Sam.gov last week.   […]

The Food and Drug Administration (FDA) has failed in recent years to follow existing acquisition policies and procedures when it comes to managing the agency’s information technology contracts, the Department of Health and Human Services (HHS) internal watchdog said. […]

health

In pursuit of their primary mission, innovators at Federal agencies must seek new ways to leverage technology. And in a post-COVID world, public health IT experts are assessing how technology can augment human workers when healthcare workers are in short supply. […]

The House on June 8 voted to approve a bill that would require the Food and Drug Administration (FDA), among other tasks, to ensure cybersecurity throughout the lifecycle of medical devices and make sure that device makers meet minimum cybersecurity requirements set by the agency. […]

Sens. Jacky Rosen, D-N.V., and Todd Young, R-Ind., have introduced legislation aimed at strengthening the cybersecurity of medical devices, and requiring the U.S. Food and Drug Administration (FDA) to review and update its medical device cybersecurity guidelines. […]

Federal Chief Data Officers (CDO) examined the processes, technologies, and strategies that should be in place to help agencies not just manage data but master and leverage it as a strategic asset, during AFCEA Bethesda’s Breakfast Webinar series on June 15. […]

As part of its overall IT modernization strategy, the FDA is looking towards developing next-generation data centers. In a request for information (RFI) posted July 9, the FDA said it is “seeking information and input from the [private sector] for planning purposes for modernization, transformation and innovations for reengaging the FDA’s Next Generation Data Center efforts.” […]

Innovation
healthcare cyber-min

The U.S. Food and Drug Administration (FDA) launched a new mobile application called the CURE ID that will allow the clinical community to report uses of existing drugs for infectious diseases that may prove difficult to treat. […]

FDA website

The Food and Drug Administration’s (FDA) new CTO, Vid Desai, began work at the agency on Aug. 19. Desai, who previously worked as Vyaire Medical’s CIO and an executive director at Quintiles Transnational, will work with FDA CIO Amy Abernethy in his new position, which had been vacant for a while. Desai will help lead […]

FDA website

The Food and Drug Administration (FDA) is creating a pilot program to test new data standards for the data collected in non-clinical studies funded by the agency, FDA announced in an upcoming Federal Register post. […]

FDA website

The U.S. Food and Drug Administration (FDA) is seeking assistance to identify vendors that can provide simulations with virtually implanted generic medical devices using a whole-heart computational model. […]

Cloud computing

The Food and Drug Administration (FDA) is looking to expand its footprint in the cloud by creating direct connections to cloud service providers, according to a solicitation released July 15. Responses are due by July 29. […]

Yesterday, the Food and Drug Administration (FDA) announced that it would be taking steps towards considering a new regulatory framework tailored to promote developing safe and effective medical devices that use artificial intelligence algorithms. […]

The Department of Homeland Security (DHS) issued an alert last week after it was discovered that as many as 750,000 medical heart devices contain critical cybersecurity vulnerabilities. […]

Sen. Mark Warner

Following up on a letter to health organizations to describe their cybersecurity challenges, Sen. Mark Warner, D-Va., sent a letter to the heads of health-related Federal agencies on Monday, calling on them to work towards a national health-sector cybersecurity strategy. […]

Machine learning AI-min
cloud cyber modernization AI
Military AI DoD Defense

A panel of Federal government artificial intelligence experts spoke on the importance of AI, ethical concerns, and use cases at the CXO Tech Forum on AI and Big Data in Government on Wednesday. […]

Medical IOT

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report on Monday, calling for the Food and Drug Administration (FDA) to improve its approach to cybersecurity for medical devices already on the market, and praising FDA’s early response to the report’s criticisms. […]

Medical IOT

The Food and Drug Administration (FDA) said today it awarded $225 million of contracts to three companies to help the agency’s Center for Biologics Evaluation and Research (CBER) improve its medical review tools. […]

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