FDA
FDA announces first company to participate in health tech pilot
Under the TEMPO pilot program, Dexcom can receive Medicare reimbursement when seniors receive care from their software.
FDA launches updated AI and consolidated data platform
The Food and Drug Administration’s flagship internal AI tool, Elsa, is being integrated with the data platform so that staff can accomplish work more easily.
FDA unveils ‘Elsa’ generative AI tool for staff
Following a successful pilot, the Food and Drug Administration unveiled its in-house large language model designed to help agency staff in drug clinical evaluations and reviews.
FDA to deploy AI assistant for research reviews by end of June
Food and Drug Administration Director Martin Makary announced the agency-wide deployment of an artificial intelligence tool to handle the monotonous components of its scientific review process.
VA announces creation of new AI testing ground with FDA
VA Undersecretary for Health Shereef Elnahal told Nextgov/FCW that the testing environment is “a check in the process” to ensure that AI tools comply with federal guidance on the use of emerging tech.
FDA and CISA need to update cyber agreement for medical devices, watchdog says
The Government Accountability Office said medical devices are not commonly hacked but still called them “a source of cybersecurity concern warranting significant attention.”
FDA forms new committee to advise on health tech
The FDA is taking nominations for the Digital Health Advisory Committee, which is expected to begin work next year.
FDA's draft plan calls for AI, other emerging tech in modernization efforts
The Food and Drug Administration is accepting comments on its Data and Technology Strategic Plan, which outlines the agency’s goals to leverage AI in its analytical processes.
GOP lawmakers tap Holman Rule to slash salaries of agency heads
If House conservatives get their way, multiple federal officials will open fiscal 2024 with $1 annual salaries.
FDA seeks industry support to develop standardized data ‘supersets’
The Food and Drug Administration is set to launch new pilot projects that aim to improve data interoperability and analysis across the public health community.
This year's Sammies includes a special COVID response category
Partnership for Public Service announced the 29 finalists for its annual Samuel J. Heyman Service to America Medals.
Unions, agencies encouraging feds to get vaccinated
Early results from federal workforce campaigns suggest that vaccine uptake could present challenges once availability for all age groups is no longer an obstacle.
Why PPE acquisition looks so shady
Furtive exchanges, police interdiction, international charter flights: our acquisition reporter takes a look at why the market for personal protective equipment looks so wild.
FDA wants to upgrade ethics filing platform
The Food and Drug Administration aims to improve the way documents for ethics rules compliance are filed and tracked.
Feds rally against shutdown as missed paychecks loom
With feds on furlough or working without pay face the prospect of a missed paycheck, President Trump signaled a long shutdown by cancelling his trip to the World Economic Forum in Davos on Jan. 22.
What federal job automation looks like
As the Trump administration aims to drive efficiency and accuracy and eliminate "low-value work," agencies are starting to think about what aspects of their operations lend themselves to automation.
FDA moves to require patching in connected medical devices
The Food and Drug Administration is looking to make sure internet-enabled medical devices can be updated to guard against cyberthreats.
FDA alerts on pacemaker recall for cyber flaw
Nearly 500,000 patients with pacemakers manufactured by Abbott, formerly St. Jude Medical, are potentially affected by in an security recall.
House panel praises cybersecurity teamwork
The House Energy & Commerce Committee staff didn't wait for a report on FDA's cyber vulnerabilities to be completed to before it let the agency know there was a big potential problem.
FDA has a role to play in software updates to medical devices
The Food and Drug Administration wants input from manufacturers and others about when a software update to a medical device would require premarket notification.
