FDA

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.”

  • By Edward Graham

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.

  • By Natalie Alms

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.

  • By Alexandra Kelley

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.

  • By Adam Mazmanian

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.

  • By Chris Riotta

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.

  • By Natalie Alms

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.

  • By Natalie Alms

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.

  • By Mark Rockwell

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.

  • By Mark Rockwell

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.

  • By Chase Gunter

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.

  • By Chase Gunter

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.

  • By Mark Rockwell

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.

  • By Lauren C. Williams
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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.

  • By Mark Rockwell

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.

  • By Chase Gunter

FDA plans major IT refresh

The Food and Drug Administration is focusing on cloud and mobility in a coming technology overhaul.

  • By Chase Gunter

FDA's cyber guidance gets key congressman's support

Rep. Jim Langevin (D-R.I.) is backing the Food and Drug Administration's proposed cybersecurity guidance for medical device manufacturers.

  • By Chase Gunter

Can the FDA secure medical devices?

Regulators and industry face the daunting challenge of keeping medical devices online while protecting against cyberthreats.

  • By Chase Gunter

FDA issues draft guidance for medical device vulnerabilities

Security can be built into the design of a product, but risks can surface throughout its life cycle, the agency said in announcing the draft guidance.

  • By Sean Lyngaas

Audit finds shortcomings in how FDA manages IT investments

The Food and Drug Administration has an IT investment budget of about $400 million a year that needs to be managed better, according to a new report from the Government Accountability Office.

  • By Alice Lipowicz

Employees sue FDA over privacy violations

A group of FDA staffers filed suit against the agency for monitoring their personal email on agency computers.

  • By FCW Staff