Security News
A vulnerability in the software update process of certain Medtronic Programmer models has determined the vendor to block the functionality on affected devices, the U.S. Food and Drug...
'Playbook' Prepared; Data Sharing Efforts PlannedIn its ongoing quest to improve the state of medical device cybersecurity, the FDA has announced a number of key moves - including the release of a...
Cybersecurity Unit Would Be Part of a Center of Excellence for Digital HealthThe Food and Drug Administration plans to launch a new digital health "center of excellence" that includes a...
New OIG Report Spells Out Need for Better Premarket ReviewsThe Food and Drug Administration should increase its scrutiny of the cybersecurity of networked medical devices before they're approved...
Agency Issues Guidance Spelling Out Its PolicyThe FDA has issued new guidance spelling out its policy for organizations using electronic health record data in FDA-regulated clinical...
Agency Issues Guidance Spelling Out Its PolicyThe FDA has issued new guidance spelling out its policy for organizations using electronic health record data in FDA-regulated clinical...
Agency Gets Suggestions for 'Software as a Medical Device' Precertification ProgramThe FDA should consider some sort of measuring stick when assessing a vendor's cybersecurity culture to determine...
Agency Says It Would Assess Vendors' 'Cybersecurity Responsibility'The FDA is proposing to pre-certify vendors of certain medical device software, including various mobile apps, allowing the...
The US Food and Drug Administration (FDA) plans to tackle security issues related to medical devices and has released a plan of action it means to implement in the near future. Broadly, plan is as...
The U.S. Food and Drug Administration (FDA) this week announced its medical device safety action plan, which includes seeking additional funding and authorities that would help it improve...