Security News

FDA Reveals Steps to Bolster Medical Device Cybersecurity
2018-10-01 17:48

'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...

The FDA's New Digital Health Cyber Unit: What Would It Do?
2018-09-27 19:48

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...

FDA to Ramp Up Medical Device Cybersecurity Scrutiny
2018-09-12 20:18

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...

FDA: Make Sure EHRs Used for Clinical Studies Are Secure
2018-07-18 20:48

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...

FDA: Make Sure EHRs Used for Clinical Trials Are Secure
2018-07-18 19:18

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...

Should the FDA Create a Cybersecurity Measuring Stick?
2018-06-12 21:03

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...

FDA Unveils Plan for 'Software as a Medical Device' Review
2018-04-27 21:17

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...

FDA plans to improve medical device cybersecurity
2018-04-23 14:05

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...

FDA Reveals New Plans for Medical Device Security
2018-04-20 15:17

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...

FDA Proposes Action to Enhance Medical Device Cybersecurity
2018-04-18 19:03

Agency Seeks Congressional Authority to Require Makers to Take Certain StepsThe FDA has issued plans for advancing the safety of medical devices, including a proposal to impose new cybersecurity...