The Food and Drug Administration is treating the data systems and IT infrastructure that capture information from medical devices as low-risk, as a way to encourage innovation. The data systems that ...

The U.S. Food and Drug Administration issued a guidance saying it will not regulate medical device data systems and systems related to medical image storage, as they don’t pose a high risk to patients ...

A popular medical monitor is the latest device produced in China to receive scrutiny for its potential cyber risks. However, it is not the only health device we should be concerned about. Experts say ...

Hospitals that are considered device manufacturers under the new medical device data system regulation may be subject to FDA inspections, according to an Association for the Advancement of Medical ...

Hospitals and medical device manufacturers must team up to help create a secure environment to protect the personal health information derived from patient monitors and other medical devices. For some ...

On Friday the FDA issued a draft guidance document that revealed the agency intends to further deregulate medical device data systems (MDDS) and some medical image transfer systems. The FDA wrote that ...

Functionality in the device firmware sends patient data to a hardcoded IP address that also downloads and executes binary files without the owner’s knowledge. US federal agencies have warned that a ...

Under a new FDA rule, hospitals that are considered device manufacturers may be investigated by the agency for compliance, according to an Association for the Advancement of Medical Instrumentation ...

In conversations about medical device cybersecurity, attention focuses on the Food and Drug Administration’s (FDA) rules and guidelines. With a refresh in 2023 that emphasized new protocols for ...

The Food and Drug Administration has finalized a regulation that provides a less-burdensome path to market for certain hardware and software products used with medical devices, according to an FDA ...

(I would like to thank John Murray of FDA, Scott Thiel of Roche Diagnostics and Russ Gray of the Anson Group for their comments on a draft. The views expressed -- right or wrong -- are only the author ...

In today’s political environment, it is hard to envision important issues where Republicans and Democrats can find common ground. Protecting the safety and security of citizens from the Chinese ...