Healthcare Information Security

Medical Device Security

FDA Implementing Risk-Based Medical Device Regulation

June 23, 2017 - The FDA will soon launch a new Digital Health Innovation Plan, which will include a focus on implementing a risk-based approach to medical device regulation, according to FDA Commissioner Scott Gottlieb, MD. Gottlieb explained in a recent blog post that FDA must ensure it has the necessary policies in place “to promote and encourage safe and effective innovation,” while still...


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Medical Device Security Rarely Tested in Healthcare Orgs

by Elizabeth Snell

With more healthcare providers implementing connected devices, medical device security should be a top priority in ensuring comprehensive cybersecurity. However, a recent survey indicates that healthcare organizations might not be doing enough...

Medical Devices Reportedly Infected in Ransomware Attack

by Elizabeth Snell

The recent WannaCry ransomware attack that infiltrated more than 150 countries and forced some European healthcare organizations to suspend certain services reportedly infected certain medical devices as well. HITRUST explained in an email update...

Medical Device Security Focus in Recent NCCoE Collaboration

by Elizabeth Snell

The National Cybersecurity Center of Excellence (NCCoE) recently released a draft of the NIST Cybersecurity Practice Guide, Securing Wireless Infusion Pumps in Healthcare Delivery Organizations, to help improve medical device security. NCCoE...

FDA Has Medical Device Cybersecurity Concerns in Abbott Labs

by Elizabeth Snell

The FDA recently sent a warning letter to Abbott Labs, explaining that there were potential medical device cybersecurity issues with some of Abbott’s devices that were acquired with Abbott’s purchase of St. Jude Medical earlier this...

Ransomware, Medical Device Security Top HIMSS17 Topics

by Elizabeth Snell

With HIMSS17 right around the corner, it’s time for healthcare IT professionals to gear up for the annual conference breaking down the industry’s hottest topics. Last year saw a drastic increase in ransomware attacks, so it should...

DHS Issues Update on St. Jude Medical Device Vulnerability

by Elizabeth Snell

Successfully exploiting a medical device vulnerability found in certain St. Jude devices may give a remote attacker access to communication endpoints, according to a recent advisory from the Department of Homeland Security (DHS). The follow-up...

FDA Finds Potential Cybersecurity Issues in St. Jude Devices

by Elizabeth Snell

Certain St. Jude Medical implantable cardiac devices were found to have cybersecurity issues, according to recent findings from the Food and Drug Administration (FDA). Pacemakers, defibrillators, and resynchronization devices help patients with...

FDA Finalizes Medical Device Cybersecurity Guidance

by Elizabeth Snell

An effective medical device cybersecurity risk management program needs to include premarket and postmarket lifecycle phases, according to recent guidance from the Food and Drug Administration (FDA). Furthermore, cybersecurity should be addressed...

Researchers Claim Medical Devices Vulnerable to DoS Attacks

by Elizabeth Snell

Implantable medical devices (IMDs), including pacemakers and Implantable Cardioverter Defibrillators (ICDs), were found to be vulnerable to denial-of-service (DoS) attacks, which could lead to patient safety issues, according to a recently published...

DHS Releases Internet of Things Security Principles

by Elizabeth Snell

The Department of Homeland Security (DHS) released a set of principles last month to help organizations as they work to ensure Internet of Things (IoT) security through the process of creating and then using connected devices. Titled, “Strategic...

House Subcommittee Talks Connected Device Cybersecurity Issues

by Elizabeth Snell

While the connected devices industry is seeing intense growth with evolving technologies, it is also important to be aware of the current cybersecurity issues, according to a recent hearing held by the House Energy and Commerce Subcommittee....

NH-ISAC, MDISS Collaborate for Medical Device Cybersecurity

by Elizabeth Snell

Three national organizations recently signed a Memorandum of Understanding (MOU) in an effort to improve medical device cybersecurity measures. The National Health Information Sharing and Analysis Center (NH-ISAC), the Medical Device Innovation,...

Is the Human Body the Cure for Mobile Data Security Concerns?

by Elizabeth Snell

Using the human body to enable a physical layer of security could possibly eliminate certain mobile data security and medical device security concerns, according to recent research. University of Washington researchers explain in a paper that...

Animas Warns of Potential Medical Device Cybersecurity Issue

by Elizabeth Snell

Animas Corporation, a Johnson & Johnson company, recently disclosed to users of a certain type of insulin pump that potential medical device cybersecurity vulnerabilities were discovered in it. The Animas OneTouch Ping insulin pump could...

St. Jude Files Lawsuit Over Medical Device Security Claims

by Elizabeth Snell

Claims over potential medical device security issues with St. Jude Medical, Inc. pacemakers and other heart devices has now led to a lawsuit. St. Jude filed a lawsuit in the United States District Court for the District of Minnesota against Muddy...

Medical Device Cybersecurity Key Focus in NIST Partnership

by Elizabeth Snell

A new risk assessment project designed for monitoring wireless IV medical infusion pumps hopes to further strengthen medical device cybersecurity across the healthcare industry. The National Institute of Standards and Technology’s (NIST)...

St. Jude Disputes Alleged Medical Device Security Issues

by Elizabeth Snell

St. Jude Medical Center recently responded to allegations that medical device security flaws exist in its pacemakers and other heart devices, calling the accusations “false and misleading.” Muddy Waters Capital LLC released a report...

How FDA Medical Device Cybersecurity Draft Affects Healthcare

by Elizabeth Snell

It is no surprise that the healthcare industry is facing increasing cybersecurity threats, and the increase in connected devices is all the more reason why covered entities need to ensure that their medical device cybersecurity measures are current...

FDA Drafts Health Data Sharing Guidance for Medical Devices

by Jacqueline Belliveau

According to recent draft guidance from the Food and Drug Administration (FDA), medical device manufacturers can look to new health data sharing guidelines to help relieve previous patient privacy concerns. “Although not generally required...

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