What do healthcare providers want from medical device manufacturers concerning network and device security? Martin Nappi, Green Hills Software The advent of the Internet of Things (IoT) has created enormous opportunity and profound challenges for any business looking to take on the digital transformation. But no industry faces more of a test to make this change […]
Cybersecurity
HHS inspector general flags FDA on cybersecurity
The U.S. Health & Human Services Dept.’s inspector general last month flagged the FDA for its “deficient” plans and processes to ensure medical device cybersecurity, saying the federal safety watchdog’s policies and procedures are “insufficient for handling post-market medical device cybersecurity events.” “FDA had not adequately tested its ability to respond to emergencies resulting from cybersecurity […]
FDA, DHS ink cooperative medtech cybersecurity agreement
The FDA said yesterday that it is partnering with the U.S. Department of Homeland Security seeking to jointly improve cybersecurity in medical devices. The two agencies inked a memorandum of agreement looking to implement a new framework that will improve coordination and cooperation between the two bodies, according to the release. Through the agreement, both […]
Report: Medtronic shuts down pacer programmer updates on hacking risk
Medtronic (NYSE:MDT) has disabled internet updates for approximately 34,000 CareLink devices designed for accessing and programming implanted pacemakers due to cybersecurity vulnerabilities with the systems, according to a Reuters report. The vulnerability, revealed this summer by cybersecurity firm researchers, could allow an outside agent to plant malware on the pacers that would allow them to […]
FDA to revamp medtech cybersecurity — with your help
FDA recently announced that it is taking additional steps to boost medtech cybersecurity, and it’s seeking outside help to do. The agency will soon release a new draft of its premarket guidance document to combat the growing threat of cyber attacks. In addition, the agency announced multiple partnerships with manufacturers, hospitals and more — as […]
FDA to step-up cybersecurity scrutiny in med device clearances
The FDA is taking steps to increase its scrutiny of efforts taken by medical device developers to limit cybersecurity vulnerabilities in their connected products, but may need to take extra steps, according to a newly released report from the US Dept. of Health and Human Services’ Office of Inspector General. The report analyzed the FDA’s […]
Report: New hack could put malware directly on Medtronic pacers, allow full control
Vulnerabilities within with Medtronic‘s (NYSE:MDT) pacemakers, its Carelink 2090 pacemaker programmer and associated infrastructure could allow an outside agent to plant malware on the pacers that would allow them to control all shocks delivered by the device, according to a new Wired report. The vulnerabilities were discovered by security firm Whitescope’s Billy Rios and QED […]
CyberMDX closes $10m Series A
Healthcare cybersecurity group CyberMDX said today it closed a $10 million Series A round of financing. The Series A round was led by Pitango Venture capital and joined by OurCrowd Qure, the New York-based company said. CyberMDX provides non-intrusive solutions related to risk management and threat prevention and detection functionality for medical devices and other […]
Medtech cybersecurity group MedCrypt raises $2m in seed round
Medical device cybersecurity group MedCrypt said today it raised $1.9 million in a seed round of financing to help support its medtech-specific embedded cybersecurity software. The round was led by Eniac Ventures and joined by Sway Ventures, Nex, Cubed, Oronoco Investments and Friedman BioVentures, the Encinitas, Calif.-based company said. “Cyber threats are an exponentially increasing […]
DHS warns of cybersecurity weakness in Medtronic N’Vision neurostim programmer
The Department of Homeland Security this week released a report warning of cybersecurity vulnerabilities in Medtronic‘s (NYSE:MDT) N’Vision clinician programmer designed for use with neurostimulation devices that could allow outside agents to access personal health data. The DHS said that the vulnerability was originally reported by Whitescope LLC, and requires an individual gain physical access to […]
Philips warns on imaging system vulnerabilities
Royal Philips (NYSE:PHG) recently released information on possible vulnerabilities in its iSite and IntelliSpace picture archiving and communications system, warning that the vulnerabilities could compromise patient confidentiality and system integrity. The Amsterdam-based company said that under specific conditions, vulnerabilities it identified “could impact or potentially compromise patient confidentiality, system integrity and/or system availability,” according to a company […]