News & Analysis as of September 20, 2024

Cybersecurity › Patient Safety

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

[Webinar] Cybersecurity Best Practices for Healthcare Entities - September 6th, 8:00 am PT

Clark Hill PLC on 8/29/2023

Cybersecurity attacks on health care systems continue to pose a threat to national security and to patient safety. In the webinar Cybersecurity Best Practices in Health Care presented by Clark Hill attorneys John Howard and...more

[Webinar] Health Care Cybersecurity: Risks, Challenges and the Path Forward - March 8th, 2:00 pm - 3:00 pm ET

Manatt, Phelps & Phillips, LLP on 2/22/2023

Hospitals, health systems and providers are targets of cyberattacks, putting valuable patient data and, more importantly, patient lives at risk. The Department of Health and Human Services’ Office of Civil Rights reported an...more

FDA’s New Draft Guidance on Cybersecurity

Gardner Law on 8/17/2022

The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Health Care Compliance Association (HCCA) on 2/17/2022

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Hospital Continues to Divert Patients Over a Week After Ransomware Attack

Robinson+Cole Data Privacy + Security Insider on 8/13/2021

Eskenazi Health in Indianapolis has been diverting emergency department patients arriving by ambulance to other area hospitals since it shut down its network following a ransomware attack on August 4, 2021....more

SweynTooth cybersecurity vulnerabilities: considerations for medical device manufacturers

Hogan Lovells on 3/19/2020

The U.S. Food and Drug Administration (FDA) announced a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited – may introduce risks for certain Bluetooth enabled medical devices. ...more

URGENT/11 Cybersecurity Vulnerabilities Could Affect Medical Devices and Hospital Networks

Robinson+Cole Data Privacy + Security Insider on 10/8/2019

On the heels of an FDA committee report concerning cybersecurity issues with medical devices, the U.S. Food and Drug Administration (FDA) issued an alert regarding cybersecurity vulnerabilities, referred to as “URGENT/11,”...more

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

Holland & Knight LLP on 1/14/2019

• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

Sheppard Mullin Richter & Hampton LLP on 11/30/2018

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

FDA, DHS Increase Coordination Over Medical Device Cybersecurity Risks to Patient Safety

Holland & Knight LLP on 10/19/2018

The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more

FDA Announces Playbook for Medical Device Cybersecurity

Robinson+Cole Data Privacy + Security Insider on 10/4/2018

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

FDA signals increasing focus on cybersecurity requirements

Hogan Lovells on 4/26/2018

With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan)...more

Best practices for managing cybersecurity risks related to IoT-connected medical devices

Hogan Lovells on 3/12/2018

Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

Hogan Lovells on 1/17/2018

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

McDermott Will & Emery on 1/28/2016

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

Health Hackers: Problems in Applying Traditional Products Liability Theories to Latent Cyber-Vulnerabilities in Medical Devices

Butler Snow LLP on 10/16/2015

October is National Cyber Security Awareness Month (yes, that’s a thing), so it seems fitting to write about an unprecedented alert recently released by the FDA to health care providers that warned of a medical device’s...more

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Cybersecurity › Patient Safety

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