Plaintiffs’ attorneys are always looking for new ways to sue pharmaceutical companies. Under the banner of “no good deed goes unpunished,” plaintiffs in California recently sued a prescription drug manufacturer after they took advantage of the manufacturer’s program to help pay for a medicine widely used to treat arthritis and plaque psoriasis. There are no
Cybersecurity
California Reaffirms Healthcare Data Privacy Standard And Rejects Class Certification
We have not written much on data privacy lately, but it remains a hot topic and one that changes rapidly as governments around the world (including numerous U.S. states) enact new data privacy laws. One thing that has not changed is the standard for proving a data privacy breach under California’s medical confidentiality statutes. For…
FDA Publishes Draft Updated Guidance on Medical Device Cybersecurity
We celebrated National Cybersecurity Awareness Month a few weeks ago by bringing you the FDA’s newly published Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, with a promise to cover the Agency’s promised update on its Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which was first…
FDA Continues Its Press On Medical Device Cybersecurity
Did you know that October is National Cybersecurity Awareness Month? Neither did we, until we started poking around the FDA’s recent press release announcing that it intends to update its guidance on medical device cybersecurity within the next few weeks. We also learned that National Cybersecurity Awareness Month has been observed each October since its…
Is the Government Protecting Your Private Information?
We were not affected by the recent ransomware attack that disabled computers worldwide, including in multiple public hospitals in the UK. At least not yet. For those who have never had the pleasure or who otherwise do not follow cybersecurity news closely, “ransomware” refers to an attack on a computer system that encrypts the user’s…