Category Archives: Cyber Risk and Social Media

Increased Enforcement and Litigation Risk for Data Breaches Involving Personal Health Information

HIPAA and HITECH have long been high priority concerns for health care and life sciences organizations. But recent developments in HIPAA enforcement and data breach litigation raises the threat level for all companies dealing with personal health information (PHI). On the enforcement front, on February 1, 2018, HHS’s Office of Civil Rights — which enforces HIPAA privacy, security, and breach notification rules — announced a $3.5 million settlement with Fresenius Medical Care North America to resolve several potential HIPAA violations. In 2013, Fresenius filed five…

Continue Reading....

FDA Draft Guidance for Postmarket Management of Cybersecurity in Medical Devices Puts Manufacturers on Notice of Potential Cybersecurity Risks

This post also appears on Goldberg Segalla’s Product Liability Playbook blog.  On January 22, 2016, citing cybersecurity threats to medical devices as a growing concern, the United States Food and Drug Administration issued draft guidance for industry and FDA administration staff for postmarket management of cybersecurity in medical devices. Public comments on the draft guidance will be open for 90 days. According to the FDA release, a growing number of medical devices are designed to be networked to improve and facilitate patient care. However, the…

Continue Reading....

FDA Cracks Down on Promotional Claims Made on Facebook

In this day and age nearly everyone has a Facebook page, including companies which often use Facebook pages to promote their products and services. Given that Facebook is quite an informal marketing medium, companies may not always scrutinize everything they post as highly as they would more organized or targeted media. But that doesn’t mean the Food and Drug Administration isn’t scrutinizing every wall post and status update. On March 12, 2014, the FDA posted an untitled letter to a Switzerland-based international drug maker, noting…

Continue Reading....