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At long last, the "sole purpose" argument used by trial courts and plaintiffs' attorneys was soundly rejected in a recent decision issued by the 11th Circuit Court of Appeals, In Re: BayCare Medical Group, No. 23-12571, May...more
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
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
The federal Patient Safety and Quality Improvement Act of 2005 (PSQIA) established a voluntary reporting system for licensed health care facilities and professionals designed to "enhance the data available to assess and...more
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
• 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
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
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
On May 24, 2016, the Department of Health & Human Services (HHS) issued guidance (Guidance) to health care providers and patient safety organizations (PSOs) in an attempt to clarify the definition of patient safety work...more