C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Tag Archives: Medical Devices

Interoperability by Design: FDA Issues New Final Guidance for Connected Medical Devices

Posted in FDA, Health IT
The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information… Continue Reading

FDA Finalizes Guidance on Low Risk “General Wellness Products”

Posted in Health IT
In a final guidance document released July 29th, the U.S. Food and Drug Administration (“FDA”) officially confirmed that it does not intend to review or require regulatory compliance for fitness trackers and certain health apps, collectively termed “general wellness products.”  This guidance, which is largely unchanged from the draft guidance issued in January 2015, coincides… Continue Reading

Recent OCR Settlements Highlight Continuing HIPAA Enforcement Trends

Posted in HIPAA & Privacy
Last week, the HHS Office of Civil Rights (OCR) announced a settlement that has far-reaching implications on the importance of complying with the HIPAA Security Rule where medical devices create and maintain electronic protected health information (ePHI).  See Data Law Insights for a post authored by Jodi Daniel, Elliot Golding, and Stephanie Willis for more… Continue Reading

FDA Publishes Cyber Guidance for Medical Devices

Posted in FDA, HIPAA & Privacy
On October 2, 2014, the FDA released a set of comprehensive guidelines governing the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The guidelines are intended to provide direction for manufacturers of medical devices on how to appropriately safeguard devices from a potential security breach; particularly in light of the sensitive medical… Continue Reading