Tag archives: final guidance

CMS Publishes Final Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities

By Stacey Murphy (US), Mark Faccenda (US), Thomas Dowdell (US) and Hayley White (US) on November 16, 2021 Posted in General, Regulatory

On November 12, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued its final guidance for hospitals to clarify how CMS and state agency surveyors will evaluate space-sharing or contracted staff and service arrangements with other hospitals or healthcare providers for compliance with the Medicare Conditions of Participation (“CoPs”). According to CMS, “[c]o-location occurs … Continue reading

FDA issues final guidance on postmarket medical device cybersecurity

By Anna Rudawski (US) on January 6, 2017 Posted in FDA & Food Safety

On December 28, 2016, the U.S. Food and Drug Administration (FDA) released final guidance on the management of cybersecurity vulnerabilities for marketed and distributed medical devices. The guidance establishes a risk-based approach for the reporting of medical device cybersecurity vulnerabilities to the FDA. The FDA guidance reflects the agency’s concerns that cybersecurity vulnerabilities in networked … Continue reading