Search Results
The default setting for search results displays All Content. If you prefer to see recent content only, please adjust the date filter.
Filter your results:
Types
Topics
77 Results Found
RFI Response: Action on Interoperability of Medical Devices, Data and Platforms to Enhance Patient Care
The AHA responds to the request for information on medical device interoperability from the Networking and Information Technology Research and Development’s Health Information Technology Research and Development Interagency Working Group.
FDA issues draft guidance on cybersecurity for medical device industry
The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity risk.
FDA announces actions to strengthen medical device cybersecurity
The Food and Drug Administration today released a framework to help hospitals and other health care providers plan for and respond to cybersecurity incidents involving medical devices.
FDA releases early results from duodenoscope reprocessing studies
Early results from studies to better understand how duodenoscopes are reprocessed in real-world settings have found higher than expected contamination rates after reprocessing.
FDA: Don’t use certain test strips to monitor blood thinner dosing
The Food and Drug Administration Friday warned physicians and patients who use medical devices to monitor levels of the blood thinner warfarin that certain test strips used with the devices may provide inaccurate results and should not be relied on to adjust the drug dosage.
HSCC issues guide to promote cyber secure medical devices, health IT
The Healthcare and Public Health Sector Coordinating Council (HSCC) today released a consensus-based guide to developing, deploying and supporting cyber-secure medical devices and health information technology across the product lifecycle and improving information sharing between manufacturers and health care organizations.
OIG: FDA should address postmarket cybersecurity risk to medical devices
The Food and Drug Administration’s policies and procedures were insufficient for handling postmarket medical device cybersecurity events, and the agency has not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices.