Speaker series: The joint FDA and University of California San Francisco-Stanford Center of Excellence in Regulatory Science and Innovation ( CERSI) is a speaker series of virtual one-hour lectures to promote regulatory science –including innovative research, education, and scientific exchange. Threat Modeling Playbook: Playbook for Threat Modeling Medical Devices is an educational resource that discusses best practices for understanding basic threat modeling concepts and processes, and how to apply them to medical devices. Incident Response Playbook: Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook is a playbook that describes the types of readiness activities that will enable health delivery organizations (HDOs) to be better prepared for a cybersecurity incident involving their medical devices and gives product developers more opportunity to address the potential for large scale, multi-patient impacts that may raise patient safety concerns. Workshops and Webinars on Cybersecurity.MOUs on Cybersecurity in Medical Devices.Cybersecurity Safety Communications and Other Alerts.The health care environment is complex, and manufacturers, hospitals, and facilities must work together to manage cybersecurity risks. Threats and vulnerabilities cannot be eliminated and reducing cybersecurity risks is especially challenging. Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. These same features also increase potential cybersecurity risks. Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients. The FDA clears, authorizes, and approves devices to be marketed when there is a reasonable assurance that the devices are safe and effective for their intended use. These tips focus on communicating with patients and aim to increase clinician comfort in approaching this topic.Īll legally-marketed medical devices have benefits and risks. OctoThe FDA released a new video, Tips for Clinicians - Keeping Your Patients’ Connected Medical Devices Safe to help clinicians discuss cybersecurity of connected medical devices with patients. The guide is a shorter version of the playbook that discusses preparedness and response activities health care organizations might want to start with as they are developing their medical device incident response program. Adding a resource appendix making it easier to find tools, references, and other resources to help health care organizations prepare for and respond to medical device cybersecurity incidents (including ransomware).Ī Playbook Quick Start Companion Guide is also available.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |