FDA Patient Engagement Meeting: Cybersecurity in Medical Devices: Communication That Empowers Patients

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https://www.fda.gov/advisory-committees ... -09102019

Patient Engagement Advisory Committee Meeting
9/10/2019 8:00 AM EDT Duration: 9:30:00
Advisory Meeting concerning cyber security of medical devices
Patient Affairs Staff (PAS)
Food and Drug Administration
U.S. Department of Health and Human Services


FDA is hosting two events this week - on Tuesday, 9/10 and Wednesday, 9/11 - that may be of interest to patients, caregivers, and the patient advocacy community. Please share with anyone who may be interested in attending. We hope that you can participate!


Patient Engagement Advisory Committee (PEAC) meeting - Cybersecurity in Medical Devices: Communication That Empowers Patients
When: Tuesday, September 10th from 8 am - 5:30 pm (ET)
Where: Holiday Inn Gaithersburg, Two Montgomery Village Ave. Gaithersburg, MD or by webcast https://www.fda.gov/media/129757/download

About: 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. These same features may also increase cybersecurity risk. Ensuring these devices continue to provide benefit requires timely and effective communication to medical device users about evolving cybersecurity risks. The PEAC provides advice to FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. The committee will discuss and make recommendations on the topic “Cybersecurity in Medical Devices: Communication That Empowers Patients.” The recommendations will address which factors the FDA and medical device industry should consider when communicating cybersecurity risks to patients and to the public.
Learn more: Visit the PEAC meeting page to view the meeting materials and get the webcast link


Webinar - The Sentinel System: FDA's Tool for Assessing Medical Product Safety and Gathering Real World Evidence
When: Wednesday, September 11th from 1-2 pm (ET)
Where: webinar
About: The Sentinel System is an increasingly vital tool in FDA's post-marketing safety surveillance system for medical products (e.g., drugs, vaccines, and medical devices). This webinar will provide an overview of Sentinel's broadening capabilities and ongoing value in regulatory decision-making. Particular focus will be on Sentinel's role in safety surveillance and use of real-world evidence (RWE). The webinar will also highlight the efforts and objectives of a patient representative-led stakeholder engagement work group that developed tailored messages to reach diverse audiences.
Learn more: click here to register for in-person attendance: https://www.eventbrite.com/e/the-sentin ... 4365866038

Are you a patient or caregiver who wants to get involved at FDA? Contact the Patient Affairs Staff (PAS) or follow us on Twitter @FDAPatientInfo. Should you wish to opt-out of future communications from the Patient Affairs Staff, please send an email to PatientAffairs@fda.gov.


Patient Affairs Staff (PAS)
Office of Medical Products and Tobacco
U.S. Food and Drug Administration
Tel: 301-796-8460
Email: PatientAffairs@fda.gov