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CDRH Patient Engagement Advisory Committee

Patient Engagement Advisory Committee meeting: Cybersecurity in Medical Devices. #PEAC2019. Tuesday, September 10, 2019, Gaithersburg, MD

2019 Advisory Committee Meeting

On September 10, 2019, the Committee discussed and made recommendations on the topic Cybersecurity in Medical Devices:  Communication That Empowers Patients.

Materials from the meeting include:

For all meeting materials, see Event Materials.

Meeting topic: Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients. These same features may also increase cybersecurity risks. Preserving the benefit of these devices requires continuous vigilance as well as timely and effective communication to medical device users about evolving cybersecurity risks. 

Committee recommendations: The recommendations provided by the committee will address:

  • Factors to be considered by FDA and industry when communicating cybersecurity risks to patients and to the public, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication. 
  • Concerns patients have about changes (such as security patches and updates) to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as healthcare providers in communicating cybersecurity risks to patients.

For more details on the meeting, see September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement.

The Patient Engagement Advisory Committee (PEAC) is the first and only advisory committee whose members are all patients, caregivers, and representatives of patient organizations.

The FDA established the Committee to help assure that the needs and experiences of patients are included as part of the FDA’s deliberations on complex issues involving the regulation of medical devices and their use by patients.

This Committee brings patients, caregivers, patient organizations, and experts together for a broader discussion of important patient-related issues. Such discussions may help inform device innovation, development, evaluation, and access and help the FDA meet its public health commitment to protect and promote public health.

For details on the Patient Engagement Advisory Committee’s charter and past meeting materials, see Advisory Committees – Patient Engagement Advisory Committee.

Committee Membership

The Committee is made up of a core of nine voting members plus one non-voting industry representative and one voting consumer representative. For specific meetings that need expertise beyond the core membership, the Committee can reach out to experts that participate on this and other advisory panels for the FDA and the National Institutes of Health.

For details on current committee members, see Roster of the Patient Engagement Advisory Committee.

For information about how to nominate yourself or another candidate to participate in the Committee, see Applying for Membership on FDA Advisory Committees.

Discussion Topics

The Committee may advise CDRH on topics such as:

  • Agency guidance and policies
  • Design of clinical investigations
  • Real-world data
  • Science of patient input
  • Communication of device benefits and risks
  • Digital health technology

Executive Summaries from previous Committee meetings include:

Related information: Meeting materials for the Patient Engagement Advisory Committee

Federal Register Notices


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