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    Medical devices

    GDPR for Medical Devices

    This training summarizes the practical considerations related to GDPR for medical devices and medical device software.

    Medical devices, especially software, can involve storing and processing sensitive personal health data as defined in General Data Protection Regulation GDPR. Compliance with the regulation builds trust towards customers and patients, supports controlled and efficient data processing and helps to manage business-critical data protection risks.

    Meeting the requirements of data protection regulation requires that the processes and information systems in which personal data are processed take the regulation into account. GDPR compliance is not achieved only by producing a privacy statement and the gaps in data protection implementation are a risk to business continuity.

    Practical considerations related to GDPR for Medical devices are summarized in this training.

    Topics

    • Personal data – what is personal data?
    • Data protection principles
    • Legal basis of personal data collection
    • Planning and resources – critical tasks
    • Measures and reporting
    • Documentation
    • Perspectives (legal, process, technical)
    • Data protection risk management
    • Implementation challenges and solutions

    Target group

    All health tech developers, medical device manufacturers and stakeholders interested in gaining specific knowledge on how to apply General Data Protection Regulation for medical devices. Special focus on start-up founders and staff, university innovator teams as well as young health tech professionals and new employees.

    Objectives

    • Know the basic GDPR considerations for medical devices
    • Are aware of data protection principles
    • Understand the necessary documents needed to demonstrate compliance
    • Are aware of the GDPR risks and controls