Principles & Practices for the Cybersecurity of Legacy Medical Devices by the International Medical Device Regulators Forum

Medical devices, their hardware, and software are increasingly connected to the Internet, sometimes called the Internet of Medical Things (IoMT) or the Internet of Things (IoT) in healthcare. Healthcare professionals access data from imaging technologies in hospitals to remote patient monitoring and alert systems at home or on the human body. Patients may use medical device software at home to aid with physical rehabilitation. The global IoT in healthcare market is expected to reach USD 169.99 billion by 2030.

Cybersecurity involves the protection of electronic information and assets from unauthorized access, use, and disclosure. There have been reported cybersecurity issues in the healthcare industry such as malware, ransomware, and data breaches and regulatory authorities have come up with principles and best practices for managing the cybersecurity of legacy medical devices.

• An introduction to cybersecurity and the various stages or phases of the medical device life cycle
• Responsibilities of the Medical Device Manufacturer throughout the medical device life cycle, including in device design/development, data transfer at device life cycle stages, vulnerabilities, and risk management
• Responsibilities of the Healthcare Professional throughout the medical device life cycle

Are you a medical device manufacturer, an entrepreneur, an executive, a software or IT professional working in the medical device industry and responsible for data security or engaging with healthcare professionals? Are you a regulatory affairs professional or consultant in the medical device sector? Are you a healthcare professional managing or accessing medical devices or medical device data? If your answer to any of the above questions is yes, this webinar is for you.

• Medical Device Manufacturers – Executives, Management
• Software / Hardware / IT / R&D personnel including but not limited to engineers, programmers, and developers in the medical device or healthcare industries
• Healthcare Professionals accessing, using, and managing Medical Devices in Hospitals or Healthcare Facilities
• Medical Radiation/ Radiologic / Radiology Technologists and Technicians Diagnostic Imaging Technologists / Technicians Regulatory Affairs Professionals & Students

Rachelle D’Souza began her career in regulatory compliance in 2007. She has provided Regulatory Affairs, Quality Assurance, Clinical, Pharmacovigilance and Medical Information support to the Pharmaceutical, Biologic, Generic, Natural Health Product, Dietary Supplement, Medical Device, Cosmetic, Pesticide and Food industries.

Rachelle has developed regulatory strategies, independently prepared regulatory submissions and secured product and site approvals from global regulatory agencies. She has also designed, implemented, and maintained global quality, pharmacovigilance and medical information systems. Rachelle’s regulatory articles and webinars on the latest global

regulatory developments have been published in print and online by regulatory professional associations, webinar hosting platforms and industry magazines.