Preparing for the Internet of Things in Medical Healthcare
Presentor: Bill Betton
Integrate of Die:
Why Collaboration is Essential in Modern Product Development
Presentor: Stephen Fluin
Summary: The next generation of medical platforms and devices need to be smarter and more connected than ever before. Learn about the ways several well-known products have lived or died on their ecosystems and integrations. Become inspired to collaborate and co-create the future of medical technology.
New Trends in Medical Device Safety:
Are you up to Date?
Presentor: Dr. Peter Havel
Summary: Medical device software regulations are a potential obstacle for medical device manufacturers seeking to be the first on the market. While current software safety regulations provide a framework for software development, technical safety requirements for medical device software are not sufficiently defined by these standards. This presentation provides an overview of the new trends impacting medical device software development including medical mobile applications, wireless communication between medical devices and networked medical devices. Additionally, it will provide tips on the technical areas which should be considered by medical device manufacturers to ensure software safety in their devices.
Mecial Device Security in Context
Presentor: Ken Hoyme
Summary: Medical devices have long had regulatory requirements for patient safety that are a primary consideration during the development and post-deployment life-cycle phases. The rapid adoption of networked medical devices to improve information speed and accuracy as well as improving workflow introduces a new class of risk – security breaches that can negatively impact safety. Manufacturers need to be able to assess and balance safety, security and usability of medical devices in a networked environment. This presentation will describe emerging guidance in medical device security risk management and recommendations for creating a secure device design process.
Securing your Medical Device:
How do Data Privacy Requirements Impact your Medical Device Design?
Presentor: Dr. Royth von Han
Summary: Several digitisation trends such as the Internet of Things (IoT), big data, deep learning and SaaS (Software as a Sevice) require increasing data access and transfer, resulting in more potential security vulnerabilities to patient data. This increasing data access and transfer includes the interconnectivity between medical devices and the more vulnerable interfaces between medical devices and non medical devices or applications. Even though most regulatory schemes have no explicit data security or data protection requirements for medical devices, regional/national requirements for privacy and data protection need to be fulfilled. Data privacy requirements can only be met with proper device design together with the protection of data acquisition and processing. This presentation gives an overview of the diversity of data protection requirements and how this relates to medical device design.