As clinical IoT devices become increasingly connected to each other and to other technologies, the ability of connected systems to safely, securely, and effectively exchange and use the information becomes critical. This session of the Global Connected Healthcare Cybersecurity Virtual Workshop series will discuss reference implementations for existing interface standards and explore critical unanswered questions regarding safety, identity, cybersecurity, and performance attributes of connected systems in the context of sustainable and scalable data and device interoperability.
There are critical needs for clinical-based interoperability standards that address clinical and non-clinical scenarios and define specific functional requirements and non-functional requirements, such as Quality of Service (QoS), quality of measurement (precision and accuracy), and, most importantly, safety to describe the essential performance requirements for such composite systems. Sustainable and scalable interoperability of data and devices can enable connectivity across networks to streamline management, deployment, and integration cycles; facilitate quality assurance and harmonization of data that maximizes its utility across systems and platforms; minimize errors and adverse events; encourage innovation by enhancing the quality of available data; and ultimately contribute to improvements in patient care and clinical outcomes.
We will explore how to best leverage emerging technologies, such as blockchain, AI/ML, and others as potential tools to mitigate interoperability challenges. Together we will develop recommendations for a pathway for standards to validate multi-vendor connected health technologies that enable a regulatory roadmap for approval of devices in interoperable composite systems.
Understanding risk factors and critical needs for clinical-based interoperability standards from a patient-centric perspective using a systems approach and engineering best practices.
Exploring real world applications and pertinent use cases related to connected healthcare and clinical IoT, such as: Uses in clinical trials, multi-access edge computing, and applications of wearable biosensors throughout the patient journey in clinical and non-clinical settings.
Understanding the role of authentication for data and device identity across the product lifecycle, including Real World Data (RWD) and Real Word Evidence (RWE).
Understanding the role of governance frameworks for data harmonization to maximize security, quality, accessibility, and utility of information driving clinical decision making.
Identifying milestones for standard interoperability frameworks that allow for novel clinical solutions to be safely and efficiently incorporated, including approaches to incorporate standards for user interaction, patient interface, and device-to-device interoperability.