Interoperability of Medical Devices in a Connected World - From Regulatory to Reality

Description: Interoperability of Software as a Medical Device (SaMD) refers to the ability of different medical software systems to work together seamlessly, exchanging and utilizing data in a standardized and efficient manner. Achieving interoperability is critical for the successful deployment of SaMD and connected devices. Interoperability challenges can impact safety and hinder adoption, while successful integration can optimize workflows and lead to better health outcomes.
Enhanced interoperability requires rigorous protocols to ensure compliance with data protection guidelines and adequate data security. Despite clear regulatory recognition of the importance of interoperability, there is no unified global framework for demonstrating compliance. SaMD manufacturers struggle to interpret high-level regulatory expectations (FDA, MDR, IMDRF, EHDS, EU Data Act) into practical design, verification, and validation strategies. The diversity of healthcare IT environments, evolving interoperability standards (e.g., HL7 FHIR, DICOM, IEEE 11073), and overlapping cybersecurity and liability considerations create uncertainty. On top, initiatives like the European Health Data Space (EHDS) significantly elevates the expectations for seamless, harmonized data sharing throughout Europe, compelling medical device manufacturers to meet far more rigorous interoperability requirements than ever before. This frequently results in inconsistent regulatory submissions, delayed approvals, and increased risk of post-market safety and security issues.

This session will explore why interoperability in healthcare is so challenging, highlight and consolidate regulatory expectations, and provide practical approaches to documenting and testing interoperability in a way that aligns with patient safety and expectations of the regulators.