People living with diabetes have many medical devices available to assist with disease management. A critical aspect that must be considered is how systems for continuous glucose monitoring and insulin pumps communicate with each other and how the data generated by these devices can be downloaded, integrated, presented and used. Not only is interoperability associated with practical challenges, but also devices must adhere to all aspects of regulatory and legal frameworks. Key issues around interoperability in terms of data ownership, privacy and the limitations of interoperability include where the responsibility/liability for device and data interoperability lies and the need for standard data-sharing protocols to allow the seamless integration of data from different sources. There is a need for standardised protocols for the open and transparent handling of data and secure integration of data into electronic health records. Here, we discuss the current status of interoperability in medical devices and data used in diabetes therapy, as well as regulatory and legal issues surrounding both device and data interoperability, focusing on Europe (including the UK) and the USA. We also discuss a potential future landscape in which a clear and transparent framework for interoperability and data handling also fulfils the needs of people living with diabetes and healthcare professionals.

3rd Department of Internal Medicine 1st Faculty of Medicine Charles University Prague Czech Republic

Department of Metabolism Digestion and Reproduction Faculty of Medicine Imperial College London London UK

Department of Paediatric Endocrinology Diabetes and Metabolic Diseases University Children's Hospital Ljubljana Slovenia

Department of Paediatrics The Hospital of Halland Kungsbacka Kungsbacka Sweden

Diabetes Research Centre University of Leicester Leicester UK

Diabetes Research Institute Mills Peninsula Medical Center San Mateo CA USA

Division of Endocrinology and Diabetology Department of Internal Medicine Medical University of Graz Graz Austria

Faculty of Medicine University of Ljubljana Ljubljana Slovenia

Institute of Clinical Sciences Sahlgrenska Academy at University of Gothenburg Gothenburg Sweden

Kinexum Harpers Ferry WV USA

School of Medicine Institute of Medical Sciences Örebro University Örebro Sweden

Science Consulting in Diabetes GmbH Düsseldorf Germany

Yale University School of Medicine New Haven CT USA

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