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A narrative commentary about interoperability in medical devices and data used in diabetes therapy from an academic EU/UK/US perspective.

ABSTRACT: 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.

SUBMITTER: Jendle J

PROVIDER: S-EPMC10789828 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature

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A narrative commentary about interoperability in medical devices and data used in diabetes therapy from an academic EU/UK/US perspective.

Jendle Johan J Adolfsson Peter P Choudhary Pratik P Dovc Klemen K Fleming Alexander A Klonoff David C DC Mader Julia K JK Oliver Nick N Sherr Jennifer L JL Šoupal Jan J Heinemann Lutz L

Diabetologia 20231202 2

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 inte ...[more]

PMID: 38041737

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Project description:BackgroundIn the future, more medical devices will be based on machine learning (ML) methods. In general, the consideration of risks is a crucial aspect for evaluating medical devices. Accordingly, risks and their associated costs should be taken into account when assessing the performance of ML-based medical devices. This paper addresses the following three research questions towards a risk-based evaluation with a focus on ML-based classification models.MethodsFirst, we analyzed how often risk-based metrics are currently utilized in the context of ML-based classification models. This was performed using a literature research based on a sample of recent scientific publications. Second, we introduce an approach for evaluating such models where expected risks and associated costs are integrated into the corresponding performance metrics. Additionally, we analyze the impact of different risk ratios on the resulting overall performance. Third, we elaborate how such risk-based approaches relate to regulatory requirements in the field of medical devices. A set of use case scenarios were utilized to demonstrate necessities and practical implications, in this regard.ResultsFirst, it was shown that currently most scientific publications do not include risk-based approaches for measuring performance. Second, it was demonstrated that risk-based considerations have a substantial impact on the outcome. The relative increase of the resulting overall risks can go up to 196% when the ratio between different types of risks (false negatives vs. false positives) changes by a factor of 10.0. Third, we elaborated that risk-based considerations need to be included into the assessment of ML-based medical devices, according to the relevant EU regulations and standards. In particular, this applies when a substantial impact on the clinical outcome / in terms of the risk-benefit relationship occurs.ConclusionIn summary, we demonstrated the necessity of a risk-based approach for the evaluation of medical devices which include ML-based classification methods. We showed that currently many scientific papers in this area do not include risk considerations. We developed basic steps towards a risk-based assessment of ML-based classifiers and elaborated consequences that could occur, when these steps are neglected. And, we demonstrated the consistency of our approach with current regulatory requirements in the EU.

Project description:BackgroundMany studies have shown increased academic problems in children with unilateral hearing loss (UHL). However, whether hearing devices can ameliorate the educational difficulties associated with UHL is not well studied. Therefore, the objective of the current systematic review was to answer the question: do nonsurgical amplification devices, bone-anchored hearing aids, and/or cochlear implants improve academic outcomes in school-aged children and adolescents with UHL?MethodsEmbase, MEDLINE, Scopus, CINAHL, APA PsycInfo, <ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link>, and Cochrane databases were searched from inception to December 21, 2022. Published, peer-reviewed studies comparing academic outcomes in patients with UHL aged ≥5 and ≤19 years with and without hearing devices (nonsurgical amplification devices, bone-anchored hearing aids, or cochlear implants) were included. Results of studies were qualitatively synthesized, and the risk of bias was evaluated with the Effective Public Health Practice Project (EPHPP) Quality Assessment Tool.ResultsA total of 5,644 non-duplicate publications were identified by the search, and four studies were included for synthesis, every one of which was investigating nonsurgical amplification. One small, single-arm study demonstrated significant improvement in subjective classroom listening difficulties after a 3- to 4-month trial with a behind-the-ear hearing aid. The other three studies of nonsurgical amplification devices showed no benefit across multiple academic outcomes with FM systems and conventional and CROS-style hearing aids.DiscussionThe small sample sizes, heterogeneous and/or ill-defined study samples, and overall low quality of the available literature ultimately make it hard to draw definitive conclusions regarding nonsurgical amplification devices' effectiveness in improving academic outcomes in children with UHL. No articles were identified that studied cochlear implants or bone-anchored hearing aids. Further studies with high-quality study design, large sample sizes, and long-term follow-up are needed to answer this clinically important question.

Dataset Information

A narrative commentary about interoperability in medical devices and data used in diabetes therapy from an academic EU/UK/US perspective.

Publications

A narrative commentary about interoperability in medical devices and data used in diabetes therapy from an academic EU/UK/US perspective.

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