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糖尿病设备的互操作性原则

Principles of Interoperability of Diabetes Devices.

作者信息

Klonoff David C, Aaron Rachel E, Tian Tiffany, Espinoza Juan C

机构信息

Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.

Diabetes Technology Society, Burlingame, CA, USA.

出版信息

J Diabetes Sci Technol. 2024 Aug 5:19322968241268235. doi: 10.1177/19322968241268235.

DOI:10.1177/19322968241268235
PMID:39101467
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11572099/
Abstract

INTRODUCTION

Better interoperability is essential to derive maximum benefit from connected wireless diabetes devices. The need for this feature of diabetes devices is supported by trends in designing better performance for three types of devices: nonmedical devices, medical devices, and diabetes devices.

FRAMEWORK

First, interoperability is a standard attribute for the performance of nonmedical devices contained in smart systems that can sense and actuate. Second, interoperability is now mandated by the US Department of Health and Human Services as carried out by the Office of the National Coordinator for Health Information technology (ONC) and the US Food and Drug Administration (FDA) to improve the performance of all medical devices. Third, new guidance from the FDA and nongovernmental professional organizations are intended to promote interoperability because this feature will improve the performance of all diabetes devices.

RECOMMENDATIONS

Wireless devices perform best when they are interoperable, and this is particularly true for diabetes devices.

摘要

引言

更好的互操作性对于从联网的无线糖尿病设备中获取最大益处至关重要。设计三种类型设备(非医疗设备、医疗设备和糖尿病设备)以实现更好性能的趋势支持了糖尿病设备这一特性的需求。

框架

首先,互操作性是智能系统中包含的可感知和驱动的非医疗设备性能的标准属性。其次,美国卫生与公众服务部下属的卫生信息技术国家协调办公室(ONC)和美国食品药品监督管理局(FDA)现在要求互操作性以提高所有医疗设备的性能。第三,FDA和非政府专业组织的新指南旨在促进互操作性,因为这一特性将提高所有糖尿病设备的性能。

建议

无线设备在具备互操作性时性能最佳,糖尿病设备尤其如此。