Silicon Labs’ Portfolio Includes SoCs Suited for Portable Medical Devices and Diabetes Management

时间： 2023-09-13 来源：Silicon Labs Blog

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With cybersecurity playing a more significant role in patient safety, it’s become one of the primary concerns in the development of wireless medical devices. In 2022 alone, the Health Insurance Portability and Accountability Act (HIPAA) Journal reported 707 data breaches of 500 or more records reported. During this period, IBM estimated the average total cost of a healthcare-related breach at $10.1 million. Today, it’s more common to see cybercriminals applying a combination of sophisticated, simultaneous information technology (IT) and operational technology (OT) attacks. Further exacerbating the problem, ransomware-as-a-service is becoming a more standard, professional service.

Security vulnerabilities in healthcare are putting people at risk. While designing with wireless functionality has improved the transfer of information and expanded the benefits of medical devices, it requires additional security measures.

Adopting Cybersecurity Guidelines for Wireless Medical Devices

The U.S. Food and Drug Administration (FDA) requires increasingly stringent certification requirements for cybersecurity in medical device design, so adhering to these measures requires a holistic approach. The Consolidated Appropriations Act dictates that all medical device submissions must include detailed cybersecurity plans, and failure to do so results in rejection.

SILICON LABS’ portfolio includes SoCs that are uniquely suited to support medical device designers:

EFR32BG27 (BG27) wireless SoCs offer an ultra-small WLCSP package (2.3 mm x 2.6 mm) capable of running on button cell batteries. The BG27 Bluetooth SoC features an integrated DCDC boost that allows operation down to 0.8 volts, enabling support for batteries that are typically used in medical applications for patches and continuous glucose monitoring (CGM) devices. Target applications include connected and portable medical devices, wearables, sensors, switches, smart locks, and both commercial and LED lighting.
EFR32BG22 (BG22) Bluetooth low energy (LE) wireless SoC solutions offer best-in-class, ultra-low transmit and receive power (4.1 mA TX at 0 dBm, 3.6 mA RX) and a high-performance, low-power Arm® Cortex®-M33 core (27 µA/MHz active, 1.2 µA sleep). Target applications include Bluetooth mesh low-power nodes, smart door locks, and personal healthcare and fitness devices.

The U.S. Food and Drug Administration (FDA) requires increasingly stringent certification requirements for cybersecurity in medical device design

Silicon Labs Custom Programming Services

In-house Custom Part Manufacturing Service (CPMS) allows secure provisioning of several highly advanced features including:

Secure Boot/Debug
Encrypted OTA
Public/Private/Secret Keys
Secure Identity Certificates

Custom features are injected during testing and assembly, which eliminates the need for third-party programming. Silicon Labs’ dedicated security team is prepared to consult on secure lifecycle development and provide a fast, cost-efficient alternative to traditional flash programming.

Cybersecurity in Diabetes Management Devices

Potential threats to the flow of information and device commands can compromise medical device function and, by extension, patient health. Maintaining the CIA triad (i.e., confidentiality, integrity, and availability) for health data and connected devices requires thoughtful cybersecurity plans.

The Diabetes Technology Society (DTS) has taken an aggressive position on cybersecurity in diabetes management with its Standard for Wireless Device Security (DTSec). DTSec was developed with input from the FDA and U.S. Department of Health and Human Services (HHS), and it will likely form the basis for the FDA’s official guidance.

First and Only DTSec-Compliant Chipset for Diabetes Management Devices

As a leader in IoT security, Silicon Labs worked with the DTS to have the first—and only—DTSec-compliant ICs on the market. With EFR32BG27, device designers stay ahead of FDA standards throughout their product’s lifecycle. Silicon Labs’ EFR32BG Series 2 Bluetooth ICs feature the highest level of Security Evaluation Standard for IoT Platforms (SESIP) certification possible to ensure robust and reliable resistance to hardware and software attacks. The SESIP certification includes IEEE 2621, the IEEE connected standard for medical devices in diabetes management. Evaluation reports are available upon request.

EFR32BG features include:

Series 2 Bluetooth LE SoC with SESIP Level 3 certification based on ISO Common Criteria
Limited physical attacker resistance
Software attacker resistance
Isolation of platform
Unbreakable TRNG

EFR32BG also includes Secure Vault to protect against attack vectors. Secure Vault offers a secure processing environment (SPE) for both hardware and software, anti-tamper, and counterfeit prevention via secure attestation and certification injection.

Through Secure Vault, the EFR32BG is also backed by:

True Random Number Generator (TRNG)
Secure/Crypto Engine
Secure Boot w/ RTSLSecure Debug
Secure OTA
Differential Power Analysis (DPA) Countermeasures

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本文由翊翊所思转载自Silicon Labs Blog，原文标题为:What DTSec Means for Portable Medical Devices and Diabetes Management，本站所有转载文章系出于传递更多信息之目的，且明确注明来源，不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。

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Silicon Labs（芯科科技）物联网无线产品选型指南

Company and product overview Bluetooth Modules Bluetooth Modules Overview Bluetooth Modules Bluetooth Low Energy Kits Bluetooth Modules Blue Gecko Wireless Modules Bluetooth Modules Bluetooth Xpress Modules Bluetooth Modules Blue Gecko Wireless SoCs Bluetooth Modules Bluetooth BR/EDR Kits Bluetooth Modules Bluetooth BR/EDR Modules proprietary wireless devices proprietary wireless devices Proprietary Kits Proprietary Wireless Sub-GHz and 2.4 GHz Dual Band Devices Proprietary Wireless Sub-GHz Devices Wi-Fi Modules Wi-Fi Modules Wi-Fi Kits Mighty Gecko Modules Mighty Gecko Modules Mighty Gecko Development Kit Mighty Gecko Modules Mighty Gecko Mesh Networking Wireless SoCs Z-Wave Modules Z-Wave Modules Z-Wave Reference Designs Z-Wave Modules Z-Wave Development Kits

SILICON LABS - 射频发射器,DUAL BAND DEVICES,低功耗蓝牙套件,RF TRANSMITTER,Z-WAVE串行接口模块,ISM BAND RECEIVERS AND TRANSMITTERS,MIGHTY GECKO入门套件,蓝牙远程模块,8位微控制器,MESH NETWORKING WIRELESS SOCS,WI-FI套件,WIRELESS MCUS,蓝牙开发套件,RF MODULES,BLUETOOTH BR/EDR KITS,BLUETOOTH MODULES,BLUETOOTH CLASS 2 MODULE,蓝牙5 PCB模块,32位微控制器,BLUETOOTH XPRESS MODULES,Z-WAVE MODULES,WI-FI KITS,CONTROLLER DEVELOPMENT KIT,射频SOC,蓝牙BR/EDR模块,Z-WAVE DEVELOPMENT KITS,BLUETOOTH AUDIO MODULE,BLUETOOTH BR/EDR MODULESBLUETOOTH BR/EDR MODULES,BLUE GECKO BLE SIP模块入门套件,WI-FI MODULES,MIGHTY GECKO模块,WI-FI XPRESS STARTER KIT,区域发展工具包,PROPRIETARY WIRELESS SUB-GHZ DEVICES,BLUETOOTH BR/EDR MODULES,BLUE GECKO WIRELESS SOCS,控制器开发工具包,Z-WAVE模块,PROPRIETARY WIRELESS DEVICES,BLUE GECKO BLUETOOTH LOW ENERGY SIP MODULE WIRELESS STARTER KIT,PROPRIETARY KITS,嵌入式开发工具包,BLUETOOTH LONG RANGE MODULE,BLUETOOTH DEVELOPMENT KIT,射频模块,Z-WAVE开发套件,RF SOCS,BLUE GECKO无线SOC,BLUE GECKO WIRELESS MODULES,8-BIT MICROCONTROLLER,无线入门套件,BLUE GECKO BLE SOC入门套件,MIGHTY GECKO STARTER KIT,BLUE GECKO无线模块,ISM频段接收机和发射机,32-BIT MICROCONTROLLER,智能蓝牙开发套件,BLUETOOTH LOW ENERGY KITS,MIGHTY GECKO MESH NETWORKING WIRELESS SOCS,BLUE GECKO BLE SIP MODULE STARTER KIT,BLUETOOTH SMART DEVELOPMENT KIT,EMBEDDED DEVELOPMENT KIT,WI-FI MODULE WIRELESS STARTER KIT,MIGHTY GECKO MODULES,WI-FI XPRESS入门套件,BLUETOOTH 5 PCB MODULE,WI-FI模块无线启动套件,PROPRIETARY WIRELESS SUB-GHZ AND 2.4 GHZ DUAL BAND DEVICES,WI-FI模块,BLUETOOTH CLASSIC AUDIO DEVELOPMENT KIT,MIGHTY GECKO DEVELOPMENT KIT,WIRELESS STARTER KIT,蓝牙经典音频开发套件,WIRELESS SUB-GHZ DEVICE,蓝牙CLASS 2模块,BLUE GECKO低功耗蓝牙SIP模块无线入门套件,蓝牙XPRESS模块,REGIONAL DEVELOPMENT KITS,BLUE GECKO BLE SOC STARTER KIT,Z-WAVE SERIAL INTERFACE MODULE,无线MCU,蓝牙音频模块,EBWT41U,ZDB5202,SLEXP8027A,EFR32FG13P233F512GM48,EFR32™,SLWSTK6061B,MGM12P,EZR32WG,EFR32FG13P231F512GM32,EFR32BG12P232F1024GM68,EFR32MG13P733F512GM48,EFR32BG13P532F512GM32,WT12,AMW007-E04,EFR32,WT32I,EZR32™,BGM121,BGM11S,WT11U,EFR32FG,EFR32FG14P233F256GM48,SLWSTK6062B,RBK-ZW500DEV-CON2,SLWSTK6120A,SLWSTK6063B,RBK-ZW500,EFR32BG12P132F1024GL125,SI4XXX,ZM5101,ZM5304,ZDB5101,ACC-UZB3-U-BRG,BGM111,EBWT11U,EFR32FG14P233F128GM48,ACC-UZB3-U-STA,MGM111,ZDB5304,SLWSTK6000B,SLWSTK6020B,WT32,SI10XX,SLWSTK6101C,EFR32MG13P632F512GM32,AMW037,EFR32FG12P433F1024GM48,DKWT32I-A,EFR32MG12P132F1024GL125,EFR32MG1P133F256GM48,BGM13S,EZR32HG,BGM13P,BGX13P,EZR32LG,MGM13P,WT41U,EFR32BG13P733F512GM48,BGX13S,SLWSTK6060B,MGM13S,SLWSTK6065B,WGM110,RBK-ZW500DEV-EMB2,EFR32BG12P433F1024GL125,EBWT12-A,ZM5202,AMW007,SLTB004A,EFR32MG14P733F256GM48,资产追踪,安全解决方案,便携式健身器材,器具,照明,便携式医疗设备,SECURITY,RETAIL,UTILITIES,CONSUMER,监测,家庭自动化,病人监护系统,ASSET TRACKING,物联网,METERING,PORTABLE FITNESS EQUIPMENT,IP摄像机,IP CAMERAS,INFUSION PUMPS,BUILDING AUTOMATION,HOME AUTOMATION,REMOTE MOBILE ACCESS,SMART HOME,POINT-OF-SALE SCANNERS,ASSET TRACKING,商业的,OCCUPANCY SENSORS,CONSUMER HEALTHCARE,BLOOD PRESSURE DEVICES,THERMOSTATS,INDUSTRIAL,PORTABLE MEDICAL EQUIPMENT,恒温器,订购按钮,SECURITY SOLUTIONS,销售点摄像机,IOT,PATIENT MONITORING SYSTEMS,HOME AUTOMATION,LIGHTING,智能计量,销售点扫描仪,MONITORING,工业,占用传感器,SMART METERING,ALARMS,楼宇自动化,零售,警报,血压装置,公用事业,COMMERCIAL,智能家居类,APPLIANCES,POINT OF SALE CAMERAS,ORDERING BUTTONS,OCCUPANCY SENSORS,THERMOSTATS,输液泵,消费保健,远程移动访问

SEPTEMBER 2018 - 选型指南 - REV A 代理服务技术支持采购服务

【IC】Silicon Labs的EFR32xG27无线SoC，外形小巧且低功耗，在物联网应用中具有极强的渗透力

EFR32xG27无线Gecko SoC是将76.8MHz的Arm Cortex-M33处理器内核与高性能2.4GHz无线电相结合的单芯片解决方案，外形小巧，同时具有丰富的功能和低功耗的特性，在物联网应用中具有极强的渗透力。

2024-10-17 - 产品代理服务技术支持采购服务

Silicon labs 蓝牙SOC选型表

Cortex-M4/M33内核,支持蓝牙5,待机功耗1.2μA;实测网络节点100+,工作温度高达125℃,提供芯片和模块。其最新的1.4μA超低功耗蓝牙SoC EFR32BG22具有主频高达76.8MHz Cortex-M33内核,16位ADC,支持蓝牙5.2与AoX定位和蓝牙Mesh协议。

Output Power Range (dBm)

Temperature Range (ºC)

Package Type

Package Size(mm)

EFR32BG24B110F1536IM48-B

Bluetooth®Wireless SoC

AES-128;AES-256;ECC;SHA-1;SHA-2

-20 to 10

-97.6DBM(1Mbit/s GFSK)

选型表 - SILICON LABS 立即选型

EFR32BG22C112无线GeckoSoC产品介绍

SILICON LABS - WIRELESS GECKO SOC,SOCS,EFR32BG22C112F352GM32-C,EFR32BG22C224F512IM32-CR,EFR32BG22C112,家庭互联,物联网应用,WELLNESS DEVICES,PORTABLE MEDICAL,消费电子遥控器,楼宇自动化,IOT DEVICES,BUILDING AUTOMATION,信标,物联网设备,CONSUMER ELECTRONICS REMOTE CONTROLS,BUILDING SECURITY,建筑安全,资产标签,体育保健用品,便携式医疗,ASSET TAGS,BEACONS,体育,CONNECTED HOME,健康设备,IOT CONNECTED APPLICATIONS,SPORTS,FITNESS

June, 2024 - 数据手册 - Revision 1.2 代理服务技术支持采购服务