At present, there are many portable medical devices in the market, most of which use wireless connection technology to transmit data to smartphones or cloud services, and most of them use Bluetooth wireless transmission technology. This article will show you the development trend of wireless connection technology for portable medical devices and related solutions introduced by Silicon Labs.
Application of portable medical devices to realize remote outpatient care
Portable medical devices can be used to continuously monitor and track the physiological condition of patients, such as blood pressure, heartbeat, blood sugar and other data. Healthcare professionals can connect to smartphone apps via Bluetooth for remote viewing of collected health data. Doctors can access data via remote outpatient care applications, enabling continuous monitoring of patients post-acute and rehabilitation periods in a convenient and non-invasive manner. Patients can also enjoy their daily life at home, while doctors can carry out medical diagnosis, observation and consultation remotely, efficiently and safely, thus effectively preventing the spread of viruses or diseases. Therefore, portable and wearable medical devices using wireless connection technology are very important to realize outpatient care services.
Most common portable medical devices such as blood glucose meter, continuous blood glucose monitor, blood pressure monitor, pulse oximeter, insulin pump and cardiac monitoring system choose Bluetooth Low Energy (BLE), which is the most widely used wireless connection technology. However, in order to enable wireless devices and applications, robust Internet of Things device security, small form-factor and high energy efficiency must be taken into consideration to achieve accurate, safe, long-life and low-cost operation. The common BLE wireless technology meets all conditions and provides the best wireless solution for device manufacturers.
The market for wireless portable medical devices is growing rapidly
Governments around the world by shifting inpatient care to more cost-effective outpatient care services to save expensive hospital resources to deal with acute and severe cases. The global outpatient care service market is expected to grow by 4.8% every year, reaching USD 113 billion by 2026 (USD 77 billion in 2018). The COVID-19 pandemic has accelerated this trend because, in many hard-hit areas of the world, hospital capacity must be quickly released for emergency care, so personal Bluetooth medical devices are urgently needed to realize efficient, safe and patient-friendly remote healthcare services.
The global healthcare transformation is also reflected in the market of wireless portable medical devices. It is estimated that by 2025, device sales are expected to grow at an average annual rate of 12%, and the total revenue will increase by USD 17 billion. Many existing device manufacturers and many new startups want to make profits in this high-profit industry. This huge development trend will make the number of new wireless portable medical devices launched in the global market reach a record high.
Security and privacy issues of portable medical devices
Modern healthcare needs more wireless medical devices to achieve cost-effective remote outpatient care services. This continuous and technology-assisted healthcare transformation has promoted the global growth of the wireless medical device market. However, security and privacy issues are easily forgotten in the booming market and the frenzy of medical digitalization.
Portable medical devices can collect, process and transmit private health data, so the security of devices becomes the most important design consideration. Data transmission must be protected at all levels to protect portable medical devices from various complex logical, physical and wireless attacks to protect patients' privacy.
In 2020, the U.S. Food and Drug Administration (FDA) issued a warning about SweynTooth vulnerabilities. Potential vulnerabilities may bring risks to medical devices that support wireless BLE, cause these devices to crash and stop running, open access rights for unauthorized commands, and expose private information, which may threaten users of Bluetooth medical devices. However, in view of the increasing number of exposed vulnerabilities, the healthcare industry and device manufacturers must prioritize wireless security in product design and development.
Security precautions of Bluetooth medical devices
When designing Bluetooth medical devices, there are many advanced security considerations that require special attention. For example, authenticate software before execution must be carried out to prevent hackers from inserting malicious code to derail devices to execute wrong software and hardware from being cloned. This is because cloned System-on-Chip (SoC), modules and fake smartphone applications will easily allow hackers to pass the authentication process and access devices and private data.
In addition, no open port is left on the product because the unprotected USB port can easily access the internal computer architecture. It is also necessary to use Bluetooth SoC with security certification and products with international security certification, such as adopting DTSec protection profile released by GlobalPlatform.org and passing the Security Evaluation Standard for IoT Platforms (SESIP).
Moreover, it is also necessary to eliminate the opportunity of differential power analysis (DPA) attack. The attacker will implement an inductive loops across a chipset and monitor induced current and system power consumption to collect power traces from many cryptographic operation samples and perform mathematical signal analysis functions based on leakage modeling to regenerate security keys. Therefore, it is very important to protect security keys. The best solution is a physically unclonable function (PUF), which can create a random and unique key according to the imperfections of individual device. The PUF key encrypts all the keys in the security key storage, and the application can handle these keys while maintaining confidentiality.
In addition, it is necessary to perform secure over-the-air (OTA) updates, combine OTA firmware updates with the Root-of-Trust and Secure Loader, authenticating the trusted source of update files, encrypting the whole process, and guaranteeing that firmware images have not been changed through a secure boot. As long as the above safety precautions are strictly observed in the process of product design and development, the security of Bluetooth medical devices can be greatly improved.
Complete Bluetooth security application solution
According to the requirements of Bluetooth applications, Silicon Labs has introduced relevant solutions, including adopting Secure Vault firmware, making the world's first wireless SoC achieve Arm PSA Level 3 certification, implementing all standard security functions on Bluetooth stack to protect applications from wireless threats, and using hardware supported mbed TLS as a trusted execution environment for Bluetooth applications to achieve chip-level security. The hardware of Silicon Labs delivers strong security through the secure boot and the root of trust and secure loader, secure OTA update, crypto engine, true random number generator and Secure Vault technology.
Depending on the application differences, the product service life of portable medical devices, including the period from product storage in the warehouse to sales and use, can range from a few days to several months, making power optimization more challenging and key design consideration. The ingenious layout design in Silicon Labs' EFR32 Series 2 chipset minimizes the total SoC power consumption (including MCU and radio) in standby and active modes. With a coin cell suitable for devices, it can run for more than 10 years. It also provides an intelligent way to extend the product's shelf life before the device is sold in stores.
In addition, high precision is also one of the primary design considerations of medical devices. Silicon Labs' EFR32 Series 2 analog front end on hardware includes 16-bit analog-to-digital converter, 12-bit digital-to-analog converter, and precise on-chip voltage reference. Advanced Series 2 design ensures that analog peripherals perform as expected during Bluetooth radio operation, enabling customers to design high accuracy medical products.
EFR32BG22C222F352GM32, introduced by Silicon Labs, is one of EFR32BG22 Series 2 wireless SoC, including a 76.8 MHz ARM Cortex-M33 core, providing plenty of processing power while integrating security functions to provide fast encryption, secure boot loading and debugging access control. The device includes 352 kB flash memory and 32 kB RAM in a QFN32 package. EFR32BG22 Series 2 wireless SoC can be used for BLE data transmission, location service and low-power node application of Bluetooth mesh network, providing the maximum power output up to 6 dBm and excellent receive sensitivity of -98.9 (1 Mbit/s GFSK) dBm. In addition, the EFR32BG22 Series 2 SoC use the same tools as the EFR32BG Series 1 SoC to provide easy migration and accelerated time to market through the development kit, Software Development Kit (SDK), mobile applications, and Silicon Labs patented network analyzer.
Conclusion
Modern healthcare systems will require many smart wireless devices to effectively treat the aging population through secure outpatient care channels. The Bluetooth medical device market is a huge development opportunity for device manufacturers and startups. Silicon Labs' Bluetooth solution, which provides robust, uncompromising security, will be the best choice for developing wireless medical devices.
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