Designing a safe BLE connection of medical devices

Portable medical devices can collect, process and transmit private health data, so device safety becomes the most important factor in the design process.

There are many portable medical devices on the market today, most of which use wireless connectivity technologies to transfer data to smartphones or cloud services, including but not limited to the Bluetooth standard. The article shows the trends in the development of wireless connection technology for portable medical devices and solutions in this area, developed by Silicon Labs.

The use of portable medical devices for the implementation of remote outpatient care

Portable medical devices can be used to continuously monitor and track a patient's physiological condition, measuring blood pressure, heart rate, blood sugar and other variables. Healthcare professionals can connect to smartphone applications via Bluetooth to remotely view collected health data. Doctors can access data via the remote outpatient care application, enabling continuous monitoring of the patient's condition after severe illnesses and their rehabilitation in a convenient and non-invasive way. Patients, on the other hand, can enjoy everyday life at home, while doctors can carry out medical diagnostics, observations and consultations remotely, efficiently and safely, thus effectively preventing the spread of viruses and diseases. Therefore, portable medical devices using wireless communication technology are very important today for the delivery of outpatient care services.

The most popular portable medical devices, such as glucometers, blood pressure monitors, pulse oximeters, insulin pumps and heart monitoring systems, include Bluetooth Low Energy (BLE) functionality, which is the most widely used wireless connectivity technology. However, in order to enable the safe operation of wireless devices and applications and to achieve accurate, safe, long-lasting and cheap operation of them, it is necessary to ensure reliable protection of the Internet of Things devices, small size and high energy efficiency. The widely available BLE wireless technology meets all the conditions and provides the best wireless solution for medical device manufacturers.

The global transformation of healthcare is also reflected in the market for wireless portable medical devices. It is estimated that by 2025, sales of devices will grow at an average annual rate of 12%, and total revenues will increase by $ 17 billion. Many existing device manufacturers and countless start-ups want to make a profit in this highly profitable industry. This clearly visible development trend will bring the number of new wireless portable medical devices to the world market to record levels.

Security and privacy issues for portable medical devices

The issues of security and privacy are easily forgotten in the dynamically developing market, in the conditions of the crazy digitization of medicine. Portable medical devices can collect, process and transmit private health data, so device safety becomes the most important factor in the design process. To protect portable medical devices from a variety of complex logical, physical, and wireless attacks, data communications must be protected at all levels.

In 2020, the U.S. Food and Drug Administration (FDA) issued a SweynTooth vulnerability alert. Potential security vulnerabilities may pose a threat to medical devices using wireless BLE, cause them to fail, breach access rights for unauthorized commands, or reveal private information that may endanger users of Bluetooth medical devices. Due to the increasing number of vulnerabilities, the healthcare industry and device manufacturers must prioritize wireless security when designing and developing products.

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