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Over the past now twenty years since 802.11b came into the market in 1999 and the Wi-Fi Alliance was formed in 2000, it has been somewhat the “wild-wild west” in terms of integration of wireless in medical devices.
Manufactures of the SOC in concert with IEEE and the Wi-Fi Alliance have done a great job addressing not only security but also quality of service. This is evident by the global acceptance of Wi-Fi in our mobility world. The author was fortunate be a part of this on the ground floor starting in 1999 working for one of the founders of the Wi-Fi Alliance.
Integra Systems has advocated for over two decades the requirement that any medical device manufacture that decides to use Wi-Fi, conduct ecosystem testing.
This is the only way to validate and verify how the client device performs in a real world environment with security and the proper quality of service. We have written a white paper a couple of years back for www.ixiacom.com that is now a part of www.keysight.com surrounding this. We consider this best of practice that is required for deployments, but also see that is a requirement for regulatory approval.
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More and more healthcare applications are using sensors that connect via BLE to a smart phone that often uploads this information to the cloud.
While this is not connected to the IT ecosystem; the Bluetooth SIG has really advanced work to address security and also quality of service.
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In terms of BLE and Quality of Service
Robustness of the wireless link is provided by using adaptive frequency hopping, Lazy Acknowledgement, 24 bit CRC, 32-bit message integrity check with a latency of under 6 msec.
BLE Security
Security is provided by 128-bit AES in CCM mode and the application layer is user defined. The Advanced Encryption Standard is a specification for the encryption of electronic data established by the U.S. National Institute of Standards and Technology (NIST). AES has been adopted by the U.S. government and is now used worldwide. CCM is a mode of operation for cryptographic block ciphers. It is an authenticated encryption algorithm designed to provide both authentication and confidentiality. CRC (cyclic redundancy check) is used. It is an error detecting code commonly used in digital networks and storage devices to detect accidental changes to raw data. Blocks of data entering these systems get a short check value attached based upon the remainder of a polynomial division of their contents. On retrieval, the calculation is repeated and in the event the check values do not match, corrective action can be taken against data corruption. CRCs are good detecting potential errors caused by any noise in transmission channels.
The wireless industry to include manufactures and industry organizations have invested major league over the past twenty years to ensure the proper security and quality of service exists in the enterprise.
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Integra Systems provides all aspects of embedded wireless design, V&V of network and co-existence testing for FDA submittals, but also enterprise predictive modeling for Wi-Fi deployments. Our experience crosses all vertical markets that is backed upon twenty plus years in this space.
