A professional educational model to provide insight into what is going on with all aspects of secure wireless medical connectivity both across the integrated delivery network, the enterprise business model, and at the device point of care of which includes the connected medical device. The goal of this content is to provide technology information and direction to help transform healthcare in 2019 through all aspects of wireless connectivity and cybersecurity. The desired result is to improve patient care and the total clinical mobility experience across the healthcare enterprise in a secure fashion.
Over the past twenty years Integra Systems, Inc. has been involved in the RTLS (Real Time Location System) space around the timing of the approval of 802.11b in 1999.
This has included but has not been limited to ultra wideband, Zigbee, ultrasound, Wi-Fi, low frequency RF, and UHF.
Our opinion with BTLE becoming the dominant PAN (personal area network) a lot has changed. What has moved the needle across the RTLS landscape was the smart phone validation as the standard incorporating BTLE. Add on to this the continued revolution of BTLE across multiple enterprise vertical markets.
Also the major WLAN manufactures are also now incorporating BTLE into their enterprise solutions both at the AP and WLAN controller for location based services.
Just like Wi-Fi becoming the standard in wireless networking; the same case is happening that BTLE 5.1 will become the standard for indoor RTLS.
According to ABI Research, over 400 million Bluetooth locations service devices are forecasted to be shipped per year 2022.
See the attached white paper: "Enhancing Bluetooth Location Services with Direction Finding"
While Bluetooth in the early days was a communications modality for small peripherals such as computer mice and keyboard, the major cross the chasm event was the introduction of the smart phone. Moore's went into effect and the growth parallels that of Wi-Fi when 802.11b was introduced in 1999. Look at the projected growth in device networks and location based services. We are actively involved in several projects for device networks, client devices, and also location based services using BTLE.
Bluetooth made its debut several years ago in devices such as laptops and desktops for the un-tethering of keyboards and the mouse. When low power Bluetooth came on the scene…things really changed. The change occurred with the smart phone incorporating this...and as they say…the rest is history. Just like Wi-Fi, Bluetooth Low Energy (BTLE) is gradually changing the game in medical devices.
Most recently I had the opportunity to work with friend to help him set up his remote connection from his pacemaker to a cloud-based monitoring network. What amazed me was the pacemaker incorporated low power Bluetooth. I think that this is a first for the industry and for a implantable device. It is the Azure™ pacemaker with BlueSync™ technology from Medtronic.
Medtronic’s first generation of MyCareLink™, drove innovation in remote monitoring by enabling the Azure™ pacemaker with BlueSych™ technology to communicate with a patient owned mobile platform. Added features include an encryption module that encrypts data using NIST (National Institute of Standards and Technology), as well as a high density Integrated Circuit which increases longevity of the pacemaker.
The MyCareLink™ mobile application with can be downloaded on your smart phone allows patient’s to see all kinds of data from their implanted device. The value to the patient is tremendous. Integrating remote monitoring to your smart phone allows for real time engagement with the patient and eliminates the need for a bedside monitor. See attached the brochure from Medtronic’s web site.
Integra Systems, Inc., has worked with a medical device manufacture to incorporate Bluetooth Low Energy into its solution. In this case we recommended www.lairdtech.com of which uses the www.nordicsemi.com SOC. Most recently we completed testing in surgical setting with a variety of wireless interferers. One of the worst offenders of interference is the electrosurgical generator. Real time information transmitted to a BTLE enabled tablet worked in a flawless fashion when the BTLE enabled medical device was less than 10cm from the ESU in a high power cutting mode.
See the latest Quarter 3/Autumn 2018 from Nordic Semiconductor
Integra Systems, Inc. www.integrasystems.org over the past twenty years has provided the connectivity knowledge and technical expertise to many companies in multiple vertical markets on a global basis based upon our decades combined of the end point device and the wireless domain knowledge experience.
Our work has extended to working with Nordic on several projects and we consider them the de-facto standard in BTLE SoC, ANT, and Thread.
While this issue of the ULP (Quarter/Spring 2018) is very interesting from the BTLE application perspective; the convergence of cellular into the IOT space with BTLE and WLAN will drive a major cross the chasm business opportunity.
Please find the latest ULP Winter 2017 Quarterly from www.nordicsemi.com.
Integra Systems, Inc., has worked with Nordic for many years on unique product development efforts for the medical device space using both ANT www.thisisant.com and BTLE. , as well as the WLAN. This however is the first issue of ULP Quarterly that “really highlights” the huge growing BTLE medical device market space.
While Bluetooth has been around for a long time. The advent of the “smart-phone” with BTLE, the Bluetooth SIG driving improvements to now the release of 5.0, the connectivity convergence has now arrived for healthcare and medicine big time in 2017. The momentum will continue in 2018. Consumers also are demanding the connectivity as well from glucose meters to in-ear wireless temperature measurements for babies. The smart phone, the application, and the "connected" device, brings it all together. (Page 3)
Some interesting highlights that sets the tone for continued medical device product development for BTLE. “The FDA has approved the first drug in the United States with a digital ingestion tracking system". The patch sends data, i.e. dosage and when the pill was taken via Bluetooth Low Energy to a smart phone application allowing patient’s and caregivers to track the ingestion of medication. (Page 11).
Everybody is concerned today about security. By the nature of BTLE and FHSS, BTLE is considered a secure protocol. While security has greatly increased over the improvements in BTLE and now 5.0, design and development efforts may want to consider the addition of an ARM TrustZone CryptoCell-310 Cryptographic module and an AES 128-bit hardware accelerator. This can provide support for a wide range of asymmetric, symmetric, and hashing cryptographic services for secure applications. In BLTE 4.2 an asymmetric encryption scheme was introduced called “secure connections”. This revision of the BTLE specification included an algorithm that generated a private key using an Elliptic key exchange method making it almost impossible to intercept.
Just like Wi-Fi, “man in the middle” attacks can pose a security to BTLE. OOB commissioning was introduced as a part of Bluetooth 4.0. This moved authentication away from the usual Bluetooth LE channels to an “out-of-band” channel which remains unknown to the prospective hacker. It seems that NFC (Near Field Communications) offers the best balance of security, but also user friendly for the implementation of the OOB channel.
NFC devices exchange information in the 13.56 MHz ISM band at rates ranging from 106 to 424kbps. Bidirectional interaction is established by bringing the devices within 4 to 10cm of each other. The NFC link can be used as the OOB channel to start the pairing process and look after authentication. Once this handshake commissioning process is completed, then communication switches to the secure Bluetooth LE link.
The value to NFC for the OOB channel is the very short distance which would make hacking via a man in the middle intercept very difficult to reveal their intent. Finally OOB commissioning also stops unwanted devices from establishing a connection with the user’s permission. From a user’s standpoint, there is no need to enter or verify a passcode.
Please find attached the latest version of Ultra Low Power Wireless Q. Integra Systems, Inc., has worked with Nordic in the past for product development of a medical device using ANT. We are in current product development with our partner on a unique Bluetooth 4.0 solution coupled to an I-Phone application. Bluetooth 5.0 is now being introduced (pages 16 &17). Open cellular standards now supporting Low Power Long Term evolution. Low Power LTE operates in up to 44 different licensed frequencies across the world, ranging from 450 MHz to 2.6 GHz. The advantages of licensed spectrum are particularly beneficial for many IoT applications; key among these are that the owners of the spectrum allocation (the carriers) can control and prioritize data, and the bands are immune from interference from other sources of RF radiation. Second because that the spectrum allocation is not shared with other RF transmissions, coexistence between connected devices is much easier to manage. LTE's coexistence technology is based on proven time-domain solutions, and other mechanisms such as autonomous denial of conflicting RF signals. LTE's coexistence mechanisms will allow a single base station (tower) to support up to 200,000 low power modems. LTE infrastructure is largely in place in 157 countries with over 380 networks.
Nordic www.nordic.semi.com continues to push the envelope.
Integra Systems has used Nordic products on several projects. Nordic Semi is a great company and provides great support.
Wireless overtakes wired headphones
Bluetooth headphones outsold wired headphones for the first time ever in the first half of 2016 according to consumer research firm NPD Group.
Bluetooth 5 provides major advances in speed, security, and meshing capabilities.
See the following specifications of the Nordic 5 SOC.
Advanced multi-protocol SoC supporting
Bluetooth 5/ANT/ 802.15.4/ 2.4GHz
Proprietary
Active
The nRF52840 SoC is an advanced, highly flexible ultra-low power multiprotocol SoC ideally suited for ultra low-power
wireless applications. The nRF52840 SoC is built around a 32-bit ARM® Cortex™-M4F CPU with 1MB flash and 256kB
RAM on chip. The embedded 2.4GHz transceiver supports Bluetooth® low energy (Bluetooth 5), 802.15.4, ANT and
proprietary 2.4GHz protocols. It is on air compatible with existing nRF52 Series, nRF51 Series, and nRF24 Series products from Nordic Semiconductor
Bluetooth 5
The nRF52840 has hardware support on-chip for Bluetooth 5. This includes long range and high throughput capability. It supports all Bluetooth low energy physical layer bit rates and modulation schemes.
Processing Power
The nRF52840 incorporates a powerful Cortex-M4F processor running at 64 MHz enabling the most demanding applications with complex arithmetic requirements to
be realized in a single chip solution. This CPU configuration supports DSP instructions, HW accelerated Floating Point Unit (FPU) calculations,single-cycle
multiply and accumulate, and hardware divide for energy-efficient processing complex operations.
Multiprotocol Radio The 2.4GHz radio supports multiple protocols including Bluetooth low energy, ANT, 802.15.4 and 2.4GHz proprietary. It supports Bluetooth low energy 2Mbs and
1Mbs and Bluetooth 5 long range (500kbs and 125kbs). The radio supports high resolution RSSI measurement and automated functions to reduce
CPU load, including EasyDMA for direct memory access for packet data and assembly. Nordic provides protocol stacks for Bluetooth low energy. ANT protocol stacks are available from ANT.
Memory to Expand
The nRF52840 has extensive on-chip memory in both flash (1MB) and RAM (256kB) offering powerful possibilities for today’s advanced wireless applications.
Power Efficiency
The nRF52840 SoC employs power and resource management to maximize application energy efficiency and battery life. The supply range between 1.7V and 5.5V
supports primary and secondary cell battery technologies and direct USB supply without the need for external regulators. All peripherals have independent and
automated clock and power management to ensure they are powered down when not required for task operation to keep power consumption to a minimum without the
application having to implement and test complex power management schemes.The nRF52840 has a comprehensive system of automated and adaptive power
management features. These features are built into all aspects of device operation from power supply switching, to peripheral bus/EasyDMA memory
management and a automated shut down of all but the absolute essential peripherals required to perform a task.
ARM® TrustZone® Cryptocell-310 ARM Cryptocell-310 is a powerful on-chip cryptographic co-processor providing cryptographic functions and services to speed
up operations significantly, save CPU processing time and reduce energy consumption. It incorporates a true random number generator (TRNG) and support for a wide range of asymmetric, symmetric and hashing cryptographic services for secure applications.
On-chip NFC tag
NFC™-A tag support is included on chip. NFC Type 2 and Type 4 tag emulation protocol stacks are provided by Nordic opening up a range of new applications,
like NFC payment, and improved user experience for existing BLE applications with Out-of-Band (OOB) pairing. OOB pairing using NFC simplifies the process of
authenticated pairing between two Bluetooth devices by exchanging authentication information over an NFC link.
USB 2.0
The nRF52840 has on-chip USB 2.0 (Full speed) support and on-chip VBUS regulation allowing for direct connection to USB hosts for data transfer and direct USB
power for hosted applications.
Package Options
The nRF52840 is available in 7x7mm 73pin AQFN package with 48 available GPIO.
SoftDevice
The Nordic protocol stacks are known as SoftDevices. The nRF52840 is supported by the S140 SoftDevice. The S140 SoftDevice is a Bluetooth 5 pre-qualified
Bluetooth low energy protocol stack.
Bluetooth and the advances to the technology just keep getting better each year. Late this year 2016 early 2017, the Bluetooth Special Interest Group (SIG) will formalize 5.0. This revised specification will provide the ability of quadrupling of range for Bluetooth low energy devices compared to the Bluetooth 4.0 standard and will double the speed of data throughout from 1 to 2Mbits/second.
The whole value of BTLE (Bluetooth Low Energy), by the SIG is to retain the low power consumption. Having high data rates means that OTA (Over the Air) firmware updates are much faster and also their may be some cross over into the WLAN space.
The original IEEE 802.11 DSSS standard before 1999, was in effect 2MBits/second. In 1999, 802.11b, the extension of 802.11 was when we know as Wi-Fi, became known, i.e. at 10Mbits/second. This launched the WLAN revolution. Was fortunate to be on the ground floor of this working for a company that co-founded the Wi-Fi Alliance.
With BTLE 5.0 developers will have flexibility to take advantage of the 2Mbits/second rate and accept a reduced range. Another option for example is intelligent lighting where data rate is not important; you can simply use a data rate of 250 kbits/second with increased range of 50 meters.
Data rates and ranges can switch back and forth per the SIG 5.0 standard. You could use the high data rate for a OTA firmware upgrade, then switch back to very low data rates for increased distances.
I like Nordic Semiconductor and have used their hardware in the past on medical device projects. www.nordisemi.com Nordic had the first Bluetooth low energy part, was the first company with a SoC integrating a 32-bit ARM Cortex processor, the first with a multi-protocol device, and the first to offer over-the-air firmware upgrades.
www.bluetooth.com
See latest ULP Q4 2016 Report from Nordic - 15MB file
Frequency Hopping Spread Spectrum (FHSS)(used in Bluetooth) is a method of transmitting radio signals by rapidly switching a carrier among many frequency channels, using a pseudorandom sequence known to both transmitter and receiver. It is used as a multiple access method in the frequency-hopping code division multiple access (FH-CDMA) scheme.
A spread-spectrum transmission offers three main advantages over a fixed-frequency transmission:
1. Spread-spectrum signals are highly resistant to narrowband interference. The process of re-collecting a spread signal spreads out the interfering signal, causing it to recede into the background.
2. Spread-spectrum signals are difficult to intercept. A spread-spectrum signal may simply appear as an increase in the background noise to a narrowband receiver. An eavesdropper may have difficulty intercepting a transmission in real time if the pseudorandom sequence is not known.
3. Spread-spectrum transmissions can share a frequency band with many types of conventional transmissions with minimal interference. The spread-spectrum signals add minimal noise to the narrow-frequency communications, and vice versa. As a result, bandwidth can be used more efficiently.
FHSS is a wireless technology that spreads its signal over rapidly changing frequencies. Each available frequency band is divided into sub-frequencies. Signals rapidly change ("hop") among these in a pre-determined order. Interference at a specific frequency will only affect the signal during that short interval. A sub-type of FHSS used in Bluetooth wireless data transfer is adaptive frequency hopping spread spectrum (AFH). Adaptive Frequency Hopping allows Bluetooth to adapt to the environment by identifying fixed sources of interference and excluding them from the list of available channels. This process of re-mapping also involves reducing the number of channels to be used by Bluetooth. The Bluetooth Specification requires a minimum set of at least twenty channels.
Frequency hopping was first used for military electronic countermeasures.
(See Hedy Lamarr Links)
https://en.wikipedia.org/wiki/Hedy_Lamarr
https://www.google.com/patents/US2292387
Because this radio communication occurs only for brief periods on a radio channel and the frequency hop channel numbers are only known to authorized receivers of the information, transmitted signals that use frequency hopping are difficult to detect and monitor.
To receive information from the transmitter, the receiver uses the exact same hopping sequence. When the transmitter and receiver frequency hopping sequences occur exactly at the same time, information can transfer from the transmitter to the receiver.
Bluetooth provides three basic security services
Authentication & Authorization: This is the process of determining who is at the other end of a Bluetooth link and if their device should have access to yours. Encryption & Data Protection: Bluetooth encrypts your data and only allows approved devices to decrypt it, making it much more difficult to for unauthorized users to capture and decipher your personal information. Privacy & Confidentiality: In addition to encrypting the data being transmitted, the latest version of Bluetooth also makes it possible to encrypt the address of the Bluetooth device itself. This makes it nearly impossible for someone else to track a device, like your phone as it moves from place to place.
Bluetooth adheres to U.S. federal security regulations, ensuring that all Bluetooth devices are capable of meeting and exceeding strict government security standards. NIST Compliant: The National Institute of Technology develops security standards and guidelines for federal agencies to protect their information and information systems.
FIPS Approved: These Federal Information Processing Standards are developed by NIST in accordance with the Federal Information Security Management ACT (FISMA).
