The Healthcare and Enterprise Wireless Experience

Wireless Convergence - WLAN, BLE, 4G

View this photo

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.

Download Ixia-T-WP-Medical-Device-Testing

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.

Download 1901_Feature_Overview_Brief_FINAL

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.

Download Bluetooth-Markets-Overview_Web

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.

Nordic Q3 2019 Newsletter

This is the latest Q3 2019 Nordic Newsletter.

Integra Systems, Inc. has worked with Nordic for a long time.... early days before BLE for SOC integration for many solutions at the PAN to the IOT.

We consider Nordic the gold standard in the convergence of the PAN with IOT.

What is exciting about this newsletter is the constant and continual evolution of the BLE standard to now include mesh and low power. The advent of the smart phone with BLE and the converged IOT standard to the enterprise will provide huge growth opportunity across multiple enterprise markets.

Download NS_WQ_Issue3_2019

CBRS - A New Frequency Band - Opportunities for Healthcare

News Alert: In September 2019 the FCC opened the door for private enterprise and carrier use of the CBRS band, labeled as “The Innovation Band”.

This shared 150MHz of spectrum has been harvested with the FCC under the guidance of the CBRS Alliance as OnGo; taking advantage of LTE and 5G protocols to deliver affordable, secure, interference/contention-free, high-quality mobile networks.

Healthcare applications and opportunities for this new band provide Wi-Fi networks to be off-loaded to the OnGo network: What are some of the benefits?

- Provisioning of an internal network that is owned and managed by the Integrated
Delivery Network
- Quality of service, policy control, and the provision of security for mobile users
that goes beyond Wi-Fi.
- Allows BYOD users to have the same quality of experience enjoyed on 4/5G while
inside a building environment.
- Drive down the cost of connectivity while enhancing the user experience.
- Decrease intrusion and security risk.
- Enhance the patient and family experience.

The ecosystem of vendors and providers that support the OnGo network are currently deploying commercial networks supporting the needs of enterprises from healthcare to hospitality and commercial real estate.

Healthcare and Hospitality have many similarities for private LTE/5G’s security, QoS, Policy Management and interference-free mobility operation. HTNG the Hospitality industry’s standards and best practices group has produced a CBRS Whitepaper available in the link below to help introduce you to the new band, OnGo and use cases.

Ballast Networks is a private LTE/5G managed services provider and a partner of Integra Systems.

https://www.ballastnetworks.com

Links of Files to Download

CBRS Alliance Mobile-Experts-OnGo.

Download Mobile-Experts-OnGo

CBRS for Hospitality White Paper

Download 2018_CBRS_for_Hospitality_White_Paper

FCC-Authorizes-Historic-OnGo-Deployments-in-3-5-GHz-CBRS-Band-Opens-Billions-in-Economic-Opportunity-for-U-S.

Download FCC Authorizes Historic OnGo™ Deployments in 3

Firewalls & Data Diodes - Best Practices for CyberSecurity

Most are very familiar with a software firewall. They are a check off box for network security.

Data diodes were designed on uncompromising technology intended to stop all unauthorized access to nuclear weapon systems.

They enforce a physical separation or "air-gap" between network segments that is enforced by the laws of physics, which are immutable and absolute - data will never be able to flow in the opposite direction, and therefore attackers will never be able to access networks through a data diode.

Integra Systems, Inc. has partnered with Owl Cyber Defense to drive new solutions through the medical device and healthcare space. See attached "What the Difference Between Firewalls & Data Diodes and CyberSecurity Best Practices.

www.owlcyberdefense.com

Download 19-OWL-DataDiodes-Firewalls

Download 19-OWL-W010-V2-Cybersecurity-Best-Practices

Integra Systems 2019 Capability Ecosystem

Integra Systems, Inc. brings to the table world class capabilities focused on software development, database design, wireless design, wireless testing, security, IOT deployment and the latest in upcoming 5G and GPRS. This is backed up by over thirty years in the wireless space and twenty two years in the delivery of excellence to our clients.

Integra Systems - Regulatory Testing Services

Over the past ten years Integra Systems, Inc. has performed testing services for a wide variety of medical device companies. This testing has had two components; ecosystem network testing for a WLAN enabled medical device and wireless-co-existence testing.

We have provided a very structured process of the authorship of a test plan and protocol, the actual testing, and the detailed end results. The end product provided has allowed companies to meet the requirements as stated in the attached document. (Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff - Document issued on: August 14, 2013)

In addition, the output documentation of this testing has provided a foundation for the proper field deployment.

Download 1618

Download Ixia-david-hoglund-medical-device-testing-6

Bluetooth v5.1 – Finally the Right Technology for Location Accuracy

Marketing Versus Reality
Since 1999 there have been a variety of technologies and RTLS solutions that have tried to provide location based accuracy that is reliable. The author here has a large amount of experience with many of these, starting out in 1999-2000, with outdoor location based solutions. For indoor based solutions; it comes down to three areas of focus. Providing the correct accuracy needed for the application, cost effectiveness, and reliability. All current technology offerings, Wi-Fi, UWB, Zigbee, Ultrasound, and IR have not really solved these challenges. A lot of this simply boils down to physics.

Why Standards Drive Adoption
The Wi-Fi revolution started in 1999 with IEEE approving 802.11b. Before that there was 802.11 DS and FH being used in enterprise solutions by a specific company for the use of mobile computing and bar code scanners. The author worked for that company. However, the Wi-Fi revolution did not really start until the Wi-Fi Alliance was formed in 2000. This allowed true interoperability between vendors at the client and access point side. Silicon vendors jumped in, standards kept improving, b, g, n, ac, and all the aspects of improving security and quality of service. The Bluetooth special interest group pretty much is following the same pathway of the Wi-Fi Alliance. The Bluetooth SIG has provided a detailed process and methodology that has driven interoperability and adoption.

How the Smart Phone has changed the paradigm
Previous to the smartphone we had laptops enabled with 802.11 that gave us true mobility away from the desktop. The smartphone while primarily used for 3G/4G connectivity also had 802.11 and Bluetooth as a combination SOC. Bluetooth also migrated from just mice and keyboards to being embedded literally in every vehicle today. This wide spread adoption has not only driven down costs, but driven up user requirements. With millions and millions of smart phones incorporating Bluetooth, it simply has become that standard that we really rely upon today. No smart phone today has Zigbee, UWB, Ultrasound or IR. However smart phones do have NFC.

Enterprise convergence to the cloud
Many applications today have moved to the cloud, the challenge is how do you get that information both in an enterprise way from say a Bluetooth enabled personal area network to that cloud? Today’s enterprise WLAN providers are now incorporating BTLE into their access points. Now the WLAN can be the backhaul to the BTLE PAN or client. Another option is simply to use a M2M IOT device. The author has provided a similar BTLE to WLAN to 4G IOT solution to the cloud. The IOT solution becomes very attractive as it is very cost effective, works, and requires no involvement of the IT organization.

Bluetooth v5.1
Current Bluetooth location based systems use signal strength to estimate distance. The Bluetooth v5.1 specification allows Bluetooth enabled devices to determine the direction of the Bluetooth signal that was transmitted. This new feature offers two different methods to determining the angle that a Bluetooth device is transmitting. These two methods are called Angle of Arrival (AoA) and Angle of Departure (AoD). These techniques require one of the two communicating devices to have an array of multiple antenna with the antenna array included in the receiving device when the AoA method is used and in the transmitting device when using AoD.

The Bluetooth Core Specification v5.1 gives the Bluetooth Low Energy (LE) controller in the receiving device the ability to generate data that can be used to calculate the directional angle of the transmitting device. Direction finding as a part of the v5.1 specification is result of several steps in the Bluetooth roadmap that will enable key enhancements to Bluetooth location services

RSSI (Received Signal Strength Indication) versus (AoA) Angle of Arrival
It is some near….versus it is precisely here.
Integra Systems is working with a technology provider that uses the latest BLE v5.1 specification that can provide accuracy from 0.1-1 meters, real time. A respected company with years of R&D and solutions to back this up.

Bluetooth and Direction Finding Location

Integra Systems, Inc. has been working for several years on many projects using our recommended SOC being Nordic.

Nordic is the market leader in Bluetooth Low Energy connectivity, with a growing portfolio of wireless devices, LTE-M and NB-IoT being the latest augmentation.

Bluetooth direction finding is the major feature of the Bluetooth 5.1 Core Specification.

It is designed to enhance location services where previously only signal strength based technology has been used with Received Signal Strength Indication (RSSI).

Bluetooth direction finding will offer a new and improved use case for Real Time Location Systems (RTLS) for asset tracking in a wide range of scenarios from logistics and warehousing to value asset security in hospitals and factories.

It also brings added user experiences in proximity-based scenarios for consumer awareness and contextual information.

Bluetooth direction finding can be used to detect location in either 2D or 3D dependent on the complexity of its implementation.

Angle of Arrival (AoA) and Angle of Departure (AoD)
Bluetooth direction finding is based around the two key concepts of Angle of Arrival (AoA) and Angle of Departure (AoD).

This makes use of the angular phase-shifts that occur between antennas as they receive (AoA) or transmit (AoD) RF signals.

With the use of antenna arrays at either side of the communication link phase shift data can be determined and from this, location can be calculated.

Medical Wearable Devices - The Market

Medical wearable devices are trying to find their niche for patient monitoring of physiological parameters in and outside of the hospital. The technology advanced cost curve is allowing this.

There is a lot of competition and investment it seems in this space. This has been going on for a number of years as the convergence of Bluetooth(r), the Smart Phone, and all kinds of applications are being developed for mobile devices for healthcare connectivity. This has allowed new companies to enter into the medical wearable space based upon this new technology and enterprise use model.

While all of this may seem new; it follows the use model of medical telemetry in the clinical space that actually got it's start in 1958 as a part of the space program. However, medical telemetry was only inside the walls of the hospital. The author has been around this space since 1983 as well provided expertise crossing all ares of medical device connectivity.

Product Design: It is often in product development the human component could be overlooked. How will the patient and/or clinician manage the wearable device and set up all the physiological parameters? Management includes the battery life and charging, the training of the clinician and patient care model, and finally the incorporation of the technology into their enterprise in a secure way.

Clinicians went to school to take care of patients...not technology.

Another area to look at is compliance. How do you know that patients outside of the hospital setting will actually use the technology? If outside of an acute care setting how will this data get to the right person? Is the data relevant and of quality for a physician to make a clinical decision on? The standard best of practice for a initial cardiac assessment is still a 12 lead EKG analysis with full interpretation.

From an executive corporate standpoint, how will the technology fit the overall business model with the correct ROI? Is the technology providing relevant and actionable data? Who owns the data and how will costs be reimbursed?

These are just some things to think about.

Proprietary versus Standards Based Wireless 2019

Over the past twenty years in the medical device community and within the healthcare enterprise there has been this debate about proprietary versus standards based wireless offerings. It started out when the Wireless Medical Telemetry Service was introduced in the late 1990's and then 802.11b being approved in 1999. The start of the Wi-Fi revolution as we know it.

The author provided OEM guidance on the first medical telemetry system using 802.11 FHSS around 1999. This was ahead of it' time but followed the logical next steps in the WLAN revolution which kicked off with the Wi-Fi Alliance forming in 2000.

Then came the whole era of smart pumps incorporating 802.11 advances from the early 2000's to another medical telemetry company architecting 802.11 as a part of their enterprise solution.

Just like Wi-Fi, Bluetooth has provided a standards based approach and is enjoyed by a surrounding community of interoperability and product roll-outs in multiple vertical markets. Millions of $ of investment in R&D has driven innovation and security advances.

The introduction of the smart phone incorporating BTLE pretty much has solidified BTLE as the standards based personal area network of choice.

Most recently several medical device companies have incorporated BTLE into their solutions to also include an implantable device. This is huge as it overcomes that argument that Wi-Fi and or BTLE is not safe, reliable, or secure. The implantable device company followed all NIST guidelines. https://www.nist.gov/topics/cryptography

We additionally see the whole proprietary real time location system model becoming legacy as BTLE 5.1 provides the granularity of accuracy. Also BTLE is fast becoming incorporated in WLAN enterprise AP(s) to include mesh capabilities

Bottom line, while proprietary wireless technology may have had it's place in healthcare; standards based architecture always wins out. It wins out because of the ground swell of investment, standards, interoperability, security, and wide spread adoption driving down cost.

Download 1901_Enhancing-Bluetooth-Location-Service_FINAL

Download 2019-Bluetooth-Market-Update

Download 1903_Mesh-Models-Overview_FINAL

Download Fulham-Health-Estate-Journal-Bluetooth