Implementation Guidelines for Cellular Modems Embedded into Medical Devices

Implementation Guidelines for Cellular Modems Embedded into Medical Devices August 2012

Executive Summary Revolutionary changes are underway in healthcare as the industry moves from expensive hospital-centric sick care to more affordable proactive healthcare monitoring and management outside the hospital. The cellular industry is working with the Continua Health Alliance to accelerate this transition and partner with the medical device community on key considerations in developing and operating sensors, gateways, and service platforms in the cellular environment. The Continua Health Alliance is a non-profit, open industry organization of more than 240 healthcare and technology companies joining together in collaboration to improve the quality of personal healthcare. This organization produces a set of guidelines that enable vendors to build interoperable sensors, home networks, tele-health platforms, and health and wellness services. The purpose of this paper is to go beyond the wireless interfaces and provide invaluable guidance, from the cellular perspective, on how to embed into and, more importantly, how to successfully operate a cellular modem in a medical device. Key design and operating considerations include power management, efficient use of network resources, accessing those resources, device management, network capability and limitations, certification, and general life cycle management of the product. Efficient power management is arguably the most important consideration. It is also essential to provide long-term cellular connectivity and thus enable longitudinal, continuous assessment of biometric data. Along with wireless medical sensors, automotive, utility, transportation, and many other verticals are making billions of connections to the same cellular network. Fewer connections and larger payloads make most efficient use of these networks. An industry standard M2M Service Layer is under development in the onem2m 1 organization to manage connectivity with cellular networks, but it is the application that utilizes these networks that must understand capabilities, capacities, and demand limitations to successfully draw upon these services. While cellular may reach 95% of the world s population, this connectivity is provided by a complex of over 800 network operators utilizing half a dozen different communication technologies. Devices with a cellular modem must be remotely managed to allow access by an operator to a given network. The good news is that mechanisms and processes are in place to easily manage these connections. Device certification is a final step to help ensure network connectivity and interoperability with other Continua compliant devices, gateways, and service platforms. The purpose of this paper is to build medical product manager and engineer awareness of the challenges associated with using cellular connectivity and to aid them in reaching out to the wireless community in order to quickly and successfully address these challenges. Efficient connectivity and interoperability are fundamental to reaching the scale necessary to serve the growing wireless healthcare global market. 1 http://www.onem2m.org/

Contents Introduction...1 Purpose...1 Definitions...1 Scope...1 Background...1 Power Management...1 Battery...1 Signaling...1 Payload...2 Network Considerations...2 Air Interface Technology...2 Radio Access...3 Radio Coverage...3 Capacity/Bandwidth...4 Efficiency...4 Concatenation... 4 Radio Resource Utilization... 5 Concurrent Network Access Attempts... 5 Multiple SMS Retries... 5 Polling... 5 Latency...5 Device Considerations...6 Form Factor...6 User Interface...6 Device Identification...7 User Identification...7 Network Authentication...7 GSM Network Authentication... 7 CDMA Network Authentication... 8 Provisioning...8 GSM Networks... 8 CDMA Networks... 8 Device Management...8 Video Codec...9 Certification...9 Regulatory...9 Federal Communication Commission (FCC) Regulatory Requirements... 9 Specific Absorption Rate (SAR)... 10 Radios and Protocols... 10 Interoperability... 10 Appendix... 11 Glossary... 11 Wireless Technology Evolution in Figures... 12 1 GSM... 12 1a GPRS/EDGE... 12 2 CDMA 2000(1xEV-DOrA)... 12 3 WCDMA (R99)... 13 3b HSPA and HSPA+... 13 4 LTE (Release 8)... 13 Legal... 14 iii

Figures Figure 1 - Cellular Network Air Interface Technology Categories...2 Figure 2 - Summary of Current Regional Network Deployment (Scale: * Low; ***** High)...3 Figure 3 - Summary of Today s Network Generational Characteristics...4 Figure 4 Average Latencies...6 Figure 5 - Regulatory Requirements in Europe are Governed by European Commission - Radio & Telecommunications Terminal Equipment (R&TTE)...9 iv

Introduction Purpose The purpose of this paper is to provide high-level device specific design guidance to product managers and engineers incorporating cellular modems into health sensors, gateways, and servers. Definitions Definitions used in this document are listed in the 1

Appendix. Scope The Continua Health Alliance Design Guidelines address the TAN/PAN/LAN/WAN interfaces between e-health devices. Design considerations that do not impact one of these interfaces, yet are essential to the successful design of devices incorporating cellular modems, are captured in this document. This document does not provide exhaustive design information, but attempts to provide the reader with sufficient information to gain an appreciation of design considerations and the knowledge necessary to engage the experts. In the event of conflict between the Continua Design Guidelines and this document, the Continua Design Guidelines take precedence. Background The Continua Health Alliance represents the interests of over 200 member companies including medical device manufacturers, health IT developers, health care providers, health insurers, wireless operators and technology firms. Continua is dedicated to establishing a system of interoperable personal wireless connected health solutions. Continua is not a standards setting body rather the Alliance selects existing commercially available standards and within those parameters adds definitions or refinements. Continua has also developed test specifications and a Certification program as a method to show compliance to Continua Design Guidelines. In its efforts to move into the mobility space, Continua has worked with leading operators, device vendors, and cellular organizations like GSMA to provide an overview of mobile network specific considerations that should be kept in mind when designing medical sensors with embedded modems so that they are interoperable and optimized for use with cellular connectivity. Today, wireless technologies that can enable more proactive personal health exist and are being applied but far greater scale of interoperability is needed to radically improve health and quality of life and eliminate unnecessary costs from the healthcare system. To become a central component of the way we manage health, personal health and medical devices must be fully interoperable with each other and with other information sources. Because broad interoperability has yet to be achieved, it is an emerging priority for health systems and for the medical and information technology industries. Power Management Battery life is often a key differentiator in the wireless consumer marketplace. Three key factors in successful power management are battery, signaling, and payload scheduling. That said, the needs of the service may demand an always-on approach for near real-time operation, in which case care should be given to the way in which this is implemented to minimize power consumption. Battery Key parameters in selecting a battery are the expected operational time between recharging or replacing the battery, frequency of use, user access (are they expected to change the battery or recharge a non-removable one), and the level of connectivity required to ensure service operation. Signaling High mobility combined with frequent access to biometric data requires devices with cellular modems to maintain regular connectivity to wireless networks. Networks are designed to minimize the amount of signaling required when the device is in an idle state. Power consumption is greatly increased when bringing up a data session due to increased signaling with the network to establish a session and use of the modem transmitter. Frequent signaling can quickly reduce battery life from weeks to days or even hours. The product development team is encouraged to minimize the number of data sessions, both to save battery life and minimize network congestion. 2

Payload Care needs to be given to understanding the end service requirements where fewer data sessions and larger payloads may be the optimal solution dependent on the priority of the delivery. To minimize power consumption and make the most efficient use of network resources aggregating data on the device for batched transmission at less frequent intervals should be considered where the service is not time critical. Network Considerations In order to effectively operate over cellular networks, key considerations that must be understood by application design engineers include the air interface technology deployed in their target market, how to access the network, availability/coverage of these networks, their data carrying capacity, the efficiency at which data can be transported, and how to work with latencies inherent in some networks. Air Interface Technology In mobile telecoms, much is made of the new generations of wireless technologies (commonly referred to as the G in networks) that is being implemented by networks and supported on new mobile devices. While 2G technology is the most widely deployed today, the industry is moving to 3G for mobile Internet and to 4G for even greater Internet speeds. Figure 1 - Cellular Network Air Interface Technology Categories Today, 2G is supported very widely in terms of global operator support and coverage within a single market. However, these networks are being turned off as users migrate to new air interface technologies that offer faster speeds. (Japan and Korea are in the process of finalizing 2G switch-off as part of a regulatory mandate.) 3G is the technology that brought the Internet to mobile, but it was not until 3.5G (e.g. HSPA, EV-DO) was launched that Mobile Internet really began to gain any true momentum. 3G and 3.5G deployments now cover a large number of countries but do not have the in-country coverage that 2G offers today. 3

4G is a common term covering the deployment of LTE and LTE Advanced, which has been launched through 2012. At the time of publication the number of operators with a live 4G service is low, with the coverage provided primarily to cities, although this is growing rapidly. Figure 2 - Summary of Current Regional Network Deployment (Scale: * Low; ***** High) Regional Coverage PDC CDMA/ RTT 1X 2G GSM GPRS EDGE TD- SCDMA 3G UMTS HSPA HSPA+ CDMA 2000 EV-DO LTE Asia/Pacific Japan * ** - - - - ***** ***** **** *** *** ** Korea - ** * * * - ***** ***** **** *** ** ** China - ** **** **** **** *** *** *** *** *** *** - Australia/ New Zealand Rest of Asia/ Pacific - ** ***** ***** ***** - ***** ***** ***** ** - * - * ***** ***** *** - **** *** ** * * * Europe - - ***** ***** **** - **** **** *** - - * Latin America - * ***** ***** **** - **** **** ** * * - Middle East & North Africa North America Sub-Saharan Africa - * ***** ***** **** - **** **** ** * * * - **** **** **** *** - **** **** *** *** *** ** - * **** **** **** - *** *** ** * * - Radio Access To protect an operator s network resources and preserve the user-experience for people utilizing those resources, mechanisms have been developed to control which user accesses the network, when, and how this is done. Application developers need to be aware that Radio Access Network (RAN) resources are shared resources and therefore should not be engaged unnecessarily or held open for long periods of times. Excessive signaling due to frequent access to network resources should be avoided whenever possible. Any pre-scheduled (automated) network access should be limited to 4-5 attempts, especially in peak hours, barring any event-triggered attempt. An example of this may be transfer of data from the device (for delay tolerant and benign applications) to the data center; data should be collected and stored on the device and transmitted when it will be used. More frequent data usage, i.e., polling less than every 5 minutes, should be avoided. Radio Coverage The coverage model discussed here anticipates that most of the embedded wireless devices with WAN modules will be used indoors. Initially most 2G and 3G network deployments were designed for outdoor use with the main coverage provided by outdoor macro cells employing antennas placed on towers, poles, and on buildings. When indoor coverage is targeted through outdoor macro cells, in-building coverage comes into picture and will depend on the Building Penetration Losses (BPL), which could vary with 1) type of building construction, 2) 4

number of walls and other openings, and 3) frequency of operation. Cellular operators have realized the importance of indoor coverage and hence significantly improved coverage, exceeding 90%, through the deployment of repeaters, femtocells, picocells, and distributed antenna systems to reach indoor coverage targets with equal reliability. While reliable coverage indoors differentiates one network from another, lack of indoor coverage in prime buildings and areas will become the distinguishing factor among service providers. Capacity/Bandwidth Choosing the correct generation of module is essential to providing the most efficient service. The parameters to be considered are the requirements for bandwidth, which are predicated by the size of the data payload to be transmitted offset against the timeliness of delivery required (latency) and the available coverage for the intended geography of usage. Figure 3 summarizes these parameters across the available generations of technology. An additional consideration to bear in mind is the expected longevity of the module chosen, as some markets are in the process of turning off their original 2G networks. Figure 3 - Summary of Today s Network Generational Characteristics Cellular Network Generation Bandwidth Data Rate* (downlink) Latency Current Coverage (* Low ***** High) GSM 9.6kbps 150-200ms ***** 2G GPRS 40kbps >500ms ***** EDGE 236.8kbps 150-200ms *** CDMA2000 1x 153Kbps/1.25 MHz 200-300ms **** UMTS 384kbps 200-250ms **** 3G HSPA 14.4Mbps 50-100ms **** HSPA+ 42Mbps 20-25ms ** CDMA EV-DO Rev B 14.7Mbps /3.75MHz 60-80ms ** LTE 170Mbps 5-10ms * Efficiency A large number of network parameters and design features impact the efficiency of a cellular network. A few high level considerations that can be influenced by the application engineer are highlighted below. Concatenation All applications should complete all designed data transfers in one active session. Establishing multiple discrete data sessions or radio connections to complete the application s intended data transfer functions is strongly discouraged. Applications should be designed to batch-upload or batch-download data to the fullest possible extent except for individual event-triggered messages or time sensitive information where information from a single event may need to be communicated in a single session. Radio Resource Utilization Applications should make every attempt to reduce signaling and release the RAN resources (radio connection) within a few seconds (e.g., 5 seconds) of the last data transfer. If additional data is expected, 5

the application may keep the radio connection open but not for more idle time than typically required perhaps up to 10 seconds depending the RAN technology employed by the network operator. A keep alive message frequency should be kept to a minimum based on the requirements of the application. Concurrent Network Access Attempts Devices and applications with delay tolerant data should distribute network access attempts over a time range wherever possible and not execute multiple network access attempts either to send or receive data at the same time. Multiple SMS Retries Transmission of a few bytes of episodic data may not justify use of a data channel. An SMS message may be employed for such data. However, there are design considerations in using SMS to transfer data. The SMS Service Centre will send a report (delivery report or failure report) for any SMS message received. After network acknowledgement has been obtained, the SMS network will deliver the message or continue to attempt to delivery of the SMS message (for up to a few days, typically). SMS retries should only be used within this period if a network report acknowledgement has not been received within a few minutes. If a network acknowledgement has not been received, the application should only retry a maximum of five more times. If after five retries a network acknowledgement has not been obtained, the application should update the status as server not reachable and wait for the next scheduled SMS session to retry. Polling Polling devices to obtain data is a common practice for many applications, but it can be very demanding on the network signaling load. Obtaining data through mobile originated data sessions is more efficient than server/host initiated transactions to mobile devices. This can best be accomplished by establishing event triggers in the device application as criteria for establishing a data session. Time based rules can also be used by the mobile device but the host application should be able to suspend connection attempts if the data is not needed. Regardless of how polling is initiated, there are several ways to optimize polling for network and data usage efficiency without affecting data transfers, such as batching together updates in to one request. Latency Applications should take dormancy wake-up times into account when determining the appropriate response timeout period between devices. When sending a message to a mobile device, the application must account for the possibility of variable response times. This scenario is caused by the target device/application being in a dormant state, causing message delivery to have added latency. Once the device wakes up or reacquires an active state, the ensuing message latency will be reduced. The dormancy wakeup timer is around 2-3 seconds and needs to be accounted for in CDMA networks. 6

Figure 4 Average Latencies 2.5G 2.75G 3G UMTS 3G EV-DO 4G LTE End-to-End Average Ping Time (RTT1) Between Network Nodes Performance is based on empirical measurements from commercially available systems. Source: CDMA Development Group; Mobile Broadband Comparison ; March 2008 Device Considerations There are many design considerations when integrating a medical device with an embedded cellular modem. Key considerations include form factor, user interface, device identification, user identification, authentication, provisioning, device management, time synchronization, and choice of codec. The GSMA has published a comprehensive paper providing guidelines for the design and development of embedded devices 2. Form Factor When a cellular modem is included into the device design, the following factors should be kept in mind: Module size can vary significantly depending upon the chosen network technologies chosen. Antenna placement and isolation is important to ensure good signal quality. If the device is worn on the body, the cellular modem should be mounted on the device away from body. Whether or not the battery is shared between the sensor and the modem. User Interface Integration of the user interface requirements for the module and medical sensor will vary depending on the level of user interaction desired for the module. Most likely there should be no need to physically 2 http://www.gsma.com/connectedliving/embedded-mobile-guidelines/ 7

interact with the module. It is typically designed to be configured Over-The-Air to minimize user interaction. The medical sensor should be the controlling factor here, combined with the use of the UICC (SIM card) to control wireless service provision. However, consideration should be given to providing the user the ability to turn the wireless module off completely, as this may be required in certain situations, e.g., when flying or visiting a hospital. Device Identification There are several mechanisms already employed on cellular networks to uniquely identify the wireless device. The unique device identifiers for both medical sensors and wireless modules give a solution provider a choice in how to implement user identity. On mobile networks that use GSM family technologies (GSM, GPRS, 3G, LTE (4G)), the International Mobile Equipment Identity or IMEI is a number used to uniquely identity every device being used on the mobile network. All GSM, WCDMA, and iden mobile phones/devices, as well as some satellite phones are assigned during manufacture a unique identifier within a 64-bit field, which can usually be found printed inside the battery compartment of the phone/device. The IMEI is only used for identifying the device and has no permanent or semi-permanent relation to the subscriber. In CDMA and EV-DO, devices are identified by a globally unique 56 bit long Mobile Equipment Identifier (MEID). Older devices use a 32 bit Electronic Serial Number (ESN), however, ESN number space has been exhausted, prompting the use of the MEID. User Identification There are several mechanisms already employed on cellular networks to uniquely identify the user of the wireless device. These mechanisms can be made available to the application engineer to provide a choice in how to implement user identity. In cellular networks a strongly protected user identity is created that usually equates to the person paying the bill for the device. This user identity is matched to a IMSI (International Mobile Subscriber Identity), which is stored in the SIM card. To address a user, for example when sending an SMS message, the network uses the MSISDN (Mobile Subscriber Integrated Services Digital Network Number) for the message or to verify the user identity to third party applications. It is also used when creating Call Data Records (CDR) for billing purposes. Network Authentication There are several mechanisms already employed on cellular networks to authenticate the wireless device. These mechanisms can be made available to the application engineer to help authenticate the user of the medical device. Every mobile customer is familiar with the experience of turning on their mobile device and being assured that the network recognizes them and will route calls to and from their device correctly. To do this, the network and the device have to establish a trust relationship that can be relied upon. This is done by using encryption algorithms and network generated challenges to the mobile device to make sure the network can be sure that the phone (and more importantly, the phone number and associated subscription) being registered onto the network is who it says it is and is entitled to access the network/service. GSM Network Authentication In order for this to take place on GSM networks, two elements are implemented within mobile connections. One is in the device and is often referred to as the SIM card or correctly called a UICC card. The SIM application on the UICC uses security credentials to generate responses to challenges generated from the network by the second element in the security relationship, the Authentication Centre (AuC). The AuC, which is a core network infrastructure element, holds security profiles for every customer subscribed to the mobile network. When the customer or subscriber needs to be authenticated, the AuC generates security parameters that are used in the challenge to the SIM application on the UICC in the 8

customer s device and also generates the expected result from the SIM application, which is then compared with the result that is returned from the SIM itself. When a successful comparison is achieved a security relationship is established and the subscriber is considered to be authenticated to the network. On the basis of this authentication the activity associated to the use of the device can be assumed to be genuine, and therefore correctly recorded and charged to that users account. CDMA Network Authentication CDMA2000 uses two types of authentication: Global Challenge The mobile authenticates itself to the Base Station each time it sends certain messages. Unique Challenge The Base Station may challenge a mobile to authenticate itself. This is typically done after the Global Challenge fails. The mobile and the Base Station each possess a copy of Shared Secret Data (SSD), which is used in the authentication process. The mobile is assigned an authentication key, called the A-key, when the subscription is activated. The A-key is used to compute the SSD. The SSD is then used in the authentication process. The Base Station may request that the mobile update the SSD. Provisioning Provisioning is the process by which an Embedded Device or a subscriber is enabled with the services required by that device or subscriber (e.g., access to packet data services). This enables subscriptions to be correctly managed, so that customers receive all services that they are entitled to and equally does not receive (and as a result, is not charged for) services to which they do not subscribe. GSM Networks There are two stages to the provisioning process on GSM networks, both of which require integration among Customer Care systems, Provisioning systems, and the Subscription management elements within the mobile operator network: Initial Provisioning When a mobile service is initially set up, both the device and network need to be set up with user credentials to enable access to the network and services. In-Life/Field Provisioning and Updates Once a mobile device has been deployed and in use, it is possible to reconfigure user, service credentials along with device setting. CDMA Networks There are two types of CDMA provisioning: Automatic and Manual. This varies between carriers and even within carriers. A popular automatic option is Over-the-Air Parameter Administration (OTAPA). OTAPA enables operators to reprogram individual devices or send mass parameter updates to devices. OTAPA eliminates the need for subscribers to visit a retail location for manual reprogramming Using Over-The-Air (OTA) methods it is possible to provision, update, and de-provision devices to the mobile network, services, and device configurations using secure protocols, thus enabling remote device management. Device Management Once a device is in the field you often need to manage it remotely so it can function either correctly or better. An example is when a user needs a device firmware update. A user may not have sufficient equipment and knowledge to perform the update actions, but also doesn't want to take the device to a 9

maintenance center. By having a device initiate its own management session, servers can perform the procedure for the user. In the end, device management aims to achieve these important functions: Bootstrap provisioning, remote maintenance, and reporting of configuration data to a device Device diagnostics and fault management Application and non-application software installation, update, and management It was recognized in 2002 that there was a requirement to standardize Device Management, as many proprietary protocols were evolving. To this end, the formation of the Open Mobile Alliance aimed to resolve this and other issues and now issues OMA DM specifications that can be used for device management of wireless devices. Video Codec There are a variety of popular mechanisms for encoding data streams or signals for transmission, storage or encryption, or decoding for playback. At the time of publication Continua Health Alliance was evaluating industry standard codecs for encoding/decoding waveforms and streaming video. Therefore, it is expected that devices will have to support these codecs in order to interoperate with Continua compliant devices. Certification Requirements for device certification vary from market to market. Most markets have regulatory requirements focusing on do no harm covering electromagnetic emissions, immunity, safety, and network harm, as well as sustainability. Major network operators also have requirements to protect their networks by ensuring minimum radio performance and device/base Station interoperability and often look to third party organizations to certify devices meet these requirements. The reader is encouraged to contact network operators in their target markets to understand the latest requirements specific to that region. Finally, Continua Health Alliance offers a certification program to ensure interoperability of Continua compliant devices. Regulatory Regulatory requirements are typically a subset or combination of FCC and EU R&TTE test requirements. Some countries accept FCC and/or R&TTE test reports. Products designed for compliance with FCC and R&TTE regulatory requirements are expected to be able to satisfy regulatory requirements for any countries in the world. Regulatory approvals can be completed by working directly with a regulator or working with third party approval agency. Third party approval agencies specialize in regional regulatory approvals and should be contacted for additional information, test requirements, and formal certification assistance. An additional source of information is the GSMA publication on this topic 3 Federal Communication Commission (FCC) Regulatory Requirements Manufacturers who wish to sell telecom, licensed RF, and low powered transmitters in the United States must have their products tested by FCC listed or accredited laboratories and certified by the FCC for EMC/Telecom compliance. In the United States cellular devices are subject to Part 15 federal regulation that sets limitations on the amount of electromagnetic interference permitted. Figure 5 - Regulatory Requirements in Europe are Governed by European Commission - Radio & Telecommunications Terminal Equipment (R&TTE) Country Regulatory Body Abbreviation Regulatory Body Brazil ANATEL Agencia Nacional de Telecomunicacoes do Brasil Canada IC Industry Canada 3 http://www.gsma.com/connectedliving/gsma-understanding-medical-device-regulation-for-mhealth-report/ 10

Country Regulatory Body Abbreviation Regulatory Body China SRRB State Radio Regulation Bureau Egypt NTRA National Telecom Regulatory Authority European Union R&TTE (CE) European Commission - Radio & Telecommunications Terminal Equipment (R&TTE) India TRAI Telecom Regulatory Authority India Indonesia POSTEL Direktorat Jenderal Pos dan Telekomunikasi Mexico COFETL Federal Communications Commission Mexico Philippines NTC National Telecommunications Commission Russia Saudi Arabia Thailand MIC CITC NTC Ministry of Information Technologies and Communications Gosstandart of Russia Communications and Information Technology Commission Notification of the National Telecommunications Commission (NTC) United States FCC Federal Communications Commission Vietnam MIC Ministry of Information and Communication Specific Absorption Rate (SAR) Specific absorption rate (SAR) is a measure of the rate at which energy is absorbed by the body when exposed to a radio frequency (RF) electromagnetic field. It is defined as the power absorbed per mass of tissue and has units of watts per kilogram (W/kg). The Federal Communication Commission (FCC) specifies SAR limits for mobile devices within the U.S. while the European Committee For Electro-technical Standardization (CENELEC) specifies SAR limits within the EU. Radios and Protocols There are three independent organizations that certify devices meet minimum radio performance and signaling conformance requirements as agreed to by network operators and wireless device manufacturers worldwide. These organizations are the Global Certification Forum (GCF), the CDMA Certification Forum (CCF), and the PCS Type Certification Review Board (PTCRB). The GCF certifies devices using radios and protocols as defined by the 3rd Generation Partnership Program (3GPP), which are deployed by the majority of network operators around the world. The CCF certifies devices using radios and protocols as defined by the 3rd Generation Partnership Program 2 (3GPP2), which are deployed primarily by network operators across North America and Asia. The PTCRB certifies 3GPP-based devices targeted for the United States market. Network operators in the most price-sensitive markets around the globe may not require third party certification but likely have some acceptance criteria. Many network operators around the globe require terminal device to undergo, in addition to third party certification, their specific network entry (also named acceptance criteria) before they are part of their offering. The reader is encouraged to contact network operators in their target market for certification and acceptance requirements. Interoperability The Continua Health Alliance looks to the aforementioned third party organizations to ensure radio level performance. However, GCF, CCF, or PTCRB certifications only ensure device connectivity to the cellular network. Continua employs its own certification program to ensure Continua compliant devices interoperate with one another given IP connectivity. The reader is directed to the TCWG Test and Certification Plan to learn the overall testing strategy, approach, and testing detail for the PAN, Sensor-LAN, WAN, and HRN interfaces. 11

Appendix Glossary Term Description 3GPP 3rd Generation Partnership Project 3GPP2 3rd Generation Partnership Project 2 A-Key Authentication Key AuC Authentication Centre BPL Building Penetration Losses CCF CDMA Certification Forum CDMA Code Division Multiple Access CDR Call Detail Record CENELEC European Committee for Electrotechnical Standardization CS Domain Circuit Switched Domain DL Download EDGE Enhanced Data rates for GSM Evolution Embedded Device A device with a cellular modem physically embedded EMC Electro Mechanical ESN Electronic Serial Number EV-DO Evolution-Data Optimized or Evolution-Data Only FDD Frequency Division Duplex FDMA Frequency Division Multiple Access GCF Global Certification Forum GMSK Gaussian Minimum Shift Keying GPRS General Packet Radio Service GSMA Global System Mobile Alliance HOM High Order Modulation HRN Health Records Network HSPA High Speed Packet Access IP Internet Protocol LAN Local Area Network LTE Long Term Evolution M2M Machine to Machine MEID Mobile Equipment Identifier MIMO Multiple In Multiple Out MPEG Motion Picture Expert Group OFDMA Orthogonal Frequency Division Multiple Access OTA Over The Air OTAPA Over The Air Parameter Administration OVSF Orthogonal Variable Spreading Factor PAN Personal Area Network PS Domain Packet Switched Domain 12

Term Description PTCRB PCS Type Certification Review Board QAM Quadrature Amplitude Modulation QPSK Quadrature Phase Shift Key RAN Radio Access Network SAR Specific Absorption Rate SC-FDMA Single Carrier Frequency Division Multiple Access SIM Subscriber Identity Module SMS Short Message Service SSD Shared Secret Data TAN Touch Area Network TCWG Test and Certification Working Group TDMA Time Division Multiple Access UICC Universal Integrated Circuit Card UL Upload WAN Wide Area Network WCDMA Wideband Code Division Multiple Access WCDMA R99 Wideband Code Division Multiple Access Release 99 WWAN Wireless Wide Area Network Authentication The process by which a mobile confirms its identity to the Base Station. Wireless Technology Evolution in Figures 1 GSM Mainly 900/1800 MHz and other frequency bands, also available in 800/1900 MHz bands 200 khz/frequency Ch with 4/12 Frequency Reuse(FR) Terminals and power: 8 power classes; in 20 mw to 5W Modulation and peak data rates: GMSK (constant envelope) and 9.6 kbps max Duplexing and Multiple Access: FDD (max 124 RF Channels) with TDMA/FDMA - 8 slots/rf Ch Traffic Types: voice (not applicable to M2M) and data (SMS, CS): 160 7-bit characters: useful for device wake-up and 9.6 kbps for CS 1a GPRS/EDGE 200 khz/ Frequency Ch with 3/9 and 4/12 FR (GPRS) and 1/3 FR for EDGE Modulation GMSK/8PSK Peak data rates: DL/UL (4+1) 80/20 kbps and 236/60 kbps 2 CDMA 2000(1xEV-DOrA) 450/800/900/1800/1900 frequency bands 1.25 mhz/frequency Ch with 1/1 FR Terminals and power classes: 4 power classes: min 200 mw to 2 W? Modulation and peak data rates: 1x BPSK and 153 kbps Modulation and peak data rates: EV-DOrA QPSK/16-QAM and 3.1 mbps (DL)/1.8 mbps (UL) 13

Duplexing and Multiple Access: FDD and CDMA/FDMA for 1x Duplexing and Multiple Access FDD and TDMA/FDMA for EV-DOrA Traffic types: 1x voice (not applicable to M2M) and data (CS /SMS and PS max 153 kbps) Traffic Types: EV-DOrA PS data only (3.1/1.8 mbps max) 3 WCDMA (R99) 850/1900 mhz/2.1 ghz and other frequency bands Modulation QPSK with WCDMA envelope using OVSF 5mHz frequency Ch and 1/1 FR Voice and data/sms/cs and PS (384 kbps max) Duplexing and Multiple Access: FDD and CDMA/FDMA Traffic Types Conversational Class: voice, video telephony, gaming: some application in M2M Streaming Class: multimedia, video on demand, webcast: some applications in M2M Interactive Class: web browsing, network gaming, etc.: M2M use in control and monitoring apps Background Class: email, SMS, downloading, etc.: wide range of M2M apps 3b HSPA and HSPA+ Same frequency bands as WCDMA R99 and FDD with either frequency channel sharing of different frequency channel Higher order modulation: 16-QAM and 64-QAM (HSPA+) in addition to QPSK PS data only 14.4/3.6 mps (HSPA) and 26/11 mbps (HSPA+) HSPA+ can also use 2x2 MIMO in addition to 64-QAM 4 LTE (Release 8) Several frequency bands (24 bands in FDD and 8 bands in TDD) Uses 1.4/3/5/10/15/20 MHz RF Ch bandwidths in the above bands OFDMA in DL and SC-FDMA in UL HOM (64-QAM) with 4x4 MIMO in DL DL/UL peak data rates depending on RF bandwidths, max being 100 Mbps (DL)/50 Mbps (UL) Packet data network only CS (SMS) with 3G 14

Legal Use of the information contained herein shall be governed solely by the terms and conditions of the Continua Health Alliance Bylaws. The document and information contained herein is not a license, either expressly or impliedly, to any intellectual property owned or controlled by any of the authors or developers of this specification. The information contained herein is provided on an AS IS basis, and, to the maximum extent permitted by applicable law, the authors and developers of this specification as well as the Continua Health Alliance hereby disclaim all other warranties and conditions, either express, implied or statutory, including but not limited to, any (if any) implied warranties, duties or conditions of merchantability, of fitness for a particular purpose, of accuracy or completeness of responses, of results, of workmanlike effort, of lack of viruses, of lack of negligence or on non-infringement. Continua is a trademark of Continua Health Alliance and CONTINUA HEALTH ALLIANCE and the CONTINUA HEALTH ALLIANCE logo are registered service marks of Continua Health Alliance. *Other names and brands may be claimed as the property of others. Copyright 2012 Continua Health Alliance. All rights reserved. 15