A Survey on Wireless Wearable Body Area Networks: A Perspective of Technology and Economy
Abstract
:1. Introduction
1.1. Research/Survey Methodology
1.2. What Questions Does This Survey Answer?
- 1.
- What is a wireless wearable body area network and its communication architecture?
- 2.
- What sensors are used in Wearable Wireless BANs, and what end products and solutions are available in the market?
- 3.
- What are the potential wireless technologies used to develop WWBANs, and what security threats and control measures are available?
- 4.
- What does the future hold, and what major challenges do the wireless wearable body area devices have to face?
- 5.
- What are the major projects and research directions in this area?
1.3. Contributions
- 1.
- During our study on WBANs, we found that a majority of the reports focus on only a particular set of viewers as discussed above.
- 2.
- The present article addresses maximum perspectives of wireless wearable body area networks such as architecture, components, sensors, devices, health systems, wireless technologies, security concerns, projects, regulations, and most important, and Compound Annual Growth Rate (CAGR).
- 3.
- A special section is added in this survey that focuses on the emerging WBAN technologies, such as energy harvesting, human body communication, quantum computing, graph neural networks (GNN), artificial intelligence (machine and deep learning), blockchain, and digital twins. Such a section is rarely seen in surveys or review articles.
- 4.
- Since the article is interdisciplinary, technical terms of a particular field are briefly explained on the spot so that a specialist of one field may understand the concepts of another without repetitive switching from this article to another.
2. WBAN Technical Issues
2.1. WBAN Architecture
Components
2.2. Types of Sensors
2.2.1. Type-I Implantable
2.2.2. Type-II Ingestibles
2.2.3. Type-III Injectables
2.2.4. Type-IV Patchable: Body Surfaced/Patched
2.2.5. Type-V Proximity-Based Devices
2.2.6. Type-VI Textile Structured Devices
2.3. Wireless Technologies
2.3.1. NFC
2.3.2. ANT
2.3.3. RuBee IEEE 1902.1
2.3.4. Sensium
2.3.5. Zarlink
2.3.6. Z-Wave and Insteon
2.3.7. Bluetooth Classic
2.3.8. Bluetooth Low Energy (BLE)
2.3.9. Zigbee
2.3.10. Ultra-Wideband (UWB)
2.3.11. LORA
2.3.12. WBAN IEEE 802.15.6
2.3.13. WiFi
2.3.14. Cellular
2.4. Application of Wearable WBANS
Vital Sign Monitoring
- 1.
- They use sensors to determine heart beat rate, walking or running steps and number of calories burned.
- 2.
- These devices can be connected to a computer, laptop, or mobile to communicate the results wirelessly.
2.5. WBAN Security Issues
2.5.1. Major Security Requirements
- 1.
- Device Authenticity: This is a very critical issue. Adversaries can implant a malevolent node in a non-line-of-sight (NLOS) location that can inject fake data and even receive legal data while acting as a legal device [128]. Thus, it is very important to validate the authenticity of the BAN devices that they claim to be [129].
- 2.
- Confidentiality: Confidentiality ensures that the information should not be disclosed to unauthorized entities while moving from wearable WBAN source to destination [130]. However, due to the open and broadcast nature of WBAN transmission, the data can be eavesdropped and disclosed to an unauthorized party. Therefore, it is always advised to encrypt data before transmission [128].
- 3.
- Integrity: It claims that information must reach the destination in its original form as was sent by the body-worn or wearable WBAN source; it must not be altered during its transfer. Due to the free-flying of wireless BAN frames, they can be intercepted and tampered with by the attacker, which may harm the health system or even the patient’s life [128,130]. That is why it is required to ensure the integrity of data using some message authentication techniques such as hashing or CRC. They ensure the data are not modified during the transition from one BAN device to another.
- 4.
- Availability: One of the most disturbing attacks is DOS (Denial of Service), which is launched against a body controller unit, cloud server, or medical server. Thus, the attack can even cause a shutdown of medical services, which may impose serious life threats on patients [128,130]. For ensuring life safety and timely treatment of the patient, health network communication systems must be available whenever a WBAN source is required to send data.
- 5.
- User Authentication/Authorization: In remotely controlled healthcare WBAN systems, only the authentic and authorized medical staff members must be able to access the data of a particular patient. User authentication can be established using well-informed mechanisms, such as username/password, PINs, fingerprints, etc. Similarly, a proper access control mechanism (e.g., Access Control Lists) must be devised to ensure authorized access to data [129].
2.5.2. Importance of Security
2.5.3. Technical Approaches
TinySec Security Solution
ECC
Biometric-Based Security Solution
Encryption
2.5.4. Wireless Security Fixes
ANT/ANT+/ANT+S
RuBee IEEE 1902.1
Sensium
Z-Wave
Zarlink
Insteon
LR-WPANs IEEE 802.15.4 Security Services
WBAN IEEE 802.15.6 Security
ZigBee Security Services
BLE Security
Bluetooth Security Protocols
- 1.
- Non-secure: No security.
- 2.
- Service-level enforced security mode A non-secure ACL (Asynchronous Connection Link) can be established using this mode. Security functions run only after the L2CAP connection-oriented or connection-less channel request is placed.
- 3.
- Link-level enforced security mode Security primitives are started before making any request for a channel is initiated and the ACL link is established.
- 4.
- Service-level enforced security mode (SSP) This is similar to service-level enforced security mode; the only difference is that only the Bluetooth devices that use secure simple pairing (SSP) can be set in this mode.
802.11 Security
3. WBAN Economical Issues
3.1. WBAN/Wearable Compound Annual Growth Rate
3.2. WEARABLE/WBAN Regulatory for Body
3.3. WEARABLE/WBAN Feasible Projects
4. Open Issues
4.1. Research Challenges
4.1.1. Security vs. Efficiency
4.1.2. Security vs. Safety
4.1.3. Security vs. Usability
4.1.4. Device Interoperability
4.1.5. Device Authentication
4.1.6. Secret Key Acquisition
4.1.7. Strict Regulations
4.2. Research Directions
- 1.
- Global RF Design: The Radio Frequency of the Wireless Wearable BAN must be such that the devices can operate in any part of the world because it is observed that some wireless channels are allowed to operate in the USA but not in other parts of the world or some channels are used in one part of the world but not in other. Thus, RF design must be able to cope with heterogeneous wearable BAN devices [38].
- 2.
- Performance: Other high-power ISM wireless devices operating in the surrounding may degrade the performance of low-power wearable and WBAN devices making them less attractive and appealing for high-quality medical and healthcare applications. For instance, Wireless Medical Telemetry Service (WMTS) frequency bands are extensively being used, but unfortunately, their use is limited to healthcare applications in the USA. Moreover, UWB is a good candidate technology for wireless wearable devices, but at the same time, it is badly affected by the interference of the co-existence of high data rate applications such as wireless multi-media.
- 3.
- 2360–2400 MHz Band: Federal Communication Commission (FCC) has opened the 2360–2400 MHz band for medical WBAN. It is believed that the band will be used to devise an artificial nervous system to reinstate sensation and mobility and regain the functionality of paralyzed limbs and organs. However, the devices based on this medical WBAN frequency band are required to test and validate against the FCC health-related rules and regulations [231]. Therefore, designing devices that exactly meet the FCC regulations is also one of the great challenges.
- 4.
- Channel Model Design: Another research challenge is the designing of the RF channel model because it plays an important part in the designing of PHY (Physical Layer) technologies. PHY is an abbreviation of the Physical Layer of TCP/IP or OSI Model. PHY is implemented to connect the MAC layer with the physical medium; in this, it is a wireless Radio Frequency (RF). PHY consists of RF, Transceiver, DSP (Digital Signal Processor), communication protocol, and channel codes. PHY is integrated with MAC in SOC (System on a Chip) technology. Examples of wireless PHY are 3G, 4G, LTE, WiMAX, and UWB.
- 5.
- Radio Antenna Design: Designing an antenna for wireless wearable BAN devices is also very critical due to restrictions on size, shape and choice of material [232,233]. Since the devices are wearable, patched on the body or implanted inside the body, the size of these antennae must be miniaturized. Designers do not have too many choices for the shape of antennae; it is the organ that puts restrictions on the shape. The material that can be used to design antennae should be harmless for the human body such as titanium or platinum. However, antennae made of such material result in low performance when compared with the antennae made up of copper.
- 6.
- Physical Layer Protocols: Physical layer protocols of wearable and BAN devices must assure low power consumption without compromising reliability, connectivity, throughput and turnaround time [5,38]. Fast wake-up from sleep mode and speedy turnaround time can significantly save the power of wearable/WBAN devices. Presently, energy efficiency is being achieved through duty cycling, but researchers are endeavoring to find new ways of energy saving such as low-power listening harvesting [234].
- 7.
- MAC Design: It is always required to have a wearable BAN MAC (Medium Access Control) layer that should be resilient to interference experienced due to the co-existence of multiple WBANs in crowded areas such as hospitals. MAC layer protocols should be adaptable to frequent topology changes. Moreover, MAC protocol of the WBAN should be able to switch to a silent channel in the case of severe interference due to the co-existence of similar networks operating in the surrounding using the same frequency band [38].
4.3. Emerging Techniques in WBAN
4.3.1. Human Body Communication (HBC)
4.3.2. Energy Harvesting
4.3.3. Quantum Computing
4.3.4. Graph Neural Networks (GNN)
4.4. Artificial Intelligence: Machine and Deep Learning
4.4.1. Blockchain
4.4.2. Digital Twins
5. Conclusions and Future Work
- 1.
- Wireless wearable BAN devices are one of the marvelous inventions in human history that improves the apex quality of human life.
- 2.
- There is great investment potential in the global industry of wireless body area networks that have also been observed from the different CAGR values reported in many global market analysis reports.
- 3.
- On the other hand, a lot of work is still required to make those devices whose manufacturing ingredients involve radio or electromagnetic waves and frequencies safe for the living body cells and tissues.
- 4.
- Wireless body area networks consist of very low-resource devices, which is why it is demanded that communication and security protocols must be light in computation, storage, and transmission because these factors are directly linked with the lifetime of BAN nodes as they are battery powered.
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Sensor | Implantation | Observation |
---|---|---|
Guardian Real-time | inside the body | Sugar |
MiniMed 530G with Enlite | wearable, injectable | Sugar |
FreeStyle | inside the body | Sugar |
Eyeglasses biosensor | body-worn | Sugar |
Eyeglasses biosensor | body-surface | Sugar |
Guardian Real-time | inside the body | Sugar |
IFever | body-worn | Temperature |
ISense | body-worn | Temperature |
Ran’s Night | body-worn | Temperature |
FeverFrida thermometer | body-surfaced | Temperature |
STEMP sensor | body-surfaced | Temperature |
Aranet medical thermometer | body-worn | Temperature |
Propeller | body-worn | Asthma |
AirSonea | body-worn | Asthma |
Wing | body-worn | Asthma |
BH1790GLC | body-worn | HR |
TCRT 1000 | body-worn | HR |
Smart QHeart Rate Sensor | body-worn | HR |
Polar H10 | body-worn | HR |
Pulse sensor | body-worn | HR |
MPU-9250 Invensense | body-worn | Motion |
MMA 8451Q, accelerometer | body-worn | Motion |
LSM 303 DLHC | body-worn | Motion |
BNO055 | body-worn | Motion |
MPU-9250 Invensense | body-worn | BP |
Biosignals plux | body-worn | BP |
Proven BPM-337BT | body-worn | BP |
Omron M7 Intelli IT | body-worn | BP |
Scheme | Standard LoRaWAN | Improved DO-SEO [85] |
---|---|---|
Mutual Authentication | ✓ | ✓ |
Secure Key Exchange | ✓ | ✓ |
Perfect Forward Secrecy | ✓ | |
End-to-End Security | ✓ | |
Thwart Replay Attack | ✓ |
Protocol | Distance Range | Data Rate | Power Consumption | Frequency Band | Suitability |
---|---|---|---|---|---|
ANT (from Garmins) | 100 m outer door | 1 Mbps | 15 mA Tx 17 mA Rx | 2.40–2.483 GHz | used in sports, fitness and health devices |
RuBee (IEEE 1902.1) | 30 m | 9.6 k | emits energy in nanoWatts, battery lasts for many years | operates below 450 kHz | considered to be a strong contestant for WBAN application |
Insteon | 30 m | 9.6 k | Battery life is 10+ years | operates below 450 kHz | considers being a good protocol for WBAN applications |
Sensium | home area | 13 k | 5 days | 131.65 KHz, 902–924 MH | extensively used in health care and diagnostic application, worthy of medical implanting cases, gastrointestinal [74]. |
Bluetooth Classic (IEEE 802.15.1) | 100 m | 1–3 Mbps | 2.5–100 mW | 2400–2483.5 MHz range within the ISM 2.4 GHz frequency band | used in different area of tele-medicine and e-health systems, but unfit for WBANs [70]. |
BLE (Bluetooth 4.2) | 50–150 m | 1 Mbps | 10 mW | 2.4 GHz | But, not suitable for frequent and steady reporting of health parameters [70]. At the |
IEEE 802.11 | 150–200 m | 54 Mbps | 1 W | 2.4 GHz (WiFi), 5 GHz | encouraging wireless technology for WBANs [70] |
Zigbee 3.0, 802.15.4 | 10–100 m | 250 kbps | 35 mW | 2.4 GHz mostly; though some devices use 784 MHz (China), 868 MHz (Europe), 915 MHz (USA, Australia) | unsuitable for critical WBAN application which are required to carry urgent data without delays [70]. |
LoRa (LoRa Alliance) | urban 2–5, suburban 15, rural 45 | 0.3–50 kbps | (customizable), battery life more than 10 Years | 169 MHz, 433 MHz, 868 MHz (Europe) and 915 MHz (North America) | used as LPWAN [88] |
NFC (ISO/IEC 18000-3) | 10 cm | 106, 100–420 kbps | 15 mA or less | 13.56 MHz | smart suits, jackets, jewelry, wrist worns, e-skin, [49] |
Z-wave | 30 cm | 106, 212 or 424 kbps | it uses 23 mA in transmission mode, battery lasts for decades even | 900 MHz (ISM), (Z-Wave Alliance ZAD12837/ITU-T G.9959) | considered to be a good protocol for WBAN applications [74]. |
SigFox | 2–5 (urban), 15 (suburban), 45 (rural) | 10–100 kbps | battery life more that 10 years | 433/868/780/915 MHz | used as LPWAN, no mobility and location support [88] |
NBIoT | 2.5–5 km | more than 250 kbps | battery life more than 10 years | Cellular (Licensed Band) | used as LPWAN, needs GPS for location support, mobility [88] |
LTECatM1 | 2.5–5 km | 1 Mbps | battery life more than 10 years | Cellular (Licensed Band) | used as LPWAN, needs GPS for location support, supports mobility [88] |
WBAN (802.15.6) | suitable for short-range human body communication | MICS (75–455, 75–187, 101–607), (101–607) Mbps, (121–971) | 0.1 W | MICS (402–405, 420–450, 863–870), ISM1 (902–928, 950–958), ISM2 (2360–2400, 2400–2483.5) | Most of the medical, non-medical, and on-body WBAN devices have adopted this standard for communication, support for location and mobility |
Product | Project | Product Type | Features |
---|---|---|---|
Life- BEAM | LifeBEAM | Helmet | Monitors beating heartrate using optical sensor |
Combat- Connect | The Army’s Program Executive Office | Wearable electronics system | disseminate information to/from WBAN using smart hub fixed with military vest/jacket |
Black Hornet | 3 FLIR SYSTEM | Automatic Pocket-sized helicopter | camera that can be fixed with armor/vest; works as elevated binocular |
Ground Warfare Acoustical Combat System | Gwacs Defense | A wearable tactical system | Identifies and locates hostile fire; detects and tracks Small UAVs |
Exo- Atlet | ExoAtlet | Lower body powered exoskeletons | Mobility assistant, reduce troop’s movement cost |
SPaRK | Spring Active | Energy-scavenging exoskeletons | Performs energy harvesting to recharge devices |
Monitoring Device/System | Vital Signs | Provider | Ref. |
---|---|---|---|
Visi Mobile System | It is (Continuous Beat-by-Beat Blood Pressure) CNiBP, Non-Invasive Blood Pressure (NiBP), ECGs, Respirations, HR, PR, SPO2, Motions and Postures. Visi Mobile System continuously leveraging on hospital’s existing WiFi infrastructure Sotera Wireless | Sotera Wireless, Inc. | [98] |
Mobile Cardiac Outpatient Telemetry (MCOT) Patch System | MCOT collects medical information using Bluetooth from sensors, transmits ECG wirelessly to BioTel Heart all the time | Bio-Tel Heart | [99,100] |
MCT 3 Lead (MCT 3L) Cardiac Telemetry | LifeWatch MCT 3 is very smart in nature, giving a distinct picture of the heart in addition to the rhythms of a heartbeat. | Bio-Tel Heart | [99] |
ePatch Extended Holter Monitoring | Records and stores heartbeats | Bio-Tel heart | [99] |
wEvent | Wireless Cardiac Event Monitor, wEvent supports arrhythmia detection with high precision | BIO-Tel Heart | [99] |
Wireless Connector for BPA-060 | Wireless Blood Pressure Monitor | Ambio Health | [101] |
Wireless Connector for Presto | Blood Glucose Monitor | Ambio Health | [101] |
WiCap | Capnography device, monitors expired (EtCO2), inspired (FiCO2) breath, respiration rate (RR), SpO2, and pulse rate (PR) | Athena GTX | [102] |
Tac Pac | Measures NIBP, HR, SpO2, and ECG | Athena GTX | [102] |
Athena Device Management Suite (ADMS) | ADMS connects different wireless vital-sign monitoring devices and is also adaptable to mobiles and smartphones, alarming, awareness, etc. | Athena GTX | [102] |
Wireless Vital Signs Monitor | Wirelessly monitors Sp02, HR, NIBP, and ECG within a range of 200 yards, ADMS compatible | Athena GTX | [102] |
Caretaker | measure CNiBP, Heart Rate, and other vital signs, android compatible | Caretaker Medical | [103] |
SmartSense | Temperature, blood pressure, pulse, SpO2, respiration, pain level, SMD, etc., via any mobile PC, draw plots of vital signs | Cadi Scientific Pte Ltd. | [104] |
HealthPatch/Vital Patch, Vista Solutions | Health monitoring system, which can measure HR, RR, temperature, posture, activity, and fall detection | Vital Connect | [105] |
Fitbit Premium+Health | It is a personalized health monitoring system that helps a person manage stress, have a sound sleep, and stay active. It provides a daily score of these signs. Users can download their data at any time | Fitbit LLC. | [106] |
Garmin Connect | Garmin Connect can track, analyze and share your health data on mobile or web | Garmin Ltd. | [107] |
Samsung Health | Galaxy smartwatch-based health solution that scores sleep and blood oxygen during sleep. It can also detect snoring and monitor running performance | Samsung Ltd. | [108] |
Apple Health Kit | It assesses the steadiness of walking, falling probability, and goodness of sleep that help helps to assess changes in health. The health data can be shared with concerned people | Apple | [109] |
Wireless Implantable Cardioverter and Defibrillators | Cardioverter and defibrillators give weak and strong electrical shocks to the heart to maintain rhythm and beating. FD approved such devices a long time ago [110,111]. Each manufacturer has introduced its remote monitoring system, pacemakers and ICDs, such as Home MonitoringTM, CareLink NetworkTM, Latitude Patient Management systemTM, and Merlin.netTM (St Jude Medical, Sylmar, USA). [112] | Biotronik, Medtronic, Boston Scientific, Merlin.net | [113,114,115,116] |
EEG, ECG, EMG, EOG, EGG monitoring devices such as Bittium FarosTM—Cardiac Monitoring | These devices can measure ECG, EMG, EEG, etc., TSE Systems, Lepu Medical Technology, Bittium Corporation, BIOPAC Systems, Inc. are major providers. Stellar Implants, NEO ECG, and Mobita are also good monitoring systems | Fabric-embedded devices available at [117] | [118,119,120,121] |
Parameters | Normal Range |
---|---|
Body Temperature | 37–37 Degrees Celsius |
Hear Beat | Rate 60–100 beats per minute |
Breathing Rate | 12–20 breaths per minute |
Oxygen Saturation | 94–99% |
Blood Sugar | 4–6 mmol/dL (72–108 mmol/dL) |
Blood Pressure | 120/80 |
Hydration level | 90–100% |
Fall Detection | 0–20 cm |
Security Issues | Secure System Requirements | Potential Security Measures |
---|---|---|
Illegitimate access to information | Dynamic secure key agreement and trust establishment | Random ephemeral key generation and distribution, use of public key cryptography |
Information Disclosure | Confidentiality and privacy | Link/network layer encryption and access control |
Data Modification | Integrity and authenticity | Keyed secure hash function and Digital signature |
Denial of Service | Availability | Intrusion detection systems and redundancy |
Compromised/Hijacked Node | Cryptosystem must be resilient to node-compromise | Anomaly detection, comprising nodes isolation |
Routing vulnerabilities | Protection of routing information | Use of secure routing algorithms |
Intrusions/Unauthorized Access to Network System | Intrusion detection and prevention, secure data aggregation, group communication and management | Intrusion detection and prevention systems |
Protocol | Security Risks | Proposed Control Measures |
---|---|---|
ANT | by default ANT+ is not encrypted, AES128 support in special cases, provided in single channel communication only, lack of authentication, MITM [137]. | network key along with network number provides different options for access control and security level [137,138] |
Rubee | no eavesdropping, high packet security due to date and time stamp [139]. | eavesdropping range is similar to that of tag range; such a close eavesdropper can be detected easily, it meets a high standard of security also being used in many US Govt. owned departments [139] of USA |
Sensium | Sensium is vulnerable to all those attacks, launched on body sensor networks, such as insider attacks, DOS, wormhole, replay, jamming, etc. [140] | per hop encryption can reduce the chances of attacks, also reduces overload over the network as well [140] |
Zigbee | insufficient integrity protection due to sending unencrypted key; location privacy, an initialization vector (or Nonce), and key management are susceptible to high-security risks; improper support of group keying [141]. Due to default weak password, misconfiguration of the Zigbee IP network, and the gateway or lack of security an attacker can bypass Zigbee authentication check [142]; replay attack, device identification attack, and packet interception are a few of the other ones [143] | time stamping, AES, and Message Integrity Codes (MIC) can be used to mitigate the risks [143]. In addition to this, since the security keys are stored in memory, adversaries can directly steal them. Therefore, it is advised to use a microcontroller for secure authentication and to eliminate the threat of physical corruption of security keys [144]. |
Bluetooth | intrusion in pico-net, MITM (Man-in-the-Middle)/Impersonation, DOS attacks, Bluejacking [142,145]. A few other reported attacks are MAC-spoofing, PIN cracking, BlueSnarfing, BlueBugging, BluePrinting, Blue over, off-line PIN recovery attack, brute-force, reflection, backdoor, Cabir worm, Skulls worm, and Lasco worm [146]. | use long PIN Codes, do not pair in public areas, and turn on non-discoverable mode after use, at the corporate level proper policies and guidelines be devised for Bluetooth pairing [145] |
WiFi | cipher attack is used to attain the encryption key through processing information exchanged between sender and receiver. WEP, WPA-PSK Dictionary, WPA/TKIP, and LEAP are a few of the cipher attacks. WiFi also faces, jamming, flooding, evil-twin threats [142,147] | separating the guest network from actual, encrypting traffic with WPA2 or WPA3, updating firmware timely, creating secure SSID, restricting WiFi to business hours only, all these measures can mitigate the attacks on WiFi [148]. |
LORA | attacker can obtain access to physical LORA device, jamming-communication channel can block with the high power radio signal, replay, beacon synchronization, traffic analysis, MITM are a few threats to LORA [84]. DOS, Bit-flipping, ACK spoofing. LoRa vulnerability survey can be viewed from [149,150]. | dynamic or ephemeral key generation, DevNonce of large size can prevent join attacks [151], Block-chain is also good for powered limited devices [88]. Use Over-The-Air-Activation (OTAA) [150] |
NFC | eavesdropping, cloning of ticket, spoofing, a man in the middle attack, corruption of data, insertion of malicious data, relay, ghost and leech, DOS, phishing, a threat to ID, PIN, credentials of credit card, etc. | shared secret keys, certificate-based authentication WEP based security can be used to reduce the probability of these attacks [73] |
Z-Wave | Z-Wave device pairing process with the controller can run many times, which attracts “key reset attack” [142,152] | vulnerability has not been fixed, more than one million devices are in the market with this vulnerability [152] |
WBAN | Key-Compromise Impersonation (KCI), Impersonation, WBAN security protocols do not forward secrecy as well [153] | using certified keys KCI can be avoided, but it is not recommended in standards due low resources of WBAN devices [153] |
Regulatory Body | Year and Location | Members | Comments |
---|---|---|---|
WHO [199] | 1948, Geneva (Switzerland) | Globe is a member of the Word Health Organization (WHO) | Looks into global health concerns. https://www.who.int/, Accessed on: 14 April 2022 |
Global Harmonization Task Force (GHTF), its website is ceased, visit [200] | 1992, USA | USA, European Union (EU), Japan, Australia and Canada, AHWP, International Organization for Standardization (ISO), and the International Electrotechnical Commission (IEC) | Volunteer, the original group of people from MDR formed it for the regulation of medical. GHTF was replaced by International Medical Device Regulators Forum (IMDRF) in 2012 with the aim build a strong foundation of GHTF. https://iris.paho.org/bitstream/handle/10665.2/51549/PAHOHSS19003_eng.pdf, Accessed on: 14 April 2022, https://www.adb.org/sites/default/files/publication/184392/better-regulation-medicine.pdf, Accessed on: 14 April 2022, https://pdf.usaid.gov/pdf_docs/PA00TPBN.pdf, Accessed on: 14 April 2022 |
IMDRF [200] | 1911, NA | Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea, USA | Successor of GHTF |
ISO [201] | 1947, Geneva Switzerland | 163 countries are members International Organization for Standardization (ISO) | largest organization in the world for formulating standards https://www.iso.org/home.html, Accessed on: 14 April 2022 |
Emergency Care Research Institute (ECRI) [202] | 1968, Pennsylvania USA | USA, European Free Trade Association (EFTA), But USA and Canada mutually developed Universal Medical Device Nomenclature System (UMDNS) | ECRI maintained UMDNS, the development of Asian Medical Device Nomenclature System (AMDNS) is also based UMDNS https://www.ecri.org/, Accessed on: 14 April 2022 |
APEC [203] | 1989, Singapore | Australia, Brunei Darussalam, Canada, Indonesia, Japan, Korea, Malaysia, New Zealand, the Philippines, Singapore, Thailand, USA, China, Hong Kong, Chinese Taipei (Taiwan), Mexico, Papua New Guinea, Chile, Peru, Russia and Vietnam | Asia-Pacific Economic Cooperation (APEC) provides forum for free trade among member countries https://www.apec.org/, Accessed on: 14 April 2022 |
Asian Harmonisation Working Party (AHWP) [204] | 1996–97, Hong Kong (Asia) | Abu Dhabi (UEA), Brunei Darussalam, Cambodia, Chile, China, Chinese Taipei (Taiwan), Hong Kong SAR, India, Indonesia, Jordan, Saudi Arabia, Korea, Laos, Malaysia, Myanmar, Pakistan, Philippines, Singapore, South Africa, Thailand, and Vietnam | It ensures the regulation of medical devices in Asia, now working on Safety Alert Dissemination System. http://www.ahwp.info/, Accessed on: 14 April 2022 |
Association of Southeast Asian Nations (ASEAN) [205] | 1967, Jakarta (South Asia) | Bangkok, Indonesia, Malaysia, Philippines, Singapore, Thailand, Brunei Darussalam, Vietnam, Laos, Myanmar and Cambodia. Within ASEAN The Medical Device Product Working Group (MDPWG) is responsible for the regulations of medical devices. | The ASEAN Medical Device Directive (AMDD) formulate basic requirements for the safety, performance and efficiency of medical devices that include a device classification and post-marketing alert system that should be circulated throughout the ASEAN. https://asean.org/, Accessed on: 14 April 2022 |
NICE [206] | 1999, UK. | European Union. UK is a member of The National Institute for Health and Care Excellence (NICE) | regulates the use health technologies and clinical practices in the UK. Also provides guidance on health care services and promotion. https://www.nice.org.uk/, Accessed on: 14 April 2022 |
ETSI [207] | 1988, Sophia Antipolis, France | European Union | ETSI regulates technical standards of ICT (Information and Communications Technologies) enabled devices, systems and services https://www.etsi.org/, Accessed on: 14 April 2022 |
FCC [208] | 1934, USA | US States comply with Federal Communications Commission (FCC) | FCC regulates radio, TV, satellite and cable communication in USA. FCC and other regulatory bodies look into the issues such as how much radio frequency/ energy absorption is harmful for humans https://www.fcc.gov/, Accessed on: 14 April 2022 |
HIPPA [209] | Act of 1936, USA | US States follows Health Insurance Portability and Accountability Act (HIPPA) | In the USA, HIPPA is responsible for ensuring that the privacy, integrity and access controls are meeting defined standards, rules and regulation. https://www.hipaa.com/, Accessed on: 14 April 2022 |
Country | Regulatory Body | Year | Purpose |
---|---|---|---|
USA | The Food and Drug Administration [210] | 1906, Maryland (USA) | oversees radio and non-radio based medical devices, medicines and drugs, cosmetics, and biologics in the USA |
Russia | Roszdravnadzor (Federal Service on Surveillance in Healthcare and Social Development | 2004, Moscow (Russia) | it handles registration, clinical safety and efficiency of medical devices. It also oversees post-market surveillance of these devices |
Russia | Gosstandart (Federal Agency for Technical Regulation and Meteorology) | 2004, Moscow (Russia) | ensures that imported devices meet all Russian standards. Its parent body is Ministry of Industry and Trade |
Russia | Rospotrebnadoz (Federal Service for Supervision in the Area of Consumer Rights and Welfare Protection) | 1922, Moscow | ensures that BAN devices meet hygienic and epidemiological regulations |
China | State Food and Drug Administration (SFDA), China Food and Drug Administration (CFDA) in 2013 China: Also a member of AHWP and APEC | CFDA (2013), NMPA (2018), Beijing (China) | accountable for the regulation of locally manufactured and imported BAN medical devices. CFDA was renamed as National Medical Products Administration in 2018 |
Hong Kong | Device Administrative Control System (MDACS), Hong Kong is also also a member of AHWP and APEC | 2004, Hong Kong | The Medical Device Division (MDD) is accountable for implementing MDACS and developing a long-term statutory regulatory framework for local and imported medical devices. The old name of MDD was Medical Device Control Office (MDCO) formed in 2004. |
India | Central Drug Standards Control Organization (CDSCO) India: Also a member of AHWP, Based on The Drugs and Cosmetics Act 1940 and Rules 1945, India | NA | works under Ministry of Health and Family Welfare. Carries regulation of medical devices, imported implantable, diagnostic kits and sterile devices require registration under the current system, registration will follow the GHTF, Central Licensing Approval Authority (CLAA) |
Iran | Ministry of Health and Medical Education—Food and Drug Administration, National Medical Device Directorate [211] | NA, NA | device classification follows GHTF, registration is similar to FDA or EU. |
Israel | Medical Device Division of the Ministry of Health (AMAR) [212] | NA, NA | devices regulation strictly follows US FDA and EU CE. |
Jordan | The Jordan Food and Drug Administration (JFDA) [213], Jordan is also a member of AHWP | 2003, Amman (Jordan) | enforces laws and regulation for medical device, if the device is approved from USA FDA and EU CE it does need clearance in Jordan |
Saudi Arabia | The Saudi Food and Drug Authority (SFDA) [214], Saudi Arabia is also a member of AHWP | 2003 | only those devices are permitted that have approval from any one of the GHTF member |
UAE | UAE Ministry of Health Drug Registration and Control Department [215], United Arab Emirates (UAE) is also a member of AHWP | NA, NA | UAE adopts guidelines of GHTF, EU, Australian TGA and USA FDA in addition to UAE Pharmacy Law No4 for 1983 |
Africa | National Medicines Regulatory Authorities (NMRA) [216,217], African Organization for Standardization (ARSO) [218], The African Network for Drugs and Diagnostic Innovation (ANDI), African Union (AU) and United Nations Economic Commission for Africa (UNECA) [219] | ARSO (1970, Kenya), UNECA (1958) | Only 7% of African countries have NMRA, 63% have minute regulations, and 31% are without regulations. ANDI was developed in phases by WHO in collaboration with TDR, AFRO and EMRO, African Development Bank, etc. [220]. More on regulatory authorities in African and East African countries can be seen from [221,222]. |
Caribbean | Pan American Health Organization (PAHO) [223], also operates in Central and South America | 1902, Washington DC | PAHO has assigned a task to ECRI to develop and coordinate programs for medical device safety and regulation |
South America | Mercado Común del Sur (MERCOSÚR) [224], Argentina, Brazil, Paraguay, Uruguay, Venezuela Chile, Bolivia, Colombia, Ecuador and Peru | 1991, Montevideo (Uruguay) | regulation for medical devices, single approval scheme similar to EU, Products with FDA/EU marks having Free Sale Certificate (FSC) or a Certificate to Foreign Government (CFG) affirm they can be sold |
Mexico | Federal Commission for the Protection against Sanitary Risk (COFEPRIS) [225] | 2001, Mexico | regulation of medical devices and IVDs. Mexico is also a member of APEC and HAFTA |
Cuba | left for the State Control of Medicines, Equipment and Medical Devices (CEMED) [226], Cuba is also a member of GHTF | NA, La Habana | regulation of medical devices based on GHTF. CCEEM is in La Habana (Cuba) |
Project | Application | Communication |
---|---|---|
Body Inertial Sensing | Meant for hospitals, where it provides information to measure three degrees of freedom | Body Sensor Networks (BSN) ZigBee/Bluetooth |
Code Blue | Targets medical care to provide pulse rate, BP, and motion information | Intra-BAN (Wired), Inter-BAN (Zigbee, Mesh), Beyond-BAN (N/A) |
LOBIN | Measures HR, BP, Temperature | Wireless Sensor Networks (IEEE 802.15.4) |
MEDISN | Used in hospitals for emergency detection | WSN for monitoring patient physiological data and multi-hop wireless backbone for carrying these data |
Unobstructive BAN | Applied in hospital and disaster events to generate alarms based on identified movements and postures | Intra-BAN is Low-power and short-range WBAN, Inter-BAN is Bluetooth, and or Beyond BAN is GSM |
WPWS | Measures temperature, humidity, and velocity of air flow | RFID like system |
BASUMA | Targeted application area is health monitoring for measuring ECG, Respirate/Breath Rate SpO2 | Intra-BAN (UWB), Inter-BAN (N/A), Beyond-BAN (N/A) |
MobileHealth | Monitoring of patients ECG in ambulance | Intra-BAN (Manual), Inter-BAN (Zigbee, Bluetooth), Beyond-BAN (GPRS, UMTS) |
AID-N | Reply BP, ECG, Pulse Rate in emergency systems | Intra-BAN (Wired), Inter-BAN (Zigbee, Bluetooth), Beyond-BAN (WiFi, Internet, Cellular Networks) |
MAHS | Targets health application to provide information about breathing and pulse rate, body motion, temperature, pressure and SpO2. | Intra-BAN (Bluetooth), Inter-BAN (Zigbee), Beyond-BAN (Internet) |
LifeMinder | Targets self-care applications. Used to report pulse rate, ECG, SpO2, temperature, body movement, emotional state intensity | Intra-BAN (Bluetooth), Inter-BAN (Bluetooth), Beyond-BAN (Internet) |
SMART | Monitor patients ECG, SpO2 while sitting in waiting room | Intra-BAN (Wired), Inter-BAN (Bluetooth), Beyond-BAN (N/A) |
CareNet | Targets remote healthcare applications to report BP, temperature and body inertial (posture and movement) information | Intra-BAN (N/A), Inter-BAN (Zigbee), Beyond-BAN (Internet, Multi-hop 802.11) |
ASNET | Targets remote healthcare applications for providing patient BP, temperature information | Intra-BAN (Wired, WiFi), Inter-BAN (Wired, WiFi), Beyond-BAN (Internet, GSM,) |
WHMS | Used in health for monitoring ECG/EKG | Intra-BAN (Wired), Inter-BAN (Wired, WiFi), Beyond-BAN (N/A) |
Human++ | Provides entertaino-medical living standard with ECG, EMG, EEG facility | Intra-BAN (UWB), Inter- BAN (N/A), Beyond-BAN (N/A) |
WiMoCA | Provides gesture detection in sports | Intra-BAN, Inter-BAN (Bluetooth), Beyond-BAN (WiFi, Cellular Networks) |
Ayushman | Used in health monitoring and provides information about EKG, BP, SpO2 and body gesture | Intra-BAN (Zigbee), Inter-BAN (WiFi), Beyond-BAN (Internet) |
Lifeguard | Applied in space and terrestrial applications to monitor ECG, respiration and pulse rate, SpO2 and body motion | Intra-BAN (Wired), Inter-BAN (Bluetooth, Internet), Beyond-BAN (Bluetooth/Internet) |
IBBT IM3 | Used in Telemedicine and Telecare application and measures patient ECG, respiration and heart rate | Intra-BAN (N/A), Inter-BAN (N/A), Beyond-BAN (Internet) |
MITHrl | Used in healthcare applications and measures patient ECG and EKG | Intra-BAN (Wired), Inter-BAN (WiFi), Beyond-BAN (N/A) |
UbiMon | Used in healthcare application and measures patient ECG and EKG, SpO2 | Intra-BAN (Zigbee), Inter-BAN (WiFi/GPRS), Beyond-BAN (WiFi/GPRS) |
H2020 MCSA ITN/EJD A-WEAR | Used in healthcare application and measures patient ECG and EKG, SpO2 | Intra-BAN (Zigbee), Inter-BAN (WiFi/GPRS), Beyond-BAN (WiFi/GPRS) |
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Bhatti, D.S.; Saleem, S.; Imran, A.; Iqbal, Z.; Alzahrani, A.; Kim, H.; Kim, K.-I. A Survey on Wireless Wearable Body Area Networks: A Perspective of Technology and Economy. Sensors 2022, 22, 7722. https://doi.org/10.3390/s22207722
Bhatti DS, Saleem S, Imran A, Iqbal Z, Alzahrani A, Kim H, Kim K-I. A Survey on Wireless Wearable Body Area Networks: A Perspective of Technology and Economy. Sensors. 2022; 22(20):7722. https://doi.org/10.3390/s22207722
Chicago/Turabian StyleBhatti, David Samuel, Shahzad Saleem, Azhar Imran, Zafar Iqbal, Abdulkareem Alzahrani, HyunJung Kim, and Ki-Il Kim. 2022. "A Survey on Wireless Wearable Body Area Networks: A Perspective of Technology and Economy" Sensors 22, no. 20: 7722. https://doi.org/10.3390/s22207722
APA StyleBhatti, D. S., Saleem, S., Imran, A., Iqbal, Z., Alzahrani, A., Kim, H., & Kim, K.-I. (2022). A Survey on Wireless Wearable Body Area Networks: A Perspective of Technology and Economy. Sensors, 22(20), 7722. https://doi.org/10.3390/s22207722