‘M2M HEALTH’ WORKING GROUP Working Document Convener: TELECOMMUNICATION ENGINEERING CENTER MINISTRY OF COMMUNICATIONS AND INFORMATION TECHNOLOGY Date: 6th Aug 2014 Revision Number: 0.0.4 Table of Contents 1 Introduction .................................................................................................................................... 3 2 Documentation conventions........................................................................................................... 3 2.1 Terms and Abbreviations ........................................................................................................ 3 2.2 Device Classifications .............................................................................................................. 4 3 Use Cases ........................................................................................................................................ 5 4 Security ........................................................................................................................................... 6 4.1 Encryption of data ................................................................................................................ 6 4.2 Exchange of Security Keys between service and nodes ............................................... 6 5 Technology adopted Profiles .......................................................................................................... 6 6 APIs for Gateway Integration .......................................................................................................... 7 7 Applicable Standards for Health ..................................................................................................... 7 7.1 BIS Standards for Health .................................................................................................... 7 7.2 Electronic Health Record Standards For India August 2013 ......................................... 8 7.3 Continua Health Standards................................................................................................. 8 7.4 ISO Standards ...................................................................................................................... 9 7.5 HL7 Standards ...................................................................................................................... 9 8 References ...................................................................................................................................... 9 9 Feedbacks...................................................................................................................................... 10 10 Appendix of Use Cases Details ................................................................................................. 11 10.1 Personal health care device ............................................................................................. 11 10.2 Elderly care/ assisted living .............................................................................................. 12 10.3 Rural scenario ..................................................................................................................... 14 10.4 Ambulance/Mobile care ..................................................................................................... 16 10.5 Smart Wearable Devices .................................................................................................. 18 10.6 Asset Tracking and Device tracking inside hospital ...................................................... 20 10.7 Patient Identification........................................................................................................... 22 10.8 Remote Patent Monitoring ................................................................................................ 24 10.9 Clinical monitoring .............................................................................................................. 24 10.10 Radiology data transfers ............................................................................................... 24 10.11 Video conferencing ........................................................................................................ 24 10.12 Remote Drug Delivery ................................................................................................... 25 10.13 Remote Robotic surgery................................................................................................ 25 10.14 Tele-call center ............................................................................................................... 25 10.15 LIS (Laboratory information System) .......................................................................... 26 11 Revision History ........................................................................................................................ 27 1 Introduction Kindly refer to Framework of Reference For Working groups of M2M domain. Working group will identify a minimum set of common requirements of Healthcare segment, focusing on vertical related market and application programming interfaces (APIs) and protocols supporting applications and services, and draft technical reports in these areas. Working groups will make use of work already carried out by any other organizations to the extent feasible to avoid duplication of work. Working groups will study standards and specifications developed / being developed by international bodies such as ETSI, IEEE and OneM2M etc. While preparing report / contribution, Indian interest will be kept in mind. Documents available in TEC will be circulated to all members. Broad functions for working groups are envisaged as below:• Collect and document information from the global M2M community and from vertical market entities on current activities and technical specifications including requirements, use cases, service and business models, etc. • Perform a gap analysis for vertical market M2M service layer needs, applications and services and APIs & protocol. • Identify a minimum common set of M2M service layer requirements and capabilities focusing on concerned vertical applications and services. • Study whether existing APIs and protocols satisfy the above requirements and capabilities to support a common M2M service layer between M2M applications and telecom networks. • Draft technical reports describing and addressing the gaps and identifying future standardization work. • Working group will primarily focus on “applications and services”, “M2M use cases and service models”, “M2M service layer requirements” and “M2M APIs and protocols”. The working group on Gateway and Architecture, while working on gateway requirements will take feedback from other working groups so as to address their needs. • Working group on a particular vertical will work in close collaboration with the stake holders who are currently working on M2M or providing M2M services in India. 2 Documentation conventions 2.1 Terms and Abbreviations BT Bluetooth BTLE Bluetooth Low Energy ECG ECG Electrocardiography EHR Electronic Health Record ITU International Telecommunications Union ISM LAN Industrial, Scientific and Medical Band of Spectrum Like 2.4GHz, 865-868MHz Local Area Network M2M Machine-to-Machine NFC Near Field Communication QoS Quality of Service QOL Quality of Life RMD Remote Monitoring Device Sub-Gig Sub Giga Hz Radio Communication USB Universal Serial Bus WAN Wide Area Network 2.2 Device Classifications Country / Market Risk / Example US Market EU Market Risk Level Example Class I Class I Low Risk Class II Class II-a and Class II-b Moderate low and high risk Class III Class III High Risk Non-Invasive Electrodes Electronic thermometers, stethoscopes and blood pressure monitors, ECG Implantable defibrillator and implantable active device in general Pandemic disease diagnosis tool 3 Use Cases Note: This section needs to be populated. It is suggested to keep 1 or 2 pages for each type of the use-case. The information bulleted below to be filled and further information can be added Usecase/ Device Requirements Type Communicati on Channel Bandwidth BT, ZigBee, Low Security Privacy Data QoS Owner Class I/ II/ III Personal health care device II H H User Low Sub-Gig, (Preventive) GPRS Elderly care/ assisted living II & III Remote Patent Monitoring II & III High H User, Hospital High (Continuous care) Rural scenario II Ambulance/ II & III Mobile care Clinical monitoring I Smart Wearable Devices I Radiology data transfers II Remote Robotic surgery III Tele-call center I Asset Tracking and Device tracking inside hospital I Patient Identification I Remote Drug Delivery III Video conferencing I H Dedicated N/w Legends: H: High, L:Low, M:Medium 4 Security 4.1 Encryption of data AES Encyption 128bit 4.2 Exchange of Security Keys between service and nodes How will services exchange the Security keys 5 Technology adopted Profiles Technology Profiles adopted World-Wide References USB Bluetooth(R) Bluetooth SMART(R) Blood Pressure Heart Rate Thermometer Glucometer Bluetooth SMART READY (R) NFC(ISO14443/ISO15693) Personal Health Device Communication PHDC 1.0 NFCForum-TS-PHDC-1.0 2013-02-27 6 APIs for Gateway Integration Define the APIs requirement for integration with Gateway/Aggregator 7 Applicable Standards for Health 7.1 BIS Standards for Health S.No BIS Standards Subject MHD 17 HEALTH INFORMATICS SECTIONAL COMMITTEE SCOPE Standardization in the field of information for health, and Health Information and Communications Technology (ICT) to achieve compatibility and interoperability between Independent systems. Also, to ensure compatibility of data for comparative statistical purposes (e.g. classifications) and to reduce duplication of effort and redundancies. To co-ordinate with the work of ISO/TC 215 Health informatics & its sub committee IS/ISO 17115:2007 Health InformaticsVocabulary for terminological systems March 2011 IS/ISO 20301:2006 Health InformaticsHealth Cards-General characteristics March 2013 FINALISED DRAFTS UNDER PRINT DOC.MHD 17(140) Health Informatics-Digital Imaging and Communication in / ISO 12052:2006 Medicine(DICOM)including workflow and data management DOC MHD 17 (0237) Health Informatics-Electronic health record communication— /ISO 13606-1:2008 Part 1: Reference model DOC MHD 17 (0238) Health Informatics-Electronic health record communication— /ISO 13606-2:2008 Part 2 Archetype interchange specification DOC MHD 17 (0239) Health Informatics-Electronic health record communication— /ISO 13606-3:2009 Part 3: Reference archetypes and term lists DOC MHD 17 Health Informatics—Interoperability of telehealth systems and networks- /ISO Reference / Path (0240) 16056-1:2004 Part 1: Introduction and definitions DOC MHD 17 (0241) Health Informatics—Interoperability of telehealth systems and networks- /ISO 16056-1:2004 Part 2 : Real-time systems DOC MHD 17 (0242) Health informatics-Requirements for an electronic health record architecture /ISO/TS 18308:2004 DOC MHD 17 (0243) Health informatics-Electronic health recordDefinition, scope and context /ISO/TR 20514:2005 DOC MHD17 (313) Health informatics- personal health devices communication Part 10404 /ISO/IEEE 11073-10404 Device specialization-Pulse oximeter DRAFT APPROVED FOR WIDE CIRCULATION DOC MHD 17 (0301) Health informatics- good principles and practices for a clinical data warehouse ISO/TR 22221:2006 7.2 Electronic Health Record Standards For India August 2013 Approved by Ministry of Health & Family Welfare, Government of India 7.3 Continua Health Standards www.continuaalliance.org 7.4 ISO Standards ISO EN 13606 Electronic Health Communication (EHRCOM) ISO Standards Subject ISO13485:2003 Medical devices - Quality management systems Requirements for regulatory purposes Medical devices – Quality management systems Guidance on the application of ISO13485:2003 ISO/TR 14969 7.5 HL7 Standards 8 References 1. Frame of Reference (FOR) document from TEC Reference / Path 9 Feedbacks Kindly feel free to send your feedback to following a. Sushil Kumar, DDG (S&D), TEC : sushil.k.123@gmail.com b. Parmatma Rai, (Convener/Co-Rapporteur, TEC) : prai64@rediffmail.com c. Ananda Sen Gupta (Rapporteur of WG, TrackMyBeat) : ananda.sengupta@trackmybeat.com d. Alok Mittal, Chairmain-WG, STMicroelectronics, alok.mittal@st.com 10 Appendix of Use Cases Details Note: This section needs to be populated. It is suggested to keep 1 or 2 pages for each type of the use-case. The information bulleted below to be filled and further information can be added 10.1 Personal health care device a. Description and Block-Diagram We can refer to the Continua Personal healthcare system b. c. d. e. f. g. h. i. j. k. l. Type of Device: Class 1/2/3 Communication channel used Data bandwidth requirements Security requirements Privacy Compliance to standard: Name Deviations: from standard Challenges Criticality of QoS Ownership of data Patient Safety Requirements 10.2 Elderly care/ assisted living a. Description and Block-Diagram Following Scenerios exist specific to Elderly care i. Fall condition: This is to detect if the user has fallen and unable to get us due to injury. The message needs to be sent to nearby Family members/Care Giver/ Hospital ii. Vital Signs monitoring : Need to monitor the health parameters and alert the health-care services for alarms etc iii. Routine checkup : Routine checkup reminders and appointment settings for monthly/timely basis iv. Scheduler for Medicines reminder: Regular medicines for Chronic diseases to be taken and reminders to be given from the server to the user. The reminders can be managed locally also by an Smart-phone App or other mechanism. However, usage of medicines needs to be recorded v. Activity monitoring: General prescription for the movement of the user, minimum steps taken and calories burnt per day monitoring Kindly refer to Continue Block diagram for the devices like: “Independent Living Activity”, “Activity Monitor” and “Medication adherence” b. Type of Device: Class 1/2/3 Type and 1 & 2 Only Post Surgical : Type 3 c. Communication channel used BT/ BTLE/ ZigBee / Low Power RF in ISM Bands This is mostly to allow user mobility in the home USB: Wired connections only for specific parameter logging from specific Instruments 2G/3G/4G/ Wifi/Broadband : for Server Connectivity through Gateway d. Data bandwidth requirements Low data rate for Personal care devices e. Security requirements Data shall be encrypted f. Privacy Data access to be provided to user, Hospital, Based on user agreement: It can be provided to Family members, Care giver, Insurance Companies g. Compliance to standard: Name Kindly refer to Continue Block diagram for the devices like: “Independent Living Activity”, “Activity Monitor” and “Medication adherence” h. Deviations: from standard i. j. k. l. Challenges Criticality of QoS Ownership of data Patient Safety Requirements 10.3 Rural scenario a. Description and Block-Diagram TBD, but similar to Continua Health diagram) In a rural health scenario, there are two typical scenarios: i. A large number of users will be catered to at a health centre, and, ii. An ASHA or ANW worker will visit individual user’s home to help monitor health In either case, the monitoring will be done using multi-user personal health devices. The key challenge here is user identification. There must be a way of uniquely identifying the user of the device, so that the data can be stored accurately against the correct user in a centrally located server. There are two options here: i. Have the user identification to be in built in the device - where the device itself exchanges data with a central server and has a process to identify the user. For example, the device has a finger scanner which then connects to central server, which responds with the matching user identification. In this case, the device will directly connect to the network (hence will have a SIM card) and will have an IP address. ii. Have the user identification be done through a gateway device - tablet or phone with SIM (with IP address). In this case, the tablet may have either a finger scanner for greater accuracy, or for cheap practical use, have a database of users, which the health personnel can select user identification from. The minimum requirement in case of a database will be to display user’s name, father’s name and/or address, so that the user can be chosen uniquely. In case, Adhaar has been implemented, that could become an identifier through local database. Technically, a personal computer can also be used as the gateway device to communicate with the device and central server. b. Type of Device: Class 1/2/3 The typical devices used will be type 1 and type 2. In special cases, there may be type 3 devices at a health centre. c. Communication channel used Here the full connectivity scenario applies, as described in the Continua Health connectivity diagram. If the device communicates through a gateway device such as a tablet/phone/PC, then the connectivity between the device and the gateway device will be bluetooth/Zigbee/NFC/USB. The gateway device will connect using WAN connectivity mechanisms to the central server on the cloud. d. Data bandwidth requirements The data bandwidth requirement for the basic health data transfer is low. However, if a database has to be downloaded locally, a one time registration process will be required for the gateway device which may have to hold a local database with some minimum information describes previously to identify the user uniquely. For that one time registration process, medium quantity of bandwidth may be necessary, but it can also be done over a slower link since it is a one time interaction. e. Security requirements The security requirements for the health scenario will be stringent as usual since we are transmitting personal health data. f. Privacy The privacy requirement will be high for personal health data. Processes will need to be in place to protect against data misuse. g. Compliance to standard: Name TBD - suitable ISO and BIS standards h. Deviations: from standard: The user identification process will be unique for Indian rural scenario, which may not apply in other situations (and in other countries). i. Challenges As discussed, the key challenge here is user identification. Creating an accurate user database is a substantial effort in a rural scenario. Hence, first, user data collection is necessary, either from Census data or data from other local authorities such as Panchayat and others. Once that is done, this data has to be uploaded to a central location, which the local gateway or device has to access and match with. In case a fingerprint database is to be maintained, or link has to be made with Adhaar database, that will be yet another substantial effort. The workaround that has been described is to have some basic user information available, but even there the data has to be collected in advance. Adding new users will also not necessarily be an easy process. j. Criticality of QoS For type 1 and type 2 device usage scenario, the QoS requirement will be low as the data collected is for longer term monitoring scenarios, and the volume of data is also small. k. Ownership of data The ownership of data will of course lie with the user. However, since the rural user is not a technologically advanced user, the Ministry of Health, Govt of India, will have to involved in the processes and database management. l. Patient Safety Requirements The devices will have to follow standard quality and safety standards as per BIS or other applicable international standards if Indian standards do not exist. 10.4 Ambulance/Mobile care a. Description and Block-Diagram i. There are following types of Ambulance services Advance transport ambulance: Contains special equipment Basic Life Support Ambulance Patient Transport Ambulance: Not much medical equipment are there ii. Two-way communication is needed using UHF/VHF/ Cellular phones This is needed to provide information to hospital about the Patient condition and physical information. Patient allergies needs to be recorded and informed to the hospital. The medical equipment can be used which can be used for measurement of the physical data and informed to the hospital Video conference is also required for transferring medical information of the patient Online 12 Lead ECG which can be transmitted from moving Ambulance. ECG with DICOM compatibility is useful. iii. iv. v. b. Type of Device: Class 1/2/3 Type 1/ 2: Vital parameters of the Patient ECG: Type 3 c. Communication channel used Since this is from Moving Vehicle, telecom network is mandatory to be used. Hence 2G/3G/4G channels will be used from Ambulance to the Server/Hospital Inside the Ambulance: Since the patient is stationary, wired connectivity can be used Like USB for the vital parameters devices to the Aggregation manager. It can be noted that inside the Automotive Vehicle, the electrical noise can be high, hence the communication channel has to be robust d. Data bandwidth requirements Vital Signs: Low ECG: High Video Streaming: Very High e. Security requirements Data shall be encrypted and secure f. Privacy Data access to be provided to Hospital directly. The usage of Ambulance would mean that this is binding to the user The data can be recorded and later provided to Family members, Care giver, Insurance Companies g. Compliance to standard: TBA h. Deviations: from standard TBA i. Challenges It can be noted that inside the Automotive Vehicle, the electrical noise can be high, hence the communication channel has to be robust j. Criticality of QoS QoS has to be high. The Patient need immediate care, hence the Ambulance is used. k. Ownership of data The ownership of data is to be with Hospital l. Patient Safety Requirements TBA 10.5 Smart Wearable Devices a. Description and Block-Diagram The Smart wearable devices include the followings type. This list is not exhaustive though i. Pedometer ii. Wearable ECG Patch iii. Pulse-Oximeter iv. Heart-Rate monitors v. Smart Glasses The purpose of the smart-wearables is to monitor health of the user while being worn by the user on the body. The recorded parameters can be stored on the memory embedded in the design or transferred to the Aggregation manager These devices need to be Battery operated since they need to be carried and hence low-power consuming. b. Type of Device: Class 1/2/3 Device Class will be 1 & 2 In some cases like ECG, it can be Class-3 Type c. Communication channel used Generally Low-Power connectivity channel to be used. These would include the following technologies i. Bluetooth Low Energy ii. ZigBee iii. Low Power Radio iv. High bandwidth products like ECG may need Bluetooth d. Data bandwidth requirements Generally the devices shall consume low bandwidth only (< few Kbps). e. Security requirements f. Privacy g. Compliance to standard: The specific approved profiles of BTLE, BT, NFC can be used h. Deviations: from standard TBA i. Challenges The data communication to be in small bursts of time to save the Battery consumption. Some companies have already launched their Smart-Watches and SmartWearables. The protocols used in these devices are to be mentioned. ( Proprietary./ Specific standards/ ). j. Criticality of QoS Since these devices to be used in Personal Area Network, the QoS shall be good from Device to the Aggregation Manager k. Ownership of data l. Patient Safety Requirements The radio transmission shall not cause any harm on the humans 10.6 Asset Tracking and Device tracking inside hospital a. Description and Block-Diagram Asset Tracking and Device Tracking is important aspect in the health sector where all the health care instrument needs to be tracked in hospital. RFID/NFC technology can play an important role in the asset tracking inside the hospital. All the hospital equipment / instruments can have a NFC passive Tag embedded with unique id of the instrument. All the entrance/exit should have NFC transceiver which would record the movement of the medical instrument/equipment and update in the database on the hospital management system. Whenever there is need to search the instrument/equipment the user can refer to the Hospital Management system which will provide the last location of the asset These tags can be mounted on the movable machines like X-Ray, UltraSound and similar equipments b. Type of Device: Class 1 type c. Communication channel used Near Field Communication (ISO14443 / ISO15693) d. Data bandwidth requirements Low data rate as NFC data rate 424 kb/s e. Security requirements No security requirements as we are just tracking the movement of the Hospital equipment /instruments. The communication between the passive tag and the NFC transceiver should be secure f. Privacy No issue of privacy. g. Compliance to standard: ISO14443 / ISO 15693 h. Deviations: from standard : None i. Challenges: All the existing instruments need to be tagged with passive NFC tag. Active Transceiver gates need to be deployed as each entrance to track the movement of the Medical instrument/equipment The asset management system needs to be integrated in the Hospital management system j. Criticality of QoS It is good to have but it will add value to the Hospital and proper tracking can be done for each instrument k. Ownership of data The database will be owned by the hospital l. Patient Safety Requirements No hazard or threat to the patient or Hospital 10.7 Patient Identification a. Description and Block-Diagram The Patient Identification is needed for correct logging of the data in the servers and systems These can be following types i. Biometric type : User uses the thumb impression as login in the system. The It can be linked to Aadhar system in India for validation and getting the user details This system is good for the Ambulance as well ii. RFID : Near Field communication tag unique to the user can be issued. It will contain a unique ID for the user and when this Tag is put on the authentication device, a unique number is used to get the Patient identity etc. This can be good for Primary health care system iii. Iris Type: The eye scan can be used as unique identity. However, the technology still needs to be deployed on mass-scale iv. Mobile Phone number: Users phone number can be used as unique ID. Though the Mobile phone penetration in the population is high the challenge is that all people do not have the mobile v. Smart-Cards : Smart cards can be used for the unique ID. These can be ISO7816 compatible. The health-system must have the smart-card reader input. Each user must have a unique Health card which will help in identification. vi. TBA b. Type of Device: Class 1/2/3 Class-1 type c. Communication channel used Biometric sensor: USB, Serial Interface (RS232, RS485) RFID Tag: NFC d. Data bandwidth requirements Biometric/Finger print scanner needs authentication from the server and hence need the Broadband/ WiFi/ Telecom network From the sensor to the medical device, it will use wired connectivity and hence Bandwidth requirements are low e. Security requirements Secure connection needed between the identifier and the Health System f. Privacy All unique identifiers are non-transferable. g. Compliance to standard: Name TBA h. Deviations: from standard i. Challenges Using the identifier for the injured patient is a challenge. Blood stains on the finger or eyes can disrupt the reading process These are good for the Out-Patient healthcare requirements j. Criticality of QoS It shall be treated as “Good to Have” However, manual entry of the user can also be done. k. Ownership of data All patient data are owned by Patient and the Hospital l. Patient Safety Requirements The unique identified not be pose a health hazard to the user 10.8 Remote Patent Monitoring a. b. c. d. e. f. g. h. i. j. k. l. Description and Block-Diagram Type of Device: Class 1/2/3 Communication channel used Data bandwidth requirements Security requirements Privacy Compliance to standard: Name Deviations: from standard Challenges Criticality of QoS Ownership of data Patient Safety Requirements 10.9 Clinical monitoring a. b. c. d. e. f. g. h. i. j. k. l. Description and Block-Diagram Type of Device: Class 1/2/3 Communication channel used Data bandwidth requirements Security requirements Privacy Compliance to standard: Name Deviations: from standard Challenges Criticality of QoS Ownership of data Patient Safety Requirements 10.10 Radiology data transfers a. b. c. d. e. f. g. h. i. j. k. l. Description and Block-Diagram Type of Device: Class 1/2/3 Communication channel used Data bandwidth requirements Security requirements Privacy Compliance to standard: Name Deviations: from standard Challenges Criticality of QoS Ownership of data Patient Safety Requirements 10.11 Video conferencing a. Description and Block-Diagram b. c. d. e. f. g. h. i. j. k. l. Type of Device: Class 1/2/3 Communication channel used Data bandwidth requirements Security requirements Privacy Compliance to standard: Name Deviations: from standard Challenges Criticality of QoS Ownership of data Patient Safety Requirements 10.12 Remote Drug Delivery a. b. c. d. e. f. g. h. i. j. k. l. Description and Block-Diagram Type of Device: Class 1/2/3 Communication channel used Data bandwidth requirements Security requirements Privacy Compliance to standard: Name Deviations: from standard Challenges Criticality of QoS Ownership of data Patient Safety Requirements 10.13 Remote Robotic surgery a. b. c. d. e. f. g. h. i. j. k. l. Description and Block-Diagram Type of Device: Class 1/2/3 Communication channel used Data bandwidth requirements Security requirements Privacy Compliance to standard: Name Deviations: from standard Challenges Criticality of QoS Ownership of data Patient Safety Requirements 10.14 Tele-call center a. b. c. d. e. Description and Block-Diagram Type of Device: Class 1/2/3 Communication channel used Data bandwidth requirements Security requirements f. g. h. i. j. k. l. Privacy Compliance to standard: Name Deviations: from standard Challenges Criticality of QoS Ownership of data Patient Safety Requirements 10.15 LIS (Laboratory information System) a. Description and Block-Diagram Connecting various semi-automatic and automatic system to main system in a laboratory/Hospital. b. c. d. e. f. g. h. i. j. k. l. Type of Device: Class 1/2/3 Communication channel used Data bandwidth requirements Security requirements Privacy Compliance to standard: Name Deviations: from standard Challenges Criticality of QoS Ownership of data Patient Safety Requirements 11 Revision History Date Revision History 6th Aug 2014 0.0.4 Use-case of Rural Health, Elderly care/ assisted living, Ambulance, Patient Identification, Smart-Wearables Asset tracking updated 5th Aug 2014 0.0.3 LIS (Laboratory Information system added) as per feedbacks 14th July 2014 0.0.2 10th July 2014 0.0.1 Summary table of Use-case and features added Moved use cases to Appendix New use-cases as discussed in conf call of 10th July added First draft presented