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TSDSI-M2M-TR-UCD_Health-V0.1.0-20150306 Technical Report Machine-to-Machine Communication (M2M) Study on Indian Use Cases Health Vertical 1 1 2 3 4 5 6 7 8 9 10 11

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TSDSI-M2M-TR-UCD_Health-V0.1.0-20150306

Technical Report

Machine-to-Machine Communication (M2M)

Study on Indian Use Cases

Health Vertical

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Contents

1. Introduction 2. Purpose 3. Intended Audience 4. Scope 5. Definitions, Abbreviations, Acronyms 6. Use Cases for Health

6.1 Mobile Care 6.2 Rural Health 6.3 Assisted Living 6.4 Smart Gadgets 6.5 Telemedicine 6.6 Video Conferencing 6.7 Health Chip 6.8 Remote Surgery 6.9 Remote Patient Monitoring 6.10 Remote Drug Delivery 6.11 Remote Asset Tracking 6.12 Remote Equipment Monitoring 6.13 RFID Identity 6.14 Hospital Information Management System (HIMS) 6.15 Laboratory Information System

7. Way Forward

Annexure – Use Case Remote Patient Monitoring (RPM)

Annexure – Use Case Remote Drug Delivery

Bibliography

Document Revision History

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1 INTRODUCTIONCommunication infrastructure is the foundation of Process Automation, Instrumentation and Control industry. This industry that has been in existence for more than 50 years. Sensor/transducer based Remote Monitoring systems, and PLC/SCADA systems with remote control capabilities have always used dedicated communication wires or wireless (Radio/Satellite etc.) systems for providing connectivity between end devices in the field and control centre. In fact, several communication protocols were created in the Industrial Automation space.

On a different plane, the scorching pace of innovations in IT technologies has led to “commoditization” of devices. These devices are intelligent, have small and flexible form factor and, more importantly, can “talk”, by integrating standard communication chips/modules of any communication technology, almost in a plug and play fashion. Therefore, the world is now witnessing emergence of devices that can communicate with each other – thus elevating automation and control engineering industry to a new level altogether – the M2M/IoT.

Industries, especially in manufacturing and process industries have been leveraging the power of “connectivity enhanced automation systems” to create solutions for improving operational efficiencies and productivity of their assets and processes. They have created industry specific standards and protocols in automation space. While many of these standards are defined at the higher levels of the OSI model, the features have been standardized pre-assuming a certain communication layer to service the application.

Till date, in most applications implemented in India in any vertical segment, the communication infrastructure selected is a captive system that is used dedicatedly for the specific solution. In a few cases, in larger organizations, certain dedicated channels of the corporate communication backbone infrastructure (if it exists) are earmarked for such solutions.

The primary reason for this is driven by the need for a safe and secure operational regime, instead of operational efficiency improvement. Automation solutions do not have a good business case in several industry segments in India (especially in Smart Grids space) due to the high TCO (CAPEX +OPEX) of the required communication systems, if these are dedicated for the solution. Even a common communication backbone at the overall organization level for all business, automation and IT needs does not make the solutions financially attractive.

As the IT sector grows in maturity in terms of robust engineering practices, creation and usage of IT tools as “products”, user organizations are willing to migrate to digital shared platforms (example - cloud) in a Platform as a service (PaaS) mode. PaaS platforms help reduce the cost of service to individual clients and at the same time brings bare minimum standard features across all vertical segments. The time is ripe for offering a common communication platform (the

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“information” highway) for applications from various vertical segments (the “data” vehicles), in order to bring down the TCO of the communication piece to affordable levels.

This brings the need for independent M2M platforms that can offer content transport capabilities in a seamless, reliable and affordable manner with universal standards for content handling and quality of service.

An independent M2M platform, that is based on a single or heterogeneous communication technology on the one hand, with a set of standard common services (OSS, BSS and much more), and standardized device interfaces, can be leveraged by multiple service providers, multiple user organizations and for multiple applications. Availability of standard interfaces on the communication and device facing sides of such a platform, will foster innovations in the communication and device segments, with assured quality of service.

One of the major responsibilities of TSDSI’s M2M group is to define an M2M framework to meet the above objectives. As part of this exercise, the group has undertaken study of various vertical segments to extract business requirements from an M2M/IoT platform perspective. This has helped the team bring out common requirements of all verticals, which in turn will become candidates for M2M platform functionalities. This document is a compilation of application use cases in various verticals studied by the team.

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2 PURPOSEIoT/M2M market is growing at the rate of approximately 8% CAGR (by no. of devices) and is expected to touch 20 billion No. of connected devices by 2020. As on date, “niche” services/solutions are being offered by players in key verticals in India as an end-to-end offering encompassing the devices, communication system and the controlling IT application. A few of these are – Automated Meter Reading in Power and Water Utilities, Electronic Toll Collection Systems in Transportation, OBD based vehicle eCall solutions in Vehicles, Telemedicine in Health, Remote Automated Cell Tower Monitoring, Street light Management systems in Smart City, Home security and Surveillance systems, Building Management Systems, Automated manufacturing in Industrial Automation etc. These qualify as M2M offerings in the specialized vertical segment.

In order to define a M2M service platform that can serve the needs of different verticals, it is important to understand the functional requirements of these verticals in sufficient depth for the appreciation of architecturally significant requirements.

TSDSI’s M2M group has undertaken study of various vertical segments to extract business requirements from an M2M/IoT perspective. This is intended to help cross pollinate useful features across different verticals for the overall benefit of the user community. Purpose of this exercise is to extract common requirements of all verticals which in turn will become candidates for M2M platform functionalities.

It also brings out the India specific implementation experience and learnings. This will help aspiring M2M platform providers to gain an understanding of the drivers for successful field implementation in the Indian ecosystem. It is believed that, India geographical market itself is a representative sample for emerging economies. Therefore, a framework that is defined to address this segment, will help to serve the needs of emerging economies market too.

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3 INTENDED AUDIENCEM2M Platform Solution providers (Solution and Technology Architects), Regulatory bodies and Policy makers.

Entrepreneurs who aspire to create products/Apps. for deployment on M2M platforms.

Underlying network service providers from various communication technology segments.

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4 SCOPEThe document gives a brief overview of M2M use case applications in Health vertical for India geographical market.

It is intended to serve as a reference point for Architects, policy makers and Regulatory bodies to understand India specific requirements and/or drivers in each area.

A few “representative” use cases are elaborated in detail describing actors and scenarios with call flows. Architecturally considerations that are significant from an M2M perspective, ranging from information exchange interface requirements, data traffic, performance requirements, deployment considerations from Indian context are covered. Regulatory and statutory compliance requirements, currently prevalent standards are also provided. The elaborated use cases describe Indian Ecosystem specific aspects. Any foreseen constraints and challenges in such implementations are also described.

Use cases selected for elaboration were based on the criteria of their perceived architectural significance on the M2M platform and/or market potential. Architectural significance covers differentiated data requirements and India geography specific deployment requirements.

The list of use cases provided in this document is not meant to be exhaustive, rather, it is a representative of the verticals, compiled bases on contributions provided by TSDSI members and subject matter experts in this domain area. Some use cases contain evolving/future requirements also.

Some use cases can “belong” to more than one vertical. These have been described in the vertical that is currently championing its implementation in India.

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5 DEFINITIONS, ABBREVIATIONS, ACRONYMS

M2M Machine to Machine

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6 USE CASES FOR HEALTH

India has made rapid strides in healthcare services since independence and is currently a medical tourism destination. However, accessibility to quality healthcare is one of the biggest challenges for a vast majority of the population. Even in metros and large cities, the traditional healthcare infrastructure is over-burdened. There are just 1.3 beds per 1000 persons in India as against WHO standard of 3.5. There are 0.59 doctors per 1000 persons as against 1.1 doctors in China, 2.15 in UK & 3.31 in USA. Infant mortality remains of concern. Medical care in India is not affordable by a majority of the population and medical insurance coverage is not affordable. Source [Economic Times].

People in general are facing increased amounts of stress due to economic and environmental challenges and changing social habits. This in turn is causing increasing incidences of diabetes, cardiovascular diseases and cancer. 77% of Population-is likely to be pre-diabetic (http://www.thehindu.com/news/national/tamil-nadu/more-than-77-million-people-in-india-have-prediabetes-expert/article5620842.ece). The demographic dividend will become the aged population in the coming 30 years, requiring access to cost effective medical services. A skewed gender ratio and female feticide are some social problems that the country is grappling with. The overall medical strategy including Public health and community medicine initiatives are not sufficiently geared to tackle this.

The government is evaluating various strategies for unifying all its health initiatives and adopt a Program Approach for their implementation. Key programs of the Indian Government in healthcare are as follows:

a) Improved efficacy of ANMsb) Village Health Sanitation and Nutrition Committees (VHSNC) c) Janani SurakshaYojana (JSY)d) National Mobile Medical Units (NMMUs)e) National Ambulance Servicesf) Janani Shishu Suraksha Karyakram (JSSK)g) Rashtriya Bal Swasthya Karyakram (RBSK)h) Mother and Child Health Wings (MCH Wings)i) Free Drugs and Free Diagnostic Service j) District Hospital and Knowledge Center (DHKC)k) National Iron+ Initiative

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The Govt. has also mandated hospitals (more than 50 beds) to digitize health records of the patient (EHCR). EHCR is an electronic record of health-related information for an individual that can be created, gathered, managed, and consulted by authorized clinicians and staff within one health care organization. EHCRs may include a range of data, including demographics, medical history, medication and allergies, immunization status, laboratory test results, radiology images, vital signs, personal statistics like age and weight, hereditary information linked to billing information. EHCR may be linked to unique identity of the patient (e.g. Aadhar). Going forward, it will be possible for patient to access patient medical history from the web-portal of the treating hospital.

Format of the EHCR data records is in the process of standardization (Open data format is one such candidate format). Government has also come up with an MDDS (Meta Data and Data Standards) Standards that has approx. 1000 data elements arranged in 39 logical entities like patient, examination, mortality, diagnosis, pharmacy etc.

On a different perspective, healthcare sector is categorized into direct, support and allied services. These services demand deployment of M2M technology for a seamless experience in improving efficiency and cost effectiveness.

In future an M2M platform enabled Ambulance service is planned to be available nationally - a common ambulance number can be dialed by patient and ambulance of the nearest proximity can be called (102 for ordinary ambulance and 108 for ambulances fitted with in-transit ICU care).

Key activities under the PM’s Swachh Bharat Mission are designed to improve overall health of our citizens. ICT technologies, especially M2M can play a significant role in these strategies. Some of the examples are Solid waste management, Sanitation (clean & green toilets), drinking water source pollution level monitoring etc.

ICT technologies can help improve the delivery of medical services, both in terms of its reach as well as quality. A majority of diagnostic and treatment delivery equipments used in the medical field today are electronic with provision for remote connectivity to facilitate monitoring from a non-proximate location. These technologies hosted on a M2M platform can bring the patient and doctor closer to each other in time and space, thus cutting down the travel time for doctor and patient. Usage of such technologies can reduce the cost of diagnostics and medical supervision.

Private sector is getting into health sector in India in a major way. Hospital chains are being established to address Primary, Secondary and Tertiary health care tiers. Mobile Clinics, Diagnostic Services and dispensaries are also coming into picture. These rely heavily on ICT technologies.

A few typical applications that can leverage M2M platforms are briefly described below:

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6.1 UC_Mobile Care:

This use case deals with transportation of patients to hospitals. Patients who are in a life threatening condition or who need immediate advanced medical attention, need to be transported to hospital in an ambulance that is fitted with near ICU like equipment. The doctor/care giver travelling with the patient in an ambulance should be able to be in contact with medical experts in the hospital so that remote expert support can be provided in transit. Patient’s vitals can be monitored remotely from the hospital via a two way communication system between the ambulance and hospital. Video conference facility between the ambulance and hospital is also required to enable hospital doctor to guide the accompanying care giver on medical actions in transit. This is the “108” Ambulance Helpline. Example- a patient who has suffered cardiac arrest, or woman in labour.

Patients not suffering from an emergency life threatening condition can be transported to hospital in a normal ambulance. Here, the attendant accompanying the patient can provide advance information to the hospital about patient medical symptoms, and medical history and allergies via a two way communication system between the ambulance and the hospital. Sophisticated medical equipment and video conference facilities are not essential in such situations. This is the “102” ambulance helpline. Example – patient with fractures.

At present, India has over eighteen (18) different models of transportation for emergency, pregnant women, children and other categories of patients. These can be broadly categorized as follows:

a. State-wide models. This is the “108 Emergency Transport Facility”, where the ambulance comes with equipment and trained staff to manage emergencies during transit.

b. Decentralized district or block-level public-private partnership (PPP) models. Here, the District Health Society (under the Govt. Department of Health) manages these services. The fleet includes government and contracted private vehicles. Example - Janani ExpressYojana in Madhya Pradesh.

c. Decentralized community-based models. These are managed by community-based organizations and there is significant involvement of communities and private vehicle owners. Typically, these vehicles are not tracked in real time by any government body. Examples are Cheeranjeevi Yojana in Gujarat, Ayushmati Scheme in West Bengal, in Khunti district of Jharkhand and in Dholpur district of Rajasthan.

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6.2 UC_Rural Health:

This use case describes role of standardized patient interview kits, audio training packs and remote telephonic support solutions in supporting ASHA (Accredited Social Health Activist) and AWW (AanganWadi worker) activities in Rural Areas.

Healthcare is the right of every individual but lack of quality infrastructure, dearth of qualified medical functionaries, and non- access to basic medicines and medical facilities thwarts its reach to 60% of population in India. Approx. 700 million people who live in rural areas face deplorable medical facilities. In rural India, where the number of Primary health care centers (PHCs) is limited, 8% of the centers do not have doctors or medical staff, 39% do not have lab technicians and 18% PHCs do not even have a pharmacist. A lot of policies and programs of the Govt. are suffering due to poor implementation.

There is a dire need of smart practices and procedures to ensure that quality and timely healthcare reaches to the deprived corners of the Indian villages. Medical services organizations can create a custom questionnaire containing multiple-choice-questions, quantitative input questions, and qualitative audio recordings, that can be broadcast to different contact groups. For example: a network of ASHA workers (community health workers) can be sent for a survey to capture self- reported data on the number of visits they did; similarly, AWWs (Aanganwadi Workers) can be sent for a survey to get data on number of children that were fed, the menu that was served, and if they are running out of ration supply and need to alert the district authorities. Audio packs with a series of tutorial messages can be created, which can be played out over a phone call to a desired contact group. For example, ASHAs or AWWs, could be sent messages on best practices to follow during ante-natal care, danger signs to look out for, and ensure that they take expectant mothers for institutional delivery. The users can also ask questions, which can be answered by experts. Thus, if ASHAs or AWWs have any questions or concerns, they can record their message which can be answered by experts live or through recordings over the phone.

6.3 UC_Assisted Living:

In India currently only 1 Senior in every 10,000 is engaged in some form of Senior Living, compared to 12 seniors in every 100 in the USA and 4 seniors in every 100 in Australia. India, is a relatively young country demographically in relation to the USA and Australia. However, by year 2025 it is estimated that India will have 173 million seniors above the age of 60 compared to the 76 million today. The current demand for senior housing in India is about 312,000 units.

Assisted Living application combines housing, support services and health care, as needed. Assisted living is designed for individuals who require assistance with everyday activities such

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as meals, medication management or assistance, bathing, dressing and transportation. Some residents may have memory disorders including Alzheimer's, or they may need help with mobility, incontinence or other challenges. Residents are assessed upon move in, or any time there is a change in condition. The assessment is used to develop an Individualized Service Plan.

6.4 UC_Smart Gadgets:

Smart watches may be cool, but wearable health monitoring devices could save your life. These gadgets now run the gamut in goals, from managing chronic disease to optimizing fitness programs. Some devices allow care givers to constantly monitor patient's medical conditions, so that doctors can be notified immediately on detection of any abnormality and thus avoid development of complications. Other devices can detect whether an elderly patient has taken a fall, or remind patients it's time to take their medications. Still other wearables allow consumers to keep tabs on their own health and fitness, helping them lose weight or sleep better.

The market for wearable sports and fitness-related monitoring devices is growing too, projected to reach 80 million device sales by 2016. Wearable devices provide output and connect to the Web in various ways. Some enable wearers to monitor their own readings using a mobile phone and a special website. Others allow data to be downloaded and viewed by third parties such as healthcare managers, or clinicians who are watching for disturbing trends that merit medical intervention. Some devices simply encourage wearers to share their fitness progress with work-out buddies and friends via social media sites.

6.5 UC_Telemedicine:

The Telehealth Counseling System is used as a Telehealth consultation service, that provides a communication service by video phone between citizens (e.g. elderly people) in rural areas and health professionals (e.g. medical doctors) in urban areas, and includes e-health device (e.g. blood pressure monitor, weight scale and pedometer) to be used by citizens at home or local community center, and an easy service to upload their data. The purpose of the Telehealth Counseling System is to provide counseling to patients remotely using video phone and easy data uploads from e-health device.

Call Flow

The routing of any call coming to the call center is as follows:

1. A patient dials Medical Call Centre (MCC) toll free telephone number2. The call is received by a Paramedic and an Electronic Medical Record (EMR) is created

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capturing patient’s demographic information, symptoms and past medical history etc.3. If the patient needs emergency care, the call is routed to one of the connected Health

Institutes and/or their ambulance service. 4. The paramedic provides basic advice to the patient based on data available at the

helpdesk. 5. If the patient asks for medical advice or if paramedic in not able to provide satisfactory

response to the patient, then the paramedic will forward call to a specialist doctor. 6. Depending upon the Teleconference session between the Patient, CCA and Specialist, the

EMR is updated. Also a comparison is drawn between the EMR (Analysis filled by CCA) and Doctor’s / Specialist’s Analysis.

7. If there is a qualitative addition by the Medical Experts to the EMR, then the EMR having Disease Symptoms, Causes, Treatment and Preventive Measures are registered in the Medical Knowledge Management system (MKMS)

8. MKMS once starts building up, will be used by all Stakeholders for Qualitative analysis and effective feedback treatment, thereby decreasing mortality rate.

Medical Call Center (MCC) Details

A Medical Call Center consists of a complex of telecommunication infrastructure, computer

support and human resources organized to effectively and efficiently manage queries raised by

farmers instantly in the local language. Mainly, Subject Matter Specialists (SMSs) using

telephone and computer (Videoconference), interact with patients to understand the disease and

treat it.

It is now also possible to utilize the impressive telecommunication roll out in the country, for

providing “service on demand” facilities to the farming community residing in rural areas.

Accordingly, it is proposed to cover the entire country by a network of Call Centres, where

farmers will be able to get expert advice through a toll free number. The caller will be connected

to a Doctor who will respond to their queries and problems. In case the respondent at this first

level is not able to satisfy the patient, an expert located at a remote medical institution within the

state or Central Govt. institution can be taken into a teleconference for providing expert advice.

This service would be available 24 hours a day. While during the office hours there would be

immediate response, beyond office hours the call would be recorded and query answered by post.

The Call Centres will support all principal languages in the country. This is a unique and

revolutionary way of communicating with the patients. This scheme has an in-built system of

monitoring and continuous evaluation for modifications and improvements. The trend of

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questions and the quality of answers would be continuously monitored to upgrade the facilities.

The services are also of a foundational nature. Many more exciting tiers will be built on this

infrastructure.

6.6 UC_Video Conferencing:

Part of Telemedicine

6.7 UC_Health Chip:IPv6 sensor chips embedded in animals has reduced the patients' /animal's death rate.IPv6 Bio Sensors for eHealth Vertical are described below:

A biosensor may be defined as a device that helps in the monitoring of a biological change. Biosensors act as critical information gathering tools in the increasingly used biological information systems.

Penetration of the medical domain by the information technology tools has resulted in an increasing usage of biosensors to monitor the critical vital signs in real time. Such information systems have varied uses. For example, medical biosensors allow the healthcare professionals to keep a continuous check on the vital parameters of a patient within a geographical area that may span from a hospital room to an entire city or even the entire globe. This requires a robust network infrastructure that may allow the sensory information to reach the destination on a continuous basis in real time thereby alerting the healthcare professionals against any medical exigency. It allows the healthcare professionals to take proactive measures rather than following a reactionary approach in extending critical healthcare facilities.

Rapid advances in specialized biomedical technology based diagnostics has led to a corresponding rise in the demand for network solutions so that the critical medical information can be shared in a seamless manner over a number of different platforms.

  The new M2M based healthcare applications include remote diagnostics and telemedicine that allow the healthcare professionals to monitor their patients round the clock, run diagnostic check on them and allow consultation through the use of various interactive communication technologies. IPv6 biosensors are being increasingly used in the medical industry to cater to a number of information needs. Biosensors allow doctors to remotely keep the vital signs of a patient under check. It also helps them monitor any noticeable

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changes on a 24x7 basis and take preemptive measures.

The various data processing tools undertake multidimensional analysis of the huge amounts of data that is collected using the IPv6 biosensors. The healthcare professionals commonly use the data visualization techniques to spot any underlying medical condition that may require intervention by the experts. Some of the obvious advantages offered by the IPv6 biosensors used in the medical industry are: 

Improved performance over the wireless networks - IPv6 is developed keeping in mind the increased transition from the wired to the wireless networks and the increasing addition of nodes requiring unique network addresses. This makes IPv6 better suited to network devices over a wireless network such as the biosensors.

Increased address space  - The increased address space offered by IPv6 allows the biosensors to have a unique IP address that is a prerequisite for them be connected directly to the Internet for applications such as remote diagnostics and telemedicine.

Optimized for high-speed data transfers - IPv6 protocol is tested to support communications over high-speed multi-gigabit per second (Gbps) data networks. Most of the critical medical applications will use the high-speed data networks for communication purposes. The erstwhile IPv4 protocol was not optimized for such high-speed data transfers.

Enhanced wireless security features - Security is a critical issue in wireless networks. It becomes all the more important when the network is being utilized by medical applications. IPv6 offers enhanced security features that make it appropriate to be used for medical biosensor wireless communications networks.

Optimized for always-on real-time networks - IPv6 protocol is optimized for high-speed always-on real-time wireless networks such as WiFi 802.11 and WiMAX. This gels very well with the network requirements of the biosensors used in the medical industry. As a result, IPv6 biosensors are best suited to provide all the real-time information requirements in the medical industry. 

We can conclude that IPv6 biosensors will play a critical role in offering monitoring and diagnostic facilities to the common man in an increasingly networked world.

6.8 UC_Remote Surgery:

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Remote surgery or telesurgery is performance of surgical procedures where the surgeon is not physically in the same location as the patient, using a robotic-tele-operator system controlled by the surgeon. The remote operator may give tactile feedback to the user. Remote surgery combines elements of robotics and high-speed data connections. A critical limiting factor is the speed, latency and reliability of the communication system between the surgeon and the patient, though trans-Atlantic surgeries have been demonstrated.

6.9 UC_Remote Patient Monitoring (RPM):

Remote patient monitoring (RPM), also called homecare tele-health, is a type of ambulatory healthcare that allows a patient to use a mobile medical device to perform a routine test and send the test data to a healthcare professional in real-time. RPM technology includes daily monitoring devices such as glucose meters for patients with diabetes and heart or blood pressure monitors for patients receiving cardiac care. Data can be sent to a physician's office by using a special tele-health computer system, by using a special software application installed on the patient's Internet-capable computer, smartphone or tablet PC. The data the patient sends is stored in a data repository so the healthcare professional can view the data as a specific instance or as a trend. RPM is frequently used with the elderly and the chronically ill, two groups of people who have high levels of medical need.

An example of Remote patient monitoring is the concept of “Med Homes” which has been practiced in some of the developed countries. “Med Homes” are medically assisted homes with M2M enabled patient monitoring environment which can be used as extended hospital facilities away from the hospital. Using remote patient monitoring system, patients which are non-critical but required continuous monitoring can be shifted to such “Med Homes” few miles away from the hospital in a cost-effective manner with resident doctors/nursing facility.

This use case is described in detail in the Annexure – Remote Patient Monitoring.

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6.10 UC_Remote Drug Delivery:

This use case talks about an easy way to manage administration of drugs/medicines to animals and monitor compliance for people far off from healthcare facilities. Drug delivery through implantables is also discussed in this use case.

This use case is described in detail in the Annexure – Remote Drug Delivery.

6.11 UC_Remote Asset Tracking:

RFID and Real time location based services (RTLS) are being widely deployed in multiple industries for asset tracking applications, within primary care facilities, research laboratories, manufacturing facilities, distribution centers, vehicle fleets, maintenance depots and elsewhere across the value chain. Real-Time Asset Tracking projects vary based on the assets themselves, the environment in which they are tracked and the business processes and corporate functions they impact. Over the past decade, there is deployment of hundreds of RFID and RTLS applications, tracking assets as diverse as medical supplies, aircraft subassemblies, agricultural seeds, tissue samples, reusable transport items, controlled pharmaceuticals, industrial machinery, lab equipment and storage trailers. In Healthcare, different kinds of organizations use asset tracking for different purposes. Hospitals and clinics may track medical equipment and consumables. Medical facilities may need to pay extra attention to the location of small, highly mobile supplies and equipment stored on their trucks. Medical laboratories need to automate medical specimen tracking, while medical device and pharmaceutical firms have asset tracking processes similar to other complex manufacturers.

6.12 UC_Remote Equipment Monitoring:

Majority of medical equipments are capital intensive and a remote equipment management can help in preventive measures to reduce the failure of medical equipments. A simple example can be seen from “Silent Observer” which sends SMS status to headquarter with respect to the machine on/off/storage statistics etc. Such a system may come handy for medical imaging and ICU related equipments as most hospitals have only limited number of such equipments due to their costs. A more comprehensive diagnostics and remote terminal system for firmware upgrade/bug fixing can cut down on the costs of visits and ensure a timely and cost effective service delivery through Remote Equipment Management.

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6.13 UC_RFID Identity:

Each time there is a patient contact, there is a potential risk of wrong treatment due to mistaken identity (especially in cases where patient is not in a condition to provide their details coherently. When registration processes rely on self-reported and subjective patient information, healthcare facilities are more vulnerable to errors, outdated or mistaken information, and even outright fraud. An example is an injured, but conscious, patient entering the emergency room without identification or an insurance card. With a patient ID verification system, the facility could confirm his name, address, and other pertinent information prior to discharge, enabling the facility to process and submit the bill in a seamless process. Proper designing and usage of a patient ID verification solution in clinical applications can streamline many hospital processes. The healthcare-related areas that can be positively affected by patient ID verification include admissions, business office, financial counseling, medical records, collections, discharge, donor programs, and clinical research/follow-up.

Many healthcare institutions are concerned if patient ID verification could affect compliance with the regulations outlined in HIPAA and EMTALA. In fact, patient ID verification can help a healthcare organization in following the guidelines by bringing electronic identification solutions to what were primarily manual processes. The Patient Identification is needed for correct logging of the data in the servers and systems. These can be following types Aadhar number, Biometric (as now being mandated by Govt. Of India), RFID, Smart-Card like Health Record Management System card etc.

6.14 UC_Hospital Information Management System (HIMS):

HIMS addresses the automation needs of all departments of a Hospital covering the administrative, clinical back office and peripheral activities. The various components envisaged under a typical HIMS architecture are as follows:

Mobile Registration process- M2M managed tablets are given to the attendants for registering the patients, connected to the DC. This would help hospitals to avoid long queues and increase overall customer satisfaction

Mobile Admission- Once registered, patients would be given a unique RFID-enabled wrist band which keeps track of patients movement inside the hospital

Patient Transfer- This M2M application would track the ambulance and then allocate them to the patients required for transfer. Also the application would work out the route planning for the ambulance to the designated hospital along would guide the driver for the necessary route through a Location application

Ambulance Management – Apart from the use case on Patient transfer, the ambulance management system would be linked to HIMS for tracking and tracing

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Patient consultation with resident doctors(Outpatient and inpatient) – The M2M telemedicine kit kept at a distant location would enable the patients to remotely consult the intended doctors wherein patient’s immediate & past health information would be converged and displayed on doctor’s handheld device

Operation theatre– all the devices placed in the OT would run on the singular m2m platform connected to the local gateway over PAN, which in turn talks to the DC over a fixedline connectivity

Blood bank, Stores and Purchases Inventory Management: Complete inventory Management with RFID tags placed on every blood bottle for effective mapping and traceability

Billing and Cash Counter: mPOS and wireless printers connected to the Patient Information Management System

Payroll– Biometric Attendance System: Biometric readers connected to the gateway over PAN would record the attendance of the patients in real time, updating the payroll muster. The payroll muster records becomes input to the Salary calculation module of HIMS

Tangible benefits like, by the use of HMS productivity of high cost resources such as labs, imaging modalities such as CT Scans, MRIs, Cath Labs, operating theatres will be improved - thus giving higher and faster return on investments. Higher satisfaction levels of hospital services by patients and relatives due to correct information being available as and when it is required, more transparency, less waiting and anxiety and fewer errors in services – medicines, diets etc. provided to them would cover intangible benefits.

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6.15 UC_Laboratory Information System:A laboratory information system (LIS) is a series of computer programs that process, store and manage data from all stages of medical processes and tests. Physicians and lab technicians use laboratory information systems to supervise many varieties of inpatient and outpatient medical testing, including hematology, chemistry, immunology and microbiology. Basic laboratory information systems commonly have features that manage patient check in, order entry, specimen processing, result entry and patient demographics. A LIS tracks and stores every detail about a patient from the minute they arrive until they leave and keeps the information stored in its database for future reference. There should be single central awareness centre across the country which sends advisory message to state, district , villages , talukas through SMS , media . The central system have the updated database and at any time that gives the current status in country. With the help of central system, a epidemic can be controlled and people can be issued advisory message. With the M2M people can also be given alert message for the symptoms of disease.

Candidate Opportunities for standardization from Health vertical perspective – medical data; patient lifecycle management w.r.t. their unique identity, linkage to their Aadhar ID for VAS etc. throughout their lifetime, and linkage to their medical records that are accessible to authorized personnel – anytime anywhere in a standard format. Patient ID- Aadhar ID – Health Records.

Medical sensors that are independent or remotely communicating type, should be medically safe. These are classified into 3 categories – Class I, II and III as per US/EU regulations. Class III devices are implantable and special care needs to be taken which are invasive in nature. Medical sensors- gateways/Aggregators – HES interfaces and data should be universally standardized so as to ensure interoperability.

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Source: www.continuaalliance.org courtesy TEC WG on Health.

While medical data needs to be transported, patient privacy needs to be maintained at all times. Thus, information on source of data, although traceable, should be protected. This is a unique requirement in Health vertical.

7 Way Forward

Standards on Health Informatics is in draft stage from M2M perspective.

In the upcoming Electronic Health Standards of India- is there any area that needs further study by TSDSI?

Does the ISO series on medical devices cover device communication aspects sufficiently from M2M perspective?

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Annexure – Use Case - Remote Patient Monitoring1 Title : UC_Health_TelehealthInfrastructure_RemotePatientMonitoring

2 ObjectiveThis use case describes the telehealth infrastructure building blocks that would enable the care-provider (hospital) to monitor patient vitals and other details remotely, and allow the patient access to the doctor from the convenience of his/her home.

3 Source (as applicable) Mani Rajakannu ([email protected]), EIS-MDD, TCS Rahul Kumar ([email protected] ), TCIL

4 Background

4.1 Current PracticeThe existing infrastructure for Telemedicine / Remote Patient Monitoring is not at all adequate to address the growing healthcare needs. There are a few instances where technology is used for example, Tele-consultation (between city-based Tertiary hospital and a satellite health care centre in a smaller town).

The Apollo Hospitals group has been a pioneer in Telemedicine in India, leveraging VSAT technology, and has provided access to secondary / tertiary consulting services to remote rural healthcare centres through VSAT. Most of the tele-consultations were mainly reviews of medical cases.

However, a full-fledged Remote Patient Monitoring initiative has not been taken up even in the metros and urban areas.

4.2 Need for Use CaseIndia poses a unique set of challenges when it comes to “accessibility of quality healthcare”. The key factors that impact healthcare are:

1. One of the most populous countries, with more than 70% of its population in rural areas (more than 25% BPL)

2. India’s Health Report Card does not look good as well : Its MMR and IMR are high, it has the highest burden of communicable diseases and lifestyle changes have led to a spurt in NCDs (Diabetes and Hypertension)

3. Healthcare infrastructure is skewed, with more than 70% of the infrastructure concentrated in urban areas.

4. The number of beds and number of doctors per 1000 people is the lowest in the world.

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A well planned RPM framework built on-top of a robust infrastructure would ease the burden on the present Healthcare System and at the same time provide access to quality healthcare that is affordable.

4.3 Indian Ecosystem Specifics( Same as current Practice )

The existing infrastructure for Telemedicine / Remote Patient Monitoring is not at all adequate to address the growing healthcare needs. There are a few instances where technology is used for example, Tele-consultation (between city-based Tertiary hospital and a satellite health care center in a smaller town).

The Apollo Hospitals group has been a pioneer in Telemedicine in India, leveraging VSAT technology, and has provided access to secondary / tertiary consulting services to remote rural healthcare centers through VSAT. Most of the tele-consultations were mainly reviews of medical cases.

However, a full-fledged Remote Patient Monitoring initiative has not been taken up even in the metros and urban areas.

5 DescriptionA typical Remote Patient Monitoring setup would consist of

a set of devices to measure patient vitals (NiBP, HR, ECG, Weight etc),

an aggregator / gateway (similar to a set-top box) that would communicate these vitals,

a back-end database (either the Hospital’s EHR system, or a PHR that the patient can control, such as MS HealthVault) to store the information

A decision-support system (that can be customized to analyze the above information and help the Care-provider. (for example trigger alerts and initiate rule-based protocols)

The aggregator/gateway could be a dedicated hardware or it could be an application running on a smartphone which would then use the GSM infrastructure to communicate the patient information to the back-end system. The communication would have to adhere to a standard format (like HL7) for interoperability. The system would also have to ensure patient privacy and security (adhere to Regulatory guidelines)

At the highest level the generic remote monitoring detailed use case focuses on the communication of patients' remote device sensor measurements to their clinicians' supporting systems, EHR and/or their personally controlled health record (PHR). Within the Machine to Machine scope, the use case is focused on the transport of messages between the remote monitoring devices and the M2M service capability provider layer. Architecturally, elements or interfaces above the service capability provider layer, such as supporting electronic systems used by the clinicians or intermediaries, is beyond the scope of the present document and are included only to provide systematic grounding. Issues highlighted include, two way message traffic, network availability for critical missions, network information security, secure device addressing and message tagging.

Some of the issues that are foreseen are:

1. Even globally, RPM is still evolving and Indian context will also have its own challenges.

2. EMR / PHR systems from different vendors may not interoperate

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3. System could be vulnerable to hackers, exposing sensitive information.

4. This system would only be suitable for routine monitoring, cannot be a substitute for the quality of service provided in an ICU ward.

6 Actors (as applicable)

Actor Name Actor Type (person, organization, device, system)

Role Description

Patient Person The person whose vitals are to be monitored. The monitoring could be in a clinical or non-clinical setting

Vital Monitor Device Interfaces on one side with the physical world, measures patient’s vitals (NiBP, Blood Sugar, ECG, Weight etc). Interfaces with a Medical Gateway at the other side. This interface could be either wired (Serial, USB) or wireless (BT, Zigbee) and these devices may either be single or multi parameter monitors.These devices may use proprietary protocol to communicate with the Gateway or use a standard protocol like ISO/IEEE 11073

Medical Gateway Device The Device that interfaces with the Vital Monitors at the patient end, aggregates the information and communicates with the back end system (EHR / PHR / CIS). This Gateway could be a dedicated hardware-based device, or software on a PC or Mobile Platform.

Communication Infrastructure (backbone)

System This infrastructure forms the back bone of the RPM set-up. It could be a combination of Land-line / mobile telecom infrastructure

Medical Records System The Database at the back-end (Could be an hospital based EMR, a Public PHR or any type of Clinical Information System

RPM Application Platform System This could be an Application Framework that leverages the Medical Records information and provides the Care-Provider a customized interface depending on the end-application (Chronic Disease Management, Clinical Trials etc)

Care Provider / Clinician Org / Person Including Doctors, Nurses and other clinical staff who are involved in monitoring the vitals, evaluate the information and intervene to take appropriate action.

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7 Contextual Illustration

8 Potential market growth

Remote Patient Monitoring's Future: The Game Is On

The personal Emergency Response System (PERS) marketplace, which is often associated with providing the elderly and chronically ill population with a remote mechanism for communicating medical emergencies while in the home, is undergoing a facelift.  Leading the way is a convergence in how traditional two-way PERS systems are intersecting with the use of real-time, Connected Health clinical measurements which monitor and track an individual’s specific medical condition in the home, well outside of the four walls of an institutional care setting.  The by-product of this convergence is a newly evolving, rapidly growing

market for Remote Patient Monitoring (RPM) & Population Surveillance.

Ironically, healthcare reform has concurrently put the industry at a crossroads for effectively managing large populations in a well-coordinated, prospective, real-time manner, in contrast to an afterthought or retrospective manner.  Healthcare reform is but one of a myriad of market forces driving these changes.  Several reform and related elements are behind this growth:

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High Risk / High Cost Individuals: Adults age 65 and older engage in the highest level of healthcare spending among all age groups.  Additionally, almost half of all healthcare spending was used to treat just 5% of the population.  Better management of these high risk / high cost individuals outside a hospital setting and in a preventive care manner is imperative to lowering healthcare costs, especially as the age structure of the overall population is projected to change greatly over the next four decades.

Managing the Growing Incidence of Chronic Conditions: Unquestionably, individuals with multiple chronic diseases place the heaviest burden on the healthcare system.  Approximately 80% of Medicare beneficiaries have one or more chronic conditions.  Four out of five major chronic conditions that account for hospitalization impact those over 65.  Better management of the elderly and their chronic conditions is not a nice-to-have but a must-have requirement.  Services for older adults need to be person-centered, coordinated across the continuum of care and focused on health and wellness.  Particularly as it applies to 24×7 prevention of acute illness episodes and disease-related disabilities, and where sophisticated, clinically-driven monitoring by population, device (PERS and “smart” Connected Health devices) and healthcare constituent (e.g. payer, provider, home care agency).

Individual Coverage Expansion (Exchanges) / Medicaid Expansion: ~16 million new enrollees are expected to join Medicaid by 2017. Additionally, the onslaught of expanded coverage across higher-risk demographics and the potential for adverse selection on public exchanges will require risk-bearing entities (payers or providers) to look for alternative methods like RPM and surveillance to lower healthcare costs and manage high-risk populations at the point of coverage versus simply at the point of encounter.

Homecare is not Only Preferred, but Essential: Overall reducing the dependency on institutional care settings has many benefits, including cost savings.  Homecare has the ability to play a tremendous role in reducing care spending by treating more people in a cost-effective manner at a fraction of the cost of other institutional settings – in some cases more than 75% lower.  Incentives are aligned to promote homecare but also provide the peace-of-mind and safety while living independently.

Readmission Reduction Programs:  Hospital readmissions for older patients cost American taxpayers more than $15 billion per year – and many are avoidable. Medicare readmission penalties established by CMS will force both payers and providers to take a fundamentally new approach to coordinating care, particularly post-discharge.  This will further incite the demand for RPM and Surveillance capabilities to identify risks well before readmission occurrences.

Consumer/Patient Engagement:  With patients, caregivers and their family members taking a more proactive role in managing their health, RPM & Surveillance is becoming increasingly prevalent in the healthcare industry.  In addition to monitoring patients with chronic conditions and senior patients, RPM & Surveillance enables patients and their family members to track vital information like blood pressure, weight change, glucose levels and other vital signs while eliminating 90% of the “unnecessary data noise” that is

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not warranting a clinical intervention.  In effect, this means a more prospective surveillance monitoring of a patient’s health management.

New, smart mobile devices, which provide 24×7 connectivity and extend a broader healthcare value proposition, are filling gaps in care for high risk/high cost patients including the chronically ill.  In our view, healthcare’s challenges are on a much-needed collision course with Connected Health innovations, including the convergence of PERS and mobility – which is why many industry watchers are optimistic about the potential cost savings.

As this plays out, marketplace spending on these solutions will likely rise – and various market sources are noting that home monitoring systems with integrated communication capabilities are expected to reach 9.4 million connections worldwide, equating to a ~27% CAGR between now and 2017.  In addition, the number of devices with integrated cellular connectivity is projected to grow at a ~47% CAGR during the same period.  Finally, Juniper Research suggests that over the next five years, RPM will result in cost savings of up to $36 billion globally and that North America will account for little over three quarters of the savings.

The game is on.  Scale and innovation are converging, and the notion of Population Health Surveillance is no longer aspirational – it is real and is emerging at the center of true care coordination initiatives for payers, risk-bearing providers and the cadre of players across the community-based care continuum.

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Annexure – Use Case - Remote Drug Delivery

1. TitleUC_Health_RemoteDrugDelivery

2. Objective

This use case talks about an easy way to provide drugs/medicines to animals and monitor compliance for people far off from healthcare facilities

3. Source (as applicable)

SumitDhingra ([email protected]), Reliance Industries Ltd.

4. Background

5. Current Practice

The patients who are on medications for long duration of time tend to comply with their medication schedule. Even though there are a lot of medication reminders and pill reminders available in the market. The patient needs to be physically present with the medicines to take them. This is big problem faced in Indian Healthcare.Some drug delivery require longer schedules. This requires longer wait for the patient restricting the patient movements

6. Need for Use Case

A reservoir that could be remotely triggered to release a drug would enable the patient or physician to achieve on-demand, reproducible, repeated, and tunable dosing. Such a device would allow precise adjustment of dosage to desired effect, with a consequent minimization of toxicity, and could obviate repeated drug administrations or device implantations, enhancing patient compliance. It should exhibit low off-state leakage to minimize basal effects, and tunable on-state release profiles that could be adjusted from pulse to sustain in real time. Recently in 2014, a few remote drug delivery systems have been introduced which are still in testing and controlled environment. Few of them are:

Irradiation based device by NCBI (National Center for Biotechnology Information)

Microchip based device by MIT spin-off in Massachusetts, backed by the Gates Foundation

The drug delivery for pain killers for patient suffering from chronic pains need to be administered for a longer duration. Additional techniques like Iontophoresis can help in non-invasive drug delivery and a wearable kit can be worn by the patient. This helps the user to

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do their routine work with the wearable drug delivery system can provide the pain reliever as per the dosage prescribed by medical practitioner

7. Indian Ecosystem Specifics ( Same as current Practice )

The majority of drug delivery systems that achieve prolonged release of drugs do so in a passive manner; drug release occurs in a more-or-less sustained manner irrespective of changing circumstances. In particular, the pattern of drug release is beyond the control of the patient or health professionals.

However, there are many situations (e.g., endocrine disorders, pain) in which drug release would ideally be provided on demand, or in which the magnitude of drug release would best be readily treatable to a specific endpoint. Apart from allowing optimal matching of treatment to need, such control could reduce side effects by minimizing excessive dosing. Moreover, a device that is administered once (e.g., by surgery or injection) and then triggered remotely could increase patient compliance, particularly in cases in which conventional administration is painful or inconvenient, or for elderly or mentally disabled patients.

Recent advances in materials science have enabled systems that respond to external stimuli such as electromagnetic fields, voltage potential like in Iontophoresis or ultrasound. They have been realized as microchips, liposomes, micro particles, nanoparticles, and macro scale polymers that release loaded drugs when the stimulus is applied. In principle, these materials enable control over the dose and timing of drug release and therefore can be used to achieve complex drug release regimens not possible with conventional passive sustained-release systems. However, most triggered systems reported to date release drug only in a burst rather than in continuous fashion, or only function for a single release event, or exhibit a poor ratio between on- and off-state release kinetics, and lack reproducibility over multiple release cycles.

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8. Description

Weather membrane based or microchip based the remote drug delivery device should support:

Triggered release Low off stage leakage Range of drug release profiles Noninvasive trigger ability within the body Different therapeutic window for different types of patients No onboard power source or logic Duration of drug release

9. Actors

Actor Name Actor Type (person, organization, device, system)

Role Description

Device – Implant, Wearable device, microchip or membrane based

Device Device responsible for initiating or controlling the drug delivery

Care provider/ Healthcare provider

Doctor or organization

Responsible for 1. Trigger the initiation of the

drug delivery 2. Program or control manually

the drug delivery3. To check and maintain history

of drug delivery4. Configure the System for drug

type, delivery time / dosage, application time,

Remote monitoring and control unit

Device Device which can receive the commands and configuration parameters from the healthcare professional and communicate with the drug delivery device and provide the required commands

wireless sensor networks

System Network which makes the communication possible

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Contextual Illustration

Drug release in body by Wireless technology/Remote technology

Generalized view of Microchip technology

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Pre-requisites (Assumptions):1. A microchip/membrane based drug delivery device.2. A remote control to trigger the device3. System at care provider’s end to track the delivery and maintain history

Information Exchange Drug delivery device/dispenser:

Drug Identifier tag: Drug to be given

Drug Quantity: Drug quantity in units

Drug duration: Duration in which the specified quantity is to be dispatched

Service Provider:Disease/Condition: Based on which the drug is chosenDrug Data (Includes all above)

Remote control:Drug initiation

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1 Interface Requirements

1. Bluetooth and/or Near field communication or any communication technology which can provide secure communication

2. Examples of communication devices include mobile computing devices, such as personal computer, personal digital assistant (PDA), tablet computer, smart phone, integrated circuit card, and so on.

3. Examples of wired communication links include cable connections such USB connection, RS 232 cable connection, and so on.

4. Examples of wireless communication links include near field communication (NFC), Bluetooth, Infra Red, ZigBee, and the like, and long distance communication protocols such as GSM, CDMA, and the like.

2 Security

Proper measures need to be taken so that the device cannot be hacked and controlled from any device other than the designated one. The communication between the Remote device and the drug dispenser needs to be secure with Encryption like AES-128 bit or more.

3 Start-up Shutdown process

The control circuitry consists of a computing unit, drug delivery dispenser, or an input source and battery. The computing unit will control the desired reservoir to be activated so that a variety of drugs may be contained in each specific reservoir. The input source can either be a memory source, remote control device or a biosensor. A battery (thin-film micro, or any chargeable or rechargeable) can be used as a power source. All of these can be patterned directly onto the device.

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4 Device Remote Health monitoring and troubleshooting

The system at care provider’s end connected to the microchip via wireless network will handle the monitoring and troubleshooting.

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Contracts and Regulations

Contracts and Regulations Impact on Use case

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Remote Medication Management System

Document issued on: October 19, 2007

ChallengesSome of the Challenges anticipated are:

1. No single design approved and commercialized yet in India or world

2. Risk in controlling and troubleshooting the device

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Bibliography

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Document Revision HistoryVersion Date Released by Change Description

Rel 1.0 20150306 6th March, 2015

Principal Author: Raahul Kumar TCIL;

Contributors: Mani Rajakannu, TCS; Ashok Khanna, TCS; Narendra Saini, Sukrut Systems; Aditya Jaiswal, Vodafone; Anuj Ashokan, TTSL; Raunaque Quaiser, STMicroelectronics; Alok Mittal, STMicroelectronics; Sumit Dhingra, Reliance JIO; Niranth Amogh, Huawei; Bindoo Srivastava, IIT Bombay; Jayeeta Saha, TSDSI;

Release 1.

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