Medical Devices, Interoperability & eHealth Standardization

INTEROPERABILITY OF

in INDIA MEDICAL DEVICES

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® 2013 Boston Scientific Corporation and its affiliates. All rights reserved.CORP-148904-AA March 2013

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At Boston Scientific, we believe that only an innovation realized can improve health, change an outlook or transform a life. That’s why we’re committed to pioneering, innovating and advancing science. Our heritage of discovery continues to drive our passion for meaningful innovations that address unmet clinical needs across a wide range of medical conditions and help patients live healthier, longer lives.

Science, no matter how advanced , is only as meaningful as the lives it transforms.

Continua Health Alliance is the only organization convening global technology industry standards to develop end-to-end, plug-and-play connectivity for personal connected health systems. Our Design Guidelines and test tools expedite the deployment of personal connected health devices and systems that will dramatically improve health management, clinical outcomes and quality of life. At the same time, Continua Design Guidelines are proven to decrease time to market and reduce development costs. Our focus is on creating a global market for personal connected health, working with a number of countries and national health ministries to support the development and implementation of groundbreaking national connected health initiatives. Continua is pleased to have an established presence in India, to advance end-to-end, plug-and-play interoperability in this important medical devices market. Continua is a strong voice for personal connected health technologies among employers, payers, regulatory bodies, government agencies and care providers, and we work collaboratively with advocacy, legislative and regulatory agencies on behalf of our membership.

Continua is pleased to carry forward our mission and represent our membership to support the e!cient, cost e"ective and bene#cial adoption of connected health in India.

Clint McClellan Board President and Chairman, Continua Health Alliance Senior Director of Strategic Marketing, Qualcomm Life Inc. a wholly owned subsidiary of Qualcomm Technologies Inc.

FOREWORD

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Chairman’s MessageGreetings from the Continua Health Alliance-India Working Group (IWG).It gives me immense pleasure to present to you the #rst report of the Continua Health Alliance-India Working Group. This report is also a unique one since this is the #rst report that brings to fore the subject of interoperability of medical devices in India.

India being the second most populous country in the world is experiencing a boom in its healthcare sector owing to the various demographic and socio-economic related factors. We are witnessing a time in this country wherein the focus is not only basic issues related to healthcare such as universal access and equity, but also on quality of care and progressive delivery concepts such as home-based care. With increase in a"ordability among a large section of the population, there is an increased demand for care to be delivered and monitored in a technologically enabled environment. With the spurt in the mHealth, this need has been further exaggerated. These factors have lead to a sharp growth in manufacturing from both indigenous and multinational medical device companies. With more number of healthcare providers embracing technology in their care delivery process, this growth is estimated to only increase in the near future.

However, extensive use of such medical devices has their own set of challenges, with interoperability leading the chart. At this pivotal juncture, our organization would like to present to you the #rst report pertaining to interoperability standards of medical devices in India. I am of the opinion that interoperability not only brings about standardization of the care delivery and monitoring processes, but also paves the way for equitable healthcare. In addition to these, adoption of interoperability standards would provide a chance for Indian medical devices manufacturers to take their products onto the international market thereby driving revenues through exports. The issue of ‘interoperability’ is missing from the agenda of the industry and the policy makers alike. Imagine hundreds of service providers delivering healthcare across India and none of their solutions being able to interface seamlessly with other systems? It would spell a disaster for patients, where data of patients could be lost or not be portable to the other system at all leading to losses beyond any statistical calculations!

Imagine what would have happened if Internet had failed? In 1982, the Internet Protocol suite (TCP/IP) was standardized, and consequently, the concept of a worldwide network of interconnected TCP/IP networks, called the Internet, was introduced. Internet could not have succeeded had there been no ‘self regulation’ and without the ‘universally accepted standards’amongst di"erent manufacturer’s and service providers. Similarly, Continua standards are the best example of self-regulation and industry wide accepted standards for interoperability and data security; the biggest headaches for any healthcare organization as healthcare moves towards automation with technology.

This report has taken about six months of research and interviews with global leaders and decision makers. All this could not have been possible without support from the industry. It would be inappropriate if I fail to put on record my deep appreciation with thanks for the support from Continua Health Alliance USA, Boston Scienti#c Corporation, and Allarch Healthcare. Without their support, this report would not have landed into your hands. I would also like to put on record my immense gratitude to Alice Borrelli, Clint McClellan , Chuck Parker, Debasis Bharadwaj, Anando Sen Gupta , Vibhav Garg, Dharmendra Ghai , Dr. Chinmya P. Chigateri, the entire team at HealthMinds'and other industry leaders for their valuable contribution to this report.

At Continua Health Alliance, we will continue to bring many more scienti#c publications covering the key issues in the Indian medical devices & healthcare IT industry. We will continue to work with Policy makers, industry partners and all other stakeholders through many more such useful reports, certi#cation programs and other activities for the bene#t of all stakeholders, keeping in mind the interest of the patients above all. I await your kind feedback on our #rst report on India.

With Kind Regards,Rajendra Pratap GuptaChairman, Continua Health Alliance – IWGwww.continuAalliance.org, Email : [email protected], Fax : +91 114582 3355

Rajendra Pratap GuptaChairmanContinua Health Alliance – IWG

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Introduction (1)

Global Medical Devices Industry (20)

Indian Medical Devices Industry (33)

Interoperability (48)

Interoperability Standards in India (59)

Conclusions and recommendations (70)

US interoperability case study (73)

Leaders speak (75)

References (80)

interoperability standards

regulatory standards

in India

devices space

interoperability standards

Table of contents

1INTEROPERABILITY OF

in INDIA MEDICAL DEVICES IntroductionIntroduction

Global Medical Devices Industry

Indian Medical Devices Industry

Interoperability

Interoperability standardsin India

Conclusions and recommendations

Background of the white paper De#nition of interoperability

Bene#ts of interoperability

Background on existing interoperability standards

Barriers and challenges to interoperability

Medical devices are pivotal in the health care delivery system due to their role in diagnosis, prevention, management, and treatment of disease conditions. The WHO [1] estimates that over 1.5 million di"erent medical devices in more than 10,000 types of generic device groups are currently available worldwide. According to industry experts, the global medical devices market will be between US$ 307.7 and 434.4 billion [2, 29] by 2017, with a CAGR of 6.1% during 2011-2017.

Innovations, technological advancements, ballooning populations and rise in demand for standard healthcare have been the driving factors for this large in$ux of medical devices in the market. In such a scenario, interoperability of medical devices, i.e. the ability to make one instrument or device to communicate with another device as well as share data with healthcare information systems seamlessly, is of utmost importance to achieve patient safety and healthcare e!ciency.

Diagnosticdevices

Monitoringmedicaldevices

Treating devices

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With advanced technologies, medical devices today are equipped to capture critical medical data even in real time. But their inability to communicate with other devices or lack of plug-and-play interoperability would seriously compromise patient care.

Absence of interoperability may a"ect some crucial functions:

The inability to use available data prevents patients from receiving better healthcare delivery. For example, a signi#cant amount of data is generated in an Emergency Medical Services vehicle (ambulance) while the patient is being transported. However, lack of interoperability may counter real time transfer of this data into the emergency medicine department at the receiving hospital. It delays the initiation of treatment procedure due to lack of medical information [22].

Synchronisation of patient's respiratory cycle with x-ray machine, especially in the emergency room, is known to improve quality of image. However, poor quality images are generated due to lack of interoperability among these devices [22].

Safety interlock and alert systems could be used to stop the $ow of pain medication from an infusion pump if a patient showed signs of respiratory distress[22]. Interoperability in this scenario can be lifesaving. Failure to connect safety interlock and alert system leads to dependency on manual monitoring, which increases the risk of fatal errors.

Lack of clarity in device interface standards and questionable reliability and performance of patient data sharing networks are serious challenges to achieving interoperability. A worldwide standard interoperable guideline can enable health care professionals to provide better patient care through an integrated system of various medical devices and data sharing with electronic health record systems. This would ensure e"ective, economic and time-bound services to patients.

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Background of the white paper

Advice from AAMI in Health Information Technology and Interoperability [HITI][3], supported by the FDA in the USA, suggests that standardization of interoperability and ensuring implementation of those standards are the key to achieving interoperability and better patient care.

In line with global e"orts, this white paper states the current scenario in global and Indian medical devices market, overview of interoperability, standards of interoperability in India, gaps and barriers to its acceptance, outline of Continua Health Alliance guideline and strategies to collaborate and coordinate with Indian standards.

There are some signi#cant reasons for the introduction of this white paper in India.

Visiongain, a London based business information provider determined that the Indian medical devices market will reach US$ 11 billion by 2023 [24], largely driven by the following three major forces:

Population: India is the second most populous nation in the world. The CIA World Fact Book [25] demographic statistics (as of 2012) divides the age structure of India's population as follows:

15-64 years

65.2%

0-14 years

29.3%

>65 years5.6%

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De#nition of interoperability




º With the current Indian population of 1.2 billion, each of these age groups contribute signi#cant numbers to the total. In the 0-14 age group, the focus would be primarily on pre and post natal care, safe delivery, mother and child health and preventive care. The country's maternal mortality rate stands at 200 deaths/100,000 live births (2010) and infant mortality rate of 46 deaths/1000 live births. In the age groups between 15-64 years, the focus would be primarily on non-communicable life style diseases, especially after the age of 40.

º Women’s health would require greater attention. Although population beyond the 65 year age group accounts for only 5.6% of the 1.2 billion, it would still amount to 67 million people. Indian population life expectancy at birth is 67 years and nation spends 2.4% of its GDP (2005) on healthcare. The country has 0.9 beds for 1000 population. The point underlined is that the nation needs a huge investment in healthcare sector. With rapid growth expected, it would acts as an anchor pole for increase in number of medical devices being utilized.

Health insurance: a major factor driving expenditure in healthcare sector is health insurance. The Indian Medical Device Market Outlook [24] places health insurance as the fastest growing non-life segment insurance in the country. Increase in healthcare insurance policy holders will contribute to providing a better structure to care delivery process in a technologically enabled environment. Due to customer demand, healthcare providers would need to ensure standard protocols and standardization across the devices they use.

'Medical Tourism': Indian medical tourism industry is currently growing at double digits as per industry estimates. In order to be on par with global standards, Indian healthcare needs to modernize and medical equipment form a signi#cant aspect of it.

When the nation is poised to witness a boom in healthcare sector, it is also facing certain challenges in the #eld of medical devices and their interoperability.

The above scenario con#rms our conviction that now is the time to release a white paper in the #eld of interoperability of medical devices in India. It will provide clarity to the various opportunities and issues involved in this area by encouraging all stakeholders to work together to adopt interoperability standards in India.

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De!nition of interoperability




De#nitions of interoperabilitySome de#nitions of interoperability are:

- ’It is the ability of a system or a product to work with other systems or products without any special e"ort from the customer’ [4].

- ‘The goal of interoperability is the exchange of computable data between computer systems which may be owned by di"erent organizations they collaborate with to ful#ll a business work$ow' [5].

Though technically both the de#nitions are accurate, they are generic in nature. Any de#nition of interoperability needs to be:

Acceptable to all the stakeholders in the health care industry Enduring Intelligible even to a non-scienti#c audience.

In a bid to de#ne interoperability in the context of healthcare devices, two major healthcare information technology organizations, namely, Healthcare Information and Management Systems Society (HIMSS) and the National Alliance for Health Information Technology (NAHIT) have worked enormously to develop consensus regarding the de#nition [6].

HIMSS [7] de#nes interoperability as ‘the ability of health information systems to work together within and across organizational boundaries in order to advance the e"ective delivery of healthcare for individuals and communities'. NAHIT has de#ned interoperability as ’the ability of di"erent information technology systems, software applications and networks to communicate, exchange data accurately, e"ectively and consistently, and use that information that has been exchanged.’

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Types of interoperability

The National Committee on Vital and Health Statistics [8] (NCVHS) Report on Uniform Data Standards for Patient Medical Record Information segregates interoperability into three types:

other but do not require recipient computer to interpret the message.

and messages between computers are interpreted at the level of data #eld.

The three levels of interoperability were further improvised by Turnista. The AAMI has adopted Turnista Model of Hierarchy [3] which had added two more levels:

elements of the data, and context of the data. At level 5, there is dynamic interoperability which is more $exible and allows changing context and relationship over time [3].

Even though the model depicts hierarchical structure of interoperability, the solutions need not be hierarchical. For example, in a rare situation, it is possible to have semantic interoperability, but not technical interoperability. The ordering is based on the typical implementation of and historical approaches to interoperability.

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Interoperability

Level 5

Level 4

Dynamic interoperability

It is $exible and allows for changing contexts and relationships over time or within the scope of speci#c transactions

Pragmatic interoperability

There is shared understanding of data, the relationships between elements of the data and the context of the data but it cannot accommodate changing relationships or context

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Five levels of interoperability [Courtesy AAMI] [3]

The AAMI Ad Hoc Group on Health Information Technology and Interoperability (HITI) performed a detailed survey on concepts of interoperability given by HIMSS, NAHIT and various other healthcare information organizations. After an in-depth consideration of standards from HL7, IEEE, ASTM, and through engaging pro#ling, testing, and certi#cation bodies like Continua and IHE, and consulting speci#c market surveys, a comprehensive de#nition was brought out. It de#ned interoperability as ’the ability of medical devices, clinical systems or their components to communicate in order to safely ful#ll an intended purpose.’

The meaning of communication in the above de#nition is interpreted in the broadest sense as incorporating communication of intent and desire to communicate. It can be safely concluded that the de#nition of HITI conveys, after considering both safety of the patient and the intended purpose of interoperability, a broader meaning that will serve as a guideline for further exploring the concept of interoperability.

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Integrability

Level 3

Level 2

Connectivity

Level 1

Semantic interoperability

The data have meaning but a full understanding of the relationships between elements of data and the context of the data is missing

Functional interoperability

Information is communicated with structure but without any meaning

Basic interoperability

Two systems have the means to communicate, but neither has a shared understanding of the structure or meaning of the data communicated

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partnership

Interoperability as a concept is currently in its incipient stage [3]. It is expected that the volume of medical devices that communicate with each other will grow manifold in near future. Setting a uniform standard in devices interoperability globally will help avoid duplication of e"orts among stakeholders. Simultaneously, it will ensure standard safety protocols, promote e"ectiveness and economic viability and allow integrated use of diagnostic and therapeutic equipment by medical practitioners. Individual components can then interact with each other, keep track of medical records through connectivity to healthcare system data base and ensure initiation of safe and e"ective action.

The principal stakeholders in the bene#ts of interoperability are:

Introduction



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Bene!ts of interoperability



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Patients Provider

IndustryGovernment

Bene#ts of interoperability8

Some of the bene#ts of standard-compliant interoperable medical devices are[3]:

Advantages to the patients

The core bene#t of interoperability is that it ensures patient safety[3]. In an emergency scenario where time is the most critical factor, prompt decision means favourable clinical outcomes, thereby positively impacting treatment outcomes. In the USA alone, a staggering >100,000 people are estimated to lose their lives every year due to preventable medical errors1. Medical device interoperability is therefore a fundamental issue and not a peripheral one.

The French National Health Insurance Agency opines that there is a new trend where patients wish to get treated at home [9]. This would result in the use of more sophisticated medical devices that enable care delivery at the patient’s residence, requiring greater interoperability among them. Numerous instruments without interoperability will create too many problems for patients. Therefore interoperability holds the key for safe and e!cient home based care.

Device interoperability will help patients receive the full bene#ts of technological innovation and enable them to manage their health at a"ordable prices. [10]

Advantages to healthcare professionals

Although an interoperable device might capture large amount of data pertaining to a patient, it remains counterproductive unless it enables clinical decision making. The most important aspect would be to help share patient data among healthcare providers across multi-disciplinary teams to enable better care services. It can also help improve the economic aspect of healthcare management by streamlining inventories, billing and record optimization [1].

Medical device connectivity enables automation of information procurement, improves data precision and facilitates integration of personal medical information into clinical work$ows pattern seamlessly [10].

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Advantages to industry

With standard guidelines in place, the e"ort of technology designers can be directed towards standardizing existing products and encouraging newer innovations. There is a clear #nancial bene#t, as companies will not need to spend resources on interoperability aspects. Instead they can focus on new functionality and use standardized interfaces. Healthy competition in research and development and manufacturing enables production of newer and high quality devices [1].

A plethora of clinical applications like electronic health record, personal health record, clinical work $ow, clinical decision making systems are con#gured to di"erent interfaces. It reduces the bene#ts of medical devices as data may not be readily usable [11]. Interoperability of medical devices that enable applications to seamlessly utilize medical data is a demand that has been recognized for quite some time by the healthcare industry.

It encourages small scale industries that specialize in certain selected devices and segments. This promotes competition, ensures quality, encourages innovation and reduces cost [10].

Advantages to the government and its collaboration with Millennium Development Goals

The Global Meet on Government Interoperability Framework (2010) was an e"ort to explore the possibility of sharing ingeniousness and knowledge to achieve e"ective interaction and integration of information, services and systems [12]. Seamless accessibility of healthcare information between government and private institutions and both inter and intra institutions can be a new step towards collaboration to achieve MDG goals.

Margaret Chan, Director General of WHO, opines that to achieve set standards, developing a global health indicator registry with standards for data, indicators, metadata, and references to analytic methods enabling tracking of progress of health programmes, are very important. Also interoperability standards both at the level of individual and aggregate records are signi#cant [13].

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Medical devices interoperability also helps medical sta" devote more time in direct patient care rather than in mining for available data. It also contributes to numerous direct and indirect bene#ts in patient care through a cascading e"ect. Despite the fact that healthcare industry is aware of the bene#ts of interoperability, the course to achieving interoperability has been a long drawn one. The need of the hour is to channelize cumulative e"orts to overcome the obstacles for its implementation and share the bene#ts across the spectrum among all the stakeholders.

Background of the existing interoperability standardsThe current scenario presents us with many medical devices interoperability standards provided by number of standards-developing organizations. These organizations have set the parameters through pioneering research in their respective #elds. Most of the interoperability standards can be categorized to follow one or several of these patterns [3].

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Enterprise and departmental systems

"First-hop" communication between individual devices and an intermediate point

departmental systems and medical devices

Point-of-care integration

for patient care

standard-based communications format. Emergency medical records and nursing $ow sheet software are two of the common examples of such a system. In such systems, data generated at the level of patient care need to be synchronized or shared with information from other sources in order to enable clinical decision making, monitoring or archiving.

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intermediate point where information is conveyed through non-standardized vendor and device-model-speci#c legacy communications methods [3]. For example in gateways between enterprise systems such as nursing records and medical devices, there are vendors who specialize in hardware and software for running these one-o" protocols.

devices enabling seamless and $exible connectivity with any clinical system in the hospital IT infrastructure. The solution supports device connectivity by interfacing with devices that use proprietary as well as standard based protocols (IEEE 11073/x73) while it uses HL7 for integration with clinical application.

information to manage or care for a speci#c patient. In this pattern, multiple devices collaborate intimately in the care of a particular patient, rather than being relatively simple, send-only data sources. These are the sorts of clinical scenarios that the ASTM F29.21 committee has advocated [3].

With a brief insight into the modes of operations of these standards, it would also be necessary to understand the key organizations that play a critical role in setting of such standards for interoperability. Although there are many such standards-developing organizations, the following nine are considered the main players.

Broadly, each one of these organizations or committees have de#ned certain standards for medical devices connectivity [10]. For example, IEEE has largely set standards for device connectivity through its IEEE 11073 protocol. HL7 has set guidelines for digital exchange of information between healthcare systems. IHE enables seamless $ow of medical information between information systems and healthcare enterprises and Continua Health Alliance de#nes benchmark for personal connected health solutions. Although these organizations have made pioneering e"orts in their respective domains, largely the protocols set by them may or may not have been accepted and adopted worldwide. The following are the nine organizations or committees that are considered important.

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IEEE-EMBS: IEEE Engineering in Biology and Medical Society [3] has to its credit the development of several standards in medical device communications. But the most noteworthy contribution is in the form of IEEE 11073 series. The principal focus is on medical devices semantic standard which includes:

a) Nomenclature standard ISO/IEEE 11073-10101b) The Domain Information Model Standard ISO/IEEE 11073-10201c) Application Pro#le Base (format) Standard ISO/IEEE 11073-20101.

The IEEE 11073 standards are the edi#ce for home health communications standards, such as those developed by the IEEE 11073 Personal Health Devices (PHD) group and by the Continua Health Alliance.

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IEEEHL7

IHE

NIST

AAMI

HIMSS

ContinuaHealth

Alliance

WestWirelessHealth

InstituteUnderwriterLaboratories

Few standardsdevelopmentorganizations

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HL7: Health Level Seven International [4] has over 2300 members including 500 corporate members covering more than 90% of information system providers in the healthcare sector. They provide all-embracing frameworks and standards for digital exchange of information between healthcare systems. HL7 strives to improve knowledge transfer between healthcare providers, government agencies, the vendor community, fellow SDOs and patients.

IHE: Integrating the Healthcare Enterprise15 has its main aim to make quality, e!ciency and safety of clinical care better by making relevant health care information easily available to both providers and patients. One of the main reasons for its existence is to pro#le HL7 messages and trim down the range of implementation possibilities allowed by HL7 and make IHE compliment system more predictable in content and form.

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in INDIA MEDICAL DEVICES Devices semantic standards

Nomenclaturestandard

The domaininformation

standard

Applicationpro#le base

(format)standard

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The scope of work of IHE

IHE PCD: The IHE Patient Care Device mainly deals with seamless connectivity of medical devices into healthcare enterprise, point-of-care clinical scenarios, to Emergency Health Record. The IHE PCD integration pro#les also include Alarm Communication Management, Device Enterprise Communication (DEC), DEC Patient Identity Binding, DEC Subscribe to Patient Data, Point-of-care Infusion Veri#cation and Rosetta Terminology Mapping.

CHA: Continua Health Alliance [16] is a consortium comprising over 200 companies dedicated mainly to ensuring interoperability of personal connected health solutions for better patient care. The principle is to extend and apply these connected solutions to enable independence and to empower individuals to better manage their health and wellness needs in a home based setting. Their core domain is in establishing design guidelines to manufacture home networks, health and wellness services and tele-health platforms. They also certify products enabling recognition of interoperability of devices through display of their logo after certi#cation. It collaborates with government regulatory agencies and leaders in healthcare industry.

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HL7Ranges of implementation posibilities from HL7 messages are large in number

IHETrims down the posibilities allowed by HL7 messages

Predictable content and form of messages

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WWHI: West Wireless Health Institute [17] is a non-pro#t organization whose key goal is to lower health care costs by patient-centred solutions. Medical devices interoperability is a vital component in reducing cost for delivery of healthcare. Research here is more focussed on #nding solutions for cost containment in the healthcare system and to cater to expectations of patients, doctors and health care organizations. They advance cost-e"ective and cost-saving model of care, enable an e!cient medical marketplace, promote practical and actionable healthcare policy and help in liberating healthcare data.

UL: Underwriter Laboratories [18] is a global independent safety science company with expertise in innovating safety. UL o"ers the most convenient and complete global regulatory access solution for medical and IVD device manufacturers [19]. Underwriter Laboratories and AAMI recently joined hands to collaborate and develop standards in interoperability [20].

NIST[3]: National Institute for Standard and Technology collaborates with IHE on testing for compatibility of HL7 messages to IHE PCD domain pro#les and works with IEEE 11073 committees, the IHE PCD Device Point-of-care Integration Work Group and the Continua Health Alliance on software tools for constructing models of device capabilities.

AAMI[3]: Association for the Advancement of Medical Instruments is a non-pro#t organization founded in 1967. It is a diverse community of nearly 7,000 healthcare technology professionals united by one important mission - supporting the healthcare community in the development, management and use of safe and e"ective medical technology.

HIMSS[28]: Health Information and Management Systems Society is a not-for-pro#t organization focused on providing global leadership for the optimal use of information technology (IT) and management systems for the betterment of healthcare. HIMSS represents nearly 50,000 individual members, of which more than two-thirds work in healthcare provider, governmental and not-for-pro#t organizations. HIMSS frames and leads healthcare practices and public policy through its content expertise, professional development, research initiatives and media vehicles designed to promote information and management systems' contributions to improving the quality, safety, access and cost-e"ectiveness of patient care.

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ASTM Subcommittee F29.21: American Society for Testing and Materials [21] is a globally recognized leader in the development and delivery of international voluntary consensus standards. They developed the 'Devices in the Integrated Clinical Environment' under the MD PnP programme and developed the ASTM F2761,which is a functional architecture describing the operations necessary to safely support medical devices interoperability in patient-centric applications.

ISO technical committee 21522: strives for standardization in the #eld of information for health, Health Information and Communications Technology to promote interoperability between independent systems, to enable compatibility and consistency for health information and data, as well as to reduce duplication of e"ort and redundancies. They are involved in data structure and interchange, semantic content, devices and business requirement for emergency health record systems.

Barriers and challenges to interoperabilityThe present scenario presents us with a plethora of devices that are used in hospitals or homes which function with their unique proprietary protocols determined by the manufacturer. These devices may use di"erent technologies such as USBs, serial ports or Bluetooth to communicate with each other. Firstly, ensuring interoperability between such stand-alone devices with di"erent propriety protocol presents a herculean challenge to manufacturers. Secondly, making patient healthcare data stored in Healthcare Information Systems [HIS] easily accessible by the provider but at the same time ensuring data security and con#dentiality of personal health information is a major challenge.

Although it is a known fact that medical device interoperability holds a multitude of advantages for all the stakeholders involved, namely the patient, government, device manufacturers and standards organizations, there are certain barriers [22] for the easy adoption of standards.

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There are several health delivery organizations and regulatory bodies working at the highest level to establish standards and regulations to achieve interoperability, but the lack of strict enforcement is hampering the creation of an interoperable eco-system [22]. Companies get away with lowest possible denominator of interoperability. The key factor in crossing this hurdle would be to ensure that all the players are involved in strict adherence to established standards.

The second most important factor is the network e"ect [22]. Networking in medical devices arena is like an ecosystem where di"erent players co-exist amongst large and smaller network systems. Larger systems are hesitant to allow smaller systems to interoperate with their devices since they gain disproportionately with this collaboration. This scenario #nally results in the domination of certain companies or institutions in order to protect their market shares and commercial interests. The needs therefore are incentives to both the parties and ensure that gain is symmetrical.

Most of the medical interoperable devices are vertically integrated [22]. Therefore interoperability remained rooted to that particular environment. The challenge is in lateral integration of medical devices between di"erent players, wherein standards need to be implemented on par with other universally accepted compatibility norms such as communication protocols. In order to progress in lateral integration, companies must support their suppliers to buy prefabricated components that are integrated one level down in the value chain.

Ensuring security and safety [23] associated with medical devices interoperability is a major challenge to manufacturers. Technically, medical devices may be developed using di"erent programming languages with their own set of software and communicating protocols. For example, in a given scenario, an enterprise or departmental system like emergency room system or nursing $ow sheet system may be using Windows or Linux. A medical device like cardiac monitor in the same emergency room itself may be using di"erent processors with an entirely di"erent operating system than that used in the departmental system. The newer mobile devices or tablets that the physician is using to stay connected may be using android or iOS.

For e"ective patient care, the data gathered by all these systems must be interoperable. In order to achieve this, there has been intensi#cation of e"ort in developing interfacing devices to enable communication between such stand-alone devices. The pursuit of seamless connectivity therefore raises fundamental questions of security and safety. In order to ensure this, all the players need to bring about set standards to negate duplication of e"orts and improve safety and security without compromising e!ciency.

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The major barriers are: 18

Loss of valuable time where clinicians are left to wait for vendors to release "drivers" in order to use a set of interoperability devices [3] is an indirect barrier. In such scenarios the overall quality of delivery of healthcare to the patient is compromised due to technical issues. Also the system integration procedures may be extremely costly and ultimately, the burden is passed on to the patient.

On the part of the vendors, a common view held is a lack of foreseeable returns for their investment. Lack of tangible incentives for achieving interoperability provides no commercial incentives to manufactures in supporting medical devices interoperability. It is important to realize among all the stakeholders that the onus is on all of them to work together to overcome these barriers to achieve medical device interoperability. The long term bene#ts of interoperability hold promise to all the stakeholders. Establishing set standards that enable both vertical and horizontal interoperability holds huge potential to all the players with main bene#ciary being the patient.

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IntroductionGlobal Medical Devices Industry


Interoperability



Overview

Global market scenario Geography speci#c market conditions

Innovations in the domain

2Global medical devices industryOverview

Medical devices are an inseparable part of the healthcare system and they play an inimitable role in prevention, diagnosis, monitoring, treatment and rehabilitation of diseases and disorders [1,2,3]. It is estimated that every day more than 50,000 types of medical devices are used in healthcare settings globally [1]. Although patient safety is the most important concern in healthcare delivery, improved e!cacy without cost escalation is also a tremendous challenge [4]. Therefore to ensure reliability, safety and performance across the spectrum, medical devices standardization is the need of the hour.

As part of the USA endeavor, the Association for the Advancement of Medical Instrumentation (AAMI) was established in 1967 with a vision to support the healthcare fraternity in the development, management and use of medical instruments 5. It is a non-pro#t organization and forms the primary source of consensus and timely information on medical instrumentation and technology [6]. As part of the global e"orts, The Global Harmonization Task Force was founded by the governments of Australia, Japan, Canada, EU and the USA in 1993 to address issues related to safety, performance and quality of medical devices [7].

Classi!cation based on use

Based on their use, devices can be broadly classi#ed into electro medical devices, electro therapeutic devices and irradiation equipment. Electro medical devices are used for diagnosis of disease, electro therapeutic devices are meant for treatment purposes and irradiation devices operate by the high energy electromagnetic waves to serve both the therapeutic and diagnostic purposes.

Classi!cation based on !eld of application

Based on the #eld of intended application, medical devices can be classi#ed as spinal devices, cardiovascular devices, neuro-modulation devices, diabetes devices, urology devices, and surgical technologies among others.

20

Global market scenarioIndustry research has reported that by 2017, the global market value of medical equipment and devices may range between US$ 307.7 and 434.4 billion, [9, 10] equal to a per capita US$ 67, and growth at a CAGR of 7.1% for the period between 2012-2017 [9].The USA is the world's largest market valued at $120.4 billion [2012], followed by Japan and Germany which hold the second and third largest market shares. The BRIC (Brazil, Russia, India, and China) nations collectively occupied a market share of 8.5% of the global market in 20129. In India, the medical devices and equipment industry is valued at US$ 2.5 billion and it contributes to only 6% of total healthcare market. Encouragingly, Indian medical devices market currently has witnessed an annual growth rate of 15% compared to 10-12% growth in the overall healthcare sector [11].

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Medical devices

Electromedical devices

Electrotherapeutic

devices

Irradiationequipment

051015202530354045

USA(US$120.40B) Japan(US$31.5B) BRIC(US$26.2B) Germany(US$23.3B)

2012 Medical devices market shares as per Espicom report



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21

According to an Espicom report, better opportunities for growth are in Asia, Latin America and Central/Eastern Europe, whereas traditional western markets represent more steady performers. With the prospect of accelerated growth and expansion of market for the medical devices industry, newer challenges have emerged and there is a need for ground work to overcome them.

Some of the major challenges are regarding safe handling and use of a vast and dynamic data base, founding of novel technology to replace established communication systems, security and privacy of a wide range of data, updating current regulatory and standardization status, developing infrastructure and mitigating socio-economic imbalances, to name a few [12,13,14,15]. With the realizaton of the fact that interconnected healthcare is the right of every individual and not a privilege, the application of interoperability is gaining signi#cance [16].

Geography speci#c market conditionsIndustry research on the medical devices markets promise substantial growth rates in the near future. As mentioned in Chapter1, increased awareness and attention towards healthcare, rapid growth of insurance sector, population explosion in developing nations and increasing trend of medical tourism are a few of the reasons that have accelerated the investments in this domain. Major markets such as the USA, European Union (EU), Japan and Canada may have to face slow annual growth rate in the coming years due to delays in regulatory approvals. In contrast, developing countries such as India and China, which are the emerging powerhouses of the devices market are o"ering double digit growth rates [17].

The USA market

The USA is now the market leader in production of medical devices with a turnover of US$120.4 billion in 2012 [18]. The USA medical devices market segmentation by revenue is represented in the following #gure. In spite of being the world’s largest market, America’s dominance in the sector has witnessed a downturn due to increase in the time required by the FDA for approval of medical devices from 90 days in 2005 to 140 days in 2010. Though the medical devices market has been estimated to grow at an average of 6.6% per year from 2012 to 2017, long drawn regulatory barriers are expected to be the primary reasons for the slowdown in this sector after 2016 [8,19].

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Geography speci#c market conditions


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The USA medical devices market is composed mainly of small enterprises with a few larger companies such as Abott, Baxter, Care Fusion, DENTSPLY, Edwards operating in the areas of diversi#ed medical products, immune disorder-infection, infusion, supply management, dental, heart valves respectively [20]. In 2007, out of 5300 medical device companies in the USA, 73% had less than 20 employees and only 15% had a maximum of 100 employees [20]. Companies are spread throughout the USA, mostly in California, New York, Pennsylvania, Michigan, Massachusetts, Illinois and Minnesota.

It has also been observed that over the past decade, the quantum of import of medical devices has increased in the USA, with China being the major supplier country. In 2010 the import and export of medical devices in the USA were US$ 27.3 billion and US$ 29.8 billion respectively.

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Medical devices product segmentation by revenue

3

18

6

53

22

10

$ 64.7 billion

Other medical and therapeutic devices

Spinal devices

Cardiovascular devices

Neuromodulation devices

Diabetes devices

Urology devices

Surgical technology



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One of the signi#cant announcements made by the FDA in December 2012 was on starting a public-private partnership venture to develop regulatory sciences that will speed up patient access to new medical devices technologies [21]. The new Medical Device Innovation Consortium (MDIC) was formed as an independent, non-pro#t corporation, receiving valuable inputs from all the stakeholders, with an aim to simplifying the process of medical devices design and pathway to market these innovations. MDIC may enable the medical devices industry to launch safe and e"ective devices to the market at a quicker pace and at a lower price. The establishment of MDIC probably would help mitigate the long drawn barriers for regulatory time which is considered a hindrance for faster market expansion.

Selected medical devices compaines which are showing accelerated growth in particular domains are listed below:

Illumina Nu Vasive Intuitive Surgical

Hologic Alere

Masimo Life Technologies

Integra LifeSciences ResMed Thermo Fisher

Personalized medicine; analysis of genetic

variation

Women’s health Broad‐based, in over 100 disease categories

Instrument and lab supplies

Noninvasive patient monitoring

Surgical products in orthopaedics

Sleep medicine and noninvasive ventilation

Analytical instruments,lab equipment

Minimally disruptive surgical products for

the spine

Robotic assisted minimally invasive

surgery



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European Union(EU) market

Europe is the second largest market for medical devices globally. It was reported that in 2007, the total turnover of the medical devices market was approximately €72.6 billion [23]. According to industry reports in 2009, Germany and France formed the larger markets with an estimated sales of €22.8 billion and €19 billion respectively [24].The United Kingdom and Italy form the other prominent markets of the region. According to Espicom report, the UK and Italy medical devices markets were sized at US$ 8.9 billion and US$ 8.4 billion respectively in 2012 [25,26].

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in INDIA MEDICAL DEVICES North American Industry Classi#cation System (NAICS) codes



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0

5

10

15

20

25

Germany France UK Italy

European Union medical devices market 2012(US$ billions)23.2

13.3

8.9 8.4

25

Asian market

As per Espicom report the Asian market in 2012 was valued at US$ 65.3 billion and is expected to exceed US$ 71 billion by 2015 [29,30]. The Asian market is complex and diverse due to the varying economic conditions of its constituent countries. One end of the spectrum is Japan not only leading the rest of the region with its largest market size, it is also the second largest market in the world. On the other end of the spectrum lie countries such as Bangladesh with negligible market exposure. Therefore, Asia o"ers a mixed bag of innovation, a"ordability and immense opportunity.

Japan

As mentioned previously, Japan stands apart from the rest in terms of market size for medical devices in the world and Asia. Additionally, Japan is also the third largest importer of medical equipment after the USA and Germany. Among the export markets in this segment, the country is the eighth largest in the world [31].




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0

5000

10000

15000

20000

25000 Asian medical devices market 2010(US$ millions)23922.0

2352.0 1517.1 1089.4 514.8 430.2 235.2 136.7

7445.9

JapanChina

India

Taiwan

Malaysia

Vietnam

Indonesia

Singapore

Bangladesh

26

IndiaThe Indian medical devices market is among the top 20 in world [33]. With its estimated size of about US$ 5.2 billion, it is basically import driven. Around 30% of the import is from the USA [34].The Indian medical devices market is a blend of a large number of small and medium sized companies focussed on producing equipment that are more cost e"ective than those manufactured by their global counterparts.

According to a report by KPMG, the medical devices market in the country is expected to grow by 23% to reach US$ 6 billion by the end of 2013 [35]. Some of the key players in the Indian medical devices market are B. Braun Pvt. Ltd., Johnson & Johnson Medical India (JJMI) Ltd., Nicholas Piramal India Ltd., Wipro GE Medical Systems, Medtronics and Boston Scienti#c [36]. Apart from those there are almost 700 Indian medical equipment companies that make a"ordable alternatives of the products o"ered by the giant players such as Phoenix Medical Systems and Per#nt Healthcare [34].

Other emerging markets

Rigorous regulatory processes, stringent reimbursement policies and ambitious procurement strategies are raising costs to manufacture and market medical devices in the developed world. In order to achieve cost containment, companies in developed countries are seeking to outsource some aspects of this develoment activty to countries outside the USA, mainly to the BRIC nations [37].

Some of the driving factors for growth in emerging markets [38]:

population are driving the demand for medical care.

healthcare services delivered in a technologically enabled environment, resulting in increased demand for healthcare IT related products and medical devices.

healthcare infrastructure indirectly impacting the medical devices market.




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Process "ow of rise of emerging market

For example, Chinese vascular and ultrasound market, Brazilian hospital bed market, Indian orthopaedic market are dominated by local players rather than MNCs. These products which are produced by the local manufacturers are comparable in quality with the MNC products but are available at a lower price. As a result, it o"ers a lucrative growth oppurtunity for the medical devices market [38].




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Global market scenario Geography speci#c market conditionsBene#ts of interoperability



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in INDIA MEDICAL DEVICESINTEROPERABILITY OF


Source: McKinsey & Co.

Phase IMNCs de#ne the market

and enter with high quality, usually imported devices

not available locally

Phase IILocal companies identify

the opportunity and reverse engineer/adapt to local requirements and get prepared to compete

with the MNCs

Phase IIISurvival of the #ttest



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28

Innovations in the domainThe innovation process involves extensive research and planning with a set of goals that the product should not only satisfy the market needs, but should also be #nancially pro#table for the manufacturer. Before initiating the innovation process, ample groundwork needs to be conducted. The major clinical demands are evaluated to analyse the market size, the extent of clinical impact and to the extent the product would satisfy the healthcare need. Information about the IP status of the intended device and its associated regulatory compliances need to be analysed. Subsequent to this foundation, the actual course of developmental action would commence. The entire course of action can be divided in the following phases.

This is a collective endeavour of multi-disciplinary teams such as research and development, marketing, legal, regulatory, reimbursement strategists, manufacturing, quality control and sales departments. Their contributions associated with the various phases of development are [39].




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Source: The Medical Device Innovation Process; John H. Linehan, PhD; Jan B. Pietzsch, PhD, Stanford University - Program in Biodesign [39].



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Phase 1: Initial opportunity and risk analysis

Phase 1a: List of clinical needs

Phase 1b: Market size, clinical impact

Phase 1c: IP analysis

Phase 1d: Detailed market analysis

Phase 1e: Regulatory, reimbursement

Phase 2: Formulation concept and feasibility phase

Phase 3: Design and development veri#cation and validation phase

Phase 4: Final validation, product launch

Phase 5: Product launch and post launch assessment

29

Global scenario in medical devices innovation

With growth in the demand for medical devices in emerging markets gaining momentum, the global perception towards innovation in medical devices technology has been changing in tandem. Though the USA still maintains its leading position in innovation, a steep rise in contributions by countries such as Brazil, India and China are tipping the scales and enormous growth is expected in these countries in this decade. The PWC Medical Technology Innovation scorecard has reported the relative status of advance in medical devices research #elds in the USA, UK, Germany, Japan, France, China, India, Israel and Brazil and is depicted in the #gure below [40]. It has been graded on #ve comparable parameters such as patents, number of researchers, publications, university and ease of regulatory approval.




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Reim

burs

emen

t

0%10%20%30%40%50%60%70%80%90%

100%

R &

D

Mar

ketin

g

Lega

l

Regu

lato

ry

Man

ufac

turin

g

Qua

lity

Clin

ical

Sale

s

Phase5

Phase4

Phase3

Phase2

Phase1

% Time breakdown per func onal group per phase30

Examples of a few breakthrough innovations in the medical devices industry

A few examples of outstanding achievents are listed below.

measure glucose level in blood non-invasively [41]. C8 MediSensors use Raman Spectroscopy to non-invasively detect glucose level in the body [42].

º Microsponges: Microsponges are biologically inert materials, made from synthetic polymers. These can store and protect the drug from the environment and provide a slow and sustained release [43]. º Implantable infusion pump: Implantable infusion pump is used to provide prolonged and intermittent drug action. They are used to deliver drug for the treatment of primary liver cancer, head/neck cancer, metastatic colorectal cancer, intrathecal therapy [44,45]. Medtronic SynchroMed® II programmable infusion pump is an intraspinal cathetar and can benon-invasively programmed [45].




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0123456789

10

US

Japa

n

Ger

man

y

Chin

a

UK

Fran

ce

Isra

el

Indi

a

Braz

il

Patents

Researchers

PublicaƟons

UniversiƟes

Ease of regulatory approval

31

PET scan: Positron Emission Tomography was considered the medical innovation of the year 2000 by Time magazine. It brings new hope to cancer patients by early detection of the tumour in the body [41].

Medical device interoperability: For obtaining e!cient real time electronic data transfer in healthcare, intercommunication of medical devices are the need of the hour. Interoperability or plug and play connectivity will improve synchronization, safety interlock and closed loop device control minimising the transcription error [46].

Barriers towards innovation

There is a sharp di"erence in innovation rates between developed countries and developing countries. Di"erences in research infrastructure, economic conditions, national and international regulatory status, cultural and social contexts are barriers and challenges to achieving the desired goals [47].

Few of the barriers are listed graphically below [47]:

Few additonal assertions

medical domain experts contributing to achieve a high quality and integrated result.




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Infrastructure

*Insu!cient sta"*Poor maintenance and repair quality

*Limited access to technical information*Lack of training

*Lack of funding

Regulatory status

*Di"erence in time of approval

*Literature not translated into national language

*Weak management culture

Barriers

Cultural and socialaspects

Economy

32

INTEROPERABILITY OF

in INDIA MEDICAL DEVICES 3Indian medical devices industry

Overview

India is a signatory to the Millennium Development Goals (MDG), a community of nations and international organizations representing comprehensive and speci#c objectives agreed upon by the world to be achieved by 2015. To achieve its goals, India has to gear up its healthcare systems, a sector which dominates the MDG agenda, wherein 3 out of 8 goals, 6 out of 21 targets and 16 out of 80 indicators are speci#c for the healthcare sector [1].

India, one of the fastest growing economies has seen a con#dent and resurgent growth in its healthcare sector over a period of time. Indian medical equipment industry is one of the most remunerative in the world. According to industry reports, the medical devices industry contributes about 9% of the cumulative healthcare revenues in the country.

IntroductionGlobal Medical Devices IndustryIndian Medical Devices Industry

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Prevalent market conditions

Market dynamics

Prominent players in medical devices market

Research and development in the medical devices domain

Overview of the regulatory standards in India

Case studies of attempts made at introducing interoperability standards

71%

9%

4%

13%3%

Diagnostics

Pharmaceuticals

Medical Insurance

Medical equipment and supplies

Hospitals

Source: India Brand Equity Foundation, November 2011

Revenue split by healthcare sectors in India

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Global market scenario Geography speci#c market conditionsInnovations in the domain

Classi!cation of medical devices in India

Medical devices in India are broadly divided into three main categories [1]:

Market share of medical devices

Medical equipment segment holds 55% of the total market share in medical technology. Medical imaging equipment such as SPECT, MRI, CT, in-vitro diagnostic and therapeutic equipment such as linear accelerators, gamma knives, etc. are a few among them.

Medical implants constitute the second biggest segment sharing 25% of the total market share. This segment includes stents, pacemakers, cardiac equipment, orthopaedics, eye, ear and dental implants.

Disposables and furniture contribute to the remaining 20% of the total medical technology market.




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55%

25%

20%

Medical equipment

Medical implants

Medical disposables and furniture

Medical technology market

Source: NIPER Ahmedabad Medical Devices Sector Analysis 2009 [1]


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Need for increase in use of medical devices in India [3]

India can be a classic example of the need for increased use of medical technology and devices for providing better healthcare services.




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Population demand

Inadequate and unequal resource allocation

to be middle class by 2020

to meet demand for next 5 years

concentrated in cities

High disease burden

(58/1000 births)

the world’s pregnancy related deaths.

diseases - TB, malaria leading causes of deaths

India diabetes capital of the world

covered by health insurance

Need for medicaldevices


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Prevalent market conditionsThe Indian medical devices market being valued at about US$ 1 billion in 2009-10 has been witnessing a growth at a CAGR of 17% for the past two years [4].

Most of the demand for increased use of medical devices in healthcare is from India’s ever expanding middle class and the a(uent class. This segment of society is growing at 17% annually and will probably continue a similar growth pattern for the next seven years [5]. In spite of a substantial presence of domestic device providers with more than 700 companies in this market, the medical devices industry in India continues to be dominated by multinationals, especially in high end medical devices space.

However, the domestic manufacturers enjoy their control over low value chain products like medical supplies and disposables [6]. Few of the devices that are witnessing accelerated growth rates are ophthalmic, dental, prosthetics, high and mid-tech equipment for endoscopy and cardiovascular devices [3].




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Medical devices - market size Medical devices - market pro!le (estimated)

38%

1%

18%

30%

7%4%2%

DisposablesConsumables

Surgical instrumentsMedical electronicsHospital equipmentImplantsDiagnostics 0

102030405060708090100

Indigenous percentage (%) Disp

osab

lesCon

sum

ables

Surg

ical in

strum

ents

Med

ical e

lectro

nics

Hospita

l equ

ipm

ent

Implan

tsDiag

nosti

cs

Imports percentage (%)

Source: Association of indian Medical Device Industry

36


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Import of medical devices in India

India is one of the major markets for import of medical devices from established companies, mainly composed of high value products. India relies on imports for about 75% of its medical devices demands, the main contributing nations being the USA and EU countries [7].

Export of medical devices

Even though 75% of high end medical technology products are imported, 60% of the products manufactured in the domestic market, mainly composed of low end products, are being exported [8]. Indian domestic medical devices market is focusing on exports in the product segment such as ophthalmic and laboratory equipment. According to a Business Standard Report, there are 200 medical devices manufacturers in Gujarat and 25-30% of their devices production is exported [9].

Market dynamicsThough India is listed among the top 20 medical equipment markets, the per capita spending of US$ 2 in 2011 keeps the market size relatively small. There has been a growing demand for medical devices, especially in the private healthcare sector, resulting in the medical devices industry gaining momentum [10].

Industry drivers [8]

Demographic factors

Varied population characteristics have contributed to the medical technology industry:

º The population above the age of 60 is estimated to increase from 89 million in 2009 to 316 million by 2050 [11].

º Increase in non-communicable diseases (NCDs) such as diabetes, cardiovascular diseases and cancers, contributing to over 42% overall mortality in India have also positively impacted the medical technology revenue generation [8].




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will increase from 8% currently to 13% by 2020, thereby resulting in increased demand for high quality health services [12].

Five Year Plan spanning 2012-13 to 2016-17 to increase the spending on healthcare from 1.4% to 2.5% of the GDP [13].

low socioeconomic population groups and to boost coverage, the government has been taking initiatives such as Employee State Insurance Scheme, Yashaswani, RSBY and various other insurance programmes. With the increase in number of people included in the ambit of insurance, the volumes for healthcare delivery would increase signi#cantly, thereby creating a demand for high quality medical devices [8].

also has contributed to the increasing revenue for the devices sector. Industry reports have estimated that 95% of new bed additions to the ecosystem will be driven by private players [14].

to avail a"ordable and high quality health care. Accreditations such as Joint Commission International (JCI) and National Accreditation Board of Hospitals (NABH) are helping hospitals to achieve desired international quality standards, thereby gaining a larger share of medical tourist market [8].

medical devices industry and establishment of a separate regulatory body for standards development, accreditations and certi#cations that may favorably impact and facilitate growth of this industry [8].

Indian companies are some of the tools to penetrate and capture opportunities in the potential devices market [9]. Few examples are:




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º Oyster Medisafe, a Hyderabad based medical devices manufacturer was acquired for its controlling stake by B. Braun.

º Trivitron Healthcare, a Chennai based medical technology company has acquired 100% stake in Finland based Ani Labsystems.

º L & T’s medical equipment business was acquired by Skanray Healthcare.

º Transasia Biomedicals, leader in in-vitro diagnostics in India acquired France based Maxmat S. A. This acquisition was made through Transasia’s Chezh subsidiary. Two USA based companies namely Drew scienti#c and JAS Diagnostics were acquired by Transasia, acilitated by Transasia Diagnostics- US unit.

º Bayer Pharma A.G’s (Germany) molecular imaging research and development portfolio was acquired by Piramal Healthcare.

Challenges in the Indian medical technology industry [8]

high-tech healthcare.

The market dynamics are bound to change with government initiatives for improving healthcare in India. Some of the noteworthy government initiatives to boost the healthcare sector have been in the 12th Five Year Plan, 2012-13 to 2016-17, which has its main focus on development of health care facilities.




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The Planning Commission has devised the #ve year plan strategy based on the vision of ‘Universal Health Coverage’ as de#ned by the High Level Expert Working Group. The plan envisions a"ordable healthcare with access to essential medical treatments and drugs for a large percentage of the population [15]. The government has permitted 100% FDI in healthcare (hospitals and diagnostic centers) and with prior approval from the government, for manufacturing and trading of medical equipment as well [16].

There have been a few research partnerships between indigenous companies and private #nancial institutions encouraging local manufacturers to develop a"ordable diagnostic technologies.

technology board, purchased the medical equipment business from Larson and Tubro (L&T) in 2012.

funded by Department of Biotechnology (DBT), Stanford University and others.

The last three companies have either availed soft loans from government bodies, or have been funded by the Indian Institutes of Sciences or the Indian Institutes of Technology [17].


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Prominent players in the medical devices market




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Case studies of attempts made at introducing interoperability standards Med tech companies in India

Edwards Life Sciences India Medtronic St. Jude Medical

Johnson & Johnson Stryker Becton Dickinson Boston Scienti#c Abbott Vascular Sushrut Surgicals Bausch & Lomb Trivitron Diagnostics

Baxter Accurex Biomedical Zimmer India Endomed Technologies

Surgicals Biopore HD Medical Services (India) Forus Health Harsoria Health Care

Eastern Medikit GE Healthcare Nidhi Meditech System Wipro Technologies

Philips Medical Texas Instruments HCL Technologies

3 M

40


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Research and development in the medical devices domainThe USA in the 20th century was one of the leaders in medical technology innovation due to its conducive environment for R&D activity. However, there has been a slowdown in the USA market enabling other nations to intensify their activities and level the playing #eld with their own R&D [19]. The Indian medical technology industry is now drawing the attention of investors, resulting in a growth spurt.

Innovation derived breakthrough products and their application in developing their respective business models can drive companies to venture into newer markets [14]. India is the second most populous country in the world and its healthcare sector has fallen short of indigenous supply of equipment. The need for innovation is the key to provide a"ordable healthcare service to its rising population. Frugal innovation would help assist inexpensive innovation methodologies to meet the demands during resource scarcity [8].

Innovation in India [20]

According to the PwC innovation scorecard tool, the Indian research statistics on the medical devices domain and investment in R&D are still very low compared to other industrialized countries. To drive innovation in medical technology it is crucial to invest in research and development, which will encourage the domestic manufacturers to develop innovative products. Innovation requires active collaborations between key entities and stakeholders. Leveraging medical technology to provide better outcomes is the sole purpose of innovation. Manufacturers have to work in tandem with hospitals, academicians and clinicians in India to develop new products.




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Expenditure on R&D as per % GDP

3.5

00.5

11.5

22.5

3

0.8

1.49

3.45

2.55 2.67

India

ChinaGer

man

y

Japan

USA

Researchers per million inhabitants

0

1000

2000

3000

4000

5000

6000

1071

3453

4663

137

5573India

ChinaGer

man

y

Japan

USA


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Research and development in the medical devices domainSome of the Indian innovations of importance are:

ECGs and ultrasound systems by GE [21, 22].

process simpler, safer and more accurate. The equipment costs INR 15 lakhs which is cheaper than imported alternatives which would cost twice as much [3].

electronic intensive care unit.

engineering company, to be loaded with latest IT solutions making it a complete cancer diagnostic system [9].




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Overview of the regulatory standards in IndiaOne of the signi#cant aspects of regulatory standards in India is the presence of multitude of regulating agencies.

and Cosmetics Act (DCA), 1940 and Rules, 1945. The centralised authority controlling medical devices is Central Drugs Standard Control Organization (CDSCO) under the Drug Controller General of India, a constituent of the Ministry of Health and Family Welfare [23, 24].

been working on restructuring the Indian medical devices regulatory framework since 2008. One of the signi#cant proposition suggested by the DST was creation of Medical Device Regulatory Authority which would operate within the CDSCO [25, 26].

Central Drug Authority, which would have a similar approach as of USFDA. In 2009, the CDSCO released the Schedule M III in which an o!cial de#nition for medical devices was provided. It also outlined a four- level risk classi#cation scheme for medical devices. This notice was approved by the Government of India but medical devices industry continues to be unregulated in practice [25].

Health and Family Welfare to standardize and make transparent the process of procurement for medical equipment, which was updated in 2011. The compendium provides technical speci#cations for medical devices to be used in various areas of medicine like cardiology, radiology, ophthalmology, etc. The compendium was valid until March 31, 2013 [27].

Medical devices in India are regulated as drugs and those that are not de#ned as drugs as per the Drugs and Cosmetics Act (DCA), 1940 and Rules, 1945, require an import license. In the present scenario there are no quality systems for medical devices in India [28].




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A timeline of major milestones for medical devices regulation in India




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2005 2006 2008 2009 2010

MoHFW-videgazette noti#cation

Compendium for Technical

Speci#cations

Noti#cation forthe registration ofmedical devices

CDSCO’sdeclaration on registration of sterile medical

devices

Medical Device Regulation Bill by Ministry ofScience and Technology

Restructure the regulation for

medical devices byDST and MoHFW

New guideline formedical devices

productregistration

Schedule M IIIrelease by CDSCO


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Medical Device Regulatory Authority

As per the proposed bill, the objective of MDRA would be to regulate and monitor the design, testing and evaluation, manufacture, packaging, labeling, import, sale, usage and disposal of medical devices, to ensure availability of safe medical devices for human use in the country.

The MDRA may facilitate the following pertaining to medical devices:

With a view to the implementation of the objects speci#ed, the MDRA, as a verbatim reproduction of the draft bill can:

Provide for noti#cation of essential principles of safety and performance of a medical device and the requirements for design and manufacturingProvide for risk based classi#cation of medical devices Notify the standards and guidelines in relation to medical devices and specify an appropriate system for enforcing various standards noti#ed under this ActProvide for a mechanism for conformity assessment using direct or third party noti#ed bodiesNotify the method of conformity identi#cation by assigning marks or other meansSpecify the requirements pertaining to conformity assessment of imported medical devices, refurbished devices, date expired devices, custom made devices and other special cases Stipulate the procedure and guidelines for testing laboratories and referral testing laboratories and noti#cation of the sameProvide for the exchange of information among the noti#ed bodies and other enforcement authorities Prescribe methodology for implementing and operating a vigilance and post-market surveillance system and taking preventive and pro-active measures Provide for enforcement of the various provisions stipulated in this Act and those relating to o"encesStipulate the manner and procedures for risk management and risk bene#t analysis. Objects and functions of MDRA provide for all or any of the other matters as speci#ed in this Act.

Along with these objectives, MDRA will also help in: Developing national/ international technical standardsSupporting international e"orts to improve and harmonize standards and regulatory practicesPromoting networking of national and international organizations to facilitate cooperation and facilitation among scienti#c groups, information and expertise exchange.




Interoperability



Overview




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Interoperability



Overview


Market dynamics





46


Interoperability



Overview


Case studies of attempts made at introducing interoperability standardsHL7 India: Health Level Seven India encourages standards adoption in medical device interoperability within India. It is an international a!liate of Health Level Seven International for India, the objective being development, promotion and implementation of international standards to be adopted by healthcare organizations, professionals and healthcare software suppliers in India [29]. Scarcity of HL7 trained professionals in India is now addressed by HL7 training and certi#cation programmes o"ered across the country targeting health management schools and healthcare focused IT #rms [30]. It successfully launched its e-learning programme in March 2010 [31].

DICOM: Digital Imaging and Communications in Medicine is an international standard which #nds widespread application in imaging equipment, printers, picture archival and communication systems (PACS). It focuses on convenient work$ow between imaging modalities 32, 33. In line with HL7, DICOM is organising conferences which will help increase the knowledge base of software developers and architects, medical imaging system integrators, physicians concerned with medical imaging, academia in medical imaging informatics, with the latest conducted in March 2013. The conference will provide educational presentations on implementation related issues of DICOM standards in India and their current activities [34].

LOINC: Logical Observation Identi#ers Names and Code is a universal code system used for laboratory and clinical #ndings [35]. From blood test to measurement of blood pressure, LOINC has a standardized term for all kinds of medical data which enables the communication of data within di"erent systems [35]. Indian Health Service(IHS) O!ce of Information Technology has planned a project with LOINC to ensure correct LOINC codes in their hospital information systems to match with Centers for Medicare & Medicaid Services(CMS) ‘meaningful use’ standards and agency standards [36].

ICD: The International Classi#cation of Diseases is a standard tool to code for diseases and procedures [37]. ICD-10 helps in summarizing and reporting data with the use of national electronic health records and interoperable information network [38].




Interoperability



Overview




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Interoperability



Overview


Market dynamics




Case studies of attempts made at introducing interop-erability standards

47

INTEROPERABILITY OF

in INDIA MEDICAL DEVICES 4Interoperability

Overview

Interoperability in healthcare can be compared with the nervous system of the human body, wherein standardized information is conveyed back and forth for seamless understanding, analysis and e"ective information sharing [1]. The concept behind it is to accept basic electronic communication standards such as controlled vocabularies, code-data set, etc. that will enable stakeholders to uniformly transmit, store, manage and interpret data 2. While the development of a design for an individual medical device itself is so complex, the concept of plug-and-play increases the design complexity further [3]. A manufacturer may not be inclined to adopt interoperability features for his stand-alone instruments [3,4] There are barriers to adoption such as time, resources, cost, space, power consumption and system resources that need to be considered before the implementation of such features into a particular design. Strategies to simplify adoption of interoperability features such as integrated approach and modular approach, [3] being proposed to devices companies to encourage adoption with their products [3].

IntroductionGlobal Medical Devices IndustryIndian Medical Devices IndustryInteroperability



Overview

Overview of Continua Health Alliance

Continua Health Alliance de#nition of interoperability

Development process of Continua Alliance guidelines

Continua certi#cation

Certi#cation process in Continua Health Alliance

48


Interoperability



Overview


Interoperability can be most convincingly de#ned by the following graphical representation [5]:

With the ever increasing burden of diseases globally, there is a dire need to adopt advanced technologies to extend healthcare services beyond the conventional clinical surrounding to a more personal and home based setting. In such scenarios, creation of private tele-health ecosystems becomes the need of the hour, and along with it, interoperability becomes the prime criteria for better delivery of care from the provider, and for e"ective and easy management of the condition by the patient. Continua Health Alliance was formed with the core ideology to advocate and provide guidance for interoperability adoption in such emerging tele-health systems [6].




Interoperability



Overview




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Uniform presentation of data

Transfer of data from one system to another keeping the purpose and meaning unaltered

Uniform movement of healthcare data

Uniform user control

Uniform safeguarding of data security and

integrity

Uniform protection of patient

Uniform assurance of a common degree of

system service

Use of underlying systems by di"erent stakeholders to keep consistency of data

Contextual information and navigational control should be present consistently

Restricted access of the data is required to maintain the quality and integrity

Con#dentiality of the patient should be maintained by restricting user

Complete availability and responsiveness of the system




Overview






49


Interoperability



Overview



Continua publishes Design Guidelines for end-to-end, plug-and-play connectivity in personal connected health, based on global industry standards for interoperability. Continua is actively engaged in partnerships with 13 international standards bodies, including IEEE, ISO, HL7 IHE, and W3C, currently represented in the Design Guidelines. Certi#cation according to Continua’s Guidelines signi#es compliance with global industry standards, and is proven to decrease time to market and reduce development costs. In order to better structure its activities, Continua Health Alliance classi#ed the market into three primary segments. In the wellness segment, Continua member organizations assist people to better manage their wellness and #tness activities with e"ective usage of interoperability standards in the devices used. Similarly, other member organizations help people manage chronic diseases and many others empower the geriatric population to live longer independently in an interconnected environment of their medical devices, to both their mobiles and computers, and to their family and care providers [7].

With more than 2000 members involving themselves in di"erent working groups in the organization [9], Continua Health Alliance comprises a group of health device original equipment manufacturers(OEM), service providers, aggregation managers(AMs) and silicon vendors, working collectively to promote interoperability guidelines for personal healthcare devices.




Interoperability



Overview




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Health and wellness

Living independentlylonger at own homeby using technology

Chronic condition management outside

the clinical setting




Overview






50


Interoperability



Overview



Continua phrases interoperability as “the ability of a client component in a device to communicate and share data with a variety of server components in an unambiguous and predictable manner to exchange data accurately, e"ectively and consistently “[8].

Continua’s objective is to form an ecosystem of connected technologies, which will enhance the e!ciency of exchanging healthcare data. The foundation of this network is based on a set of interoperability guidelines which designate how devices manufactured by multiple companies can co-operate. The #rst set of Continua standards focus on particulars of available standards of Bluetooth, USB, IEEE 11073 and HL7. That will facilitate the patient to monitor weight, blood pressure, glucose, oxygen levels and share the data with their physician [10]. Till date Continua has selected standards for their appropriate interfaces as described in the table below [11].




Interoperability



Overview




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Interfaces Standards

Device ConnectivityPersonal area network(PAN)Local area network(LAN)

ISOIEEEBluetooth: Health Device Pro#le (HDP)Bluetooth Low EnergyUSBZigBee

Wide Area Network (WAN) Interface Combination of Ethernet, WiFi and cellular

Health Records Standards Integrating the Healthcare Enterprise (IHE) CrossEnterprise Document Reliable Interchange (XDR)

Health Level 7 (HL7) Personal Health Monitoring (PHM) Report




Overview






51


Interoperability



Overview


Standards for PAN and device data exchange have been identi#ed and developed in version 1 of Continua’s guidelines, particularly in the area of extension of IEEE11073 standards for Personal Health Devices (PHD) [13]




Interoperability



Overview




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Device/other Standard StatusPulse oximeter

ThermometerWeighing scaleGlucose meterCardiovascularStrengthActivity hubOptimized data exchange

Blood pressure monitor

Basic ECGINR-blood coagulationInsulin pumpBody composition analyzer

Physical activity monitorPeak $ow

Medication monitorTechnical report- overview

Completed

CompletedCompletedCompletedCompletedCompletedCompletedCompleted

Completed

DraftDraftDraftDraft

DraftDraft

CompletedDraft

IEEE 11073-10404

IEEE 11073-10408IEEE 11073-10415IEEE 11073-10417IEEE 11073-10441IEEE 11073-10442IEEE 11073-10471IEEE 11073-20601

IEEE 11073-10407

IEEE P11073-10406IEEE P11073-10418IEEE P11073-10419IEEE P11073-10420

IEEE P11073-10443IEEE P11073-10421

IEEE P11073-10472IEEE P11073-0103




Overview






52


Interoperability



Overview


The Continua Network Architecture [7]




Interoperability



Overview




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Source: The Next Generation of Healthcare: Personal Connected Health & Wellness www.continuaalliance.org

Personal Device

Thermometer

Thermometer

Pulse/blood pressure

Weight scale

Weight scale

Cardio/ strength

IndependentLiving activity

Peak $ow

MĞĚŝĐĂƟŽŶadherence

Physical activity

Elecltrocardiogram

Insulin pump

Continua architecture - we enable PCH at the intercace

AggregationManager

TelehealthServiceCenter

HealthRecords/Networks

PHR

EHR

NHIN

HIE

WiFi, 2G,3G & 4G

PersonalArea

Network(PAN)

Interface

WideArea

Network(WAN)

Interface

HealthRecord

Network(HRN)

Interface




Overview






53

Interoperable device ecosystem of Continua uses Personal Area Network Interface connecting a personal computer, or a mobile phone or dedicated cellular hub and such application hosting devices with a PAN device. A PAN device can be a sensor (glucometer, pedometer, heart rate monitor) or an actuator (device that can shut o" gas in an emergency or sets o" an alarm). PAN interface has lower and upper open system interconnection layers. ISO/ IEEE 11073 Optimized Exchange Protocol is used to implement PAN interface upper layers and lower layers and both wireless and wired links such as Bluetooth (HDP) or USB respectively.

The bound PAN device’s information is aggregated and shared by a LAN device which is connected to the application hosting device via a Local Area Network Interface. LAN devices can also provide sensor and actuator functionalities directly. This implies that both LAN and PAN interfaces can use the same device data model, thereby aligning to the core ideology of interoperability.

Application hosting devices are connected to one or more Wireless Area Network devices via a WAN interface. A WAN device provides a wide range of value adding services by collecting all the information, for example health monitoring services hosted on a network based server. The upper layers of the WAN interface and LAN interface use compatible device data models.

A WAN device communicates with the health record device via the Electronic/Personal Health Record Network Interface which provides a health record database, managed and operated by traditional healthcare service providers [6].


Interoperability



Overview





Interoperability



Overview




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Overview






54

Development process of Continua Alliance Guidelines Continua’s Design Guidelines enable alignment of di"erent vendors and domains focussing on chronic disease management, independent ageing and health and wellness. Continua’s approach is inspired by di"erent solution domains such as Wi-Fi Alliance and Digital Living Network Alliance. The use of industry standards is the foundation for development of design guidelines by Continua. The result is the adaptation of the following methodology [ 6]:


Interoperability



Overview





Interoperability



Overview




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Continua process: developing the Design Guidelines

1. Submission of ideas2. Use case development3. Balloting4. Use case sponsorship5. Decomposition into work items6. Gap analysis7. Guidelines development8. Balloting9. Approval10. Testing11. Public release & comment period

Development cycleUse case

Requirements

Standards

Guidelines




Overview






55


Interoperability



Overview





Interoperability



Overview




INTEROPERABILITY OF






Overview






Submittals are consolidated with the generalised use cases list

Capabilities, interfaces and devices are prioritsed based on the listings

Derivation of desired functionality and requirements for the guidelines

Survey for existing standards building organizations in the industry

Selection of candidate standards

Selected standards are relooked for if they identify and address the gaps

Formation of guidelines over standards

Member submits use cases with regards to problems in interoperability

56


logo which ensures the interoperability of the product with other certi#ed products 10. This certi#ed technology ensures the advantages of devices data over manually input data by


Interoperability



Overview





Interoperability



Overview




INTEROPERABILITY OF






Overview






57


Continua Health Alliance o"ers free test tools and Continua Certi#ed Experts (CCE) to help the members in their product certi#cation process. It also provides for testing and certi#cation training programmes for technology teams desirous of seeking Continua certi#cation for their products [15].


Interoperability



Overview





Interoperability



Overview




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After completion of theproduct, member startspre-testing by usingtransport of Continua test tools

After the certi#cation process legal document is signed

PAN certi#cation tests are done attest labHRN self test are performed by Continua vendor

1st prepare

to certify

2nd apply toContinua

3rdTest at Continua

lab (PAN) orSelf-test (HRN)

4th Receive certi#cation

mark

After pre-testing member appliesto ContinuaTest lab provides testing date tomember




Overview





Certi#cation process in Conti-nua Health Alliance

58

INTEROPERABILITY OF

in INDIA MEDICAL DEVICES 5Interoperability standards in India

The gaps and barriers to acceptance

The major gap in the context of medical devices interoperability is a conspicuous disparity between expected standards and existing standards. Analysing the gap would be the #rst step in understanding the current status and to strategize to augment remedial measures, either to minimise or eliminate the gap. This is a major priority since Indian medical devices market is showing signs of promising double digit growth in the future.

One of the major di"erences and a barrier that separates India from other established markets in setting of uniform interoperability standards is the presence of a multitude of agencies regulating medical devices in India. For example, in the USA it is the FDA, the MHRA in UK, French National Agency of Medicine and Health Products Safety (ANSM) in France who deal with food, drugs, devices and other related aspects under a single banner. This avoids duplication of e"orts and promotes better regulation and monitoring which bene#ts both the manufacturers and customers. However in India, medical devices do not have any separate regulatory status. Central Drugs Standard Control Organization (CDSCO) is mainly responsible for its regulation. In addition to it, Ministry of Health and Family Welfare (MoHFW), Bureau of Indian Standards (BIS) and Atomic Energy Regulatory Board (AERB) also regulate various aspects of the medical devices electronic sector. Due to multiplicity of agencies, there is a dearth of co-ordination, the end result being confusion regarding regulation [1].

To avoid the problem of diversity and to introduce harmonization in Indian medical devices regulation, a draft bill has been proposed to establish a distinct governing body, to be named Medical Device Regulatory Authority (MDRA) [2]. Additionally, the medical devices industry is highly dynamic and an appropriate framework for Intellectual Property Rights protection is an absolute necessity if India is to promote innovation and R&D locally. Disparity in standardization and regulation in medical devices market is pulling down the healthcare interoperability grade in India. Therefore the key aspect lies in identifying the root cause for the gaps and bridging them. This chapter focusses on some of the main areas of concern in Indian medical devices industry.

IntroductionGlobal Medical Devices IndustryIndian Medical Devices IndustryInteroperabilityInteroperability standardsin India



Introduction of interoperability standards

Overcoming the challenges of introducing interoperability standards

Collaboration of Continua standards with Indian regulatory standards

Impact of introducing interoper-ability standards in India

59

The following are some of the major barriers or hindrances leading to gaps in standards:

Management of vast and dynamic data bases: This is a general gap due to the inherent complexity of medical domain itself. Due to close interaction of complex systems, e.g. during diagnosis and investigation of disease, treatment, procedures, drug and pharmacology, disease classi#cation, large volumes of data are generated. To manage this entire range of data and to enable them to be shared among di"erent devices, it needs infrastructure in terms of technology, standardization, skilled and quali#ed personnel [3].

Multiple gateway technologies and other technical aspects: Availability of di"erent gateway technologies is reducing the incentive for di"erent healthcare providers in setting up certi#ed interoperable devices in their healthcare facilities. The current commercially available gateway equipment and software enables the healthcare facility to create an interoperable environment with their existing equipment, but in the process, such multiple gateway software increase complexity of the process.

Indian technology sector is driven by low level of broadband and personal computer penetration. Biased technical rules and regulations too are creating hindrance to attaining the goals of medical device interoperability standards [4].

Insu#cient budgetary allocation: As mentioned earlier, three-fourth of the Indian medical device market is driven by import. To reduce dependency on imported devices, incentives [1] should be introduced in the market. It is observed that the most technologically advanced and hi-tech products are developed in an ecosystem driven by innovation. There is a need for such aninnovation cycle to be developed in India to achieve an indigenous manufacturing ecosystem. This over a period of time will reduce dependence on imports and enable the country to achieve a well framed eco-system.

As per The Indian Medical Device Market Outlook [5] the domestic manufacturing industry currently is largely focused on low value products. There is a need not only for investment in medical devices market across the value chain, but also an immediate necessity of standardization in terms of interoperability before a large segment of domestic industry engages itself into manufacturing high end devices. Enormous monetary involvement is needed to re-establish a complete framework. Alteration in entire software and hardware setup and availability of trained and skilled professionals, are holding back the industry from taking up such initiatives [6].

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60

Patient healthcare information (PHI) privacy and security: Con#dentiality of the healthcare data is of prime concern [8] as healthcare organizations are challenged with two opposing sets of requirements. On the one hand they have to meet the expectation of medical practitioners to enable them to seamlessly access data and on the other hand to meet the expectation of the patient to maintain the privacy and security control of personal data.

As the dynamic healthcare sector reaches beyond hospitals to neighbourhood clinics and home based care, privacy of patient data and healthcare databases are a signi#cant challenge and industry must leap one step ahead to protect data infringement. There are three major security concerns namely internal breach, regulatory compliance and inadequate deployment of technology.

Ensuring a streamlined data security and auditing is a major gap that has to be bridged. With economic liberalization, Indian healthcare outsourcing market is being consolidated. To utilize maximum potential it has to move towards higher level in the value chain. Lack of stringency in data protection act is inhibiting the Indian outsourcing market from $ourishing [9].

Current regulatory and standardization status: There are inadequate regulatory guidelines and a large number of devices are still dealt under Drugs and Cosmetics Act (DCA) of 1940. Thousands of newer devices like heart valves, cardiac stents, scalp vein sets are not covered under DCA and do not require registration at all [10]. Poor regulatory plan and structure is one of the root causes for de#cient advanced interoperability standardization in India[11]. In 2006, Ministry of Science and Technology has proposed the Medical Devices Regulation Bill (MDRB) which has the agenda to establish a Medical Device Regulatory Authority(MDRA) in India[12]. Lack of e"ective privacy legislation and improper cybercrime and intellectual property act also act as barriers to achieving success in the attempt to bring about healthcare interoperability [4]. The royalty paid for the patent associated with the interoperability software is counterproductive [13].

Organizational interoperability: Indian organizational processes are not pliable enough to be interoperable. Joint initiative of the public and private sector to co-ordinate with each other is the need of the hour[14]. Independent initiatives to implement standard and certi#cation processes by di"erent organizations have led to overlap and competition. In a resource constrained business environment such as India, with a few institutions charging a fee for implementing standards, it is resulting in increase in the cost of certi#ed products, thereby surfacing as a barrier to adoption[15]. Moreover restriction of componentization and standards exists within a device manufacturer’s establishment due to a vertically integrated environment [7]. This setting is highly non conducive for devices integration between products from di"erent manufacturers.

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Adoption of standards across the nation: The medical equipment market is largely driven by mega healthcare facilities located in major cities in India. As identi#ed in the WHO Priority Medical Devices Project, lower adoption is a result of 4As - A"ordability, Accessibility, Appropriateness, and Awareness [1] The adoptability of medical electronic device is notably lower in smaller towns and rural areas. As nearly 70% of the nation is rural, interoperability standards will have to be adopted in tier II and tier III cities as well.

Apart from the above mentioned areas, availability of limited quantitative research and heterogeneity of the systems create complications in implementing interoperability standards in Indian healthcare industry [16].

INTEROPERABILITY OF


Insu!cient budgetary allocation

Lack of adoptability

Lack of participation in international standard development process

Inadequate infrastructure to develop standards

Inadequate funding in standardization

Insu!cient standardized resources

The feature and specialization of most of the imported devices are

not customized to appropriately #t in Indian

market

With the economic liberalization. Indian healthcare outsourcing market is getting extreme popularity. Lack of data protection

law is limiting Indian outsourcing companies to the lower end of value chain, restricting them only to medical billing,

insurance claim processing and transcription. To initiate seamless $ow of data India

needs advanced data protection law.

Lack of awareness of national importance of standards. Private industries are less involved

in development of standards. Healthcare facilities are not willing to invest

on new concept of interoperability unlessthey are sure about the longevity of the

implemented standards.The healthcare information is

highly sensitive. To run interoperability, seamless $ow of data requires higher level of

privacy protections, quality assurance and security.

Unauthorized accidental or intentional disclosure of PHI is considered violation of HIPPA

Patient Healthcare Information (PHI),

privacy and security

Availability of multiple gateway

technologiesIs a barrier to

achieveinteroperability

standard

Availability of advanced gateway

technologies are further

complicating the acceptance

of standard interoperability

guidelines by the healthcare providers.

Gap and factors augmenting the gap

Augmenting factor

The gap








62

Introduction of interoperability standards Interoperability standards in health care IT play a very important role. They are essential to ensure that di"erent medical devices can be used seamlessly. Established recognizable standards hasten the approval process making it easier and less expensive [18]. The #rst healthcare interoperability testing was conducted in India in March 2011 at the Phillips Innovation Centre, Bangalore, organised by Integrating the Healthcare Enterprise. The point of discussion was relevance of interoperability in healthcare.

Lately with India being an attractive market for the healthcare investors and considering the expected escalation in growth, there is a rising need for interoperable healthcare products in the country. Standardization will allow both small and big investors to compete with each other and aid the consumer to get cost e"ective and improved outcomes [19].

MCIT (Microsoft certi#ed IT professional) and Apollo Health Street Limited (AHSL) have taken initiatives to set up interoperability standards in India. They fabricated a national structure for Information Technology Infrastructure for Health through health information standards [3]. The major areas which were addressed include:

INTEROPERABILITY OF


Principal healthcare components

Data elements

Health identi!ers

Clinical data representation (Clinical Standards)

Minimum data sets

Healthcare billing formats

Message standards

Public informatics education

Privacy and con!dentiality information




Introduction of interoperabil-ity standards




63

Data elements include patient demographics, hospital administration data and health assurance data. Health identi#ers focus on healthcare professional’s data, healthcare facilities’ data, and individual and employee identi#ers. Clinical standardization classi#es three critical areas such as disease codes recommendation by ICD-10, procedures codes by ICD-10-PCS and clinical observation codes by LOINC (Logical Observation Identi#ers Names and Codes). They further suggested text messaging standardization by HL7 and imaging standard by DICOM [3].

Overcoming the challenges of introducing interoperability standards Earlier attempts to introduce standards in interoperability were fragmented in nature involving various standard building organizations. In spite of the challenges in interoperability standard adoption and implementation, there are holistic ways forward with approaches to overcome the challenges involving all the stakeholders. Adoption of standards would require innovative and creative solutions that could work in multiple organizational environments. Strong leadership accompanied by collaborations and expectations of multiple parties will enhance the awareness and adoption status of interoperability standards. Discussed below are the roles of multiple stakeholders in this industry.

Government and regulatory bodies: A dedicated regulatory framework exclusively for medical technology industry would address the issues of multiple proponents involved in this sector and would facilitate creation of new regulatory paradigms in this #eld. Government initiatives for introducing incentives would promote broader interoperability standard adoption among the industry. Improving standard enforcement and ensuring the participation of domestic market is possible by aligning incentives, expectations and accountability [20]. As the manufacturing costs for standard driven interoperable devices are high [21], funding resources must be identi#ed. Such measures and government assistance will help overcome price barriers for research and development initiatives. There is also an urgent need for development of health information security systems across the country for a widespread acceptance of mobile medical technology. Currently apart from C-DAC (Centre for Development of Advanced Computing) there does not exist any other agency working towards Health Informatics and Electronic Health Records [22] in India.

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Interoperability and standards promoting organizations: Multiple standard development organizations compose their respective individual standards. These standards however tend to get non interoperable at an inter institutional level [23]. Such issues can be checked by standard promoting organizations such as Continua Health Alliance. These organizations similar to Continua would work with existing standard bodies to resolve gaps and provide guidelines for optimum use of interoperability standards. In the lines of Continua, product certi#cation programmes are e"ective ways of interoperability and standard adoption as these certi#ed devices will produce recognizable logos as a promise of interoperability. Such certi#ed products hence would also decrease the complexity of interoperable environment brought about by multiple gateway software [24].

Devices Manufacturers

º Vertically integrated environment of device manufacturers restricts standardization to their respective premises. It is a major challenge in industry wide standard adoption which is important in producing interoperable medical devices. This can be combated by industry initiated workshops which would involve major industry players. Such frequent activities would encourage a lateral work progress among multiple manufacturers advocating standard adoption among the industry.

º A consortium of medical devices manufacturers across the country would promote adoption of industry wide interoperability standards.

º This consortium of medical devices manufacturers should work laterally with government and standards advocacy agencies such as Continua to bring about nationally harmonized standard acceptance.

º Encouraging the vendors of medical devices manufacturers to produce standard driven ancillary devices would help disseminate standard acceptance across the spectrum.

º Medical devices industries can build the capacity of their workforce by educating them on the advantages of adopting internationally accepted interoperability standards.

º Major medical devices manufacturers in the country can take lead in acknowledging standards in interoperability by following the standards themselves. This would create a baseline of industry standards encouraging smaller companies to follow their lead.

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65

Healthcare providers: As consumers are the direct bene#ciary of interoperable medical devices, hospitals and other healthcare service providers should insist on interoperable, standard driven medical devices. The development and testing costs are high for industry wide standards adoption. The healthcare providers therefore should o"er clear and consistent requirements as customers to the device manufacturers. This would improve the incentive $ow from the consumers, encouraging device manufacturers. Approximately 26.3 million people in India have access to internet via their mobile phones among active internet users in the cities [25]. Hospital administrators therefore must consider mobility of hospital environments beyond their walls and should try to leverage this usage of medical devices for improved and cost e"ective healthcare delivery.

Collaboration of Continua standards with Indian regulatory standards Continua is dedicated to the development of Design Guidelines and test tools to expedite the deployment of personal connected health devices and systems that will dramatically improve health management, clinical outcomes and quality of life. In India, Continua wishes to craft a"ordable healthcare plans for patients with limited healthcare access. The company provides guidelines for medical devices interoperability grouping together di"erent standards put forth by multiple organisations such as International Standard Organization (IEEE 11073), HL7, DICOM, etc. However, as one of the standard developing organization by itself, Continua cannot address multiple issues in devices interoperability [26].

As an initial step, the Continua Health Alliance supported by the Telemedicine Society of India, decided to launch the Continua India working group in November 2011.

In India, government organizations such as the Department of Information Technology (DIT) and Indian Space Research Organization (ISRO) have for promoting e-health along with Ministry of Health and Family Welfare (MoHFW) and Ministry of External A"airs (MEA) [27]. As part of this broad implementation plan for uniform standards in e-health, the government bodies have taken multiple initiatives wherein DIT has de#ned the standards for telemedicine systems and the MoHFW has set up a national telemedicine task force [28].

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Collaboration of Continua standards with Indian regula-tory standards


66

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The central government’s Bureau of Indian Standards (BIS) was established to promote standardization in multiple sectors in the country. BIS operates various Management System Certi#cation Schemes under which it provides licenses to various organizations and service providers [29]. Identifying and collaborating with such organizations will facilitate standard development and information exchange, synergizing the complete ecosystem.

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National TelemedicineTask Force

Interoperability,standards for datatransmission, training

De#nes nationaltelemedicine grid

De#nes standardsand structures forEMR and patientdatabase

Drafts for nationalpolicies on telemedicine

Sets up Health SATProvidestelemedicine facilitiesto rural India

ISRO

Involved innetworking of districthospitals

Setting up communityinformation centres

Telemedicine and telehealth educationfacilities

DITIntitiated projects:Integerated Disease Surveilllance Project,National DigitalMedical LibraryConsortium,National Rural TelemedicineProject, NationalMedical CollegeTelemedicineNetworking

MoHFW






Collaboration of Continua standards with Indian regula-tory standards


67

Impact of introducing interoperability standards in India Identi#cation of existing standards is critical for both introducing as well as assessing the impact of interoperability. Addressing a particular requirement using an existing standard is often better than creating an altogether new speci#cation, irrespective of its complexity or status of completeness [35]. Accepting the world class international interoperability standard among the medical devices manufacturers and the regulatory bodies will help develop better standard based interoperable framework, allowing safe and e!cient incorporation of unique clinical solutions [36].

notable number of healthcare service providers will request for interoperability functionality, creating market incentives for the participating vendors, and encouraging adoption of these standards6. Healthcare players are becoming increasingly sensitive to pharmaco-economic evaluations when it comes to product manufacturing and reimbursements [37].

bodies will minimize e"orts on medical devices interface integration [21].

applications. Collaborations of international standards with the existing national guidelines will encourage research and development to provide solutions pertaining to the current clinical and economic requirements [21].

third party to integrate standard compliant devices which in turn makes the entire process economical, thereby making healthcare devices utility a"ordable and accessible to a wider population.

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Impact of introducing interoperability standards in India

68

complete standards, a few issues are inevitable [26]:

º Reduced functionality: the amateur status of the standards may hinder the complete coverage in all user cases. º Lower acceptability: a widespread adoption of standards will determine its long term success. The mainstream medical devices players can be reluctant to adopt standards as the assumption of these standards may not be suitable for them.

India therefore is in an urgent need for change in the medical devices regulatory framework and standards. The current scenario of devices standards and interoperability in India would markedly change on collaboration with Continua. The joint e"ort would bene#t the medical devices fraternity by giving indigenous products a global competitive edge which would further encourage exports of high end devices. Continua collaboration would also improve healthcare delivery in India by encouraging the tele-health industry bringing together standards and health technology solutions.

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Impact of introducing interoperability standards in India

69

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in INDIA MEDICAL DEVICES 6Conclusions and recommendations

The Indian medical electronics sector and its products in the healthcare domain have been on a positive growth path in the past decade. However the accessibility, a"ordability and market penetration of medical technology remains a challenge in a highly socioeconomically diverse India. With the rise in the population and increased demand for standardized healthcare, medical device interoperability has a prime role to play in providing e!cient healthcare in India. While many such challenges exist, one of the obvious problems in achieving devices interoperability is de#cient standardization. Creating products to a single standard often stymies innovation and may be expensive, and hence the core products may not be interoperable.

However, the data being captured or generated from the various devices need to be sent to a common database. Hence just making the communication interface fully interoperable can create substantial value for patient and clinician, resulting in better health outcomes. Of course, data security and accuracy concerns may have to be addressed through a common standard. Working towards a dedicated mission to provide standardized healthcare facilities Continua Health Alliance along with Indian industry partners can help create self reliant ecosystems of healthcare providers, patients, manufacturers and regulatory.

Standards development can follow the typical process used by standard development organizations, though implementation and widespread adoption of these standards holds the key to success.

IntroductionGlobal Medical Devices IndustryIndian Medical Devices IndustryInteroperabilityInteroperability standardsin IndiaConclusions and recommendations

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industry representatives, and advocacy bodies such as Continua should be responsible for overseeing the implementation of standards in India.

same must be encouraged by government regulatory bodies.

standards. They should encourage their suppliers to buy communicable devices. Regulatory bodies can help achieve this by organizing workshops and awareness programmes in the industry.

and all the major stakeholders networked with telecom providers can be highly e"ective in standards implementation.

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Following are few strategies and recommendations suggested: [1, 2, 3, 4, and 5]

Identifying existingadoptablestandards

Need for standardcon#rmation

Identifying fundingresourses

Ensuring input from interestedstakeholders

Standarddevelopment

Public opinioninvitation for draftstandard

Opinion of interested parties

Draft revision Review,approval andpublishing

Periodicstandard revision


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for safe and e"ective use of patient data utilization by healthcare providing organizations, regulated by a national authority and in line with international standards. The government can facilitate approval of composite devices that follow system level standards, which will contribute to the overall success of interoperability standards in India.

a joint public private venture by LifeScience Alley along with FDA and other related organizations, an innovation consortium can be set up as a Public Private Partnership (PPP) venture in India to develop novel technology and to achieve regulatory consensus which would drive innovation andhasten commercialization of indigenous products [6,7]. Commitment and involvement of regulatory bodies will impart con#dence to the multiple stakeholders for innovation of composite interoperable devices and market development for such products.

implementation [8].

a detailed validation process to ensure safety.

ensure an extensive standard adoption and implementation.

Certi#cation of medical devices for interoperability by Continua will reduce their integration costs thereby increasing the a"ordability of health care services. Hospitals can achieve their desired quality standards through such accreditations. Collaboration between Continua and multiple stakeholders in the country with respect to medical devices would encourage innovation which would in turn lead to market creation by medical devices manufacturers. Innovation accompanied by a conducive regulatory environment will encourage low end device manufacturers to enter the high end segment, further inspiring high end devices exports. Similar associations will continuously change the dynamics of the Indian medical devices industry in the coming decades, increasing a"ordability and accessibility of international standard healthcare delivery to all the population.

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Why interoperability ?

Hospitals using interoperability and standards

In 90% hospitals using interoperable devices, when there are 6 to 12 devices around ICU beds, not more than 3 types of devices are integrated for interoperability.

Impact of lack of interoperability97% of hospital expense with no added value relates to lack of interoperability.

Who bene!ts?

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US interoperability case study

Drug errors20%

Dia

gnos

tic

erro

rs 1

7%

Failure in

preventing

injury 12%

Minimization of

excessive testing

Reduction in

length of

hospital stay

for patients

Reduced device integration and

development costs

Healthcare providers - 93%Payers- 6%

Interoperability advantages

Reference: The Value of Medical Device Interoperability, West Health Institute; 2013.

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Minimization of adverse eventsINTEROPERABILITY OF


US interoperability case study

Minimization of drug errors

Reduction in diagnostic errors

Reduction in ‘Failure to prevent injury’ errors

Fastening result availability to clinicians/ pharmacists

Facilitating ordering decision through automation

Provision of electronic health records

Seamless connectivity between patient monitoring devices with medication administration devices

Timely and systematic provision of symptom readings and test results to care providers

‘Ready to be withdrawn’ from the treatment assessments can be made available to physicians. Ex: lesser the number of ventilator days, fewer chances of pneumonia.

Decreased incidence of post operative shock: vital signs monitoring systems integration with alarm systems facilitates early intervention.

Savings with interoperability

Minimization of excessive testing

Reduction in length of hospital stay for patients

Reduced device integration and development costs

Charting or #ling errors related to redundant testing- 39%

Integration of EHR with physician and communication systems will facilitate digital storage of medical images and their automated transmission.

Health care savings by avoiding excessive testing- $ 3 billion (37% of total excessive testing expense).

Inpatient stay reduction by fasten-ing the availability of test results and faster decision making by the clinician is worth $ 17.8 billion dollars (approx 4% of total ED and inpatient spending).

If device vendors could achieve interoperability by adopting one set of standards, approx $ 430 can be saved in medical device devel-opment and testing.

Providers spend around $10,000 / bed/ year as integration costs.

66% of these costs could be reduced by commonly adopted standards in interoperability.

Reference: The Value of Medical Device Interoperability, West Health Institute; 2013.

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Leaders speakEstablishing an interoperable ecosystem of personal health devices and technology platforms in India is a critical step in advancing personal connected health solutions for the citizens of India. Continua Health Alliance is pleased to be working closely with Indian device manufacturers, government o!cials, policy makers and healthcare leaders to improve health and wellness in the country, and ensure that these devices are convenient and secure for consumers and healthcare providers. Chuck Parker, Executive Director, Continua Health Alliance

Current healthcare initiatives as deployed by organizations like the National Rural Healthcare Mission (NRHM) at the national level focus more on critical primary healthcare access and early screening and detection of endemic diseases than on data standards and interoperability. Standards organizations have a vital and challenging role to play in these programs at an early stage to establish guidelines and practices that can be carried across programs. This will be critical for scalable and a"ordable healthcare across the country.Sham B, CEO, i2i Telesolutions

Over the course of the past nine months, Continua made signi#cant progress in the adoption of its Design Guidelines. Government o!cials and agencies are now realizing the value that Continua interoperability Guidelines – with the underlying standards - provide for personalized health care. Whole countries like Denmark and Singapore, as well as regions like Abu Dhabi (UAE), adopted Continua as their framework for personalized health to realize their objectives of more e!cient and e"ective delivery of health care in the prevention and treatment of chronic diseases like diabetes, heart failure and hypertension. Interoperability is the key for scalable care delivery, especially into rural areas as found on the Indian subcontinent. Continua is excited about the prospect to work collaboratively with local organizations from industry, government agencies and care providers to realize an ecosystem of connected health in India.Horst Merkle, Director, Information Management Systems,Diabetes Care, Roche Diagnostics Corp. Vice President, Continua Health Alliance

Access to interoperable medical technologies is the fundamental requirement for equitable healthcare. Continua is a matchless opportunity for domestic / Indian medical device manufacturers to get their devices continua complaint and tap the global market . There are phenomenal opportunities to meet the global purchasers directly via Continua connect meetings . No other organisation in the world o"ers such a platform & opportunityRajendra Pratap Gupta , Healthcare Policy Expert and Chairman, Continua Health Alliance - India Working Group

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Given the demographics of India, in order to address the country’s diverse healthcare needs, clinical information needs to $ow seamlessly across systems, networks and between hospitals and physicians. Accelerating the adoption of interoperability standards is an immediate need for this country to make healthcare more accessible. This will make it easier to share health related information, so that clinicians and patients have the required information in time to help them make appropriate decisions.M.R. Srinivas Prasad, Head, Healthcare R&D, Philips Innovation Centre, Bangalore

To increase penetration of medical technology to improve health outcomes in india we need to standardise and make interoperability a must for all device manufacturers. The devices specially point of care equipment which are most useful for population screening need to be scaled up and used maximally.Dr B.S.Ratta, VP, TSI. Chairman, IAeHC

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Leaders speak

Medical device industry in India needs a big push in terms of innovation which needs to address unmet medical need of India to improve quality of life by reducing maternal and child mortality, improved geriatric care and management of communicable and non communicable diseases.Though medical device industry is establishing its strong base in India, it lacks synergy between devices which is a must for a developing country like India. There is a strong need for a rationalized interoperability standard between devices which can streamline usage of di"erent devices and address the unmet medical need, deliver a"ordable healthcare for all.Dr Shirshendu Mukherjee, Senior Strategic Advisor, R&D Initiative - India Wellcome Trust

Providers, whether individual practitioners or institutional care givers need to move to coordinated care models. It is the only way to overcome the huge spend that is incurred today on a per visit, per test model and the only real solution for treating patients with chronic diseases e"ectively. There is also a need to align #nancial incentives to promote coordination within the medical care system. Policy makers need to administer regulations and policies that drive reach and e"ectiveness in healthcare. The goal should be that each individual has access to a"ordable healthcare with focus on primary, wellness and preventive health.Pankaj Vaish, CEO, HealthFore

Since many of the manufacturers use their own proprietary software for their products, It is a di!cult task to connect di"erent formats into a single platform. It is high time that we have a common platform to have smooth interoperability of various ophthalmic equipment, so that images captured during the camps can be transferred easily and also integration with HIS/EMR for patient’s follow-up shall be achieved.Dr Sheila John, Sankara Nethralaya

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Leaders speak

Interoperability is the ability of diverse systems to work together. There are di"erent medical devices that are typically purchased from di"erent manufacturers, and often require costly IT customization so their various functions can be integrated. Medical devices are essential to the practice of modern medicine. Clinical measurements such as blood pressure and temperature, x-ray and ultrasound imaging, administration of intravenous medications, and support of critical life functions all require medical devices. However, despite our reliance on sophisticated medical equipment, most devices are not designed to interconnect with other devices. Therefore, it is di!cult to connect individual devices into integrated medical systems to improve patient care and avoid unnecessary accidents. The reason innovation/expertise is happening or available in silos.Shailendra Ravi , Senior Director, Business Strategy and Emerging Markets, EMC India

Standardization is most necessary in variety of aspects – for protection of the users, making a level playing #eld for the providers and buyers, and as an agreement for the required performance. However, the barriers for standardization of the devices and solutions need to be minimized. If the barriers are too high, the most innovative, small, local players in the industry will never make it across such barriers, resulting in depriving general population of bene#ts of such cost-e"ective technologies. While an idea of #nancial incentives in promoting adoption of device interoperability is welcome, a deep focus on reducing barriers to reach interoperability is a must. This can be achieved in multiple ways – one would be to make the standards and compliance tools publicly available for easy access; another would be to provide innovative fee structuring, like royalties based on sale, for smaller companies which could include assistance for achieving compliance. There is also a need for multiple mandated certifying agencies.Sameer Subhash Sawarkar , Founder & CEO, Neurosynaptic Communications Pvt. Ltd.

Bringing about Interoperability in medical devices space is all about mindset change amongst the device manufacturers and healthcare providers. Interoperability and component orientation has to be a core design consideration in both products and services.The Indian consumer is a sleeping giant who needs to be woken up – patient and physician groups need to be actively engaged. Standards bodies are one part of the solution to this jigsaw puzzle.The other signi#cantly in$uential part is patient activism. Standard bodies should proactively encourage, assist and engage with patient and physician activism, industry and the governments, perhaps across international fora. More public-private partnerships chaperoned and mentored by standards bodies are the only way to achieve this.Prabal Chakraborty, Chairman, AMCHAM Medical Device CommitteeVP & MD, Boston Scienti!c India Pvt Ltd

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Indian medical technology standards are being drafted in line with the various internationally accepted standards such as the IEC and ISO standards. Currently, the conformance to standards is purely voluntary and we do not have a comprehensive regulatory system that would prevent non-conforming products from entering the market.Vijay Simha, CEO, OneBreath Inc.

Interoperability is the holy grail for realizing bene#ts of healthcare informatics and knowledge management roadmap. Strategized e"ort must be undertaken to implement standards based interoperable architecture to safeguard departmental, enterprise or regional healthcare programs objectives and outcomes. Interoperability must not be mistaken as IT issue but instead should be addressed and be governed by clinical leadership as stepping stone for research and clinical informatics. Convincing evidence demonstrates failure of many nationwide healthcare programs towards lack of planning in making sure that data and information are interoperable. Faster health information exchange provides no value in absence of meaningful and accurate information interpretation, ultimately improving care delivery and saving lives.Dharmendra K. Ghai, Member, Advisory Board, HIMSS Asia Paci!c India Chapter

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Indian healthcare industry is passing through a very interesting stage, where we are trying to address rural health and non-communicable chronic diseases. In both the cases there is an acute shortage of relevant health experts. This creates a pressing need for the use of diagnostic devices that assist in timely and accurate monitoring of key health parameters. Interoperability is pivotal in linking health experts to derive prognosis and solutions for remote patients. Continua Health Alliance is an open interoperability standard driven by the industry, for the industry, which provides readymade solution to address this challenge in an holistic manner.Debasis Bharadwaj, Lead- Solutions Architect, Intel Corporation

Information and communication technologies (ICTs) can enable life-changing improvements in the quality and e!ciency of healthcare, especially for people living in rural, remote or underserved areas. Healthcare is one area where we cannot a"ord to have competing proprietary technologies fragmenting the market, reducing interoperability and increasing services’ costs. ITU is working on ensuring that International standards for e-health are established to overcome the interoperability issuesSameer Sharma , Senior Advisor, International Telecommunication Union, Regional O"ce for Asia and the Paci!c

There is a need for interoperability at all levels Medical Education , Preventive Health , Healthcare delivery and Accreditation Systems and information technology is the best way to achieve itProfessor Dr Sanjay Bedi, President Indian Association for Medical Informatics - IAMIProfessor in Pathology, MM Institute of Medical Sciences Ambala

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Leaders speak

I think the role of standards and interoperability has the highest importance in making healthcare a"ordable now. It will avoid unnecessary costs involved in porting or customization. Also having a common platform across specialities is very important and relevant in the current healthcare delivery scenario. K. Chandrashekhar, MD, Forus Health

We need integrated medical systems with seamless data interchange to improve patient care, and reduce chance of errors and also improve operation e!ciencies. Technology companies need to work out di"erent business models that do not burden the customer (hospital) with upfront costs, but is more of a pay-as-you-grow model.Vijaya Verma, Founder and CEO, Yos Technologies

In a vast country like India, it is virtually impossible to build a single healthcare information system and get it accepted by every public and private organisation in every state. It is much better to let groups build what they need to, but have well de#ned, mandatory interoperability and interface standards so that the systems can work together, and data can be extracted when needed.Ananda Sen Gupta, Managing Director, Trackmybeat Healthcare. Member, Continua Health Alliance

There is no formal Policy or strategy de#ned to improve infrastructure and pool of trained medical professionals to handle medical device interoperability boom in India. Now is the time for a policy review so that Domestic Industry Growth exceeds 20 -25% by increasing its share in the Domestic & International MarketRajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry

In healthcare and pharma, India su"ers from fragmentation in di"erent ways. Interoperability - in all senses - hardware, software and data - would be the #rst step towards unlocking the potential for both growing the market and also achieving better health outcomes.Dr. Myshkin Ingawale, Director, Biosense Technologies Pvt. Ltd.

Software developments, interface technologies, reporting systems, fully automated systems, etc. have huge impact on the diagnosis /therapeutics of medical devices interoperability. Kalyana Raman, Trivitron Healthcare

Medical Device Regulatory Pro#le for India is de#ned under “The Medical Devices Regulation Bill, 2006” implemented by Medical Device Regulatory Authority of India. It is implemented by Establishment of Medical Device Safety Appellate Tribunal. While e"orts are on for implementation of the Act, India is making e"orts to establish “ Health Technology Assessment (HTA)” similar to the lines of NICE, UK.Professor Indrajeet Bhattacharya, Healthcare -IT, Formerly Additional Director, NIELIT (erstwhile DOEACC Society), Dept. of IT(DeITY), Govt.of India. Member, EMR Standardisation Committee, MoHFW, Govt. of India

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Chapter 1 References

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1. Enhancing access to healthcare through innovation - Medical technology in India, FICCI, Jun 2011.2. www.ibef.org/download/Healthcare50112.pd3. http://www.google.co.in/url?q=http://www.deloitte.com/assets/Dcom-India/Local%2520Assets/Documents/ Medical_technology_Industry_in_India.pdf&sa=U&ei=6iAjUd_GEIuMrgeLxYHACA&ved=0CC8QFjAFOAo&usg= AFQjCNGZDPaXvsxRnEYSkCgbAPuFz0NQbw4. Indian Semiconductor Association. (2010). Current status and potential for medical electronics in India. Retrieved on July 4th 2011 from http://isaonline.org/documents/ISA_MedElecn_Executive_Summary__Dec_2010.pdf5. http://www.medicaldevice-network.com/features/feature617256. http://www.indiaoppi.com/OPPI%20Position%20Paper%20on%20Medical%20Diagnostics%20and%20Medical%20Devices.pdf 7. http://www.emergogroup.com/#les/india-webinar.pdf8. http://www.deloitte.com/assets/Dcom-India/Local%20Assets/Documents/Indian_Medical_Electronics_Industry.pdf9. Healthcare Pulse, Medical Devices- India Insight 2013.10 . http://www.kpmg.com/in/en/issuesandinsights/articlespublications/kbuzz/pages/healthcare.aspx11. United Nations, Department of Economic and Social A"airs Population Division. (2009). World Population Ageing 2009. A United Nations Report (ESA/P/WP/212). Retrieved on August 6th, 2011 from http://www.un.org/ esa/population/publications/WPA2009/WPA2009_WorkingPaper.pdf12. Mckinsey&Company. Gearing up for healthcare 3.0. New Delhi; 2010. Available from: http://www.mckinsey.com/ locations/india/mckinseyonindia/pdf/Gearing_up_for_Healthcare_3_0.pdf13. http://planningcommission.nic.in/plans/planrel/12appdrft/appraoch_12plan.pdf53.14. http://download.pwc.com/ie/pubs/2012_taking_advantage_of_the_medtech_market_potential_in_india.pdf15. India healthcare: Inspiring possibilities, Challenging Journey, MCKinsey and Company, Report prepared for CII, Dec 201216. PwC Global Healthcare Deals Quarterly, January 2012.17. http://www.dst.gov.in/about_us/ar10-11/PDF/c_4_technology%20.pdf18. http://www.#cci.com/sector/76/Project_docs/Medical_Devices_and_Equipment_Sector_pro#le.pdf19. http://americanactionforum.org/sites/default/#les/OHC_MedDevIndPrimer.pdf20. http://www.pwc.com/us/en/health-industries/health-research-institute/innovation-scorecard/index.jhtml21. 5th MEDICAL TECHNOLOGY CONFERENCE- Emerging Medical Technologies - Enabling and Transforming Healthcare Delivery 24 AUGUST 2012, NEW DELHI22. http://www.business-standard.com/india/news/ge-healthcare-innovates-in-india-for-bottomthe- pyramid/356947/23. http://www.google.co.in/url?q=http://www.emergogroup.com/services/india/india-medical-device-registration &sa=U&ei=nwsnUbnyIYLprQe_pIDoBQ&ved=0CB8QFjAA&usg=AFQjCNG7LrFdeMRUjTv30zFeMXgxaSQ1oQ24. http://cdsco.nic.in/Medical_div/medical_device_division.htm25. India’s Latest Medical Device Regulation Developments, Ames Gross and Arthur Chyan, Paci#c Bridge Medical.26. Draft Bill; Dr B Hari Gopal; Adviser;Department of Science & Technology27. ttp://www.pharmaphorum.com/2012/10/05/healthcare-markets-asia-indian-medical-device-regulatory-updates/28. Regulation of medical devices outside the European Union, Susan Lamph, JRSM, April 2012 vol. 105 no. suppl 1 S12-S21

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29. http://www.hl7india.org/News.aspx30. http://ehealth.eletsonline.com/2008/07/11157/31. http://www.csc.com/in/insights/53582health_level_seven_hl7_for_electronic_data_exchange32. Oosterwijk H. The DICOM standard, overview and characteristics. Available from: http://www.ringholm.de/ docs/02010_en.htm. [Last accessed on 2007 Apr 10].33. DICOM, HL7 and IHE: A basic primer on Healthcare Standards for Radiologists, IK Indrajit, BS Verma, 2007, Vol: 17, Issue:2, Page:66-6834. http://dicomconference.org/dicom-conference/35. http://loinc.org/36. http://loinc.org/adopters/indian-health-service-o!ce-of-information-technology.html/?searchterm=interoperability37. http://www.who.int/classi#cations/icd/en/38. http://www.amia.org/sites/amia.org/#les/icd-10-jointstatement.pdf

Chapter 4 References1. http://www.per#cient.com/Industries/Healthcare/System-Interoperability2. “The Value of Healthcare Information Exchange and Interoperability” Centre for Information Technology, Leadership, 2004; http://www.partners.org/cird/pdfs/CITL_HIEI.pdf3. Medical Device Interoperability: An Embedded Solution. by Andrew Leone,STMicroelectronics; http://web.arrownac.com/sites/default/#les/pdfs/WP_MEDICAL_INTEROPERABILITY_2011_01_01_A.pdf4. http://www.interconnected-health.org/presentations/04-T2-01_Jacob.pdf5. http://www.himss.org/content/#les/interoperability_de#nition_background_060905.pdf6. http://www.continuaalliance.org/sites/default/#les/IEEE_Pervasive_Computing_Q407_Continua_Article_2.pdf7. http://www.continuaalliance.org/sites/default/#les/Continua%20Overview%20Presentation%20021513.pdf8. http://workshop.andago.com/pdf/michael_kirwan.pdf9. http://www.continuaalliance.org/sites/default/#les/Continua_Overview_Presentation_v19.9.pdf10. Principles of Health Interoperability HL7 and SNOMED. Tim Benson. Page 95. http://books.google.co.in/books? id=CNcCcdUsoOYC&pg=PA95&dq=Continua+principles+of+interoperability+CDISC&hl=en&sa=X&ei=CFMsUa TlDoTIrQftx4CICw&ved=0CDcQ6AEwAA#v=onepage&q=Continua%20principles%20of%20interoperability% 20CDISC&f=false11. http://www.ti.com/pdfs/wtbu/agg_mgr_swpy026.pdf12. http://www.continuaalliance.org/sites/default/#les/28_Quality_Standards.pdf 13. http://www.continuaalliance.org/sites/default/#les/132-138_IT_WorldMA2010.pdf14. http://cdn.medgadget.com/img/20344343.jpg15. http://www.prnewswire.com/news-releases/continua-health-alliance-design-guidelines-now-available-free-to- developers-reducing-development-costs-for-plug-n-play-personal-health-solutions-147148915.html

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1. Indian Medical Electronics Industry. Outlook 2020. http://www.deloitte.com/assets/Dcom-India/Local% 20Assets/Documents/Indian_Medical_Electronics_Industry.pdf2. Draft Bill; Dr B Hari Gopal; Adviser;Department of Science & Technology;page 13www.dst.gov.in/whats_new/ whats_new07/MDRA-Act.pdf3. http://www.medinfo.cdac.in/resources/events/mig-symp-08/pdf/presentation/Mukhopadhyay.pdf4. http://portal.bsa.org/cloudscorecard2012/assets/pdfs/country_reports/Country_Report_India.pdf5. http://www.visiongain.com/Report/933/Indian-Medical-Device-Market-Outlook-2013-20236. Karim,2008;https://sites.google.com/site/electronicpatientrecordsystems/table-of-contents/chapter-2-literature-review7. http://www.newelectronics.co.uk/electronics-technology/the-challenges-for-medical-device-interoperability/45693/8. http://healthcare.#nancialexpress.com/201202/market04.shtml9. http://jurisonline.in/?p=199410. India’s Latest Medical Device Regulation Developments, Paci#c Bridge Medical, Ames Gross and Arthur Chyan, 201111. http://www.itu.int/dms_pub/itu-t/oth/23/01/T23010000170001PDFE.pdf12. http://singhassociates.in/UploadImg/NewsImages/Vol%20V%20Issue%20IX.pdf13. http://www.openforumeurope.org/library/onepage-briefs/ofe-open-standards-onepage-2008.pdf14. http://www.csi-sigegov.org/2/1_414_2.pdf15. https://itunews.itu.int/En/2472-E8209health-standards-and-interoperability.note.aspx16. http://www.ncbi.nlm.nih.gov/pubmed/1670259017. http://www.itu.int/en/ITU-T/gap/Pages/default.aspx18. Standardizing to Ensure the Safety of Electrical Medical Equipment, Bernie Liebler, Director, Technology & Regulatory A"airs, Advanced Medical Technology Association (AdvaMed), United States National Committee of the IEC, Vol: 7, No:119. ftp://medical.nema.org/MEDICAL/dicom/Conference/Abstracts/Harwalkar-TESTATHON%20Report%20v0%202.pdf20. Medical Device Interoperability A Safer Path Forward, Priority Issues from the 2012 AAMI–FDA Interoperability Summit.21. Medical device interoperability, AAMI white paper, 201222. Current Status of Information Security for Electronic Health Record Services in India available from http://precog.iiitd.edu.in/events/spsymposium13/SPSymposium_#les/SPsymposium-papers/SPsymposium-paper26.pdf23. E-health Standards and Interoperability ITU-T Technology Watch Report April 201224. Continua health alliance FAQ available from http://www.continuaalliance.org/sites/default/#les/Continua_FAQ _-_CES_2012__FINAL.PDF.25. Report on internet in India. 2011 available from www.iamai.in/upload/research/11720111091101/icube_3nov11_56.pdf 26. http://www.google.co.in/url?q=http://www.gsma.com/connectedliving/wp-content/uploads/2012/03/ mobilearchitectureinteractive241111.pdf&sa=U&ei=RyY4UYbMO8TprQeor4DoDw&ved=0CB0QFjAAOAo&usg= AFQjCNH4npEiss0TZxpzhLE3dQORq3QuYw

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27. National E"orts on Standardization in Health Informatics, B. S. Bedi, 200828. Telemedicine in India: current scenario and the future.Mishra SK, Kapoor L, Singh IP, Telemed J E Health. 2009 Jul-Aug;15(6):568-75. doi: 10.1089/tmj.2009.0059.29. http://business.gov.in/manage_business/bis_iso.php30. http://www.telemedindia.org/Policy/ntf.html31. Enabling Specialty Healthcare to the Rural and Remote Population of India, ISRO32. Application Of Telemedicine In India -- An Overview, SubhasisBandyopadhyay,Journal of Today’s Biological Sciences : Research & Review (JTBSRR), Vol.1,Issue 1,page 148-152 ,December 30,2012 33. India Country Report on Tele Health Initiatives, Prof S K Mishra, UN/ India/ Regional Workshop on Using space technology for Tele- epidemiology to bene#t Asia and the Paci#c region, 2008.34. Prof S K Mishra HOD Endocrine Surgery and Nodal O!cer Telemedicine Programme, School of Tele medicine and Bio Informatics, SGPGI, Lucknow35. http://www.aspect-project.org/node/17436. http://www.nist.gov/healthcare/emerging/deviceinteroperability.cfm37. Pharma 2020: Virtual R&D, PwC, June 2007


1. http://www.newelectronics.co.uk/electronics-technology/the-challenges-for-medical-device-interoperability/45693/2. Medical device interoperability, AAMI white paper, 20123. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070627.htm4. Medical Device Regulations: Global overview and guiding principles, World Health Organization Geneva.5. The Role of Health Data Standards in Developing Countries Abdullah I. ALKRAIJI1, Thomas W. JACKSON, Ian MURRAY Department of Information Science, Loughborough University, Loughborough, UK, Journal of Health Informatics in Developing Countries,Vol. 6 No. 2, 2012. 6. http://www.deviceconsortium.org/7. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm330416.htm

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Disclaimer

The Continua Health Alliance – India Working Group has exercised professional care and diligence in collection and processing of the information in this report.

However, the data used in the preparation of this report (and on which the report is based) was provided by third-party sources. This report is intended to provide general information on a particular subject or subjects and is not an exhaustive treatment of such subject(s) and accordingly is not intended to constitute professional advice or services. The information is not intended to be relied upon as the sole basis for any decision which may a"ect you or your business.

The Continua Health Alliance – India Working Group makes no representations or warranties about the accuracy of the data in this report. The Continua Health Alliance – India Working Group is not liable to any user of this report or any person or entity for any inaccuracy of information contained in this report or form any omissions or errors in its content, regardless of the cause for such inaccuracy, error or omission.

Furthermore, to the extent permitted by law, the Continua Health Alliance – India Working Group, its members, employees or agents accept no liability, and disclaim all responsibility for the consequences of you or anyone else acting, or refraining from acting, in relying upon information contained in this report or for any decision based on it, or for any consequential, special, incidental or punitive damages to any person or entity for any matter relating to this report even of advised of the possibility of such damages.

The presence of advertising or a sponsor logo does not constitute an endorsement by the Continua Health Association - India Working Group, nor a guarantee for the quality, value or e"ectiveness of any products, services or methods advertised by our sponsors. The Continua Health Alliance - India Working Group maintains editorial independence and operational separation from our corporate sponsors. The The Continua Health Association - India Working Group makes decisions about the information we provide without interference from our corporate sponsors and none of the information in the report is altered or edited by our corporate sponsors at any time.

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What is Continua Connect?

With a mission to promote an ecosystem of interoperable, plug-n-play personal connected devices and services, Continua Health Alliance provides support to governments adopting Continua’s interoperability standards into a federal or regional connected health program. Continua Connect events bring together government purchasers with developers and integrators of Continua compliant devices, systems and services during the preparation or acquisition phase of an implementation. These events are designed speci#cally to highlight new and available technologies and facilitate timely rollout for the target program, as well as to enhance business opportunities for members, promote public-private partnerships and support the technology economy in the host nation.

Continua’s Public Sector Partners

August 2012 marked a watershed moment for Personal Connected Health and for Continua: Denmark, a nation known for its healthcare advances, announced that it would build the reference architecture for its federal telemedicine program using Continua’s Design Guidelines. Denmark’s Action Plan for Telemedicine adopted Continua’s standards to govern the collection and transmission of personal health data from patients’ homes; the sharing of medical documents and images; and management of health records, medical appointments and other related information.

A global acceleration of government interest in connected health has brought about a succession of milestones for Continua since that time. Continua is currently readying for national implementations in Japan, Singapore and Abu Dhabi, is in active discussions with governments around the globe and continues to #eld membership inquiries from the public sector. For example, in June 2012, the U.S. Department of Defense (DoD), Joint Program Committee-1, through the U.S. Army Medical Research and Materiel Command, Telemedicine and Advanced Technology Research Center (TATRC), became a member of Continua.

Continua Connect events represent an opportunity to develop lasting partnerships for the purpose of advancing government initiatives and creating economic growth in the connected health sector. Events are designed to meet the needs of Continua’s public sector partners, and can comprise demonstrations, interoperability showcases, and networking.

These events allow the Host country or organization to see hands-on technology running and a chance for their internal or employed developers to engage in real demonstrations of integrating the devices, services, and information into actionable data sets. The Continua Connect events are modeled on our already successful PlugFest activities that enable companies to quickly test and connect devices together while in development. This step furthers these connections to allow Purchaser organizations or Countries to see these demonstrations or actually connect data.

Upcoming Continua Connect Events

Abu Dhabi/Wequaya Project – Scope of Project: The Wequaya project will initially target cardiovascular disease and diabetes among Abu Dhabi’s population of 2.4 million people, with plans to expand to include other chronic illnesses. The program's mobile technology platform, built on Continua’s Design Guidelines, will be designed to motivate behavior change to improve nutrition, increase physical activity and reduce tobacco use. Event Timing: TBD. Singapore – Scope of Project: Singapore’s 5.2 million people will have access to Continua-compliant devices, apps and a Personal Health Records System, which will be tethered to

the national EHR system. Singapore’s health infrastructure was rated 6th among 55 nations. Event Timing: TBD.

For information on how to participate in a Continua Connect event, contact:Chuck Parker, Executive Director, Continua Health AllianceEmail: [email protected]: 781-724-8872, O!ce: 254-433-8588

Continua Connect Events

Technology Showcase & Networking Events to Support Connected Health Initiatives in the Public Sector

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Medical Devices, Interoperability & eHealth Standardization

Health & Medicine