INTEROPERABLE MONITORINGDEVICE ECOSYSTEM

Pratheep PS, QuEST Global

A WHITEPAPER

Stakeholders and Challenges

Pratheep PS, QuEST Global

A WHITEPAPER

Abstract

Monitoring devices and their role in smart healthcare ecosystem

4 Key stakeholders

Consumers

Providers

Payers

Innovators

5 Layer interoperable monitoring ecosystem

Data sources

Monitoring devices

Health data dateways

Data systems

Data consumers

Challenges

Fragmented systems and solutions

Diversity of monitoring devices

Lack of standardization in data format

Ownership and lifecyle management of health data

Conclusion

About QuEST

Related collateral

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CONTENTS

2018

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ABSTRACTWorld Health Organization (WHO) estimates that 20% - 40% of global health care spending is wasted. The primary reasons for such wastage being ineffective clinical care, redundant and repetitive prescriptions, inefficient hospital administration, and fraud. The good news is that a significant part of such inefficiencies can be prevented through a real-time collection and analysis of data from different devices. Interoperability of devices and systems is critical to build such an efficient ecosystem. Interoperability is a vital component for providing effective, personalised, affordable, and high-quality healthcare. At the end of this paper you will know:

How new-age monitoring devices are taking centre-stage in the world of smart-healthcare

Key stakeholders that interact with the connected-care continuum

Five layers of the interoperable monitoring ecosystem

Challenges to achieve the desired end-state

MONITORING DEVICES AND THEIR ROLE IN SMART HEALTHCARE ECOSYSTEM

According to the 2016 HealthLeaders Media Industry Survey, 62% of the healthcare providers are in various stages of implementing a pilot program that would help them make the transition from fee-for-service to value-based models.

The tech-savvy, value conscious consumers are demanding high-quality, low-cost and accessible healthcare services. The adoption of remote health services like mHealth are on the rise. Global mHealth application market is expected rise to $26Bn in revenue by 2018 with a growth at 32.5% CAGR1.

Monitoring devices play a vital role in all the three aspects of healthcare – Wellness, Diagnostics and Therapeutics. Wellness segment constitutes of basic wellness devices, such as FitbitB that measures the heart rate, number of steps taken, quality of sleep and other fitness related metrics. ECG monitors, and CPAP devices are respective examples of diagnostics and therapeutics monitoring devices. Fig 1.1 depicts the relationship that monitoring devices have with each of the healthcare aspects. In Fig 1.1, the over-encompassing healthcare delivery and management systems refers to healthcare data systems including HIS, PACS and LIMS.

Globally, the healthcare industry has been witnessing a tectonic shift in business models. Volume based fee-for-service models are giving way to value-based models.

Healthcare Delivery &Management Systems

Wellness

DiagnosticsTherapeutics

MonitoringDevices

Fig 1.1 – Interaction ofMonitoring devices with

various aspects of healthcare

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Cater to the market demand for cost-effective high-qualitypersonalized healthcare

Communicate, exchange data and use the data for intelligent decision making

The diverse portfolio of devices must be interoperable to:

The rising importance of monitoring devices is pushing the R&D investment for monitoring devices at an above average industry growth rate of 6.5% to reach $3.4 B by 2021A. R&D investment in overall medical devices industry has been on the rise as well and is expected to reach $36.4 B by 2021A. The comparison to the overall medical devices is depicted in Fig 1.2.

Thus, interoperability of devices becomes critical for connected devices to deliver quality healthcare. Despite the significance of interoperability, medical device OEMs face multiple challenges in its implementation.

Hematology and Cardiology monitoring devices constitute about 50% of the total R&D spending within the monitoring devices segmentA. The Fig 1.3 depicts the R&D spend in different sub-segments within the monitoring devices segment.

Fig 1.3 – R&D Spending within the Monitoring Devices segment

7.4%

7.7%

5.4%

6.6%

6.1%

5.1%

7.2%

3.4

2.5

CAGR

6.5%

2021E2016

0.8

0.1

Cardiology Respiratory Obstetrics & GynocologyAnesthesiology Neurology General Purpose*Hematology

*General Purpose monitoring devices include multy-parameterpatient monitors such as temperature and weight monitors

0.1

0.1

0.2

0.2

1.1

0.8

0.30.3

0.6

0.6

0.20.4

Fig 1.2 – R&D Spendingin Monitoring devices &

overall Medical

6.5%

5.6%27.7

CAGR

2021E2016

Monitoring Rest

36.4

3.42.5

-The values are in USD BN

-The values are in USD BN

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Biggest needs are optimizing cost, quality of recovery and accessibility of healthcare

Tech savvy customer prefer preven-tive healthcare to reactive treatments

Expect easy storage and transferabil-ity of their healthcare information among Health Delivery Organiza-tions (HDOs) and across geographies

The following are some of the consumer characteristics

Healthcare Ecosystem

Regulatory & Standards Framework

4 KEY STAKEHOLDERS

Consumers

Smart healthcare is made possible through the collaboration of varied stakeholders. The four critical stakeholders in the healthcare environment are Consumers, Providers, Payers & Innovators. The stakeholder details are depicted in Fig 2.12. Regulatory bodies and the healthcare ecosystem influences the interaction among these stakeholders.

The smart healthcare system design is being driven by the needs and challenges of these four players. Typically, players interact with each other, resulting in a holistic ecosystem. The scale and nature of such interactions varies among the stakeholders.

Consumers are the ones who avail healthcare services e.g. Individuals, Families and Communities.

An essential component for making such services possible is an interoperable ecosystem of healthcare devices and data.

Additionally, with personal healthcare data going online, privacy and security have become a major concern among the consumers. Developing healthcare systems that comply to HIPAA3A (Health Insurance Portability and Accountability Act of 1996) for the US market or Directive on Data Protection3B for the European market are essential for maintaining privacy and security standards.

Fig 2.1 – Stakeholders in the healthcare ecosystem

CONSUMERSIndividual

FamilyCommunity

(HDOs)Clinics

HospitalsLabs

Doctors

Insurance FirmsGovernmentIndividuals

Other Institutions

Medical device OEMSLife science R&DPharmaceuticals

Biotech firmsUniversities

PROVIDERS PAYERS INNOVATORS

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Providers2

Providers include Health Delivery Organizations (HDOs) such as hospitals, clinics and doctors.

HDOs, such as hospitals, are complex business establishments that have multiple workflows that need to operate seamlessly. Primary workflows include patient management and care management. Secondary workflows include inventory management, vendor management, waste management and workforce management. HDOs have a dire need to integrate the communication workflow among various systems to enable seamless clinical workflow and reduce redundancy.

Additionally, HDOs also need to make their patient data interoperable with other HDOs to enable a unified smart healthcare ecosystem. In 2016, only 6% of healthcare providers believed that data obtained from exchange partners on different Electronic Health Records (EHRs) can be used effectively on improving patient care4.

HDOs continuously spend on maintaining and managing change in IT systems. The frequent technology upgradations are is pushing for the need

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Payersto develop plug and play systems that can continuously and economically integrate with latest technologies. Hospitals are believed to have spent $66BN on IT in 2017 in USA5.

Cybersecurity concerns increase as multiple systems go online and become interoperable. In 2016, safety of more than 27 million patient records was compromised spread across 450 data security breach incidents6. Data security breaches are costly affairs — especially if they involve HIPAA violations. Advocate Health System paid $5.55 MN in 20166. Memorial Healthcare System paid 5.5 MN in 20176.

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Fig 2.2 – Payers Contribution Split for US Healthcare Spending in 2015

Payers are the ones who pay for the healthcare services. Insurance companies are the biggest players here. Individuals, Government and other institutions can also be payers. Fig 2.27 depicts the payer contribution split for the US Healthcare spending in 2015.

The payers constantly look out to optimize their cost of service. Thus, it is in the best interest of the payers to help the consumers to be in constant state of wellness. Payers, such as insurance companies, collaborate with consumers to build sustainable business models that lead to improved profitability and reduced payout. For example, periodic health data monitoring helps in early detection of ailments; lifestyle monitoring enables consumers to correct their lifestyle and take preventive actions.

Moreover, payers are on a constant endeavor to identify the most optimum healthcare solutions from the constantly evolving list of options. Hence, the payers are major stakeholders in developing a robust monitoring ecosystem that would enable them and their customers to become proactive players in healthcare. The Affordable Care Act in the US mandates that 80% to 85% of the premiums collected from healthcare consumers should be invested in quality and efficiency measures8.

Hospital Care | $ 1036.1B (38%)

US Health Care Spending 1960-2015: Who Pays?

Total 2015 Spending: $2717.2B

Prescription Drugs | $ 324.6B (12%)

Nursing care Facilities | $ 156.8B (6%)Other Health Care | $ 163.3B (6%)

Dental Services | $ 117.5B (4%)Home Health Care | $ 88.8B (3%)

Other Medical Products | $ 107.5B (4%)Other Professional Services | $ 87.8B (3%)

Physician and Clinical Services| $ 634.9B (23%)

Out-of-pocket | $32.1B (3%)Private Insurance | $403.6B (39%)Medicare | $257.0B (25%)

Medicaid | $185.1B (18%)Other Public Insurance | $63.3B (6%)Other Payers | $94.9B (9%)

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Data sources1

Innovators4

This segment includes the ones who invest in R&D, design, development and manufacturing of healthcare products. Innovators are the biggest among the four stakeholders and includes medical device companies, pharmaceutical firms, biomedical and life science R&D institutes.

Medical devices companies constantly develop new and connected products that monitor various body vitals. Global market for connected medical devices is expected to reach $1.3BN by 2021 at a CAGR of 26%9. Typically, these devices have their own communication protocols and data standards making the communication among them cumbersome. To enable smart healthcare, implementing interoperability in these devices becomes critical.

As new technologies in medical devices emerge, the regulatory bodies keep updating the compliance requirements. This adds to the complexity of product development for the innovators. For instance, in the US, FDA has recently issued guidelines for pre-market and post-market management of Cybersecurity in medical devices10. As the technology evolves, FDA is constantly collaborating with industry leaders to upgrade the cyber security regulations11.

Innovators such as the medical device OEMS are witnessing a paradigm shift in the kind of services provided to the healthcare consumer. There is a clear movement from providing pure-play products to bundling services with products. The industry is experiencing increase in demand for services such as personalized healthcare and preventive diagnosis.

Medtronic has collaborated with IBM to develop a predictive diabetes management solution12. Johnson & Johnson and IBM have partnered to use advanced data analytics and insights to transform patient experience and delivering better care solutions13. Such services are developed on a robust interoperable ecosystem.

5 LAYER INTEROPERABLE MONITORING ECOSYSTEMThe defining characteristic of the future monitoring ecosystem is interoperability - new monitoring devices would be plug-and-play, the data sources would be interoperable, and all stakeholders would access relevant healthcare data to generate various insights.

The ecosystem is broadly split into five layers and each layer’s components and the interaction among them are depicted in Fig. 3.1. The five layers are explained below:

Data can range from simple body activity metrics that measures fitness and performance (number of steps taken per day or heart rate) to critical metrics that are relevant in emergency or rescue scenarios (oxygen saturation and pulse rate). The data source devices can range from wellness, sports, and performance devices to critical medical devices operated by healthcare experts like doctors and nurses. Personal profiles, lifestyle information and social media information can also be other sources of data.

Monitoring devices2

Health data gateways3

Data systems4

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Fig 3.1 – The emerging landscape of interoperable monitoring ecosystem

Monitoring devices constitute the terminal end of the data capturing systems and transmits body vitals to a remote system. These devices can either transmit data to the Personal Health Records (PHRs) through gateway devices or by themselves if they are enabled with relevant communication capabilities. Monitoring devices can be classified into two groups – native interoperable device and non-interoperable devices. Majority of the existing connected medical devices are not native interoperable devices. However, a large number of non-native interoperable devices could be re-engineered and made interoperable. Leading OEMs partner with various product engineering service providers to enable interoperability in such devices.

Typically, these devices are existing communication devices such as mobile phones and WIFI routers. These devices typically do not fall under the purview of the healthcare industry. However, the gateways provide a crucial link in the healthcare ecosystem. Gateways can be classified into 2 broad areas – Medical specific gateways and generic commercial gateways. Qualcomm and other niche technology firms provide medical specific gateways. Qualcomm life provides 2NetB, a secure medical grade cloud based infrastructure that enables remote monitoring14. The commercial gateways are again classified into Industrial gateways and personal gateways.

Gateways are elements that enable transfer of data from the terminal monitoring devices to Personal Health Records (PHRs).

The fourth layer includes data systems and the associated applications around the data systems. PHRs, an example of data systems, are repositories that enable collection, storage and analysis of healthcare data. Personal Health Data (PHDs),

Social Personal useCommercial and public

health uses Consultation uses

Use cases : Data use

Many more uses of data

Use cases : Data Generation

Health data gateways | ISPs |GPRS | Data Aggregator Apps etc.

ISO/IEE 11073 Profile Devices....More devices in future

Many more sources of data

Commercial Data Systems( Servers | Clouds | ISP | Vaults | Drives | Apps etc )

PHD

HISEMR

Wearables

Sports | Fitness |Performance

Personal + Family Wellness

Remote PatientMonitoring

Emergency | RescueAmbulatory

General Health Implants/Non implants Vitals Monitoring

Clinical Medical DevicesWellness Devices

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The four stakeholders mentioned above have a singular objective – mature their systems to enable smart healthcare. The stakeholders have developed fragmented approaches organically to solve local business problems. Currently all these four groups, though driving to solve the same problem, are addressing parts of the problem in a disparate fashion. Standardization in each group, with its many players, varies significantly.

The groups, in many areas, witnesses minimal to zero standardization.

Leading medical device OEMs have developed proprietary monitoring systems with varying degrees of interoperability. Even within these proprietary systems, not all devices are compliant with interoperability standards. Such varied standardization within a same system is common in the healthcare industry.

In order to build a consolidated common platform, we need to start looking at the needs of these four groups of stakeholders. The key to exploring the possibilities of developing a common solution is to understand two aspects - the objectives each group is trying to achieve & their current concerns.

Data consumers5

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Hospital Information System (HIS) and Electronic Medical Records (EMRs) are some of the healthcare data systems available today. Interoperability among the various PHRs is critical to develop a robust monitoring ecosystem that enables analysis. Google Cloud has healthcare solutions that can manage patient data or connect to other PHRs and run analytics on the data to provide meaningful insights15.

Data consumers run the healthcare data collected in the PHRs through analytical tools and generate insights for various purposes. Customized healthcare, preventive diagnostics and other such use cases are business benefits derived by leveraging technologies like Big Data Analytics and Artificial Intelligence on the collected data. Analytics and AI have the potential to bring value at multiple stages – from personal wellness to community health detection and treatment; fraud detection and efficient reimbursement workflows for insurance companies. Medical OEMs and technology firms are already providing such services in varying capacities.

CHALLENGESFragmented systems and solutions

Diversity of monitoring devicesA plethora of monitoring devices exist - from simple wearables to critical pacemakers with integrated monitoring systems. Each device has its own architecture, communication standards and protocols. Thus, communication among these monitoring devices or to a gateway device like a mobile phone or a WIFI router becomes challenging.

Consortiums like Personal Connected Health Alliance (Continua Health Alliance) invest in developing device profile standards that enable development of end-to-end, plug-and-play connectivity modules of monitoring devices. Devices that are ContinuaB compliant would be interoperable making the healthcare ecosystem move one step closer towards becoming smart.

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Lack of standardization in data formatsHealthcare data that is transmitted from various devices are stored multiple times in multiple repositories. Such disparate data architecture increases redundancy, inefficiency, complexity, and cost. Moreover, currently, each segment in the healthcare landscape operates in silos and hence the data definition is unique to its system. However, a smart interoperable healthcare ecosystem requires that various applications depend on data across multiple systems. This necessitates a uniform and standard method to define health data.

The following are some data standards that have emerged for different purposes:

ISO/IEEE 11073 – a communication standard that enables medical devices to connect with external computer systems and to automatically capture detailed data of body vitals and device information. The ISO/IEEE 11073 has set standards for about 20 monitoring devices. The organization is working on creating standards for other devices

HL7 (Health Level 7) – a standard for transfer of clinical and administrative data among software applications

Technology leaders, such as Microsoft, have invested in creating Personal Health Records (PHRs) where customers could volunteer to synchronize their existing health records. Microsoft’s HealthVault allows data exchange among devices such as blood pressure monitors, heart rate monitors and weighing machines. HealthVault is also DICOM compliant thus being interoperable with imaging devices16.

Apple’s ResearchKit and CareKit are software frameworks that enable application development, data collection and analysis17.

Ownership and lifecycle management of health dataWho owns the healthcare data? The proliferation of connected devices and rising number of players in the smart healthcare space raises the important issue of healthcare data ownership. Deciding who owns the health data and who pays for it becomes all the more critical

For example, a consumer using a smart weighing scale that periodically measures weight and transfers the data to a central repository for analysis. The stakeholders include the device user for the data source, the device manufacturer (weighing scale), the communication gateway provider, the data aggregator and analyzer, and the data consumer. If the data is not consistently and accurately collected, there is ambiguity about who is responsible for the data irregularity. Ambiguity in ownership of data can result in serious consequences in scenarios where accurate and timely data capture is critical e.g. diabetes monitoring.

When an organization shuts down its operation, questions around data, ownership and its transfer arise. When Google Health was phased out it 2012, the organization provided users options to export their data to Microsoft HealthVault18.

Thus, setting these responsibilities clearly is a crucial step to realize a smart healthcare environment19.

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CONCLUSIONInteroperability is vital to enable intelligent, high-quality, low-cost healthcare across all geographies. Currently, a few disparate healthcare systems exhibit varying levels of interoperability.

The desired state of the smart healthcare ecosystems will have an evolved state of interoperability built around various industry standards. The ecosystem will exhibit data, communication, and workflow interoperability. All the stakeholders in the healthcare ecosystem will have access to appropriate health data to build personalized, predictive and efficient healthcare services.

As we have seen, the healthcare industry is facing multiple challenges to reach this desired state. However, numerous industry bodies and players are collaborating to develop standards and measures to achieve the interoperability objective.

ABOUT QUESTQuEST Global is a focused global engineering solutions provider with a proven track record of 20 years serving the product development & production engineering needs of high technology companies in the Aero Engines, Aerospace & Defence, Hi-Tech & Industrial, Medical Devices, Oil & Gas, Power, and Transportation industries. The company offers mechanical, electrical, electronics, embedded, engineering software, engineering analytics, manufacturing engineering and supply chain transformative solutions across the complete engineering lifecycle.

RELATED COLLATERALBlog - ‘Boundaries of responsibility in the connected medical device world’

Blog – ‘Designing interoperable medical imaging devices’

Blog – ‘Cybersecurity in the Continua world’

Point of View – ‘Challenges of developing interoperable monitoring devices’

QuEST’s offerings in Medical Devices: Diagnostic Imaging | Monitoring Devices

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SOURCEShttps://medium.com/@Adoriasoft_Com/healthcare-mobile-app-development-and-mhealth-apps-in-2017-eb307d4cad36

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EU General Data Protection Regulation 2016/6792

http://www.dhcs.ca.gov/formsandpubs/laws/hipaa/Pages/1.10HIPAATitleInformation.aspx3A

http://ec.europa.eu/justice/data-protection/index_en.htm3B

KLAS Research’s Report on “Interoperability 2016: From a Clinician View - Frustrating Reality or Hopeful Future”.4

http://cognitivemedicalsystems.com/much-will-u-s-health-market-worth-2017/5

https://www.formstack.com/blog/2017/health-security-breach-response/6

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http://www.chcf.org/publications/2017/09/data-viz-hcc-national

http://fortune.com/2014/09/24/health-insurance-invest-startups/https://www.prnewswire.com/news-releases/medical-device-connectivity-market-worth-13441-million-usd-by-2 021-597767741.html

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm482022.pdf

https://www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.htm

http://www.medtronic.com/us-en/about/news/ibm-diabetes.html

https://www.jnj.com/media-center/press-releases/johnson-johnson-and-ibm-announce-plans-to-collaborate-on -advanced-solutions-designed-to-transform-healthcare-deliveryhttps://www.jnj.com/media-center/press-releases/johnson-johnson-and-ibm-announce-pla

https://www.google.com/cloud/solutions/healthcare-life-sciences/

https://international.healthvault.com/in/en

https://www.apple.com/in/researchkit/https://www.technologyreview.com/s/424535/how-a-broken-medical-system-killed-google-health/

IEC 80001-1:2010: Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities, and activities

Research and Analysis, Zinnov Management ConsultingTrademarks and proprietary elements that belong to various organizations. QuEST Global does not have any associations with these brands. They have been called out for reference purpose only.

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