Editorial Trends and Challenges in Translation of Point-of-Care Technologies in Healthcare.

Point-of-Care Technologies (POCT) in Healthcare have emerged as a potential pathway in global and resource-limited environments towards improving access to healthcare with emphasis on preventive, personalized and precision medicine. The potential uses for POC technologies by patients or clinicians are many-from home-based monitoring to semi-managed and clinical inpatient healthcare. However, it is yet to be proven precisely what technologies are necessary or how they should be used to make an impact in improving access to quality healthcare. Although there is great potential for the application of new technologies in healthcare, physicians are skeptical about POCT since they fear it will generate large amounts of unreliable and overwhelming information of unknown benefit. Because the benefits and acceptance of POCT are unknown, a necessary first step in its development is performing market research of patients and clinicians to determine what POCT protocols would be most beneficial and acceptable. Research into POCT involves first understanding what the needs are of patients and clinicians, and then researching the best way to apply new technology to improve clinical care based on the understanding of these needs. The conference featured 5 keynote, 8 panel and 4 breakout sessions involving leaders from several stakeholder groups, including technology research, federal funding and regulatory agencies, industry and clinical healthcare. Through numerous presentations and group discussions, the conference participants concluded that the future of POCT depends upon facilitation of collaborative translational research towards development and meaningful validation of POCT in addressing specific healthcare and clinical needs with clear benefits and user acceptance.

Note: This editorial for the JTEHM HI-POCT-2017 Special Issue is based on the discussions at the 2016 IEEE-NIH Special Topics Conference on Healthcare Innovations and Point-Of-Care Technologies. The paper contains a summary of some of the keynote and panel presentations.

Introduction and Background

As the life expectance across the globe is increasing, the changing demographics demand technology-driven healthcare protocols for better monitoring, screening and point-of-care (POC) diagnosis to augment clinical and managed healthcare for seniors. Furthermore, technological advances in portable electronic devices and information and communication networks point towards potential benefits in improving global healthcare through preventive, personalized and precision medicine. The potential benefits of Point-Of-Care Technologies (POCT) may even become more important in specific areas of outbreaks of communicable diseases as well as managing non-communicable diseases in resource-limited environments. Though early conceptual developments and technological breakthroughs in POC diagnostic devices with electronic healthcare information integration appear to be instrumental in improving global healthcare in aging populations at affordable costs, there are significant challenges in developing clear understanding of how these benefits would be realized in a meaningful way. It is not clear how POCT would effectively address needs and expectations from all user groups, connecting diverse groups of patients, semi-skilled healthcare providers and clinicians.

To address the grand challenge of providing preventive, personalized and precision medicine-based quality global healthcare at affordable cost, we started an initiative that brings together leaders from all stakeholder groups—representing academic, federal, industry and clinical research and healthcare providers communities—with the First IEEE International Conference on Point-of-Care Healthcare Technologies held in Bangalore, India on January 16–18, 2013. The conference provided an international forum with clinicians, healthcare providers, industry experts, innovators, researchers, and students to discuss clinical needs and technology solutions toward commercialization and translation to clinical applications across different environments and infrastructures. This meeting was then followed by the IEEE-NIH Conferences on Healthcare Innovations and POC Technologies held in 2014 (Seattle), and 2015 (NIH-Bethesda). These conferences further emphasized the strategic need for the development of collaborative opportunities and resources to promote POC healthcare technologies [items 1)–4) in the Appendix]. Figure 1 represents a schematic of the issues that evolved from discussions at these meeting.

FIGURE 1.

POCT impact and paradigm with major infrastructure support and issues (taken from [item 1) in the Appendix]).

The 2016 IEEE-NIH Special Topic Conference on Healthcare Innovations and POC Technologies was held in Cancun from November 6 through November 9, 2016 with more than 150 attendees from academic and federal research laboratories, industry, regulatory agencies and the clinical community. The conference features 5 keynote and 22 panel speakers representing all stakeholder groups involved in research, development, translation and implementation of POC technologies for healthcare applications. With 5 keynote and 8 panel sessions, the current and future challenges in POCT were discussed. Four breakout sessions focused open discussion on clinical issues, challenges in user acceptance (clinical and patient) and the critical need for interoperable standards. This report presents a summary of the discussion held at the conference with the concluding remarks to focus on strategic tactics to facilitate translational science and engineering towards clinical use and validation of POC technologies.

Trends and Challenges in Point-of-Care Technologies: Healthcare and Clinical Needs

Point-of-Care (POC) diagnostic devices have the potential to accelerate the delivery of high-quality healthcare to the right patient, at the right time, and with optimal clinical and public health outcomes. In particular, recent advances in genomic and precision medicine offer the additional potential to further personalize POC diagnostic devices and tools and maximize the desired health impact at the individual and population levels. Not surprisingly, these expectations have fueled tremendous advances in the science and technology of POC diagnostic device development. Since Tovar’s seminal description of a bedside agglutination test using whole blood for the rapid diagnosis of tularemia in 1946, the spectrum of diagnoses now enabled include other infectious, metabolic, hematologic, endocrine, cardiovascular, pulmonary, cerebrovascular, and other diseases. Many of these advances have been possible because of dramatic improvements in the development of multiple substrate-specific biosensors and electrodes, multi-spectral imaging and monitoring, advances in miniaturization, and myriad enabling platforms and technologies [item 4) in the Appendix].

Recent successes in developing smart portable sensors and biomarkers in diagnosing certain infections and communicable disease such as HIV, and monitoring non-communicable diseases/symptoms such as glucose monitors for diabetics have been encouraging in setting up expectations for potential benefits of POCT in healthcare. However, clinical users may have different expectations and specific needs for the use of information from POCT devices. All five keynote speakers presented evidence of significant mortality rates in specific communicable and non-communicable diseases that hold the potential to be lowered via proactive patient monitoring, early diagnosis and personalized and precision clinical care. However, they all cautioned that clinical applications for POCT should be carefully selected for translation and validation for better patient/clinical care. In the opening keynote address, Dr. Wendy Nilsen described a set of questions that may be beneficial to select clinical needs for POCT and evaluate their impact. The breakout sessions on clinical and patient acceptance also raised similar questions to identify a clinical problem for a potential POCT solution:

Is the clinical problem right and significant for better healthcare?

Can the clinical problem be better managed with a potential POCT solution?

Would the POCT provide additional information that would help diagnosis and treatment?

How often does the POCT monitoring need to be done?

Who will use this information?

Do POCT devices provide reliable and robust information?

Does the POCT device provide secured and patient validated information?

How is the information stored and communicated for preliminary and subsequent diagnostic analyses?

How is the POCT data integrated with other data such as Electronic Health Records (EHR)?

The keynote speakers also emphasized that these solutions can only be developed through collaborative transdisciplinary research, innovation and translation involving all stakeholders and users early in the development phase.

Dr. George Mensah noted that POC technologies and diagnostics are ideal for the special constraints of diverse clinical settings, including homes, rural areas, acute care settings, ambulatory care and clinical research centers [item 5) in the Appendix]. The locations for application of POCT are endless, including intensive care units, neonatal care units, radiology and imaging suites, emergency care, operating rooms, renal dialysis units, diabetic clinics, delivery facilities, practitioners’ offices, outpatient and off-site clinics, nursing homes, pharmacies and in-home patient care. Smartphone based sensor and information technologies are already showing a great deal of promise for clinical applications [item 6) in the Appendix]. It was also pointed out that there is a long and very involved cycle of POCT innovation and its validation in clinical environments to demonstrate its impact. A complete description is provided by Harpaz et al. [item 7) in the Appendix]. On an encouraging note, the number of publications in the POCT area has risen exponentially from 1,904 during 1987–1996 to 22,316 during 2007–2016. It is interesting to note that recent papers published in POCT-related areas provide a complete spectrum of translational research issues from development to evaluation and clinical application. However, few of these studies address the important challenges of clinical acceptance, adoption, and adaptation with respect to providers, patients, and payers; provider and patient usage adherence; other implementation research outcomes; determinants of clinical meaningful use; cost-benefit or cost-effectiveness analyses (CEA or CBA); fidelity of POC device use in a variety of healthcare and real world settings; and sustainable strategies for dissemination, scale-up, and spread, especially in low-resource settings. Dr. Mensah also emphasized that evidence is critical in providing convincing arguments for the use and benefits of POCT in healthcare. The evidence must be obtained from systematic evaluation using well-defined performance and usability matrices.

Along with ongoing investigations on the impact of POCT for various clinical healthcare applications [items 6)–8) in the Appendix], the global market for POC devices is expected to grow with a compound growth rate of 9.8% from 2016 to 2021 while the Asia-Pacific’s POCT market is expected to grow the most at the CAGR of 14.2% [item 8) in the Appendix]. The global POCT market was estimated as more than $23 billion with an estimation of reaching to $37 billion in 2021, according to a recent market study [item 8) in the Appendix].

Dr. Julian Goldman presented several clinical scenarios where inaccurate and unreliable measurements from POC devices can complicate the clinical assessment in both supervised and unsupervised settings. He noted that it is critical that interoperability and calibration standards are carefully developed for POCT devices to be connected with healthcare information systems.

Though there are considerable issues in assuring that the information from POCT devices has sufficient integrity, security, sampling rate and patient validation, storage of the massive amount of data and information gathered by POC devices also poses a challenge by itself, particularly at the level of the interface between the POC and a central information data server such as an EHR that has its own requirements to manage large amounts of patient, diagnostics and treatment information. Dr. Hector Gallardo Rincon presented an overview of the implementation of EHRs in Mexico and demonstrated the use of EHRs in improving patient management and care. It is expected that such healthcare information systems and databases would help evidence based preventive, personalized and precision medicine in the future.

Point-of-Care Technologies in Resource Limited Environments

Developing countries and areas with limited resource settings have different challenges for the use and implementation of POCT devices and associated ICT for diagnostic and therapeutic applications. The breakout session led by Drs. James Gallarda and Tiffani Lash addressed these challenges from three perspectives: supply, demand and facilitation of POCT in limited resource settings.

With respect to the perspective of the Supply Stakeholder Group, the main challenges to designing, developing, and manufacturing high impact POC diagnostics in low and middle income countries include:

Proprietary interests: Innovators exist in silos

Lack of real early understanding of the end user and the intended use in a specific setting

Disconnect between developers and clinicians on the de facto needs (“Field of Dreams” syndrome)

Iterative development in the country

Devices are too costly; lack of design for low cost manufacturing

Lack of marketing/education to build demand from low to middle income country (LMIC) stakeholders; little to no funding

LMICs are usually not part of the development team early on – a best practice is to bring the demand stakeholder along in the journey (champion at the end)

On the other side, there are additional challenges with the Demand Stakeholder Group on developing pathways for rapid and efficient uptake and use. These issues include:

Country healthcare systems are heterogeneous/siloed; lack of goal alignment

Device is not cost effective and/or affordable

LMICs have limited budgets – focus on ideas matching country priorities

Lack of understanding – educate and marketing (real) value

“Why can’t we be included in the western innovation?” Local stakeholders must be leaders/co-creators of the future

What else is “’in it for me”? – create jobs, education (“made in Kenya by Kenyans”)

Stock outs - unreliable supply chain

The discussion in the breakout session also identified issues related to the Facilitating Stakeholder Group. These issues related to facilitating institutions in supporting POC diagnostics include:

Facilitating stakeholders are siloed; lack of goal alignment

Facilitators bridge supply and demand (WHO, NGOs, R&D/procurement funders like NIH, Bill and Melinda Gates Foundation, Wellcome Trust, Global Fund, President’s Emergency Plan for AIDS Relief (PEPFAR) program)

Find a knowledgeable local champion for the POCT inside the LMIC government- someone who understands how the government works

Who are the influential facilitating stakeholders? How to identify and engage?

Harmonize governing boards (e.g., local ethics committee could slow down the work)

Implementation research is critically underemphasized! Is the device scale feasible? Will there be an impact?

Point of Care Technologies: Clinical Use and Patient Acceptance

Drs. Edward Livingston, Ronald Dixon, Srini Tridandapani and Pamela Bhatti addressed joint breakout sessions on clinical and patient acceptance of POCT. While there is a general agreement that POCT may improve health, it is not yet known precisely what technologies are necessary or how they should be used. Although there is great potential for the application of new technologies in healthcare, physicians are skeptical about POCT since they fear it will generate overwhelming amounts of unreliable information of unknown benefit. Careful consideration is necessary before selecting what diseases and technologies should be pursued.

Because the benefits and acceptance of POCT are unknown, a necessary first step in its development is performing market research of patients and clinicians to determine what POCT they would like to have. Research into POCT involves first understanding what the needs are of patients and clinicians and then researching the best way to apply new technology to improve clinical care based on the understanding of these needs.

The potential uses for POC technologies by patients or clinicians are many. Of necessity, the clinical and patient use group limited its discussion to outpatient management of chronic disease. There are numerous potential applications for POC technologies in the inpatient arena. However, in order to develop actionable recommendations, we focused our efforts on one major application, chronic disease management, and did not try to encompass all possible clinical applications of POC technology.

Within chronic disease management, we focused on a common clinical condition for which there is no disagreement about the need to treat and that treatments are readily available. Hypertension fulfills these criteria and is a disease our group acknowledged is a reasonable focus for POC technology development. Diabetes management is also amenable to POC technology development, though it is somewhat more difficult to manage than hypertension. Metabolic syndrome and obesity are also worthy topics for development of POCTs to assist in their management but because they tend to respond poorly to current treatments, developing POCT to assist in their management is best deferred until POCT itself is more mature.

Risk factor management such as smoking control and obesity management are other good targets for POC development but also might be best deferred until there is a better understanding of how to implement POC technology that is useful for clinicians and patients.

POCT development is complicated by substantial heterogeneity in clinical care. A recent analysis of rural and urban POC needs demonstrated that acceptance of POC technologies is substantial in urban practices but little interest exists for POCT in rural environments [item 6) in the Appendix]. Most likely, patients at high risk for complications of a disease like hypertension would benefit the most from POC technology assistance in managing their disease. Some patients will embrace POC technologies and others will reject it. These complexities in the contextual aspects of the patient’s care will present difficulties in optimizing the application of POC technology for chronic disease management.

When developing POCTs for chronic disease management six major factors require consideration: Five issues were identified that complicate the development of clinically useful POCT

Development of a useful monitoring system

Data accuracy and reliability

Acquisition of data that is actionable

Patient adherence to the monitoring and treatment systems

Self efficacy- the ability of patients to respond to information obtained from POCT

Appropriate clinical decision-making in response to data obtained by POC devices

No one size fits all – POCT will require customization for use in specific populations based on their needs, wants and desires. For example, as mentioned above, there are differences in the acceptance for use of POC technology in the urban and rural environments. Systems developed for the urban environment will not likely be successful in the rural setting. This would require developing different systems based on environmental differences between patients and clinicians

Need to understand the unique needs in different settings – in order to develop a technology that might successfully facilitate improved management of a disease such as hypertension in the urban and rural environment a thorough understanding of the clinical needs and how they differ in these two environments is necessary. Only after studies have been done to understand the unique requirements for different healthcare settings can POC technologies be developed to facilitate provision of healthcare in these environments. These studies include ethnographic analysis to accurately assess the ecosystem.

Contextual and cultural impact of POC technologies must be considered – the total environment in which the patient lives must be accounted for when developing POC technologies. Some patients will have a great deal of support and can receive help in the use of POC technologies and in the implementation of treatments dictated by information provided by POC technologies. Other patients will have very little support and the use of POC technology to assist in their healthcare management will differ.

POCT platforms must be tailored for individual diseases and unique clinical conditions.

Algorithms will be necessary to facilitate interpretation of information obtained from POC technologies. Currently physicians are overloaded with information and any new system that is developed intending to improve disease management must reduce, and not increase, physician workload. Thus, algorithms that facilitate interpretation of data obtained from POCT must be integral to the overall development of these technologies in order for them to be clinically useful.

POCT platforms as a whole must be subtractive for the clinician community to embrace them. Ingesting and using the information supplied should save time in a clinician’s day, and not be equivalent or additive or the clinician community will not have an incentive to adopt POCT.

Other factors to consider when developing POCT include:

Use POCT to achieve behavioral modification. Behavioral modification is a major component of treatments for important disease such as obesity. It is also necessary to improve adherence to easily treated diseases such as hypertension-a condition that is easily treated with medication but, in practice, compliance with taking medications is a major problem. The NIH Office of Behavioral and Social Science Research (OBSSR) should be consulted to facilitate these efforts.

POCT should be used to facilitate continuity of care

POCT should be developed that facilitates the development and maintenance of patient-clinician relationships. Successful treatments rely, in part, on establishing a trusting patient-clinician relationship. In an ever-increasingly fragmented healthcare system, developing these relationships is increasingly difficult. When developing POCT, consideration should be given to creation of POCTs that help support the patient-clinician relationship.

POCT development can be facilitated by using existing technologies such as Alexa, Google etc. The rationale is that patients may build upon an existing level of comfort with commercial accessible technologies for personal and lifestyle management.

Point of Care Technologies: Interoperability, Standards and Regulatory Considerations

The breakout session on Interoperability, Standards and Validation led by Drs. Atam Dhawan and Julian Goldman focused on the critical need for having reliable, accurate, pateient validated data from POCT devuices connected to an EHR or other patient infromation system through secured communication. As the POCT devices may be operated by pateients and other users in unmanaged unsupervised settings, it is very important that the devices are interoperable and can be self-caliberated or at least caliberated with minimal interaction with users. The inetroperability requirements may include:

Guiding principles – all data normally available to the user/operator should be available via the electronic data interface (EDI) [Note - this excludes proprietary manufacturer data]

The state and change in state of any operator-adjustable setting must be made available through the electronic data interface (e.g., alarm settings, signal averaging time, and computation constants).

Important device attributes, such as software and firmware revisions, time of last clock update, and equipment maintenance-related data must also be interoperable [item 9) in the Appendix].

Data Needed from Devices

Test result data, clinical messages

Device status, performance, calibration data, technical messages

Metadata – e.g. user info, environment of use, site of measurement, geolocation of measurement, time stamp in UTC and local time, signal quality metrics

Research/Innovation opportunity to generate novel data to support information about clinical context of use and device state [item 10) in the Appendix].

Data to devices

Software (algorithm) upgrades, patches, cybersecurity updates, time updates

Setting changes or device control (closed loop, operating protocols, safety interlocks)

Interface – acknowledgement message, command and command control messages, Quality of Service (QoS), availability or lack thereof, bandwidth requirements or specifications, etc.

Eventually standards must support reliable transmission and use of above data

System – EHR, EMR, Patient or Population Monitoring Service or equivalent, personal health record systems, registries

Example – TI Diabetes management. Access to data from POC devices (glucometer) and data from Smartphone app – ideally via API.

Open documentation of API is helpful, but not necessarily interoperable nor standardized

Standards for emerging POCT are not yet available

FDA interoperability (draft) guidance – will affect validation of interoperability claims (and cybersecurity)

Furthermore, the discussion emphasized the meaningful use of POCT with a set of pre-defined performance measures and an evaluation matrix. This may include:

Validation of performance

Compare performance across:

Devices

Patient populations

Platform based integration (e.g., mobile device) enables acquiring concurrent data from other sensors and sources required for validation of POCT devices

Support value proposition for diverse stakeholders

Patients and their caregivers

Providers

Payors

Engineering support – equipment management and maintenance (Health Technology Management)

Device manufacturers

Researchers (clinical and engineering)

Standards Development Organizations (SDOs)

Federal agencies

NHRA, notified bodies, patient data portals

The breakout session finally noted that secured information communication protocols and cybersecurity measures are essential for POCT devices to connect to clinicians and healthcare providers as well as insurance providers/payors. The study groups should address and investigate these issues to develop standard protocols. These measures may include:

Risk based application of cybersecurity protections

Risk to patient and device

Risk assessemnt (could be standardized for POCT)

Protect performance of devices

Maintain availability of data (e.g., ransomware)

Prevent unauthorized access to data (test results or PHI)

Prevent data alteration or manipulation (e.g., via man-in-the-middle attack)

POCT applications on diverse platforms

Stand-alone devices with embedded OS

Apps on mobile phone platforms

Apps on consumer computing platforms

Enhanced cybersecurity with effective interoperability

System data is needed to baseline and monitor performance of system components (sensors, actuators, platforms) – lack of interoperabilty impairs this core requirement. (Consider FDA cybersecurity guidance (pre and post market). FDA site: http://www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.htm)

Understanding the FDA medical device premarket regulatory process helps streamline the path from research to market for commercialization. The FDA regulates all products that meet the definition of a medical device defined in Section 201(h) of the U.S. Federal FD&C Act. Entrepreneurial medical device firms face many translational challenges, including regulatory issues. Device classification determines the appropriate type of premarketing application and the regulatory requirements for new medical devices. Understanding the risk-based regulatory paradigm in premarket evaluation, FDA’s device classification system, and conforming level of control should improve the outlook of commercial success in the introduction of novel devices in the U.S. market.

Concluding Remarks: Challenges and Future Directions

In summary, many clinical conditions could be better managed with the assistance of POCT. The best chance technology development has for success in improving health care will be if the technologies are developed for disease entities having well established and easily deliverable treatments that are known to be highly effective. Moreover, appropriate clinical and user studies may be designed to test the efficacy of POCT. One such disease is hypertension. Development of the POCTs must account for heterogeneity between patients and the environments in which they live. The technologies will need to lessen the workload a physician must apply to treating a particular clinical condition, and/or improve the clinician-patient interaction, in order for the clinician community to accept the use of these technologies.

While clinical needs can drive healthcare technology innovations, implementation of certain technologies can create new clinical needs. With the emergence of hundreds of new point-of-care devices gathering patient data, two new needs emerge: 1) authentication of these data sources to prevent wrong-patient errors, and 2) personalization of this data so that this massive data does not prevent patient-centered care.

Translational research from the lab bench to the marketplace where products and services are provided and consumed is far more difficult and time-consuming than many people estimate or are willing to tolerate. For the benefit of humanity, on the other hand, our mission points us to incessantly making engineering innovations with creativity, collaboration and perseverance so that a better healthcare system for prevention, diagnosis, therapy and management can be developed and deployed around the world, although the problems look daunting and impossible. To make the (seemingly) impossible possible takes courage, confidence and competence with partnership, patience and determination. Also, we have to get out from our comfortable silo and break down the tall walls between researchers, laboratories, departments/disciplines, institutions, and countries.

Papers in the HI-POCT 2017 Special Issue

This special issue on Healthcare Innovations and Point-of-Care Technologies (HI-POCT 2017) presents 8 papers, including extended versions of some of the papers presented at the 2016 IEEE-NIH Special Topics Conference on Healthcare Innovations and Point-Of-Care Technologies.

Continuing the discussion on global healthcare, a review of cost-effective and affordable POC technologies for cancer care including detection, treatment and therapeutic intervention is provided in the paper by Haney et al. [item 11) in the Appendix]. They argue for affordable POCTs for cancer care in low and medium income countries with a focus on imaging tools, in vitro diagnostics, and treatment to encourage innovation and further investment. It is a critical unmet need specifically in developing countries.

Towards using POCT for cancer detection, the paper by Shell and Gregory [item 12) in the Appendix] introduces a portable desktop prototype device that provides highly accurate neural network classification of malignant and benign tissue. They show the potential to provide healthcare providers and clinicians with a fast non-invasive accurate assessment of biopsied or sectioned excised tissue in various clinical settings.

There is a rapidly growing strong interest in the development of POC technologies for cardiovascular applications. DeGregory et al. [item 13) in the Appendix] present an inexpensive point-of-care sensor for detecting the primary heart failure marker peptide, NT-proBNP. They also discuss the challenges in further development of the technology for clinical acceptance.

As POC technologies are also targeted to help outpatient care at the hospital, Adjei et al. [item 14) in the Appendix] demonstrate the potential use of a computerized model in managing local anesthesia to minimize risks to the patient during surgery. They present their model of physiological metrics and numerical pain ratings from patients, in order to model the link between the modulation of cardiovascular responses and pain in varicose vein surgeries.

Quality dental healthcare is a critical unmet need in many resource-constrained environments. The potential use of POC technologies in dental applications is demonstrated by Angelino et al. [item 15) in the Appendix]. They show the construction of an NIR (850 nm) LED imaging system for teeth imaging and evaluations. The NIR system was successfully used to detect secondary, amalgam-occluded and early caries lesions without supplementary image processing.

As discussed above, home-based monitoring is expected to become an integral part of e-health, specifically for the elderly population. Li et al. [item 16) in the Appendix] present a very interesting concept of using passive radar to capture and recognize human body movements, respiration, and physical activities. An innovative two-stage signal processing framework is outlined to enable the multi-purpose monitoring function. A novel smartphone-based POCT for urinalysis is presented by Ra et al. [item 17) in the Appendix]. They show that using their algorithm on a smartphone, images of urine color-strips can be better evaluated for diagnosis under environmental illumination conditions without any calibration requirements. Thus the POCT can be used for real-life applications by a common user.

Diagnosis and management of sleep apnea is a growing and critical concern in both developed and less developed countries. Nakamura et al. [item 18) in the Appendix] present an automatic sleep-stage monitoring system for recording the electroencephalogram (ear-EEG). The characteristic features of recorded readings from their affordable and wearable in-ear sensor are analyzed for sleep pattern monitoring and classification.

These papers clearly demonstrate the wide-spectrum applications of POCT in global affordable personalized healthcare to support the precision medicine initiative. Though POCT is logically expected to provide real impact in improving healthcare, this impact has not yet been fully demonstrated through carefully designed clinical studies and assessment. The synergy among all stakeholder groups on the development, testing and evaluation of POCT is critical but the acceptance of patients, users, healthcare providers, clinicians, payors and regulatory agencies are important in experiencing the full potential impact in global affordable healthcare.