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The year 2019 has been a difficult phase for India’s healthcare sector. The sector experienced some headwinds, with regulators bringing in stringent policy interventions such as price cap for med devices and conducted surprise raids for quality checks etc. We also saw some private healthcare businesses struggled to stay afloat as organisations battled to balance cost and profitability. The investment scenario in healthcare was also affected.

Nevertheless, the good news is that industry analysts, health economists, investment experts and the government all seem to foresee a promising future in the next decade. The healthcare market is estimated to reach $ 372 billion by 2022, states the IBEF report.

Moreover, the Ministry of Health & Family Welfare is planning to further enhance its healthcare budget to 2.5% of GDP by 2025. The Indian Government has also developed a Sustainable Development Goals (SDG) targeted to be achieved by 2030.This is an attempt to ensure health, end poverty and ensure prosperity and peace for the people. As part of this agenda, one of the SDGs focusses strongly on health. It aims to promote the healthy living and well-being for people of all age groups by eradicating all forms of malnutrition and achieving universal access to safe drinking water, hygiene and sanitation.

On the private healthcare front, analysts anticipate a surge in investments. The rising adoption of digital technologies, automation and more will be the key drivers for growth. Express Healthcare 20th anniversary special issue ‘Healthcare 2030 and beyond’ looks at various aspects that will enable India progress on the world health map. It will cover trends shaping the future healthcare landscape to attain sustainable health systems; emerging technologie-s; new age healthcare and medical education news, new research requirements, environmental health issues, integration of healthcare services; health financing, economics and insurance; patient-based care and empowering the patient and new models of care.

Surfing the health data deluge with CDSS

Though there is general consensus on the benefits of clinical decision support systems (CDSS), cost, implementation glitches and divided opinion among clinicians remain painpoints
By Viveka Roychowdhury

World over, technology has changed the way medicine is practised. As a health IT tool, powered by artificial intelligence (AI), clinical decision support systems (CDSS), a broad term covering software used to help healthcare professionals make accurate decisions, have become the standard in most large healthcare institutions. In India, the Digital India push has seen more healthcare facilities adopt basic features like electronic medical/health records (EMR/EHRs).

Though the top management of many healthcare facilities agree on the benefits of CDSS, cost remains a major drawback. As Joy Chakraborty, Chief Operating Officer, PD Hinduja Hospital, Mumbai puts it, “One of the main reasons for failure of complete acceptance and proliferation of CDSS in our country is that the costs are quite prohibitive.” Currently costs range from approximately Rs50 lakh plus for the software, plus license costs on a user-to-user basis.

But he agrees that “as our country moves towards a culture of defensive medicine to counter the increase in medical tort cases, it may be a good time to invest in CDSS. This easy access to best practices and guidelines will ensure they are followed and the treatment given to patients will not be challenged easily.”

A long term bet

The sector has seen steady support from investors. According to a Mercom Capital Group report on global venture capital (VC) funding in 2019, CDSS with $138 million was the sixth top funded categories in Q3 2019. The category had nine transactions in the quarter. The report tracks global VC funding and includes VC, private equity, and corporate VC.

For comparison, the top funded category was telemedicine ($651 million), followed by mHealth apps ($391 million), analytics ($201 million), mobile wireless ($173 million), healthcare service booking ($151 million). Practice management solutions trailed at the seventh position with $119 million.

The funding trend across the first nine months of FY 2019 (See graphic, Top-funded digital health /healthcare IT) reveals a similar trend, with CDSS at sixth position with $425 million in funding. According to Reports and Data, the global CDSS market was valued at $488.2 million in 2018 and is expected to reach $1.17 billion by 2026, at a CAGR of 11.4 per cent.

What the regulators say

As the implementation of CDSS spreads across the globe and finds applications in more scenarios, regulatory agencies are paying more attention to the sector. In the US Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report of 2014, the term ‘clinical decision support’ or ‘CDS’ is described as a variety of tools including, but not limited to: computerised alerts and reminders for providers and patients; clinical guidelines; condition-specific order sets; focussed patient data reports and summaries; documentation templates; diagnostic support; and contextually relevant reference information.

On September 27, 2019 the US FDA released a draft guidance on CDS software to provide clarity on the scope of FDA’s oversight of clinical decision support software intended for health care professionals, patients, or caregivers.

In India, the Digital India push has spawned similar sector specific initiatives. The Ministry of Health & Family Welfare sector has recently released the draft National Digital Health Blueprint and in December 2016, the notification of the Electronic Health Record (EHR) Standards (Version 2016) for India. This regulatory push is expected to increase the use of such CDSS tools in hospitals, both public and private, across India.

CDSS in public health

Given the geographical spread of the country, there is a huge difference in standards of healthcare delivery in India’s public health sphere. This is where standardised care guidelines, which are the backbone of CDSS, can make a huge difference to clinical outcomes.

Thus, there are moves to implement some facets of CDSS in public health initiatives. The government has invited suggestions on the draft digital health blueprint from stakeholders and Elsevier is one of the companies to share its recommendations to the government with an overall recommendation to use more AI-enabled solutions to address challenges in India. And secondly, to move from being in-patient, hospital-focussed to community, outpatient focussed, with an emphasis on curative treatment to prevention.

As John Danaher, President Clinical Solutions, Elsevier puts it, ” The core (need) is to standardise the delivery of care to ensure that care delivered is safe, clinically effective and of the highest quality. Our content and software helps clinicians, nurses, home health (ASHA) workers make more accurate diagnoses at the point-of-care. And ensures that the right medication is given once a diagnosis is made It makes sure that (when that patient is admitted), that patient’s care is coordinated during the entire hospitalisation, be it for diabetes, hypertension, etc.”

Giving more details, Shankar Kaul, MD, Elsevier Health Solutions, India and South East Asia says, “When it comes to clinical decision support, we are working with the government bodies like Niti Aayog as well as NGOs like the Piramal Group to make sure we are providing the right solutions, tailored to the needs of the population, like primary screening for certain diseases. We are at advanced stages of trying to prototype some of these products and customise these products in India. This can complement the work being done by Niti Aayog and Ayushman Bharat.”

Emphasising the two pronged challenge, Kaul says, “One part is the access to care, to ensure that the vulnerable sections of population who were not getting treatment are getting treatment. The second part is that the treatment they get should be quality treatment. That’s an area that the National Health Authority (NHA) will have to pay attention to. There are many robust and affordable ways of doing it and that is what we are doing.”

Citing an example, Danaher and Kaul talk about how ASHA workers and ANMs, equipped with hand held devices, can be used for primary screening of some of the major issues facing India. For instance, improvement of maternal and child health indices has been a focus area of the government. These hand held devices loaded with maternal and child care guidelines could provide a standard level of care to the communities they serve. At the same time, they could also begin capturing data about the patients in a particular community which could help government officials plan resources accordingly. Once detected, the patients can be taken through evidence based care and can be treated at the health and wellness centres of public hospitals as required.

The CDSS provider should also ensure that the content is tailored to the country/community’s needs, which means that the content is available in local languages and can be used with local clinical guidelines.

Kaul also says that such devices can be used in areas with intermittent or no connectivity and can be easily utilised by people who are not very skilled in healthcare like the ASHA workers and ANMs, right up to healthcare providers themselves.

Danaher stressed that Elsevier is very focussed on how the company can help India address the need to train more doctors and nurses who can go into the community and provide care.

“We believe there is a significant need for technologies to help ASHA workers, who are on the front line, (they are) the last mile delivery (who) are a very big focus for the government. That’s an area that was broken and can be fixed with AI-enabled solutions”, says Kaul.

Start ups have chosen selected niches to offer clinical decision support solutions. One example of an AI-based clinical decision solution is NIRAMAI’s radiation-free, non-invasive, non-touch, breast cancer screening solution for hospitals and diagnostic centers. The solution is accurate, affordable, privacy-aware and can be used for women of all ages, including women under 45 years. As the solution is portable, it is also amenable for screening camps in rural areas and corporate health camps.

The core technology in NIRAMAI, called Thermalytix, uses a high-resolution thermal sensing device and cloud-hosted AI-based solution for analysing thermal images. The innovative machine learning techniques used in NIRAMAI’s solution have led to nine US granted patents. NIRAMAI’s technology detects breast cancer at a much earlier stage than traditional methods or self-examination. Early and timely diagnossis is key to improving clinical outcomes especially in cancer.

Dr Geetha Manjunath, CEO and CTO, NIRAMAI believes that “NIRAMAI’s automated clinical decision solution which addresses a key issue in women’s health, has the potential to drastically reduce deaths due to breast cancer globally. The progressive innovation in this
industry coupled with the government’s support is sure to accelerate healthcare penetration and enhance the value for patients.”

Reducing medical errors

At a larger level, be it public health, private clinics, corporate or public hospitals, the case for CDSS in India seems clear. Crowded public hospitals and waiting rooms of private clinics underline the paucity of medical personnel and facilities and a high patient load. This is the perfect setting for medical errors.

Prashant Mishra, Managing Director, BMJ India cites an article published in The BMJ, according to which the average time that India’s neighbourhood doctors spend with patients is a negligible two minutes whereas the same time for doctors in the US is 18 minutes. Such a short consultation length is likely to adversely affect patient care and the workload and stress of the consulting physician.

Medical errors are not confined to India. Another study from The BMJ observed that if medical errors were a disease, it would be the third largest killer in the US. While there hasn’t been an equivalent study for India, Mishra refers to a study conducted in 2013 by Harvard University which estimates that 5.2 million injuries occur across India each year (out of the 43 million globally) due to medical errors and adverse events.

Mishra thus makes the case that “a CDS tool that provides quick, evidence-based answers becomes imperative. By arming providers with trusted resources, it is less likely that unreliable information will be used in clinical decision-making thus leaving the clinicians with more quality time for the patients.”

Customised yet standardised

Technology providers have long realised that a cookie cutter CDSS are not useful beyond a certain point. Solutions and content that work in another market may not work in India, simply because each country has its own challenges. Agreeing with this, Kaul says, “As we move into CDS, having localised solutions is going to be very important. We have to ensure that our CDS are not just safe, effective and of the highest quality but most importantly, are relevant for the local market.”

Thus their strategy going forward will be to rely on local opinion leaders who may or may not utilise guidelines which come from the (other countries and associations) UK, US or any other bodies/ country. “They want guidelines that are relevant to the societies, the associations that they belong to. So making sure that there is local buy in from key opinion leaders for this information is going to be very important,” explains Kaul.

But Danaher also reasons that there are similarities between countries which could be leveraged. “I’ve had the benefit of working in South East Asia during my career as a caregiver/physician, in hospitals in the under-served areas of Karachi, Pakistan in hospitals and in the slums. So I am familiar with the environment of delivering care to under-served populations as well as those that have access to care. Some of the challenges are similar in India.”

Mishra of BMJ India also understands the importance of local guidelines in ensuring consistency of care. Thus in 2020, BMJ India will be enabling organisations to add local information for users (such as local guidelines, prescribing formularies and protocols), and link them to relevant topics in their CDSS product. This will ensure that healthcare professionals have all the information they need in one place, asserts Mishra.

Navigating towards a glitch-free CDSS

There is broad consensus among medical personnel about the worth of CDSS but implementation challenges remain, even in bigger corporate chain hospitals. For instance, a delay in implementing EMRs at Fortis has been an impediment towards adopting CDSS to its full potential, says Dr Gaurav Mahindra, Associate General Manager, Medical Strategy and Operations Group, Fortis Healthcare. In his opinion, “A CDSS is an important facilitator for clinicians, nurses and medical staff in a rapidly evolving health and healthcare set up. As a pan-India network, Fortis Healthcare recognises the immense benefits and potential offered by such a health IT system.”

Thus delays in deeper implementation are not for want of clinicians’ buy in. Hinduja Hospital, Mumbai has not opted for a CDSS in a structured manner but according to Chakraborty, the hospital staff has easy access to publications, keys and reference material on their intranet and in their library. He concurs that “CDSS reduces the burden on the clinical staff and hence helps to tackle information overload by delivering clear and crisp ‘information’ instead of just ‘data’.

Converting the cynics

Besides the cost of CDSS, Chakraborty refers to several other challenges. He highlights the lack of interoperability with reporting and EHR software, validity of the information and a lack of accepted evaluation standards as the top two concerns. It can also be time-consuming to use.

Importantly, clinicians perceive CDSS as a threat to their clinical judgment. There is also ‘alert fatigue’ among clinicians. “Although there are several benefits for the use of CDSS, these (issues) need to be resolved effectively before CDSS can convert the cynics,” says Chakraborty.

Dr Shilpa Tatake, COO, Jupiter Hospital, Thane, Mumbai too concurs that the initial adaptation to EMR was challenging, as there were technical errors due to download speed, saving errors, etc. Timely entries and roll over of information leading to lack of assessment in system were also issues.

Dr Mahindra of Fortis Hospitals rationalises the challenges as those to be expected with any support system. “CDSS may be considered as an extension of business intelligence (BI), as it enables decision making for the user. Considering the enormity of medical facts that need to be known, the quantum of medical literature getting updated continuously and emergence of Evidence Based Medicine, receiving relevant information through CDSS enables taking timely decision.”

However, as a means of knowledge management, Dr Mahindra points out that any support system is likely to face considerable challenges, namely managing such a system requires both clinical and IT expertise. Secondly, the capability to handle huge volume of ever-increasing data from various sources/ departments and keeping pace with it.

Staff in charge of implementing a CDSS also have to ensure that there is zero/ minimum down time and data loss. They also have to devise a standard format to handle and integrate different data types in a single framework. The absence of healthcare domain certifications/ accreditations for selecting the right product is another challenge to implementation of CDSS, concludes Dr Mahindra.

Chakraborty perhaps reflects the tug of war in many hospitals when he refers to the “divided opinion” regarding adoption of CDSS. “The more techno-savvy younger staff is eager to adopt but at the same time they are wary regarding the authenticity of information and the time consuming aspect. The older generation on the other hand still struggle with using the solutions and when they do, they find the CDSS too prescriptive along with an added component of a ‘threat’ to their clinical judgment.”

Benefits of CDSS

Listing the benefits to the nursing functions, Dr Tatake of Jupiter Hospitals says CDSS brought in easy documentation, and therefore saves time. It also avoids duplication of data entry, while legibility and authenticity is maintained. CDSS minimises errors and manipulation, decreases file work and incidences of document misplacement, ensures accuracy and completeness in documentation, is user friendly and results in uniformity in documentation. Doctors get real time accessibility from anywhere anytime, can form a timely plan of treatment and can also perform a retrospective evaluation.

Dr Mahindra too says that in spite of challenges, medical staff at Fortis have largely been enthused with the possibility of BI facilitating informed decisions, thereby reducing errors and improving patient care. Hospitals today have made CDSS training part of normal duties. At Jupiter Thane, new joinee nurses receive an orientation to EMRs during their induction, as well as continual departmental training along with buddy, according to Dr Tatake. Doctors can access comprehensive data of a patient including the haemodynamic parameters, pathology and radiology reports including the films are readily available for decision making through EMR.

The paucity of medical personnel combined with the high patient load leads to high chances of medical errors. Has CDSS addressed this issue without compromising on clinical care? Agreeing Chakraborty of Hinduja Hospitals says, “That this is especially true in smaller set ups or in rural and remote locations and even in healthcare organisations in tier III cities where this imbalance of healthcare personnel is more pronounced and the access to regular medical updates or specialist opinion is inadequate. It is in these types of locations wherein CDSS can help reduce chances of medical errors greatly influence patient outcomes.”

However, in hindsight, Dr Mahindra raises an important issue, commenting that “increasing engagement of stakeholders in the design, implementation and use of CDSS has been one of the important expectations from end users.” Would the CDSS implementation story been smooth if solution providers had engaged with end users from the design stage?

CDSS as a service enabler

Even with these benefits, CDSS champions must fight for their share of a hospital’s investment budget, because gains might not be so evident and might take some time to be evident. And with shrinking profit margins, this is not an easy task As Mahindra of Fortis explains, “One of the greatest challenges in the adoption of such a system is the limited ability to prepare and justify a financial business case. It remains difficult to demonstrate the return on investment especially against many intangible benefits accrued towards patient care. However, CDSS must be viewed as not just a technological feature but also as a service enabler that helps clinicians and patients make informed decisions about choice of treatment offered.”

The perception that CDSS will add to the cost of treatment without adding value can be countered by citing studies which have proved the value of CDSS. Dr Mahindra refers to a study which indicates implementing CDSS for sepsis management in an in-patient setting was instrumental in reducing length of stay, resulting in savings for patient as well as for the institution.

Chakraborty too feels that with a clear guideline to be followed, the chance of correct diagnosis is increased and a crisp treatment plan can be made which will of course avoid any unnecessary costs ensuring the cost of treatment is kept under control.

Dr Tatake offers another perspective, pointing out that the day-to-day paper required for all clinical documentation is considered to be costlier than EMR and its server. EMR and the associated logistics requires one-time installation and data can be stored easily.

Refuting the perception that CDSS is a high cost, Mishra points out that on the contrary, CDSS systems can reduce care costs by eliminating duplicate and unnecessary investigations. Clinicians use CDSS to diagnose and improve care by eliminating unnecessary testing, enhancing patient safety and avoiding potentially dangerous and costly complications. Thus he reasons, using a CDSS can lower costs and increase efficiency.

A step-by-step process

Implementing a CDSS is not an overnight operation and today organisations do have options at every step of the process. As hospitals and clinical practitioners are at different stages of the digitlisation journey, there are ways to cope with the the challenge of interoperability of existing digital systems like EHR as they implement a CDSS.

Chakraborty concurs that while a holistic system wherein the CDSS is completely integrated with the patient electronic health record is an ideal set up. That said, this is not a mandatory requirement for use of the CDSS.

As he explains,”When the organisation is still in the process of adoption of EMR, web or phone based apps allow an easy access to get information required by the doctors for clinical decisions. These solutions allow for selection of treatment based on symptoms, investigation results, etc. with checklist based protocols which need to input basic information into the system. This system can be eventually integrated with the EMR as the organisation use of the EMR matures.”

Dr Tatake of Jupiter Hospital, Thane, Mumbai believes that hospitals can address the challenge of inter-operability of existing digital systems like EHRs with a newly adopted CDSS by identifying the requirements and then merging it with CDSS. They can also schedule need based and time based updations. Maintaining an openness and readiness to adapt to newer technology advances is also important.

End user push back

In the initial phases of implementation, clinicians, especially at senior levels, tended to view the use of CDSS as an erosion of their decision-making responsibilities. There were also concerns that the use of such systems might reduce the decision taking ability of medical students and clinicians.

But these concerns seem to have been addressed in time. As Dr Mahindra rationalises, “CDSS must be viewed as a facilitator for improved patient care and decision making, not intending to replace clinician judgment. It is not a substitute for the skills acquired by clinicians through years of rigorous training and practice. Instead, it is an opportunity to support clinicians with artificial intelligence as digitisation of health data takes place. As a health IT system, it should assist medical staff in managing complex cases and voluminous data towards timely and informed decisions.”

Chakraborty says this ‘real’ threat as perceived by several clinicians especially the older generation can be tackled. “It is upto the developers of the CDSS to emphasise on the benefits of the system like avoiding information overload by curating of data into relevant bytes, by ensuring authenticity of the data. Also the CDSS teams need to emphasise and assure doctors that eventually all CDSS does is to give the guidelines – the ‘support’, the eventual decision making will always be a skill set of the clinicians. The CDSS developers should also support continuing profession development (CPDs) where medical updates are given to doctors to help them hone these skills.”

Mishra emphasises that CDSS is a point of care to aid clinicians in decision making, it gives best possible option and not a decision in itself. The penultimate decision still lies with the doctor.

Supporting the clinician

Giving an insight into the thought process behind designing CDSS tools Mishra of BMJ India explains,”CDSS tool providers are very careful to indicate that CDS does not, in any way, trump the decision-making of the doctor or other clinicians. Instead, it is a tool that provides quick access to additional or relevant information and research on evidence-based care that leverages this information within the EHR. Using the right information can help tailor care to individual patients based on their current health status and medical history.”

Thus he says, “CDS does not replace physician judgment. Rather it provides a richer set of relevant clinical information, drawn from the most current research, allowing the provider to make more timely, informed and higher quality care decisions.”

Dr Mahindra points out that one of the means of improving patient care through adoption use of CDSS is its ability to amalgamate patient’s medical history, lab and test results, and evidence-based guidelines for best care practices, thereby reducing errors. These tools have proven to be/ have the potential in addressing errors by focussing more on the preventive aspects of patient safety, namely computerised alerts and reminders to care providers and patients, eliminating drug interactions and drug duplication, tracking allergies, proactively managing cases by suggesting clinical guidelines/ pathways/ protocols, and providing condition-specific order sets, providing focussed patient data reports and summaries as well as documentation templates. These tools could help in reduction of errors and adverse events, promotion of best practices for quality and safety and rapid response to emergencies.

Future of CDSS CDSS solution providers have tried to address the various challenges. On the pricing front, Mishra explains that the pricing varies depending upon the way the CDSS is accessed, i.e, standalone basis including the app version or the CDSS being integrated within the EHR/EMR systems and the level of integration required. The pricing will also depend upon the number of FTEs or the number of beds and the number of locations. On a standalone basis BMJ India does have individual and institutional subscription price for our customers and users.

However understanding the “price sensitivities and the paying capacity of the customers in India” he says BMJ India has “appropriate country level discounts applicable to create an opportunity for our customers to afford our CDS and deliver improved clinical and patient outcomes.”

Dr Mahindra too gives suggestions on other features which may increase adoption saying, “CDSS content and capabilities need to be reliable and shareable for it to be easily accepted and adopted across health care organisations and health IT systems. Other features which may increase adoption could be optimal user interfaces and ease of usability, learning from each other’s implementation experience, devising strategies towards increasing CDSS adoption in real-world scenarios that consider change management and people management as essential requirements, explication of the value proposition offered by such a system, continuous improvement and improvisations based on feedback from clinicians and patients, designing actual workflow patterns for clinician/ nursing use and benchmarking of systems for validation and comparisons.

CDSS could also be considered as a resource to help address the shortage of medical colleges and therefore medical personnel in the country. A case study by three doctors from PGIMER Chandigarh shows how vital the need for efficient and authoritative decision-support is for postgraduates makeing the transition from the classroom into clinical environments,. The study highlighted that unlike traditional textbooks, each topic within the solution used at PGIMER was broken down into various sections. The bite-sized components made it very easy to access, read and digest the information. Doctors can then drill down further and read the relevant information in depth. The inclusion of evidence grades was particularly valuable to assess the quality of the information presented. The case study concluded that such content could aid in resource constrained setting for faster access to clinical information.

Signing off, Chakraborty says, “CDSS will never be able to replace the human component of medical professionals; however with the help of CDSS the clinicians can function more efficiently thus allowing to cover a larger group in a shorter period. Also with the help of CDSS qualified medical personnel can make decisions for their patient’s treatment circumventing the need of another specialist. This will be of great help in rural areas and tier III cities where the shortage of medical personnel is more prevalent.”

Dr Mahindra believes that CDSS has the potential to emerge as one of the most significant manifestation of artificial intelligence (AI) impacting healthcare and health IT. “A CDSS tool which can use an algorithm on data and suggest best practices would be able to enhance the efficiency of medical staff.”

Thus the verdict on CDSS seems clear. However solutions providers will need to listen more closely to their users and ensure their products reflect actual clinical needs and business realities. CDSS will have to be a partnership to towards a common goal of safer, more efficient and affordable clinical outcomes, as well as add to the health facility’s bottomline, in all settings.

ASHA workersclinical decision support systemsIBEF reportINDIAN HEALTHCARE 2030Mercom Capital GroupMinistry of Health & Family Welfarepublic healthSustainable development goalsUS Food and Drug Administration Safety and Innovation ActVenture capitalviveka roychowdhury
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