Category: Healthcare & Life Sciences

The Future of Decentralized Clinical Trials Starts with a Patient-first Design Approach | Blog

The biggest benefit of Decentralized Clinical Trials (DCT) is the opportunity to enhance the patient experience, but the process is rife with challenges that create disengagement. The problem is not that patients are unengaged, but rather the vendor products are not always very engaging. The solution lies in undertaking a patient-first approach. Discover the tenets of a patient-first design approach in this second blog in our continuing coverage of this timely topic.

The pandemic has propelled decentralized clinical trials (DCT) into the mainstream, and multiple enterprises have transitioned into the virtual model for conducting clinical trials. Both enterprises and DCT vendors have stated that improved patient experience is the biggest benefit of the decentralized model. What do enterprises mean when they talk about patient experience? Read our blog, How Decentralized Clinical Trials Put the Patient Experience at the Forefront, to find out.

To deliver a superior patient experience and derive maximum benefit from this model of conducting trials, enterprises and vendors must be aware of the patient-facing challenges that might pose major hindrances. A closer look at the top challenges will help businesses develop effective measures to improve patient engagement and retention.

Major patient-facing challenges

The entire remote model has reduced in-person interactions. Insufficient communication from sites and sponsors often leads to disengagement among patients. The human touch, an important psychological aspect in healthcare, goes missing in this model. Added to this is the burden of learning about new products and technologies.

Patients have very limited digital literacy and may find it extremely difficult to operate a new sensor, a smartphone, or an application. Vendors are struggling to develop  robust training and support programs while enterprise buyers are more concerned about patient education capabilities and post-implementation support in their sourcing criteria.

All these factors create a general sense of discomfort and disengagement among patients, thereby defeating the principal benefit that vendors and enterprises expect from a DCT solution.

How can vendors overcome patient-facing challenges?

Designing a patient-centric solution is the best way to address these challenges. Having a deeper understanding of patients’ journeys and their pain points, while involving them in solution design will lead to greater compliance and engagement. The following exhibit highlights the various tenets of a patient-first solution.

Exhibit 1: Tenets of a patient-first design approach

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Six aspects of a patient-first design approach

  • Empathetic: DCT solutions should portray a deep understanding of the needs, well-being, and interests of patients, fostering trust and emotional connection. Vendors need to map the entire trial journey and look at it more holistically rather than logistically. Incorporating patient feedback into designing solutions will reduce a lot of stress and burden on patients
  • Secured: Concerns with data security, compliance, and privacy have increased with the rise in DCT adoption. Patients fear the consequences of device and network hacking, data leaks, and unauthorized access to data. DCT vendors must incorporate stringent security and compliance measures, secure the networks, and prevent all types of unauthorized access. With precise security measures in place, patients will feel safer with their data and will be more willing to share data for clinical research
  • Adaptable: DCT solutions must be able to incorporate the changing patient context, needs, and preferences to build fluid experiences. The same solutions should be adaptable and scalable as per the study requirement, ensuring a consistent patient experience and providing long-term sustainability
  • Engaging: Delivering engaging content is the best way to keep patients motivated in this digital world. Interactive educational materials, timely communication of trial progress (lay summaries), and patient reports go a long way in increasing patient engagement and retention. Patients can be motivated by increasing their trial literacy, setting up patient advocacy boards, and rewarding them for their contributions to the trial
  • Personalized: A one-size-fits-all solution will not work as patient experience varies at each stage and with each individual. Individualized care and personalized solutions help in building trust, loyalty, and retention rates among patients. Giving patients the liberty to choose their treatment plans (wherever possible), creating patient-specific digital ads, and supporting patients via artificial intelligence (AI) assistants are some of the ways to incorporate personalization into clinical trials
  • Reciprocity: Patients, vendors, and enterprises should be encouraged to communicate and share relevant experiences. Beyond trial periods, vendors and enterprises can engage patients with information on lifestyle, new developments on drugs or medical devices, upcoming trials, diet plans, etc. This type of communication will increase the willingness among patients to share personal data with AI systems as well as the scope with vendors, leading to more customized solutions that promote relevant and progressive experiences

Patients do not want to be treated as mere statistics. They want the touch of empathy and personalization, pushing DCT vendors to think more ‘humanly’ and add ‘emotional’ content while designing DCT solutions.

When all the above elements are incorporated in building DCT solutions, it will not only increase participation and adherence but also improve the brand value and bottom line for DCT vendors.

Over and above the empathy-backed approach toward creating a patient-centric solution, DCT vendors and enterprise buyers can look further at certain initiatives aimed at improving patient experience.

A sheer lack of awareness among patients regarding ongoing or planned trials exists. Enterprise buyers and vendors should spread information about upcoming clinical trials and steps to participate in them while promoting the ease of using digital technologies (via social media, newsroom, public releases, etc.). Home-care nurses or physicians still must make monthly calls or visits to motivate patients and add some scope for face-to-face interactions between patients and healthcare professionals.

Though the pivot or the integral enabler for DCT solutions is technology and connected systems, the focus should be on improving the patient experience and building the future towards a patient-intuitive smart DCT solution suite.

What are your views on how businesses can improve the patient experience? Reach out to [email protected] and [email protected] to discuss further.

Interoperability in Healthcare – Key Regulatory Implications and Beyond (Part 2) | Blog

The CMS Interoperability and Patient Access final rule has enabled key healthcare stakeholders – payers, providers, and health IT vendors – to realign their strategic goals and work toward enhancing member engagement and care delivery.

While interoperability in healthcare can deliver numerous benefits, complying with the rules can be complex and we are closely tracking this issue. In our earlier blog, we covered the evolution of interoperability over the years, the interoperability rule, and the challenges enterprises face in deciphering this regulation.

Read on for part two in our blog series that focuses on the data sets that need to be shared, steps involved in the data sourcing process, and the areas enterprises must focus on to navigate through the interoperability rule.

Which data gets shared as part of the interoperability rule, and what is the data sourcing process?

The interoperability rule has mandated payers to share across member- and plan-level information with the help of two Application Programming Interfaces (APIs) – patient access and provider directory. The rule also clearly identifies distinct data sets that need to be shared through both the APIs, as illustrated below.

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Having discovered what data needs to be shared, the next big question for enterprises is understanding how to extract this data. To make the necessary data available to its members through open APIs, enterprises primarily have to perform these three key steps: source system identification, data mapping, and data transformation.

  • Source system identification: As healthcare organizations store member information across multiple systems such as claims management system, Electronic Health Records (EHRs), etc., the primary objective is to identify the right source systems that house the information needed to be shared through the APIs
  • Data mapping: Data elements mandated by CMS are populated across various Fast Healthcare Interoperability Resources (FHIR) profiles such as patient profile, practitioner profile, etc. These data elements must be mapped against the respective source systems by matching the fields from the source database to the target database
  • Data transformation: FHIR profiles consist of data elements with attributes such as cardinality, data type, and binding value sets. The mapped data will have to be transformed into the FHIR recommended format by adhering to the data attributes (for example, translation of system codes into industry-specific codes, usage of industry- standard unique identifiers such as National Provider Identifier (NPI), Clinical Laboratory Improvement Amendments (CLIA) number, etc.)

 How do enterprises navigate through the CMS interoperability rule?

Although the interoperability rule defines IT investments payers, providers, and Health Information Technology (HIT) vendors must make, enterprises also need to plan for other critical aspects such as infrastructure scalability and data security in parallel. These areas will be crucial given the increasing data volume and demand for more streamlined services around data access and utilization.

The exhibit below illustrates the key IT remodeling themes and corresponding transformation levers for interoperability implementation in a healthcare enterprise.

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FHIR-based API ecosystem

The interoperability rule states that healthcare enterprises should establish API interfaces for all systems handling member/patient data and that the data transferred among healthcare entities – including the member/patient – should be in a standardized format. A robust API-led interoperability strategy can help healthcare enterprises curb the data liquidity issue within their ecosystems. The FHIR-based APIs will enable data format standardization between different endpoints, decrease development time, and save storage space on endpoint devices.

But just creating and establishing FHIR-based APIs will not suffice. Enterprises need to integrate and orchestrate formats other than FHIR. While connectivity with standard or off-the-shelf systems will be easier, homegrown/custom systems will be challenging to map to FHIR standards. In-house development teams and technology vendors will have to create workarounds to modify existing components that consider the potential variability in medical terminologies.

Infrastructure layer

With the implementation of FHIR-based APIs, enterprises must assess scalability challenges within their existing infrastructures. To accommodate the upcoming member/patient data access requests and enable quick data retrieval, enterprises should start to manage their current data storage and compute capacities. Enterprises can approach the data scalability and infrastructure issue by either leveraging existing infrastructure to build an FHIR-based layer or partner with technology vendors to leverage their data, cloud, or FHIR platforms.

Security layer

As healthcare enterprises will have access to multiple data sources, healthcare interoperability might open the door to security breaches and cybersecurity threats that may not have existed if the data resided within the enterprise. With the influx of data from other healthcare entities, current standard security checks might not be able to cross-reference and validate the identity of the entity requesting access, creating openings for data breaches. To manage these security challenges, added investment in particular focus areas (e.g., application penetration testing, consent management, member education) can help enterprises achieve sustainable data security.

The road ahead

While enterprises are complying with the CMS mandate, an increased focus must be put on how they can look beyond regulations to address some of the key pain points in the industry, such as patient experience, care management and outcomes, and total cost of care. With data flowing seamlessly across the healthcare ecosystem, enterprises should identify and invest in areas that would be crucial to creating long-term business value while also giving them a competitive edge.

As part of our third blog in this series, we will next cover how healthcare enterprises can approach the interoperability rule beyond the mandate to reap long-term benefits, key investment areas, value for enterprises, and an interoperability enablement framework that provides a view into the required IT components for regulatory compliance and what goes beyond regulation.

Please feel free to reach out to [email protected] to share your experience and ask questions.

How Decentralized Clinical Trials Put the Patient Experience at the Forefront | Blog

How Decentralized Clinical Trials Put the Patient Experience at the Forefront

With the COVID-19 pandemic accelerating the adoption of Decentralized Clinical Trials (DCT), the opportunity to deliver a patient-centric experience is viewed as a top benefit of this alternative mode of clinical trials that uses digital and remote technologies. What factors are enterprise buyers looking for DCT vendors to provide in their platforms to increase satisfaction and ultimately drive patient enrollments? Learn about the five factors that go into a “patient centered” experience in this blog.

When COVID-19 brought traditional clinical trials to an abrupt halt, Decentralized Clinical Trials (DCT) proved to be a savior for sponsors looking to safely restart their paused research activities. While DCTs have been around for a decade and are slowly gaining traction, the pandemic accelerated the use of these alternative methods to collect clinical trial data through sensors or remote monitoring devices carried by a patient.

The top reason for moving toward this model has been its patient-centered focus that makes it easier for more people from a broader geographic area to participate in trials without the need to visit a site.

The growing mainstream acceptance for DCTs has increased the appetite among clinical research organizations (CROs) and sponsors to adopt the latest technologies and virtual models for clinical trials. This has resulted in an uptick in innovation and DCT product adoption recently. We see DCT vendors increasingly focus on co-innovation, continuous product improvement, and market education to help clients get started on their DCT journey.

Top benefits of DCT adoption

Our Decentralized Clinical Trial Products PEAK Matrix® Assessment 2021 found the most promising benefit for enterprises to consider decentralizing their trials is the opportunity to enhance the patient experience – a benefit that two out of three DCT product buyers also agree with based on Everest Group interviews. Other advantages of DCTs include reducing trial costs and timelines, attracting a more diverse patient population, and capturing real-time data for trials.

With DCTs, patients can now take part in a study from the comfort of their homes, spend more time with their family members, and focus on work and other responsibilities. This mode of clinical trial also opens the door to the patients who suffer from mobility issues and allows sponsors to reach a global audience, increasing inclusivity and diversion.

This new patient-centric approach is driving increased enrollment and retention rates. With these valuable benefits, it is not surprising that having a people-orientated platform has become central to enterprise buyers in making their sourcing decisions – even more so than innovation or reviews from other buyers.

What do buyers want from DCT vendors?

What do enterprises buyers mean when they talk about patient experience? Multiple facets contribute to the notion of patient experience as presented in the exhibit below.

Exhibit 1: What enterprises buyers mean when they say patient experience

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Five factors to enhance patient experience with DCTs

Patient experience can be broken down into the following aspects:

  • User-friendly interface – The User Interface (UI) of DCT applications and devices must be simple, yet effective. They must provide clear instructions and display only relevant and concise content. It should be well organized, making all options easily accessible and ensuring that the application can be used with minimal explanation
  • Easy to set up platform/app – Patients should have an easy time setting up a wearable, sensor, or application. It should be intuitive even to an average user with limited exposure to digital devices. The device should be as close as possible to a ready-to-use mode
  • Smooth operation – The applications or devices should not pester patients with unnecessary notifications, malfunctions, or failures that would cause unwanted frustrations, resulting in reduced patient engagement. A smooth operation with minimal or zero disruption is the best-case scenario
  • Robust education and training – Patients come with different levels of digital literacy, and they need to be supported during the trials. They must be aware of how to enroll themselves for the trial, schedule appointments, feed in data, and get important information about their health and the trial. Sponsors can create the knowledge pool, conduct training sessions, and build artificial intelligence (AI) bots to provide education and training to patients
  • Multilingual app and support – To reach a global audience, multilingual offering and support must be available. The devices or applications used should provide instructions and information in the commonly used languages across the world. If a trial is geographically focused, the regional language should be configured in the device

Enterprises want DCT solutions to integrate smoothly into the daily lives and operations of patients. Patients should not feel isolated when doing the trial since the significant amount of digital literacy required might deter them from participating.

Vendors also need to be aware of the top patient-related challenges that might hinder them from elevating the patient experience through their products and services. Multiple challenges might lead to an inferior experience, resulting in disengagement and dropouts. DCT vendors and enterprise buyers must identify these challenges and take discrete steps to improve the patient experience and engagement.

Keep following this space as we dive into the top patient-related challenges and present initiatives aimed at improving the patient experience.

What are your views on the patient experience in DCTs? Reach out to [email protected] and [email protected] to discuss more.

How Analytics and Automation Can Help Health Plans Improve Medicare Advantage Star Ratings | Blog

Customer analytics and automation solutions can be a key differentiator in helping health insurers achieve better Medicare Advantage (MA) Star Ratings with changes that emphasize the customer experience coming by 2023. At a time when delivery of high-quality healthcare services is a priority and competition is intensifying, taking the right steps now can make a difference for both providers and patients. To learn more, read on.     

Why the MA Star Ratings are important

Health care quality and MA enrollments have significantly improved since the Centers for Medicare & Medicaid Services (CMS) introduced a five-star rating system in 2007 that scores each plan’s performance across numerous measures over a prior 18-month period.

The major goals of the MA Star Rating program are to incentivize insurers to improve their performance and to help patients compare and choose high-quality plans. These Star Ratings have become a crucial yardstick to help beneficiaries select the best plan for themselves.

As a result of the program, more customers are enrolled in higher-quality health plans. According to Medicare, MA enrollment has more than doubled in the past decade, with 26 million Americans currently enrolled this year.

What led CMS to change the ratings?

Over the years, the criteria used to assess plan performance has become more stringent, with CMS changing the cut-point levels to achieve the ratings across 47 different measures. Even after raising the standards, average scores have improved, reflecting a continued push by providers to improve the quality of services.

The Star Rating divides the measures into separate categories and assigns a different weight to each area. In May 2020, CMS increased the weight given to measures related to customer experience, such as patient experience, complaints, and barriers to receiving care, from 35 percent of the total score last year to comprising nearly 60 percent of the overall rating by 2023.

CMS made this change to encourage plans to provide the best service to beneficiaries, resulting in better engagement and health outcomes.

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Patients’ Experience and Complaints Measure: These reflect beneficiaries’ perspectives of the care they received

Measures Capturing Access: These reflect processes and issues that could create barriers to receiving needed care

How does this impact health plans?

The changes in the Star Ratings can bring significant value to plans in the following ways:

  • Increased revenue – Better Star Ratings can lead to an increase in member enrollment, resulting in higher revenue
  • Financial incentives – CMS offers financial incentives in the form of bonus payments known as Quality Bonus Payments (QBPs) to plans that achieve high star ratings. In addition, the share of savings that plans must provide to enrollees as the beneficiary rebate is tied to the plan’s rating. Plans that are awarded four or more stars earn a five percent bonus payment. They also receive higher rebates that are returned to the members in the form of supplemental benefits or lower premiums
  • Improved customer engagement – By improving their ratings, plans also benefit from higher plan renewals and lower attritions while driving down operational costs

Insurers will have to strategize differently to understand how the rating changes affect them. For example, a plan that currently has the highest 5-star overall rating but average scores in customer metrics will see a decline in its overall ratings if it maintains similar scores in 2023 because of the increased weight given to customer-related metrics.

For plans that have ratings below 5-star, this change represents a big opportunity to significantly increase their overall ratings by improving their customer metrics.

What’s next?

Currently, nearly all plans use customer analytics and automation in some capacity to drive customer engagement. Following the changes in Star Ratings, the creation of a personalized, seamless experience across the customer journey that result in holistic engagement should be the end target for plans to realize the maximum benefits.

As competition in the health plan landscape intensifies over expanding their MA customer base, lowering the churn rate, and generating more revenue, efficiently leveraging analytics and automation solutions will become the key differentiator. Here are some ways users can gain a competitive advantage by using technology:

  • Deploying automation solutions to optimize call center operations that automate script/process tools and eliminate the repetitive tasks to support high-call volumes. This will allow human agents to dedicate more of their efforts towards high-priority customer segments to improve the customer experience and reduce operations cost
  • Leveraging analytics solutions such as customer journey analytics, channel analytics, and sales analytics to analyze customer history and behaviors for enhanced member segmentation and profiling. This will allow the plans to have seamless omnichannel outreach and engagement initiatives across different member segments

In the short term, existing analytics and automation solutions will need to be optimized and scaled to enhance customer engagement. Moving forward, customer analytics and automation will need to be integrated and deployed across the value chain of health plans to realize the full potential.

The ball is now in the court of health plans to capture this opportunity and turn the new Star Ratings in their favor by taking the right steps. While the outcome for health plans remains to be seen, these changes will certainly improve the member experience, especially at a time when delivery of high-quality healthcare services is a key priority.

To share your experiences on the CMS Medicare Advantage Star Rating changes, contact  [email protected] or  [email protected].

Healthcare Interoperability Is Coming – How Your Enterprise Can Navigate the New Rules | Blog

With the deadline for the first phase of the healthcare interoperability rule coming July 1, are enterprises fully prepared to accommodate the changes and the interoperability mandate as a whole?

Our three-part blog will guide your organization through the regulatory implications, implementation approach, and future opportunities. To learn more about the evolution of interoperability and the challenges enterprises face in deciphering the new regulations, read on.

After decades of trying, interoperability is getting closer.

The Interoperability and Patient Access final rule has provided the impetus needed to finally bring together data from healthcare payers, providers, and health information technology (HIT) vendors for patients to easily access information and coordinate their healthcare.

Announced in 2019 by the Centers for Medicare & Medicaid Services (CMS) and The Office of the National Coordinator for Health Information Technology (ONC), the final rule laid down definite protocols and data standards to comply with unified data transmission between members, payers, and providers.

Healthcare enterprises originally had until January 1, 2021 to implement the Interoperability and Patient Access final rule. However, concerns over COVID-19 led CMS to push back the deadline for meeting the requirements, giving them until July 1, 2021 to comply. The regulation has provided a necessary push to healthcare enterprises for building a strong IT foundation to spur smooth data transfer among stakeholders and healthcare organizations.

So, what’s the buzz about? What does healthcare interoperability mean?

Simply put, interoperability is the capability of healthcare systems and applications such as Electronic Health Records (EHRs), Electronic Medical Record (EMRs), and claims data management systems to converse with each other and have an effortless information exchange. The vision is for members and patients to be able to access their healthcare data at their convenience.

Healthcare enterprises have been trying to implement interoperable systems within their infrastructure for decades. But many challenges and restrictions regarding technology immaturity and technical and financial debt have restricted them from achieving full interoperability. This started to change in the early 2000s with technological advances and a legislative push toward interoperability.

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What changes are coming for healthcare enterprises and healthcare IT vendors?

To help healthcare enterprises achieve the goal of making health data accessible to members or patients from anywhere, CMS and ONC have put forward the following key provisions:

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What are the biggest challenges healthcare enterprises face to interoperability?

Below are the major hurdles enterprises will need to overcome to implement interoperability:

  • Misaligned incentives: The incentives of the stakeholders are misaligned with the goals of interoperability. For example, every HIT vendor currently sells proprietary systems. If interoperability becomes a reality, the customers will no longer encounter proprietary lock-in and will be free to choose any vendor. As a result, interoperability would dilute the competitive advantage of the HIT vendors and cannibalize their existing revenue streams
  • Complementary technology enablers: To avoid large upfront investment from each stakeholder, the entire technology framework might be cloud-driven. A host of APIs would need to be developed to enable information sharing between the common platform and the numerous proprietary databases currently used. Similarly, a secure API ecosystem would have to be implemented for external data sharing
  • Security of data: Enterprises might require third-party app developers to create their own branded applications for accessing health data. However, there is no regulatory authority over third-party apps and their use of protected health information. Also, with interoperability coming into play, the entire healthcare database might be located at one central platform, making it an easy target for cyber attackers

Interoperability is a journey and an opportunity for healthcare enterprises to assess and remodel their infrastructure. A strong interoperable infrastructure will ensure that healthcare enterprises reap the benefits of their current investments in the long term – enabling them to handle any future technology or industry changes.

To lead the industry, healthcare enterprises need to look beyond the areas defined in the regulation and also focus on a scalable, robust IT architecture, a security-led ecosystem, and the role of analytics in the long run.

To read more about interoperability and emerging opportunity areas in healthcare, read the next installations in our blog series, where we will talk about the interoperability framework and areas of investment for healthcare enterprises. Please feel free to reach out to [email protected] to share your experiences and questions.

The Prescription to Evaluating Telemedicine Is Using a Holistic Framework | Blog

Telemedicine became an essential tool for delivering healthcare services remotely during COVID-19. But was this growing trend of virtual doctor visits truly effective, and will it continue post-pandemic? Current evaluation systems present many limitations to determining how well telemedicine is performing. A more comprehensive framework is needed to get the RX to success. Read on to find out what is needed.      

With telemedicine adoption surging and gaining greater acceptance by physicians and patients, determining the quality of the services provided has become critically important. Moving ahead, providers must have satisfactory answers to such lingering questions as: How do you effectively evaluate telemedicine? What impact do all the stakeholders involved have in the evaluation?  Are the current evaluations extensive enough to cover all factors?

While telemedicine usage skyrocketed due to the unavoidable circumstances of the pandemic and provided many immediate benefits, we now need to understand if its usage will continue in the long term as normalcy returns.

In comparison to in-person visits, telemedicine is more complicated, especially when considering the additional stakeholder responsibility involved from payers, providers, policymakers, technology providers, and consumers.

Beyond the care outcome that is usually gauged in typical face-to-face appointments, such factors as implementation, delivery, and repeatability must also be rated to determine the true value of telemedicine.

The need of the hour is creating better, extensive, and holistic evaluation frameworks that take into consideration most, if not all, of the dimensions that affect the overall care and patient experience delivered virtually.

Obstacles to overcome

Telemedicine evaluation frameworks and methodologies have been evolving. However, the sluggish rate of telemedicine adoption and skepticism toward its practice until now has delayed the progress in creating a more comprehensive evaluation framework.

Also presenting obstacles to a more holistic approach are the considerable variations in focus areas and the narrow and isolated scope of evaluation, such as those only considering specific clinical areas, measuring patient satisfaction, evaluating technology, assessing cost and efficiency, etc., separately.

While piecemeal evaluations catering to specific aspects of the telemedicine continuum help gauge a particular aspect, they cannot effectively capture the wider and more complex horizons of telemedicine.

A better holistic framework that encapsulates all evident and latent aspects starting from defining the needs of telemedicine care to measuring long-term health and experience outcomes is needed.

Telemedicine evaluation elements

Telemedicine providers need to look deeper than healthcare outcomes and consider the more abstract elements like patient and provider satisfaction, usability, and repeatability. The framework currently used by the Institute for a Broadband-Enabled Society (IBES) uses patient control, clinical quality of care, organizational sustainability, and technology capabilities as its factors.

Another example of a framework, which stems from academic roots, uses an assessment model looking at three dimensions based on functionality (consultation, diagnosis, monitoring, and mentoring), technology (modes, network design, and connectivity), and applications (treatment modalities, medical specialty, disease types, and sites). All such frameworks tend to take a certain perspective of a technological lens or care-outcome focused framework.

Six areas to consider when building or updating telemedicine evaluations

A framework for evaluation must span across the entire gamut of possible action points while looking at all the potential barriers and bottlenecks. The below framework attempts to cover the many diverse factors that are indispensable to telemedicine’s success.

Key Elements: Holistic Telemedicine Framework

telemedicine

Everest Group (2021)

  • Medical and human – This includes looking at health outcomes, the number and type of medical conditions, the nature of medical services provided (diagnosis, treatment, wellness advice, etc.), and the spectrum of care provided. Also to be evaluated are all the interacting human entities that play a part in healthcare delivery, such as provider staff and expertise, non-medical staff, technical teams, support, and maintenance personnel
  • Behavioral – This covers the behavioral aspects of the patient/client and provider such as awareness, perception, satisfaction, acceptability, adaptability, and other elements that encompass how involved stakeholders respond and react to a telemedicine application should be rated
  • Organizational – All aspects defining and involving care provider, patient, payer, administration, and technology structure need to be graded. This includes evaluating the leadership, organizational culture, workflows, hospital information systems, teams involved, etc.
  • Technological and knowledge – Technology tools and the technical knowledge that enables telemedicine to thrive should be reviewed, including the information systems, databases, platforms, software, applications, security systems, and other technological infrastructures in use. Also to be rated are the knowledge constitutes of interoperability, data quality, systems speed/performance, maintenance, and support, etc.
  • Economic – Elements relating to the economic and financial aspects that include financial performance, investment returns, financing business, and economic impact are all aspects to take into consideration
  • Regulatory, legal, and compliance – Evaluation of resolutions involving reimbursements, state and federal laws, compliance, privacy issues, medical legalities, technological compliances, and other legal/regulatory issues are all factors to be looked at

Organizational leaders need to step back and look at the complex structure in addition to their individual functions to gain a holistic understanding and reach the larger goal of building a successful telemedicine practice.

By expanding the view to these key areas, organizations will gain a more accurate picture of the effectiveness of telemedicine and be able to determine whether it will be sustainable in everyday instances moving forward.

Everest Group’s recent research, Unpacking the Rise of Telehealth, captures key insights of the telehealth market, covering trends across adoption, technology, and service provider dynamics. Please drop us your thoughts and reach out to us for a conversation at [email protected] or [email protected].

Keys to Developing a Successful Population Health Management Strategy – Unified Data Can Provide Full Patient Picture and Improve Outcomes | Blog

The US spends more on healthcare than other developed countries but has the worst health outcomes of high-income nations. One solution for improving this dilemma is applying Population Health Management (PHM).

PHM is a process used to improve the health outcomes of the broader population by utilizing resources in predicting and preventing diseases, identifying at-risk clusters and those in need of proactive intervention, and promoting the health of the population through integrated care techniques.

The healthcare models of countries such as France, Germany, Italy, Spain, and Japan are carefully designed to control costs and produce better outcomes. Most healthcare enterprises in the US have now recognized this need and are taking mammoth steps to embrace population health initiatives.

Important data sets required for population health

The core of population health management lies in accessing and analyzing healthcare data, including claims data, data present in Electronic Health Records (EHRs), wearables, Social Determinants of Health (SDOH), and social media.

The key to developing a successful PHM strategy lies in being able to access all of this data rather than specific chunks. Different types of data sets come with varied challenges. While claims data is easily accessible, it lacks the details on behavior, outcomes, reactions, and responses that are needed to create an end-to-end picture of the patient.

Meanwhile, data available in EHRs is highly important in terms of insights but still difficult to access. Even with recent regulations, not all the data present in the EHRs that is relevant for clinical research will become accessible.

The end-to-end platforms available for PHM can integrate data across devices and aggregate and analyze this data to ensure access to a complete patient record, thereby enabling better decision making.

What are the current challenges to adoption?

Despite the advantages of PHM, interoperability and current reimbursement models present obstacles.

Population health management solutions rely on the underlying data to create significant health interventions. Healthcare data doubles every 80 days, yet most of this data isn’t accessible. A lot of the data in the EHRs is unstructured, which makes it difficult to extract. Even with the recent interoperability mandates from the Office of the National Coordinator for Health Information Technology (ONC), not all the data will become accessible. A lot of the research-grade data that is relevant for complex interventions won’t be accessible immediately and eventually will be rolled out.

Changes also are needed in reimbursement models. Current healthcare models are based on the principle of fee-for-service, which are more focused on promoting volumes and dealing with illness than delivering value by promoting overall health. There is very little incentive to implement preventative and holistic care strategies, engage with patients, and encourage them to take charge of their health.

Creating a successful PHM strategy

Here are a few measures that organizations can take toward PHM success:

  • Integrate PHM with the broader interoperability strategy – This will draw the maximum benefit out of the available pool of data. It is a journey that requires both long-term and short-term strategies that are informed by data
  • Take proactive steps to include risk-based contracts and bundled payment models – These are critical to first understanding the costs of care. This includes adopting value-based payments and understanding the cost implications in a population health management setting, which means looking beyond single episodes with patients
  • Actively invest in integrated care solutions – These integrated care solutions bring together all parties involved in delivering healthcare, coordinate their services by sharing information, and transform healthcare into a seamless experience for the patient. Increasingly, this care is moving away from emergency department visits and lengthy hospital stays to more accessible and less costly settings in homes, schools, and at work. Technology adoption is critical to delivering this level of “connected health”
  • Invest in patient engagement as an essential part of the broader population health strategy – This will help organizations capture and utilize patient-generated health outcomes data, enable patients to participate more actively in their health outcomes, make regular wellness initiatives a part of their daily routine, and further improve medication adherence

How have you planned your PHM strategy? To share your experiences and learn more about PHM, reach out to Priya Sahni, [email protected].

The Changing Face of the CRO: Becoming the Everything Store for Decentralized Trials | Blog

On February 24th, 2021 we saw an announcement of one of the largest mergers/acquisitions that the CRO space has ever witnessed. ICON, the Dublin-based global CRO, announced that it has entered into a definitive agreement to acquire rival North Carolina-based PRA Health Sciences in a deal valued at US$12 billion. The deal, which makes the combined entity the second-largest CRO, next only to IQVIA (itself a merger of IMS Health and Quintiles), is one of the many instances of the rapidly consolidating CRO industry, accelerated by COVID-19.

Pushing the gas on decentralized trials

While there are a lot of potential synergies in this acquisition, such as minimum overlap in terms of geography, deeper therapeutic capabilities, and broader service offerings, one important takeaway from this acquisition echoed by Dr. Steve Cutler, Chief Executive Officer of ICON, is the shift towards Decentralized Trials (DCTs).

With decentralized trials gaining importance, thanks to the pandemic, there has been an increasing focus from CROs to shore up their capabilities and develop an integrated solution. For instance, Bioclinca and ERT recently announced a merger that enabled the combined entity to provide holistic solutions in eCOA, imaging, and clinical trial management solutions. ICON, through this acquisition, has set out to achieve an integrated offering in DCTs as well. It seeks to combine its home health services, site network, and wearables technology with the mobile health and connected health platforms and other real-world data solutions from PRA Health Sciences.

Becoming the everything store for decentralized trials

Traditionally, a CRO was considered a business process service provider, managing trial operations in regulatory, safety, and clinical conduct. Very few offered technology solutions along with business process services as this was often considered the forte of product vendors such as Oracle Health Sciences and Medidata. However, with the pandemic halting clinical trials, stakeholders analyzed how to restart paused clinical trials by virtualizing certain components of the trials through some short-term fixes, such as use of eConsent and eCOAs solutions, resulting in an uptick in DCTs.

Initially, partnerships had been the preferred route for CROs to support DCTs, for example, the Covance partnership with Medable wherein Covance’s patient and site interface would be powered by Medable’s DCT offerings. However, the recent M&A activity suggests that CROs are now considering adding product capabilities to enable DCTs by acquiring product players (such as what Bioclinica did with ERT) or by acquiring CROs with strong technology capabilities to support such trials (such as ICON and PRA Health Sciences). The result – offering a one-stop-shop solution to support DCTs, as highlighted in the visual below.

Figure 1: A one-stop shop solution for supporting decentralized trials

A one-stop shop solution for supporting decentralized trials

The advantage of such an integrated solution is that it augments the CRO’s value proposition to conduct DCTs – integrating platforms, services, site networks, and data capabilities, all into one place. Such CROs can now provide patient recruitment, engagement, and retention services (which has traditionally been their stronghold) using the underlying DCT suite through which the patient can enroll, record clinical outcomes, and engage in video consultation with the doctors/physicians. Additionally, they can also provide auxiliary support services, such as the provisioning of devices used for remote patient health monitoring and offering home nursing services aimed at reducing or eliminating patient visits to trial sites, medical record review services to check for completeness, accuracy, and compliance of medical data, and remote CRA services to oversee the DCT.

Implications for CROs

While, at first, the advantages of an in-house DCT suite seem to improve the value proposition for the CRO, it is also pertinent to note that in this scenario, CROs are also competing directly with DCT product vendors such as Medable and Science 37. The key challenge for CROs would be in convincing clients who still hesitate, while adopting technology offerings given their business process services heritage.

CROs aiming to walk down the acquisition path should keep the following pointers in mind:

  • Innovate or perish: CROs would be competing directly with product vendors – an industry notorious for innovation. Investments aimed at improving the product quality, product enhancements, and fixing issues would be critical to win client trust
  • Incorporate success stories: Showcasing client success stories and case studies will reduce client hesitation to adopt the one-stop DCT solution and drive increased product uptake
  • Offer innovative commercial constructs: Traditional ways of contracting (for example, per study or volume-based constructs) may not work with DCTs. While offering clients a BPaaS construct, check for risk-sharing agreements as clients appreciate vendors who showcase skin in the game

Looking into the crystal ball

The DCT space is ripe for disruption and the string of M&A activities shows the increasing emphasis that CROs are putting on DCTs. As efforts to improve the value proposition intensity and innovation ensue, the industry can expect more tuck-in acquisitions and even some mega-mergers, such as ICON and PRA Health Sciences, to continue well into the future. What are your thoughts on this? Let us know at [email protected] and [email protected]

Amazon HealthLake: A Step Further in AWS’ Healthcare Strategy | Blog

It’s been close to a month since Amazon Web Services (AWS) announced Amazon HealthLake at its 2020 annual (and virtual) conference. After observing the reactions from various industry participants, we thought it was time to offer our opinion.

Amazon HealthLake is a HIPAA-eligible service that aims to support interoperability standards and further drive the use of big data analytics in healthcare and life sciences. The service is essentially a data lake tailored for the healthcare and life sciences industry. It will aggregate an organization’s data across various silos and disparate formats into a centralized AWS data lake, and automatically normalize this information using machine learning. It will be capable of identifying each piece of clinical information and tagging and indexing events in a timeline view with standardized labels so they can be easily searched. This structured data can then be offloaded to a service such as Amazon SageMaker to train machine learning models for advanced analytics. HealthLake will also structure all the data into the Fast Healthcare Interoperability Resources (FHIR) industry standard format to enable data sharing throughout the organization.

Exhibit 1: Amazon HealthLake

Amazon HealthLake

Source: AWS (https://aws.amazon.com/healthlake/)

What’s in it for the healthcare and life sciences industry?

This is definitely a positive step for AWS to showcase an industry-specific solution for its clients and prospects. Amazon HealthLake provides a contextualized solution for addressing some critical challenges the healthcare and life sciences industry is facing, namely working with siloed, unstructured, and incomplete data stored across multiple systems, lab reports, medical images, insurance claims, and time-series data (for example, heart ECG or brain EEG traces.) Putting data at the center of the business allows the development of innovative products and services and provides the opportunity to revolutionize business models. AWS’s approach enables healthcare industry professionals to focus on mission-critical activities while it manages the data complexity.

Some of the key use cases for HealthLake include:

  • Payers – HealthLake will help health insurance companies predict more accurate insurance premiums, design data-driven insurance policies, and carry out effective claims management by bringing together a complete view of a patient’s medical history.
  • Providers – Healthlake can integrate with other AWS machine learning and analytics services, like Amazon SageMaker and QuickSight, to improve efficiency and reduce hospital waste. Some of the core use cases include population health management, clinical decision support, revenue cycle management, scheduling optimization, reducing unnecessary procedures, and addressing privacy and security requirements.
  • Pharma/Biotech – Clinical researchers are struggling with ever-increasing volumes of data from trial sites, patients, CROs, and other vendors, as well as from newer resources like EHR and wearable technology. HealthLake can help life sciences enterprises revolutionize data-driven R&D, advance clinical research with predictive analytics, and enhance pharmacovigilance.

HealthLake fits perfectly in Amazon’s data-hinged healthcare strategy

Amazon is aiming to transform healthcare by putting a well-developed range of integrated technology solutions supported by a second-to-none data asset, similar to its disruptive approach in the retail industry with low costs, high customer convenience, and a great recommendation engine. A key prong of its strategy is healthcare cloud computing, as payers, providers, and life sciences enterprises adopt more cloud computing services to stay on top of the rising volume of patient data.

Amazon HealthLake is another sign that AWS views healthcare as an industry with massive growth potential for its cloud services. AWS has been steadily rolling out HIPAA-eligible computing tools over the past few years in a race with Google Cloud and Microsoft Azure as the industry cloud war intensifies in the nascent healthcare cloud computing space. ​In 2019, the company announced Amazon Transcribe Medical, a voice transcription service for physicians that inputs text directly into medical records. In 2018, it introduced Amazon Comprehend Medical, a service that uses AI to mine medical records for information that can be used to improve patient treatment and reduce costs.

While AWS’s long-term strategy for healthcare is anyone’s guess right now, it will certainly be an interesting player to watch as well as an exciting one to partner with and compete against.

It’s Time for IT Operating Model Transformation in the Medical Device Industry | Blog

As the world is working to contain the spread of COVID-19 through safety measures and vaccine development, the medical device industry also is starting to show signs of recovery from the pandemic’s impact. The decline in elective procedures hit medical device organizations’ revenue hard in the first half of 2020. But increasing demand for COVID-19 diagnostic tests is stabilizing growth and compensating for the negative impact on routine testing procedures. To support growth dynamics and ensure a stable recovery, initiatives focused on cost reduction and operating margin optimization are the top priorities for most medical device organizations. For example:

  • Stryker is looking at organization-wide cost transformation for better margin expansion.
  • Medtronic announced its restructuring plan to save up to US$475 million per year.
  • Baxter expects to achieve an operating margin of 23-24% by 2023 through cost optimization.

 How can IT operating model transformation help?

To achieve significant cost savings, medical device companies need to scale their digital transformations to reap maximum benefits, which mandates IT operating model transformation. Based on a recent survey we conducted with 200 CXOs, 80% of firms that adopt an IT operating model transformation believe they’re on their way to establishing market leadership in their respective industries, expanding to serve new market and customer segments, and achieving over one-and-a-half times more cost savings than those that haven’t initiated a similar transformation. An enterprise-wide IT operating model transformation could help medical device companies realize cost benefits and maintain a competitive edge in the market.

Yet, according to our 2020 research, nearly 78% of enterprises fail to implement their digital transformation as envisioned.

What are medical device companies doing wrong?

Most medical device companies that are transforming IT achieve success in running pilot projects but fail to realize the same impact across the breadth and depth of their enterprises, because they equate IT transformation with either technology overhaul or operating model transformation, instead of pursuing them together. Exclusively focusing on technology transformation fails because it is a siloed approach that relies too much on technology without integrating the necessary operating model changes. On the other hand, changes in only the operating model result in superficial restructuring of business units that are focused on driving tactical and incremental efficiencies, eventually leading to a plateau phase. Clearly, companies need to embrace a balanced focus on both technology and operating model transformation to scale and sustain the transformation benefits.

What’s the best approach to IT operating model transformation?

The exhibit below is a framework that outlines the strategy and solution elements that enable an IT operating model transformation. Medical device companies can leverage this framework as a blueprint to design a holistic, best-in-class approach across both strategy and solution design.

Everest Group’s Target IT Operating Model Framework

Everest Group's Target IT Ops model framework

When creating the strategic roadmap, medical device enterprises should articulate a vision statement that ties together both business and IT objectives, and also carefully consider how to communicate the vision across the organization. Building an adaptable and agile organization that is resilient and collaborative is instrumental in this long journey, as 70% of enterprises believe organization structure is a barrier to scaling digital initiatives. Furthermore, effectively resourcing the IT operating model transformation and monitoring performance through cross-functional, outcome-based business metrics are keys to its success.

To complement the well-defined strategy with a strong solution framework, medical device companies should establish a strategic partner ecosystem with a fit-for-purpose portfolio of vendors. Traditional IT sourcing partnerships with a cost-centric model should evolve to a value-adding, strategic model focused on driving innovation and enabling business value. To truly scale the digital transformation and break up siloed investments, they should identify strategic partners that will equip them with the right talent, and scale the adoption of relevant next-generation technologies, so that – together – they can drive innovation with a common objective of achieving the defined vision.

As medical device organizations embark on their IT operating model transformations, we suggest a three-stage approach:

  • Lay out the building blocks by painting an organization-wide vision and introducing the agile way of working by building integrated multidisciplinary teams.
  • Enable the IT organization with the right solutions to become a business value orchestrator.
  • Scale the impact by synchronizing effects across solutions and constantly monitoring progress through well-defined business metrics.

Please share your views on IT operating model transformation with us at [email protected] and [email protected].

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