Cardiac Health is Top of Mind. The Quest to ‘Zero’ Avoidable Cardiac-Related Deaths Continues. 

Cardiac disease is one of the top health concerns in the United States. According to the Centers for Disease Control and Prevention (CDC), heart disease remains the leading cause of death for both men and women. As this major public health issue affects a large portion of the population, it has led to a significant focus on heart health in the public and private sectors. 

Given its prevalence, it’s no surprise cardiac health is top of mind for clinicians, even as recent statistics are increasingly positive. Heart attacks have seen a downward trend thanks to advancements like improved emergency response, better detection, public health initiatives, and lifestyle interventions. Rates for heart disease decreased from a peak of 307.4 per 100,000 people in 1950 to 134.6 in 1996—a decline of 56%. This trend continues today, decreasing from 182.8 per 100,000 in 2009 to 161.5 in 2019.

Even with the marked decrease in heart attacks, there’s still progress to be made. Research suggests preventable cardiac deaths have various causes, including poor healthcare access, limited heart health awareness, inadequate preventative care, and inefficient emergency response. These challenges are compounded in ‘medical deserts,’ where resources are scarce. A GoodRx whitepaper notes that 80% of the population lacks adequate access to healthcare, which results in significantly poorer cardiac outcomes. 

Out-of-hospital cardiac arrest (OHCA) occurs at a rate of ~356,000 annually, with nearly 90% fatal. Meanwhile, the survival rate to hospital discharge after EMS-treated OHCA is only about 10%. This suggests that preventable cardiac death is still a major concern, as even a single avoidable death is one too many. 

Medical Deserts, Virtual Telemetry, and the Power of AI to Enable Access and Agility at Scale

Instead of accepting current cardiac outcomes as a reality, providers can be inspired and motivated by the ‘zero’ milestone, a hypothetical state in which the number of avoidable cardiac deaths reaches zero. Naturally, all providers aspire towards such a vision, but the question remains: Is it achievable? And if so, how? 

One way to revitalize ‘medical deserts’ and amplify proactivity in cardiac interventions is through virtual telemetry, which brings higher acuity levels of monitoring to patients regardless of location—and due to the communication nature of telemetry’s monitoring and transmitting data in near real-time, as cardiac events are occurring, it enables providers faster access to analyze and act with unprecedented speed. Virtual telemetry has the potential to be truly transformative, but tapping into its full potential is not without challenges. As cardiologists continue to scale higher levels of acuity monitoring across patient populations, they face a mounting data problem. 

Analyzing vast and nuanced cardiac datasets, which most frequently do not represent a major cardiac event, has historically been a hurdle in unlocking the full potential of virtual telemetry. How can providers wade through all of the data, uncover significant trends, and take preventative action? The answer is AI-enabled analysis support. And this isn’t just another AI buzzword—it has tangible and transformative applications in virtual telemetry cardiac use cases. 

While there is perhaps no condition that has impacted more lives than heart disease, there is possibly no technology that has captivated public attention more than AI. Let’s examine AI’s potential to transform virtual telemetry’s hurdles into strengths for healthcare organizations. 

Unpacking Virtual Telemetry Challenges 

AI accelerates healthcare innovation in exciting new ways and has the potential to revolutionize heart health. To understand AI’s power in cardiac care, we must first examine some of the key challenges continuing to plague remote patient monitoring (RPM):

• Intermittent symptoms: When reviewing data from a specific period through discrete analysis, providers risk missing critical pieces of the picture. The signs can be even more nuanced when dealing with preventative care, requiring a longer monitoring period to recognize and understand anomalies outside of major events.
  
• Contiguous, not continuous monitoring: While some solutions on the market claim to offer “continuous” monitoring, these solutions often suffer from a lack of continuity. This is due to breaks in connectivity from incomplete data transmission to having to remove the device to charge it, thus creating gaps in monitoring, all in addition to a variety of other factors that make it hard to understand the full picture and improve the precision and timeliness of care. 

• Data overload: When continuous monitoring is available, the amount of data generated is simply too great to be accurately analyzed in a timely fashion—at least not without additional technology that can prioritize and surface insights. Data overload stands in the way of proactive and timely interventions.

• Provider resource constraints: The data challenge is intensified by the ongoing shortage of providers and time constraints among busy cardiologists lacking time for manual analysis. A recent report highlighted a shortage of 1,600 general cardiologists and 2,000 interventional cardiologists. To meet the expected demand, the number of cardiologists will need to double by 2050. 

• Data acuity inadequacies: In many cases, even continuous remote patient monitoring data is limited in acuity. Higher acuity levels are especially valuable when diagnosing more nuanced conditions in their early phases or that occur outside an event. 

• Poor technology integration: There’s often poor integration between RPM platforms and other systems inside the hospital—including electronic health records (EHR), telehealth solutions, data analysis tools, patient portals, and many more. Disparate systems result in data leakage, gaps, and latency—all of which challenge hospitals to realize the full potential of RPM.

Taking the Challenges Heart-On: The Power of AI-Enabled Analysis

AI-enabled analysis represents a seismic shift in addressing the limitations of RPM, turning obstacles into opportunities for improved cardiac care. Here’s how AI is making a difference:

• Overcoming intermittent symptoms and data limitations: AI algorithms excel at detecting patterns that may be indiscernible to the human eye. By analyzing long-term data trends, AI can identify subtle changes or early warning signs of cardiac issues, even when symptoms are intermittent or elusive. This continuous, nuanced analysis helps in early detection and intervention, potentially preventing major events.
  
• Transforming contiguous into continuous monitoring: Virtual telemetry solutions must evolve into being able to support both contiguous and continuous monitoring. Inside a facility with robust communications like Wi-Fi, these platforms’ AI-enabled analysis enables data to be transmitted continuously and then compensates in remote, virtual, or mobile environments by seamlessly switching to cellular and then to Wi-Fi, should it be supported in a patient’s home. Further solutions must utilize intelligent charging strategies to eliminate potentially dangerous gaps in monitoring, allowing the patient to wear the device at all times and maintain connectivity as their communications environment changes, thus ensuring a more consistent monitoring capability—and never missing a beat.
  
• Managing data overload: With the ability to process vast amounts of data quickly, AI systems can sift through the excess to find meaningful insights and present them to the human cardiologist to empower decision-making. AI-enabled analysis can also prioritize critical information, surfacing urgent insights and allowing cardiologists to focus on the most important information first. In addition, AI can dynamically filter false alarms and notify healthcare providers of patterns or events to be addressed.
  
• Easing provider resource constraints: It’s no secret that healthcare teams are experiencing burnout in their day-to-day practice. By automating routine data analysis, AI significantly reduces provider workloads. This efficiency is vital in the face of ongoing staff shortages and a high demand for cardiac care. AI offers quick, accurate, and actionable insights, allowing providers to focus on patient care rather than data analysis.
  
• Enhancing data acuity: Enabled by modern RPM solutions, which provide far greater acuity than previously possible, AI’s advanced algorithms can detect nuances in data that indicate early stages of cardiac conditions. In addition, by its very nature, AI analysis continually improves over time, leading to higher levels of analytical acuity. This high level of data acuity is essential for diagnosing conditions before they escalate, aiding preventative care and better management of chronic heart diseases.
  
• Improving technology integration: AI facilitates better integration of RPM with other hospital systems like EHRs and telehealth solutions. It can harmonize data from disparate sources, establishing a unified and comprehensive view of patient health. This integration is essential to enabling precision medicine and personalized care. 

The above points are further supported by continuous improvements in virtual telemetry that enhance the continuity, acuity, and timeliness of RPM cardiac data. And let us not forget the power of AI-enabled analysis and virtual telemetry to simultaneously advance healthcare’s most critical goals: improving the quality of the patient experience, supporting population health, lowering per capita costs (via reduced readmissions, quicker discharges, and less costly care), and ultimately improving patient outcomes (via a lower probability of fatal cardiac events).

The Future of Cardiac Care is Here: AI-enabled Analysis and Virtual Telemetry are Leading the Way

Virtual telemetry plays a starring role in the healthcare AI revolution by providing AI models with the continuous, high acuity, and near real-time data needed for analysis. As the industry continues to navigate AI’s utility and long-term role, AI-enabled analysis in RPM represents a tangible and highly valuable application of AI that is accessible to healthcare providers today.

As healthcare embraces AI’s many enhancements to patient care, it must do so with an eye on quality, data integrity, security, compliance, and innovation—the essential tenets to successfully adopting healthcare technology. 

As for AI-enabled analysis in cardiology, providers can start by finding and embracing a modern virtual telemetry platform that prioritizes data acuity and delivers tools for AI-enabled analysis. With the right platform and a shared vision, providers will be well on their way to reducing—and hopefully, one day eliminating—avoidable cardiac deaths.

About Stuart Long

Stuart has been the CEO of InfoBionic since March 2017. He underscores the company’s commitment to widespread market adoption of its transformative wireless remote patient monitoring platform for chronic disease management. With more than 25 years of experience in the medical device market, Stuart brings expertise in achieving rapid commercial growth. Before joining InfoBionic, he was CEO at Monarch Medical Systems, LLC, and global chief marketing and sales officer for CapsuleTech, Inc.

Feeding early in life, particularly for a newborn, is typically breast-feeding or a bottle of formula. Infants tend to cry when they’re hungry and stop eating when they’re full. It’s a very natural and important process that tends to have cues as to how well the baby is tolerating its diet, whether that be spit up or colic or other agitations such as gas.  While newborn feeding can be route with challenges for both mom and baby it tends to be a simpatico engagement that yields good results for most babies early in life.

In utero, a developing fetus is nourished through its umbilical cord tied to the mom. The infant receives the most personalized form of nutrition, informed by biological feedback, and while some experience metabolic challenges, by and large, most fetuses achieve optimal growth, using this dyad mechanism.

Where true challenges arise is when a fetus is delivered prior to 37 weeks gestation and with increasing frequency as young as 22 weeks gestation, that is a preterm infant, and nutrition now needs to be provided from sources that are not tailor-made to her or him.  This period immediately following premature delivery would have been the third trimester of pregnancy – a critical developmental epoch for a fetus.

In these cases, not only can the infant not communicate when it’s hungry, nutrition often must be delivered intravenously or via a tube to the gut as the baby cannot suck, swallow, and breathe to breast-feed or take a bottle and in many cases the organs of the gut have not completed development. This nutritional labor of love falls to the clinical care teams in the neonatal intensive care unit. Preterm infants are often fed every 2 to 3 hours – tiny amounts of nutrition that are attempting to meet their needs and match their energy expenditures. It may surprise you to know that a preterm infant needs as many calories per kilo per day as Michael Phelps when he was swimming in the Beijing Olympics when he was consuming nearly 12,000 calories a day. Preterm infants need this to meet their ‘peak performance’ to optimize brain development and growth.

As with adults, nutrition is not simply about calories.  Various components of nutrition are essential for a baby to grow and develop properly, and these elements need to be accounted for in any provision of nutrition to these vulnerable infants.  Moreover, as a preterm infant matures, her nutritional targets change, exacerbating the risk of errors or omissions and increasing the complexity for clinical teams:

This table illustrates the target nutrients per kg of body weight for a typical 28-week gestation preemie.  The values in “( )” represent current academically supported ranges for various babies.

Clinical teams have a relentless and dogged pursuit of achieving optimal nutrition, including the balance of proteins, lipids, carbohydrates, vitamins, and micronutrients to support growth and development that the fetus would have achieved inside mom. Not only is it mathematically challenging and labor-intensive it is fraught with fits and starts as concerns about intolerance, and G.I. disease create doubt in the minds of the clinical care teams.  Physical and natural limits on the total volume and the concentration (osmolality) of the diet create the need for delicate and deliberate balancing.

Beyond an intravenous nutrition-based diet, the typical preterm infant will progress to the mother’s own milk, donor milk, or preterm infant formula. However, human milk creates an inconsistent diet with unknown macro and micronutrients, so clinical teams use reference values.  This complicates the calculations for achieving optimal targets given the base diet contributions are unknown and inconsistent. Here’s an example to illustrate the complexity and calculation intensity of feeding a preterm infant.  

Baby Warren is a 28-weeker (born 12 weeks early) who’s been in the NICU for two weeks, post-menstrual age of 30 weeks.  Today she weighs 1300 grams.  She is being fed human donor milk (mother’s unavailable – and while Mom’s milk would have matched the required nutritional profile better, Donor milk is universally from humans that are much further postpartum) and is on full enteral (no IV nutrition) feeding on a Q3 schedule (every 3 hours).  The protocol recommends feeding at a rate of 120ml/kg/day at this stage in the journey.  

Questions:  How many mL of donor milk should Baby Warren receive at her 1pm feeding?  If you are providing unfortified donor milk, does she meet each of her macronutrient targets? 

Nutritional Targets (macronutrients)

Decileters (dL)

Extra credit if you show your work.  Solution at end of document.

While reference ranges are used for calculating these targets, in reality their compositions can vary widely among mothers and even for a given mother on a daily basis resulting in inconsistent delivery of nutrients despite clinicians’ best efforts.  Deficits accumulate during the weeks and months of an infant’s stay, which causes infants to fail to reach their full potential.  Nearly 50% of infants born under 32 weeks gestation experience growth faltering and nearly 40% experience neurodevelopmental delays and disabilities.

Variability In Ranges Among Human Milk 

What if, instead of reference values, one assumes the milk provided only provides the bottom end of the range when you complete the above exercise?  

Probably as importantly, community hospitals or those in areas of low-resourced centers, often find themselves without resident expertise in registered dietitians or nutritionists, so not only are they caring for the sickest and tiniest infants, but the expertise is unavailable or a shared resource among the hospital. This exacerbates challenges with delivering optimal nutrition, increasing health disparities.

Knowing nutrition is the most modifiable risk factor in healthcare and recognizing the immensely challenging burden it places on clinical care teams, how can we improve infant outcomes and reduce the burden while increasing the confidence of our clinical care teams?

SOLUTION:

Answer if you assume low end of nutrient ranges with % variance vs. target

About Tracy Warren

Tracy Warren is the chief executive officer of Astarte Medical. She is a former technology startup investor who has long advocated for women’s and children’s health issues.

halfway across the globe, make customizations and know exactly when it will be delivered. Navigating the portal of a healthcare system to find a physician who specializes in the care they need or make an appointment can be an ordeal in comparison. Clunky and confusing, they can frustrate patients, exacerbate worry, delay treatment and harm the reputation and business of a healthcare entity.

Traditional e-commerce giants from Amazon to Walmart have set a high bar for user experiences (UX) with sites that are simple to use and slick. Make no mistake, there’s great awareness in healthcare that the industry has catching up to do in this realm. Yet, when you consider digital upgrades and look under the technology hood, you can find an engine with crucial pieces that’ll be difficult to bypass or bring into the future. You’ll need to keep some of that, so you must prioritize where you can maximize impact.  

Digital ecosystems in healthcare must be able to evolve and keep pace with consumer trends and corporate strategy. Yet, while organizations develop three, five or ten-year strategic corporate plans, most fail to incorporate a digital roadmap. This encompasses a system’s entire digital footprint — website, integrations, back office, intranet and more — enabling it to anticipate technological and operational changes and iterate accordingly. It’s as important as corporate strategy, and not only should these areas receive similar focus, they shouldn’t be siloed.

Untying the knot

It’s understandable why healthcare has been slower to advance on the digital front. Entities face a mix of legacy systems and inherent complexities that come with managing the patient experience. Upgrades are not like traditional e-commerce conversions because healthcare deals with very private information, requiring extensive security measures. Change involves a broader scope of work. This has made e-commerce vendors more amenable to efforts aimed solely at experimentation for the sake of innovation itself.

Even progressive organizations that have brought in various systems to handle parts of the patient journey – whether it be a portal or a better way to share data amongst providers – face serious challenges. Often, new solutions are layered upon existing resources, creating a Gordian knot of the underlying infrastructure. You can bring in a slew of best-of-breed solutions, but you still have to get them to work with core platforms.

The key lies in delivering both an elevated experience for consumers and a nimble digital ecosystem that can be easily managed and built upon by your digital technology team. Though it might be too expensive, disruptive and impractical to do a full rip and replace, you can undertake updates with digital road mapping techniques that’ll align internal stakeholders, audiences and technology with your team’s capabilities, ultimately improving the consumer experience, enhancing loyalty and driving revenue.

Knowing your needs

It’s easy to get locked into extended discussions when something is complex and the issues are great. Road mapping takes into account your entire digital footprint and aligns it with corporate strategy to create a one- or multi-year plan that anticipates both technological and operational changes. It basically breaks down those large, costly problems into smaller, feasible, deliverable projects and initiatives. 

Still, before mapping, you must first understand your needs. So, the first step is conducting a needs analysis to identify technology problems and root causes while defining the overall deficiencies that impede progress. What is your current landscape? What are the pain points with the platforms you have? Are there opportunities to consolidate technology? Should you bring in new tools to address particular patient needs? From this understanding, you can establish priorities and build out a roadmap showing what you’re going to accomplish and when. 

It’s important to take time on the needed analysis to make sure you are internally in sync. On any day, you’re likely to get five different opinions about what needs to happen in the next quarter. So, this is about ensuring all stakeholders understand the priorities and agree on how to move forward. It really is a strategic exercise and their buy-in is what prevents second-guessing when you’re heading in a direction and well down the road. Because making a sharp turn could waste the million dollars you’ve already invested in the project. 

Even so, you don’t build a roadmap once – change is inevitable. It is not uncommon to begin a project, see an opportunity, and something further down the line needs to be re-prioritized. A competing healthcare system could shift market focus and spur a critical pivot. A roadmap must evolve, even as you’re delivering it. In many ways, it’s akin to what has always been done with agile delivery – prioritize, prioritize, then prioritize again. 

At the very least, road mapping is a means for all stakeholders – from the C-suite to technology teams to individual departments like marketing – to understand where a health system is heading. Change may come, but with everyone reading from the same page, an organization can confidently continue to move forward. 

Drawing the map

A strategic digital roadmap should encompass and define many things. It should benchmark data and include key performance indicators to measure performance. It should set interval milestones for periods such as six months, a year, three years, etc. It should anticipate upgrades and known large-scale projects. And it should also take maintenance and opportunities for innovation into consideration. 

When attempting to align digital and corporate strategies, remember what differentiates your health system. Not only should this be reflected in landing pages and sharp copy, but it should also carry throughout the entire UX on your website. Additionally, mergers and acquisitions can increase a healthcare system’s competitive edge, so your digital assets need to be built to scale. Particular attention should be paid to expanded location-based personalization, an intranet to serve additional personnel and robust telehealth tools. 

Rules of the road

When creating a digital roadmap, we recommend utilizing the 70/20/10 rule. Here’s how that breaks down:

• Existing strategy — 70%: This amount of budget and effort should be applied to what has proven successful and will guarantee a return on investment. Aim it at such things as maintenance and upgrades to your existing platform, marketing automation, new or expanded content resources, A/B testing, action buttons on high-trafficked web pages, security upgrades and enhanced accessibility.

• Incremental strategy — 20%: This should address growth areas with strong potential to deliver returns, though these are not guaranteed. This should entail measures you want to test that could set your organization apart. Examples include chatbots, artificial intelligence, health personalization and interactive elements. 

• Disruptive strategy — 10%: This should be reserved for particularly bold and untested ideas. An example would be something proprietary developed alongside a digital partner. Be sure to set aside this resource for daring ideas that could produce a major benefit.

Getting there

Creating a strong digital roadmap is no longer a “nice to have”, it’s critical to success and a sustainable web presence. With this in mind, you may want to bring in a firm focused on digital healthcare ecosystems to ensure each element — UX, design, technology, marketing — is covered in your strategy. They can also guide you in finding a digital experience platform (DXPs) with the right suite of tools for delivering, managing and optimizing the patient experience across channels.

Now is the time to evaluate your digital footprint alongside your system’s strategic goals. By taking the time to create a roadmap now, you’ll set your organization up for a more predictable, affordable and successful approach for taking patients and your health system where it wants to go. 

About Michael Kinkaid

Michael Kinkaid is the Chief Technology Officer at Reason One Inc. He is passionate about creating excellent outcomes and experiences with digital solutions. He wears many hats in his day-to-day work at Reason One, from leading the studio’s technical direction, providing coaching and strategy on adopting agile practices and serving as the solution architecture guru. 

One of the most pressing and often overlooked challenges in healthcare today is how to reach and effectively treat dually diagnosed patients — commonly, individuals who grapple with both mental health problems and substance use issues. According to the Substance Abuse and Mental Health Services Administration, more than one in four adults living with a serious mental health issue also has a substance use issue. The unique challenges these individuals face, along with the impact of social determinants of health, present formidable obstacles to their recovery. 

Mental Illness and Substance Use Disorder: A Common Comorbidity

The relationship between mental illness and substance use disorder (SUD) is profound: people who suffer from mental health disorders are more likely to turn to drugs or alcohol as a coping mechanism, inadvertently leading to substance use problems. Conversely, individuals with substance use disorders may experience heightened anxiety, depression, or other mental health issues as a direct result of their substance misuse. The cycle is vicious and self-sustaining.

Mental health conditions and substance use can exacerbate each other, creating a complex and intertwined web that entraps many individuals. A “one-size-fits-all” approach to treatment is insufficient when confronted with the intricacies of dually diagnosed patients. It’s not merely a matter of addressing mental health or substance use in isolation, but understanding how the two interact and developing a comprehensive treatment plan.

Unique Challenges for Dually Diagnosed Patients

The challenges that dually diagnosed patients face are multifaceted and can impede their access to behavioral health services and hinder their chances of successful treatment. These challenges include: 

Stigma: Dually diagnosed patients often suffer from a double burden of stigma. Society stigmatizes mental health issues or substance use problems separately, but the stigma intensifies when both conditions are present, discouraging individuals from seeking help and making them feel like societal outcasts.

Complex Clinical Needs: Treating dually diagnosed patients requires a high degree of clinical expertise. The interplay between mental health and substance use is intricate, making it challenging for healthcare providers to deliver effective care without a nuanced understanding of both conditions.

Fragmented Care: The fragmentation of health care services poses a significant barrier to dually diagnosed patients. Many healthcare systems are designed to address either mental health or substance use, leading to disjointed care. This fragmentation not only diminishes the quality of care but also deters patients from engaging effectively with the healthcare system.

Related to this is the need for coordinated care. Dually diagnosed patients require integrated and coordinated services, but these services are often siloed, with mental health professionals and addiction specialists working independently. This lack of coordination can lead to conflicting treatment plans and poor patient outcomes.

Social Determinants of Health

It is essential to recognize that the challenges faced by dually diagnosed patients extend beyond the clinical realm. Social determinants of health — i.e. where people are born, raised, learn, worship, etc. — play a pivotal role in shaping an individual’s initial access to care and their subsequent outcomes within the health care system. Addressing these social determinants is a vital component of reaching and supporting dually diagnosed patients.

Access to Care: Economic disparities and geographical barriers can limit access to behavioral health services. Dually diagnosed patients from disadvantaged backgrounds often find themselves trapped in a cycle of limited access and inadequate care.

Housing and Stability: Stable housing is a fundamental determinant of health. Dually diagnosed patients who lack housing stability face additional challenges in obtaining the support they need. The link between homelessness and substance use is well-established, making housing interventions crucial.

Support Systems: Strong social support is essential for individuals facing dual diagnoses. Dually diagnosed patients often grapple with strained relationships, isolation and the loss of social support. Reconnecting them with supportive networks is vital for their recovery.

The Role of the Health Care Continuum

To improve the behavioral health outcomes of dually diagnosed patients, a paradigm shift is imperative. The entire healthcare continuum, from payers to primary care providers to specialty behavioral health services, must come together to address this crisis comprehensively.

Integrated Care Models: Health care systems should adopt integrated care models that bridge the gap between mental health and substance use services. This means creating multidisciplinary teams that collaborate to provide holistic care.

Training and Education: Healthcare professionals need enhanced training and education to understand the unique needs of dually diagnosed patients. They must be equipped to recognize the signs, employ appropriate assessment tools and deliver effective interventions.

Community-Based Services: Expanding community-based services can improve access to care for dually diagnosed patients. This includes outreach programs, crisis intervention and peer support initiatives tailored to their needs.

Reducing Stigma: Healthcare organizations should actively engage in anti-stigma campaigns to reduce the societal prejudice surrounding mental health and substance use. Normalizing conversations about dually diagnosed patients is essential for encouraging them to seek help.

Advocacy and Policy Reform: Advocacy efforts should target policy reform to ensure that behavioral health services are equitable and accessible to all. Policymakers should prioritize the needs of dually diagnosed patients in health care reform initiatives.

Access to Timely Care: Perhaps most important is ensuring that these patients have access to the care they need when they need it. Currently, people suffering from SUD face wait times that can average more than three months for an initial visit to a mental health care provider. New solutions from third-party vendors are addressing this challenge head-on, utilizing a combination of technology and human expertise to connect people with care quickly. Health plans should embrace these solutions to solve the access problem for their members.  

The Solution

The current crisis of dually diagnosed patients demands a holistic and empathetic approach. The challenges they face, both within the healthcare system and from social determinants of health, necessitate a coordinated effort from all facets of the healthcare continuum. Only by addressing the unique challenges of dual diagnosis and eliminating the obstacles to care can we help patients recover and regain control of their well-being.  

About Dr. Bernard DiCasimirro

Dr. Bernard DiCasimirro, D.O., is the Chief Medical Officer of Lucet, a leading provider of behavioral health solutions and services to commercial health plans, government agencies, and other sponsors of care. Before Lucet, Dr. DiCasimirro was the medical director for PerformCare, spent over four years as an Optum/United Healthcare associate medical director, served as the primary psychiatric consultant for the Pennsylvania Bureau of Program Integrity, and has experience extending to correctional psychiatry as the statewide psychiatric director for the Pennsylvania Department of Corrections. Working in all levels of psychiatry and substance use care for more than 25 years, Dr. DiCasimirro is board-certified in general psychiatry and licensed in Pennsylvania, Iowa, Arizona, Arkansas, Kansas, Missouri, the District of Columbia, South Carolina, Louisiana, and New Jersey. He holds a Bachelor of Arts from Franklin and Marshall College in Pennsylvania and graduated with honors from Des Moines University, where he obtained his D.O.

Leaps in healthcare technology continue to benefit humankind: from the advent of the X-ray in the 19^th century to dialysis, CT, MRI, and other machines in the 20^th century, to a new breadth of digital tools in this era. Perhaps the most auspicious of these is artificial intelligence (AI), with its wide-ranging applications for predictive analytics, drug development, personalized medicine, and robot-assisted surgery.

While the integration of AI into healthcare diagnosis and treatment holds unlimited potential to revolutionize the field – improving patient outcomes, reducing costs, and enhancing overall efficiency – that heady promise is not without peril. The more deeply that AI embeds into healthcare, the greater the cybersecurity risk it creates. Indeed, AI is already transforming the threat landscape across the entire medical profession.

Assessing AI Risks

Although artificial intelligence is seen as a disruptive force with unknown consequences, the International Association of Privacy Professionals estimates that over half of AI governance approaches are simply being built on top of existing privacy programs and that only 20% of established organizations have begun to initiate formalized AI practices and guidelines. While there are certainly foundational controls for underlying IT systems that power these AI models that are still completely relevant and necessary, we must also acknowledge the novel risks introduced by AI that potentially endanger patient privacy and health, as well as the safety and reputation of medical institutions. The advent of AI requires us to build new approaches to cybersecurity policies, strategies, and tactics on top of our already well-established foundation. Status quo is important, but not enough.

In dealing with still-nascent technology, health professionals must continuously remain aware of AI behavioral risks that could result in incorrect diagnoses or data hallucinations. AI systems are only as good as the quality and volume of their training data. Promoting transparency in AI models and deep testing, President Biden recently issued an executive order on Safe, Secure, and Trustworthy Artificial Intelligence. Along with tasking the Department of Health and Human Services with addressing unsafe healthcare practices and actual harms involving AI, the order seeks to set national standards for rigorous red-team testing to ensure that AI systems are safe before their public release and use.

Traditional security measures are better positioned to manage AI-related threats from cyber-criminals. Hospitals, for example, have increasingly been the target of malware and ransomware attacks. This past August, Prospect Medical Holdings took its main computer network offline after an incident affecting 16 hospitals and over 100 other medical facilities across the U.S. for nearly six weeks, an attack that exposed the private information of 24,000+ workers. AI-assisted security models must provide a counterweight to the use of the technology that helps attackers craft better social engineering attacks, more efficiently probe IT systems for weaknesses, and create malware that evades detection mechanisms.

Many healthcare organizations rely on third-party vendors for AI solutions. These vendors may unwittingly introduce vulnerabilities like the ones just described into healthcare systems, creating far-reaching consequences. This third-party dynamic that means less control by internal security teams is nothing new. Third parties have been the leading source of breaches in the healthcare ecosystem for several years. But the additional complexity of vendors’ use of AI, where data is going, and what controls are in place on it make an already complex problem even more so. 

Implementing Security Measures

Healthcare organizations, proficient at preventing and quelling attacks on the human body, must concurrently embrace the need to strengthen their own systems by placing cybersecurity near the top of their overall AI integration strategies. These measures, constructed to harness the benefits of AI while safeguarding patient data and safety, include:

• Multi-Point Defense: Guided by the need for redundancy, institutions need to create and implement a cybersecurity strategy that considers incorporating defensive AI capabilities and includes multiple elements such as firewalls, intrusion detection systems, and advanced threat detection, a multi-pronged approach that can spot and mitigate threats at various levels.
• Data Encryption and Access Control: Protecting sensitive data and restricting access to authorized personnel begins with robust encryption protocols. Strong access control mechanisms should be implemented to prevent improper access to AI systems, underlying training models and infrastructure, and private patient records.
• Third-Party Vendor Assessment: Due diligence is required to thoroughly vet third-party vendors and their cybersecurity practices. At this stage of maturity in the AI risk management space, simply knowing if your third parties are deploying AI models in their solutions and how your company data is being used within that model is probably sufficient. More detailed depth of control implementation will come as standards bodies like HITRUST and NIST build AI-specific control frameworks.  
• Incident Response Plans: AI systems should be a vital part of any organization’s incident response plans in order to identify the unknown that AI technologies might present in your standard DR/IR operations and to minimize downtime and data loss in the event of a cyberattack either using AI capabilities or against an AI system. 
• Ongoing Security Audits and Updates: Conduct periodic security audits of AI systems and overall healthcare infrastructure to ensure your standard security controls are functioning.
• Employee Training and Awareness: Implement mandatory AI cybersecurity training for all healthcare staff, making them aware of the privacy and data loss risks of “off-the-shelf” AI technologies and of the advances in phishing techniques, deep fake capabilities, and other deceptive practices used by cyber attackers augmented by AI.

AI can be either a friend or foe of the healthcare sector, with the ability to improve lives or cause even further breach problems in an already reeling industry. By implementing robust security measures, raising staff awareness, and collaborating with trustworthy vendors, the industry can forge ahead with confidence and care.

About Morgan Hague

Morgan Hague is the Manager of IT Risk Management with Meditology Services, a top-ranked provider of information risk management, cybersecurity, privacy, and regulatory compliance consulting services exclusively for healthcare organizations. 

About Britton Burton 
Britton Burton is the Senior Director of TPRM Strategy with its sister company, CORL Technologies, tech-enabled managed services for vendor risk management and compliance.

Finding a frustrated patient sitting in a waiting room has become familiar. Three and a half years after the pandemic’s start, the medical field is still feeling the ripple effects. Burnout and staffing shortages plague offices nationwide, causing tasks to pile up and the lack of prioritization for patient care. Feelings of frustration can cause patients to either leave a doctor’s office before seeing a provider or go to a different one. 

According to McKinsey, patients are 28% less likely to switch physicians when content with their experience. Technology is readily accessible at our fingertips 24/7. Administrative decision-makers should use it to their advantage to address common industry pain points, like tackling mountains of paperwork or inefficient scheduling. 

To streamline the check-in process and encourage a positive experience, here are four ways providers can boost the patient journey with digital check-ins: 

1. Digitize the Documents

Patients have limited free time, and consideration goes a long way. Specialists sometimes require dozens of pages of documents to be completed before an appointment. Rather than forcing patients to arrive early, providers can digitize documents for completion. Digital documentation is convenient for patients – allowing them to complete paperwork from the comfort of their own homes at their own pace. 

Patient engagement platforms, all-in-one software for patient communications, are an effective way to gather, vet, and store sensitive information.  Not only do they cut the amount of paperwork in offices, but they also streamline tasks for administrative staff. With less paper, fewer staff need to be dedicated to tedious office tasks like scanning and data entry. Documents can also be reviewed in advance, saving administrators time and energy hunting down patients for additional information.  

2. Liberate the Front Desk 

First impressions matter. An extensive line in a medical waiting room is not a great one. The front desk is a vital artery to every practice and should avoid getting clogged when possible. Providers can embrace a digital/self-check-in process to prevent lines from forming. Digital check-ins aim to simplify the intake process for staff by reducing paperwork, data entries, and document scans. During the height of the pandemic, eCheck-ins grew in popularity. Yet, an alarming 83% of medical providers still use the front desk as the primary method for checking in patients. 

When patients do not complete mandatory registration information before their appointment, they can do so at the office using self-serve kiosks. Self-serve kiosks are an excellent option for patients who might not have technology or may not be as tech-savvy. On-premises self-check-in grants more significant control over the process while keeping the front desk unoccupied. This allows staff to focus on other tedious tasks, like insurance verification, which can be a grueling part of the intake process. With online forms, patients can assemble credentials from the comfort of their homes without the pressure of fumbling through personal items at the front desk. 

3. Give Clear Instructions on What to Expect

Supplying details to a patient about their visit, such as office location and procedure details, is another excellent method to boost satisfaction. Medical appointments can be stressful, and the unknown can be anxiety-inducing. Letting patients know precisely what they can expect during their visit helps calm nerves. This past year, nearly half of women reported putting off preventative care services, and 55% of men reported not getting regular health screenings. The lack of prioritization can be attributed to high appointment costs, challenges in booking an appointment, and a lack of awareness regarding the frequency of certain types of exams. Considering the patient’s needs and emotions humanizes your practice, re-enforcing the relationship. 

Navigating unfamiliar medical facilities can also cause stress and added anxiety before an appointment. Consider patient engagement platforms that offer wayfinding solutions to help patients find your office. Wayfinding solutions help the front desk by preventing time-consuming phone calls to deliver directions and encouraging patients to arrive on time for appointments. 

4. Automate Reminders 

Each year, the healthcare industry loses $150 billion in missed appointments. To reduce the number of no-shows, healthcare practices can integrate automated reminders into their patient communication strategy. Automatic emails and AI SMS messages notify patients of upcoming appointments without gluing staff to the phone all day. Some patient engagement platforms are compatible with electronic health records (EHRs) to seamlessly and reliably integrate data. 

Physician practices need to work smarter, not harder. With a digital check-in process, providers are taking the first step in boosting patient engagement and loyalty. Digital check-ins benefit patients and providers by eliminating additional administrative tasks and preventing appointment delays. Patient engagement technology permits staff to focus on patient care and patients to experience a seamless, stress-free appointment. 

About Vijay Verma

Vijay Verma heads the design and development of TeleVox’s Generative AI-based Virtual Agent platform. Vijay has 10+ years of experience in building solutions that drive up customer self-service and increasing contact center efficiency. His first foray into this problem set was with Comcast Corporation, where he launched SMS as a self-service channel, which resulted in a 150M call reduction in the call centers. Most recently, he was head of emerging tech and transformation at Children’s Hospital of Philadelphia, where he led the design and development of multiple patient and employee solutions to address health equity and staff burnout challenges using Conversational Solutions.

Seldom do people receive as much important information as quickly as they do during doctor’s visits and hospital stays. Stressful settings, unfamiliar terms, too-brief conversations, and the heightened emotions surrounding health issues combine to make it difficult for patients to comprehend and recall what they’re told.

Nearly two in three Americans are not extremely confident in their understanding of the health information they discuss with their doctor, according to a 2021 study from the American Health Information Management Association Foundation. The survey also found that 24% of patients don’t understand all the information their doctor provides and 31% won’t even remember it immediately following an appointment. Fifteen percent of respondents report sometimes feeling more confused about their health than they did before the visit.       

The numbers are worse for hospital stays. Only 50% to 60% of patients remember key information from recent inpatient stays, including such vital information as diagnosis and changes in medication, according to a recent study in The Joint Commission Journal on Quality and Patient Safety.

It’s common for patients to have questions after an appointment or hospital stay. These can range from a simple follow-up query to questions about medication or new symptoms. While both providers and patients desire easy two-way communication, it’s the responsibility of the provider to make it possible and to encourage patients to engage with their care.

The right technology can improve the patient’s ability to retain information, thus enhancing their health outcomes and overall satisfaction with their care.

Make information accessible and understandable with patient portals

A patient portal is an online tool that offers patients 24/7 access to their health information from any digital device. It provides detailed summaries of office visits, hospital stays, medication lists, and lab results. It allows patients to review the details of their visits at their convenience, rather than having to remember all the information provided during the actual visit.

More advanced patient portals often provide resources such as patient education materials related to a patient’s diagnoses and procedures. This allows for more in-depth learning and understanding at the patient’s own pace. Having this information readily available for reference not only strengthens information retention but also promotes patient autonomy and engagement in their care.

Advanced patient portals will also provide patients with succinct post-visit instruction summaries following an in-patient or ambulatory encounter. This guides patients in what they should do when they are home and on their own, providing an often much-needed reminder of what they were told during their visit. In addition, if they have any questions, they can send a secure portal message to their provider.

Automate delivery of post-visit instructions to patients

In addition to the information provided within a patient portal, healthcare providers can implement patient engagement solutions that identify patients by their diagnosis or procedure and automatically send them pertinent information. This information, delivered according to patient preference, might include instructions for post-operative care, details about managing their condition, or reminders about follow-up appointments.

This targeted, personalized information ensures patients receive what is relevant to their care. The automated aspect reduces the chance of omission or error and allows information to be provided in a timely manner, further reinforcing what was communicated during the visit and enhancing the patient’s understanding and recall.

Provide convenient messaging options for patients

Dynamic patient communication is a necessity for today’s healthcare consumers. Providing patients with the ability to opt-in for text messaging with their providers is a must for modern provider organizations. Giving the patient options like opt-in texting or secure two-way messaging provides patients and healthcare providers with an easy, secure, and confidential way to communicate. These platforms enable patients to ask questions about their care or treatment outside the confines of a medical appointment, making them more likely to clarify any doubts or misunderstandings. 

Similarly, healthcare providers can use these platforms to send messages, reminders, or additional information directly to the patient. This continuous exchange of information promotes patient education, engagement, and retention.

Send automated surveys to check patient understanding

Automated surveys and patient-reported outcomes after a medical visit or hospital stay can be useful tools to identify gaps in a patient’s understanding. They can also provide healthcare providers with real-time feedback about a patient’s comprehension of their care or treatment plan.

Surveys with targeted questions about care instructions, medication schedules, or follow-up visits can reveal areas where the patient may need more explanation or support. They also offer the patient another opportunity to think about their care and possibly recognize questions they hadn’t thought of during the appointment.

Automate care management and population health

Advanced patient engagement platforms can enhance manual care management and population health efforts. Patient populations can be established across provider organizations that are directly correlated with value-based care efforts. Care management campaigns can leverage automation to activate or engage patients to take specific actions that will yield a positive health outcome. These campaigns can automate efforts to educate patients about their condition, assist them in filling prescriptions/encourage adherence, provide streamlined processes for scheduling interval care, and keep patients and providers in sync between visits.

Technology plays an integral role in supporting patient information retention and engagement. Using the strategies outlined above, healthcare providers can create a more patient-centered, interactive, and efficient healthcare model that facilitates patients’ understanding, involvement, and satisfaction in their care process.

About  Gary Hamilton

Gary Hamilton has led InteliChart as CEO since its inception in 2010. He brings a wealth of clinical and technical expertise associated with consumer-patient engagement and provider practice operations. Gary drives corporate strategy, product innovation, and direction toward one common objective: to enable providers to successfully engage and empower their patients to attain successful outcomes. Prior to InteliChart, Gary held leadership positions with Integrated Healthcare Solutions and Atlantic Healthcare Management.

If you ever visited the nurses’ office or had an eye exam at school as a child, you benefitted from campus healthcare initiatives. Community schools can (and should) go beyond education to serve as critical healthcare providers for students, staff, and their families. 

Unfortunately, many school districts have been forced to re-evaluate their healthcare options in recent years due to financial challenges, staffing issues, and the general volatility that accompanied the COVID-19 pandemic. 

Instead of cutting back on healthcare services, now is the time for schools to look for innovative new solutions to provide better care. By keeping the entire school community healthy, schools facilitate more successful learning for every student and a safer environment for all.  

Let’s take a look at why on-campus healthcare in schools is so vital, how it’s changed over the years, and what schools can do today to improve their healthcare options. 

The History of Healthcare in Schools

Public schools in the United States have provided some form of healthcare for over a century. Most schools started offering health education and care in the late 19th century, and many states started officially mandating that schools provide healthcare around the 1920s. 

In the decades since, school healthcare initiatives have expanded dramatically, providing essential screenings for young children, facilitating vaccinations, and promoting awareness to prevent the spread of illness. 

However, since 2020, many schools have been in survival mode. Navigating the challenging COVID-19 pandemic and resulting economic fallout has meant that many schools have needed to alter or cut back on their healthcare programs. 

During the pandemic, many schools switched to an online learning model, which also made it difficult to provide healthcare services to those in need. Although most schools have since returned to in-person learning, reinstating those healthcare services has been challenging. 

Nationwide labor shortages have made it difficult for schools to rehire staff members who previously performed these services. Additionally, many school districts across the country have seen a drop in funding. 

This is partially because COVID-19-related emergency funds have run out, but many schools have also seen drops in enrollment and therefore funding. Tighter budgets mean that schools often have to cut back to the bare minimum when it comes to healthcare. 

This lack of healthcare has real consequences for students. Many students and their families, particularly those who have lower-income backgrounds, rely on their schools for essential health screenings and basic care for illness and injury. 

It’s estimated that roughly 4.2% of children in the United States don’t have any health insurance and even families that do often rely on free in-school care options to manage costs. In other words, school healthcare isn’t just a luxury for some, but a necessity. 

Benefits of School Healthcare Initiatives

Making basic healthcare available at school results in a variety of benefits not only for students but for their families and the entire community. 

The biggest benefit is that it makes basic healthcare accessible to all students, regardless of their background or socioeconomic status. Even if students don’t have health insurance or a primary care provider, they will still get basic health screenings and checks to ensure that serious health issues don’t go untreated. 

When in-school health screenings are conducted regularly, they have the opportunity to catch physical and mental illnesses that might have otherwise gone untreated. Schools can offer screenings for everything from vision and hearing impairment to ADHD and autism. Getting these diagnoses early in life ensures that students get the support they need as they grow and develop. 

Additionally, school healthcare initiatives reduce the rate of absences related to illness or injury. When students and staff have access to preventative care and education, they’re less likely to take sick days. Fewer absences equate to more valuable time spent in the classroom and ultimately, a better education. 

On-campus healthcare has become particularly important in the wake of the COVID-19 pandemic. COVID-19 and other respiratory illnesses can spread quickly throughout any school. When schools can provide vaccinations, PPE, and treatments for highly communicable illnesses, they prevent them from spreading throughout the school and causing mass absences. 

Improving On-Campus Healthcare Initiatives

Despite the unique challenges that schools are facing, it’s more important than ever to provide healthcare options for students. Instead of tackling these challenges solo, many schools should consider bringing in an expert healthcare partner.

By working with an outside healthcare partner, schools can provide a broader range of services to students while staying within their budgets. Ideally, a healthcare partner should specialize in education and understand the unique challenges that schools face when it comes to healthcare. 

One of the biggest advantages of working with a third-party healthcare specialist is that they tend to be more cost-efficient than hiring full-time healthcare staff to work in schools. Applying for grants and other financial support can help schools stretch a tight budget even further. 

Additionally, these third parties already have the skills and the resources to offer a broad range of tests and other services. This means schools won’t have to spend extra time or money training new staff members. A healthcare partner can even provide helpful guidance on regulations in specific states to ensure that the school’s offerings are up to par. 

In-School Healthcare for Everyone

Schools play such an important role in every child’s development, and healthcare is a key part of this. By prioritizing on-campus care, schools create a better learning environment for students and support a healthier, happier community for everyone.

About Thomas Shaffer

Thomas Shaffer stands at the helm of Campus Clinic, holding the esteemed position of President. In this role, he spearheads a transformative healthcare initiative, providing school-based healthcare solutions that are revolutionizing healthcare access on campuses. With a robust professional background, Shaffer’s journey into the realm of school-based healthcare is marked by his expertise as a healthcare consultant and his dedicated service as a Board Member for a Covid Clinic.

Since its inception, Shaffer has been the driving force behind Campus Clinic, guiding the company’s mission to broaden access to healthcare services within school environments. Campus Clinic’s vision, perfectly aligned with Shaffer’s, revolves around the radical transformation of healthcare accessibility on school campuses. Under Shaffer’s leadership, the company actively engages with the community, collaborating with school districts to deliver high-quality healthcare services. His instrumental role in fostering these vital community initiatives reflects his commitment to enhancing healthcare accessibility and making a lasting impact on the lives of students. Through his dedication, Campus Clinic continues to pave the way for comprehensive and accessible healthcare within the educational landscape.

Anyone reading this article knows that the healthcare industry accounts for nearly a fifth of the U.S. economy.  ‘Big Tech’ companies like Amazon and consumer-focused giants like Walmart know it too.  Companies with deep technology capabilities, unmatched capital, and customer-friendly reputations are making renewed investments in the healthcare industry. Technology and consumer-facing companies this large cannot ignore a market this large.

The response of the health industry has ranged from panic to unconcern (‘seen it before’).  Amazon’s acquisition of One Medical last year caused many health industry leaders to reassess primary and virtual care models and cost structures.

On the other hand, many technology companies have already lost billions trying to enter and ‘disrupt’ the market, only to find out that the industry is incredibly complex, has powerful entrenched interests, and requires substantial subject matter expertise.  Is anyone still using Microsoft Health Vault (RIP: 2007–2019)?  How did giants like JP Morgan, Berkshire Hathaway, and Amazon perform with Haven (RIP: 2018 – 2021)?  These are brilliant companies.  Healthcare isn’t easy.

The real issue here is the consumerization of healthcare, and the reasons why.  The news story isn’t that Amazon or Big Tech will take over the market.  The news is that everyone will need to address the consumer demands that the healthcare industry is currently failing with, which Amazon and others want to deliver.  The industry is being prompted to change by consumer demand – and Amazon thinks they can deliver on this.  Maybe big tech will succeed (I hope so), maybe not.  But eventually, some health leaders will deliver.  Those that do not will disappear over time.

Consumers want healthcare experiences that are convenient, real-time, and personalized – just like the experiences they expect in other aspects of their lives. However, the U.S. healthcare industry’s legacy administrative technology infrastructure is simply unable to support these expectations. Payer health market and administration professionals find themselves with the impossible task of delivering a caliber of experience similar to that of an Uber app with outdated systems that rely on four-decade-old EDI connections and incomplete data, resulting in limited real-time data updates and analytics datasets that are updated monthly. 

In contrast, behind their app, Uber’s infrastructure is coordinating information about your location (and thousands of other passengers), your driver’s location (and thousands of other drivers), your destination, and all the traffic in between, along with payment, trust, and other data…all in real-time.  Imagine if Uber updated its operational data once a day and refreshed its analytics data once a month.  We would all still be standing on a street corner, waiving our arms around, hoping a taxi would drive by.

The healthcare industry’s version of spending 20 minutes waving for a taxi is waiting an average of 20 days to get an appointment with a new family physician. By the way, this is the wait after searching provider network directories to find providers that are in-network and willing to take on new patients.

According to a 2022 survey conducted by Merritt Hawkins and AMN Healthcare and cited by the AAFP, the average wait time for a new family physician appointment is 20.6 days.  This compares to 26.6 days for a new cardiology appointment and 31.4 days for a new OB/GYN.  New market competitors see an opportunity.

Five years ago, the wait was even worse: the 20.6-day average wait for a new family medicine appointment is a 30% reduction in wait times since the last survey in 2017.  The four other specialties experienced average wait times that increased by a range of 7% to 48%.  What changed?  During this period, there was a rapid expansion of virtual, urgent, and retail primary care.  Providing more consumer-friendly hours, 24/7 virtual care access, and remote patient monitoring will improve customer experiences.

But the modernization needed in healthcare must also happen deep, within the plumbing and wiring of information technology that moves clinical, administrative, and financial data around the healthcare ecosystem.  Even if new market entrants update the consumer experience at their respective care endpoints of the healthcare system, they must still either work with the other ‘nodes’ of the system, such as other providers and payers…or they can opt-out and force their consumers patients to coordinate these administrative tasks themselves.

Amazon furthered its market entry by making access to One Medical virtual and in-person care more available to Amazon Prime members.  Yet Amazon/One Medical and its members will still need to coordinate this care, and all its clinical, financial, and administrative information, within a broader healthcare ecosystem.

Healthcare data is still moved around using slow, document-based X.12 EDI and stored in narrow siloes––when it is meaningfully stored at all.  Driven by government mandates, there have been real efforts to enable more fluid sharing of clinical EHR data, but there has still been very little government or industry effort to make administrative and financial healthcare data more interoperable and usable in real time.

To continue with the Uber analogy, this would be like app-enabling the passenger and driver match but then requiring the parties to haggle on price, and then co-pay with cash or a credit card for part of the ride and bill a third party for the remainder.

While new entrants can provide better consumer experiences for parts of the patient journey, all market participants, including end-payers, end-providers, and all the parties in between, will need to update the data routing and storage infrastructure that enables our healthcare system to function if we aspire to provide better end-to-end customer journeys.

The industry urgently needs innovators and collaborators to create modern platforms and sharing standards to provide the seamless experiences consumers demand.  Otherwise, change to customer experience will only be superficial and app-deep. 

About Virgial Bretz

Virgil Bretz is the co-founder and CEO of MacroHealth, a platform Healthcare FinTech company. He has more than 25 years of entrepreneurial and executive experience in the American and international health technology and insurance industry. Previously he was a co-founder and Partner at VIDA Health Ltd, a health insurance, technology and capital advisory firm that was merged into MacroHealth in 2017. MacroHealth connects and optimizes payer relationships with health solution partners. Partners that provide payers services such as out-of-area coverage options, out-of-network options, or specialty networks, which could include pharmacy management solutions or fertility solutions, as examples. MacroHealth does this by using its proprietary platform called the MacroHealth Intelligent Exchange (MiX). It is a first-of-its-kind SaaS platform that uses a transparent digital healthcare marketplace ecosystem, allowing payers to easily make informed business decisions and collaborate with their partners in a way that saves time and money.

In healthcare, sensitive data comes with great responsibility. For companies entrusted with managing and protecting patients’ personal information, ensuring the privacy of that data must be the highest priority. These companies are called to act as vigilant guardians, especially when you consider that secure and accurate data can literally save lives.

Enter the concept of ‘privacy and security by design,’ an approach that goes beyond merely meeting compliance standards and, instead, embedding security at the very core of business operations. With privacy and security as non-negotiable foundations, organizations can effectively fortify their defenses — as long as they continue to adapt to new technology and ever-evolving cyber threats.

Here are some of the essential principles and practices that underpin ‘privacy and security by design,’ enabling health organizations to safeguard patient data and ensure the highest level of privacy and security in their operations.

Limit data collection to only what’s necessary

The first step in fortifying the security of healthcare data is to limit data collection to the bare essentials. Often, organizations collect more data than they actually need, inadvertently increasing the risk of exposure. By taking a minimalist approach to data collection, companies not only reduce the amount of sensitive information at risk but also simplify data management.

This approach aligns with the principle of data minimization, a key aspect of privacy regulations like the General Data Protection Regulation (GDPR) and HIPAA. By collecting only what is strictly necessary for the intended purpose, healthcare organizations reduce their data footprint and, at the same time, their potential attack surface.

Employ appropriate encryption for data in transit and at rest

Encryption lies at the heart of data security. It ensures that even if unauthorized actors gain access to data, they cannot decipher it without the necessary decryption keys. In healthcare, where patient data constantly moves between devices and systems, employing appropriate encryption for data in transit is a non-negotiable requirement.

Moreover, data at rest, stored on servers and in databases, is equally susceptible to breaches. Strong encryption measures, such as end-to-end encryption and advanced encryption algorithms, provide an additional layer of security. In the event of a breach, encrypted data remains indecipherable, safeguarding the privacy of patients and maintaining the integrity of healthcare records.

Practice daily blocking and tackling to maintain strong security posture

When it comes to healthcare data security, a proactive stance is vital. It’s not enough to set up defenses and assume they will remain impenetrable forever. Threat landscapes evolve, and cybercriminals become more sophisticated with every passing day. To uphold a strong security posture, healthcare organizations must prioritize daily blocking and tackling.

This means practicing not only the cybersecurity basics — like backing up data, using multi-factor authentication and handling passwords securely — but also employing more advanced tactics, including developing a hierarchical cybersecurity policy, simplifying technology infrastructure and ensuring IoT security. It also means continuously monitoring, threat hunting, patching and reducing your attack surfaces where possible. 

To hold organizations accountable to these cybersecurity best practices, it’s essential to regularly audit and test your systems. Audits serve as a comprehensive review of an organization’s security infrastructure, policies and procedures, and can help identify vulnerabilities and areas that require improvement. Readiness tests or mock event/breach exercises, on the other hand, involve simulated cyber attacks to assess the effectiveness of an organization’s current security measures in a real-world scenario. By continuously evaluating and refining their security protocols, healthcare companies can stay ahead of potential threats and vulnerabilities.

Stay informed about industry threats and security 

The field of cybersecurity is dynamic and ever-evolving. New threats emerge, and innovative solutions are developed to counter them. To remain effective in safeguarding healthcare data, organizations must stay informed about the latest developments in the security landscape.

Staying safe requires actively monitoring security news, particularly, reading reports and alerts from third parties as well as real-time feeds from the proper channels to stay up-to-date with the latest intel. Organizations should also seek out opportunities, where possible, to participate in industry-specific forums and collaborate with cybersecurity experts. In addition, it’s essential to prioritize regular staff training to keep cybersecurity skills sharp and foster a culture of security awareness within the organization. By keeping their knowledge current, healthcare organizations can adapt quickly to emerging threats and implement the necessary defenses, ensuring that patient data remains secure in the face of continuously evolving risks.

In healthcare, the responsibility of safeguarding sensitive data isn’t just a legal or ethical obligation — it’s a matter of life and death. By the same token, ‘privacy and security by design’ isn’t just a buzzword. It’s a fundamental approach that not only acknowledges the gravity of this responsibility but allows healthcare organizations to build an advanced security posture that goes above and beyond compliance requirements to protect the privacy and well-being of patients.

About Chris Bowen

Chris is the Founder and Chief Information Security Officer at ClearDATA. He leads ClearDATA’s internal privacy, security and compliance strategies as well as advises on the security and privacy risks faced by customers, which include global healthcare organizations, health insurance companies, providers, life science companies, and market-leading innovators from Asia Pacific, North America, and Europe. Mr. Bowen also leads ClearDATA’s international security risk consulting practice and has provided counsel to some of the world’s largest healthcare organizations.

He is a Certified Information Privacy Professional (CIPP/US) and Certified Information Privacy Technologist (CIPT) from the International Association of Privacy Professionals (IAPP), and Certified Information Systems Security Professional (CISSP) and a Certified Cloud Security Professional from (ISC)2. As one of the leading experts on patient privacy and health data security, Chris has authored dozens of articles and is a frequent speaker at national healthcare industry events.

The current NHS waiting list has hit 7.3 million in the UK, increasing monthly. A recent survey conducted by the NHS revealed only 21.3% of staff reported that there is enough headcount available for them to do their job properly and 44.8% admitted to witnessing errors, near misses, or incidents that could have hurt staff or patients. The same frustrations exist in the US healthcare system. In a letter sent in March to the House Energy and Commerce Committee, the American Hospital Association called the workforce shortage hospitals were experiencing a “national emergency,” projecting the overall shortage of nurses to reach 1.1 million by the end of the year. And it’s not just nurses: Professionals from medical lab workers to paramedics are in short supply. Rising backups beginning in the emergency department have been described as the canary in the coal mine. Clearly, something must change.

Short of a reversal of the global staffing shortage, hospitals and health systems must find ways to do more with less transforming workflows through efficiency and optimization as other industries have been driven to do. Healthcare has always been reactive by nature, but transforming healthcare processes, in a similar manner to successful manufacturing processes, while preserving quality care and patient relationships will take a big transition from reactive to proactive. 

One strategy involves reverse bed chain, a concept created to improve patient flow across a hospital environment and alleviate pressure within emergency departments (ED). According to the NHS, flow within the healthcare setting is defined by the movement of patients, information or equipment between departments, staff groups or organizations as part of a care pathway. With a reverse bed chain in place, this continuous flow ensures that each step in the care process is completed without delay. This is like Just in Time (JIT) manufacturing processes made famous by Toyota. 

Two areas to be targeted are patient flow and capacity planning, improving both the experience for staff and patients and increasing the number of patients being seen. 

So, how does reverse bed chain work, and how will this help the NHS?

Improving Patient Flow

The traditional method of patient movement begins in a “pull” process with the patient being discharged from hospital and their movement from a base ward to the discharge lounge. A porter or patient logistics staff would move the patient from the ward out to the lounge then have to transition across the hospital to the assessment ward to collect the second patient and then move them to the base ward, the base ward where the first patient was moved from. Upon completion, the porter would then head to ED and collect the 3rd patient before moving them to the Assessment ward (where the porter moved patient 2 from). In principle, the discharge of a patient from the hospital initiates a pull through each ward and ultimately from the ED.

If, however, we were able to bundle multiple patients and their move-related tasks together, into a single group, time could be reduced that would otherwise been lost by patient logistics staff and backlog in ED, as the delivery location of patient 1 will be the collection location of patient 2 and so on.  Although this can be mapped out on paper or in a spreadsheet, to efficiently create a pull process, hospitals will need technology to assist. 

New location and tasking technology offered in a “lite tech” format utilizing a simple-to-use phone-based app offers hospitals and health systems the ability to group patient moves into a single task, displaying the order in which the group needs to be carried out.  Assignment of the task group is based upon the task handler’s location within the building, ensuring that we issue the task to the right person who can get to the start location the quickest.

Improving capacity 

By moving patients in a synchronized manner, the backlog in ED is addressed, and delay-related harm is mitigated.  Together this “light tech” solution can improve the patient experience, keep care flowing, and help support staff across hospitals.

This means that long-term workforce issues can be resolved, for example, clinical staff can continue to care for patients while other team members are perfectly aligned where they can make the most impact. 

About Connie Moser

Connie Moser is a serial entrepreneur with several successful exits to her credit and more than 30 years of experience building healthcare information technology organizations. Connie is known industry-wide as a true leader who relentlessly pursues growth through realized customer value, all while building loyal teams that routinely follow her to new opportunities. 

As the Chief Executive of Navenio, a UK-based technology company focused on logistical intelligence in healthcare, she is validating her leadership skills with successful revenue transactions as she did as the CEO of Verge Health (now RLDatix) and building a strong presence in the US and global healthcare market. Team empowerment and mentoring younger employees have been a constant throughout her lengthy career and a source of deep satisfaction. Her mentorship extends to her work as a long-time board member of her alma mater Ripon College since 2013.    

Outside of her professional life, Connie has also held a board position with the Competency and Credentialing Institute for non-profit organizations focused on nursing certification. She is a frequent speaker and industry expert often called upon to provide feedback by the venture and private equity community around new analytically enabled solutions and companies.

In Handel Jones’ literary alarm, “When AI Rules the World,” we are drawn to envision an age where AI doesn’t merely complement but dominates every strand of our societal fabric. One domain in dire need of this revolutionary touch is healthcare — a sector where the United States, alarmingly, trails behind in the global AI adoption race. When nearly one-fifth of our GDP feeds a system that sees Americans facing graver health outcomes than other high-income nations, it’s clear: our approach needs recalibration. 

With over 27 years immersed at the crossroads of technology and healthcare, I’ve witnessed the transformative ripples AI can engender. But our hesitant pace to adopt AI threatens to stunt U.S. healthcare evolution. It’s high time we herald a new standard.

The Disjointed Dance of AI in U.S. Healthcare

Currently, AI’s imprint on U.S. healthcare resembles a patchwork quilt. Rather than seamlessly integrating AI into all areas of medicine, it’s isolated to single systems, such as MRI machines or ultrasound hardware. This approach feels like déjà vu of the healthcare system’s disjointed strategy for the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), which, despite a $35b investment, failed to solve the healthcare interoperability issue.

Critique aside, the HITECH Act did increase the adoption of digital medical health records. But this shift in practice took a federally mandated law to become a reality. Innovations abound but lack the cohesive strategy seen in visionary endeavors like the U.K.’s move to digitally overhaul the NHS. With a staggering 75% of our country’s medical communication still tethered to ancient fax machines, our sluggishness is evident. If the U.K. can lead the charge, surely we can echo their strides?

The Game-Changing Potential of AI in Healthcare

Beyond the looming shadow of “AI domination” lies its life-altering promise. A recent August 2023 Swedish study serves as a testament: AI-aided mammogram analyses detected 20% more cancers while maintaining accuracy. The transformative influence doesn’t stop there. AI’s prowess in streamlining physicians’ schedules not only diminishes patient wait times but can significantly reduce physician burnout, which has reached epidemic levels in the wake of the global pandemic, as evident in Ochsner Health’s 2018 experiment using AI-powered scheduling systems.

If AI can detect cancers and reduce medical burnout, imagine its potential in combatting a silent crisis. Medical errors such as prescription mistakes account for up to 250,000 deaths each year in the U.S., making it the third-leading cause of death. A common medical error — and one I experienced myself — is a miscalculated prescription dose. A few years back, I headed to my local pharmacy like I do monthly to fill my prednisone prescription. After swiping my credit card and pocketing the receipt, I stepped aside and pulled out my prescription. I was shocked when my usual bottle of 30 pills contained 450. The bottle even included instructions to take 15 pills daily instead of my regular single daily pill. 

When I informed the pharmacist of the mistake, she told me that the computer system confirmed the dosage. A team of hospital providers had incorrectly entered my prescription through a digital fax gateway (the same fax system the NHS is trying to ban). This photo of digital data instructed the pharmacist to prescribe me 15 times my usual prescription. If that same data had been transferred as a digital text field, algorithms would have instantly flagged the abnormal dosage. Just as in my case, medical errors, such as pharmaceutical mistakes, are often caused by a mix of outdated technology and bad data. There is unlimited opportunity for AI technology to make an immediate impact on lives and prevent these minute yet consequential errors.

A New Dawn: AI Integration Requires Cultural and Policy Evolution

We’re on the cusp of an evolution. But like any change, it’s met with hesitation. The bottom line is that many Americans do not trust AI. According to Pew Research, six in ten U.S. adults would feel uncomfortable if their healthcare provider relied on AI for diagnostic and treatment decisions. This position, coupled with regulatory inertia, hampers the harmonization of AI and human expertise — an alliance that could redefine healthcare excellence.

Robust governmental frameworks are imperative to seamlessly integrate AI technology into a system centered on patient privacy and data protection. In our digital era, threats abound. But with vigilance, the summit (however towering) is attainable. The U.S. should seek inspiration from the European Union and its approach to developing concrete rules for using AI safely and securely. 

A Heartbeat Synced with Code: The Future of Healthcare

In marrying AI and human medical acumen, we stand on the brink of a healthcare renaissance. A world where medical errors dwindle, cancers are detected promptly and physician well-being is prioritized is within our grasp. As we ride this wave of technological marvel, we must never lose sight of the heartbeat — the intrinsic human values underpinning every line of code. Our moral duty, especially in healthcare, is to ensure this digital heartbeat pulsates in harmony with our collective conscience.

 As we stand at the intersection of humanity and technology, we must remember that our choices today will shape our stories tomorrow. It’s time to make AI not just a chapter but a central character in our healthcare narrative.

About Charles Aunger

Charles is a Managing Director of Technology at Health2047.  He is an internationally recognized IT professional, with over 27 years’ experience in leading the development, operation and transformation of technology solutions to achieve strategic business goals for global organizations across the healthcare sector. Prior to joining Health2047, he was Senior Executive IT Director at Stanford Healthcare, where he led the team delivering innovative technology services to over 15,000 personnel across 64 facilities, and before then was Senior Vice President at Cleveland Clinic Abu Dhabi, where he led the strategic planning and tactical execution efforts around cost balancing, business model development, and technical operations optimization.  An ELITE Group Executive and Distinguished Fellow by Royal Charter of the British Computer Society since 2014, over the course of his career he has held senior consultancy, technical architect and director-level positions at BUPA Healthcare, Accenture, KPMG, Citrix, Microsoft and Glaxo Wellcome.  Charles holds a BSc in Electronics/Computing from Oxford Brookes University and an MSc Honors in Information Systems Management from the University of Liverpool.

When you leave the doctor, you’ll have a plan of care in hand. For instance, when you break an ankle, you may get instructions for the next 24 hours, a prescription, a follow-up appointment, a number to call if something goes wrong and a picture of what your next six weeks might look like. These plans are comprehensive and consider things like your activity level, the specific way your bone is broken, your ability to make it to appointments and any medication allergies. 

This level of care is the standard in healthcare, but historically, the billing and payments components haven’t reflected that. Often, patients leave confused about how much they owe, why they owe it or who they owe. Then, when they get the bill, they may not be sure how to settle it. A payment plan should be just as in-depth as a care plan and tailored as precisely. 

Like the treatment for an injury, patients don’t have control over how payment options are presented to them. Personalized, seamless payment journeys that are easy to understand for the patient should be the standard for healthcare—after all, it’s their job to soothe painful experiences. 

Patient-Centric Payments Model

When it comes to payments, other industries can get away with limited options. For instance, a grocery store doesn’t need to offer widespread “buy now, pay later” options and can restrict the use of checks or certain types of credit cards with little to no backlash. However, in the healthcare industry, we know that’s not the case. Often, patients receive unexpected bills, which are not budgeted for and can be extremely high depending on the level of care provided. On top of that, the bills are frequently difficult to understand, and the charges aren’t clear. This is certainly different from going to the store with a normal weekly grocery budget and knowing exactly what you’re buying and how you’re going to pay. Combine these unexpected expenses with the emotional turmoil of illness or injury and limited payment options, and you will see patients who are either unwilling or unable to pay their medical bills. Currently, it’s estimated that 1 in 10 adults in America owe some amount of medical debt, adding up to about 23 million people, three million of whom owe more than $10,000. One study even found a third of single-family households are unable to pay a bill of $2,000 or more upfront. 

The reality is that despite these steep or unexpected expenses, healthcare organizations still rely on those bills to continue to provide a high level of care to all patients. Like any other aspect of healthcare, the payment process should be empathetic, accessible and patient-centered. By taking patient preferences fully into account and using payment journey technology combined with clear billing practices, healthcare organizations can get ahead of bill abandonment, accelerate necessary cash flows and, most importantly, enhance the customer experience. 

Patient Payment Preferences

So, what could those differing preferences look like? A recent survey found that 74% of consumers prefer to pay digitally as opposed to receiving paper statements in the mail. Though this seems to point overwhelmingly to organizations pivoting to digital-only billing and payments, digital and physical options don’t have to be mutually exclusive. In this case, 26% of consumers would still prefer to receive and pay their bills physically. In a field where bills can fluctuate from a simple co-pay to thousands of dollars, it’s important to give patients the choice of how bills are paid. 

To address the needs of all patients, healthcare organizations should focus on offering a patient-centric payment journey. Just like a doctor might create a care plan for patients who are being discharged from the hospital, the billing department should also personalize their own kind of care plan. Healthcare organizations should prioritize a payment journey that lets patients choose how to receive their bills and gives them a clear explanation about the charges on the bill and how to pay it. By allowing patients to shape their journeys and choose the payment options that work best for their needs, healthcare organizations can provide a more empathy-led approach that aligns with the other areas of patient care. Without providing these options, they risk continuing down the path of bill abandonment, and their standard of patient care won’t be consistent throughout the customer experience. 

Continuing a High Standard of Care

At the end of the day, payments and billing are a part of the patient experience, and when treated without proper care, can ruin the entire encounter. We can all agree each patient is unique, and their preferences reflect that. On an individual level, patients have health issues, care needs and payment preferences, and healthcare organizations should consider the payment and billing journey to be an extension of their quality of care. In the constantly changing landscape of healthcare, a patient-centric approach to payments is a beacon of empathy and efficiency and will finish out the experience the way patients deserve.  

As healthcare organizations navigate the complexity of billing and payments, it’s important to consider the diverse patient preferences and ensure all bills are issued with clarity and empathy. In the pursuit of sustaining the delicate balance between financial sustainability and compassionate care, healthcare organizations must embrace the power of choice in payments. By acknowledging the uniqueness of each patient and making billing and payments more straightforward and seamless, healthcare providers can combat ever-present billing struggles and foster stronger patient relationships while reducing bill abandonment and frustration.

About Suman Chaudhuri

Suman Chaudhuri is the Vice President at CSG Forte, a company that provides SaaS software that enables companies to digitally connect with their customers and monetize those relationships. In his role as VP, Chaudhuri leads Forte’s Payments business that services retail, healthcare, government, property management, and many other verticals across Enterprise and SMB.

In the healthcare ecosystem, automation and data intelligence continue to gain momentum as artificial intelligence (AI) and machine learning (ML) are integrated to streamline and accelerate processes. 

The clinical trial space is one area where pharmaceutical companies are leveraging these technologies to improve operations, in particular, data processing. A typical clinical trial generates over 13,000 documents in various formats, including text, audio, video and images, making it difficult to collect, organize and analyze the data. Intelligent document processing (IDP) can help by automating these tasks, boosting productivity, speeding up processes, improving accuracy and saving money. 

In this article, we dive into how to implement IDP in the digital content flow of a clinical trial using transformative technologies like digital twinning, AI/ML, natural language processing (NLP), and generative AI agents. These technologies can automate the implementation process, enabling the rapid and intelligent transformation of thousands of documents into valuable research insights that can enable researchers to uncover hidden patterns and trends that could lead to new breakthroughs in medicine.

Assessment and planning

As the saying goes “fail to plan, plan to fail,” implementing IDP is no exception. Before implementing an IDP platform, sponsors must carefully consider their goals and objectives, specify their document processing requirements, as well as the types of documents that need to be processed and identify areas for improvement. It is important to be aware of the challenges that pharmaceutical companies face in their data flow during clinical trials. For example, manually populating site folders and electronic trial master files (eTMFs) is time-consuming and can lead to problems such as limited document security and data privacy, archiving and retrieval difficulties and human error, which can result in a failure rate of up to 25%.

In addition, the strict regulatory requirements in the healthcare industry mean that IDP systems must ensure patient privacy protection and maintain audit trails. Security continues to be a crucial aspect to prevent unauthorized access to sensitive data. It is because of these two challenges that the pharmaceutical industry has been cautious about integrating generative AI into regulated and sensitive data workflows, which in turn has slowed down adoption. 

To overcome resistance to change in this conservative industry, it is important to demonstrate the value of AI-driven solutions and ensure that they are secure, private and compliant.

Implementing IDP in Clinical Trials

Selecting an IDP solution that meets the specific needs of the organization, including support for the relevant document formats and languages is obviously a key factor. Evaluating the solution’s AI/ML capabilities, its ability to integrate with existing systems, to incorporate technology and data science and integrate AI and generative AI, are all essential for handling digital content. The ability to analyze diverse documents often reveals hidden insights and patterns not easily detected through traditional methods.

To implement IDP successfully in a clinical trial’s digital content flow, companies must follow these crucial steps:

1. Quality auto-review – Data quality is essential in healthcare and since AI’s effectiveness relies on the quality of its training data, it is paramount to promptly identify incoming content and verify its layout correctness and data convertibility. Clean and organize the data to ensure that it is in a format that can be processed by the IDP solution. This may involve tasks such as removing errors, converting images and scans to text and standardizing data formats, if necessary. If the system detects any issues, it should flag the information for user review and resubmission in real time. This will speed up data collection and quality control processes.
2. Digital twin and classification – Deploying digital twins – continuously updated virtual representations of assets – helps with digitization of all clinical trial content for universal accessibility. This data can be used to train generative AI models to recognize patterns and relationships. Companies can also use digital twins to perform pre-audit checks, proactively populate eTMF and electronic common technical document (eCTD) and gain insights from past trials. Finally by maintaining the look and feel of the original content in digital twin structure it allows for a better user experience and easy to understand traceability back to source.
3. Auto-translations – The ability to automatically convert content into other languages is an important step in deploying IDP. This can be done using domain-specific regulatory or safety language ontology sets. Auto-translation streamlines communications and drives efficiency gains.
4. Sensitive data handling – Data privacy has become an intrinsic part of any clinical trial, so it is important to automate safe processes for sourcing, linking, combining, reusing and sharing protected data. Deploying privacy analytics can enhance the retention of sensitive data by running redaction capabilities and providing only relevant content to users.
5. Entity extraction – Once content is digitized, teams need to be able to recognize the sections within that content and find information. NLP and natural language understanding (NLU) enable understanding of text and its meaning. For example, NLP can be used to analyze scheduled assessments for a patient and find out what is required of the patient in their participation.   This information can then be used to build appropriate models to best manage patient burden.
6. Insights and best actions – Technology can be used to aid in content analysis and generate actionable insights in risk assessment, patient burden, protocol amendments, potential outcomes and theoretical modeling. AI deployment and generative AI training leverage digital twins and NLP to enable natural language generation. Entity extraction is used to identify text, and another program interprets its meaning. A third program generates responses, insights, and next steps. The combination of digital twins and NLP enhances data understanding, enabling generative AI models to learn essential patterns and relationships for precise predictions and the creation of creative content.

The Benefits of Automating IDP

The automation of IDP is gaining popularity as a way to address legacy IDP challenges which involve speeding up operations, enabling continuous processing, improving accuracy, enhancing collaboration and ensuring regulatory compliance.

One of the key benefits of automating IDP in clinical trials is the ability to immediately review the quality of content from trial sites before it is fed into the eTMF for final trial file storage. This is achieved by adopting an API-enabled SaaS solution for automating IDP and having it in site folders. Overall, this process allows to identify and resolve issues early on, such as missing signatures, scan issues and layout problems

Automated eTMF systems offer a number of features that can help to address manual processing issues, including document version control, audit trails, notifications, remote accessibility and advanced search capabilities. They help eliminate manual eTMF entry while maintaining quality. These solutions index documents, automate workflows, aid translations, reduce processing time and free up employees for value-added tasks. Furthermore, they can handle scans and images in any language, extracting metadata and creating digital twins for better recognition.

Another important benefit of automating IDP in clinical trials is the ability to gain clear insights into whether trial sites have seen, acknowledged and understood protocol amendments. This is essential for optimizing communications with sites and ensuring regulatory compliance. 

Automated IDP solutions can provide some of the highest levels of visibility by monitoring version control and audit trails. At a glance, IDP key benefits have to do with:

• Expediting clinical trials timelines – By automating the document processing tasks, IDP can help to accelerate the pace of clinical trials.
• Improving accuracy – IDP can reduce the risk of human error in the data collection and analysis process.
• Gaining deeper insights – IDP can help organizations to uncover hidden patterns and trends in clinical trial data that would be difficult to detect manually.
• Reducing costs – IDP can help to reduce the costs associated with manual data processing and analysis.

The Future Role of Technology

As pharmaceutical companies continue to seek ways to automate and streamline clinical trial processes, IDP’s transformative technologies are playing an increasingly important role by driving greater efficiencies and enabling more significant insights into research.

Significantly, more pharmaceutical companies are bringing all their content into digital form, which is allowing the industry to embrace AI more fully through safe approaches such as IDP. Companies are increasingly exploring generative AI applications for data mining, template creation, quality control, site communication and clinical trial operation guides. Generative AI can rapidly identify potential trial participants from medical records and monitor patients by analyzing medical data promptly and detecting safety issues. In the next couple of years, we expect to see pharmaceutical companies to set the foundation for their long-term journey with AI by developing and deploying “mini” versions of generative AI models internally. This will allow them to reap the benefits of AI while protecting the quality and security of their sensitive data.

The drug development journey with AI is already underway and is only going to accelerate in the coming years. IDP is a powerful tool that can help organizations to improve the efficiency and effectiveness of their clinical trials. By following the critical steps outlined above, organizations can successfully implement IDP and start benefiting from it. Taking a careful approach via steppingstones such as IDP, the pharmaceutical industry can ensure that it is well-positioned to capitalize on the full potential of AI.

About Gary Shorter – Head, AI and Data Science, IQVIA Technologies

Gary pursues the use of emerging technology to provide new and more efficient capabilities to enhance clinical trial management. This includes development of new design software through to more recent advancements with AI/ML capabilities where his team has developed several micro-products and micro-services that can be plugged in and used by any SaaS solution.

Healthcare delivery organizations and those working with them that are still in business are either well aware of their duties under HIPAA, work with managed service providers that understand the law well, or…are lucky to have made it this far. Even for organizations that have steered clear of both cyberattacks and regulatory fines, vigilance is essential to maintaining a clean bill of (cybersecurity) health.

With HIPAA guidance and enforcement practices shifting increasingly quickly right now, businesses must adapt their cybersecurity strategies to remain alert and in step with regulators’ most current expectations.

The fines they are a-changin’

Historically, HIPAA regulators have most often levied fines in the seven-figure range—but levied them relatively sparingly. As a result, HIPAA enforcement actions have long been viewed as a force of nature akin to lightning strikes: extremely lethal to most businesses, but just as extremely rare. That state of play has made it easy for organizations to adopt a dangerous “It won’t happen to me” attitude, as well as the mindset that fines could happen to anyone with bad enough luck.

HIPAA regulators are now changing their enforcement practices to take that perception of luck out of the equation—and force every organization that touches sensitive patient data to get serious about cybersecurity.

Regulators’ new strategy: assign five-figure fines per violation that most businesses can afford, and ramp up enforcement to make sure all organizations might receive a fine if they aren’t meeting their regulatory obligations. Ironically, this affordable-pricing strategy was pioneered by ransomware attackers in recent years, who have moved away from huge price tags that had their victims defiantly abandoning data, and become clever in sizing ransoms such that a business’s easiest choice is to pay up. With HIPAA regulators now applying clear and constant pressure via fines, organizations are correctly incentivized to maintain compliant cybersecurity practices and avoid writing checks to either law enforcers or lawbreakers.

HIPAA security controls have caught up with the times

When HIPAA was first enacted in 1996, the law’s writers looked to contemporary cybersecurity frameworks (like the versions of ISO and NIST in use at the time) to borrow guidance on effective controls for ensuring the safety of patient health information. Needless to say, a thing or two has changed in the 27 years since, from the sophistication of cyberattack strategies to the introduction of more modernized cybersecurity frameworks. 

The recent bill H.R.7898 has now addressed this discrepancy, allowing organizations to align their HIPAA security policies with modern control sets. Organizations should take full advantage of this development, mapping HIPAA to today’s most effective security standards (such as NIST CSF or ISO 27001) in order to increase the effectiveness of their protections.

New guidelines suggest that HIPAA is no longer DIY for smaller businesses

Back in 2005, the government drafted the Health Industry Cybersecurity Practices (HICP) guidelines to provide healthcare organizations with recommendations and best practices for complying with HIPAA and protecting their patients’ data. Throughout the HICP’s history up until just recently, these guidelines maintained a DIY tone, telling organizations how to accomplish and maintain HIPAA-compliant cybersecurity internally. 

However, a recent substantial overhaul of 405(d) HICP guidelines now directly offers advice on how to select an effective and trustworthy security-minded MSP (or MSSP) partner. At the root of this change: cyber threats and corresponding cybersecurity countermeasures in the HICP guidelines have become so complicated that smaller-scale healthcare delivery organizations and businesses attached to them can no longer be expected to navigate those complexities without expert support. For example, prescriptive cybersecurity controls, including automated threat detection and mitigation, are quickly becoming essential. Getting this right substantially curtails security risk—if in the hands of those (internally or externally) who know how to leverage those tools optimally.

The more things change…

While the sophistication of modern-day cyberattacks and security protections has reached an unprecedented level, the fundamentals remain the same. Safeguarding patients’ HIPAA-protected data requires thorough risk assessments to flag vulnerabilities, effective data encryption and access control, continuous employee training, and incident response planning to meet and overcome challenges as they arrive. Pairing that strong foundation with evolving protections—aligned with an awareness of the latest regulatory behaviors, security controls, and HIPAA guidelines—is the recipe for successful healthcare cybersecurity today.

About Cam Roberson 

Cam Roberson is Vice President at Beachhead Solutions, a San-Jose-based cybersecurity company. Cam previously worked in product management roles at Apple.