Department of Health and Human Services Secretary Robert F. Kennedy Jr. has floated a seismic idea: adding autism to the list of conditions covered by the Vaccine Injury Compensation Program. The program, known as VICP, provides a system for families to file claims against vaccine providers in cases in which they experience severe side effects. Kennedy has also suggested broadening the definitions of two serious brain conditions — encephalopathy and encephalitis — so that autism cases could qualify.

Either move, experts warn, would unleash a flood of claims, threatening the program’s financial stability and handing vaccine opponents a powerful new talking point.

Legally, HHS “is required to undergo notice and comment rulemaking to revise the table,” said Richard Hughes, a law firm partner who teaches at George Washington University. The “table” is a list of specific injuries that the U.S. government accepts as presumed to be caused by a vaccine if those injuries occur within a certain time window. If someone can show they meet the criteria, they have a simpler path to securing compensation without having to prove fault. Autism is not in the table because a link between vaccines and autism has been thoroughly debunked.

If autism is added, Hughes explained, the VICP could face “an exorbitant number of claims that would threaten the viability of the program.”

Asked about its possible plans, an HHS spokesperson told CBS News the agency does not comment on future or potential policy decisions.

Carole Johnson, former administrator of the Health Resources and Services Administration, which oversees VICP, cautioned that the system is already overburdened: “The backlog is not just a function of management, it’s built into the statute itself. That’s important context for any conversation about adding new categories of claims.”

Dorit Reiss, a law professor at the University of California College of the Law-San Francisco, said that any such change would be exploited: “This can, and likely will, be used to cast doubt on vaccines.”

Compensation Without Causation

The Vaccine Injury Compensation Program was born of crisis. In 1982, “Vaccine Roulette,” a television documentary, aired nationwide, alleging routine childhood shots were causing seizures, brain damage, and even sudden infant death. The program alarmed parents and triggered a surge of lawsuits against vaccine makers.

“That led to a flood of litigation against vaccine makers,” recalled Paul Offit, a pediatric infectious disease specialist and vaccine inventor at the University of Pennsylvania. “I mean, to the point that it drove them out of the business. … By the mid-1980s, there were $3.2 billion worth of lawsuits against these companies.”

Were it not for the VICP, Offit said, “We wouldn’t have vaccines for American children. The companies — it wasn’t worth it for them.”

The National Childhood Vaccine Injury Act of 1986 created a no-fault system. Families who believed a vaccine caused harm could file a claim; if the injury appeared on the table within a set time frame, compensation was automatic. If not, claimants could present medical evidence. The system had two purposes: provide compensation and protect the vaccine supply.

From the beginning, the table was understood not as a scientific document but as a legal tool.

“It’s a legal document and things can be included for policy reasons even if the causation evidence is weak,” Reiss said. She explained, “The program is designed to be generous, to compensate in cases of doubt.”

But, she said, “autism is not in that category. The science is clear. Adding it would be pure politics.”

This tension — between law, science, and public perception — has defined the program for nearly four decades.

What Expansion Would Mean in Practice

Since 1988, federal data shows more than 25,000 petitions to the VICP have been adjudicated; of those, 12,019 were granted compensation and 13,007 were dismissed. About 60% of compensated cases involved negotiated settlements in which HHS drew no conclusion about the cause. Over the same period, billions of vaccine doses were safely administered to millions of Americans.

Adding autism to the VICP table would change that picture overnight.

Federal estimates suggest up to 48,000 children could qualify immediately under a “profound autism” standard, with potential payouts averaging $2 million per case, at an initial cost of nearly $100 billion, followed by annual totals of about $30 billion a year — dwarfing the current $4 billion trust, a new analysis finds.

“Any case where the symptoms appeared in the past eight years and the parents blame vaccines,” Reiss said. “I don’t know how many that would be. The fund has a surplus of over $4 billion. One seriously disabled child’s care can cost millions, so a significant number, say 100,000 compensations, might exhaust it.”

Furthermore, with only eight special masters handling cases, the system would also be paralyzed by backlogs.

The stakes are not just fiscal. If the fund collapses under the weight of autism claims, vaccine makers may question whether producing vaccines for the U.S. market is worth the risk. That would mirror the crisis of the 1980s, which led to the establishment of the VICP.

Autism and the Courts

In the late 1990s and early 2000s, Andrew Wakefield’s now-retracted paper alleging a link between the MMR vaccine and autism fueled a surge of VICP claims. By 2002, the VICP was swamped with petitions alleging vaccines had caused autism. The court consolidated thousands of cases into the Omnibus Autism Proceedings, selecting a handful of test cases to decide them all.

After years of hearings and expert testimony, the conclusion was unequivocal: vaccines do not cause autism. In 2010, the court ruled against petitioners on every theory of causation. The U.S. Court of Federal Claims affirmed, and the Court of Appeals upheld, the decision.

“That precedent is binding,” said Richard Hughes, a vaccine law expert at George Washington University and former VICP legal counsel. “Autism was litigated thoroughly and rejected. That still carries weight in the court today.”

The Ghost of Hannah Poling

Yet, the vaccine-autism debate has never quite faded. In 2008, the government conceded a case involving Hannah Poling, a girl with a rare mitochondrial disorder who developed autism-like symptoms after vaccination. Officials stressed the concession was specific to her condition, not evidence of a general link. But headlines told another story: “Family to Receive $1.5 Million in First-Ever Vaccine Autism Court Award.”

The Poling case fueled years of confusion.

Autism Science Today

The science is clearer than ever. Autism begins early in pregnancy, not in toddlerhood when most vaccines are given.

“Vaccinations … happened around the time families were recognizing symptoms of autism in their children,” said Catherine Lord, a UCLA clinical psychologist and specialist in autism diagnosis. “However, we now know that autism begins much earlier, likely as the fetus develops during pregnancy, so it cannot be an explanation.”

Peter Hotez, a pediatric infectious disease specialist and vaccine scientist at the Baylor College of Medicine who is also the father of a young adult with autism, underscores that point: “The drivers of autism are genetics and, in rare cases, environmental exposures during pregnancy, not vaccines. We’ve been over this ground for decades, and the evidence is overwhelming.”

Sarah Despres, former legal counsel to the secretary of Health and Human Services in the Biden administration and now a consultant to nonprofit organizations on immunization policy, adds that the compensation program itself is often misunderstood.

“The table was originally written as a political document,” she said. “The purpose of the program was to be swift, generous, and fair. … There would be cases that may not be caused by the vaccine but would be compensated if you went through this table injury scheme, where you don’t have to prove causation.”

What’s at risk: Harm from the Diseases Themselves

The stakes are not abstract. Measles, one of the most contagious pathogens on Earth, spreads so efficiently that one infected child can transmit it to 90% of susceptible contacts. Before vaccinations began in the 1960s, measles sickened hundreds of thousands annually in the U.S., killing hundreds and causing thousands of cases of encephalitis and lifelong disability. Complications included pneumonia, brain swelling, and, in rare cases, a fatal degenerative brain disorder called subacute sclerosing panencephalitis, or SSPE, that can strike years later. This year, a school-age child in Los Angeles County died of SSPE after contracting measles in infancy, before being eligible for vaccination.

Mumps was once a near-universal childhood illness. Though often dismissed as mild, it can cause sterility in men, meningitis, and permanent hearing loss. Outbreaks on college campuses, as recently as the 2000s, showed how quickly it can return when vaccination rates slip.

Rubella, also known as German measles, is mild in most children, but can be devastating during pregnancy. Congenital Rubella Syndrome, or CRS, caused waves of tragedy before the development of the vaccine: Thousands of babies each year were born blind, deaf, with heart defects, or with intellectual disabilities. In medical texts, autism itself is listed as one of CRS’ sequelae, or possible consequences — proof that rubella infection, not vaccination, can contribute to developmental disorders.

Measles, mumps, and rubella “are not trivial,” said Walt Orenstein, former head of the Centers for Disease Control and Prevention’s immunization program. “Fever, high fever, is common … and they have frequent complications.”

And yet, as these diseases fade from living memory, a counternarrative has gained traction. On Sept. 29, the nonprofit Physicians for Informed Consent, a group that disputes the scientific consensus on vaccines, announced it had mailed its “Silver Booklet” on vaccine safety to every member of Congress, as well as to President Donald Trump and Vice President JD Vance. The book claims that “vaccines are not proven to be safer than the diseases they intend to prevent,” and calls on federal leaders to punish states that restrict vaccine exemptions. (The booklet isn’t free. The group sells copies for $25 on Amazon.)

Scientists say this framing misrepresents the basic math of risk. “Measles is one of the most important infectious diseases in human history,” notes “Plotkin’s Vaccines,” the field’s authoritative textbook. “The widespread use of measles vaccines in the late 20th and early 21st centuries led to a further marked reduction in measles deaths. Measles vaccination averted an estimated 31.7 million deaths from 2000 to 2020.”

Kennedy’s possible move to expand the Vaccine Injury Compensation Program hinges on casting doubt — on suggesting that science is unsettled, that vaccines may be riskier than diseases.

“One tactic used to argue that vaccines cause autism is the use of compensation decisions from the National Vaccine Injury Compensation Program to claim such a link,” said Reiss of UC Law-San Francisco. “Even the cases that most closely address the question of vaccines and autism do not show the link that opponents claim exists, and many of the cases used are misrepresented and misused.”

Offit underscores the danger on the perception side. “When people see the Vaccine Injury Compensation program, they assume that any money that is given is because there was a vaccine injury,” he said.

Kathryn Edwards, an expert in pediatric infectious diseases and vaccine safety at Vanderbilt University, said, “Expanding compensation for issues that are not clearly related to vaccines … suggests that these conditions are related to vaccines when they are not.” She compared it to the removal of thimerosal, a preservative dropped from most childhood vaccines to ease public fears, despite no evidence of harm. “Now, we are still suffering from that action.”

Public health experts stress that such narratives invert reality. The very diseases being downplayed once killed or disabled tens of thousands of American children each year. As pediatrician, psychiatrist, and medical historian Howard Markel put it: “Back a hundred years ago, everybody lost a kid or knew a kid who died of one of these diseases. … We never conquer germs, we wrestle them to a draw. That’s the best we do. And so this is a real … handicap to the other side, the microbes who live to infect.”

Families and the Future

The hardest voices to reckon with are those of families. Parents of autistic children often feel abandoned — unsupported by disability programs, exhausted by care needs, searching for answers. Kennedy’s appeal to them is emotional, not scientific.

Reiss noted that families deserve far more support but argues that it shouldn’t come through VICP.

“The program is to award compensation to those injured by vaccines,” she said. “We should have more direct support — disability funding, disability aid. Kennedy has been taking HHS in the opposite direction, cutting services where we need more.”

Despres made the same point: “The goal of the program really was if there’s a close call, we’re going to err on the side of compensation. … And it’s really important that everyone understands that compensation does not mean that the vaccine actually caused the injury. … And I think we have seen statistics around the compensation program misused by those who would want to sow distrust in vaccines, to say vaccines are unsafe, when in fact … that’s not what this is.”

UCLA’s Lord urged a shift in focus. “For the last 50 years, science has focused on the biological causes of autism, which has led to great progress, especially in genetics,” she said. Of Secretary Kennedy, she said, “He could help more by acknowledging the value of science, but also the need to better attend to the actual lives of autistic people and their families.”

What Comes Next?

If Kennedy decides to move forward with such a plan, HHS would need to draft a rule, open it to public comment, and then defend the change in court. The pushback will be fierce: from scientists, from public health leaders, and from families who fear being misled yet again.

The debate over adding autism to the Vaccine Injury Table is not just a policy debate. The program was built on the principle of compensation without causation, a fragile balance designed to sustain both trust and supply. Adding autism could collapse that distinction entirely.

[KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.]

The post Inside the High-Stakes Battle Over Vaccine Injury Compensation, Autism, and Public Trust appeared first on Medika Life.

Medika Life has covered the halls of JPMorgan in San Francisco, ViVE in Nashville, and the Digital Health Summit in Boston. But the outreach received before BIO—from stakeholders in Austin, Belfast, Milan, Riyadh, and Tulsa—suggested something seismic was shifting. At BIO 2025, that story came into focus: a world where health innovation is no longer limited by geography but defined by vision, investment and intention.

The Biotechnology Innovation Organization isn’t just where technologies are launched and global biotech identities are shaped. What we witnessed in Boston this year wasn’t just presence, but purpose. From Riyadh to Milan, leaders arrived not merely to exhibit, but to engage. They came to say, ‘We are here. We are investing. We are innovating.’ BIO 2025 stood out for its sheer scale and energy—a mosaic of emerging voices ready to help steer the next wave of life science breakthroughs.

Global Trends: Infrastructure, Incentives and Inclusion Drive Expansion

A common thread across these rising biotech regions is the power of public-sector catalysts. Investment in R&D tax credits, translational research centers, and workforce training has de-risked innovation for early-stage companies. Regions like Oklahoma and Northern Ireland exemplify how government partnerships with academia and industry can create a vibrant life sciences pipeline.

In parallel, digital innovation is enabling smaller regions to leapfrog traditional limitations. AI-led discovery, digital twins, and virtual trial platforms are reducing costs and increasing speed-to-data. This convergence of science and software is helping new hubs like Austin and Riyadh accelerate globally competitive capabilities in diagnostics, personalized medicine, and regulatory science.

“We’re not competing with Boston—we’re complementing it,” said a delegate from Invest Northern Ireland. “In a connected world, biotech ecosystems aren’t isolated—they’re collaborative nodes on a global grid.”

Meanwhile, leaders from Italy’s Ministry for Foreign Affairs and Saudi Arabia’s SFDA emphasized the importance of regulatory agility. Their message was clear: modern biotech requires modern policy. Whether through centralized ethics boards, digital review platforms, or alignment with international standards, regulatory transformation is essential to scale innovation.

These developments signal a broader inflection point—biotech is no longer about place. It’s about purpose, policy, and partnerships.

Austin: Where Tech Meets Translational Medicine

Austin is no longer just the city of live music and digital startups. With more than 300 life science companies and a 74% employment boom in biotech over the past five years, it’s transforming into a powerhouse of translational medicine.

Heavyweights like Thermo Fisher, Natera, and Luminex now call Austin home, joined by trailblazers such as Paradromics, Elligo Health Research, and Prophase Biostudios. These companies blend biotech, medtech, and AI in ways that are shaping the next frontier in diagnostics, therapeutics, and digital health.

“As one of the country’s fastest-growing emerging life sciences hubs, the Austin region is responsible for a significant portion of the biotechnology sector’s growth in Texas,” said Ed Latson, CEO of Opportunity Austin. “Our tech talent, VC ecosystem, and institutions like UT Austin are driving an uptick in innovations, with over 350 life science patents issued to Austin companies in the past five years.”

Austin’s 4.4 million square feet of science innovation space—plus another 1.1 million square feet under construction—signals that this rise is more than momentum. It’s movement.

Italy: From Scientific Legacy to Global Scale

Italy’s BIO 2025 pavilion was both a showcase and a statement: this country is stepping into biotech leadership. Long known for its academic excellence, Italy is now connecting its research infrastructure to industrial manufacturing and global markets.

With 770 production sites and the largest Contract Development and Manufacturing Organization output in Europe (€3.6B), Italy is scaling up innovation across oncology, AI diagnostics, and organ-on-chip development. Companies like BiomimX, Math Biology, Genenta Science, and InSilicoTrials are bridging cutting-edge science with clinical utility.

“Italy’s presence at BIO Boston reflects years of work by the Italian Trade Agency to promote an integrated system of scientific expertise, high-tech supply chains, and a talent-rich ecosystem,” shared Erica Di Giovancarlo, Director of the ITA New York Office.

Initiatives like the Montalcini Global Biotech Tour and policy instruments from the Ministry for Foreign Affairs support this ambition.

“Pharma is one of Italy’s top global exports,” noted Mauro Battocchi, Director General. “That would be unthinkable without a strong base in R&D, regulation, and manufacturing.”

Northern Ireland: Precision Science with Global Reach

With 250+ companies and $2.5 billion in revenue, Northern Ireland’s life sciences sector has grown 75% in just three years. The delegation to BIO was led by Invest Northern Ireland and featured companies from drug discovery (AMPLY), CRO services (Almac, Celerion), and diagnostics (Randox).

Queen’s University Belfast and Ulster University deeply anchored the region’s ecosystem. Global companies are noting that Celerion recently relocated its UK Phase I operations to Belfast’s new iREACH facility, betting on local talent and translational research capacity.

From scientific rigor to export capability—145+ countries and counting—Northern Ireland proves that locale doesn’t limit global vision.

Oklahoma: Equity-Focused Innovation with Local Roots

Oklahoma’s biotech renaissance is rooted in intentionality—it is focused on equity, local workforce development, and community-based innovation. Biosciences now contributes more than $16 billion to the state’s economic impact, with more than 750 companies and 42,000 jobs.

The Oklahoma delegation at BIO emphasized sustainability, manufacturing, and health equity, with standout organizations including Wheeler Bio, BioTC, ParaNano, and Utopia Plastix.

“We’re not here to be a branch office,” one delegate told me. “We’re here to bring Oklahoma’s soul to the bioscience table.”

With significant support from the Oklahoma Center for the Advancement of Science & Technology (OCAST), OKBioStart, and the University of Oklahoma, this state is redefining what it means to be an innovation hub.

Saudi Arabia: A New Powerhouse for Biotech Partnerships

Saudi Arabia came to BIO with a clear strategy and global ambitions. Led by His Excellency Prof. Dr. Hisham Saad Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), the Kingdom made its voice heard across two key sessions.

At “Global Biotechnology at a Crossroads,” Dr. Aljadhey discussed Saudi Arabia’s modernization of clinical trials and regulatory frameworks, aligning with international standards. At “Partnering for Progress,” he showcased the Kingdom’s integrated biotech ecosystem, spanning R&D, data, manufacturing, and patient care.

Beyond BIO, the SFDA delegation engaged with Harvard University and global pharmaceutical leaders and joined a private sector roundtable hosted by BIO and the U.S. Chamber of Commerce. These engagements reflect Saudi Arabia’s commitment to cross-border collaboration, secure supply chains, and sustainable innovation infrastructure.

With leaders from the Saudi Ministry of Health, King Faisal Specialist Hospital, and the National Institute of Health also in attendance, the message was clear: Saudi Arabia is ready to be a regional biotech hub with global reach.

The New Map of Global Innovation

This isn’t just a reshuffling of zip codes. It’s a redrawing of the innovation map—pushed forward by ecosystems committed to inclusion, science, sustainability, and scale.

These five rising regions aren’t simply showing up. They’re standing up—challenging legacy thinking, collapsing silos, and reminding the world that leadership in life sciences doesn’t require a familiar address. It requires ambition, alignment, and action.

At BIO 2025, the message was unmistakable: where you innovate matters less than why you innovate—and for whom.

From Austin’s AI-powered translational medicine to Saudi Arabia’s regulatory reinvention, the next wave of breakthroughs will be shaped not by old borders but bold commitments.

Expectations are high. Patients in Milan and Muskogee, Belfast and Boston, Riyadh and Rochester are not waiting for innovation to trickle down. They are looking globally—for the fastest path to solutions that sustain and save lives.

The future of biotech is already in motion. It’s inclusive. It’s intentional. And it’s unstoppable.

The post BIO – Biotech Without Borders  appeared first on Medika Life.

When I asked him what sparked joy — my now-standard question for new consults — he didn’t hesitate.

“Travel,” he said, his eyes lighting up. “Dozens of countries. I love learning how people live, eat, think.”

Then he paused. “But if I had to choose just one?”

He leaned forward, almost conspiratorially.

“Japan. Lived there over 25 years.”

I perked up. “Hontō ni?”

“Eh? Hontō hontō!” he beamed.

And just like that, the oncology suite turned into an izakaya.

We chatted in Japanese for several minutes — I, a Black man from the Pacific Northwest with a Japanese wife and a daughter who had attended college in Kyoto; he, a white man with a surprising Tokyo accent and stories that could have filled a dozen ryokans.

The nurses outside the curtain must’ve been baffled.

There we were: two middle-aged men, dressed like surgical extras, speaking rapid-fire Japanese about onsen, natto, and konbini snacks.

In radiation oncology, these are the moments you don’t forget.

The Kind of Joy You Can’t Buy

When our conversation drifted back to English, we kept circling the same theme: experience.

He told me about sleeping in the Sinai desert under a blanket of stars.

About sipping strong coffee in Addis Ababa.

About riding motorcycles through Southeast Asia before Google Maps existed.

What he didn’t talk about were things.

No fancy watches.

No new Teslas.

No gadgets.

Just the texture of moments lived.

And it hit me: the joy that lit up his face wasn’t the kind you get from opening a box.

It was the kind you earn by stepping into the unfamiliar. The kind that asks something of you — and gives back more than it takes.

The Science of Why It Feels So Good

We tend to think happiness is about comfort.

But psychologists like Dr. Laurie Santos (of Yale’s wildly popular Science of Well-Being class) suggest that the happiest people spend less on stuff and more on experiences.

Why?

Because of experiences:

• Give us stories we can retell
• Bring us into contact with others
• They are often tied to personal growth
• Don’t lose their sparkle the way objects do

A new phone gets old fast. But your first tuk-tuk ride in Bangkok? That stays with you.

There’s even a term for the trap we fall into with material things: hedonic adaptation.

The idea is that we quickly get used to new pleasures.

The house, the car, the clothes — they stop thrilling us.

But experiences?

They stay vivid.

I wrote about a similar theme in 10 Tiny Habits That Make You Healthier, Calmer, and Harder to Kill — the idea that intentional living creates lasting joy, not just fleeting dopamine hits.

My Favorite Journeys

Some of my favorite travel memories come from places that required a little more effort than, say, Paris or London.

• Egypt: navigating the frenetic, poetic chaos of Cairo traffic, then standing in stillness before the pyramids.
• Turkey: sipping tea in the shadow of the Blue Mosque, hearing the call to prayer echo across centuries.
• Japan: of course — always Japan — with its contradictions, its grace, its reverence for detail.
• Indonesia: maybe my favorite of all, where time moves differently and kindness is a national trait.

These places didn’t just offer a change of scenery. They offered a shift in me — the way I saw others, the way I understood culture, the way I experienced time.

What Travel (and Cancer) Teaches Us

My patient and I shared one more truth that day: that illness, like travel, strips you down to what matters.

It makes you see the world in a different light.

It humbles you.

And if you let it, it can open you.

Sometimes I think the best journeys aren’t measured in miles, but in mindset.

You don’t have to get on a plane.

You just have to notice something new.

Final Thoughts

That day in the exam room, two men with nothing in common on paper laughed like old friends, because we shared a language — and not just Japanese.

We shared curiosity.

And in that moment, amid machines and masks and schedules, we were both simply human.

Let the numbers tell the story.

• Free Download: “Debunked: 7 Health ‘Facts’ That Are Quietly Hurting You — Grab It Here.”
• Liked this story? Read “25 Ways to Reduce Your Cancer Risk” or “What Dying Men Confessed When No One Was Listening.”

Author bio: Michael Hunter, MD, is a cancer doctor, travel junkie, and collector of patient wisdom. His new ebook, What Dying Patients Taught Me About Living, is available here.

P.S. If this story resonated with you, follow me for weekly insights from the clinic and beyond.

The post Clinic Notes: I Didn’t Expect to Speak Japanese Today appeared first on Medika Life.

After cardiac surgery, patients are at risk for both high and low blood sugar, which can lead to serious complications. Managing these fluctuations requires careful insulin dosing, but existing protocols often fall short due to the unpredictable nature of ICU care and differences among patients, say the investigators. 

To address this challenge, the research team created a reinforcement learning model, named GLUCOSE, that recommends insulin doses tailored to each patient’s needs. In tests using data from real-world ICU cases, GLUCOSE matched or even outperformed experienced clinicians in keeping blood sugar levels within a safe range—despite having access to only current patient data, while doctors used full patient histories. 

“Our study shows that artificial intelligence can be thoughtfully and responsibly developed to support, rather than replace, the clinical judgment of health care professionals,” says co-senior corresponding author Ankit Sakhuja, MBBS, MS, Associate Professor of Medicine (Data-Driven and Digital Medicine) and a member of the Institute for Critical Care Medicine at the Icahn School of Medicine at Mount Sinai. “In complex and high-pressure environments like the ICU, tools like GLUCOSE can provide real-time data-driven guidance tailored to individual patients. This kind of decision support can enhance safety, reduce the risk of complications, and ultimately allow clinicians to focus more of their attention on critical aspects of patient care.” 

The research team trained GLUCOSE using reinforcement learning, which allowed the system to learn optimal decisions through trial and error. They also used advanced methods—conservative and distributional reinforcement learning—to ensure the model made cautious, reliable recommendations. The model was then rigorously evaluated and compared to real-world clinical practices. 

While the results are promising, the researchers caution that GLUCOSE is not intended to replace doctors. It serves as a clinical decision support tool, offering suggestions that physicians can choose to follow based on their judgment and the broader clinical picture. 

The model could eventually be integrated into electronic health record systems to provide real-time insulin dosing guidance in the ICU, helping reduce complications and improve outcomes. Future steps include adapting the tool for use in other hospital settings, running clinical trials, and exploring ways to integrate it into routine care. 

One current limitation is that the model does not yet factor in nutrition data, which may affect longer-term glucose control. Still, the ability of GLUCOSE to make accurate recommendations based on limited real-time data highlights its potential to enhance safety and efficiency in postsurgical care. 

“Our goal is to develop AI systems that meaningfully augment the capabilities of health care providers and ultimately improve patient outcomes,” says co-senior corresponding author Girish N. Nadkarni, MD, MPH, Chair of the Windreich Department of Artificial Intelligence and Human Health, Director of the Hasso Plattner Institute for Digital Health, and Irene and Dr. Arthur M. Fishberg Professor of Medicine at the Icahn School of Medicine at Mount Sinai, and Chief AI Officer of the Mount Sinai Health System. “By learning from real-world clinical data and delivering personalized recommendations in real time, models like GLUCOSE represent an important advance toward integrating trustworthy data-driven tools into the clinical workflow. This study offers a glimpse of how AI can be thoughtfully embedded into care to support providers in delivering safer, more precise treatment.” 

The paper is titled “A Distributional Reinforcement Learning Model for Optimal Glucose Control After Cardiac Surgery.” 

The study’s authors, as listed in the journal, are Jacob M. Desman, Zhang-Wei Hong, Moein Sabounchi, Ashwin S. Sawant, Jaskirat Gill, Ana C. Costa, Gagan Kumar, Rajeev Sharma, Arpeta Gupta, Paul McCarthy, Veena Nandwani, Doug Powell, Alexandra Carideo, Donnie Goodwin, Sanam Ahmed, Umesh Gidwani, Matthew A. Levin, Robin Varghese, Farzan Filsoufi, Robert Freeman, Avniel Shetreat-Klein, Alexander W. Charney, Ira Hofer, Lili Chan, David Reich, Patricia Kovatch, Roopa Kohli-Seth, Monica Kraft, Pulkit Agrawal, John A. Kellum, Girish N. Nadkarni, and Ankit Sakhuja. 

The study was funded, in part, by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health grant 5K08DK131286, and by the Clinical and Translational Science Awards (CTSA) grant UL1TR004419 from the National Center for Advancing Translational Sciences. Research reported in this publication was also supported by the Office of Research Infrastructure of the National Institutes of Health under award numbers S10OD026880 and S10OD030463.  

See the journal paper for conflicts of interest: https://www.nature.com/articles/s41746-025-01709-9. 

About Mount Sinai’s Windreich Department of AI and Human Health   

Led by Girish N. Nadkarni, MD, MPH—an international authority on the safe, effective, and ethical use of AI in health care—Mount Sinai’s Windreich Department of AI and Human Health is the first of its kind at a U.S. medical school, pioneering transformative advancements at the intersection of artificial intelligence and human health.  

The Department is committed to leveraging AI in a responsible, effective, ethical, and safe manner to transform research, clinical care, education, and operations. By bringing together world-class AI expertise, cutting-edge infrastructure, and unparalleled computational power, the department is advancing breakthroughs in multi-scale, multimodal data integration while streamlining pathways for rapid testing and translation into practice.  

The Department benefits from dynamic collaborations across Mount Sinai, including with the Hasso Plattner Institute for Digital Health at Mount Sinai—a partnership between the Hasso Plattner Institute for Digital Engineering in Potsdam, Germany, and the Mount Sinai Health System—which complements its mission by advancing data-driven approaches to improve patient care and health outcomes.  

At the heart of this innovation is the renowned Icahn School of Medicine at Mount Sinai, which serves as a central hub for learning and collaboration. This unique integration enables dynamic partnerships across institutes, academic departments, hospitals, and outpatient centers, driving progress in disease prevention, improving treatments for complex illnesses, and elevating quality of life on a global scale.  

In 2024, the Department’s innovative NutriScan AI application, developed by the Mount Sinai Health System Clinical Data Science team in partnership with Department faculty, earned Mount Sinai Health System the prestigious Hearst Health Prize. NutriScan is designed to facilitate faster identification and treatment of malnutrition in hospitalized patients. This machine learning tool improves malnutrition diagnosis rates and resource utilization, demonstrating the impactful application of AI in health care.  

For more information on Mount Sinai’s Windreich Department of AI and Human Health, visit: ai.mssm.edu  

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“The fault, dear Brutus, is not in our stars, but in ourselves…”
— William Shakespeare, Julius Caesar.

That quote haunted me for years, long before I ever held a linear accelerator’s joystick or delivered radiation to a tumor curled around someone’s spine.

Back then, I didn’t fully grasp its relevance to my work.

Now, after decades in oncology, I see it with stark clarity.

Because here’s the truth:

Up to 42% of cancers are preventable — not through miracle drugs or genetic luck, but through modifiable, everyday choices.

This observation isn’t about blame.

It’s about power.

And it’s time we stopped whispering about it.

Even through the fog of risk, we can walk toward healing. 42% of cancers are preventable, and every step counts.

🔁 Why Cancer Isn’t Just Bad Luck: The Myth of Randomness

When patients hear “cancer,” the next question is often whispered:

Did I cause this?

It’s a painful, complicated moment.

I always remind them: no one deserves this, and no one gets cancer from one bad meal or missed screening.

But I also tell them we know that cancer is not a lightning strike.

Yes, some cancers come from sheer genetic chaos.

But others arise from a slow, silent drift, shaped by inflammation, environment, and habit.

🔁 Inflammation and Obesity: The Hidden Cancer Risks

You don’t see inflammation in the mirror. But it shapes your fate.

Low-grade, chronic inflammation — often fueled by excess fat, poor diet, poor sleep, and stress — is a known contributor to several cancers, including colorectal, breast, and liver.

Chronic inflammation in the etiology of disease across the life span – Nature Medicine

www.nature.com

We once thought of obesity as a cosmetic issue. Now we understand it as a biological amplifier of cancer risk:

• Fat cells release cytokines and estrogen-like compounds
• These can trigger DNA damage and tumor-promoting environments

I’m not judging anyone’s weight. I’m inviting a deeper understanding of how the body works — and how we can gently steer it.

Diseases desperate grown,
By desperate appliance are relieved,
Or not at all.”
— Shakespeare, Hamlet.

Sometimes, small daily shifts are our most potent medicine.

🔁 How Alcohol, Smoking & Diet Tip the Scales

If you asked me what four lifestyle changes would make the biggest impact on global cancer rates, I’d say this:

1. Stop smoking
2. Drink less alcohol
3. Eat more plants and fewer processed foods
4. Move

🥃 Alcohol

Alcohol is a group 1 carcinogen, the same class as tobacco and asbestos.³

It increases the risk for at least seven cancers, including breast and colorectal.

And even “moderate” drinking has risks, especially for those with other risk factors.

No level of alcohol consumption is safe for our health

. www.who.int. int.

🍽️ Diet

Ultra-processed foods cause inflammation, metabolic dysfunction, and now, higher cancer risk.

A 2023 study in The Lancet tied them to a 29% increased risk of colorectal cancer.⁴

It’s not about moral purity. It’s about stacking the odds in your favor.

Prevention Isn’t Perfection. It’s Daily Poetry.

When I talk to patients, I don’t hand them guilt. I hand them a possibility.

• A walk after dinner to quiet insulin spikes
• A decision to swap soda for tea
• A full night of sleep instead of doomscrolling

These things may seem small, but they are acts of devotion, not just to the body, but to the life it still wants.

Though this be madness, yet there is method in’t.”
— Hamlet.

Health is not about perfection. It’s about rhythm.

About small, quiet methods repeated until they shape destiny.

The Truth I Wish More People Knew

When people find out I’m a cancer doctor, they usually ask about treatments.

But the conversation I wish we had more often is this:

What can I do now, before the diagnosis, to change the story?

The answer isn’t sexy. It’s not a pill or a breakthrough headline.

It’s this:

Cancer isn’t always random. And your choices — however small — are not meaningless.

You deserve to know that.

A Gentle Invitation

I don’t write this to scare you.

I write it because knowledge is power, and silence is not protection.

Here’s the truth:

• Cancer is common.
• Up to 42% is preventable.
• That prevention is made of ordinary acts repeated with quiet courage.

What’s one habit you’ve changed for your long-term health? I’d love to hear.

The post Cancer Isn’t Random: What 42% of Diagnoses Have in Common — and How You Can Lower Your Risk. appeared first on Medika Life.

In this exclusive conversation, I join Hal Wolf, President and CEO of HIMSS, to explore HIMSS’s evolving role in fostering collaboration between hospitals, startups, and policymakers. With the health-ecosystem landscape tracking the early days of a new administration, uncertainties remain—ranging from regulatory shifts to funding allocations. Yet, as Wolf underscores, HIMSS remains steadfast in advancing health equity, supporting digital transformation, and offering actionable strategies that improve care delivery.

This conversation occurs between ViVE in Nashville and HIMSS in Las Vegas—two health gatherings that bring innovators, policymakers, and industry leaders together. While ViVE spotlights digital health startups, investment trends, and edgy sparks, HIMSS serves as the broader convening ground for professionals shaping the future of health information and technology. HIMSS is where the work happens—the “Davos” of health information.

Wolf outlines key issues such as integrating artificial intelligence in hospital systems, the role of primary care in driving better patient outcomes, and how organizations must balance innovation with financial realities. At HIMSS, essential dialogue between established institutions and emerging disruptors has never been more crucial.

Join us as we delve into the forces shaping the health system’s future—where technology, policy, and leadership converge to improve patient outcomes and system-wide efficiency.

Medika Life Editor Gil Bashe: In examining hospital systems, we focus on how information flows within our industry and who has access to it. We still have a lot to learn. These are the first few weeks of the new administration, and we don’t know how things will unfold, how the Senate Committees will approach these discussions, or how actions will be implemented. Will we rely on Executive Orders? If that’s the case, we know where to focus our attention. You’re a remarkable ambassador for the discipline and the sector, and certainly for HIMSS, a professional association, trade association, and global NGO.

People come to HIMSS with tremendous optimism, hoping to gain insights that will make them more effective. I prefer to focus on current developments and HIMSS priorities rather than just reacting to them; that’s a different conversation. I’ll also note that the administration’s conversation around health access, cost, and priorities is still in motion.

HIMSS CEO Hal Wolf: We don’t know enough to discuss new policies and their potential outcomes. One challenge will be securing funding. While we know things will be different, we don’t know where the policies will land. Still, we know that HIMSS is dedicated to its vision and mission statements as they fundamentally relate to realizing the full health potential of every human everywhere.

We are dedicated to health equity and will stay dedicated to it. Our collaboration with governments and NGOs worldwide and our fundamental principles will not change, nor should they! We’ll work with our principles within the context of whatever comes out of the White House.

We worked well with the previous Trump administration and collaborated effectively with ONC and HHS on various initiatives. We look forward to advancing the HIMSS mission within the established parameters.

Bashe: HIMSS is far more than an annual mammoth gathering; it’s a professional society that covers the full spectrum of health information and technology – from cybersecurity to economics to professional development and government policies. Unlike other popular meetings that primarily focus on networking, HIMSS is where professionals from around the globe come to set objectives, strategies, and operational priorities. It’s 30,000 feet and 3,000 in scope.

Wolf: This morning at 6:00 a.m., I had an interesting conversation with the CEO of a successful start-up that is getting distribution now and beginning to roll. At HIMSS, we see the merging of different worlds.

We have our core population, core members of the health ecosystem– hospitals, clinics, health operations, nurse practitioners, CMIOS, CIOS, physician leaders, and administrators. This group represents a significant portion of the HIMSS membership, which includes over 120,000 members.  

On the other hand, we have the entire global app ecosystem that drives innovation and introduces new ideas. As you know, many of these ideas and innovations are driven by personal experiences. A family member encountered a situation, and they tried to solve it. Or have worked in the industry, identified a gap, and pursued it.

They often have a long list of improvements to address, and, often, they aren’t performing well financially. Their reimbursement processes are a little murky, and this uncertainty might increase in 2025.

How much time do they have to integrate innovations that don’t directly impact their outcomes, quality, access or bottom line? Because everything’s being looked at in that piece.

We need to understand that the situation changes as the market evolves. What is the critical point where innovation intersects with standard operating procedures, and what does it look like? How can information from one area influence the other? We must determine how to identify the good and the bad and how to present them to the market.

What happens at the global conference? What happens in chapter meetings? What happens in the papers that are submitted? What happens in the insights? Much of this depends on how these elements connect.

Bashe: Many diverse health information communities come together yearly at HIMSS. You have consistently made this gathering relevant. This year, a new startup section called Emerge addresses a critical need within the HIMSS community. You just started with the story about a startup enterprise. Could you share some important and innovative aspects that will be highlighted at this year’s gathering?

Wolf: That’s a pressing question, so I’ll divide it into multiple parts because it’s challenging.

We’re part of the industry, so let’s return to your original premises to find the answer. You mentioned “competing,” which refers to people competing against each other. However, you also have specific points of interest to consider.

The benefit engine can determine how much money you’ll receive in reimbursement for a particular service. However, if you’re on the insurance or payer side, the configuration may depend on whether it’s for North America or a Ministry of Health. Here, the goal is to anticipate the costs incurred in treating a patient. This perspective aligns with an actuarial professional trying to understand and guide the process forward.

I’ve observed hospital systems are starting to integrate AI functionalities, but currently, only 5 to 7% are using it effectively, from an operational standpoint,

For example, when someone walks to the front desk and says their right arm is hurting, the staff collects the information by typing it into a form. They ask a couple of questions, such as “Who’s your primary care doctor? Who’s your insurance company? Are you on managed care? Is this new? What other ailments do you have? What other prescriptions do you have?” They must ask those questions if they don’t have that information readily available. That data feeds into new algorithms on the AI side.

In the background, AI analyzes the information and makes predictive models about how long this person would be in the hospital, what resources they will consume, and how much revenue it will generate. It’s occurring in the background, without the front desk staff being aware of AI’s calculations; meanwhile, the administrator is beginning to recognize the impact of these advancements. The inbound process begins with appropriate testing, questioning, and, if necessary, into a bed.

Meanwhile, the hospital administrator or the system managing the situation assesses the resources the patient will need, whether they will need a specialist and whether the specialist will be available when needed. By the time an exam takes place, they can inform the patient about what to expect in the next 24 to 48 hours, whether they will be staying at the hospital or going home. This preparation and communication represent the positive aspects of the process.  

The dark side is that the hospital engine in the background might say, “We’re not going to get a lot of money out of this. This is not a good use of our beds/time. If we maximize profits, we should send this person on and see what the next person will bring because our algorithm told us that five people would come in with congestive heart failure, and we do make money on that.”

The person writing this down may never realize what is happening; they won’t know that the system will indicate that the hospital is full, even though there might be capacity. Instead, they will tell the person to go down the street to Acme Community Hospital, which can take care of them, explaining that their system lacks resources. That is a dark coin flip to what could happen.

Bashe: Many hospital networks are acquiring primary care practices as feeder systems in their facilities. For example, if a patient is told, “You need to do a cardiac stress test. Do you have a cardiologist?” and they respond with “No?” the primary care provider can then say, “Why don’t you let me arrange that for you.” The primary care satellite site is closing the loop on a fragmented system. While the hospital system benefits economically from the service, patients benefit, and the primary care satellite site serves as a conduit for care.

I’m always thinking about the benefits of technology in enhancing the hospital and primary care systems. Imagine a doctor saying, “You know, you’ll have many questions. I will be here to help you frame your thinking around those questions. Our system has an LLM model. Let’s call it Dr. Hal. You can ask Dr. Hal every question regarding your congestive heart failure or prostate cancer. Dr. Hal is the composite wisdom of all the experts in our system and is here to address your questions.”

The creative aspect of our discipline, combined with information, is becoming a superpower. We use data to guide our supply chain resourcing and leverage information to promptly provide patients with confidence and comfort. We ensure greater access to accurate information vetted by the system, so patients do not depend solely on Dr. Google.

Wolf: The actual value of AI is knowledge management. It allows a very broad and capable synthesis of vast amounts of data and information that no human can keep up with. For example, in the 1970s, clinicians had access to three to four journals, where editors picked what was important enough to be published. These journals had to be printed and mailed out, resulting in about 400 peer-reviewed articles per year reaching healthcare professionals. If you read one a day, you could keep up. Today, more than 10,000 articles will be published this year alone. All that information, knowledge management, and sharing will occur collaboratively, and there is no way for anyone to synthesize all that.

AI plays a crucial role in operational and clinical decision support by turning information into knowledge, with recommendations that lead to changes in operations, suggestions, and care.

In clinical care, pharmacy, or whatever path you’re on, these recommendations are communicated back to physicians with an explanation of why they are a recommendation and the source of that information.

I think part of the maturity that we’re seeing, and you’ll see at HIMSS 2025, is the evolution of AI since our session three years ago. Back then, we held a session titled, “What is AI, and what does it mean?” The panel discussed its potential application in healthcare, and at that time, chat had just been introduced, and people were starting to look at it. Some people were on stage calling for a six-month hiatus before we allowed anything to go forward.

Last year, we saw glimpses of initial uses of AI being deployed operationally, albeit only in a few hospital systems. But it was beginning to happen, and we knew that AI was in the background of devices or operational considerations. Where would the benefit engines come from? The algorithms were starting to be built, and we had a particular point of looking out for biases. We started talking about biases within AI and realized that no matter what you do, there will always be some biases. It’s unavoidable. What was the source information for AI, and how do I ensure I utilize it to the best of my ability?

You’ll see the presentation of how people are using it on a scale. What are examples of its success, and what are some of its limitations? Numerous applications are set to emerge. You’re going to see them on the floor, where people are using components of AI in the background to produce better products that are more efficient and can guide operations as well as at-home care, and all those pieces are being brought forward. The common link between it and your point is on the information side of the house. How good is the starting information, and how broad does it go? Where is the opportunity from a linking standpoint?

To achieve this, a private-public partnership is essential. If you’re looking at algorithms and information that utilize global data that gets turned into global information, it has an impact. Most healthcare systems around the globe are publicly held. They’re not privately held. The United States is an aberration due to its vast amounts of privately held institutions versus publicly held ones.

Bashe:  Are you seeing more of that regarding the technology being used proactively?

Wolf: Yes, and that’s a good thing. We’ve always wanted to see that proper reimbursement takes place and proper services rendered. Many things in a system can get missed, but not an overwhelming amount.  If hospital systems perform well, they typically operate on a 2 percent to three percent margin, but many run at a loss, making proper reimbursements difficult. Large actuarial departments played a key role in the past, with various organizations providing revenue support, which was a huge thing even 15 years ago. However, over time, those efforts began to converge.

The real opportunity lies beneath the surface. It must coincide with an understanding of the care that was delivered. Right next to that benefit realization is the value proposition. What was the quality of what was rendered? Was the care appropriately given? Did we miss something in the diagnosis?

Bashe: One of the things that I worry about is not New York City or Los Angeles. Medical centers such as Mount Sinai, NYU Langone, Weil-Cornell, Columbia Presbyterian, and Memorial Sloan Kettering, much like their counterparts in Boston, Chicago, and the Bay area, provide excellent care. However, in rural America, someone can live three hours from a tertiary care center.

Your approach of using information to improve the care of almost 29 percent of the US population applies, I think, to other nations where people live far from centers of excellence. What are your thoughts about devices, wearables, remote patient monitoring and information, and protecting the information from your standpoint?

Wolf:  Wearables and home monitoring have transformed patient engagement, making health data more immediate and actionable. It’s fascinating. My wife and I compare our Oura daily. How did you sleep? How’s your heart rhythm? We’re finding the features and working through them. She lives anonymously. We are very engaged in our health. How far did we walk? What was our heart rate? Let’s do the 6-minute walk today and see. Were you snoring last night?

All of that is going on, and that’s an engagement level. The information flows from me to my ring, and then my ring says, do you want to share it with Apple? I said yes, and my wife said no; she didn’t want it to flow to another company. Apple will know how well I sleep – I don’t worry about it. If they want to dive into it, there is a profile about me and my general health. They could also derive that from the stuff I buy and the credit card information. That’s always been the case.

If you remember, back in the 1980s, we were already using demographic data with Donnelly overlays. I worked for Time Warner in the early 1990s when Time magazines were delivered to your door. The Time magazine that arrived at your next-door neighbor was different from yours—not the content, but the cover and the ads in the back. You may have gotten an ad for a sports car, and your neighbor may have gotten one for a minivan.

It was specifically designed based on the Donnelly reports, which provided insights about the household. We’re starting to shape recommendations at the personal level of the care an individual should receive.

Why wouldn’t a physician or a clinician want every piece of information on this Oura ring to be included in a patient’s profile? This information would help complete the picture needed to utilize sophisticated knowledge management systems, tapping into tens of thousands of research papers and combining that data with the person’s unique health details. The richer that information becomes, the more accurate it becomes, the more mistakes it makes, the more positively it helps the next person.

Bashe: Often, when I speak to doctors and nurses in the health system, we talk about the Electronic Medical Record (EMR). They’re candid: “We have an EMR system—it’s not perfect, we know that, and it’s getting better and better.” Yet, they often say, “Did you read that patient’s EMR data?” and then they’ll say, “I don’t have time to read the EMR.” While best practices come from committees, you play a unique role as an advisor to corporations. You’re the sounding board for major corporations, whether AWS, Epic, Microsoft, or Oracle. I’m sure they will listen to you because you’re the voice of the global community.

Wolf: We don’t have a dog in the race against them as a competitor.

Bashe: As a not-for-profit society that operates at a global NGO level, when you look at your role and the challenges you face, how does HIMSS address constant sector transformation? HIMSS and its members are constantly evolving because you represent applied information. The system is getting more interesting and more creative.

Look at the challenges that HIMSS owns and represents and your mission, which is obviously to improve access to care. As the organization’s leader, you’re clear and committed to this role, but you’ve seen difficulties implementing cultural or systemic changes.

What’s your guidance for the community? Please don’t take out a ruler and slap people on their hands. You’re obviously about supporting the system’s evolution, making it better. Can you share insights on how you’re filtering down best practices within this evolving landscape? How do you reflect on these challenges that arise and guide systems to understand that care is delivered to the front lines and is not always in hospitals? It’s specialists or primary care—physicians in their little offices worldwide.

Wolf: This is precisely what we discuss daily at HIMSS, and it’s central to our global work. Let’s walk through our view of the ecosystem and how we influence what you just related to because it’s our core.

Hospital systems – or, more importantly, governments worldwide – including our own, recognize their fundamental responsibility to care for their populations. Let’s set the United States aside for a second.

Ministries of Health in countries around the world are accountable for the well-being of their citizens. We’ll talk about citizens for a minute. The people living within their country want a healthy population, which improves the economy. They’re smart enough to know that a healthier population, or one cared for, efficiently reduces the constant increase in costs within healthcare systems. No one is looking to save money; instead, the goal is to slow the escalating costs of healthcare systems, which seem to rise every year.  

Information is the driver behind everything, but to your point, the combination of people, processes, and technology shapes the outcome. Technology is rarely an issue here; the challenge lies in implementing and changing culture. The pandemic forced a significant global cultural change, and while it may seem that it’s deeply in our rear-view mirror, its impact is still felt. Telemedicine, the idea of using information, and the idea of remote care to alleviate the pressures on the front line became a standard feature, and people recognize that.

We see the impact in our relationships with organizations like the WHO in Europe. Take Romania, for example, where we just signed an agreement to help them develop a strategic plan to deliver digital health transformation. HIMSS is focused on four major points.

1. First is digital health transformation.
2. Second is the deployment and utilization of AI as a tool.
3. Third is cyber security to protect that information and ensure that it works for the betterment of their ecosystem with less hassle.
4. Fourth is workforce development, which trains people to understand these tools before they can utilize them to their fullest extent.

Those are our four main areas. When we think about digital health transformation, we start with the HIMSS maturity models from five to seven years ago.

Back then, our maturity models were a checklist of technology. Do you have that technology? Are you wired? That used to be the baseline, what we now consider table stakes. It’s not table stakes anymore.

We’ve transformed our maturity models to reflect quality, access, correctness, and fundamental value. How are you using the information? How does it improve the flow?

From an IT standpoint, we began looking at our maturity models like a stack. It starts with the information layer. What does the infrastructure look like? How is it laid out? How does your data need to be laid out? Where does the electronic medical record go on top of that? How do those two pieces feed into each other? How do you utilize the radiology and the pictures that are in there? How does that flow? What’s your analytical layer? How does this work?

Where are you getting your information, and how are you handling your analytics? How does that tie itself back into the infrastructure? How does that information flow from your reporting back into your EMR and the data layer? How does that data layer tie in when discussing the imaging ecosystem? What’s your continuity of care, the CCMM? How does it flow across the board to ensure you’re not dropping a patient?

We’ve created a stack of maturity models that form the foundation of how information flows from the patient across hospitals, clinics, and homes, wherever the case is provided, to ensure you can keep up with them. And we present these maturity models not just as a technology checklist. Anyone can do that—it’s not meaningless—but anyone can do that. The true focus is on how you use these technologies.

How do you ensure that the relationship between the patient and pharmacy utilization, as well as the benefit realization, is maintained? And how does all this tie together?

Whether it’s community service, a hospital system, or a home, what we’ve created in those stacks is a blueprint that any hospital system, country, or large-scale region can use to identify the technology needed and deploy it for its maximum benefit. 

People do assessments in hospital systems. For HIMSS members in the United States, these assessments are part of the membership, allowing them unlimited access to evaluate their systems. They can conduct these assessments online, check their status, and aim for levels 6 and 7, which is when all those benefits kick in. That’s when we do our validations.

We also do white papers, thought leadership, and HIMSS events, panels and educational programs. More than 300 academic programs are coming up at HIMSS in 2025, with more than 150 offering CE credits.

But these experiences are all based on the output, what worked, and what didn’t work. As you know, learning from others’ mistakes is just as valuable as learning from their successes. Some of the most impactful lessons come from those who try something, fail, and then fix it.

That’s where HIMSS and advisory services come in. We’re presenting the aggregated global knowledge of what’s working and what isn’t.

Most ecosystems don’t work the same way the United States does because most don’t have the same amount of money invested in it. We draw from many healthcare systems- from the U.S., to Romania, Italy, Germany, Singapore, Indonesia, Malaysia and Australia. We learn from all these countries, bring it together in our membership, and figure out what we have learned. How does it impact the models? We do these reviews in a constant session. That’s how we make the society work.

Bashe: It’s a brilliant use of human capital and composite wisdom. As we’re gearing toward the end of our conversation, I wanted to ask you about the Emerge Innovation Experience– this is a first-time gathering, but the concept of start-ups at HIMSS is nothing new. What’s different now is that you’ve recognized that start-ups are a unique culture with unique needs. You’ve assembled a cohort of leaders dedicated to helping these start-ups succeed. What are your expectations from Emerge?

Wolf: First, I’m very interested in the outcome of Emerge. This is the first time that we’re going to try to bring that mesh point I mentioned earlier, where innovations meet operations. They’ve chosen some excellent examples of what can come forward. I think it’s got the right practicality and innovative forethought. From what I’ve heard from people involved in it and talking to people on the committee, I’ve listened to everything from “Wow! This is fantastic and very innovative!” to “It could have been stronger.”

If I talk to heavy innovator startups, they reply that it doesn’t go far enough and could be really “wow.” Meanwhile, those focused on operations often reply that it’s “really pushing the edge.” What that tells me is that it’s in the right mesh point.

What I’m curious to see is how it is received. Many smart people have been working on it, focusing on what will have the biggest impact on operations and be ready for prime time tomorrow, especially in areas like AI utilization and operational impact. What is one step beyond? We also have an incubator ecosystem there.

The Emerge Innovation Experience will be unique, and I look forward to that outcome.

Bashe: I always value your candor.

Wolf: Sometimes, I can get criticized for it, but I believe in absolute transparency. The beautiful part about thought leadership is that we share these thoughts, which makes HIMSS thrive. Transparency is a strength in a positive society. If we’re not transparent with each other, we can’t advance. My grandfather taught me a long time ago that the three most essential phrases in business are “I don’t know, I’ll find out, and I’ll get back to you.” “I don’t know” is critically important.

What’s beautiful about healthcare is that you learn something new every day. It’s impossible to be in the health sector without learning something new every day unless you don’t ask a single question, read nothing, or stay in a room and shut the door.  

Just today, I learned something about HIMSS. I didn’t know because I was asking about a process. A question was raised, and I followed the thread through the organization and found one I’d never seen before, which was exciting.

I appreciate the philosophical and real questions you’re asking. We’re excited about HIMSS 2025 and the learning opportunities it will offer. It’s also about the big picture of what’s happening globally. We call it the Global Conference because it brings together Ministries of Health and NGOs worldwide. It all comes together. This is our largest membership meeting, and we’re thrilled that there’s at least a 35% increase in people signing up for HIMSS membership compared to last year.

Bashe: I’ll be attending this year. As always, thank you for the in-depth exchange. *****

In this insightful conversation, Hal Wolf, President and CEO of HIMSS, explores the critical forces shaping the sector’s future. As industry and governments navigate a rapidly evolving policy landscape under a new administration’s eyes, hospital systems, startups and policymakers must adapt to changing regulations, funding challenges, and digital transformation. Wolf highlights HIMSS’ role as a global leader in uniting a diverse ecosystem to advance health equity, interoperability, and patient-centered care.

A key theme of the discussion is how data and AI are transforming payer, provider and product innovation operations – how information can improve people’s lives. Wolf explains how AI-driven predictive models are integrated to optimize patient care and resource allocation. However, he also warns of ethical concerns—such as the potential for financial-driven decision-making that could prioritize revenue over patient needs. HIMSS plays a vital role in ensuring there is a balance between digital health innovation aligns with quality care and equitable access.

As digital tools, AI, and large language models (LLMs) become more integrated into healthcare, Wolf and Bashe discuss how these advancements can empower providers and patient-enhancing decision-making, improving operational efficiency and offering trusted, system-vetted health information.

As HIMSS prepares for its annual global conference, Wolf emphasizes its role in shaping industry priorities. HIMSS is not just an event; it’s a society that defines strategies, policies, and innovations that drive the future of health. With an expanding ecosystem of startups and industry veterans, HIMSS remains a pivotal force in bridging technology, policy and patient care.

The post The Future of Health Information and Innovation: A Conversation with HIMSS CEO Hal Wolf appeared first on Medika Life.

“First 100 days,” said Means, a former consultant to Big Pharma who uses the social platform X to focus attention on chronic disease. “What should be done to reform the FDA?”

The question was more than rhetorical. Means is among a cadre of health business leaders and nonmainstream doctors who are influencing President Donald Trump’s focus on health policy.

Trump’s return to the White House has given Means and others in this space significant clout in shaping the nascent health policies of the new administration and its federal agencies. It’s also giving newfound momentum to “Make America Healthy Again,” or MAHA, a controversial movement that challenges prevailing thinking on public health and chronic disease.

Its followers couch their ideals in phrases like “health freedom” and “true health.” Their stated causes are as diverse as revamping certain agricultural subsidies, firing National Institutes of Health employees, rethinking childhood vaccination schedules, and banning marketing of ultra-processed foods to children on TV.

Public health leaders say the emerging Trump administration’s interest in elevating the sometimes unorthodox concepts could be catastrophic, eroding decades of scientific progress while spurring a rise in preventable disease. They worry the administration’s support could weaken trust in public health agencies.

Georges Benjamin, executive director of the American Public Health Association, said he welcomes broad intellectual scientific discussion but is concerned that Trump will parrot untested and unproven public health ideas he hears as if they are fact.

Experience has shown that people with unproven ideas will have his ear and his “very large bully pulpit,” he said. “Because he’s president, people will believe he won’t say things that aren’t true. This president, he will.”

But those in the MAHA camp have a very different take. They say they have been maligned as dangerous for questioning the status quo. The election has given them an enormous opportunity to shape politics and policies, and they say they won’t undermine public health. Instead, they say, they will restore trust in federal health agencies that lost public support during the pandemic.

“It may be a brilliant strategy by the right,” said Peter McCullough, a cardiologist who has come under fire for saying covid-19 vaccines are unsafe. He was describing some of the election-season messaging that mainstreamed their perspectives. “The right was saying we care about medical and environmental issues. The left was pursuing abortion rights and a negative campaign on Trump. But everyone should care about health. Health should be apolitical.”

The movement is largely anti-regulatory and anti-big government, whether concerning raw milk or drug approvals, although implementing changes would require more regulation. Many of its concepts cross over to include ideas that have also been championed by some on the far left.

Robert F. Kennedy Jr., an anti-vaccine activist Trump has nominated to run the Department of Health and Human Services, has called for firing hundreds of people at the National Institutes of Health, removing fluoride from water, boosting federal support for psychedelic therapy, and loosening restrictions on raw milk, consumption of which can expose consumers to foodborne illness. Its sale has prompted federal raids on farms for not complying with food safety regulations.

Means has called for top-down changes at the U.S. Department of Agriculture, which he says has been co-opted by the food industry.

Though he himself is not trained in science or medicine, he has said people had almost no chance of dying of covid-19 if they were “metabolically healthy,” referring to eating, sleeping, exercise, and stress management habits, and has said that about 85% of deaths and health care costs in the U.S. are tied to preventable foodborne metabolic conditions.

A co-founder of Truemed, a company that helps consumers use pretax savings and reimbursement programs on supplements, sleep aids, and exercise equipment, Means says he has had conversations behind closed doors with dozens of members of Congress. He said he also helped bring RFK Jr. and Trump together. RFK Jr. endorsed Trump in August after ending his independent presidential campaign.

“I had this vision for a year, actually. It sounds very woo-woo, but I was in a sweat tent with him in Austin at a campaign event six months before, and I just had this strong vision of him standing with Trump,” Means said recently on the Joe Rogan Experience podcast.

The former self-described never-Trumper said that, after Trump’s first assassination attempt, he felt it was a powerful moment. Means called RFK Jr. and worked with conservative political commentator Tucker Carlson to connect him to the former president. Trump and RFK Jr. then had weeks of conversations about topics such as child obesity and causes of infertility, Means said.

“I really felt, and he felt, like this could be a realignment of American politics,” Means said.

He is joined in the effort by his sister, Casey Means, a Stanford University-trained doctor and co-author with her brother of “Good Energy,” a book about improving metabolic health. The duo has blamed Big Pharma and the agriculture industry for increasing rates of obesity, depression, and chronic health conditions in the country. They have also raised questions about vaccines.

“Yeah, I bet that one vaccine probably isn’t causing autism, but what about the 20 that they are getting before 18 months,” Casey Means said in the Joe Rogan podcast episode with her brother.

The movement, which challenges what its adherents call “the cult of science,” gained significant traction during the pandemic, fueled by a backlash against vaccine and mask mandates that flourished during the Biden administration. Many of its supporters say they gained followers who believed they had been misled on the effectiveness of covid-19 vaccines.

In July 2022, Deborah Birx, covid-19 response coordinator in Trump’s first administration, said on Fox News that “we overplayed the vaccines,” although she noted that they do work.

Anthony Fauci, who advised Trump during the pandemic, in December 2020 called the vaccines a game changer that could diminish covid-19 the way the polio vaccine did for that disease.

Eventually, though, it became evident that the shots don’t necessarily prevent transmission and the effectiveness of the booster wanes with time, which some conservatives say led to disillusionment that has driven interest in the health freedom movement.

Federal health officials say the rollout of the covid vaccine was a turning point in the pandemic and that the shots lessen the severity of the disease by teaching the immune system to recognize and fight the virus that causes it.

Postelection, some Trump allies such as Elon Musk have called for Fauci to be prosecuted. Fauci declined to comment.

Joe Grogan, a former director of the White House’s Domestic Policy Council and assistant to Trump, said conservatives have been trying to articulate why government control of health care is troublesome.

“Two things have happened. The government went totally overboard and lied about many things during covid and showed no compassion about people’s needs outside of covid,” he said. “RFK Jr. came along and articulated very simply that government control of health care can’t be trusted, and we’re spending money, and it isn’t making anyone healthier. In some instances, it may be making people sicker.”

The MAHA movement capitalizes on many of the nonconventional health concepts that have been darlings of the left, such as promoting organic foods and food as medicine. But in an environment of polarized politics, the growing prominence of leaders who challenge what they call the cult of science could lead to more public confusion and division, some health analysts say.

Jeffrey Singer, a surgeon and senior fellow at the Cato Institute, a libertarian public policy research group, said in a statement that he agrees with RFK Jr.’s focus on reevaluating the public health system. But he said it comes with risks.

“I am concerned that many of RFK Jr.’s claims about vaccine safety, environmental toxins, and food additives lack evidence, have stoked public fears, and contributed to a decline in childhood vaccination rates,” he said.

Measles vaccination among kindergartners in the U.S. dropped to 92.7% in the 2023-24 school year from 95.2% in the 2019-20 school year, according to the Centers for Disease Control and Prevention. The agency said that has left about 280,000 kindergartners at risk.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

The post Make America Healthy Again: An Unconventional Movement That May Have Found Its Moment appeared first on Medika Life.

Introduction

Infant vaccination has been a cornerstone of global health, demonstrating over more than 100 years the health and socio-economic benefits of the reduced burden of infectious diseases. Yet, despite being the most cost-effective intervention after hygiene improvements, vaccination has repeatedly faced multiple challenges in its implementation. From the difficulty of ensuring sustainable and equitable access to vaccines, to the programmatic complexity of an increasing number of vaccine-preventable diseases and socio-cultural challenges to vaccine uptake, various factors continue to jeopardize the optimal benefits of vaccination.

Pertussis, also known as whooping cough, used to be one of the primary causes of childhood disease and death worldwide until the 1980s. Vaccination has since successfully reduced the overall burden and mortality from pertussis¹, yet it remains among the ten major causes of mortality in children < 5 years-old². Modelled estimates suggested as many as 116,510 deaths globally in 2019³. In fact, as early as twenty years after generalized vaccination, epidemiologic trends, first in the USA^4, then in France⁵ and in other European countries, showed that the disease was still not sufficiently controlled.

There are numerous factors that contribute to the issue: 1) the waning of the protection elicited by infection or vaccination, 2) the absence or low uptake of regular vaccine booster doses beyond early childhood, 3) demographic dynamics such as the aging of previously unvaccinated cohorts exposed to the intense pre-vaccination force of infection, along with 4) high transmissibility of the pathogen. These factors coalesce to rebuild the pool of susceptible individuals after initial vaccine introduction.

Individuals not only become ill with pertussis but also intensify the circulation of the pathogen across age groups, inducing a shift of the burden towards unvaccinated individuals. The latter may be too young to be vaccinated or be under-vaccinated because they do not have access to, are not eligible to, or chose not to receive vaccination, including boosters.

Pertussis is highly transmissible and natural infection or vaccination does not produce life-long immunity. As a result, its control at the population level requires a high rate of vaccine-induced protection across age groups. Modelling of the pertussis epidemiology in Massachusetts, USA, has shown that suboptimal vaccination across age groups has resulted in the resurgence observed across the 2010-2020 period⁶.

Data from outbreaks across the 2010s have shown that large-scale outbreaks are still an ongoing issue. California for example had its worst outbreak in 60 years in 2010⁷. While the disease had nearly disappeared during the COVID-19 pandemic, likely owing to non-pharmaceutical interventions and possibly under-detection, since 2022, sizeable outbreaks have re-started to occur on all continents. The patterns observed in these outbreaks reflect the same trends as observed in the 2010s.

On one hand, in high-income countries and some middle-income countries, vaccine coverage rates are close to, or above 90% with the primary series in infancy. This has shifted the burden of pertussis to infants too young to be vaccinated (especially those whose mothers have not received a booster vaccine during pregnancy), and older children, adolescents and adults in the absence of booster vaccinations.

Outbreaks in the UK⁸, Denmark⁹, Spain¹⁰, or Russia¹¹ in 2023-2024 followed this pattern. On the other hand, many low- and middle-income countries have struggled with maintaining or achieving the necessary high vaccine coverage rates (VCR). Most do not offer comprehensive booster vaccination yet, and often have limited surveillance capacity. As a result, these countries typically have a heterogeneous and incomplete understanding of the burden of pertussis and its distribution.

As observed in the 2022-2024 outbreaks in South Africa^12,13,14, Indonesia¹⁵ and the Philippines¹⁶, where suboptimal infant VCRs persist, the disease and its associated mortality likely continue to affect infants of various ages, including of the age to be vaccinated, along with older age groups.

Contrary to pertussis, a respiratory bacterial disease for which neither infection nor vaccines induce long-term protection, polio is a rare yet devastating neurological complication of a just as highly infectious enterovirus, which induces strong and long-lasting immunity as an infection and as a vaccine. Vaccination has reduced polio cases by over 99% since its introduction. More than 40 cases of wild-type polio have been reported in 2024¹⁷. We may be closer to eradication, but reductions in VCR have placed this goal in jeopardy.

The continued use of oral polio vaccine (OPV) in settings struggling to achieve and maintain high VCRs and the challenges encountered in the discontinuation of OPV2 vaccines have resulted in persistent circulation of vaccine-derived polioviruses (cVDPV¹⁸) which are the cause of more than 90% of cases of paralytic polio today.

Yet, even following eradication, inactivated polio vaccine (IPV) will continue to be a necessary component of routine immunization (RI) due to the potential for resurgence that may arise from issues such as reservoirs of wild-type or vaccine-derived virus and disease slipping by surveillance programs, or from contamination from stockpiles of the virus.

 Vaccine coverage rates are in jeopardy

The high infectiousness of B. pertussis and poliomyelitis virus requires VCRs exceeding 90% for all doses and – in the case of pertussis – regular immune boosting to ensure durable protection to control the diseases and avoid large outbreaks^19,20,21,22  as highlighted by global vaccine targets.

The rapid resurgence of pertussis incidence in the UK following infant VCR decrease in the wake of the whole-cell pertussis vaccine safety scare in the 1970s²³, or the re-appearance of cases among young children in Australia after the country removed the toddler booster dose of pertussis vaccine in 2003 should serve as historical demonstrations that compliance and timeliness for all doses of the recommended pertussis vaccination schedule are essential to pertussis control^24,25.

Unfortunately, not only are we not reaching these targets globally, but VCRs have been decreasing in countries across the globe and the COVID-19 pandemic made matters worse²⁶. There had been progress in the WHO SEARO region with a significant improvement in VCR from 2010 to 2019, but the COVID-19 pandemic pushed it back to 82%, comparable to the level observed in 2010. This has since risen to 91% in 2022, returning to pre-COVID-19 levels²⁷. But post-COVID19, most RI systems have still not recovered.

There had been a notable decline in VCR in the Americas in recent years, with DTP-3 vaccination, used as a benchmark for VCR, reported to have dropped from a high point of 96% in 2015 to 77% by 2022, by which time it had started to recover from a low of 68% in 2021²⁷. Even in HICs such as France, there were delays in RI due to the pandemic²⁸. UNICEF estimates that 67 million children missed out entirely or partially on RI between 2019 and 2021; 48 million of them missed out entirely²⁹. Global and national figures of vaccine coverage reported by UNICEF, WHO or national institutions often are not a complete representation of the heterogeneous, subnational situations.

Numerous countries of all socio-economic development strata face situations where, even if country-level infant VCRs are high, communities with low VCRs, often for a variety of reasons, pose a challenge to disease control creating fertile ground for outbreaks. This had already been observed in the 2010s, with a number of outbreaks in North America. Communities with high vaccine exemption rates were found to exacerbate circulation of the pathogen and concentrated initial outbreaks eventually spilled into the broader community^30,31,32,33.

Recent post-COVID-19 epidemiology of pertussis is demonstrating this once more, with instances in Israel and Thailand, where outbreaks in 2023 were initially concentrated among poorly vaccinated religious communities ^34,35.  

While the COVID-19 pandemic has wreaked havoc in healthcare systems, including vaccination programs, the difficulty many countries face in reaching and sustaining high VCRs has been a long-standing issue that has had an increasing impact in recent years. Suboptimal VCRs can have multiple causes, and the 5 As principle³⁶ (Access, Affordability, Awareness, Activation, Acceptance) provides an excellent framework for evaluating them. Access, or lack of it, refers to various parameters of healthcare and vaccination services which may impact the capability of individuals to receive vaccination such as distance and location, hours of opening, staffing and vaccine stock availability.

Affordability denotes the ability of individuals to afford vaccination, both in terms of financial and non-financial costs, for example, in terms of time away from work to receive the vaccine. While these first two parameters may vary from country to country, diphtheria, tetanus, pertussis and polio vaccinations have long been established as the cornerstone of vaccination programs in all countries. The framework’s concept of awareness encompasses the extent and limitations in the knowledge of disease risk and of the vaccination schedule, which can affect the willingness and motivation to vaccinate, leading to complacency.

Activation is related to awareness as it refers to the motivation of parents and healthcare providers, through reminders or nudges towards ensuring complete and timely vaccination of the infants. In this regard, the role of healthcare providers in activating parents towards vaccinating their children is essential. Issues such as healthcare providers opposing mandatory vaccination (as demonstrated in a study from Switzerland³⁷) have further cemented some individuals against vaccination, impacting VCR.

Finally, acceptance has likely become one of the core factors affecting vaccine uptake, notably in the wake of the COVID-19 pandemic. Vaccine hesitancy is associated with a lack of trust in vaccine safety and science, and skepticism about vaccine efficacy^38,39. It was increasingly affecting VCRs before the COVID-19 pandemic, but the large-scale vaccination campaigns against COVID-19 further fueled vaccine hesitancy⁴⁰.

How hexavalent vaccines have become the standard of care

The value of combination vaccines has been long recognized and explains why pertussis vaccines have been combined with other antigens in a single injection practically since their development. With combined pediatric vaccines, children benefit from fewer injections, resulting in less discomfort, fewer potential episodes of adverse effects, and improved adherence to vaccination schedules⁴¹. For parents, acceptability has been shown to be higher when appointments are reduced through fewer injections⁴².

Studies in the Gambia and South Africa documented concerns among parents about a child receiving more than two injections in a single visit^43,44. The fewer injections afforded by combination vaccines also mitigate productivity loss due to medical appointments for parents. From the perspective of healthcare providers, fewer injections reduce the time imposed on medical staff for the administration – a critical advantage in low-resource settings – while reducing administrative burden and potential for errors and injuries.

For the overall health system, not only do combination vaccines ease the logistical management of vaccines (e.g. cold chain management, procurement and distribution administration), and open up the RI programs for new vaccines, but they have also been shown to improve VCRs for all covered diseases^41,45,46, reducing the potential for outbreak occurrence, and in turn, potentially easing the burden on the healthcare system.

Until the early years of the 21^st century and up to recent years in many countries, pentavalent vaccines were established as the standard of care⁴⁷. However, different pentavalent vaccines contained different antigens. Pentavalent vaccines developed with whole-cell pertussis vaccine (wP) lacked IPV, an essential element of polio eradication, while pentavalent vaccines produced with acellular pertussis vaccine (aP) lacked Hep B. This divergence meant that gaps and inequities remained globally in the immunization of infants.

Technological advances, first attained with aP vaccines and more recently with wP vaccines, led to the formulation of hexavalent vaccines providing immunization against diphtheria, tetanus, pertussis, hepatitis B, Hib disease and polio with inactivated vaccine in a single injection. This breakthrough holds the promise of providing all infants worldwide with early protection against six diseases, cementing polio eradication efforts into infant RI⁴⁸.

The introduction of hexavalent in South Africa reduced the number of injections per visit, potentially saving three visits and three Hep B injections while implementing five new vaccines (four IPV + one Hib) into existing RI schedules. This has saved an average of 8 USD per child and 3 USD of additional savings in HCP labor costs and parents’ time. Consequently, combination vaccines help save around 10 USD per child in South Africa⁴⁹.

Characteristics of aP vs wP hexavalent

Manufacturing and composition

While hexavalent vaccines are increasingly viewed as the gold standard of care for infant vaccination, the fundamental difference in pertussis antigen composition between aP and wP-based hexavalent formulations has important implications.

Whole-cell pertussis vaccines are suspensions of the entire Bordetella pertussis organism that has been inactivated. This bacterium is fastidious to grow, and the complexity of its more than 3000 antigens makes it impossible to precisely characterize the composition of the vaccine and its reproducibility⁵⁰. As a result, different wP vaccines and different batches of the same wP vaccine may contain variable amounts of protective antigens and reactogenic components⁵¹.

The use of an optic measure of bacterial density in wP vaccine formulation and of imprecise and poorly controlled potency assays for measurement of potency⁵² reflects and reinforces this lack of control over the vaccine composition and precludes prediction of its efficacy from potency measures⁵³.

In contrast, aP vaccines are formulated using purified antigens, including at least the pertussis toxin, and one or more adhesins for most aP vaccines. Each antigen is purified and detoxified individually, ensuring the removal of most reactogenic components of the bacterium. The formulation relies on precise quantification of each antigen, resulting in the inclusion of defined amounts of each antigen in the final vaccine⁵¹. As a result, the composition of aP vaccines, confirmed through antigen-specific precise evaluation of potency, has proven reliable and reproducible since their development in the 1990s.

Efficacy/effectiveness

This fundamental difference in control over the consistency in antigenic composition of pertussis vaccines has direct implications for their immunogenicity and protective effect. Historical wP vaccines were tested for efficacy in the clinical trials of aP vaccines in the 1990s. These wP vaccines, which are no longer produced, were found to range in efficacy from 36% to 98% for different wP vaccines, as well as for the same wP vaccine in different trials⁵⁴.

The current wP vaccines have never been tested for their efficacy against pertussis disease in a randomized clinical trial, and the single available study of effectiveness recently conducted in the Central Africa Republic would appear to put their protective effectiveness and duration in doubt⁵⁵. Furthermore, the inherent difficulty in producing wP vaccines of consistent composition resulting from the difficulty in standardizing the culture of B. pertussis is compounded by the use of inadequate clinical immunogenicity assays in the few clinical trials conducted with the current wP vaccines. These assays are generally semi-quantitative and designed to diagnose pertussis. They are rarely validated for precisely quantifying the immune response to a pertussis vaccine⁵⁶.

For this combination of reasons, wP vaccines have previously been shown to give variable results between different manufacturers, but also for the same manufacturer with different assays^57,58,59. This makes it difficult to reliably evaluate the strength and consistency of the immune response elicited by wP vaccines, let alone comparing immune responses between vaccines.

In contrast, the aP vaccines used in the formulation of currently licensed hexavalent vaccines, regardless of the number of pertussis antigens, demonstrated consistent levels of efficacy in the 1990s clinical trials, and recent real-world evidence has confirmed their continued, consistent effectiveness^60,61,62,63. Extensive clinical development plans have yielded a large body of evidence on their immunogenicity. Clinical trials conducted in diverse settings using many of the existing infant vaccination schedules have confirmed through validated immunological assays that currently licensed aP hexavalent vaccines induce robust and consistent immune responses^64,65,66.

The immunity induced by pertussis vaccines, wP or aP, as by disease, is not life-long and has been shown to wane over time as illustrated by peaking disease incidence in age groups several years away from their last dose of vaccine⁶⁷. There has been controversy over a potential different duration of protection elicited by aP and wP vaccines^68,69,70.  Yet, while several studies have tried to measure the duration of protection afforded by currently used aP vaccines, only very little data exist on the effectiveness, let alone its duration, of currently used wP vaccines^55,71,72,73. 

Newer studies have clearly demonstrated that neither aP nor wP provides long-lived protection and that a robust booster schedule is required to ensure prolonged protection and disease control^55,74,75,76.

Safety profile

The development of aP vaccines was triggered by concerns not only about the reliability and efficacy of wP vaccines but also their reactogenicity. The higher reactogenicity of wP vaccines compared to aP vaccines has long been demonstrated^77,78, including the impact it can have on vaccine acceptance and completion of vaccine schedules.

In a Cochrane meta-analysis of historical clinical trials, wP recipients had a 77% higher risk of failing to complete their schedule due to adverse events compared with aP recipients⁷⁸. The study also found that aP recipients did not have any statistically significant increase in risk of failing to complete their vaccination schedule compared to the placebo control group, indicating a high degree of acceptability.

In more recent evidence, the frequency of adverse events reported in a phase 3 clinical trial following vaccination with one of the current hexavalent wP vaccines was largely higher than with an aP hexavalent vaccine in the same population using the same schedule^57,79. In fact, real-world evidence analyzed at the time the Chilean national immunization program transitioned from wP to aP vaccines showed a 67% reduction in the reporting of adverse events⁸⁰.

This higher reactogenicity of wP vaccines was found to affect acceptance and completion of the infant schedule of vaccination in a recent example of high media coverage of a series of severe adverse event-related hospitalizations and one death following wP vaccination in Vietnam resulting in a significant drop in VCR⁸¹.

Hesitation regarding adverse events was also observed in Brazil, where a study in São Paulo state showed a 20% decrease in schedule completeness and timeliness in children of parents who reported a previous adverse event following vaccination compared with parents who did not report an adverse event⁸².

Finally, the difficulty in ensuring consistent composition of wP vaccines, including in reactogenic components also poses a challenge to the sustainability of VCRs. In two examples in Chile and in El Salvador^83,84, a change in the supplier of the wP pentavalent vaccine used in the national immunization programs of these countries resulted in a near doubling of the frequencies of adverse events, including serious adverse events such as febrile seizures and hypotonic-hyporesponsive episodes.

Such unexpected, dramatic increases in the frequency of adverse events can further erode parental confidence in the safety of the vaccines and their willingness to see their child fully vaccinated. 

Inequities resulting from the different profiles of aP and wP vaccines

In countries where wP vaccines remain the only publicly funded pertussis vaccines, the higher reactogenicity of wP vaccines poses the risk of lower acceptance and VCR among the poorer segments of the population, leaving infants unprotected against pertussis as well as the other diseases included in the combination vaccines such as diphtheria, as well as polio in hexavalent combinations.

Pentavalent acellular pertussis vaccine introduction in Costa Rica was followed by a marked increase in VCR, this was most prominent among the lowest wealth quintiles. In 2011 the overall coverage among the lowest wealth quintile was 79.2% for the third dose of pneumococcal conjugate. By 2018 this had risen to 94.4%⁸⁵.

Inequities also arise from the burden of reactogenicity. In countries where aP vaccines are only available to those who can afford to pay for them, the poorer families also have to bear the economic burden of higher frequency and severity of adverse events resulting from publicly funded wP vaccines.

The potentially variable safety and efficacy profile of wP vaccines may also expose infants of lower-income families to inequitable exposure to health burdens due to the increased risk of adverse events and potentially increased risk of disease compared to those who can afford more consistent aP vaccines.

The higher nominal cost of purchase of aP vaccines compared to wP vaccines is often an important limitation to ensuring publicly funded, equitable access to aP vaccines, especially in developing and emerging economies. However, the cost of vaccination programs reaches well beyond the procurement cost of vaccines; it encompasses not only the vaccine purchase but also the costs of its logistical management as well as the cost of managing adverse events following immunization, the cost of VCR catch-up campaigns and the cost of illness resulting from under-vaccination.

Considering the economics of the broader public health budget, the adoption of aP hexavalent vaccines in national immunization programs (NIPs) represents a much smaller premium compared to the purchase price of the vaccines⁸⁶.

 Conclusion

The scientific and technological advances in vaccine production of the last two decades have yielded options for routine immunization that can help achieve the WHO’s Immunization Agenda 2023 to “leave no one behind” and to help ensure infants worldwide receive adequate and complete protection against up to 6 diseases in a single injection.

A purposeful decision needs to be made, however, when deciding to opt for a pentavalent or a hexavalent, and for the type of hexavalent vaccine sourced for a national immunization program. In making this decision, policymakers should consider the following factors.

Acceptability of hexavalent vaccines

Multiple injections have been shown⁴³ to be less acceptable to parents, and hexavalent vaccines can reduce this concern. This has been demonstrated across numerous economic settings, including the examples illustrated above in the United States, South Africa, and Gambia.

Evidence has demonstrated time and time again and in every setting that elevated reactogenicity can hinder the achievement and maintenance of the required high VCRs. Besides the higher healthcare costs associated with adverse event management, these lower VCRs may induce increases in the incidence of the disease and increased costs for public health authorities both for disease management and vaccination catch-up.

While these considerations are likely applicable in all settings, the heterogeneous robustness of surveillance settings may mean that local, sentinel surveillance studies with trained pediatricians in selected healthcare facilities may be required to establish convincing evidence.

Conserving vaccine system resources

Hexavalent vaccination presents the opportunity to reduce the number of necessary vaccination doses while optimizing efficiency (resource needs over results achieved). Though up-front costs may be higher, hexavalent acellular vaccination may be more cost-effective in the long run through their contribution to help raise and sustain VCRs.

Costs must be determined on a country-specific basis, and include additional costs incurred through adverse reactions and remediation of suboptimal VCRs (disease costs, catch-up costs).

Reducing the number of zero-dose and under-immunized children, aiming toward the global vaccine agenda

Zero-dose children have increased in number since the start of the pandemic, increasing the risk of disease and creating reservoirs of transmission, typically among geographically isolated and/or economically vulnerable communities. Hexavalent vaccination, as with all the component parts of the vaccine, will reduce long-term disability and impairment. This must be factored into costs.

Hexavalent can help VCR for the six antigens in the same way that pentavalent improved VCR for Hib/Hep B and DTP3⁴⁵. There is a need for high VCR to reduce the risk of polio recurrence. Following the withdrawal of OPV, coverage with IPV will be essential to prevent resurgence. The inclusion of IPV as part of hexavalent vaccination ensures its use in routine immunization and is aligned with the WHO’s recommendations⁸⁷.

Sustainability stemming from reliability

Higher predictability of safety and efficacy of aP vaccines is key in ensuring high National Immunization Programme VCR, and reliability of disease control at the population level. Acellular pertussis vaccines have been used for over 25 years and have a well-established safety, efficacy and effectiveness profile. This is sharply contrasted by the very limited to complete lack of available data for currently used wP vaccines.

Strong pharmacovigilance and surveillance of the disease in countries still using wP vaccines would help in the reassessment of the type of vaccine used in their national immunization programs. These data will increase awareness of the disease for public health authorities and establish the need for robust programs with reliable vaccines.

[This consensus paper is based on the discussions of a global expert panel (consisting of the paper’s authors) focusing on paediatric immunisation, supported by Sanofi.]

References

1. Yeung KHT, Duclos P, Nelson EAS, Hutubessy RCW. An update of the global burden of pertussis in children younger than 5 years: a modelling study. The Lancet Infectious diseases. 2017;17(9):974-980. doi: https://doi.org/10.1016/S1473-3099(17)30390-0
2. ‌Causes of death in children under 5. Our World in Data. https://ourworldindata.org/grapher/causes-of-death-in-children-under-5
3. Nie Y, Zhang Y, Yang Z, et al. Global burden of pertussis in 204 countries and territories, from 1990 to 2019: results from the Global Burden of Disease Study 2019. BMC public health. 2024;24(1). doi:  https://doi.org/10.1186/s12889-024-18968-y
4. Bass JW, Stephenson SR. The return of pertussis. The Pediatric Infectious Disease Journal. 1987;6(2):141. https://journals.lww.com/pidj/citation/1987/02000/the_return_of_pertussis.1.aspx
5. Baron S, Njamkepo E, Grimprel E, et al. Epidemiology of pertussis in French hospitals in 1993 and 1994: thirty years after a routine use of vaccination. The Pediatric Infectious Disease Journal. 1998;17(5):412-418. doi:  https://doi.org/10.1097/00006454-199805000-00013
6. Domenech de Cellès M, Magpantay FMG, King AA, Rohani P. The impact of past vaccination coverage and immunity on pertussis resurgence. Science Translational Medicine. 2018;10(434). doi: https://doi.org/10.1126/scitranslmed.aaj1748
7. Winter K, Harriman K, Zipprich J, et al. California pertussis epidemic, 2010. The Journal of Pediatrics. 2012;161(6):1091-1096. doi: https://doi.org/10.1016/j.jpeds.2012.05.041
8. UK Health Security Agency. Confirmed cases of pertussis in England by month. GOV.UK. Published March 8, 2024. https://www.gov.uk/government/publications/pertussis-epidemiology-in-england-2024/confirmed-cases-of-pertussis-in-england-by-month
9. Nordholm AC, Emborg HD, Nørgaard SK, et al. Pertussis epidemic in Denmark, August 2023 to February 2024. Euro Surveillance: Bulletin Europeen Sur Les Maladies Transmissibles = European Communicable Disease Bulletin. 2024;29(14):2400160. doi: https://doi.org/10.2807/1560-7917.ES.2024.29.14.2400160
10. Informe Sobre La Situació Epidemiològica de La Tos Ferina a Catalunya (Període 2014-2024) 03 de Maig de 2024. Accessed September 5, 2024. https://scientiasalut.gencat.cat/bitstream/handle/11351/11043/informe_situacio_epidemiologica_tos_ferina_catalunya_periode_2014_2024.pdf?sequence=6
11. РБК. Whooping cough cases in the region have increased more than 10-fold. РБК. Published March 27, 2024. Accessed September 5, 2024. https://nsk.rbc.ru/nsk/27/03/2024/6603d33c9a79472f3aad21b1
12. March-Communique. NICD. Published March 2023. Accessed September 5, 2024. https://www.nicd.ac.za/wp-content/uploads/2023/03/NICD-March-Communique.pdf
13. January-Communique. NICD. Published January 2023. Accessed September 5, 2024. https://www.nicd.ac.za/wp-content/uploads/2023/01/NICD-Communique-JAN-2023.pdf
14. WHO Immunization Data portal – Detail Page. Immunization Data. Published 2023. Accessed September 5, 2024. https://immunizationdata.who.int/global/wiise-detail-page/diphtheria-tetanus-toxoid-and-pertussis-(dtp)-vaccination-coverage?CODE=ZAF&ANTIGEN=&YEAR=
15. Communication from Kementerian Kesehatan Republik Indonesia
16. Weekly Disease Surveillance Report. Department of Health. https://doh.gov.ph/health-statistics/weekly-disease-surveillance-report/
17. GPEI-This Week. Polioeradication.org. Published 2024. Accessed October 10, 2024.

18. Global Polio Eradication Initiative. GPEI-OPV. polio global eradication initiative . Published 2016. https://polioeradication.org/polio-today/polio-prevention/the-vaccines/opv/
19. Girard DZ. The cost of epidemiological transition: A study of a decrease in pertussis vaccination coverage. Health Policy. 2005;74(3):287-303. doi: https://doi.org/10.1016/j.healthpol.2005.01.015
20. Hoest C, Seidman JC, Lee G, et al. Vaccine coverage and adherence to EPI schedules in eight resource poor settings in the MAL-ED cohort study. Vaccine. 2017;35(3):443-451. doi: https://doi.org/10.1016/j.vaccine.2016.11.075
21. Pertussis vaccines: WHO position paper – August 2015. www.who.int. https://www.who.int/publications/i/item/WHO-WER9035
22. Polio vaccines: WHO position paper – June 2022. www.who.int. https://www.who.int/publications/i/item/WHO-WER9725-277-300
23. Amirthalingam G, Gupta S, Campbell H. Pertussis immunisation and control in England and Wales, 1957 to 2012: a historical review. Eurosurveillance. 2013;18(38):20587. doi: https://doi.org/10.2807/1560-7917.es2013.18.38.20587
24. Marshall KS, Quinn HE, Pillsbury AJ, Maguire JE, Lucas RM, Dey A. Australian vaccine preventable disease epidemiological review series: Pertussis, 2013–2018. Communicable Diseases Intelligence. 2022;46. doi: https://doi.org/10.33321/cdi.2022.46.3
25. Heininger U. Referring to: Wilkinson K, Righolt CH, Elliott LJ, Fanella S, Mahmud SM. Pertussis vaccine effectiveness and duration of protection – a systematic review and meta-analysis. Vaccine. 2021 May 27;39(23):3120–3130. Vaccine. 2022;40(26):3530. doi: https://doi.org/10.1016/j.vaccine.2022.04.075
26. Immunization Roadmap to 2030. UNICEF. Published January 2023. Accessed September 5, 2024. https://www.unicef.org/media/138976/file/UNICEF%20Immunization%20Roadmap%20To%202030.pdf
27. DTP-3 Antigen Immunization Coverage Data. WHO. Published 2023. https://immunizationdata.who.int/pages/coverage/DTP.html?GROUP=WHO_REGIONS&ANTIGEN=DTPCV3&YEAR=&CODE=
28. Cohen R, Ashman M, Taha MK, et al. Pediatric Infectious Disease Group (GPIP) position paper on the immune debt of the COVID-19 pandemic in childhood, how can we fill the immunity gap? Infectious Diseases Now. 2021;51(5):418-423. doi: https://doi.org/10.1016/j.idnow.2021.05.004
29. UNICEF. The State of the World’s Children. www.unicef.org. Published 2018. https://www.unicef.org/reports/state-of-worlds-children
30. Atwell JE, Van Otterloo J, Zipprich J, et al. Nonmedical Vaccine Exemptions and Pertussis in California, 2010. PEDIATRICS. 2013;132(4):624-630. doi: https://doi.org/10.1542/peds.2013-0878
31. Glanz JM, Narwaney KJ, Newcomer SR, et al. Association Between Undervaccination With Diphtheria, Tetanus Toxoids, and Acellular Pertussis (DTaP) Vaccine and Risk of Pertussis Infection in Children 3 to 36 Months of Age. JAMA Pediatrics. 2013;167(11):1060. doi: https://doi.org/10.1001/jamapediatrics.2013.2353
32. Imdad A, Tserenpuntsag B, Blog DS, Halsey NA, Easton DE, Shaw J. Religious Exemptions for Immunization and Risk of Pertussis in New York State, 2000-2011. PEDIATRICS. 2013;132(1):37-43. doi: https://doi.org/10.1542/peds.2012-3449
33. Deeks S, Lim G, Walton R, et al. Prolonged Pertussis Outbreak in Ontario Originating in an Under-immunized Religious Community. Canada Communicable Disease Report. 2014;40(3):42-49. doi: https://doi.org/10.14745/ccdr.v40i03a03
34. Chen Stein-Zamir, Shoob H, Abramson N, Emilie Hannah Brown, Zimmermann Y. Pertussis outbreak mainly in unvaccinated young children in ultra-orthodox Jewish groups, Jerusalem, Israel 2023. Epidemiology and Infection. 2023;151. doi: https://doi.org/10.1017/s0950268823001577
35. Whooping cough spreading among children in 3 southern provinces. Thaipbs.or.th. Published 2024. Accessed September 5, 2024. https://world.thaipbs.or.th/whooping-cough-spreading-among-children-in-3-southern-provinces/
36. Thomson A, Robinson K, Vallée-Tourangeau G. The 5As: A practical taxonomy for the determinants of vaccine uptake. Vaccine. 2016;34(8):1018-1024. doi: https://doi.org/10.1016/j.vaccine.2015.11.065
37. Dietrich LG, Lüthy A, Lucas Ramanathan P, et al. Healthcare professional and professional stakeholders’ perspectives on vaccine mandates in Switzerland: A mixed-methods study. Vaccine. 2022;40(51). doi: https://doi.org/10.1016/j.vaccine.2021.12.071
38. Galagali PM, Kinikar AA, Kumar VS. Vaccine Hesitancy: Obstacles and Challenges. Current Pediatrics Reports. 2022;10(4). doi: https://doi.org/10.1007/s40124-022-00278-9
39. Figueiredo A de, Simas C, Karafillakis E, Paterson P, Larson HJ. Mapping global trends in vaccine confidence and investigating barriers to vaccine uptake: a large-scale retrospective temporal modelling study. The Lancet. 2020;396(10255). doi: https://doi.org/10.1016/S0140-6736(20)31558-0
40. Kricorian K, Civen R, Equils O. COVID-19 vaccine hesitancy: misinformation and perceptions of vaccine safety. Human Vaccines & Immunotherapeutics. 2021;18(1):1-8. doi: https://doi.org/10.1080/21645515.2021.1950504
41. Kurosky SK, Davis KL, Krishnarajah G. Effect of combination vaccines on completion and compliance of childhood vaccinations in the United States. Human Vaccines & Immunotherapeutics. 2017;13(11):2494-2502. doi: https://doi.org/10.1080/21645515.2017.1362515
42. Melman ST. Multiple immunizations. Ouch! Archives of Family Medicine. 1994;3(7):615-618. doi: https://doi.org/10.1001/archfami.3.7.615
43. Idoko OT, Hampton LM, Mboizi RB, et al. Acceptance of multiple injectable vaccines in a single immunization visit in The Gambia pre and post introduction of inactivated polio vaccine. Vaccine. 2016;34(41):5034-5039. doi: https://doi.org/10.1016/j.vaccine.2016.07.021
44. Hanani Tabana, Dudley L, Knight S, et al. The acceptability of three vaccine injections given to infants during a single clinic visit in South Africa. BMC Public Health. 2016;16(1). doi: https://doi.org/10.1186/s12889-016-3324-2
45. M Mahmud Khan, Juan Camilo Vargas-Zambrano, Laurent Coudeville. How did the adoption of wP-pentavalent affect the global paediatric vaccine coverage rate? A multicountry panel data analysis. BMJ open. 2022;12(4):e053236-e053236. doi: https://doi.org/10.1136/bmjopen-2021-053236
46. Kalies H, Grote V, Verstraeten T, Hessel L, Schmitt HJ, von Kries R. The Use of Combination Vaccines Has Improved Timeliness of Vaccination in Children. The Pediatric Infectious Disease Journal. 2006;25(6):507-512. doi: https://doi.org/10.1097/01.inf.0000222413.47344.23
47. Pentavalent vaccine support. Gavi.org. Published June 26, 2024. Accessed September 5, 2024. https://www.gavi.org/types-support/vaccine-support/pentavalent#:~:text=Protects%20against%20five%20major%20diseases
48. Torres-Martinez C, Chaparro E, Mariño AC, et al. Recommendations for modernizing infant vaccination schedules with combination vaccines in Colombia and Peru. Revista Panamericana de Salud Pública. 2023;47:1. doi: https://doi.org/10.26633/rpsp.2023.24
49. Batson A, Glassman A, Federgruen A, et al. The world needs to prepare now to prevent polio resurgence post eradication. BMJ Global Health. 2022;7(12):e011485. doi: https://doi.org/10.1136/bmjgh-2022-011485
50. Bouchez V, Guiso N. Bordetella pertussis,B. parapertussis, vaccines and cycles of whooping cough. Carbonetti N, ed. Pathogens and Disease. 2015;73(7):ftv055. doi: https://doi.org/10.1093/femspd/ftv055
51. The immunological basis for immunization series: module 4: pertussis, update 2017. WHO https://www.who.int/publications/i/item/the-immunological-basis-for-immunization-series-module-4-pertussis-update-2017
52. D Mohammadbagher, M Noofeli, Karimi G. Comparative Assessment of the Whole-cell Pertussis Vaccine Potency Using Serological and Intracerebral Mouse Protection Methods. PubMed. 2019;74(2):103-109. doi: https://doi.org/10.22092/ari.2018.108852.1096
53. Jefferson T. Why the MRC randomized trials of whooping cough (pertussis) vaccines remain important more than half a century after they were done. Journal of the Royal Society of Medicine. 2007;100(7):343-345. doi: https://doi.org/10.1177/014107680710000720
54. Alghounaim M, Alsaffar Z, Alfraij A, Bin-Hasan S, Hussain E. Whole-Cell and Acellular Pertussis Vaccine: Reflections on Efficacy. Medical Principles and Practice. 2022;31(4):313-321. doi: https://doi.org/10.1159/000525468
55. E. Kalthan, C. Lakei-Abdon, P. Wol-Wol, C.M. Pamatika, Belizaire MR. Case study of a 2022 pertussis epidemic in the Baoro sub-prefecture (Central African Republic). Infectious Diseases Now. 2023;53(8):104778-104778. doi: https://doi.org/10.1016/j.idnow.2023.104778
56. Varghese K, Bartlett W, Zheng L, et al. A New Electrochemiluminescence-Based Multiplex Assay for the Assessment of Human Antibody Responses to Bordetella pertussis Vaccines. Infectious Diseases and Therapy. 2021;10(4):2539-2561. doi: https://doi.org/10.1007/s40121-021-00530-7
57. Sharma H, Yadav S, Lalwani S, et al. Immunogenicity and safety of an indigenously manufactured reconstituted pentavalent (DTwP-HBV+Hib) vaccine in comparison with a foreign competitor following primary and booster immunization in Indian children. Human Vaccines. 2011;7(4):451-457. doi: https://doi.org/10.4161/hv.7.4.14208
58. Ekrami Noghabi M, Saffar MJ, Rezai S, et al. Immunogenicity and Complications of the Pentavalent Vaccine in Iranian Children. Frontiers in Pediatrics. 2021;9. doi: https://doi.org/10.3389/fped.2021.716779
59. Sharma H, Parekh S, Pramod Pujari, et al. A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants. npj Vaccines. 2024;9(1). doi: https://doi.org/10.1038/s41541-024-00828-w
60. Edwards KM, Decker MD, F. Heath Damron. Pertussis Vaccines. Elsevier eBooks. Published online January 1, 2023:763-815.e19. doi: https://doi.org/10.1016/b978-0-323-79058-1.00045-1
61. Pertussis surveillance in Sweden – 23rd annual report. Folkhalsomyndigheten.se. Published November 11, 2022. Accessed September 5, 2024. https://www.folkhalsomyndigheten.se/publikationer-och-material/publikationsarkiv/p/pertussis-surveillance-in-sweden-23rd-annual-report/
62. Sánchez-González G, Luna-Casas G, Mascareñas C, Macina D, Vargas-Zambrano JC. Pertussis in Mexico from 2000 to 2019: A real-world study of incidence, vaccination coverage, and vaccine effectiveness. Vaccine. 2023;41(41):6105-6111. doi: https://doi.org/10.1016/j.vaccine.2023.08.046
63. Klein NP, Bartlett J, Fireman B, et al. Waning protection following 5 doses of a 3-component diphtheria, tetanus, and acellular pertussis vaccine. Vaccine. 2017;35(26):3395-3400. doi: https://doi.org/10.1016/j.vaccine.2017.05.008
64. Syed YY. DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination. Pediatric Drugs. 2019;21(5):397-408. doi: https://doi.org/10.1007/s40272-019-00353-7
65. Boisnard F, Manson C, Serradell L, Macina D. DTaP-IPV-HB-Hib vaccine (Hexaxim): an update 10 years after first licensure. Expert Review of Vaccines. Published online November 7, 2023. doi: https://doi.org/10.1080/14760584.2023.2280236
66. Dhillon S. DTPa-HBV-IPV/Hib Vaccine (Infanrix hexaTM). Drugs. 2010;70(8):1021-1058. doi: https://doi.org/10.2165/11204830-000000000-00000
67. Wendelboe AM, Van Rie A, Salmaso S, Englund JA. Duration of Immunity Against Pertussis After Natural Infection or Vaccination. Pediatric Infectious Disease Journal. 2005;24(5):S58-S61. doi: https://doi.org/10.1097/01.inf.0000160914.59160.41
68. Witt MA, Arias L, Katz PH, Truong ET, Witt DJ. Reduced Risk of Pertussis Among Persons Ever Vaccinated With Whole Cell Pertussis Vaccine Compared to Recipients of Acellular Pertussis Vaccines in a Large US Cohort. Clinical Infectious Diseases. 2013;56(9):1248-1254. doi: https://doi.org/10.1093/cid/cit046
69. Kiraly N, Dharmage SC, Allen KJ. Reduced Risk of Pertussis Among Persons Ever Vaccinated With Whole-Cell Pertussis Vaccine Compared to Recipients of Acellular Pertussis Vaccines May Have Been Confounded by Age. Clinical Infectious Diseases. 2013;57(5):770-770. doi: https://doi.org/10.1093/cid/cit351
70. Philippe André, Johnson DR, Greenberg DP, Decker MD. Reduced Risk of Pertussis in Whole-Cell Compared to Acellular Vaccine Recipients Is Not Supported When Data Are Stratified by Age. Clinical Infectious Diseases. 2013;57(11):1658-1660. doi: https://doi.org/10.1093/cid/cit552
71. Pertussis vaccines: WHO position paper, August 2015—Recommendations. Vaccine. 2016;34(12):1423-1425. doi: https://doi.org/10.1016/j.vaccine.2015.10.136
72. Savage RD, Bell CA, Righolt CH, et al. A multisite study of pertussis vaccine effectiveness by time since last vaccine dose from three Canadian provinces: A Canadian Immunization Research Network study. Vaccine. 2021;39(20):2772-2779. doi: https://doi.org/10.1016/j.vaccine.2021.03.031
73. Misegades LK, Winter K, Harriman K, et al. Association of Childhood Pertussis With Receipt of 5 Doses of Pertussis Vaccine by Time Since Last Vaccine Dose, California, 2010. JAMA. 2012;308(20):2126. doi: https://doi.org/10.1001/jama.2012.14939
74. Noel G, Farzad Badmasti, Vajihe Sadat Nikbin, et al. Transversal sero-epidemiological study of Bordetella pertussis in Tehran, Iran. PloS ONE. 2020;15(9):e0238398-e0238398. doi: https://doi.org/10.1371/journal.pone.0238398
75. Paradowska-Stankiewicz I, Rumik A, Bogusz J, et al. Duration of protection against Bordetella pertussis infection elicited by whole-cell and acellular vaccine priming in Polish children and adolescents. Vaccine. 2021;39(41):6067-6073. doi: https://doi.org/10.1016/j.vaccine.2021.08.105
76. Rane MS, Rohani P, Halloran ME. Durability of protection after 5 doses of acellular pertussis vaccine among 5–9 year old children in King County, Washington. Vaccine. 2021;39(41):6144-6150. doi: https://doi.org/10.1016/j.vaccine.2021.08.070
77. Patterson J, Kagina BM, Gold M, Hussey GD, Muloiwa R. Comparison of adverse events following immunisation with acellular and whole-cell pertussis vaccines: A systematic review. Vaccine. 2018;36(40):6007-6016. doi: https://doi.org/10.1016/j.vaccine.2018.08.022
78. Zhang L, Prietsch SO, Axelsson I, Halperin SA. Acellular vaccines for preventing whooping cough in children. Cochrane Database of Systematic Reviews. Published online September 17, 2014. doi: https://doi.org/10.1002/14651858.cd001478.pub6
79. Chhatwal J, Lalwani S, Vidor E. Immunogenicity and Safety of a Liquid Hexavalent Vaccine in Indian Infants. Indian Pediatrics. 2017;54(1):15-20. doi: https://doi.org/10.1007/s13312-017-0989-2
80. Aguirre-Boza F, San P, Valenzuela T. How were DTP-related adverse events reduced after the introduction of an acellular pertussis vaccine in Chile? Human Vaccines & Immunotherapeutics. 2021;17(11):4225-4234. doi: https://doi.org/10.1080/21645515.2021.1965424
81. OAI N. 30 kids hospitalized after ComBE Five vaccination. SGGP English Edition. Published 2019. Accessed September 6, 2024. https://en.sggp.org.vn/30-kids-hospitalized-after-combe-five-vaccination-post76647.html
82. Érica Marvila Garcia, Nery C, Eliseu Alves Waldman, Paula A. Factors Associated with the Completeness of the Vaccination Schedule of Children at 12 and 24 Months of Age in a Brazilian Medium-Size Municipality. Journal of Pediatric Nursing. 2021;60:e46-e53. doi: https://doi.org/10.1016/j.pedn.2021.02.028
83. Oliva Thomsen P, Adiela Saldaña, Cerda J, Abarca K. Seguridad en vacunas: descripción de los eventos adversos notificados al sistema de vigilancia en Chile, 2014 a 2016. Revista Chilena De Infectologia. 2019;36(4):461-468. doi: https://doi.org/10.4067/s0716-10182019000400461 
84. Elas M, Villatoro N, Pezzoli L. Disproportionality analysis of reported drug adverse events to assess a potential safety signal for pentavalent vaccine in 2019 in El Salvador. Vaccine. Published online July 2021. doi: https://doi.org/10.1016/j.vaccine.2021.07.010
85. Avila-Agüero ML, Camacho-Badilla K, Ulloa-Gutierrez R, Espinal-Tejada C, Morice-Trejos A, Cherry JD. Epidemiology of pertussis in Costa Rica and the impact of vaccination: A 58-year experience (1961–2018). Vaccine. 2022;40(2):223-228. doi: https://doi.org/10.1016/j.vaccine.2021.11.078
86. Olivera I, Grau C, Dibarboure H, et al. Valuing the cost of improving Chilean primary vaccination: a cost minimization analysis of a hexavalent vaccine. BMC health services research. 2020;20(1). doi: https://doi.org/10.1186/s12913-020-05115-7
87. Weekly Epidemiological Record Relevé Épidémiologique Hebdomadaire.; 2016. Accessed October 28, 2019. https://www.who.int/wer/2016/wer9112.pdf

The post The Role of Pediatric Hexavalent Vaccines to Leave No Child Behind on Pertussis and Polio Protection appeared first on Medika Life.

Not to take anything away from the Senator’s apparent concern for his constituents’ real, valid frustration with the health system, but is his villain the right one? Is it a fundamental misreading of the facts of the US health ecosystem to believe that there is any one villain in the system at all? The real, underlying reason that the US health system is so fragmented is that the system itself is the problem. And, as it must be, the system will be the source of any viable solution that makes navigating less challenging and more holistically unified.

Stop Blaming Individual Sectors — Look at the Aggregate

High drug prices are just one symptom of a health ecosystem already becoming increasingly fragmented several decades ago. The problem was well-established and recognized when economist Dr. Alain C. Enthoven wrote about it in the American Journal of Managed Care more than a decade ago, positing that inefficient allocation of resources negatively impacted quality, cost of care and medicines, and patient outcomes.

Since then, little has changed. In 2016, FINN Partners released a survey showing that the fragmented health ecosystem was placing an ever-greater burden on patients, the people the system is supposed to protect and serve — and was increasingly failing. Eight years later, the results of this survey will not have changed significantly.

For decades, payers, patients, policymakers, product innovators, and providers turned a blind eye to fragmentation. And while policymakers prefer to spotlight a popular villain — drug cost — the relentless search for villains won’t fix fragmentation. If we attack one piece of the ecosystem rather than look at the problem, we will fail to make meaningful change. While putting pharmaceutical company CEOs under the glare of the Senate HELP spotlight may provide a tremendous election-year photo-op, bipartisan grandstanding is antithetical to addressing the health system’s continued splintering.

If the System Were a Patient with Multi-System Failure, Would We Treat Only One Organ?

We now know beyond a doubt that the health system is fragmented and has a cost impact. It is time to move from this era of fragmentation into the “post-fragmentation” period. Rather than finger-pointing and finding scapegoats, what’s needed is a fuller understanding of how the system works — and fails to work — for the patient. This requires looking at the full picture objectively, without accusation, to understand better how the different players in the system can work together to support the same goal: a health system in which the patient, not the system itself, is the health system’s true beneficiary.

It’s a fact: prescription drug prices in the United States are higher than in other nations, averaging 2.78 times those seen in 33 different countries, according to the February 2024 RAND report. But are pharma companies the sole cause of this patient burden and health-system chaos? Absolutely not: drug costs comprise about 11 percent of the total $4 trillion in US health expenditures. In reality, provider and hospital services total almost half of US health spend (31.4 percent and 20.3 percent respectively).

Fragmentation Adds to Patient Care Burdens and Costs

Fragmentation leads to out-of-control spending across the system. According to a 2018 Commonwealth Fund study, Medicare recipients “with three to four chronic conditions and highly fragmented care are 14 percent more likely to visit the emergency department, and six percent more likely to have a hospital admission.”

If the US health system were a publicly traded corporation, this hemorrhaging of cash would have been decisively stopped years ago. Taken together, the $4 trillion in annual US healthcare costs can be laid on the doorstep of nearly every player in the ecosystem, from insurance companies to PBMs, pharmacies, pharmaceutical companies, government, hospitals, and venture capital, to name a few — even endless consumer demand and neglected preventive care.

Operating with a business-as-usual approach will carry steep costs in money and lives. When the system fails to engage people proactively with heightened risk for heart disease, cancer, diabetes, and other non-communicable illnesses, when it denies patients diagnostic procedures ordered by their physicians, when it shifts patients from working medications to substitute therapies due to a non-medical switch decision, curiously, some parts of the system benefit to the detriment of patients.

These situations shouldn’t be, as the consequences of the current line and the decisions they reward can be dire, leading to rising costs, diminished patient care, and even death. Ultimately, the chaos around care delivery comes from considering patients a necessary fly in the system’s ointment. The patient is not the health system customer. The system is a customer unto itself.

Can We All Focus On Why the System Exists — To Heal Patients?

We recognize the health system’s failings but must also identify its strengths and potential for improvement. This will allow us to reorient our thinking and ask, “Now, what do we do to put the patient back into focus as the ultimate customer and the preferred beneficiary of the system?”

Stanford Physician Ilana Yurkiewicz, an internist, hematologist, and oncologist, in her book Fragmented: A Doctor’s Quest to Piece Together American Health Care, published by W. W. Norton, argues that it’s actually fragmentation that’s the central failure of health care today, resulting in a system that uses more than twice the economic resources other developed nations dedicate toward health and which results in poorer life expectancy outcomes:

“There’s an unspoken assumption when we go to see a doctor: the doctor knows our medical story and is making decisions based on that story. But reality frequently falls short. Medical records vanish when we switch doctors. Critical details of life-saving treatment plans get lost in muddled electronic charts. The doctors we see change according to specialty, hospital shifts, or an insurer’s whims.”

No longer are we debating whether the system is fragmented or not. We must shift our mindsets and drop the mistaken belief that identifying bad players in the ecosystem will fix the problem. With ecosystem fragmentation as the diagnosis, what is the treatment path to better management? This is where “Health System Kinetics” (HSK) enters. HSK fosters collaboration and leverages health information technologies — AI, ChatGPT, GenAI, and LLMs — to create an eco-dynamic that prioritizes people’s well-being and works toward longer, healthier lives.

The Health System is Greater Than Its Sector Parts — Study its Kinetics

Health System Kinetics objectively studies factors and sector-to-sector relationships influencing individual and collective health outcomes. It includes biological, environmental, social, and economic determinants of health. Understanding health system kinetics will allow the health system to evolve for the better, benefiting its stakeholders and addressing gaps and inefficiencies in people’s care by fostering a proactive, positive approach.

Understanding why fragmented care is a system-wide illness is a starting point we passed long ago. Looking at the health ecosystem as an ever-changing aggregate — kinetics — rather than separate sectors at fault is the opportunity to move beyond the present chaos.

Fragmentation goes beyond the left hand, not knowing what the right is doing. Too often, it means that the left hand won’t acknowledge the right hand’s very existence. While rising costs concern everyone, it’s essential to keep our eye on the goal of keeping people healthier at home, out of the hospital, and, if possible, far away from illnesses. To do that, we must address the misalignment of incentives and lack of coordination in the health ecosystem.

Applying Health System Kinetics will allow us to understand better how we can do this to provide better patient care, reduce health professional burnout, and give patients with chronic conditions greater attention. The objective study of the interconnectedness of the parts of the healthc system will promote a better understanding of how these components work together now — and how they can be changed to work better together in the future. Failing to take this approach means we won’t see meaningful change, and that’s not an option.

Do Not Let the Virus Kill its Host — the Health System

We have diagnosed the illness that plagues our health system; it’s a virus called fragmentation. It’s time to examine our biases, behaviors, and business goals. The primary mission is to recognize that we are people — sometimes patients — all seeking to enjoy a healthier life. Suppose fragmentation is the wall that separates us from better access to care. In that case, health professionals in every ecosystem sector can be empowered to pursue their calling with passion and tear down that wall.

Looking for a villain in the health ecosystem, something lawmakers have been doing for the last several election cycles, may be suitable for campaigning but not for progress — not for continued innovation and patient care. Progress can only be achieved when we get past the mindset of the period in which we have been — the period of acknowledging the system is fragmented — and move into the post-fragmentation era, in which we view the system through the lens of health kinetics and eco-dynamics.

When we look at and understand how all parts of the system work together — or fail to –we enter an era in which we no longer debate who’s to blame. Proper understanding will allow us to compromise, adjust our aims, improve our practices, and finally, make changes that remove the health system as its own beneficiary, replacing it with the patient as the system’s customer.

[Special thanks to John Bianchi for his review of this health policy economics article that shifts the conversation from sector-to-sector blame to a forward-looking perspective; to industry friend and mentor John Nosta for encouraging me to put these thoughts into publication and to Dr. Dean and Anne Ornish, pioneers in preventive and consumer empowered health and co-founders of Ornish Lifestyle Medicine.]

The post We Know the Health Ecosystem is Fragmented, Resulting in Rising Costs and Poorer Patient Outcomes, But What Are We Doing About It? appeared first on Medika Life.

Medika Life was given an opportunity to interview four HIMSS leaders – to hear more about plans for the Orlando global meeting and the priorities staff embrace year-round. It was clear that HIMSS staff see their roles as a professional responsibility and largely a public health mission.

Here are the #HIMSS24 Content Highlights:

• HIMSS Connect
• Keynotes
• Policy Issues
• Nursing and Informatics
• Start-Ups & Entrepreneurs

Gil Bashe, Editor-in-Chief, Medika Life: The health industry has many essential trade associations of different types that we know of.  PhRMA and BIO, and to some extent, HIMSS, could be seen that way, but it has grassroots membership. There are certainly very senior people in our industry who are HIMSS members. You could say HIMSS has grassroots and grasstops affiliations.

HIMSS – NOW 125,000 Strong

Christine Buck, Chief Marketing and Communications Officer, HIMSS:  Yes.  That’s right.  Let me offer context for Medika Life readers about HIMSS.  HIMSS is a 60-year-old organization and a global society that has evolved and changed.  It’s inspiring to see our community working to find solutions, thinking together as opposed to thinking in silos. And that’s what we need. We need to be the bridge. We need to be a transparent provider of democratized information.

Our membership has grown to more than 125,000 members. We landed on “Creating Tomorrow’s Health” because we are about the future, about bringing together individuals who care about generative AI and the patient. This is the difference between where we think about solutions not for the sake of an organization but the ultimate audience we all serve – patients. So that’s an exciting responsibility.

Bashe: I would very much appreciate knowing a bit about the fact that when we get together in two weeks in Orlando, some of the policy conversations will occur, from modernizing HIPAA to cyber security aspects. HIMSS is at the forefront of community building. It also tries to create a safe environment so that information can be used to improve the human condition. Could you share a little bit about that?

Tom Leary, SVP, Head of Government Relations, HIMSS:  Our policy initiatives are set by the board of directors and society members.  We are focusing on health equity. Everything needs to be pointed toward health equity so that we can leverage technology and data science to improve the human condition you’re talking about.

Specifically, concerning global conferences, we’re anticipating a lot of conversations in several key areas.

Artificial intelligence has just overtaken all the discussions around public policy. Several camps are starting to form. Some think AI is the panacea for the patient’s condition, provider burden, or any other categories we might want to discuss or that stakeholders might want to discuss.  The other camp is the fearful individuals- whether AI is taking their jobs or AI is making decisions where providers are not in the middle. It’s those kinds of conversations around artificial intelligence that we anticipate having.

Cyber security and data privacy.  The more that health care remains in the top five targeted sectors, we would fully anticipate a lot of conversation around how to maintain a high degree of vigilance and preparedness, and, quite frankly, both policymakers and our members want to talk about it, such as  “What do you know that I need to know so that I can better prepare my organization against a cyber-attack?”

Data modernization is a third key area for us that we anticipate a lot of dialogue on, particularly from the US perspective. What we saw from the global pandemic was a borderless global issue. Much investment in some areas, particularly in the clinical setting around technology advancements, resulted in excellent preparedness. However, we are still dealing with many paper-based approaches in the realm of public health and population health. So, how do you modernize the public health community?  We are facilitating ideas and conversations to address global public health priorities.

We’re very excited. A critical development in the last 48 hours is that the CDC Director, Dr. Mandy Cohen, will be the first CDC Director and, in close to 15 years, the only Director to address any HIMSS audience. More specifically, the top session that she’ll be sharing with the office of the National Coordinator is on the whole issue of data monetization. Those are three key areas that we’re looking at, particularly from a conference perspective. We can also get into some other year-round topics.

Challenges of Technology Linked to Patient Care

Bashe: I will want someone to address year-round topics because I see the annual meeting as the beginning or culmination of the year. I do have a question regarding innovation because we often talk about information. Still, I often find that many people from the digital health innovation sector attend HIMSS annually and at the national meeting.

Some of them come from chief technology offices or chief information offices or people involved in information services, or they’re people developing systems in terms of augmented intelligence or Chat GPT, the application of higher technologies to synthesize information.

Other people are looking at the integration of tools. Smart wearables, all these intelligent applications. I would very much appreciate your perspective as HIMSS leaders in talking a little bit about the role that HIMSS plays in supporting digital health innovation that collects and shares information.

Toni Laracuente, Senior Vice President & Global Head of Analytics, HIMSS:  My background in the clinical space is as a thoracic ICU nurse, which was my specialty for many years, and then I moved into quality improvements and Hospital Administration.

In the early days of electronic medical records, what you just described with nurses saying, “Oh, I don’t have time to look at that,” those were kind of the dark days of digital health, when systems were designed primarily as billing systems or departmental systems that were very focused on billing but had limited functionality and workflow process for the clinician, for the nurses, the doctors, physical therapists, and any other kind of ancillary professional service the patient may encounter.

Our practice within HIMSS analytics is genuinely focused on digital transformation. When I say digital transformation, I’m talking about the innovative, intentional, and clinically designed use of data and technology systems.

But people first, tech last. We look at people, processing data, and then technology because our approach is for digital transformation to be successful; it has to be person-centric and focused on the needs of the people who will be using and experiencing that technology.

It’s not a “one size fits all”.  The work we do with our digital maturity adoption models – you may have heard of the MRAM and ERAM adoption models. That’s the most well-known. But we have digital maturity models that span the entire care continuum. Suppose you consider any care delivery environment where a person may seek and access health care. In that case, our maturity models can assist and provide guidance and strategy for the digital transformation of those care delivery environments. The focus is on the person-centric or the patient-centric digital health ecosystem.

That is one of the presentations I’ll give at the global conference. It’s the use of digital maturity and digital transformation to build a person-centric digital health ecosystem. It needs to be a seamless process from the first encounter to the end of the encounter, from Pre-Natal right through to the End of Life.

Most importantly, it has to work seamlessly for everybody coming into contact with the system. So, that means using innovative technology. But the technology needs to work in the background. Then, the people using that technology can focus on their jobs. And we don’t have those situations where the nurses say, “Well, I don’t have time to read a digital health record.”

The response should be: “That is a tool that enables me to do my job so much better because I have access to the information that I need when and where I need it.” And the same is true for anybody, whether that’s the patient, the patient’s family, the physician, or any other healthcare provider.

Our maturity models are the focus of our work. All our maturity models have eight stages, and in the very beginning, at that stage of 0, 1, 2, which is pretty much where 95% of US and global healthcare systems sit in that early stage of digital maturity.

We often encounter process automation in some ways, but not digital transformation. Our tools and methodologies are designed to guide organizations from that piecemeal, fragmented use of technology and healthcare delivery to digital transformation, where you start at Pre-Natal and go through End of Life.

Leary: Regarding innovation, we’re very excited to have the ARAPH, the new Advanced Research Program Agency for Health (ARPA-H), which is a bipartisan development. They have about $2.5 billion that they want to spend on innovation, and they have a mandate to get the word out. Their deputy director is coming to the global conference to educate the healthcare community, from startups to large organizations, and to work with them.

Innovation can be stretched; what’s the next version of innovation in healthcare? They must find those innovative thoughts and voices and adequately fund them in a tight budgetary environment. Here in the US, they have $2.5 billion. And it’s a bipartisan belief that we need to continue to invest in that kind of approach.

It’s very similar to what happened with the 21st Century Cures Act. ARPA-H is new, and we’re very excited to have their senior officials there with us in the meeting with the startups and large organizations.

Global Meeting Hosting Government Leaders

Buck: I want to add that we have the South Korean Minister of Health is expected to attend, and representatives from Samsung Medical Center, which you’re going to be hearing a lot more about in terms of the innovation that they’re driving as a Stage 7 hospital system, but the message and the outcomes that they are going is a great touchpoint for all organizations around the world.

Bashe: To your point about the South Korean Minister of Health coming. It’s truly a global meeting, although it’s hosted in the United States.  

Hong Kong spends about 6 to 7% of its GDP on Health. They live about 15 years longer than we do in the United States. One of the things I find hopeful is that when I’m visiting and speaking to colleagues in other nations, most health information is digitized, consumers have their health records, and they are moveable.

Christine, to your point: when you and the senior staff are dealing with members of other governments worldwide, I imagine you’re serving an unofficial diplomatic role for the US health system with other people interested in sharing best practices. Could you give a glimmer about your global insights of not just dealing with the membership of HIMSS? I think you said there are 125,000 members now.

Buck: Toni, when you were speaking, the individuals in HIMSS come from a technology background; I have a FinTech background, and Toni is an actual patient care advocate. Everyone is invested in some way.  Hal Wolf, our CEO and President, is a person who works toward democratizing information between countries, dignitaries, and organizations, and that, to me, is a profound shift where we’re not keeping the information in for our benefit or someone else.

Our senior team comprises practitioners and developers of these new ideas, drawing ideas from the entire HIMSS staff and community. They’re leading panels like Toni or developing products.

Leary: The excellent collaboration between our organization and your experience has been so helpful to my growth—the beauty of what’s happening at global conferences. Perhaps we’ll get as high as 80 countries this year. They’re all searching for that digital health transformation approach, and sharing what they’ve learned and lessons they could learn from others is the key to the conference conversation and throughout the year.

The world looks at the 10-year investment that the United States made in digital health transformation, from 2010 through 2021, in the Medicaid/Medicare providers and all the providers that updated their systems. When the pandemic hit the United States, for all its politics around vaccination and immunization, aside from that, the United States was technologically ready to layer on telehealth services and various capabilities such as data and analytics because they’ve invested.

What we’re seeing in different parts of the world is curiosity about how the US did it, what kind of investment is needed, and what you would avoid if you were to do it again.

The Germans, for example, last year held a very impactful conversation with several members of the US Government on “If you had to do meaningful use over again, what would you do differently?” and struggling with the issue of not only provider burden but providers and patients “opt-in opt-out” of a program, whether it’s somewhere in Europe or Asia, or Central and South America.

They all want to get to that transformation—part of this conversation we’ll be having at our second Ministerial summit. Several years ago, we experienced the Minister of Tajikistan in one room, and the Columbian Minister of Health was in the next room, and they didn’t interact.

What we designed last year and again this year is a Ministerial Summit to talk about health equity, technology, and some of the capabilities we can all embrace as a community.

We’re expecting senior leaders from between 15 and 20 countries to sit around a table for two hours on Wednesday afternoon and continue the conversation into the evening at the international reception. They have those leaders together, talking about the vision for the future.

Bashe: The NGO element of HIMSS comes across. It’s a membership-based NGO. You are trying to advance collaboration and standards around how information can improve people’s lives and be somewhat universal. A nation’s borders do not trap information, and information shared can accelerate our understanding of how to deal with everything, from social determinants of health to the cost of health to the efficient use of health personnel, all that is driven by information. HIMSS is a depository of how processes impact performance in terms of health information. Would that be accurate?

Preparing for the Next Pandemic

Leary: That’s absolutely part of what we’ve seen over the last couple of years, which is that information sharing helps to advance not only individual countries but regional and global initiatives. The conversation that we had around the European health data spaces they developed for the EU was a big piece of legislation. There was concern that individual countries would be able to lock down their data.

If that is the case, what happened with the pandemic? What was the response to the pandemic, where data on COVID-19 from the early days of Asia would not have made their way to Europe, the United States, the Americas, and Africa? Researchers were able to work together because the data flowed from place to place, turning it into actionable information and vaccination and policies.

Suppose we don’t have those global dialogues around the power of the data and turning it into actionable information. In that case, you don’t have that kind of rapid response in a global pandemic.

Bashe:  As the HIMSS C-suite team, you’re part of a bigger puzzle. Your pieces have to align together, and I appreciate that. But regarding your mandate responsibility to the HIMSS community, could you share an expectation or hope you’d like to see come out of the upcoming meeting?

Buck:  My expectation and hope are that we create the energy for people to not just convene at one moment in time for a few days, but that it carries on 365 days a year and that we also create a stronger connection to the value that HIMSS bring to members, to organizational affiliates, to providers and patients. My goal is to get the human message out there and have all the passion and hard work come out from the team you see here and everyone who attends and creates that community.

Jim Burnett, Vice President, Engagement Strategies, HIMSS: HIMSS is an entire constellation involving research, analytics, government relations, professional development, and our chapter community. What we have is this community, which offers a wealth of engagement opportunities. In going through the study of all our different member communities, what I’m finding most clear is we need to draw people into that community from this important event. They need to come into the government relations group from the government; they need to go into the analytic tool sets to roadmap their digital transformation.

At the event, I hope our broader community is getting a lot more exposure and that we are helping people understand that it’s not this point in time. It’s not this individual session that you’re sitting in. It starts there and then crawls through that spider web through all these other supportive products and services that come out with the association.

Bashe: I notice that HIMSS members are deeply committed to the organization. It’s not like I’m sending in my annual check; they feel that by being a member of HIMSS, they are part of that conversation, part of the process of the evolution of the system, of how the information will be used.

Jim Burnett, how much of your role is spent in terms of looking at member retention and member acquisition, but also making sure that people understand the culture, the inherent values of HIMSS, and the responsibility that HIMSS feels in terms of how the information will be used to improve the health system?

Burnett: It’s about the overall value driven by the community and the collaboration. Most hospital systems aren’t in competition with one another. It’s the rising tide lifting all boats. To ensure that all these voices are heard, that their case studies are involved in our research, that their voices are indeed heard in the community, and that they can share their best practices.

That is the actual value of that community piece. It’s not necessarily the most prominent voices. You need to be able to pull from the corners of the room, draw people out, and get their perspectives on the conversation. I think that’s a critical point.

Professional Development to Initiatives on the Hill

Bashe: It’s not about digitally emailing your membership that their dues are up. Tom, how big is your policy team?

Leary: Our policy team is seven people. We deputize everyone on this screen, the rest of the organization, and the membership, so our policy team is 125,000 people. We’re seven staff. It’s a good thing.

Bashe: Is there a piece of legislation or conversation you and the team are hyper-focused on right now? What do you feel concerns the American health system here in the US?

Leary: We’re very focused on proper Office of National Coordinator funding.  They haven’t had a reasonable budget since their first year. They’re the little agency that can. 

There are two other pieces of legislation that we’re pounding on for this year. One is the telehealth provisions from the pandemic, which were extended through December of this year. And we’re working across the coalition to make that policy permanent. We’ve seen the benefit of telehealth. We’ve all benefited from it. The greater access and better healthcare outcomes. Those were set to go back to March 12, 2020, in terms of policy structure if we don’t make that policy permanent.

Laracuente: From an analytics product perspective, we are launching our newest digital maturity model, the infrastructure adoption model, and that launch is happening at our booth at 4 pm on Tuesday.

We’ve invested heavily in completely rewriting and modernizing this model. Throughout this session, we discussed using artificial intelligence, cyber security, and technology infrastructure. Overarching the in-frame model enables an organization to manage the risk of having technology. Financial risk, data, security, and privacy risk. And the risk that comes with user adoption and getting the greatest return on investment.

We’re launching that. But from an all-encompassing digital health ecosystem view. I love that you started this conversation by discussing the connections between patients with health problems. Jim mentioned that hospitals work together to try to lift each other in healthcare. When we look at health outcomes, all of the work we do in digital transformation is focused on improving the health of populations everywhere.

Part of what I’m touching on in my presentation on Tuesday is – are you familiar with the quintuple-

aim of health from public health improvement? Everything we do is focused on improving population health outcomes. Still, worldwide health care is focused on that overarching premise of the quintuple aim – improving access to care, improving patient experience, workforce experience, health, equity, reducing costs, and enhancing value for money.

We’re positioning our work in digital transformation and the maturity models in alignment with that. We’re very focused on how the digital security models deliver health outcomes and how those outcomes contribute to our provider organizations achieving success across those five domains of the quintuple.

You mentioned innovation earlier, and one thing that I wanted to touch on is when it comes to artificial intelligence, there’s a lot of discussion and hype around it, i.e., AI will take our jobs in healthcare. That couldn’t be further from the truth. AI will help us do our jobs much better, the jobs we’re all here to do, and why we get out of bed every day.

AI Will Unleash Waves of Practical Applications that Improve Patient Care

Bashe: There was a recent trending piece in Medika Life about pathologists and AI that reduces their attention when they feel they have more specificity and improve accuracy.

Laracuente: AI is perfectly positioned to do that when we look at the HIMSS mission around equity and health outcomes. I always start any conversation about AI and the workforce with the premise that AI will not replace healthcare providers or physicians. However, the physicians who use AI to do their jobs better and more efficiently will replace those who don’t.

Bashe:  The technology of the horseless carriage replaced blacksmiths through time. Technology has replaced professionals. I know that that’s very true. Humanity wins, hands down. It is unleashing as Innovation Theorist John Nosta proclaims, “the cognitive age.” Open-minded people who can hone their curiosity and ask the right questions will be valuable. Those who can’t put two words together will be in trouble.

Buck: That’s what I love about HIMSS – we’re substantive. We’re the real deal. We’re not fly by night. I love that about this whole conversation, but the entire organization and our community worldwide are the substantive providers of the suitable types of information people seek.

Bashe:  Everything is rooted in information. How we respect information, access it, and democratize it is essential. HIMSS is in incredible hands thanks to your collaborative leadership.  Thank you for sharing these thoughts and essential priorities for improved healthcare access and delivery to Medika Life readers.  I’m looking forward to continuing this conversation in Orlando.

Here is a special preview of the “Health Unabashed” interview with HIMSS CEO and President Hal Wolf on Healthcare NOW Radio from Monday, March 11th to Sunday evening, March 24th.

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Special thanks to Albe Zakes, HIMSS Director, Corporate Communications for facilitating this conversation with HIMSS leadership.

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