A new FDA program aims to develop strategies and guidelines for health systems delivering care in the patient’s home
Health systems are getting more help planning new remote patient monitoring (RPM) and acute care and hospital at home programs.
The U.S. Food and Drug Administration (FDA) has announced the launch of the Home as a Health Care Hub, a resource designed to help healthcare executives understand how to design programs that deliver care in the home setting. As part of this program, the FDA’s Center for Devices and Radiological Health (CDRH) is contracting with an architectural firm to explore how healthcare and health equity can be included in home design.
“While many care options are currently attempting to use the home as a virtual clinical site, very few have considered the structural and critical elements of the home that will be required to absorb this transference of care,” Jeff Shuren, MD, JD, director of the CDRH, and Michelle Tarver, MD, PhD, the CDRH’s deputy director for transformation, said in a press release.” Moreover, devices intended for use in the home tend to be designed to operate in isolation rather than as part of an integrated, holistic environment. As a result, patients may have to use several disparate medical devices, some never intended for the home environment, rather than interact with medical-grade, consumer-designed, customizable technologies that seamlessly integrate into an individual person's lifestyle.”
The program builds on an intriguing trend in healthcare, in which health systems and hospitals are looking to shift more services out of the hospital, clinic, and doctor’s office and into the patient’s home. This includes RPM programs that enable care teams to monitor patients at home, either by gathering patient data at selected times or with continuous monitoring, and acute care and hospital at home programs that combine RPM, virtual care, and in-person care.
That transition isn’t so easy. While the consumer technology industry is seeing huge growth in wearables and smart devices that include healthcare uses, clinicians are wary of the reliability of data coming from these devices and don’t know how to use them. As well, while the home offers a new setting for healthcare delivery, clinicians need to better understand the both the challenges and the advantages of delivering healthcare in that setting.
“We have an untapped resource in the home,” Hon Pak, vice president and head of the digital health team at Samsung Electronics and a former Kaiser Permanente executive, said during a CES 2024 panel on this topic this past January in Las Vegas. “Fundamentally, we have to change the model” of how care is delivered.
The new program will also take aim at another key strategy in healthcare innovation: Addressing health inequity, or challenges to healthcare access and treatment caused by social drivers of health.
“This partnership includes collaboration with patient groups, healthcare providers, and the medical device industry to build the Home as a Health Care Hub,” Shuren and Tarver said in the press release. “This prototype will serve as an idea lab, not only to connect with populations most affected by health inequity, but also for medical device developers, policy makers, and providers to begin developing home-based solutions that advance health equity.”
“Existing models that have examined care delivery at home have found great patient satisfaction, good adherence, and potential cost savings to healthcare systems,” they added. “By beginning with dwellings in rural locations and lower-income communities, the planned prototype will be intentionally designed with the goal of advancing health equity.”
The two executives said the program is part of a redesign of healthcare to focus on the patient, with care plans that meet a patient’s needs and desired rather than a plan that forces the patient to adjust to new roles or routines. As such, care providers need to understand the environment around the patient.
“The Home as a Health Care Hub prototype is the beginning of the conversation—helping device developers consider novel design approaches, aiding providers to consider opportunities to educate patients and extend care options, generating discussions on value-based care paradigms, and opening opportunities to bring clinical trials and other evidence generation processes to underrepresented communities through the home,” they said.
The new will be unveiled sometime this year as an AR/VR prototype.
A study launched in 82 HCA Healthcare hospitals found that an AI tool could help staff identify and react to an infection and help contain an outbreak
Healthcare organizations are training an AI tool to rapidly identify outbreaks within a health system, giving clinicians more time to contain the infection and treat patients.
A four-year study in 82 hospitals across the US, recently posted in The New England Journal of Medicine, found that the automated tool reduced potential outbreaks by 64% compared to traditional methods of identifying an outbreak. The tool identified potential outbreaks, on average, three times per year per hospital.
“Outbreaks in hospitals are often missed or detected late, after preventable infections have occurred,” Meghan A. Baker, MD, ScD, a Harvard Medical School assistant professor of population medicine at the Harvard Pilgrim Health Care Institute and lead investigator of the study, said in a press release. “This study provides a practical and standardized approach to identify early transmission and halt events that could become an outbreak in hospitals.”
Funded by the U.S. Centers for Disease Control and Prevention (CDC), the CLUSTER study was conducted in 2019-22 at hospitals within the HCA Healthcare system by a team of investigators from HCA, the Harvard Pilgrim Health Care Institute, and the University of California, Irvine (UCI) Health.
The research aims to help a healthcare industry still reeling from the effects of the COVID-19 pandemic (which, coincidentally, interrupted this study) and looking for better methods of tracking outbreaks before they cripple hospitals and harm more people. Researchers are turning to AI tools to sort through data and more quickly and accurately identify trends.
“Despite significant progress in reducing healthcare-associated infection outbreaks, including of antimicrobial-resistant pathogens, they remain an industry challenge and can present as clusters that signal potential for transmission to patients,” Joseph Perz, DrPH, MA, senior advisor for public health programs in the CDC’s Division of Healthcare Quality Promotion and a committee member for the CDC’s Council for Outbreak Response: Healthcare-Associated Infections, said in the release. “The CLUSTER trial provides evidence that early detection powered by automation tools and quick action can prevent outbreaks from growing.”
In this trial, researchers created an “algorithm-driven statistical detection tool” that combed through laboratory data for signs of more than 100 bacterial and fungal infections, then posted real-time alerts to infection control programs. The process included both an automated review of patients’ clinical cultures and a statistical assessment of whether patients with these specific infections were increasing in number.
The results of the study were affected by the COVID-19 pandemic. According to researchers, automated alerts weren’t as effective during the pandemic because hospital staff were so busy that they weren’t able to respond to the alerts in time. Researchers decided instead to focus on the results gained prior to the pandemic.
The research team said the underlying software will be available to all health systems, but it must be integrated into their EHR and other clinical workflow platforms.
The ONC and The Sequoia Project have added new enhancements for FHIR adoption in version 2.0 of the Common Agreement, which sets thew stage for nationwide interoperability through the TEFCA framework
Federal officials are showing further support for FHIR with the release of version 2.0 of the Common Agreement, which established the foundation for the Trusted Exchange Framework and Common Agreement (TEFCA) data exchange framework.
HL7’s Fast Healthcare Interoperability Resources (FHIR) Application Programming Interface (API) exchange has long been seen as a key element to nationwide interoperability, but many are worried that healthcare organizations are ready to embrace the standards just yet. Version 2.0, released by the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) and The Sequoia Projects, ONC’s Recognized Coordinating Entity (RCE) for TEFCA, includes enhancements and updates for FHIR support.
“Today’s release includes framework enhancements, including greater use of FHIR, better support for use cases beyond treatment, and simplified onboarding for participants like clinicians, digital health apps, public health agencies, and other end users of health data,” Mariann Yeager, The Sequoia Project CEO and RCE lead, said in a press release.
“We have long intended for TEFCA to have the capacity to enable FHIR API exchange,” ONC chief Mickey Tripathi, PhD, added in the release. “This is in direct response to the health IT industry’s move toward standardized APIs with modern privacy and security safeguards, and allows TEFCA to keep pace with the advanced, secure data services approaches used by the tech industry.
"What makes us different is we're offering [patients] immediacy."
A new disruptor is taking aim at the healthcare industry’s busiest site: The Emergency Department.
Concierge care programs designed specifically for urgent and emergency care are finding support from consumers who don’t want to wait several hours in an ED, along with primary care providers who don’t want to send their patients there. The service offers a cash-only alternative to the ED and could pull more patients away from hospitals and health systems.
“The experience [of an ED] is so challenging,” says Brad Olson, CEO of Sollis Health, which operates 11 clinics in New York City and the nearby Hamptons, as well as California and South Florida, and serves some 18,000 members. “What makes us different is we’re offering [patients] immediacy.”
Launched in 2016 in New York as Priority Private Care, Sollis is building a business model through partnerships with consumers, primary care providers, and businesses who want to avoid the traffic and time spent in an ED, which sees more than 130 million visits a year. The company offers a concierge care model that bypasses payers, and also offers a range of services that include diagnostics, labs and vaccines, virtual care, specialty care, even house calls.
The model adds another wrinkle to the crowded urgent care market, where hospitals and health systems are already competing with retail and stand-alone urgent care clinics that not only pull patients out of the ED, but offer additional resources and connections that pull a patient further outside the health system’s orbit of care.
Olson is quick to point out that Sollis Health is a disruptor, but not necessarily a competitor to health systems and hospitals—he notes the company has partnerships in place with more than 30 health systems for everything from ED services to specialty consults. He notes one clinic is located not far from Cedars-Sinai in Los Angeles and is partnering with the hospital even while giving consumers an alternative to Cedars-Sinai’s ED.
The ’disruptor’ moniker is important. Olson, a former executive with Peloton and Starwood Hotels & Resorts, brings a retail mentality to healthcare that is propelling companies like Amazon, Walmart, and Walgreens in the healthcare space. He notes that consumers are turning away from hospitals and health systems because of the complexity and cost of healthcare, and they certainly don’t want to wait several hours in a crowded hospital waiting room for fragmented care that leads to more scheduled visits in other locations.
The University of Rochester Medical Center is banking (literally) on a new strategy for extending its telehealth network into rural areas of New York.
In a partnership with Five Star Bank, Verizon, and digital health companies Higi Health and Dexcare, URMC is co-locating telehealth stations in Five Star branches across the western part of the state. The model aims to improve access to care for rural residents, especially those on Medicaid and Medicare, who face geographical and technological barriers.
Michael Hasselberg, PhD, URMC's chief digital health officer, says the health system came out of the pandemic seeing measurable benefits in a telehealth platform for rural residents, but most were using a phone to access care. In order to include Medicare and Medicaid reimbursements, URMC needed to establish an audio-visual telemedicine link.
Tackling social determinants of health (SDOH)
There will be many benefits to this new model, and tackling SDOH is one. Co-locating a telehealth station in a bank gives URMC an opportunity to address several SDOH.
"Financial health is so closely tied to physical health," noted Hasselberg, who said a patient could be referred to the bank right after the telehealth visit for help understanding, planning for, and paying medical bills. "We might be able to affect healthcare access and financial instability at the same time."
Hasselberg sees plenty of opportunities to expand the program, not only to other bank branches and potentially other banks, but to assisted living and skilled care facilities, which struggle to connect their patients to the care they need. In addition, he sees more services being available through the kiosks, including chronic care management and follow-up care. They could even be used as access points for resident sot connect with local primary care physicians.
"We all went into this going, 'This may be a nothing-burger,'" he said. "And patients [may] go, 'I don't know about getting healthcare in a bank.' But what if it does work? That's the really exciting part. Because if this does work, it could be transformative. It could be replicated across other health systems and across other banks across the country."
The Mayo Clinic is working on an AI tool that will integrate with the EHR, prompting clinicians to identify and address both SDOH and clinical bias.
Researchers at The Mayo Clinic in Arizona are developing an AI tool within the EHR that will help clinicians identify and address social determinants of health—including when their own actions contribute to clinical bias.
The health system is partnering with TruLite Health to create a platform that will enable both clinicians to identify SDOH and take steps to address access and care gaps. The AI tool, called Truity, mines patient data for signs of health inequity and develops patient-specific recommendations for care management.
“It incorporates so many factors, including social determinants of health, in a real-time, easily accessible platform that is available to the clinical team [and] to the patient,” says Nathan Delafield, MD, FACP, an internal medicine physician at the Mayo Clinic who’s working on the technology.
Delafield, who’s working with two other researchers to get the tool ready for implementation later this year, says health system leaders are anxious to take on some of healthcare’s biggest access challenges but not at the expense of adding more task to already overworked providers.
“For decades, our healthcare system has been challenged by the gradual acknowledgement of healthcare disparities, without meaningful, tangible solutions to address them,” he says. “But evidence would suggest that most physicians are ill-equipped to meaningfully address them.”
Research by Deloitte indicates that health inequities cost the U.S. healthcare industry about $320 billion a year, and that price tag could top $1 trillion by 2040 if the industry doesn’t take action. That would include understanding why health systems spend thousands of dollars more per year to treat minorities for a variety of chronic conditions than to treat white patients with the same health concerns.
Healthcare organizations are making it a priority to address SDOH, but many have struggled to find the right strategy. Some are developing tools that address specific challenges like food insecurity, while others create separate platforms to address SDOH from outside the EHR, requiring providers to take extra steps to include that in care management.
Delafield says the Mayo Clinic is taking its time with this technology to make sure it’s integrated into a provider’s regular workflow.
“We want to be really diligent” about taking the time to study workflows and make this interoperable with minimal disruption, he says, rather than developing a tool that “becomes another source of excessive clicks.”
The technology, he says, will be designed to analyze patient data from a wide variety of sources to not only identify the barriers to care but also common clinical practices that may lead to health inequity. This would give clinicians an opportunity to learn how health inequity may be created or sustained by a doctor’s actions.
And it will also be made available to patients, he says, “so that patients will understand that these things are being considered as we’re evaluating their overall healthcare.”
Aside from giving providers patient-specific care management recommendations, the platform will also be designed to connect patients with health coaches employed by TruLite Health. Over time, Delafield says, as Mayo Clinic providers learn how to identify and address SDOH and clinical bias, they’ll likely develop the skills to become health coaches themselves.
“I think we will see some clinical change [and] some behavioral change that will improve clinical outcomes,” he says.
The California-based cancer care center is launching two mobile health units this year to bring screening services and other resources to underserved communities.
One of the nation’s largest cancer care providers is launching a mobile health program to boost access to screening services for underserved populations.
City of Hope, based in California, is rolling out a fully staffed mobile health clinic to neighborhoods in Antelope Valley and greater Los Angeles, and plans to launch a second vehicle later this year. The two clinics will offer mammograms and screening capabilities for as many as 15 different types of cancer, as well as resources for further care coordination and treatment.
"Our comprehensive mobile cancer prevention and screening program is the next step in our mission to expand access to optimal cancer care, bringing our expertise outside the walls of our campus and into the communities we serve,” Harlan Levine, MD, president of health innovation and policy at City of Hope, said in a press release. “We know that identifying and addressing cancers early saves lives, and we want to do our part to ensure every person has access to these services and help create a healthier, more equitable future for all.”
City’s of Hope’s mobile health strategy is a growing trend in the US, as more and more healthcare organizations look to address healthcare access issues and bring more services to consumers in their homes, businesses, and communities. Mobile health programs can reach people who might not be able to or want to visit a doctor, and who might be ignoring or postponing a health issue that, left unchecked, could become serious, even fatal.
The program is supported by a Health Resources and Services Administration (HRSA) grant secured with the help of California Rep. Mike Garcia; it will be sustained, officials say, through charitable donations.
With HLTH, ViVE, and HIMSS, the industry seems to have settled on a schedule for fostering new ideas and technologies
As the busy exhibit hall at this year’s HIMSS24 conference in Orlando can attest, healthcare’s biggest technology event is back. But that success is tied to a change in how the industry’s decision-makers view HIMSS and its main competitors, ViVE and HLTH.
Simply put, HIMSS is becoming the place to talk collaboration and make technology deals that power a lot of the industry’s innovation efforts. But unless they’re appearing in a session or accepting an award, the C-Suite is staying away and delegating that authority to others—namely, executives who are actually using the technology.
“We need to understand what clinicians really want,” said David Sides, president and CEO of NextGen Healthcare. “And the value is in the details.”
And the ROI has to be immediate.
“Everyone is focused on doing more with less,” added Brendan Watkins, chief analytics officer at Stanford Children’s Health. “So when you look at something, you look at how it delivers the right insights to improve decision-making.”
At HLTH and especially ViVE, the C-Suite was notably present. And CIOs, CEOs, CTOs, CNOs and CFOs weren’t coming for the free food, drinks, and entertainment (though that may have helped). They were making the trip to get together with their peers and discuss strategy, and to see some of the newer ideas and technologies that aim to push healthcare out of its doldrums and advance value-based care.
HIMSS CEO Hal Wolf said as much during his press get-together as HIMSS24 opened this year. He’s not looking to attract the top-level executives, but targeting those within the health systems and hospitals who benefit the most from the technology. They’re the ones who can really define the ROI for a new platform or tool and tell their bosses whether it’s working or just costing valuable time and money.
That deals were being made at HIMSS this year is proof that the industry is focused on using technology to address its biggest pain points. AI and security were the top topics, and while health systems and hospital leaders were looking for solutions and partners to address those needs, vendors were talking to each other as well about collaborations that would create enterprise-wide, multi-point products instead of niche solutions.
“There’s quality, and then there’s paper cuts,” said David Linz, MD, chief medical informatics officer at Florida’s NCH Healthcare. “You want something that makes a difference.”
And many of these conversations were fueled by discussions that had started at HLTH and carried over to ViVE (or were even begun at CES). At those events, executives bounced ideas off each other and talked about how the industry as a whole could embrace the technology it needs. The panels and discussions were more high-level, reflecting an industry intent on collaboration.
With that in mind, the healthcare industry seems to be settling into a rhythm that will define the innovation landscape. The ideas and debates will percolate up through HLTH and ViVE, then find footing at HIMSS through deals and collaborations.
The Match IT Act of 2024, now before Congress, would create a federal definition for 'patient match rate' that providers would address as they would a clinical quality measurement
A new bill before Congress aims to jump-start the unique patient identifier conversation by creating a healthcare industry standard definition for “patient match rate” and improving provider efforts to match patients with their health records.
The Patient Matching and Transparency in Certified Health IT (Match IT) Act of 2024, introduced in February by US Reps. Mike Kelly (R-PA) and Bill Foster (D-IL), would, if passed into law, set the bar for providers in matching patients to their records. It would establish the patient match rate as a clinical quality measurement, creating standards by which providers identify patients with their services and information.
The legislation addresses a key pain point in the interoperability arena, where supporters have long argued for the establishment of a unique patient identifier (UPI), or individual code similar to a social security number that would be used by providers to identify and match patient data. While that debate has bogged down (with some critics blaming the heated political environment), this bill would move away from that issue and give health systems something to work with.
“We have this major issue in the industry that’s costing lives, costing money, costing time [and] causing a lot of frustration,” says Aaron Miri, MBA, FCHIME, CHCIO, senior vice president and chief information and digital health officer at Baptist Health Jacksonville. “This gives us [an opportunity] to create a measurement of success, a benchmark.”
Clay Ritchey, CEO of digital identity management company Verato, said the bill comes as the industry is making a “mad dash” toward digital transformation and interoperability. Healthcare executives are struggling, he says, to manage and use vast amounts of data, including unstructured data coming in from outside the EHR, and trying to avoid data silos as they move toward value-based care.
“We often don’t know who’s who across each of these touch points,” he says. “That’s why we need meaningful standards in place.”
In a press release introducing the bill, Kelly said 35% percent of all denied claims result from inaccurate patient identification, costing the average hospital $2.5 million and the industry more than $6.7 billion annually. In addition, the cost of repeated or unnecessary care due to inaccurate medical data costs $1,950 per patient inpatient stay and more than $1,700 per ED visit.
And that’s not counting the patients who suffer harm from an unnecessary medial procedure (such as surgery on the wrong site or incorrectly prescribed medications).
"This legislation would promote interoperability of patient matching systems, which would protect patients and decrease burdens on healthcare providers,” added Foster.
The bill has drawn support from a number of healthcare organizations, including HIMSS, CHIME, and AHIMA, all part of the Patient ID NOW coalition. Another member of that coalition is Intermountain Health, whose chief digital and information officer, Craig Richardville, MBA, CHCIO, also backs the bill.
“[T]his legislation will address our nation’s current inability to consistently and accurately identify patients to their health records. Improved standardization of patient demographic data will lead to more accurate patient matching, which in turn will produce advances in patient safety, more complete information for clinical care, and cost savings from reducing the need for repeated medical care, among other benefits,” Richardville said in a Patient ID NOW press release on the legislation.
Aside from reducing patient harm and unnecessary medical expenses, Miri said the bill would gives hospital and health system executives an important tool in managing patient data—including that of their own doctors and nurses. And with Baptist Health Jacksonville managing some 35 million unique patients now and seeing roughly 100 people a day moving into northern Florida, the health system needs to keep track of who it’s treating and hire more clinicians to handle the growth.
It would also fit well with the industry’s emphasis on patient-centered care and patient engagement initiatives.
“We have a consumer demand that’s insatiable for their own data,” he points out.
So while the UPI argument seems stalled, advocates for the Match IT Act of 2024 are hoping that bipartisan support will propel the bill at a time when Congress is struggling to agree on anything.
The health system is working with a Norwegian digital health company to develop an app that would allow parents to test their babies at home
Intermountain Health is developing a digital health app for smartphones that will help parents identify jaundice in their babies at home.
The Salt Lake City-based health system is partnering with Norwegian digital health company Picterus AS to create the app, which would use a smartphone camera and a laminated card to measure bilirubin levels in newborns without the need for a return trip to the hospital or clinic and a blood draw.
“Bilirubin and jaundice management has long been based in the hospital and the clinic,” Tim Bahr, MD, an neonatologist who is leading the study, said in a press release. “Taking a newborn to the clinic or laboratory for frequent blood tests in the first days of life can be a huge inconvenience and burden on families. We hope to simplify this care and move more of it into the home. This is a win for families and for our healthcare system.”
The app addresses a care management pain point for hospitals. According to the March of Dimes, three of every five babies born in the US develop jaundice within days after birth. Many recover quickly with little medical intervention, but jaundice can lead to serious health concerns, including Hyperbilirubinemia, brain damage, or hearing loss, if untreated.
Intermountain, which greets and tests 33,000 newborns a year, aims to turn the smartphone into a diagnostic tool that would enable parents to quickly check their baby’s health at home after discharge from the hospital, and to contact their care providers if jaundice is evident. Parents would use their phone to snap roughly six photos of the laminated calibration card placed on the chest of their baby, and the app would translate those photos into a diagnosis.
“We do know that parents are pretty good at taking pictures of their babies,” Bahr noted in the press release.
“This technology is exciting to us because it makes it possible to measure the bilirubin in a baby without taking blood,” he added. “Right now, the only way to measure bilirubin levels in babies is to take them to a laboratory and draw blood. By having this technology available on a smartphone, we will eventually empower parents to make these measurements without having to leave their homes with an easily accessible and affordable tool.”
The health system is testing the digital health tool on about 300 term babies born at Intermountain Utah Valley Hospital in Provo, Intermountain McKay-Dee Hospital in Ogden, and Intermountain Medical Center in Murray, as well as on about 100 pre-term babies. They’ll test the app against the traditional method of drawing blood.
If proven reliable and introduced to clinical care, the app could not only save new parents the hassle of return trips and treatment, but help providers identify and treat jaundice earlier and more effectively, improving clinical outcomes and reducing costs.