The health system is getting feedback from the front lines to make sure its Virtual Nursing program will meet expectations and become a permanent part of patient care
Virtual nursing programs require careful planning. And no one knows that better than the nurses.
“Including those bedside nurses [in planning] is the most important thing you can ever do,” says Laura Gartner, DNP, MS, RN, RN-BC, NEA-BC, Associate CNIO for Jefferson Health. “Because if you just try to [drop] a program into their unit without taking what they think is important, it’s not going to be successful because it’s not going to fit into their day or what they would value.”
Gartner is one of the point people for the Philadelphia-based health system’s Virtual Nursing program, which is entering its second iteration after a 90-day pilot in 2023 on two floors of one hospital. They’ve sharpened their focus now, she says, with funding for a more durable model and clear goals for sustainability and scalability.
“We’re not calling it a pilot any more because we’re not piloting this,” she says. “We know we’re moving forward with it.”
Jefferson Health is one of a handful of health systems across the country taking part in the HealthLeaders Virtual Nursing Masterminds program, a series of virtual meetings capped off by an in-person event in June. The program is taking a deep dive into virtual nursing strategies with perspectives from some of the top health systems and executives in the country.
Gartner says involving nurses in every phase of the program is crucial, because they know what will work and what won’t. And as Jefferson Health moved beyond the pilot and began to map out a more permanent program, those nurses helped to point out that the bedside nurse and the virtual nurse are two different roles requiring unique skillsets.
“A lesson we learned is that talking to a person through a computer is much different than talking to a person where you can, say, touch their shoulder,” Gartner says. The bedside nurse has always had that in-person connection to patients that influences every task from care delivery to communication. Simply taking a nurse, putting him or her in front of a computer in a separate room and telling him/her to continue being a nurse won’t cut it.
“That’s a little bit of a different conversation and skill set,” she notes, adding that Jefferson Health is working with a local nursing school to plot how to teach “webside” manner.
Gartner says the health system “threw out a broad net” in coming up with goals for the pilot, and has since narrowed its focus.
“With that first phase pilot, use cases came out of the woodwork,” she notes. “But if you focus on everything, do you really make a difference on anything?”
Where they do want to make a difference is on stress, which affects everything from nurse turnover to quality and safety.
That’s why it’s important, Gartner says, to create a partnership between the floor and virtual nurse, so that they’re working together on patient care. And that involves making sure both nurses are comfortable in their roles and their environments.
“I do hope that goes beyond just assigning the tasks to someone, so more of that working in concert with each other, being part of that care team, like you were there on the floor.”
The HealthLeaders Mastermind seriesis an exclusive series of calls and events with healthcare executives. This Virtual NursingMastermind series features ideas, solutions, and insights onexceling your virtual nursing program.Please join the community at our LinkedIn page.
To inquire about participating in an upcoming Mastermind series or attending a HealthLeaders Exchange event, email us at exchange@healthleadersmedia.com.
The House Ways and Means Committee has approved a bill that would extend CMS pandemic-era telehealth waivers another two years and the Acute Hospital Care at Home waiver another five years
While prospects look dim for making pandemic-era telehealth waivers permanent, a bill before Congress could at least extend some flexibilities and one popular program beyond the end of this year.
The House Ways and Means Committee has voted to advance the Preserving Telehealth, Hospital and Ambulance Access Act (HR 8261), which would, among other things, continue pandemic-era Medicare waivers enacted by the Centers for Medicare and Medicaid Services (CMS) for telehealth access and coverage through 2026 and extend the CMS Acute Hospital Care at Home waiver for an additional five years, to the end of 2029.
Those waivers had been set to expire with the end of the COVID-19 Public Health Emergency but were continued to the end of this year.
With regard to telehealth waivers, the proposed legislation would waive geographic and originating site restrictions on telehealth delivery, enable federally qualified health centers (FQHCs) and rural health clinics (RHCs) to use telehealth, expand the list of providers able to use telehealth, allow providers to use audio-only telemedicine platforms, such as the phone, and enable behavioral health providers to treat patients via telehealth without a required initial in-person evaluation.
In addition, the bill would give health systems five more years to seek reimbursement from Medicare for Hospital at Home programs that meet the requirements of the AHCaH waiver. More than 300 health systems are currently running programs that meet the CMS requirements.
Supporters say the House committee’s markup and approval of the bill is good news at a time when positive steps forward are hard to find. A number of bills before Congress have sought to make the telehealth and Hospital at Home waivers permanent, but despite seeing widespread support on both sides of the aisle, none of those bills appear to be going anywhere this year.
“While we prefer Medicare telehealth flexibilities be made permanent, we understand the dynamics and applaud the Committee for a two-year extension of many of the critical flexibilities without arbitrary and unnecessary guardrails such as in-person requirements,” Kyle Zebley, senior vice president of public policy for the American Telemedicine Association and executive director of ATA Action, said in a press release.
Zebley pointed out that the committee’s markup and approval of the bill isn’t a guarantee that Congress will pass or even vote on the bill. He also noted that some proposals, including one that would ease rules around the use of telehealth to prescribe controlled substances, were left off the passed bill.
“This is not over yet,” he said. “There will be additional markups and other committees need to weigh in, as we continue to push for telehealth permanency.”
A UCSF study has found that a ChatGPT-4 LLM can prioritize Emergency Department patients for treatment with 89% accuracy
Healthcare organizations looking for help prioritizing patients in the Emergency Department could benefit from an AI tool developed by researchers at the University of California San Francisco (UCSF).
Researchers tested the ChatGPT-4 large language model (LLM) on 10,000 sets of patients seen at the UCSF ED between 2012 and 2023, and found that the tool accurately assessed clinical acuity in 89% of the cases. A subset of 500 cases evaluated by a clinician as well as AI found that AI outperformed the clinician, 88% to 86%.
The study, which appears this week in JAMA, could give health systems a valuable tool for triaging ED patients, particularly during times of heavy traffic or staff shortages. By assessing severity more quickly, the hospital could direct ED staff to those patients in need of emergency care and speed up time to treatment, eventually improving clinical outcomes.
“Imagine two patients who need to be transported to the hospital but there is only one ambulance, or a physician is on call and there are three people paging her at the same time, and she has to determine who to respond to first,” Christopher Williams, MB, BCHir, a UCSF postdoctoral scholar at the Baker Institute and lead author of the study, said in a UCSF press release.
Using data from more than 250,000 ED visits, Williams and his colleagues used an AI model to extract data from clinical notes and determine the severity of the injury. They then compared that analysis to the patient’s score on the Emergency Severity Index (ESI), which rates patients on a scale of 1-5 and is used by ED nurses to prioritize care delivery.
The ESI “uses an algorithm to categorize patients arriving at the ED, estimating the severity of their condition and anticipated future resource use,” Williams and his colleagues said in the study. “The ESI is assigned based on a combination of initial vital sign assessments, the patient’s presenting symptoms, and the clinical judgment of the triage clinician, who is often a trained registered nurse. By capturing clinical acuity at triage, the ESI can be used as a surrogate marker to evaluate, at scale, whether LLMs can correctly assess the severity of a patient’s condition on presentation to the ED. This can be achieved by providing the LLM with patient clinical histories documented in ED physician notes, prompting the model to compare histories to determine which patient has the higher acuity, and evaluating the model output against the ground truth as determined by ESI score.”
While proving the value of the AI tool, Williams pointed out that the technology shouldn’t be introduced to an ED just yet. An incorrect assessment could cause delays in treatment that could harm the patient or even lead to death. In addition, AI tools could reflect biases caused by the data used to train the model, further expanding care gaps for underserved populations.
“It’s great to show that AI can do cool stuff, but it’s most important to consider who is being helped and who is being hindered by this technology,” William said in the press release, while calling for more clinical trials and research. “Is just being able to do something the bar for using AI, or is it being able to do something well, for all types of patients?”
The South Carolina health system, part of the HealthLeaders Virtual Nursing Mastermind series, is learning to measure ROI in specific, actionable tasks, such as communication
A key component to launching an effective Virtual Nursing program is communication. How will the virtual nurse communicate with the floor nurse, as well as with the patient?
“Clear delineation of roles and communication is going to be really important,” says Emily Warr, administrator for the Center of Telehealth at the Medical University of South Carolina (MUSC), which launched a second iteration of its Virtual Nursing program about six months ago and is now monitoring the program in five hospitals.
Warr says it’s critical to identify specific KPIs in evaluating the success of a Virtual Nursing program, and to focus on small, measurable actions rather than larger concepts. For example, it’s great to say such a program will reduce time spent on admissions and discharge, but there are many factors that go into those processes that Virtual Nursing won’t affect.
“A virtual nurse, as one member of the team, cannot carry all of the factors that impact, say, an HCAHPS score on a unit,” she points out. A more effective way of measuring value would be to focus on single factor, such as how communication between nurses affects admissions or discharge times.
MUSC is one of a handful of health systems across the country that are taking part in the HealthLeaders Virtual Nursing Masterminds program, a series of virtual meetings capped off by an in-person event in June. The program is taking a deep dive into virtual nursing strategies with perspectives from some of the top health systems and executives in the country.
MUSC launched its first version of a Virtual Nursing program about two years ago, with a focus on mentoring new nurses. Warr said that program didn’t produce the ROI needed to be sustainable, so the health system looked for more “hard outcomes.” That led to a discussion about how to identify meaningful outcomes and understand the KPIs that go into defining a program’s value.
“We needed to focus on something that we felt we could impact and choose to measure,” she says, such as “very specific, task-oriented things.”
In the six months that version 2.0 has been in play, Warr says they’ve learned a few things about those tasks. During the first two months, as everyone was getting used to the new approach, the virtual nurse would often reach out to the floor nurse to take tasks. But as time has passed, the floor nurse is reaching out more often tp the virtual nurse to hand off tasks. In other words, the two nurses are communicating more freely (and equally) about their workflows.
Warr anticipates those conversations will lead to a smoother or more seamless collaboration between floor nurse and virtual nurse, which in turn will lead to better administrative outcomes and, eventually, improved clinical outcomes.
“We’re still learning and evolving (in) what we’re tracking … and where we’re able to make a measurable impact,” she says. But the results so far are truly encouraging.
The HealthLeaders Mastermind seriesis an exclusive series of calls and events with healthcare executives. This Virtual NursingMastermind series features ideas, solutions, and insights onexceling your virtual nursing program.Please join the community at our LinkedIn page.
To inquire about participating in an upcoming Mastermind series or attending a HealthLeaders Exchange event, email us at exchange@healthleadersmedia.com.
The health system will be launching a new platform this month to improve care management for patients in cancer treatment
As health systems across the country look for small but significant ways to use AI, Intermountain Health is putting the technology to work improving care management for patients in cancer treatment programs.
The Salt Lake City-based health system is partnering with San Francisco’s Memora Health on a care management platform designed to reduce the workload on nurses and give patients quick and seamless access to the resources they need.
"The moment a person is diagnosed with cancer, their life changes,” Derrick Haslem, MD, Intermountain’s senior medical director for cancer care, said in a March press release announcing the partnership. “Being able to provide consistent communication with patients to address questions and concerns about their care is critical and very important to us, Memora's technology helps our busy care teams with daily tasks and empowers them to focus on what matters most: delivering high-quality care to our patients."
Phil Wood, program director for Intermountain Ventures, says the health system is looking for ways to insert AI into care management pathways that typically take a lot of time and effort. By using the technology to handle messaging, which is primarily and administrative task, Intermountain is freeing up its nurses and clinicians to focus on clinical work.
“It doesn’t change the messaging,” Wood points out. “Clinicians want to have control over the patient’s care. This [creates] a more effective way of communicating … and gives nurses back their time to focus on more acute and urgent cases.”
The platform uses AI to help patients with their care plan once they’ve left the hospital or doctor’s office, answering patient questions and guiding them to online resources. When a question or concern is complex, the system connects the patient with the care team for follow-up.
Wood, noting Intermountain hopes to have the program up and running by the end of this month, says success hinges on whether the patients engage with the platform and feel comfortable with the technology. Early KPIs will focus on engagement surveys and patient satisfaction scores, while other benchmarks will target whether patients follow their care plans, especially in medication adherence, and whether operational workflows are improved.
As health systems look to adopt consumer-facing technology, healthcare leadership will need to focus on those questions. Where can technology replace a clinician and where might it interfere with the relationship between doctor (or nurse) and patient? And can the platform (and the health system) adjust to patients uncomfortable with the technology and preferring more in-person interactions?
Wood says the oncology space is the ideal space to test the platform because of the importance of communicating with patients at home. Once this program is established and the value proven, he expects to expand it to other surgical services, and perhaps eventually into chronic care management. At the same time, Intermountain will be looking for new opportunities for EHR integration as the health system continues its switch from Cerner to Epic.
“Having an easy way for the patient to interact with the health system” is crucial to improving patient engagement and clinical outcomes, he says.
While disruptors are having a hard time figuring out healthcare, health systems and hospitals are embracing telehealth as a standard of care
As the American Telemedicine Association gathers next week for its annual conference, attendees will find plenty to discuss.
Telehealth had its moment in the spotlight with the pandemic, when both the healthcare industry and consumers found they couldn't live without it. While adoption dropped with the return to in-person care, the general consensus is that telehealth is now a part of the care spectrum. The best evidence of this may be the announcement that both the Joint Commission and the National Committee for Quality Assurance are developing new accreditation standards for virtual care.
That said, telehealth advocates are still waiting for policy and regulations to catch up. Many states have upgraded their telehealth guidelines in the wake of the pandemic, and the Centers for Medicare and Medicaid Services (CMS) has made some of its pandemic-era telehealth waivers permanent while extending others to the end of this year. Several bills before Congress aim to make those waivers permanent, but there's no guarantee that any action will be taken on those bills.
Finally, the direct-to-consumer and primary care telehealth marketplace is seeing some upheaval. Walmart's recent announcement that it is shuttering its in-store clinics as well as its telehealth program wasn't entirely unexpected—UnitedHealth is shutting down Optum Virtual Care, CVS Health isn't seeing any growth, and both Amwell and Teladoc have been encountering problems as well. Those companies are finding that telehealth for primary care isn't profitable, while health systems are finding those telehealth services are still in demand, and necessary.
At the ViVE 2024 conference earlier this year in Los Angeles, Sheeza Hussein, Steady MD's chief growth officer, noted that the direct-to-consumer telehealth industry is awash with small companies (and providers) offering virtual care for specific services, like pediatric care, sexual health, and weight loss. This, along with functional medicine, or testing and diagnostic services for chronic care, and pharma companies are driving the growth in DTC telehealth.
These issues and more will dominate the discussion at ATA's Nexus event next week. For a further look at what to expect, listen to this podcast with Nate Lacktman, a partner in the Foley & Lardner law firm, chair of its national Telemedicine & Digital Health Industry Team, and a member of the ATA's Board of Directors.
The health system is putting 'Telehealth for Nursing' to the test in one hospital, and getting results that will aid in scaling and sustaining the program
Intermountain Health's new Telehealth for Nursing program may be checking all the boxes for a virtual nursing pilot, with KPIs that focus on improving patient outcomes and cutting down on wasted time. But executives are also keeping an eye on the intangibles.
Becky Fox, chief clinical information officer for the Salt Lake City-based health system, and HealthLeaders Mastermind participant, says an innovative program has to include an "other" box, especially when it deals with front-ling clinical work. That's because nurses can take a new idea developed by health system executives and make it better.
"We kind of leave it as an 'other' field because we know that nurses are the best entrepreneurial, innovative folks, and if anyone's going to figure out another way that anyone can use telehealth and these technologies, then our nursing staff are going to do it," she says. "We always have a KPI that's other things we have learned or other benefits that we have seen along the way."
Intermountain is one of a handful of health systems across the country that are taking part in the HealthLeaders Virtual Nursing Masterminds program, a series of virtual meetings capped off by an in-person event in June. The program is taking a deep dive into virtual nursing strategies with perspectives from some of the top health systems and executives in the country.
Like so many other health systems, Intermountain is just getting started on the journey, with a small pilot program in one hospital. Fox says the concept was launched to address not only the ongoing nursing shortage, but to improve the patient experience. The pilot program uses a virtual nursing station within the hospital and shifts nurses on the unit between in-person and virtual care.
Fox says the program will evolve as Intermountain learn more about the nuances of virtual nursing, but she has been surprised so far in how the nurses are responding. While visiting the hospital a few weeks ago, Fox says she talked with a nurse involved in the pilot.
"She said 'I really wanted to do follow-up,'" Fox recalls. "'This patient told me this amazing story of his life. I really connected with him.' And so she wanted to do a follow-up. So that goes in the 'other' category."
"So now we're looking at, as other healthcare organizations have done, do we have a follow-up telehealth visit with that patient with that nurse, [maybe] two days later, to say 'Hey, Mr. Smith, I just wanted to see how you were doing. You were telling me the other day that you were concerned about this. Have you had your needs met? And having that [extra] touchpoint."
"What I also heard was the value that the nurse felt with [the program]," Fox adds. "That's one of the things that has [resonated], the gratitude. When we see that and hear that and feel that from patients, that's one of the things that we oftentimes hear in [nurse] burnout stories. That they didn't feel that they got to be their best."
Fox says Intermountain executives are learning a lot from this pilot program, and that both nurses and patients are seeing the value.
"They do feel connected regardless of the fact that the nurse is on a laptop, a mobile cart, or whether they are connecting with the clinician on a big monitor in the room," she says. "They feel like they're being supported, educated, and know how to care for themselves when they go home."
Those feelings, Fox says, will help executives as they move from a pilot in one hospital to a program in several hospitals. And that's why the 'other' box is just as important as any of the KPIs.
The HealthLeaders Mastermind seriesis an exclusive series of calls and events with healthcare executives. This Virtual NursingMastermind series features ideas, solutions, and insights onexceling your virtual nursing program.Please join the community at our LinkedIn page.
To inquire about participating in an upcoming Mastermind series or attending a HealthLeaders Exchange event, email us at exchange@healthleadersmedia.com.
With an aggressive innovation strategy, the New Jersey health system wants to be a force of change rather than a passive participant
Healthcare innovation is a popular topic these days as healthcare organizations strive to redefine care delivery in a time of tight margins and increasing competition. But for all the talk of AI, virtual services, and value-based care, how do executives identify what needs to be changed?
Health systems looking for an innovation model could check out the Atlantic Health System. The New Jersey-based organization, comprising six hospitals and more than 400 care sites, is fostering new ideas through the Atlantic Health Venture Studio, which not only offers capital investments but also provides mentorship, forges strategic partnerships with new and emerging companies and offers product and service c-development for in-house partners.
"We wanted to take a more proactive and intentional approach," says Doug Hayes, the studio's executive director. "We don't want to just passively receive the innovations that are coming out of the market. We want to actually help play a role."
Hayes, who ran his own New York City-based venture studio for eight years and was a partner and executive director of Blueprint Health, launching close to 50 VC-backed digital health startups, joined Atlantic Health roughly three years ago, when the health system had decided to develop its own venture studio.
The timing was right. Coming out of the pandemic, many health systems were struggling with staff shortages and mandates to improve care, while the innovation landscape was filled with new ideas and technologies aimed to tackle those pain points. At the same time so-called disruptors, such as Amazon, Google, Walmart, and the large pharmacy chains, were jumping into the sandbox with new strategies aimed at addressing healthcare's problems and giving consumers an easier way to access care.
Hayes points out that the disruptors, coming in from more consumer-friendly industries, are "very good at what they do. [And] that's a type of thinking that … we're not accustomed to thinking in healthcare."
But healthcare is different—as proven by Walmart's decision to close its in-store health clinics and telehealth program, UnitedHealth's shuttering of Optum Virtual Care and the continuing problems faced by Teladoc and American Well. Hayes notes that healthcare organizations can embrace new ideas from outside the industry and perhaps even partner with disruptors, but they have to own their innovation strategies.
In other words, they want to be the disruptor.
"We're not going to be looking to them to think about what we've got to do," he says. "We have a growing internal competency and fluency around innovation."
In other words, healthcare organizations like Atlantic Health aren't necessarily interested in the next shiny object. They're focused on creating a comprehensive strategy that identifies new ideas and tools and fosters growth and integration into the enterprise.
Hayes says the venture studio has developed a few key guidelines along the way:
Don't mix innovation with the operating budget. Atlantic Health separates its investment funds from the operations budget, instead using long-term capital to support innovation. Hayes says it's important to make clear that innovation isn't taking money that would otherwise be used for salaries, new hires, or other operational expenses.
Innovation and technology are also separate. The key to enacting any meaningful change, says Hayes, is change management. Oftentimes the most meaningful changes come in workflow redesign or operational adjustments. New tech is a tool that can be used to achieve better or new results, but there's a lot of groundwork that has to be done first.
"Goals are for people who want to accomplish something once, and systems are for people who want to accomplish something repeatedly," he points out. "We're trying to set up a system."
Good ideas can come from anywhere. Ditch the thinking that the only good ideas come from the management level. Clinicians and nurses have the front-line knowledge to come up with the most effective workarounds, or new ideas to address pain points. Likewise, a small start-up might see things differently than a tech giant and come up with a better solution. Hayes says the key is to create an atmosphere that welcomes ideas from any and all sources and gives them the right support and resources to develop.
An example of this, he says, is Atlantic Health Advancements (AHA), a $500,000 fund set up to catalyze ideas from within the health system. The program targets small projects, often process innovations typically generated from front-line staff like nurses. A program like this, Hayes says, instills an interest in employees to be creative and come up with new ways of doing things, while giving management a forum for letting those ideas gain traction.
Be nimble, and ready to act quickly. "Anyone or any health system that thinks they can predict where the future of technology is going to lie in 18 months is lying to you or themselves or both," says Hayes. Healthcare organizations have to diversify their approach to innovation, pivoting when something doesn't work out and being willing to "look under the hood" just to see where a new idea or tech might go.
And at a time when healthcare organizations are struggling to make ends meet, an important benchmark for any innovation is ROI. Hayes says Atlantic Health treats this business line as any venture studio would.
"We want outsized and uncorrelated returns," he says. "And we don't just want the return. We want these partners to make us smarter."
That's what health systems across the country are pursuing. And while the so-called disruptors are taking a hit at present, it's imperative that healthcare executives understand the need for change, and the value of affecting that change rather than waiting for change to happen.
"The things that got us here won't get us there," says Hayes of the push to redefine care. "Our patients don't ow us a lifetime of committed usage … so we need to earn their business over time."
The changes are aimed to close gaps around HIPAA and help healthcare organizations and consumers control the use of personal health information
Federal officials are making sweeping changes to regulations around digital health apps and platforms in an effort to combat data breaches and fill in the gaps around the Health Insurance Portability and Accountability Act (HIPAA).
The U.S. Federal Trade Commission (FTC) last week announced final changes to the Health Breach Notification Rule (HBNR), which requires vendors of personal health records (PHR) and related entities that are not covered by HIPAA to notify individuals, the FTC and, in some cases, the media of a breach of unsecured personally identifiable health data. The rule also requires third-party service providers to vendors of PHRs and PHR-related entities to notify such vendors and PHR related entities following the discovery of a breach.
The changes aim to close loopholes caused by the proliferation of third-party apps and platforms in the digital health ecosystem and give both healthcare providers and consumers more control over the use and reliability of healthcare data.
“Protecting consumers’ sensitive health data is a high priority for the FTC,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. “With the increasing use of health apps and connected devices, the updated HBNR will ensure it keeps pace with changes in the health marketplace.”
The changes include:
Revised definitions. Several definitions were rewritten to include health apps and similar technologies not covered by HIPAA. This includes redefining “PHR identifiable health information” and adding new definitions for “covered healthcare provider” and “healthcare services or supplies.”
Clarifying ‘breach of security.’ A “breach of security” will now include any unauthorized acquisition of identifiable health information that occurs as a result of a data security breach or an unauthorized disclosure.
Revised definition of PHR related entity. The definition of a “PHR related entity” will now cover entities that offer products and services through the online services, including mobile applications, of vendors of personal health records. It also makes clear that only entities that access or send unsecured PHR identifiable health information to a personal health record — rather than entities that access or send any information to a personal health record — qualify as PHR related entities.
Clarifying multiple sources of PHR identifiable health information: The final rule clarifies what it means for a personal health record to draw PHR identifiable health information from multiple sources.
Expanded use of electronic notification: The final rule authorizes the expanded use of e-mail and other electronic means of providing clear and effective notice to consumers of a breach.
Expanded consumer notice content: The required content that must be provided in the notice to consumers has been expanded to include the name or identity (or, where providing the full name or identity would pose a risk to individuals or the entity providing notice, a description) of any third parties that acquired unsecured PHR identifiable health information as a result of a breach of security.
New timing requirements. For breaches involving 500 or more individuals, covered entities must notify the FTC at the same time they send notices to affected individuals, which must occur without unreasonable delay and in no case later than 60 calendar days after the discovery of a breach of security.
Improved readability. The final rule also includes changes to improve the rule’s readability and promote compliance.
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.
