Steward Health Care has a six-point action plan to emerge as a sustainable business, but will it work?
On the heels of a tumultuous few months, Steward Health Care is now moving into its next operational phase: “sustainability.”
How will it do this? Well, from funding to asset sales to leadership communication, Steward says it has a plan to stay afloat.
But first, let's revisit how we got here
As we know, Steward, established over a decade ago through a partnership between a private equity firm and a CEO with a mission to revitalize struggling Boston-based hospitals, grew to 33 community hospitals spanning eight states.
However, the health system, facing challenges since late last year, found itself in a financial crisis.
Seeking restructuring advisors in January has sparked rumors of a potential bankruptcy filing.
As media coverage continues to intensify on Steward's struggles in Massachusetts, the health system's ability to overcome these obstacles and maintain its strong position in the healthcare industry remains uncertain, but as stated, Steward says it has a plan.
Digging out
OK, back to the plan. Steward says it is implementing a six-point action plan to emerge as a sustainable business. Let’s take a look at what Steward has in store.
Funding and Financial Stability
According to the press release, Steward has recently finalized a robust financing agreement that will provide a $150 million cash infusion to provide additional liquidity as the company marches towards the sale of its highly desired asset physician group Stewardship Health.
This would allow Steward to reset its operations and address vendor obligations.
“Included in these agreements, the lenders have provided an additional ‘vote of confidence’ in this plan. They have not only decided to increase their financial commitment to Steward through the bridge loan, but they have also agreed to extend their forbearance agreement through April 30, 2024, to give the Company time to execute this plan,” the release says.
Employee Retention and Continuity
To maintain staffing and levels of care, Steward has successfully negotiated new labor agreements with the MNA and SEIU and secured and maintained its pension plan for employees, according to the press release.
It is continuing to incentivize its employees to ensure that medical centers and physician’s offices are open and continuing to serve patients and the broader community.
Steward says it has instituted a plan to attract nursing employees to work at its busiest hospitals and has offered “referral” fees to current employees of up to $40,000 per hired employee.
Asset Sales
Steward is in process and working proactively to immediately sell non-essential assets, including Steward-owned aviation and downsizing its non-patient footprint through back-office consolidations.
In addition, Steward is continuing to actively seek strategic opportunities to divest non-core assets with a focus on improving the system’s liquidity position, the press release says.
Northeast Restructuring
Steward has retained Alix Partners to advise on a restructuring of Steward to better support their hospitals.
Cooperation and Transparency in Massachusetts
Steward sent a letter in response Governor Healey on February 21.
“Steward has tried to be transparent, compliant, and cooperative over the years in providing a significant amount of detailed and relevant financial documentation to various state agencies and regulatory bodies and moving forward it commits to do even better,” the press release says.
Leadership Communication
Senior Steward representatives intend to meet with public officials in the Commonwealth to discuss the go forward plan for ensuring continued first-class care to its patient population.
What’s in store for the future?
While a solid plan of action is a step in the right direction, Steward's financial crisis could be far from over.
There's even worry of a potential ripple effect causing problems for hospitals all over the country. In fact, Federal officials say the uncertainty surrounding the future of Steward's hospitals could result in tougher regulations of for-profit health care.
This situation should serve as a cautionary tale for other hospital and health system CFOs. It highlights the importance of closely monitoring financial health, diversifying revenue streams, and being prepared for unexpected challenges.
The success of AI varies, and depends largely on proper implementation.
AI is currently being implemented in many aspects of nursing, including documentation, admission and discharge processes, measuring and monitoring vitals, and data collection and analysis.
According to Betty Jo Rocchio, Senior Vice President and Chief Nurse Executive at Mercy, a lot of thoughtful planning goes into ensuring that AI won’t become a disruptor to nurses.
Here's what CNOs need to know about AI in nursing.
With ViVE 2024 picking up steam this week in Los Angeles, here's what attendees are talking about
A few trends picked up during the first two days at ViVE 2024:
Telehealth isn't dead. Despite the recent struggles of Amwell and Teladoc, two of the biggest kids in the sandbox, telehealth is as popular as ever. The growth is being driven by disruptors, non-traditional providers and others who want a quick and seamless path to connect their patient/customer to a clinician.
Sheeza Hussein, chief growth officer at Steady MD, says the industry is swamped with small companies offering personal treatments for a wide variety of issues, like women's health, weight loss, behavioral health, and even pediatric care. There are also companies offering functional medicine, or testing and diagnostic services that provide a more detailed look at a chronic condition. On top of that, pharma companies are looking for telehealth platforms for consumers involved in studies, and pharmacies are looking to expand their base of services.
The end result is a market flooded with telehealth opportunities, and a challenge for health systems and hospitals trying to keep their place in the market. Jen Goldsack, CEO of the Digital Medicine Society (DiMe), says Amazon's recent launch of its chronic care platform (with Omada as its first partner) offered a clear warning sign to healthcare executives that they have to keep up—and rather than think about the disruptors as competitors, look instead for ways to collaborate.
Amwell President and CEO Roy Schoenberg, MD, MPH, moderating a panel session on the intersection of old and new ideas in healthcare, noted research that says one-quarter of all healthcare experiences will be digital by 2030.
Nurses need help. No segment of the healthcare ecosystem is more in need of new ideas and technology than nurses, who are facing the brunt of workforce shortage and stress/burnout issues. The American Telemedicine Association convened a special summit late last year on Virtual Nursing, and ViVE has its own special track this week.
The challenges are many. Nurses are retiring young or quitting. Having lived through the chaos of COVID, they're suffering from stress, and they're often at the center of competing priorities and philosophies within the hospital. New strategies for teaching the nurses of tomorrow and building the workforce are great, but unless hospitals and health systems change the environment by giving them tools to improve their workload, it won't make much of a difference.
More and more care will be in the home. The Acute Hospital Care at Home program, supported by the Centers for Medicare & Medicaid Services (CMS), took off during the pandemic and is now in place in more than 300 health systems across the country. The CMS waiver that enables organizations to get Medicare reimbursement for the program is due to expire at the end of the year, but the talk here is that CMS will extend that waiver as it seeks more data on the program's overall costs and value, especially in clinical outcomes.
That being said, the strategy won't go away. Healthcare executives are embracing remote patient monitoring (RPM) as a means of connecting with patients at home, reducing return and emergency visits, and improving chronic care management. Patient engagement and satisfaction are growing in importance as benchmarks, and patients would much prefer to stay at home, where studies have shown they tend to heal faster.
The acute care at home concept, which combines aspects of RPM and telemedicine with in-person care, will likely evolve far beyond the model being used now, regardless of reimbursement. Some health systems have already stood up their own programs independent of the CMS model and are working toward sustainability. Others are working with payers to support the program. In short, the value of the home in managing and improving care is significant.
AI moves beyond potential. This has already been said, but ViVE is proving the point. For the past year everyone has talked about the promise of AI to address and maybe even solve healthcare's biggest problems. It's time to prove that point. Many health systems have multiple AI projects up and running (some with more than 100 separate programs or uses). And they're starting to see the data that proves value. While the technology is still relatively young and there are a lot of questions to be answered around data gathering, monitoring, and especially governance, healthcare executives want to see the ROI of specific applications now.
Cybersecurity is back on the agenda. With the Optum news hanging over the convention center this week and recent studies indicating a 140% increase in data breaches over the past year, healthcare executives are once again talking about security and privacy. AI certainly plays a part in that conversation, but what's more important is the need for an industry-wide approach, supported by federal policy. The Biden administration has taken some steps to create a national framework of best practice, but the talk here is that some, if not all, of those recommendations should be mandatory.
Virtual care, wearables, and AI are going to revolutionize nursing, says this CNO.
On this week’s episode of HL Shorts, we hear from Lisa Dolan, Senior Vice President and Chief Nursing Officer at Ardent Health Services, about technological trends in nursing. Tune in to hear her insights.
AI can be a huge disruptor, but it has a lot of potential.
AI is currently being implemented in many aspects of nursing, including documentation, admission and discharge processes, measuring and monitoring vitals, and data collection and analysis.
However, the success of AI varies, and depends largely on proper implementation.
According to Betty Jo Rocchio, Senior Vice President and Chief Nurse Executive at Mercy, a lot of thoughtful planning goes into ensuring that AI won’t become a disruptor to nurses.
“It’s not just automated intelligence, but how we augment that intelligence that the nurse brings to the bedside,” Rocchio said.
Solving problems
Ultimately, the goal of any CNO wanting to implement AI in their workforce is to solve problems and make the delivery of care more efficient and effective.
“We can never replace the care that we deliver and the critical thinking of a nurse,” Rocchio continued, “but we can help nurses be much more equipped to be able to deliver… care in a much more streamlined fashion.”
Rocchio said Mercy is partnering with Epic and Microsoft, along with other resources, to implement new processes and smaller innovations that will lead to larger future projects.
One problem that the team at Mercy is trying to solve is handoffs between departments. Typically, according to Rocchio, when a patient arrives in the emergency department and is admitted, there is typically a handoff from the emergency department nurse to the inpatient nurse.
To make this process more efficient, Mercy is exploring the use of AI to first develop a note from the emergency department record, then develop the key points in an AI automated fashion. The last step would be to deliver that note to the inpatient nurse via the nurses’ mobile phones.
“We’re trying to use AI to scour that record and deliver the most important points up to the inpatient nurse without nursing having to intervene,” Rocchio said.
AI is also assisting CNOs, not just bedside nurses.
Mercy has launched a workforce platform that allows the team to get the right clinician to the right spot without manual intervention. Rocchio said they are using AI in the background to calculate the number of necessary shifts and set the rate on incentive shifts for nurses who want extra work.
“Just like [how] Uber and Lyft use a supply-and-demand model and use data in the background,” Rocchio said, “we’re starting to use that in healthcare to be able to develop our workforce and get them in the right spots at the right time.”
AI technology can also help with hiring and recruiting processes.
“We use platforms now for hiring and recruiting that [help] candidates get to the right spot for interviews quicker,” Rocchio continued, “as well as deliver information to the candidates and collect [candidate] information… [that helps us] prioritize the areas we want to focus on.”
Challenges and concerns
As with any new technology or trend, there are challenges that come along with implementation, that CNOs should carefully consider before moving forward.
“An office is a very dangerous place to start making decisions about clinical areas from,” Rocchio stated.
The nurses themselves do have concerns about AI, but not about the use of it. The concern lies with understanding how AI will fit into their nursing practice. Nurses want to make sure that AI is going to actually be incorporated into their workflows.
“There’s no concern as long as [implementing AI] isn’t done to [nurses], but it’s done with them,” Rocchio said.
Patients, on the other hand, are very excited about AI technology. According to Rocchio, patients want information to come to them quickly and completely, and if AI can accomplish that, then they view it as a positive.
“It’s just frightening to [patients] if [information] comes in pieces,” Rocchio said, “but if it’s a part of their standard care and they can see it, they’re embracing their piece in helping us reach their healthcare goals.”
Solutions
To help test new AI and mitigate some of these concerns, Mercy has launched innovation units where frontline staff can also give their input. The innovation units are there to help not only nurses, but also staff in other departments, to see where the technology could help them in their workflows.
“It’s not just AI off to the side, it’s AI embedded into the workflows and how that comes together with the frontline giving us their feedback on how it works,” Rocchio said. “We’re doing some rapid cycle improvement processes with this and making sure that we’re taking the frontline into account.”
Alongside innovation units, Mercy has put up electronic boards in every patient room that provide a connection point for information between the patient, the family, the nurse, and the physician. The boards also help speed up communication and set goals with the patient, said Rocchio.
“We’re finding [that] the power of those boards and connecting [them] into the electronic health record is helping nurses think about how they plan their day better,” Rocchio said, “and I think that’s going to be a real game changer.”
Additionally, Mercy has been using AI in the background to monitor the blood sugar of patients living with diabetes, Rocchio said. The AI tool pushes information to the patient and allows physicians and nurses to see that information as well. Clinical staff can then clearly communicate with patients in a timely manner and help them manage their blood sugar. The data can also be g used to monitor health trends for the patient.
“If it’s buried in a medical record, somebody has to dig it out to have communications,” Rocchio said, “but when AI serves it up to the physician, the nurse, and the patient, we’re able to stay on top of it in real time.”
Measuring outcomes and success
According to Rocchio, Mercy has already seen great outcomes from the testing they’ve done in their innovation units, and in other areas of the health system. In general, the team has been able to take information and compare it with other metrics.
“We export that data into dashboards and allow our frontline nurse leaders to make good decisions around filling shifts [and] how often they need help,” Rocchio said, “in a very automated fashion, so they don’t have to manually do it.”
The same thing is true for patients, the data is aggregated, and both patients and providers are able to track, trend, and monitor patient health conditions.
Mercy has been measuring how many EHR clicks are being saved i through a mobile platform that nurses can use to chart at the bedside.
“To date, we’ve saved over 200,000 clicks in the electronic medical record,” Rocchio said, “which is important because that keeps nurses by the bedside, not spending time in documentation.”
Advice for CNOs
The implementation of AI technology can be overwhelming, so it’s important that CNOs approach it carefully and strategically.
“Get a partner that’s been working in the AI lane, like Microsoft or Google, or somebody that’s used it outside of healthcare first,” Rocchio said. “[Somebody] that understands the limitations as well as the power of it, because we’re just dipping our toe in and we want to make sure we use it in the right way.”
Rocchio recommends looking at the problems in workflows and addressing them in ways that do not involve manual intervention, but use technology or analytics to present the problem in a different way.
“It takes us leaders thinking about things differently and how to solve them,” Rocchio said, “because today the world’s moving in a while different direction.”
Everyone's talking about gen AI, but how is it actually being used?
While Hollywood may be all abuzz at the quickly rising fortunes of Barry Keoghan, generative Ai is seeing a similar ascendancy in healthcare. But will both avoid the bombs and tabloid headlines and fulfill their potential?
As ViVE 2024 kicks into gear today at the Los Angeles Convention Center, AI is on everyone’s minds. And while the past year has seen stories ad infinitum on the promise for large language models and gen AI to rid healthcare of its biggest headaches, the talk on the floor is that it’s time to show everyone what it really does.
“Every health system is investing a great deal in AI solutions,” says Harjinder Sandhu, chief technology officer for Microsoft’s Health and Life Sciences Platforms and Solutions, a partner for many health systems putting AI to the test. “You have to. There’s really no choice. But readiness really depends on the complexity of the use case and the risk of the use case.”
“What I see is a lot of caution,” he adds. “[Health systems] are being very tentative in thinking about these use cases. I see a lot more confusion than I see jumping too fast right now.”
Sandhu, who will be part of a ViVE panel this week discussing AI readiness, says healthcare leadership is understandably cautious in moving forward with projects that carry a lot of risk, especially as the industry is still trying to figure out governance. But that doesn’t mean they haven’t come up with plenty of ideas.
“I’ve literally been in sessions where, over a four-hour period, you’ll have a group that puts Post-It notes on a board with, like, 300 use cases,” he says. “And [they’ll] say ‘Here’s all the different areas we want to be able to impact.’”
Some of the biggest, brightest Post-It notes are focused on using gen AI to capture conversations and turn them into valuable clinical information in the EHR. At a time where every healthcare organization is dealing with a shortage of clinicians and a surge in stress and burnout, it’s those tasks that are causing the most conflict. Those in the know call it “pajama time,” as in the time spent by clinicians each evening at home going over their notes from the day’s patient encounters and translating them into information they can use for care management.
Microsoft and Nuance recently rolled out DAX Copilot, which integrates directly into the Epic EHR. It’s one of several tools from a number of AI vendors aimed at that particular pai n point.
“It’s probably one of the fastest growing products that we have witnessed in terms of how quickly physicians are taking to it and adopting it,” Sandhu says of the market in general. “It is starting to make an enormous difference in how physicians view their work and their work-life balance.”
This particular tool captures the conversation right after it has taken place, giving clinicians their notes immediately after the patient encounter, while the conversations are still fresh. They can review those notes for accuracy, then submit them into the EHR.
That review process is crucial. The technology is still relatively new, and still liable to make mistakes. That’s why practically any use of AI in healthcare at this time needs a “human in the loop” to review and sign off on the final product.
“You have to approach [AI tools] always with a hint of skepticism,” Sandhu points out. “Be a little bit skeptical about what they produce and double-check and triple-check.”
But the benefits are significant. Any tool that can integrate easily into a clinician’s workflow and reduce translational tasks—especially during nights and weekends—pulls time away from the computer and puts it back where it should be: In front of the patient or the family. Sandhu says those tools should see the lion’s share of adoption over the next year or two, especially as clinicians test them out and vendors work to fine-tune the process. It’s worth noting that gen AI is designed to learn as it goes along, so that a tool will learn a clinician’s habits and language and become better at transcribing.
Beyond that, Sandhu says healthcare decision-makers are keen to apply gen AI to another crucial pain point: Nursing workflows. Nurses are struggling just as much, if not more than, any other healthcare provider, and they need AI to reduce that overload and put them back in front of patients. But they also need technology that is designed for them.
Even farther out, Sandhu sees an expanding market for gen AI technology that can capture and, more importantly, analyze conversations. Consider a tool that that study the patient encounter for signs of mental health distress, enabling specialists or even primary care providers to identify patients in need of help just by how they talk to someone.
“We’re kind of in this new age of literacy with AI,” he says.
So at this point, as the attendees at ViVE settle in under a crisp California sun, a lot of talk will be about what’s on stage now, and how it’s playing in the market, and not so much about that next big thing or the future blockbuster. It’s nice to see where this will all go, but there’s a view among the executives that new ideas have to show ROI now, not later. Healthcare needs help now.
Probably not, but next week’s conference will bring together an impressive list of C-Suite decision-makers to discuss how some of the newest and most innovative strategies and technologies are being put to use
From overstressed nurses to overeager AI enthusiasts, next week’s ViVE 2024 conference in Los Angeles aims to take on some of the biggest issues in healthcare innovation.
The annual event, co-produced by HLTH and the College of Health Information Management Executives (CHIME), targets the healthcare industry C-suite in innovation and technology with an agenda that’s heavy on panels and presentations. Topics of discussion will include disruptors in the healthcare space, AI, data management and interoperability, policy, sustainability, and digital health.
In keeping with a growing theme in healthcare conferences this year, ViVE has created a special program for nursing leaders. Faced with high rates of stress and burnout, nursing execs are looking for strategies and technologies that not only improve workflows and wellness, but also take advantage of the nurse’s unique skills and front-line care duties. This includes everything from new ideas for nurse education and training to the adoption of Virtual Nursing programs.
The conference comes at a crucial time for the industry. With tech companies like Apple, Google, and Microsoft and retail giants like Amazon, Walmart, and Walgreens applying new ideas to the healthcare space and a current economy that puts a premium of reducing costs and finding an immediate ROI, health systems and hospitals are under a lot of pressure to do better. That may be why the agenda features an impressive number of healthcare executives, including panels with as many as three execs from different health networks.
Specifically, they’ll be talking about topics like the rapid rise of Generative AI, VC investment in health system ownership, consumer-facing and retail strategies in care delivery, remote patient monitoring and home-based care, challenges with scaling and sustaining telehealth and virtual care platforms, and data management and analysis (a wide-ranging topic that includes interoperability, cybersecurity, and patient access to data).
As with many conferences, the value to C-suite executives will be in seeing where these concepts are already being put to use, and whether they’ve proven their value. Decision-makers want to see that value now, rather than in a few years, and they’ll be looking for programs already in place, with clear benchmarks and outcomes.
And while any event like this shines the spotlight on new technology, like AI and VR, the industry is shifting its perspective to look for value not in point or niche solutions, but tools and platforms that can be integrated into larger, enterprise-wide programs. Returning attendees often make it a point to see which vendors from previous conferences are still exhibiting and which “shiny new objects” have dulled and been pushed aside.
And if that isn’t enough, there will also be a Billy Idol concert.
CNOs must be role models in a healthy work environment, says this nursing leader.
There is an overwhelming sense of nurse dissatisfaction in the industry, due to exhaustion from heavy workloads, staffing shortages, workplace violence incidents, and other external disruptors.
A healthy work environment is necessary for nurses to thrive, and for patients to get the highest quality care and experience when visiting a health system.
As part of our coverage on healthy work environments, we sat down with Vicki Good, Chief Clinical Officer at the American Association of Critical-Care Nurses (AACN), to learn more about the AACN's six standards for a healthy work environment, and the new Health Work Environment National Collaborative program.
Stephen Ranjan believes teamwork is just as crucial as technology in building successful digital healthcare solutions in the pharma space
Stephen Ranjan learned how to be innovative while growing up in India.
"Living in India, you learn to be resourceful," the global head of digital health at Roche Pharma recalls. "You don't have access to everything, and yet you still find ways to solve the challenges that you encounter. I brought that attitude with me when I came to the U.S."
When Ranjan moved to America to attend college, he found a market for his skills, and a career was born.
"In the U.S., if you can help people solve problems, they will give you opportunities to do so,” he says. “I ended up working at the help desk of my university. I built software that allowed the help desk to track student loaner laptops. This job paid for my college."
At his first job at Epic Systems, Ranjan was introduced to how software can enable efficiency in healthcare. He says he wanted to introduce those technology solutions to the pharma industry, where there were plenty of problems to be solved.
He's had plenty of opportunities. Prior to joining Roche, Ranjan held positions at Merck & Co. and Johnson & Johnson. He says he has seen digital health technology advance, but it still has many more opportunities to improve the patient's health journey.
"About 15 years ago, the industry was just beginning to dabble with technology in the form of websites, social media, and those types of things," he says. "But over the years, pharma has gone through a transformation. The uptake at first started on the sales and marketing side, but in the last 10 years, there has been more investments in the R&D side, especially right now with AI. That has been a huge, huge transformation."
Ranjan says most of the advancements in patient care have been made in cardiovascular, metabolic disease, and mental health, where technologies like continuous glucose monitors are helping patients self-manage their care.
A Lifetime of Experience
Today, Ranjan is using his years of experience to steer the company toward more digital health innovations that improve patient health management. Before he became global head at Roche, he was responsible for the Roche Diabetes Care Digital Health business, where he was instrumental in the growth of engaged users on mySugr and the Roche Diabetes Care Platform.
Ranjan says one of his biggest achievements happened in 2017, while he was working at Merck. He and his team collaborated with the Alexa team at Amazon and Luminary Labs to create an open innovation challenge in diabetes. The task for contestants was to discover a way to use voice technology to help diabetes patients manage their disease.
The challenge generated an increased focus on voice technology worldwide and spurred more companies to develop their technologies to become more healthcare-compatible.
"We're seeing a lot more voice applications being developed," Ranjan says. "The highlight for me from running a challenge like this was to see the impact ripple across the globe and motivate the market to think more about solving some of these problems."
Teamwork Over Technology
Ranjan has focused often on building new teams that can carry out the mission of the company.
"I've learned a lot about how to build teams," he says. "I don't invest in ideas. I invest in teams who are solving complex problems."
He believes his approach to building teams has influenced their success. And although the technology they use is an important part in reaching goals, he says building teams that can work together well to create solutions is a bigger priority.
Building a strong team, Ranjan says, requires hiring people who are equipped to bump up against a brick wall and still persevere, and to get creative and find other ways to make things work.
"Great team members are willing to learn new things and adjust to the new learnings,” he says, “because [in] this area [that] we're in, there's never a straightforward answer.”
"You have to be willing to try and experiment and maybe even fail,” he adds, “but [you] learn from it so that you can get better at making decisions the next time around.”
According to Ranjan, team members need to possess the potential and willingness to learn and grow as they face problems within the business or other challenges in an organization. Tolerance for failure and moving on are also important.
"The last bit for me, personally, has been patience," he says. "This is a long game. If we really want to impact patient lives and use technology to impact them, you can't rush through these things.”
Staying on the Path to Innovation
Ranjan sees a bright future ahead.
“For me, this is such an exciting space,” he says. “We are working to empower patients to manage their disease and live a better life, and that's the vision that I'm excited about--watching our teams push and innovate. We will have some successes, but we will also have a lot of learnings. And that's going to become all part of the innovation."
Ranjan and his family recently moved to Switzerland, where he's taking advantage of the Alpine scenery and climate, as well as the cycling culture.
"I'm not quite as good at cycling as people here [in Switzerland]," he says. "But I'm embracing it and I'm enjoying bike rides with my boys. My other hobby is I love to take photos of birds in flight. There's something about the way birds fly and how they move that's fascinating to me, and I love capturing those moments."
Ranjan's long-term vision is to continue using digital health to overcome obstacles and better the lives of those dealing with chronic diseases.
"We, as an industry, still have a long ways to go in digital health and I'm hoping that I can continue to lead teams to figure out new ways to meet the needs of patients,” he says. “Because at the end of the day, what motivates me is knowing that we are resolving problems for patients, but potentially also for someone we know. We are really in the service of helping people."
The agency is warning that no devices have been approved that can accurately measure a user’s blood glucose without piercing the skin
Federal regulators are hitting the pause button on digital health advancements for diabetes care management.
The U.S. Food and Drug Administration (FDA) has issued a safety alert indicating that smartwatches or smart rings that claim to measure a user’s blood glucose levels without piercing the skin should are not reliable and should not be trusted.
“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency said.
Some 38.4 million Americans live with diabetes, according to a 2021 report from the American Diabetes Association (ADA), and experts say that population is the fastest growing chronic care population in the nation. Care management includes monitoring blood glucose levels throughout the day and taking immediate action (such as injecting insulin) when those levels are out of particular range. A trending high or low blood glucose level could lead to serious health issues, including coma and death.
Digital health advances have greatly improved care management for diabetes over the past two decades, including wearable sensors that can track blood glucose and administer doses of insulin when needed and AI-enhanced tools that can identify trending blood glucose levels before they become dangerous or are even noticed.
While the industry has been working on wearables that can accurately measure blood glucose without pricking the skin, that technology hasn’t yet been perfected.
“The FDA routinely monitors the medical device market and became aware of unauthorized products being marketed to consumers,” the agency said in its alert. “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels. Additionally, the FDA is alerting consumers about this issue and making the public aware that smartwatches and smart rings should not be used to measure blood glucose levels.”
