The Washington-based health system, which spans more than 50 hospitals in seven states, tested the technology earlier this year with Premera Blue Cross, one of the largest health plans in the Pacific Northwest. Officials say it was vetted by internal teams as well as HEDIS (Healthcare Effectiveness Data and Information Set) auditors.
With the tool, Providence pushes to the head of the pack in the nationwide quest for interoperability through national FHIR standards, alongside federal efforts to develop TEFCA (Trusted Exchange Framework and Common Agreement). The goal is to create a national framework for the exchange of all data between healthcare organizations, health information exchanges, payers, consumers, and other stakeholders, eliminating silos, improving clinical and business operations, and moving the industry toward value-based care.
“Interoperability is critical within value-based care, and FHIR integration allows healthcare organizations to exchange comprehensive clinical data that enables more accurate risk assessments, enhances care coordination and captures outcomes more effectively,” Michael Westover, the health system’s vice president of population health informatics, said in a press release. “By using a national standard for contract gap closure and capturing the much-needed clinical data, we empower all stakeholders in their ecosystem to make more informed decisions, improve patient outcomes and enhance the overall quality of care to our patients – who are always at the center of all our efforts.”
The nation, as a whole, has been struggling to reach interoperability because of the lack of standards for data sets, particularly at a time when the industry is seeing a wealth of unstructured data from sources outside the health system. As a result, few organizations use the same rules to organize and share data, using everything from spreadsheets, fax machines, emails, and secure file transfer protocols (SFTP) to share information.
In an email to HealthLeaders, Westover said Providence is a “trailblazer” in developing data exchange standards that meet HEDIS quality measures.
“We had to wrestle with a new data standard, new technology, and a new data security model,” he said. “We tested for months with our health plan partners and frankly learned some hard lessons as we used a generic clinical exchange standard for a targeted business case. We are now using what we’ve learned to scale the platform with other health plans.”
At Providence, the health system’s data-as-a-service (DaaS) tool leverages the Member Attribution (ATR), Clinical Data exchange (CDex) and Bulk Implementation Guides as national data exchange standards developed through the HL7 Da Vinci Project, which is billed as an industry-led project to enhance data sharing between payers and providers to enable the industry’s transition to value-based care.
A key aspect of the project was securing participation from a payer.
“We initially targeted the clinical data elements for 15 or so clinical measures that have a big impact on patient care and payer finances,” Westover explained. “We were surprised at how excited our health plan partners were and how they immediately asked us to expand the number of included measures and the qualifying patient population in the dataset. Our partners quickly saw the impact this type of DaaS could make on their business during difficult financial times.”
“Payers currently get much of their clinical data from patient charts and from data manually keyed into clunky websites or spreadsheets,” he added. “This solution allows health plans to exchange curated patient data rapidly using a nationwide standard format. If health plans can get higher quality data faster and easier than they could before, they will outperform their competition on important HEDIS, 5-Star, value-based care metrics, and other government programs.”
According to Westover, more efficient data exchange with payers means that providers and payers will have a shared understanding of their patient populations, which in turn will help improve care management and coordination.
Providence executives plan on using the tool to partner with other payers and vendors on data exchange..
“The technological and regulatory environments are evolving so quickly that we expect to see a few different approaches to these types of healthcare interoperability challenges,” Westover said. “Some groups will ask their EMR vendors to take care of it for them. The most successful health organizations will be those that can exchange vital data more efficiently than the rest.”
Trinity Health uses virtual care, teamwork to address workforce, clinical care issues.
Trinity Health is taking a team approach in redesigning care delivery inside the hospital, using a three-person model that includes nurses, nursing assistants, and virtual care technology.
During a session in the HealthLeaders Virtual Nursing Mastermind series, Gay Landstrom, RN, PhD, NEA-BC, FAONL, FACHE, FAAN, CNO for the Michigan-based health system with 101 hospitals in 27 states, says the model, piloted in the summer of 2022 and is now live in roughly 40 sites, addresses not only the growing shortage of skilled nurses but a need to reduce complicated workflows that negatively affect patient care and staff morale.
“We realized that we needed to create teams,” she says. “This is a fundamental change to how we [deliver] patient care.”
Health systems across the country are turning to a variety of tools and strategies, many of them centered on virtual nursing. While the emphasis is on making the most of the shrinking nursing workforce by reducing stressful workflows, these programs are also increasingly targeting clinical outcomes, ranging from reduced length of stay to improved monitoring and patient engagement. And at a time when ROI for these programs hasn’t yet been proven, the more achievable benchmarks the better.
Landstrom says the driving force behind Trinity Health Together Team Virtual Connected Care is a shortage of nurses who want to work in acute care settings. To address this, the health system “tried a lot of things,” she says, from robots to scribes, before settling on a team-based approach.
Trinity’s three-person strategy is unique. The floor team consists of a nurse and either an LPN or CNA, with the former handling the nursing duties at the bedside and the latter doing tasks that don’t require an RN. The third team member, a veteran nurse, is in the telehealth center, monitoring patients and assisting the bedside team (as well as doctors) with documentation and consults.
Landstrom says leadership did a lot of research prior to launching the program and found that 40% of the tasks done by nurses on the floor can be done by someone other than an RN. Teaming a nurse with an LPN/CNA, she says, enables the nurse to work at the top of his or her license.
The virtual nurse, meanwhile, sits in the background, offering support when needed, answering calls from patients, and keeping watch over several rooms. Their tasks include documenting, monitoring, assisting with handoffs, rounding, working with doctors during examinations, and helping patients to understand doctors’ comments.
“There’s a great deal [of task] that a virtual nurse can do,” Landstrom says. “More than we thought they could. And they function here as a team.”
Landstrom says the virtual nursing role is typically filled by veteran nurses, and that some nurses “can picture having a longer career” by working as a virtual nurse. This could help Trinity and other health systems retain nurses who are considering leaving or retiring.
Indeed, one of the challenges to creating this model, says Murielle Beene, DNP, MBA, MPH, MS, RN-BC, PMP, FAAN, FAMIA, Trinity Health’s senior vice president and chief health informatics officer, is recruiting the LPNs and CNAs. As a result, Trinity has been working on updating its nurse assistant development program and has been in touch with nursing schools to determine how to bring more people into the workforce.
As for the technology, Beene said the health system “had to buy a lot of TVs” to establish the right platform for the virtual nursing component. While some health systems use tablets or telemedicine carts, an increasing number are using TVs built specifically for the healthcare setting and providing both entertainment and clinical services, ranging from audio-visual conferencing to access to resources and education.
“Technology assessments are vital” to establishing a good base for the program, Beene says. “It’s very important that we have seamless integration, and that was a challenge.”
Beyond the technology, both Beene and Landstrom say the biggest challenge to making this program work is change management. Redesigning inpatient care management is a drastic adjustment in how things are typically done inside a hospital, and it’s safe to say not everyone will be receptive to the changes from the outset. Executives need to map out these changes and lead staff through them, identifying the pain points and the benefits.
“We’re not just teaching people new workflows but coaching them,” says Landstrom.
Skepticism “was expected,” adds Beene, though management underestimated how much resistance they encountered.
“You don’t just drop this [new program] in and then leave,” she says. “This has to be part of the culture, and it involves a transformation of the mindset.”
Beene and Landstrom also found that coming into each hospital with a one-size-fits-all program was not working, and that each hospital not only had different strengths and needs, but different methods. That meant understanding the unique workflows and talents in each hospital and leaving enough room in the program model to adjust accordingly.
Likewise, Landstrom says, the three-person model “is not a model for all clinical areas.” She says it has shown value in med-surg, telemetry, and step-down care, but doesn’t quite fit on other wings of the hospital.
“We’ll be developing other models like this,” she says.
Landstrom also says it’s too early to determine ROI for this platform. While staff support and retention is an important goal, that alone probably won’t sustain the program. By charting clinical outcomes and aiming for pain points in monitoring, charting in the medical record, and patient discharge and room turnover times, she’s hoping the benefits will materialize in better patient outcomes, a shorter length of stay, and cost savings.
“It’s really a new way of thinking how we go about taking care of our patients,” says Beene.
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The Boston-based health system is the third to collaborate with the retailer on programs that shift care from the hospital to the home.
Mass General Brigham has announced a partnership with Best Buy Health to reinforce its acute care at home and remote patient monitoring (RPM) programs.
The Boston-based health system, one of the first to develop a hospital at home program and post studies proving positive clinical outcomes, joins Geisinger and Atrium Health in partnering with the retail giant, which jumped into the healthcare space with its purchase of Current Health in 2021. The collaboration gives the health systems a consumer-facing platform through which selected patients will be supplied with the appropriate medical equipment and have access to technical support.
“At Mass General Brigham, we are building the integrated healthcare system of the future across the entire continuum of patient care needs,” Heather O’Sullivan, MS, RN, A-GNP, president of Mass general Brigham’s Healthcare at Home program, said in a press release. “As a recognized leader of Home Hospital services, we understand that consumers are increasingly choosing the comfort of care at home as an alternative to traditional, facility-based delivery settings. By enabling our world-class provider services with technology that matters, we are elevating system capabilities and, most importantly, improving clinical outcomes for the communities we serve today while preparing for the future delivery of care more broadly.”
Massachusetts General Hospital and Brigham and Women’s Hospital were two of the first hospitals to launch acute care at home programs in 2016, before merging in 2020. The health system has treated more than 3,000 patients in its Home Hospital program, including nearly 1,000 this year, and recently received federal and state approval to expand the platform to treat patients from three more hospitals.
Acute care at home programs, which combine digital health and telehealth with daily in-person care visits, have grown in popularity since the pandemic, as health systems look to shift more services out of the hospital and into the home. The program enables health systems to reduce costly and staff-intensive in-patient services, while giving patients the opportunity to recover in their own homes, which studies have shown to improve clinical outcomes. The Centers for Medical & Medicaid Services has its own version of the platform, which requires hospitals to follow strict guidelines for Medicare reimbursement.
Through the Best Buy partnership, patients have access to the Current Health platform, including Geek Squad services, in which a team from the retailer is dispatched to the patient’s home to assess the home environment, install the right equipment and train patients on how to use the devices.
"We're fundamentally changing healthcare," Chris McGhee, Current Health’s founder and CEO, said during an interview at this year’s HIMSS conference in Chicago, noting the Best Buy can pick and choose the technology needed to make the best and most reliable connections between a patient in the homes and his or her care team at a hospital. "Hospitals value that curation."
Mass General Brigham officials say the partnership will not only bolster their existing programs but help develop new ones.
The Health and Human Services Department recently updated TEFCA to what it calls “version 1.1,” with specific tweaks and clarifications. Officials said the updates to the QHIN (Qualified Health Information Network) Technical Framework, FHIR (HL7 Fast Healthcare Interoperability Resources), and standard operating procedures will be unveiled during the Office of the National Coordinator for Health IT (ONC) annual meeting on December 14-15.
Of particular interest is the news that TEFCA will support FHIR-based transactions. Supporters say this is a key element to the industry’s acceptance of TEFCA as a roadmap to interoperability, while critics argue that many organizations aren’t yet ready to embrace FHIR.
“We have … committed to having TEFCA support FHIR-based exchange because API scalability needs TEFCA, and we are pleased to report that this will soon be a reality as well,” Mark Knee, an ONC deputy division director, and Jawana Henry, an interoperability systems branch chief and health coach at the ONC, wrote in an ONC blog last week. “The Common Agreement Version 2.0 is actively under development with a publication goal of no later than the end of Spring 2024. This version will include participation enhancements and technical updates to require support for Health Level Seven (HL7) FHIR-based transactions within 2024.”
"We're thrilled to see FHIR-based exchange make it into Version 2.0 of the Common Agreement,” Steven Lane, chief medical officer for Health Gorilla, one of the seven HHS-designated candidate QHINs, said in an e-mail to HealthLeaders. “ONC's FHIR roadmap for TEFCA exchange pointed us in this direction long ago, and it’s great to see we’re moving down the path. There was a lot of debate around TEFCA without FHIR, so we're glad to see the issue finally put to rest."
“Last week’s announcement is an indication we are getting close to a critical step in the launch of TEFCA,” Paul Wilder, executive director of the CommonWell Health Alliance, a non-profit trade association and a candidate QHIN, said in an e-mail to HealthLeaders. “We expect to have live production QHINs next month. It also acknowledges TEFCA is a living, learning framework that embraces iterative improvement with a scaled approach to FHIR being next. The rapid advancement of TEFCA and an explicit mention of FHIR indicates a desire to put FHIR at scale on the TEFCA speed ramp with significant steps expected in 2024.”
Also part of the process is the recent release of proposed disincentives for healthcare organizations engaged in information blocking. Health system leaders are particularly interested in this hotly-debated issue and will likely make their feelings know to ONC as this moves forward.
“The hard work of aligning the 21st Century Cures Act’s key priorities in API adoption, nationwide network interoperability, and Information Blocking is now being realized,” Knee and Henry wrote in their blog. “The launch of TEFCA this year, support for FHIR next year, and the recent release of draft rules to close remaining gaps in enforcement of Information Blocking are mutually reinforcing initiatives that will significantly advance interoperability in the coming years.”
The health system announced its dedicated space for innovation during the HLTH conference, with plans to support and develop new technologies and ideas to address healthcare’s biggest pain points.
Sutter Health is joining the ranks of health systems with built-in innovation incubators.
The Sacramento-based 24-hospital health system is opening an innovation center “aimed at fostering creative solutions to some of today’s biggest healthcare challenges.” Warner Thomas, Sutter Health’s president and CEO, unveiled the plan at last month’s HLTH conference and said the center should be up and running in San Francisco in early 2024.
The health system is one of at least a dozen major health systems, including UPMC, Houston Methodist, the Mayo Clinic, the Cleveland Clinic, and OSF Healthcare, who are looking to develop new technologies and ideas from within, with the goal of using their networks of hospitals and healthcare sites to test out and validate—and then potentially market—those products.
Speaking on the main stage at HLTH, Thomas said Sutter Health’s goal is to create an integrated network that enables consumers and patients to address all their healthcare needs in one place.
“Patients don’t want to go to 20 different [locations] to get healthcare,” he said. ‘They want an integrated health system.”
“We need to create an integrated experience, not a one-off experience,” he added.
Under Chief Innovation Officer Chris Waugh and chief health innovation officer Albert Chan, MD, MS, Sutter Health has built a reputation for focusing on human-centered design in healthcare. The health system recently beefed up Waugh’s team by luring two top executives from Ochsner Health: Richard Milani, MD, who was Ochsner’s chief clinical transformation officer and had led the health system’s Innovation Ochsner program for more than 11 years, is now Sutter’s chief clinical innovation officer, and Laura Wilt, who was Ochsner’s chief information officer for roughly a decade, has taken on the role of chief digital officer.
“Digital innovation is propelling healthcare into the future, and integrated systems like Sutter Health are leading the way,” Wilt said in a press release accompanying Thomas’ announcement at HLTH. “Establishing an intentional space for innovation sends a clear signal that Sutter, alongside our partners, is more committed than ever to deliver on our mission of making healthcare simpler, more engaging and deeply human.”
“We believe healthcare is at an inflection point,” added Waugh. “Sutter’s history is etched with groundbreaking innovations and partnerships that have elevated the patient experience. With the innovation center, we’re propelling our mission to new heights – igniting innovation through an unapologetically human-centric lens and ensuring a dynamic transformation that enhances the experience for both patients and providers alike.”
Thomas, who noted Sutter Health would also expand its investment strategy, said health systems are under pressure during a tight economy to be “more connected to our patients all the time.” That means investing in and supporting connected health tools and concepts that enable care management and coordination at the best time and place for both patients and their care teams.
That also means working together with other organizations to connect those care paths.
“Innovation thrives when we collaborate,” he said in the press release. “Together with innovation industry leaders, we are charting a new course to revolutionize the way care is delivered. Whether it’s in how we manage chronic diseases or provide care at home, our commitment to pushing the boundaries of what’s possible in healthcare has never been stronger. We want the work done here to have a ripple effect, transforming the entire healthcare ecosystem by benefiting both clinicians and patients. We invite visionaries who share our passion for innovation and improving the lives of patients to join us on this journey.”
At Valley Children’s Hospital, Jeremy Woods is digging into a patient’s genes and developing databases that uncover how diseases are created. “We’re no longer thinking one treatment per disease state,” he says.
Genetic testing is a relatively new and exciting concept in healthcare, giving doctors an intricate look at how diseases are created. And Jeremy Woods, MD, is developing rapid genetic tests and building databases that are changing how children are diagnosed and treated.
“We’re using data to get the patient’s best diagnosis and treatment based on their individual biology,” says the director of precision medicine at Valley Children’s Hospital in Madera, California. “We’re no longer thinking one treatment per disease state. We’re … getting real answers and providing precise treatments.”
Woods, who worked at UCLA Health before coming to Valley Children’s in 2020, is at the forefront of an innovative time in healthcare, with new and improved technology and strategies that are allowing researchers to get at the roots of disease diagnosis and treatment. Genetic testing and DNA analysis on newborns, for example, could help doctors identify and treat diseases early, saving millions of dollars in downhill healthcare costs and improving clinical outcomes—perhaps even curing patients.
Valley Children’s is part of Project Baby Bear, a consortium of California children’s hospitals launched in 2018 and funded by the state of California to develop rapid whole genome sequencing (rWGS) for ICU infants. In the first 18 months of the program, the genetic codes of 178 critically ill babies at five hospitals were sequenced, with some 43% receiving a diagnosis of their condition within three days and about a third receiving changes in treatment.
“This was a watershed moment in genomic medicine,” says Woods. “There are more than 3 billion pieces of information in the human genome, and it used to cost millions [of dollars] to sequence it. Now it costs about $200 and we can [provide results] in about a week, sometimes a day. The rate of innovation over the past three to five years has been stupendous.”
Jeremy Woods, MD, director of precision medicine, Valley Children's Hospital. Photo courtesy Valley Children's.
Woods says he treats about 2,000 patients per year, many with rare diseases.
“I deal with a disease that I had probably never heard of every day,” he says. “There are so many genetic variants that we don’t understand properly. That’s why collecting and analyzing all this data is important.”
And that has produced results. Using a database of genetic sequences that he developed, Woods was able to identify a rare genetic disorder, called Zellweger Syndrome, and trace its roots back to indigenous farmers from central Mexico. Although currently uncurable, Woods and his colleagues were able to send detailed information back to OB-GYNs in Mexico so that they could begin early screening to catch and treat the condition more quickly.
While this is an example of how data can be analyzed to produce meaningful, value-based outcomes, Woods says there’s not enough analyzing being done right now. Health systems need the technology, including AI, to take all that data coming in and curate it. And they need EHR platforms that can integrate that data.
“Many people [undergo genetic screening] and get their results in a PDF, which they forget about,” Woods says. “That’s why it’s so important” that the data is embedded into the EHR, where it can prompt doctors to take a closer look and have discussion with their patients.”
With that data, he says, healthcare providers can also identify populations that exhibit a prevalence of a specific disorder, then design community outreach programs that support screening, identification, and early treatment. And it can be used by genetic counselors to support—or rule out—expensive lab tests and new treatments.
On another level, Woods sees the continued development of pharmacogenomics, or programs that study how a person’s genetic makeup reacts to medications. This, in turn, would help the pharma industry develop more effective medications, while giving clinicians more insight into what drugs will and won’t work for specific patients.
Woods says support for precision medicine and genetic testing is slowly gaining steam. Payers, including some Medicare and Medicaid programs, are now covering genetic testing when it’s recommended by a patient’s doctor. And the technology will someday be refined so that genetic tests can be sequenced at the patient’s bedside, in less than an hour, and inputted directly into the EHR.
Precision medicine “is still a somewhat nebulous concept,” he says. “The biggest challenge right now might be education.”
The provision, included in the final 2024 Medicare Physician Fee Schedule, enables health systems to bill Medicare for telehealth services delivered from the doctor’s home.
A key Medicare reimbursement for health systems the deploy telehealth services has been extended through the end of 2024, along with a measure that gives physicians who work from home some privacy and security.
The Centers for Medicare & Medicaid Services has included in its final CY 2024 Medicare Physician Fee Schedule (PFS) Medicare reimbursement for providers who use virtual care at home to treat patients. In addition, the provision states that providers will not be required to list their home address as a practice location.
“Clinicians, their loved ones, and other stakeholders can breathe a sigh of relief – at least until the end of 2024 – that Medicare providers will not be required to publicly report their home address as their practice location,” Kyle Zebley, senior vice president of public policy for the American Telemedicine Association (ATA) and executive director of ATA Action, said in a press release. “This reprieve will help to maintain the safety and privacy of physicians and removes a significant roadblock to access to care.”
Supporters have argued that enabling physicians to bill Medicare for telehealth services delivered from their homes will give health systems more leeway to develop virtual care programs that cater to the needs of both patients and providers. This, in turn, would create better, more sustainable and scalable platforms and encourage providers to give the technology a try.
“Allowing appropriately licensed and credentialed providers to practice telehealth from their home improves patient access to healthcare services, reduces healthcare costs, while maintaining and meeting patient demand for care,” the letter stated. “This was necessary during the height of the COVID-19 pandemic and remains just as important today amidst provider workforce shortages and burnout, given that 78 percent of health care practitioners agree that retaining the opinion to provide virtual care from a location convenient to the practitioner would ‘significantly reduce the challenges of stress, burnout, or fatigue’ facing their profession and eight in 10 indicate that this flexibility would make them more likely to continue providing medical care.”
Just as important is the ruling that providers don’t have to include their home addresses as a point of care. Increasing numbers of doctors have been targeted by angry consumers, hate groups, and even people looking for some means of accessing opioids, putting the lives of themselves and their families in danger.
Zebley says CMS’ actions have also set the stage for a very busy 2024, telehealth-wise.
“With nearly all of the flexibilities established during the COVID-19 public health emergency (PHE) extended until the end of 2024, we can expect a telehealth policy ‘Super Bowl’ at the end of next year,” he said. “We have the unprecedented opportunity to impact transformative changes to how healthcare is delivered.”
The study finds that pharmacists could save millions of lives and more than $1 trillion in healthcare costs if they were given more leeway to help patients with chronic care management and coordination.
As pharmacies struggle to find their footing in a hard economy, a study out of Virginia Commonwealth University makes the argument that pharmacists could save millions of lives and cut healthcare costs significantly if they were allowed to help manage patients with chronic conditions.
The study, published today in the Journal of the American Medical Association (JAMA), finds that pharmacists who are given more leeway to help patients living with hypertension could prevent more than 15 million heart attacks, roughly 8 million strokes, and more than 4 million cases each of angina and heart failure and save $1.1 trillion over 30 years, or more than $10,100 per patient.
The study supports a long-running argument that pharmacists should be allowed to perform more care management and coordination services, and it could help the likes of Walgreens, CVS, and Rite Aid as they seek to reverse losses and redefine themselves as community healthcare hubs.
“Pharmacists’ role as healthcare providers tends to be underused in the community, and this is really about how pharmacists can provide for their communities in a way that improves access to care for hypertension,” Dave Dixon, PharmD, corresponding author of the study and the Nancy L. and Ronald H. McFarlane Professor of Pharmacy and chair of the Department of Pharmacotherapy and Outcomes Science at the VCU School of Pharmacy, said in a story provided by VCU.
“Although pharmacists currently have some type of prescribing privileges in 49 states and Washington, D.C., they are not recognized as providers under the Social Security Act,” he added. “This is one of the major barriers to implementing these life-saving – and cost-saving – measures for patients.”
According to the study, pharmacists could trigger these outcomes by becoming more active members of a patient’s care team, including offering advice on health and wellness, helping patients adhere to their medication regimen, and assisting in prescribing certain medications. This would be especially impactful in underserved communities, whose residents have much higher rates of death due to hypertension and where the pharmacy is visited more often than a doctor’s office or clinic.
According to a 2022 study published in the Journal of the American Pharmacists Association, more than 95% of Americans live within five miles of a community pharmacy, and they visit pharmacies 12 times more often than a primary care provider. With the nation in the midst of a shortage of healthcare professionals, advocates say pharmacies could support local health systems by taking on more services that a PCP would normally provide.
In addition, Dixon and his colleagues found that the improved outcomes that result in interventions by pharmacists could give patient more than 30 million “quality-adjusted life years,” or years where one’s quality of life is better than it would have been had those care management steps not been taken.
“Being that hypertension affects so many Americans – we’re talking about over 100 million people in the U.S. – I think the impact is tremendous because everybody knows somebody with high blood pressure,” said Dixon. “It’s one of the leading causes of heart disease and kidney failure in the world.”
At issue is a 2022 bulletin that prohibits HIPAA-covered entities from using technology that captures the IP address of people visiting public-facing websites.
Healthcare organizations are pushing back against a federal rule restricting hospitals from using tracking technology to collect data from consumers visiting their web portals.
The American Hospital Association (AHA), Texas Hospital Association, Texas Health Resources, and United Regional Health Care System have filed suit against the federal government, charging that the Health and Human Services Department has exceeded its statutory authority in preventing providers from collecting the IP addresses of people visiting public-facing websites.
The lawsuit calls for the elimination of “an unlawful, harmful, and counterproductive rule that has upended hospitals’ and health systems’ ability to share healthcare information with the communities they serve, analyze their own websites to enhance accessibility, and improve public health.”
“The Department of Health and Human Services’ new rule restricting the use of critical third-party technologies has real-world impacts on the public, who are now unable to access vital health information,” AHA President and CEO Rick Pollack said in a press release “In fact, these technologies are so essential that federal agencies themselves still use many of the same tools on their own webpages, including Medicare.gov, Tricare.mil, Health.mil, and various Veterans Health Administration sites. We cannot understand why HHS created this ‘rule for thee but not for me.”
The suit targets a bulletin issued in December 2022 by the HHS Office for Civil Rights (OCR) highlighting the use of online tracking technologies by Health Insurance Portability and Accountability Act (HIPAA) covered entities and business associates. The bulletin states that regulated entities such as hospitals “are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of PHI to tracking technology vendors or any other violations of HIPAA Rules.”
According to the AHA and others supporting the lawsuit, that interpretation of HIPAA rules would prevent hospitals “from using commonplace web technologies to analyze use of their websites and communicate effectively with the populations they serve.”
“Simply put, OCR’s new rule harms the very people it purports to protect,” Pollack said. “The federal government’s repeated threats to enforce this unlawful rule tie hospitals’ hands as trusted messengers of reliable healthcare information.”
The suit alleges that common technologies used by healthcare organizations such as analytics software, video technologies, translation and accessibility services, and digital maps would be rendered ineffective without access to IP-address information.
“That statute allows hospitals to rely on third-party tools that capture IP address information because that information cannot reasonably be used to identify an individual whose healthcare relates to the webpage visit,” the AHA says. “By restricting use of these common tools on public-facing webpages on this basis, OCR violated HIPAA and has acted without legal authority. In addition, the suit alleges that OCR unlawfully issued this Bulletin without providing any reasoning supporting its novel legal assertions, without acknowledging the government’s own use of implicated third-party technologies, and without following required notice-and-comment rulemaking processes.”
Healthcare organizations and tech companies say the President's Executive Order is a good first step toward establishing AI policy, but will actions support the words?
The order "directs the most sweeping actions ever taken to protect Americans from the potential risks of AI systems," a fact sheet accompanying the order states. But there's little detail about how it would affect healthcare organizations or technology companies working with them.
Across all industries, Biden's order seeks to balance regulations with encouragement, establishing guidelines for controlling risk while giving the green-light to grants and other funding models to support research.
Specifically for healthcare, the President is giving the U.S. Health and Human Services (HHS) Department six months to draft a strategy to determine whether AI meets the standards for delivering healthcare, and he asks HHS to create a task force within the year to create a plan for responsible AI use.
In addition, the order calls on companies developing generative AI tools to notify the government when they are testing those tools and to share the results of those tests.
Through HHS, Biden's order envisions grants that would cover, among other things:
Developing AI-enabled tools that create personalized immune-response treatments.
Improving the quality of data used in AI tools.
Addressing administrative tasks that improve efficiency and contribute to stress and burnout.
Improving care for veterans and developing nationwide "AI Tech Sprint" competitions to support start-ups and small healthcare tech companies.
Reaction to the announcement was, for the most part, positive, with health system executives and industry analysts praising the administration for taking action. But at the same time, many noted that the nation is lagging behind Europe in developing AI policy, and many healthcare organizations are already testing and even using AI tools.
"While many general principles of AI ethics apply across industries, the healthcare sector has its own set of unique ethical considerations," he noted. "This is due to the high stakes involved in patient care, the sensitive nature of health data, and the critical impact on individuals and public health."
"It is critical that AI in healthcare benefit all sectors of the population, as AI could worsen existing inequalities if not carefully designed and implemented," he added. "It's also critical that we ensure AI systems in healthcare are both accurate and reliable. Ethical concerns arise when AI is used for diagnosis or treatment without robust validation, as errors can lead to incorrect medical decisions."
To that end, many of the tech giants developing AI tools—sometimes in partnerships with health systems—pledged at a July meeting at the White House to adhere to a set of voluntary guidelines, including allowing independent experts to assess tools before public debut, researching societal risks related to AI, and allowing third parties to test for system vulnerabilities.
Among health systems, Duke Health announced the launch of an AI and Innovation Lab and Center of Excellence in a five-year partnership with Microsoft "aimed at responsibly and ethically harnessing the potential of generative artificial intelligence (AI) and cloud technology to redefine the healthcare landscape."
Among those weighing in on the President's order was Bill Gassen, president and CEO of Sanford Health, who attended Biden's press conference at the White House.
“We believe that emerging AI technologies have the potential to positively transform the future of care delivery [and] advance rural health equity and are key to the industry's long-term sustainability," he said. "While we need to be appropriately cautious in our adoption of these technologies, we are supportive of the development of frameworks and guidelines that would enable healthcare providers to responsibly and safely use AI-enabled technology so that we can address some of the most pressing challenges in healthcare today related to our workforce, access to care and quality improvement for all."
"It will be critical that the guidance strikes the right balance between setting appropriate guardrails but is not unnecessarily stifling so we do not impede innovation and progress where it’s needed most," he added. "We look forward to collaborating with industry leaders, elected officials and the Administration on these efforts to ensure we can harness these technologies in the best interest of our patients and caregivers.”
One organization taking advantage of the hype surrounding Biden's Executive Order was the American Telemedicine Association, which published its guidelines for responsible use of AI in telemedicine programs.
"With today's Executive Order issued by President Biden to ensure the safe, secure, and trustworthy use of artificial intelligence, our timely release of the ATA's AI Principles can help chart the way forward as the administration works to create new standards for AI's potentially game-changing capabilities," Kyle Zebley, the ATA's senior vice president of public policy, said in a release. "AI is already being used in telehealth and its future potential is endless, especially to harness the reams of data that our healthcare system produces, including data collected from virtual care technologies, to improve healthcare delivery."
Several AI companies also chimed in, praising the administration for starting the conversation.
"Overall, the executive order is a great start and begins to lay a policy foundation to harness the benefits of AI, while addressing key challenges," Rajeev Ronanki, CEO of Lyric, said in a message to HealthLeaders. "By integrating it with ethical frameworks, liability, training/upskilling, AI literacy, oversight & auditing, data interoperability, and transparency, policy-makers can create a more comprehensive framework for AI."
But the question is whether HHS or another government entity has a plan—or the muscle—to go after a vendor or health system that runs afoul of the guidelines, and whether they can step in before serious damage is done. How will healthcare executives feel about HHS oversight? And will there be enough guidance from the government to help health systems map out and execute reliable and effective AI strategies?
