New research from the Regenstrief Institute gives health system executives specific recommendations on how to use their EHRs to help clinicians identify and prescribe drugs to their patients.
New research out of the Regenstrief Institute gives health system executives specific recommendations on how to use EHRs to reduce dangerous drug-drug interactions.
“Drug-drug interactions are very common, more common than a lot of people outside the healthcare system expect,” Michael Weiner, MD, MPH, a researcher with the US Department of Veterans Affairs, Regenstrief Institute, and Indiana University School of Medicine and senior author of the study, said in a press release. “In the US, these interactions lead to hundreds of thousands of hospitalizations in any given year at an enormous cost. Most of these drug interactions are preventable.”
With the advent of EHRs and digital health technology, health systems are looking to reduce those interactions by pinpointing when they can occur and giving clinicians on-demand access to information to prevent them. But that technology depends on understanding how clinicians prescribe drugs and how they look for dangerous interactions.
“This study was needed because we previously didn’t have a great understanding of how clinicians actually make decisions in assessing these interactions,” Weiner said. “No one had really taken apart the thinking process step-by-step to understand it from the beginning to the end. There's a patient, there's a drug and another drug. There is now a potential interaction. There's been a decision about how to resolve it following an assessment and then a resolution process. Understanding all this is very important if we are hoping to design improvements to the medical system that enhance patient safety.”
The study, recently published in BMJ Open, identified 19 information cues used by clinicians to manage drug-drug interactions, including information on the potential severity of a drug reaction, side-effects, a patient’s expected duration of exposure to an interaction, patient-specific conditions, a patient’s need for those drugs, and the characteristics of safer medications. Using that list, Weiner and his colleagues developed recommendations for designing alerts through the EHR.
They are:
Provide information on the expected range of timing of potential drug-drug interaction effects (days, weeks, months, or years).
Give clinicians a platform to review multiple electronic drug-drug interaction reference sources directly from the alert, side-by-side.
Leverage data analytics to populate drug-drug interaction alerts with "smart" displays of alternative drugs that align with three criteria used by clinicians.
Provide recommendations on the alert along with associated patient characteristics (for example, “monitor, if patient indicates willingness and capability of measuring blood pressure daily”).
Alissa Russ-Jara, PhD, a researcher at the Purdue University College of Pharmacy and US Department of Veterans Affairs, Regenstrief Institute affiliated scientist, and the study’s lead author, said the research highlighted the fact that no two clinicians use the same protocols in assessing drug-drug interactions.
After interviewing all of the clinicians involved in the study, she said in the press release, “many … expressed surprise at how much nuance went into their own decision. Their decisions often occur so rapidly, yet involve so much expertise. Ours was the first study to really unpack that for their decisions around drug-drug interactions.”
“We expect our findings can improve the design and usability of drug-drug interaction alerts for clinicians, and so they can more effectively aid patient safety,” she added. “Our study focused on clinical decision-making, regardless of whether the clinician was warned by an alert or not, so our findings have implications for clinicians, informatics leaders, and patients, and for any EHR system.”
The use of EHRs has grown substantially over the last decade, but patients still face problems getting to their health data
EHRs may be commonplace in healthcare, but that doesn’t mean everyone can access them, according to a new report from the Health and Human Services Department’s Office of the National Coordinator for Health IT.
Now that patients have had a taste for easy access to their health records, they’re demanding more. During the pandemic, patients wanted access to their records following a telehealth visit and to obtain COVID 19 test results. More patients also wanted to message their providers following the pandemic, at a rate of 53% in 2018, and climbing up to 64% in 2022.
Healthcare apps have made access to records even easier, and by 2022 more than half of patients were using apps to access their EHR data. They were also looking at their records more frequently than web-based portal users. In 2020 the ONC’s Cures Final Rule Act required certified health IT developers to create broader patient access through apps with standards-based application programming interfaces (APIs).
According to the ONC, healthcare organizations are seeing three barriers to patients being able to access their data:
Not All Apps Are Created Equal
Currently, a majority of patients are not using emerging third-party apps that have adopted APIs; Instead, they’re using apps provided by their healthcare provider or an online patient portal. APIs make information more widely available across smartphone apps, and they do so in a more secure method than other apps and web-based portals. By encouraging patients to use these API based apps, healthcare providers can ensure their patients are easily accessing their data in the most secure manner.
But What Does It Mean?
Another problem with EHR technology is that they don’t offer detailed explanations of diagnoses or test results. Patients may have access to their health records, but that doesn’t mean they understand them, especially complicated diagnoses. Research shows that patients like having timely access to their test results on their patient portal, rather than waiting for a call from their doctor. Going forward, health IT developers will need to monitor this and evolve the technology to add more context for patients.
Disparities and Barriers
Lastly, certain populations still face barriers to accessing their medical records. There are “disparities in patient access by race and ethnicity, education, income, and other socio-demographic factors,” according to a study by the Health and Human Service Department’s Office of the National Coordinator for Health IT. Other barriers include internet access, health literacy, and language. Although the ONC provides resources for patients to access and manage their health records through different methods, this issue persists.
The healthcare industry’s rocky relationship with EHRs will continue as long as patients have problems accessing their information. Providers need to step up and take action to ensure all patients have access to, understand, and can manage their health records
Technology can be a huge disruptor if implemented incorrectly.
On this week’s episode of HLM Shorts, we hear from Betty Jo Rocchio, Senior Vice President and Chief Nurse Executive at Mercy, about the technological challenges that her team faced while building Mercy’s new nursing innovation unit. Tune in to hear her insights.
Transcript (edited for clarity):
Have there been any unexpected challenges or outcomes regarding Mercy’s new nursing innovation unit?
Rocchio: Getting technology to play nice in the clinical environment with that ease of use is a heavy lift, which is why it can be such a big disruptor. If it's not put in and worked into workflow, we end up working around the technology.
So, making sure that the technology we pick is delivering to the satisfaction of the front lines is key. It's as simple as vital signs being taken by a machine and automatically having them documented in our electronic medical records, so nobody has to touch it.
That was a heavy lift with a lot of interfaces and things that you wouldn't think in the background, so our Mercy technology team has really been working overtime to lean in and help us.
Faced with competition from disruptors, health systems are expanding their pharmacy services to capture additional income and improve clinical care
Amid increased competition from disruptors and retail chains, health systems are expanding their pharmacy operations beyond the hospital, in some cases building stand-alone community pharmacies or co-locating them with clinics to compete directly with the likes of Walgreens, Rite Aid, and CVS.
“It’s a huge opportunity,” says Rebecca Taylor, vice president of the pharmacy service line at UPMC, which now has 17 pharmacies within its network, some located inside clinics. “Ambulatory pharmacies have been around for a long time, but there are a lot of factors that are driving this new opportunity” for health systems to expand their reach.
With intense competition in the healthcare space, health systems are seizing on the opportunity to expand pharmacy services as a means of improving the scope of services they provide to patients. Many want to keep the patient within the hospital’s network, integrating all healthcare services through the medical record, a strategy that segues into the concept of value-based care and the medical home.
Others see the pharmacy as an attractive business line. Through the 340B Drug Pricing Program, health systems can be reimbursed through Medicaid for outpatient drugs sold to uninsured and low-income patients. They’re also looking to capture more specialty pharmacy services and prescriptions lost to neighborhood and community pharmacies, not to mention the profits from other goods and services sold through a retail location.
And while neighborhood and community pharmacies are looking to adopt more healthcare services and become community health centers, they’re also struggling. Rite Aid has filed for bankruptcy, while Walgreens and CVS are closing hundreds of stores, leaving communities without that resource for filling prescriptions. Health systems can fill that gap with their own pharmacies.
Making an Argument for Pharmacy Expansion
Nicole Faucher, MS, president of Clearway Health, a Massachusetts-based company spun out of Boston Medical Center that partners with health systems and hospitals to strengthen their specialty pharmacy programs, says health systems have three primary reasons for expanding their pharmacy services:
Creating a new service line. When patients fill their prescriptions at a local pharmacy, they’re taking business away from the hospital. A health system can keep that business in-house with its own pharmacy service, as well as influencing the patient to consider more health and wellness services and products.
Improving clinical outcomes. By keeping pharmacy services in-house, a health system can link all of those services through the medical record, ensuring continuity of care and reducing gaps in care or siloed services. In addition, the pharmacist becomes an integral part of the care team and the care management plan, improving medication adherence and helping patients with any medication-based issues that might otherwise be delayed or go unanswered.
Improving patient loyalty and engagement. Health systems that include pharmacy services are seen by patients as being more attentive to and involved in care management and coordination. That patient will be more likely to stay with the health system, listen to advice on other services and resources within the health system, and recommend that health system to family and friends.
The decision to expand pharmacy services can’t be taken lightly. These projects are expensive, and they require plenty of research and planning. One look at how Walgreens, Rite Aid, and CVS are doing right now with the healthcare ambitions would be enough to scare anyone away.
“This isn’t just ‘Build it and they will come,’” warns Faucher, who says health system leadership needs to think long and hard about whether to take this on.
Among the considerations that go into planning a pharmacy expansion:
Understanding the patient population and community. Will patients shift their allegiance from local pharmacies to a hospital-run pharmacy?
Site selection and staffing. Will a stand-alone pharmacy work, or should these services be co-located with a clinic, medical offices, or other programs? Building and/or rental costs will figure prominently in this strategy, as will costs for staffing a stand-alone pharmacy.
Delivery. Will this be a traditional pharmacy that handles over-the-counter and walk-in traffic, or will it be strictly mail-order? If the latter, how will deliveries be handled? If the former, will the pharmacy handle prescriptions only or offer other goods and services?
Contract negotiations. A health system will need to handle contracts with pharmacy benefit managers (PBMs), payers, and health plans, along with any delivery services. In addition, there will be contracts with drug distributors to consider.
Sustainability. How much business will a pharmacy need to generate to be sustainable? This will determine what other services or products are offered.
Alongside managing the aspects of a 340B program, Faucher says a health system must also decide how to manage business with other pharmacies. Some 15% of all prescriptions involve medications that are handled by specialty pharmacies.
“There really isn’t a one size that fits” for every health system, she says.
Addressing Both Clinical and Business Goals
At Signature Healthcare, based in southeastern Massachusetts, the decision to expand pharmacy services addressed both clinical and business goals. A significant percentage of the health system’s patient base are members of government health plans, making the 340B program an attractive addition to their bottom line.
“We make a little more of a margin on that,” says Stephen Borges, Signature’s vice president of financial operations.
But the health system also wants to create a more connected health experience for its patients, many of whom are underserved, he says. That means adding pharmacy techs in critical care units, medical offices, and clinics to be part of the care team, and locating a retail pharmacy in their largest physician office building near the hospital.
“We’re reinventing care for our patients,” Borges says.
Signature Health had partnered with the local Walgreens chain prior to this change in strategy, even enabling Walgreens pharmacists to come into the hospital to meet with patients before they were discharged. But there were still gaps in care, he says, that comes with having two separate organizations try to care for the same patient.
“We want our pharmacists to have the ability to do more with our patients,” Borges says. That includes creating a patient assistance program to work with patients who struggle to pay their bills and find other ways of meeting prescription costs.
One of the challenges to implementing this new strategy was getting buy-in from physicians who might not see the pharmacist as a member of the care team. Borges says it took some time and effort to get everyone comfortable with each other; he credits the successful integration to the work of physician champions identified ahead of time by the health system.
Another challenge was getting support from patients who have always gotten their prescriptions filled at the local pharmacy.
“We didn’t anticipate that it would be so hard to convince people to move away from CVS and Walgreens,” Borges says.
Addressing the Patient’s Needs
At UPMC, Taylor says expanding the health system’s footprint to include more pharmacy services gives them the chance to have a greater impact on clinical outcomes.
Pharmacists who are part of the health system and the care team, she says, can work with providers and patients to fine-tune medication management, identifying potential drug reactions and alternatives to costly medications. They can answer patient questions that might not be asked in a separate pharmacy, work with patients who have trouble paying for medications, and collaborate with doctors when a patient struggles with medication adherence or displays adverse effects to taking a certain medication. They can also help the health system with vaccinations and other public and community health outreach programs.
Taylor says the additional service line also enables UPMC to attract and hire skilled pharmacists, especially those who’d prefer to work with a health system rather than a retail pharmacy.
Studies back up the idea that the pharmacist—regardless of whether he/she is employed by the hospital or another company--should be part of the care team. Recent research done at Virginia Commonwealth University found that pharmacists could prevent more than 15 million heart attacks and nearly 8 million strokes and save $1.1 trillion in healthcare costs over 30 years if they were allowed to be more active in managing care for patients.
Taylor sees an improvement in reduced rehospitalizations. Pharmacists who are part of the care team can spot problems before they become serious, she notes, alerting physicians and enabling them to intervene while the patient is at home.
The Impact of Technology
One reason for heightened interest in the pharmacy space is the availability of new technology. Telehealth and digital health tools make it easier for clinicians and pharmacists to communicate with each other and with patients, creating or modifying care plans on the go and prescribing and filling prescriptions virtually. And with the popularity of online and mail-order prescriptions surging, health systems can also take advantage of online platforms to handle prescriptions in bulk and mail them to patients.
“That certainly makes it easier,” says Taylor. “And in the future, there will be other technologies that will make it feasible to do a hub-and-spoke model,” enabling health systems to manage distant pharmacy sites from one central location.
“Internet prescription fills have gone through the roof,” adds Borges.
A report recently issued by the Center for Connected Medicine finds that more than half of health systems with their own ambulatory pharmacies “believe retailers and technology companies are having either a moderate or strong influence on their hospital’s pharmacy strategy.”
According to the report, many health systems are planning to invest in digital health technology to improve their pharmacy services. Among the more popular platforms are integrated patient portals, prescription fills and refills and payments through an app, and medication adherence services (such as reminders).
Faucher, of Clearway Health, says the integration of patient portals and EHRs with pharmacy services gives health systems an opportunity to play a more active role in care management. Doctors can check in with both pharmacists and patients online to make sure prescribed medications are being taken and are effective, while pharmacists and patients can respond more quickly if something isn’t working.
Faucher says health systems have an opportunity to grow their business by single digits with a more aggressive pharmacy strategy, and by double digits if they adopt specialty pharmacy services. Beyond the profit margins, they have an opportunity to improve care by being more of a healthcare partner with patients who are demanding more collaboration with their care teams.
“Health systems need to have a pharmacy strategy,” she says. “This will be a continuing trend.”
This CNO has advice for the huge challenges facing nurse leaders as we enter the new year.
As we dive into the new year, CNOs must be prepared to deal with the new and ongoing challenges facing the nursing industry. Lisa Dolan, Senior Vice President and Chief Nursing Officer at Ardent Health Services, has laid out what she thinks are the five biggest issues that nurses will face in 2024.
5. Burnout
Burnout is a widespread issue for clinical staff throughout all of healthcare, especially since the pandemic.
“The roles are so difficult at times,” Dolan says, “and so being able to have a healthy work environment for people to feel comfortable in, and not experience the rate of burnout that they have over the past several years [will be key].”
CNOs should be open and talk about burnout, and validate that it is a real issue. Dolan recommends wellbeing check-ins and holding debriefings after serious incidents with patients, and finding creative ways to help staff adjust when they encounter big life events.
She also says recognizing people and celebrating their wins is crucial, and getting feedback from patients is a great way to give that recognition to the nurses who care for them.
4. Frontline nursing leaders
Retaining frontline nursing leaders will also be on many CNO agendas. Retention is already difficult in nursing, and it’s crucial that frontline nursing leaders be present long-term for their units to help promote teamwork and to maintain a strong workplace culture.
“It’s one of the toughest positions in the hospital,” Dolan says, “So being able to retain and support those frontline leaders will be key.”
3. Innovation
There are all kinds of new technologies arriving at the forefront in nursing, and it’s the CNO’s job to know how to incorporate them correctly into nursing strategy.
“There’s so much great innovation going on,” Dolan says, “but how we incorporate [technology] so that it’s helpful to the nurse and not adding additional burden to the nurse is especially important.”
Virtual nursing and virtual care platforms are keys to the future, according to Dolan. Virtual care in nursing can help with data collection, patient admission and discharge, patient education, and family education.
“There’s many things that a virtual nurse can assist a bedside nurse to complete and do,” she says, “and [they] actually feel like they have more time to spend with the patient.”
Dolan also emphasizes the benefits of wearable technology and smart rooms. Wearables can help nurses monitor vital signs and patient status, freeing up staff so they can spend time completing other tasks. Wearables also have the potential to help with hospital to home care, because patients can continue wearing the technology that will keep monitoring their progress.
Smart rooms and smart room technology also will add to further advancement in patient monitoring, and help take some of the burden off nurses. Smart rooms can hear and listen, which opens up the possibility of real-time transcription of the documentation nurses record for patients. This technology could also help prevent workplace violence or safety incidents from escalating too much, Dolan says.
2. Stabilization of support roles
One of the biggest challenges in nursing is stabilization of support roles. It’s becoming more and more difficult to be competitive in staffing support roles, which Dolan says is a key concern.
“As nursing becomes more and more taxed,” she says, “It’s especially important that we have a support team around the nurse.”
1. Supply of nurses
At the top of the list is the supply of nurses. The demand for nurses is outpacing the supply, and it is essential that CNOs use their influence to implement strategies to help fix this problem.
“Trying to help re-energize the public about healthcare careers and how fulfilling they can be is a key piece and a key role for the CNOs going forward in their communities,” Dolan says.
She also believes that creative partnerships with academic programs and institutions can help produce more nurses. Both healthcare and academic settings are short-staffed and need help, and there is an opportunity for one to provide support to the other, and vice versa.
“If we can be creative in our partnership efforts with those academic settings to help augment their staffing and clinical instructors, and allow them to take additional students,” she says, “that would all be very helpful as well.”
Jumping into the new year
Several other trends will continue to affect nursing in 2024. Dolan believes we’re going to see continued emphasis on quality and safety measures in the workplace, for both patients and staff.
“That whole focus of pay for performance and meeting all of those key metrics is going to be continue to be really important,” she says.
At Ardent Health Services, she says they will see a transition from a patient experience in the hospital to a consumer experience across the whole system. This shift in strategy considers the experience of patients when they interact with system processes, such as making appointments or accessing their health information through their Epic chart.
Additionally, health systems will experiment with new care delivery models. Since there are not enough nurses to support historic approaches, there will be new team approaches to care, Dolan says.
“That whole ability for people to work as a collaborative group, and come together [to] care for a patient,” she says, “I think is going to be key into the future over the next year.”
Federal officials have unveiled a new strategy to address rising cybersecurity incidents. It includes incentives to improve data security, beefed-up guidelines, and the potential for cuts in reimbursement.
With cybersecurity incidents occurring on an almost-daily basis in the healthcare sector, federal regulators are looking to take a more active role in improving data security.
The Health and Human Services Department has released a new strategy for cybersecurity, centered on four steps aimed at improving the healthcare landscape. The six-page document builds off of the Biden administration’s National Cybersecurity Strategy, which was unveiled last March, and follows recent actions taken by federal agencies to boost security, including the release of healthcare-specific practices and training resources, guidance on medical device security from the US Food and Drug Administration, and new telehealth guidelines from the HHS Office of Civil Rights (OCR).
“The healthcare sector is particularly vulnerable, and the stakes are especially high,” HHS Secretary Javier Becerra said in a release accompanying the strategy. “Our commitment to this work reflects that urgency and importance. HHS is working with healthcare and public health partners to bolster our cyber security capabilities nationwide.”
The information comes at a particularly vulnerable time for the healthcare industry, which has seen an alarming increase in large data breaches and ransomware attacks in recent months. According to the OCR, the industry has seen an almost two-fold increase in large breaches from 2018 to 2022, from 369 incidents to 712, while ransomware attacks have surged 278% in that time.
“Cyber incidents affecting hospitals and health systems have led to extended care disruptions caused by multi-week outages; patient diversion to other facilities; and strain on acute care provisioning and capacity, causing cancelled medical appointments, non-rendered services, and delayed medical procedures (particularly elective procedures),” the HHS report notes. “More importantly, they put patients’ safety at risk and impact local and surrounding communities that depend on the availability of the local emergency department, radiology unit, or cancer center for life-saving care.”
With that in mind, HHS is planning to take a more active role in pushing the healthcare industry to improve its defenses. The agency plans to:
Establish voluntary cybersecurity performance goals for the healthcare sector;
Provide resources to incentivize and implement these cybersecurity practices;
Implement an HHS-wide strategy to support greater enforcement and accountability; and
Expand and mature the one-stop shop within HHS for healthcare sector cybersecurity.
Of particular note are the financial incentives that the government will be offering to health systems who need help becoming more secure. According to the report, the HHS will be launching a program to help struggling hospitals cover the up-front costs of installing “essential” cybersecurity performance goals (CPGs), and a program that offers incentives for hospitals to invest in advanced cybersecurity practices to implement “advanced” CPGs.
In addition, the HHS strategy will include new cybersecurity requirements for hospitals that will be enforced through the Centers for Medicare & Medicaid Services (CMS), an indication that the feds could tie compliance to Medicare and Medicaid reimbursements. As well, the OCR is scheduled to update the Health Insurance Portability and Accountability (HIPAA) Security Rule this coming spring to include cybersecurity requirements.
Not everyone is on board with the HHS strategy. Chris Bowen, founder and chief information security officer for ClearDATA, says the industry should get even tougher.
“While a gesture towards progress, [the strategy] falls critically short of what's imperative in today's climate,” he said in an e-mail to HealthLeaders. “Suggesting voluntary measures is akin to applying a band-aid on a hemorrhage, it's time for HHS to enforce rigorous, non-negotiable cybersecurity standards and to provide the necessary resources and mandates.”
“The sector's talent gap in cybersecurity is no secret, and it places our hospitals at a disadvantage, jeopardizing patient safety,” he adds. “We must look to the strategies of those who have robustly safeguarded healthcare data and replicate their assertive approach. Protecting lives extends beyond the physical realm; it encompasses shielding patients from the lethal threat of cyber-attacks. To accept minimum, voluntary standards is to tacitly endorse a status quo that endangers our patients.”
HealthLeaders strategy editor Jay Asser is joined by Brianna Motley, principal at Sg2, to talk about capacity challenges and how data can help identify the most impactful operational and care design solutions to alleviate constraints.
MIT researchers are working on an ingestible that vibrates when swallowed, tricking the stomach into thinking it’s full
Can a vibrating pill help healthcare providers create sustainable and effective weight loss treatments?
That’s the question researchers at the Massachusetts Institute of Technology are trying to answer as they experiment with the latest in healthcare ingestibles. The MIT team has developed a pill enhanced with technology that is programmed to vibrate for about 30 minutes after being swallowed, activating receptors within the body that signal the stomach is full.
“For somebody who wants to lose weight or control their appetite, it could be taken before each meal,” Shriya Srinivasan, a former MIT graduate student and assistant professor of bioengineering at Harvard University who’s leading the study, said in an MIT news piece. “This could be really interesting in that it would provide an option that could minimize the side effects that we see with the other pharmacological treatments out there.”
Characterized by the popularity surrounding new drugs like Ozempic and Wegovy, healthcare providers are looking for new ways to address obesity and weight-related issues, which play a role in many chronic health conditions. Some 42% of US adults are affected by obesity, and it’s estimated that more than 160 million Americans are on a diet at any given time and spending more than $70 billion a year on commercial weight-loss plans, supplements and other diet programs.
Yet for all the products and treatments on the market, many people struggle to consistently stay within a diet plan, primarily because habits are very hard to break. Healthcare providers have long struggled to design treatment plans that are sustainable and keep patients engaged over the long run.
Digital health tools, such as digital therapeutics, aim to tackle that challenge by targeting behavior change.
One method of tackling behavior change is by tricking the body into thinking it’s full. For Srinivasan and Giovanni Traverso, an associate professor of mechanical engineering and MIT and a gastroenterologist at Brigham and Women’s Hospital, that led to the creation of the VIBES pill, which vibrates in the stomach, affecting the vagus nerve, which then sends messages to the brain that the stomach is full.
Srinivasan, Traverso, and their research team tested the VIBES pill on Yorkshire pigs, who were given the pill 20 minutes before being fed. They found that the pill not only stimulated the release of hormones that signaled satiety, but also reduced the animals’ food intake by about 40%.
The study, which was funded by the National Institutes of Health, Novo Nordisk, and the National Science Foundation, among others, is still in its early stages.
“The behavioral change is profound, and that’s using the endogenous system rather than any exogenous therapeutic,” Traverso said in the MIT news story. “We have the potential to overcome some of the challenges and costs associated with delivery of biologic drugs by modulating the enteric nervous system.”
“For a lot of populations, some of the more effective therapies for obesity are very costly,” added Srinivasan. “At scale, our device could be manufactured at a pretty cost-effective price point. I’d love to see how this would transform care and therapy for people in global health settings who may not have access to some of the more sophisticated or expensive options that are available today.”
Federal regulators are scrambling to create guidelines for the ethical use of AI in a number of industries. Will healthcare collaborate or stake its own claim to governance?
As we head into the new year, the hot topic on every healthcare executive’s minds is AI. And one of the biggest questions surrounding the technology centers on who will regulate it.
The Biden Administration set the tone this past October with an Executive Order that places much of the federal regulatory burden on the Health and Human Services Department and the Office of the National Coordinator for Health IT (ONC), a position held by Micky Tripathi. HHS then set the schedule with a final order in December that calls for more transparency in AI tools used in clinical setting by the end of the coming year.
While much of the action so far focuses on the technology vendors who are designing AI tools, health system leaders are keeping a close watch on how the federal government will affect their use of the technology. Many health systems are developing and using their own tools and platforms and pledging to maintain ethical standards in any clinical applications.
“We have a culture of responsibility that goes alongside agile innovation,” Ashley Beecy, MD, FACC, medical director of AI operations at NewYork-Presbyterian and an assistant professor of medicine at Weill Cornell Medical College, said in a HealthLeaders interview earlier this year, prior to Biden’s Executive Order. “Health systems have a unique opportunity” to establish their own standards for the proper use of AI.
Tarun Kapoor, MD, MBA, senior vice president and chief digital transformation officer at New Jersey-based Virtua Health, says healthcare organizations have the clinical background needed to develop effective and sustainable AI governance. They know how it’s going to be used in healthcare, and can focus on the nuances that federal regulators might miss.
“We have to get a lot better at [regulating AI] because we’re the ones using it,” he says.
Like many health (if not all) health systems using AI these days, Virtua Health has a policy that any AI services have a human being in the loop, meaning no actions are taken on AI-generated content until they’ve been reviewed by at least one flesh-and-blood supervisor. At this stage, when most projects are trained on back-office tasks, that’s a safe bet; but when the technology works its way into clinical decision-making, that additional step may be critical.
“Always put physicians in front of those decisions,” says Siva Namasivayam, CEO for Cohere Health, a Boston-based company that focuses on using AI to improve the prior authorization process. He says the technology should be used to enhance the physician’s role—what he calls “getting to the yes factor—rather than replacing it.
“We never use AI to say no,” he adds.
But who gets to make those decisions? The Biden Administration wants to be part of that chain of command, and is setting its sights on a collaborative environment, having secured voluntary pledges from more than three dozen health systems, payer organizations, and technology vendors to use AI responsibly. The agreement centers on a new catchphrase for ethical use: FAVES, which stands for Fair, Appropriate, Valid, Effective, and Safe.
The healthcare industry, still smarting from having electronic medical records forced on them before they were really ready for adoption, is playing nice for now. But in many hospitals, the C-Suite is facing pressure to take command of AI governance and make it an industry priority.
“You govern yourself at a level higher than the law,” says Kapoor.
He notes that health systems like Virtua Health are being very careful in how they use the technology, and not just green-lighting any potential use.
“Just because you can say anything and create your own [projects] doesn’t mean I’m going to let you say anything and do them,” he points out.
Kapoor says healthcare providers will understand the flaws in AI technology and the risks they present better than anyone outside the industry. And health systems like Virtua Health are addressing these challenges with steering committees that comprise not only clinical leaders but those in finance, IT, legal, and operational areas of the organization.
Arlen Meyers, president and CEO of the Society of Physician Entrepreneurs, a professor emeritus at the University of Colorado School of Medicine and Colorado School of Public Health, says the industry has to step up and show leadership at a time when AI governance is still in flux. He notes hundreds of healthcare organizations have created dedicated centers of excellence for AI, and some have vowed to develop ethics and standards of use. Consumers, as well, could get into the act, helping to form an ‘AI Bill of Rights’ for patients.
“Right now, nobody trusts the government or the industry to regulate this,” he says. “When you look at who should be regulating what … the industry should be setting the guardrails.”
This next year will be pivotal in establishing governance for AI, as more and more health systems use the technology and push the boundaries beyond administrative use and into clinical applications. While the Biden administration is looking to fast-track regulation through HHS and the ONC, many wonder whether the healthcare industry will wait that long, or let a federal agency propose the first rules.
Others are wondering what it will take to create regulations that will work. One look at the current debate over interoperability and data blocking standards makes it clear that just because rules are created doesn’t mean they’ll be readily accepted.
“In the end, you follow the money,” says Meyers, who anticipates that healthcare and government will have to come to some sort of agreement to create something long-lasting. “That’s how the [rules] will be made.”
Nurses want to work with in-house teams that they can rely on, but it’s complicated.
Across the country, nursing unions are citing compensation, working conditions, and staffing issues- and now most recently, outsourcing—as their reasons to go on strike.
Registered nurses at SMM Health Saint Louis University Hospital have announced that they will hold a two-day strike beginning on December 27 to protest the outsourcing of RN jobs and management’s attempts at union-busting. This announcement was made by the National Nurses Organizing Committee (NNOC) and National Nurses United (NNU) following a vote on December 8 that authorized the nurse bargaining team to call a strike.
Why turn to outsourcing?
Outsourcing is not a new phenomenon in healthcare, according to Katie Boston-Leary, Director of Nursing Programs at the American Nurses Association.
“Leaders opt to outsourcing after doing capital and operational cost analysis if they feel that there is a market for certain talents or expertise and they are unable to compete,” she says.
According to the NNU, SMM Health has been outsourcing nurse positions rather than hiring full-time nurses, which the union believes creates a revolving door of staff that do not become as involved in the surrounding community. This has been a concern throughout the industry during the ongoing nursing shortage, and with turnover rates as high as they are now.
Differing viewpoints
From the CNO perspective, there are two sides to the issue.
“Nurses would rather work with permanent members of the team and not a rotating group of nurses that seemingly have less requirements from a system perspective,” Boston-Leary says. “And that is making more money than them, [and] in some cases have lesser experience.”
On the other hand, outsourcing may sometimes be one of the only available options.
“Leaders have to maintain operations by utilizing outsourced talent when they are unable to recruit,” Boston-Leary states. “As much as they abhor [the] high labor spend.”
Even without enough nurses, patients still need staff to care for them, and health systems still need to provide the people to do so.
“When you think about it, a nurse can resign [from] a position with as little as two weeks’ notice, but it could take one to three years to replace that nurse,” says Boston-Leary. “In the meantime, emergency and surgical departments are busy and they need staffed beds, which [are] also at a premium.”
The perspective of the nurses at Saint Louis University Hospital who are going on strike is clear. They believe that the ever-changing staff interrupts patient care and will impact the future of their health system for a long time.
“Temporary, outside agency staff should only be used to fill occasional gaps,” said Sarah DeWilde, RN in the medical-surgical unit at SLUH in the NNU statement. “Outsourcing will only exacerbate the current staffing crisis and further erode the quality of patient care for years to come.”
