The changes are aimed to close gaps around HIPAA and help healthcare organizations and consumers control the use of personal health information

Federal officials are making sweeping changes to regulations around digital health apps and platforms in an effort to combat data breaches and fill in the gaps around the Health Insurance Portability and Accountability Act (HIPAA).

The U.S. Federal Trade Commission (FTC) last week announced final changes to the Health Breach Notification Rule (HBNR), which requires vendors of personal health records (PHR) and related entities that are not covered by HIPAA to notify individuals, the FTC and, in some cases, the media of a breach of unsecured personally identifiable health data. The rule also requires third-party service providers to vendors of PHRs and PHR-related entities to notify such vendors and PHR related entities following the discovery of a breach.

The changes aim to close loopholes caused by the proliferation of third-party apps and platforms in the digital health ecosystem and give both healthcare providers and consumers more control over the use and reliability of healthcare data.

“Protecting consumers’ sensitive health data is a high priority for the FTC,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. “With the increasing use of health apps and connected devices, the updated HBNR will ensure it keeps pace with changes in the health marketplace.”

The changes include:

• Revised definitions. Several definitions were rewritten to include health apps and similar technologies not covered by HIPAA. This includes redefining “PHR identifiable health information” and adding new definitions for “covered healthcare provider” and “healthcare services or supplies.”
• Clarifying ‘breach of security.’ A “breach of security” will now include any unauthorized acquisition of identifiable health information that occurs as a result of a data security breach or an unauthorized disclosure.
• Revised definition of PHR related entity. The definition of a “PHR related entity” will now cover entities that offer products and services through the online services, including mobile applications, of vendors of personal health records. It also makes clear that only entities that access or send unsecured PHR identifiable health information to a personal health record — rather than entities that access or send any information to a personal health record — qualify as PHR related entities.
• Clarifying multiple sources of PHR identifiable health information: The final rule clarifies what it means for a personal health record to draw PHR identifiable health information from multiple sources.
• Expanded use of electronic notification: The final rule authorizes the expanded use of e-mail and other electronic means of providing clear and effective notice to consumers of a breach.
• Expanded consumer notice content: The required content that must be provided in the notice to consumers has been expanded to include the name or identity (or, where providing the full name or identity would pose a risk to individuals or the entity providing notice, a description) of any third parties that acquired unsecured PHR identifiable health information as a result of a breach of security.
• New timing requirements. For breaches involving 500 or more individuals, covered entities must notify the FTC at the same time they send notices to affected individuals, which must occur without unreasonable delay and in no case later than 60 calendar days after the discovery of a breach of security.
• Improved readability. The final rule also includes changes to improve the rule’s readability and promote compliance.

From the frontline to the C-Suite, nurse leaders say they need a seat at the table.

Nurse leaders have a lot on their plates.

From ensuring nurses have a say in the integration of AI into healthcare systems, to improving the public perception of nursing, to demonstrating the value of nursing to the C-Suite, a CNO’s work is complex.

In times like these strategizing with peers is key, and that’s exactly what dozens of nurse leaders from across the country are doing right now.

The HealthLeaders CNO Exchange is well on its way as the participating members discuss these pain points in nursing and innovative solutions for dealing with them.

Here are three areas where nurse leaders say nurses need a seat at the table.

AI

The emergence of AI in healthcare has the potential to turn the industry upside down, and in many ways it already has.

The biggest concern amongst nurses, according to the Exchange members, is making sure that nurses have a seat at the table in determining how AI will be integrated into their health systems. The implementation of any new technology can become a hindrance if not implemented correctly, so it is crucial that CNOs partner with technology teams to determine the best ways to move forward.

Another key factor is messaging. CNOs need to make sure they are communicating to their nurses that AI is not there to replace them, but rather to support them and help offload some of the more administrative tasks so they can spend more time at the bedside.

Perception of nursing

In terms of recruitment and retention, the public perception of nursing on social media has been affecting the number of people wanting to become nurses. According to the members, the public outlook on the profession has become very negative, and nurse leaders have lost control of the narrative.

Some of the solutions that were discussed include utilizing social media to spin a more positive message about nursing and about working in healthcare. CNOs should consider bringing in experts who are familiar with social media and enlisting their help to create a more positive message that can then help draw new potential candidates into the industry.

Value of nursing

One of the biggest hurdles that CNOs have to jump through is presenting the ROI for nursing to the rest of the C-Suite. According to the Exchange members, the cost of nursing is distributed between other parts of the budget, even though nursing makes up the largest portion of the healthcare workforce.

To the members, the important thing is that nurses are valued and appreciated for the services they provide, and recognized for the revenue that they bring to the health systems through quality care and patient interactions. One recommendation from the members is that CNOs should round with their CFOs, when possible, to demonstrate what's happening at the bedside, and have open lines of communication with other members of the C-Suite.

Stay tuned for more takeaways from the 2024 CNO Exchange.

The HealthLeaders Exchange is an executive community for sharing ideas, solutions, and insights. Please join the community at our LinkedIn page. 

To inquire about attending a HealthLeaders Revenue Cycle Exchange event, email us at exchange@healthleadersmedia.com. 

A new FDA program aims to develop strategies and guidelines for health systems delivering care in the patient’s home

Health systems are getting more help planning new remote patient monitoring (RPM) and acute care and hospital at home programs.

The U.S. Food and Drug Administration (FDA) has announced the launch of the Home as a Health Care Hub, a resource designed to help healthcare executives understand how to design programs that deliver care in the home setting. As part of this program, the FDA’s Center for Devices and Radiological Health (CDRH) is contracting with an architectural firm to explore how healthcare and health equity can be included in home design.

“While many care options are currently attempting to use the home as a virtual clinical site, very few have considered the structural and critical elements of the home that will be required to absorb this transference of care,” Jeff Shuren, MD, JD, director of the CDRH, and Michelle Tarver, MD, PhD, the CDRH’s deputy director for transformation, said in a press release.” Moreover, devices intended for use in the home tend to be designed to operate in isolation rather than as part of an integrated, holistic environment. As a result, patients may have to use several disparate medical devices, some never intended for the home environment, rather than interact with medical-grade, consumer-designed, customizable technologies that seamlessly integrate into an individual person's lifestyle.”

The program builds on an intriguing trend in healthcare, in which health systems and hospitals are looking to shift more services out of the hospital, clinic, and doctor’s office and into the patient’s home. This includes RPM programs that enable care teams to monitor patients at home, either by gathering patient data at selected times or with continuous monitoring, and acute care and hospital at home programs that combine RPM, virtual care, and in-person care.

That transition isn’t so easy. While the consumer technology industry is seeing huge growth in wearables and smart devices that include healthcare uses, clinicians are wary of the reliability of data coming from these devices and don’t know how to use them. As well, while the home offers a new setting for healthcare delivery, clinicians need to better understand the both the challenges and the advantages of delivering healthcare in that setting.

“We have an untapped resource in the home,” Hon Pak, vice president and head of the digital health team at Samsung Electronics and a former Kaiser Permanente executive, said during a CES 2024 panel on this topic this past January in Las Vegas. “Fundamentally, we have to change the model” of how care is delivered.

The new program will also take aim at another key strategy in healthcare innovation: Addressing health inequity, or challenges to healthcare access and treatment caused by social drivers of health.

“This partnership includes collaboration with patient groups, healthcare providers, and the medical device industry to build the Home as a Health Care Hub,” Shuren and Tarver said in the press release. “This prototype will serve as an idea lab, not only to connect with populations most affected by health inequity, but also for medical device developers, policy makers, and providers to begin developing home-based solutions that advance health equity.”

“Existing models that have examined care delivery at home have found great patient satisfaction, good adherence, and potential cost savings to healthcare systems,” they added. “By beginning with dwellings in rural locations and lower-income communities, the planned prototype will be intentionally designed with the goal of advancing health equity.”

[Also read: Patient Experience Is Crucial to the Success of Hospital at Home.]

The two executives said the program is part of a redesign of healthcare to focus on the patient, with care plans that meet a patient’s needs and desired rather than a plan that forces the patient to adjust to new roles or routines. As such, care providers need to understand the environment around the patient.

“The Home as a Health Care Hub prototype is the beginning of the conversation—helping device developers consider novel design approaches, aiding providers to consider opportunities to educate patients and extend care options, generating discussions on value-based care paradigms, and opening opportunities to bring clinical trials and other evidence generation processes to underrepresented communities through the home,” they said. 

The new will be unveiled sometime this year as an AR/VR prototype.

Workforce development continues to be a top concern for nurse leaders. 

Many nurse leaders are strategizing as best they can to deal with the growing nursing shortage and how to incorporate new innovative solutions for redesigning care models to fit the modern care needs of patients.  

Here are some of the workforce development issues keeping CNOs up at night. 

Click here to read the accompanying article. 

A study launched in 82 HCA Healthcare hospitals found that an AI tool could help staff identify and react to an infection and help contain an outbreak

Healthcare organizations are training an AI tool to rapidly identify outbreaks within a health system, giving clinicians more time to contain the infection and treat patients.

A four-year study in 82 hospitals across the US, recently posted in The New England Journal of Medicine, found that the automated tool reduced potential outbreaks by 64% compared to traditional methods of identifying an outbreak. The tool identified potential outbreaks, on average, three times per year per hospital.

“Outbreaks in hospitals are often missed or detected late, after preventable infections have occurred,” Meghan A. Baker, MD, ScD, a Harvard Medical School assistant professor of population medicine at the Harvard Pilgrim Health Care Institute and lead investigator of the study, said in a press release. “This study provides a practical and standardized approach to identify early transmission and halt events that could become an outbreak in hospitals.”

Funded by the U.S. Centers for Disease Control and Prevention (CDC), the CLUSTER study was conducted in 2019-22 at hospitals within the HCA Healthcare system by a team of investigators from HCA, the Harvard Pilgrim Health Care Institute, and the University of California, Irvine (UCI) Health.

The research aims to help a healthcare industry still reeling from the effects of the COVID-19 pandemic (which, coincidentally, interrupted this study) and looking for better methods of tracking outbreaks before they cripple hospitals and harm more people. Researchers are turning to AI tools to sort through data and more quickly and accurately identify trends.

“Despite significant progress in reducing healthcare-associated infection outbreaks, including of antimicrobial-resistant pathogens, they remain an industry challenge and can present as clusters that signal potential for transmission to patients,” Joseph Perz, DrPH, MA, senior advisor for public health programs in the CDC’s Division of Healthcare Quality Promotion and a committee member for the CDC’s Council for Outbreak Response: Healthcare-Associated Infections, said in the release. “The CLUSTER trial provides evidence that early detection powered by automation tools and quick action can prevent outbreaks from growing.”

In this trial, researchers created an “algorithm-driven statistical detection tool” that combed through laboratory data for signs of more than 100 bacterial and fungal infections, then posted real-time alerts to infection control programs. The process included both an automated review of patients’ clinical cultures and a statistical assessment of whether patients with these specific infections were increasing in number.

The results of the study were affected by the COVID-19 pandemic. According to researchers, automated alerts weren’t as effective during the pandemic because hospital staff were so busy that they weren’t able to respond to the alerts in time. Researchers decided instead to focus on the results gained prior to the pandemic.

The research team said the underlying software will be available to all health systems, but it must be integrated into their EHR and other clinical workflow platforms.

The ONC and The Sequoia Project have added new enhancements for FHIR adoption in version 2.0 of the Common Agreement, which sets thew stage for nationwide interoperability through the TEFCA framework

Federal officials are showing further support for FHIR with the release of version 2.0 of the Common Agreement, which established the foundation for the Trusted Exchange Framework and Common Agreement (TEFCA) data exchange framework.

HL7’s Fast Healthcare Interoperability Resources (FHIR) Application Programming Interface (API) exchange has long been seen as a key element to nationwide interoperability, but many are worried that healthcare organizations are ready to embrace the standards just yet. Version 2.0, released by the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) and The Sequoia Projects, ONC’s Recognized Coordinating Entity (RCE) for TEFCA, includes enhancements and updates for FHIR support.

“Today’s release includes framework enhancements, including greater use of FHIR, better support for use cases beyond treatment, and simplified onboarding for participants like clinicians, digital health apps, public health agencies, and other end users of health data,” Mariann Yeager, The Sequoia Project CEO and RCE lead, said in a press release.

[Also read: TEFCA Gets Ready for its Moment in the Spotlight.]

“We have long intended for TEFCA to have the capacity to enable FHIR API exchange,” ONC chief Mickey Tripathi, PhD, added in the release. “This is in direct response to the health IT industry’s move toward standardized APIs with modern privacy and security safeguards, and allows TEFCA to keep pace with the advanced, secure data services approaches used by the tech industry.

To date, The Sequoia Project and ONC have named seven Qualified Health Information Networks (QHINs), who are working to integrate TEFCA into their data-sharing activities.

Nurse leaders must come together to tackle these three main pain points in workforce development. 

2024 has been a wild ride in the world of healthcare so far. With increasing turnover rates and the rapid rise of new technologies pushing their way to the forefront, the question of how to address core issues becomes increasingly dizzying.  

UMMS' new CNE aims to lead the health system on a journey to become a high reliability organization.

Peggy Norton-Rosko brings more than three decades of nursing experience and leadership. Most recently, Norton-Rosko served as the Regional Chief Nursing Officer for Trinity Health's Illinois and Indiana regions, where she oversaw nursing practices across a network that included an academic medical center, two community hospitals and a large ambulatory care network. She also served as an affiliate faculty member with the Loyola University Chicago Marcella Niehoff School of Nursing.

Following a nationwide search, Norton-Rosko has been named Chief Nurse Executive for the University of Maryland Medical System (UMMS), an academic-focused system which employs more than 9,300 nurses, effective May 20^th.

For our latest installment of the Exec, we sat down with Norton-Rosko to discuss how she began her journey into nursing, her thoughts on the future of virtual nursing, and meeting the needs of a multigenerational workforce.

The average tenure of employees on the VPs team is 10 years.

Succession planning was revealed to be a common issue among revenue cycle executives during the recent HealthLeaders’ Revenue Cycle Exchange. The leaders agreed on its importance, yet many stated their organizations didn’t have the time to allocate towards it.

However, at Moffitt Cancer Center in Tampa, Florida, Lynn Ansley, Healthleaders Exchange member and vice president of revenue cycle management, has made succession planning an integral part of the employee experience for her team and has seen great outcomes because of it.

Where to Start

Simply creating an organizational chart is a step in the right direction.

“When you look up an [organization’s leadership] chart, no matter where you’re sitting in that org chart, you want to know there’s a path for you to go,” Ansley told HealthLeaders. “Whether it’s up or even laterally across the organization.”

Succession planning then begins with an informational interview, where the employee is able to learn more about the role or department they’re interested in, qualifications, and discuss what they need to do to meet those qualifications.

During this stage, in particular, Ansley looks for potential leaders and will give them stretch assignments, which is a task where they have the chance to display their skills and capabilities as a leader.

They’ll be included in the organizational wide programs Moffitt’s development team puts together where they learn more about the organization and how different roles intersect with each other. Employees will also meet with their leader each quarter for professional development meetings to check their progress.

“When you look down in any area of my front, middle, and back-end shared services, there’s a pipeline of who’s up next for that leadership role,” Ansley said.

Different ladders within the organization require a particular HFMA certification, which, upon receiving the certification, makes them qualified to advance in the organization and increases their marketability should they ever decide to pursue other opportunities at a different organization.

Pictured: Lynn Ansley attends the 2024 Revenue Cycle Exchange.

Looking Forward

In addition to training opportunities, employees are encouraged to think about how and where they want to grow in the organization, especially now that the practice is growing.

“What I encourage our team members to do a lot is not just focus on the next six months, but look out a little bit further,” Ansley said.

“If the role that you think you want isn’t available today, we’re going to be multiplying the number of opportunities in the short term and into the next 10 years.”

The average tenure of members on Ansley’s team and leaders she reports to is 10 years. Because of this, she stated, the organization has a wealth of internal knowledge on their operations and processes, which contributes to a greater culture of continuous learning and improvement.

“We have a lot of, I call it ‘musical chairs’ in rev cycle, because it means that our team members are growing throughout all of the areas,” Ansley said.

“I’m not sure that there’s any more valuable of a team member that has sat in multiple seats on the bus and got to see the view from all of those different angles to see how the cycle really impacts one another.”

The HealthLeaders Exchange is an executive community for sharing ideas, solutions, and insights. Please join the community at our LinkedIn page.

To inquire about attending a HealthLeaders Revenue Cycle Exchange event, email us at exchange@healthleadersmedia.com.