In brief: Another cyberattack, DOJ task force on monopolies & AI use in health care 

ST. LOUIS – Ascension Healthcare has announced it detected unusual activity on select technology systems on May 8 and now believes it is due to a cybersecurity event. 

The large health system says it has engaged Mandiant, a third-party expert, to assist in the investigation and remediation process, and it has notified the appropriate authorities. 

“We responded immediately, initiated our investigation and activated our remediation efforts,” a spokesperson said. “Access to some systems has been interrupted as this process continues. Our care teams are trained for these kinds of disruptions and have initiated procedures to ensure patient care delivery continues to be safe and as minimally impacted as possible. We continue to assess the impact and duration of the disruption.” 

Ascension Healthcare spans about 134,000 associates, 35,000 affiliated providers and 140 hospitals, serving communities in 19 states and the District of Columbia. In fiscal year 2023, it provided $2.2 billion in care for people living in poverty and other community benefit programs. 

In a May 11 update, the health system says it has notified law enforcement, as well as government partners, including the FBI, the Cybersecurity and Infrastructure Security Agency, the Department of Health and Human Services and the American Hospital Association. It is also sharing relevant threat intelligence with the Health Information Share and Analysis Center so others can take steps to protect themselves from similar incidents. 

“While our restoration work continues in earnest, our focus is on restoring systems as safely as possible,” a spokesperson stated. “While we expect this process will take time to complete, we are making progress, and systems are being restored in a coordinated manner at each of our care sites. We will continue to share updates on our recovery process.” 

DOJ targets health care monopolies, collusion 

WASHINGTON – The U.S. Department of Justice has formed a Task Force on Health Care Monopolies and Collusion (HCMC) within its Antitrust Division to guide its enforcement strategy and policy approach, including by facilitating advocacy, investigations and, where warranted, civil and criminal enforcement in health care markets. 

“Every year, Americans spend trillions of dollars on health care, money that is increasingly being gobbled up by a small number of payers, providers and dominant intermediaries that have consolidated their way to power in communities across the country,” said Assistant Attorney General Jonathan Kanter of the DOJ’s Antitrust Division. “The task force will identify and root out monopolies and collusive practices that increase costs, decrease quality and create single points of failure in the health care industry.” 

HCMC’s mission 

The HCMC will consider widespread competition concerns shared by patients, health care professionals, businesses and entrepreneurs, including issues regarding payer-provider consolidation, serial acquisitions, labor and quality of care, medical billing, health care IT services, access to and misuse of health care data and more. It will bring together civil and criminal prosecutors, economists, health care industry experts, technologists, data scientists, investigators and policy advisors from across the division’s Civil, Criminal, Litigation and Policy Programs, and the Expert Analysis Group, to identify and address pressing antitrust problems in health care markets. 

Its leader 

The HCMC will be directed by Katrina Rouse, a long-serving antitrust prosecutor who joined the Antitrust Division in 2011. She previously served as chief of the division’s Defense, Industrials and Aerospace Section, assistant chief of the division’s San Francisco Office, a Special Assistant U.S. Attorney and a trial attorney in the division’s Healthcare and Consumer Products Section. 

The industry’s reaction 

“This is a very encouraging development and it’s long overdue,” said B. Douglas Hoey, CEO of the National Community Pharmacists Association. “The PBM/insurance conglomerates are among the most aggressive, ruthless, and predatory corporate actors in the entire economy. The largest corporate pharmacy in the world owns the largest PBM in the world. The other large PBMs are owned by, or entangled with, some of the largest insurance companies in the world. These corporate Frankenstein monsters use their size and leverage to starve community pharmacies by often paying them less than what the pharmacy pays for the medicine and steering community pharmacies’ patients into their own retail pharmacies, or their own mail-order and specialty pharmacies. These anticompetitive business practices are leading to reduced access to care for patients and higher prescription costs.” 

The Antitrust Division welcomes input and information from the public, including from practitioners, patients, researchers, business owners and others who have direct insight into competition concerns in the health care industry. Members of the public can share their experiences with HCMC by visiting HealthyCompetition.gov. 

Medically Home shores up hospital-at-home with Siemens, BrightStar Care 

BOSTON – Medically Home Group and Siemens Healthineers are collaborating to expand the growing movement of providing advanced medical care to patients in their homes. Siemens Healthineers, with strong partnerships with health systems across the country, offers proven technologies that complement Medically Home's strong strategic customer and partner base and differentiated network of 18 services available 24/7 that support high-acuity care in the home. "We share a vision for advanced health care, where patients' preferences to be cared for at home are being met in innovative new ways,” said Raphael Rakowski, executive chairperson of Medically Home Group. “There is no more fitting partner than Siemens Healthineers to bring meaningful insight, technology, and established healthcare relationships to this patient-centric movement.” New programs that health systems can design for their patient-at-home programs using Medically Home and Siemens Healthineers capabilities could include: 

• In home diagnostics: Expanding the range of advanced diagnostic services available to patients at home, including ultrasound, mobile CT capabilities and lab-quality blood analysis. 

• Data coordination: Drawing insights from millions of data points to inform AI-powered algorithms and enhance machine learning capabilities, enriching Medically Home's proprietary technology platform, the Cesia Continuum.  

Medically Home also recently announced that it has expanded its relationships with BrightStar Care to include two new markets in California and New Jersey, following a successful launch in Arizona in the fall of 2023. BrightStar Care, a home care and medical staffing agency with more than 380 corporate-owned and franchise locations, has broadened its offerings to include primary in-home clinician and transport services. 

AdvaMed makes recs on using AI in health care 

WASHINGTON – AdvaMed has responded to a request for information from U.S. Rep. Ami Bera, D-Calif., on the use of artificial intelligence in health care. In a letter to Bera, the group outlines measures that could ensure AI is used safely and reliably in health care, including: 

• Improving policies for access to data sets necessary to develop effective AI algorithms and promote AI innovation.   

• Expanding FDA’s authorization to permit use of electronic labeling (e-labeling) in lieu of paper labeling. e-labeling, particularly for software-based devices, is a more efficient and environmentally conscientious method to transfer information to the user. Further, e-labeling offers flexibilities in the presentation of information that can promote health care equity. For example, e-labeling font size can be adjusted for the visually impaired and can be provided in multiple languages and formats.  

• Revising the current FDA guidance on Clinical Decision Support Software to ensure the recommendations better align with the 21st Century Cures Act (e.g., ensure AI-based CDS that produces a single output, such as a recommendation for a particular treatment option that is consistent with common treatment guidelines, wouldn’t de facto be regulated as a medical device). 

“We recognize that the pace of innovation is fast, but we believe the FDA’s existing regulatory authorities are robust and flexible to ensure the safe and effective use of AI/ML technology in medical devices,” AdvaMed stated in the letter. “As state and federal legislators seek to ensure AI/ML-enabled technologies in all industries are used safely, FDA should continue to maintain regulatory oversight of medical devices, including the interoperability between devices and non-devices.” 

To read AdvaMed’s letter in full, go here. 

OxyGo names COO 

ORLANDO, Fla. – OxyGo has named Chris Carter COO. He was most recently COO-Americas for TP Aerospace for five years and senior director of operations for Invacare for 17 years. “I am thrilled to join the OxyGo team,” he said. “I’m excited to apply my skills and experience as we work together. It’s a great time to be part of this passionate group, and I’m looking forward to what we can achieve together.” Carter’s expertise includes highly regulated sectors, such as the medical device and aviation industries, where he has advocated for improvements in safety, quality, delivery and cost. “We are so happy to welcome Chris Carter to our team,” said Victoria Marquard-Schultz, CEO of OxyGo. “His impressive background and leadership qualities are perfect for guiding our operations as we continue to grow and innovate.”  

RESNA seeks feedback on tilt 

ARLINGTON, Va. – RESNA announced on May 8 that it has opened for public comment an update to the “RESNA Position on the Application of Tilt, Recline and Elevating Leg Rests.” The original position paper was published in 2017. “This updated paper includes a Wheelchairs Literature Update,” the organization stated. “The paper synthesizes current literature to guide practitioners in decision-making and use of seat functions for individuals who require customized medical devices.” Because the paper is an update to a previously published study and because it has already undergone extensive expert review within the Wheeled Mobility and Seating Special Interest Group, it will be open for only a 30-day public comment period. Submit comments using the RESNA Position Paper Comment Form and then send them via email to trlpositionpaper@gmail.com. To read the paper in full, go here. 

FDA releases guidance on ‘remanufacturing’ of devices 

WASHINGTON – The U.S. Food and Drug Administration has issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final guidance was issued following the agency’s extensive review of post-market information and consideration of public comments, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing” of a medical device.  “Today’s action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance or intended use.” The final guidance sets forth guiding principles that the FDA recommends applying in the context of remanufacturing, a flowchart to help determine whether activities may be remanufacturing and examples that may be help to industry. Additionally, the guidance recommends certain information be included in the labeling of reusable medical devices regarding their preventive maintenance and repair, including instructions on how to adequately return a device to its performance and safety specifications established by the OEM. The FDA began more closely examining remanufacturing and servicing and the impact of such activities on the quality, safety and continued effectiveness of devices in 2016, when the agency opened a public docket and held a workshop to get public and industry input. Subsequently, the agency published a report, “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices,” which detailed the FDA’s plan to provide clarity on the distinction between remanufacturing and servicing that was consistently requested in public comments. The final guidance is an output of that report.