Government Regulations | 24x7 | Leading Resource for Healthcare Technology Management Professionals https://24x7mag.com/standards/regulations/ 24x7 Magazine offers in-depth coverage and the latest news in Healthcare Technology Management, serving as the premier resource for HTM professionals seeking industry insights and updates. Mon, 23 Jun 2025 15:03:16 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.1 https://24x7mag.com/wp-content/uploads/2019/07/cropped-24x7-Logo-fav-1-32x32.png Government Regulations | 24x7 | Leading Resource for Healthcare Technology Management Professionals https://24x7mag.com/standards/regulations/ 32 32 ECRI Launches Free AI Resource Hub to Support Safe Implementation in Healthcare https://24x7mag.com/standards/regulations/ecri-institute/ecri-launches-free-ai-resource-hub-support-safe-implementation-healthcare/ https://24x7mag.com/standards/regulations/ecri-institute/ecri-launches-free-ai-resource-hub-support-safe-implementation-healthcare/#respond Mon, 23 Jun 2025 15:03:12 +0000 https://24x7mag.com/?p=390156 The collection includes guidance on risk mitigation, regulatory clarity, and ethical use.

ECRI has published a collection of resources that can help healthcare leaders safely integrate artificial intelligence (AI) solutions into care delivery.

Healthcare organizations are increasingly looking to AI to streamline workflows and cut costs, but AI can pose significant risks to patient safety if not properly assessed and managed. 

AI-enabled tools offer wide-ranging benefits, and predictive AI is already being tested and used in care delivery with its scope set to expand into even more applications. These systems depend on high-quality data, robust clinical validation, and a clear understanding of their intended use. Inadequate training data, poor integration,and lack of transparency can lead to inappropriate outputs and degraded care.

ECRI’s new AI Resource Hub provides free, publicly accessible tools designed to help organizations thoughtfully procure, implement, and oversee AI technologies while addressing these critical safety and performance concerns.

The hub includes position papers, webinars, expert-authored articles, and regulatory insights. Among the key materials is ECRI’s seven-point position paper, which offers recommendations for assessing functionality, mitigating bias, and ensuring clinical validation. The paper also answers critical questions around regulatory clearance and post-deployment monitoring.

Additional resources cover ECRI’s recent submission to the White House Office of Science and Technology Policy, ethical frameworks for AI use, and guidance for managing machine learning updates in AI-enabled medical devices.

The resource hub also features materials previously available only to ECRI members, reflecting what the organization calls an “unmet need” for industry-wide support in responsible AI integration.

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Advocate Health, Joint Commission Partner on Systemwide Accreditation Initiative https://24x7mag.com/standards/regulations/accreditation/advocate-health-joint-commission-partner-systemwide-accreditation-initiative/ https://24x7mag.com/standards/regulations/accreditation/advocate-health-joint-commission-partner-systemwide-accreditation-initiative/#respond Wed, 11 Jun 2025 15:45:00 +0000 https://24x7mag.com/?p=389982 The initiative aims to enhance patient safety, care quality, and performance consistency across 69 hospitals.

Advocate Health and The Joint Commission have announced a new collaboration focused on improving patient safety and care quality across the health system’s 69 hospitals. The initiative will use systemwide accreditation and performance benchmarking to identify opportunities for continuous improvement and operational efficiency.

As part of the agreement, Advocate Health—one of the largest nonprofit integrated health systems in the US—will pursue hospital accreditation across its entire network. The approach is intended to support consistent quality standards across facilities and provide a framework for measuring outcomes within the system and against comparable peer groups.

According to The Joint Commission, the benchmarking tools available through its accreditation process allow for both system-level and facility-specific performance views, helping healthcare teams assess strengths and target areas in need of improvement.

“When hospitals and clinics deliver higher quality care, people get to spend more time where it matters most—with their families, loved ones, and in the work they find meaningful,” says Advocate Health chief medical officer Betty Chu, MD, in a release. “By aligning our organization around a unified set of evidence-based standards, we’re empowering our entire team to drive improvements for all.”

Jonathan B. Perlin, MD, PhD, president and CEO of The Joint Commission, adds in a release: “A systemwide approach to accreditation is best for health systems to deliver safe and quality care, which in turn benefits patients, the workforce, and communities. We look forward to working with Advocate Health to build resilient health care, enable continuous improvement, and share data, insights, and experiences to advance health outcomes.”

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Joint Commission and NQF Reveal 2024 Eisenberg Award Honorees https://24x7mag.com/standards/regulations/joint-commission-regulations/joint-commission-nqf-reveal-2024-eisenberg-award-honorees/ https://24x7mag.com/standards/regulations/joint-commission-regulations/joint-commission-nqf-reveal-2024-eisenberg-award-honorees/#respond Tue, 03 Jun 2025 09:01:00 +0000 https://24x7mag.com/?p=389958 The Joint Commission and NQF have announced the 2024 Eisenberg Award recipients, recognizing national, local, and individual achievements in patient safety and healthcare quality.

The Joint Commission and the National Quality Forum (NQF) have named the recipients of the 2024 John M. Eisenberg Patient Safety and Quality Awards, which recognize major contributions to improving healthcare safety and outcomes.

Awards are presented in three categories, and winners are selected by a panel of national patient safety and quality experts. The 2024 honorees are:

  • National Level Innovation in Patient Safety and Quality: CommonSpirit Health, Chicago, for its innovative approach to achieving and sustaining clinical excellence
  • Local Level Innovation in Patient Safety and Quality: Parkland Health, Dallas, for identifying and preventing missed opportunities for diagnosis
  • Individual Achievement: Elliott K. Main, MD, clinical professor of obstetrics and gynecology at Stanford University School of Medicine, Stanford, California

The awards, established in 2002, honor the legacy of John M. Eisenberg, MD, MBA, a former administrator of the Agency for Healthcare Research and Quality and a founding NQF board member.

“CommonSpirit Health, Parkland Health and Dr Elliott K. Main are proving what’s possible when a commitment to patient safety and quality is applied to new, innovative ways of approaching challenges that are facing our industry,” says Jonathan B. Perlin, MD, PhD, president and chief executive officer, The Joint Commission and Joint Commission International, in a release. “By working toward a future where patients and staff everywhere experience the safest, highest quality care across all healthcare settings, the recipients of the 2024 Eisenberg Awards are setting new benchmarks and inspiring future leaders to advance innovation in safety and quality.”

Recognizing Systemwide Improvements in Care

CommonSpirit Health was honored for implementing an innovative approach to achieving and sustaining clinical excellence. By utilizing quality and patient safety measures to identify improvement opportunities, CommonSpirit prioritized three key areas: heart failure, maternal hypertension, and catheter-associated urinary tract infections. 

After implementing an eight-step quality improvement model and an advanced technology suite, CommonSpirit achieved improvements in hospital mortality rates, heart failure mortality, and disparities in care. Its virtually integrated care model embeds virtual nurses into hospital care teams at many of its locations to mentor new staff, reduce workload, manage care transitions, and cultivate collaborative patient care. Their efforts have led to improved care for more than 409,130 patients over three years and prevented more than 2,700 harm events across 99 acute care hospitals.

Improving Diagnosis Through Data and AI

Parkland Health was honored for developing a surveillance program to address missed opportunities for diagnosis. Initially focused on tracking delayed imaging findings, the program evolved to manage six high-risk diagnostic scenarios through a centralized digital health center. Key innovations include an AI language model that achieved 97.2% accuracy in identifying delayed imaging findings, a population health management tool, bilingual staff trained in motivational interviewing, and the integration of social workers. 

Parkland’s efforts delivered improvements for its patients:

  • Achieved completed recommended follow-up studies in 91% of patients with abnormal imaging studies, with 4.3% of completed cases being found to have cancer and 3% to have a medical issue requiring surgical intervention.
  • Delays in overdue imaging surveillance findings decreased from 17% to 9%.
  • Follow-up rates for abnormal mammograms improved from 83% to 87%.
  • Abnormal tumor marker follow-up gaps decreased by 27%.

A Career Spent Advancing Maternal Health

Elliott K. Main, MD, clinical professor of obstetrics and gynecology at Stanford University School of Medicine, is a national leader in maternal quality and safety, directing programs at the hospital, health system, state, and national levels. Among his accomplishments, he co-founded state and national-level quality improvement collaboratives for maternal health, including the California Maternal Quality Care Collaborative, which became the model for large-scale maternal quality improvement learning collaboratives. 

Nationally, he led the formation of the Alliance for Innovation on Maternal Health and has aided the development of state perinatal quality collaboratives across 49 states. Main led research to establish four national perinatal care metrics used in both Joint Commission and Centers for Medicare and Medicaid Services programs. He also led the development of widely adopted obstetric quality improvement toolkits and national safety bundles. At the state level, he led the creation of the Maternal Data Center, which provides timely and low-burden outcome data and analysis to hospitals across California, Oregon, and Washington.

The 2024 Eisenberg Award winners will be recognized at UNIFY 2025: Convening for Quality, to be held Sept. 16-17 in Washington, DC. Their work will also be profiled in a special issue of The Joint Commission Journal on Quality and Patient Safety later this year.

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Tariff Pressures May Be Driving Advance Buying of Elective-Use Medical Devices https://24x7mag.com/standards/regulations/tariff-pressures-driving-advance-buying-elective-use-medical-devices/ https://24x7mag.com/standards/regulations/tariff-pressures-driving-advance-buying-elective-use-medical-devices/#respond Tue, 27 May 2025 20:55:40 +0000 https://24x7mag.com/?p=389895 New data indicate increased spending on certain medical devices.

Amid growing tariff pressures, some US healthcare facilities may be increasing purchases of certain medical devices, according to GlobalData, which notes recent spending shifts that could reflect efforts to get ahead of potential price hikes.

According to GlobalData’s US Healthcare Facility Invoicing Database, across 56 tracked medical device markets, the top 20 facilities by March 2025 have spent an average of 6.7% more in April. This increase doesn’t appear to be attributed to specific markets. Across most covered markets, some facilities increased their spend in April, while others decreased spend.

“Necessary procedures such as aspiration thrombectomy will need to continue being done, whereas elective procedures such as hip reconstruction can be delayed,” says Amy Paterson, medical analyst at GlobalData, in a release. “If prices of devices are driven up by tariffs, hospitals will either face shrinking profit margins or increase the cost to patients, and patients might not be able to afford the increased procedure costs.” 

Spending on Medical Devices for Elective vs Necessary Procedures

The data suggests that hospitals may be pre-purchasing devices used in elective procedures in anticipation of rising costs, while maintaining steady purchasing patterns for devices used in urgent procedures.

For aspiration thrombectomy, considered a necessary procedure, there was a 30% decline in purchasing from March to April 2024. Consistently, the period from March to April this year also saw a 30% decline. This suggests that the top facilities have not been stocking up on aspiration thrombectomy devices despite tariffs.  

In contrast, facilities showed increased purchasing of devices used in elective procedures. From March to April 2025, US healthcare facilities increased their average spending on hip reconstruction devices by 18%, compared to a 3% decline during the same period last year. Spending on knee reconstruction devices also rose 9% over the same timeframe, compared to a 13% drop from March to April 2024.

GlobalData expects steady purchasing for essential procedure devices to continue. For elective-use devices, such as those used in hip and knee reconstruction, recent purchasing increases may lead to slower future orders if facilities have already built up supply in anticipation of higher costs.

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Joint Commission to Apply AI to Accreditation and Certification Process https://24x7mag.com/standards/regulations/joint-commission-regulations/joint-commission-apply-ai-accreditation-certification-process/ https://24x7mag.com/standards/regulations/joint-commission-regulations/joint-commission-apply-ai-accreditation-certification-process/#comments Wed, 21 May 2025 11:39:00 +0000 https://24x7mag.com/?p=389837 A new partnership aims to apply artificial intelligence to help healthcare organizations better manage accreditation data and benchmark quality.

The Joint Commission and Palantir Technologies announced a long-term strategic partnership aimed at improving how healthcare organization and accreditation data are gathered and utilized. This is intended to support healthcare organizations in benchmarking quality and improving outcomes. 

By leveraging Palantir’s data analytics and artificial intelligence (AI), this collaboration will allow both The Joint Commission and healthcare organizations to increase operational efficiency in the management of quality standards for accreditation and certification, according to a press release from the Joint Commission and Palantir.

“Leveraging AI and advanced data analytics will help us better understand the links between the care process and measured outcomes necessary for a step change in clinical operations and performance,” says Jonathan B. Perlin, MD, PhD, president and CEO of The Joint Commission, in a release. “Palantir’s emerging leadership in healthcare transformation makes them the ideal partner to support data-driven improvement and agile product development that reduces provider burden and enhances the quality of patient care.”

Applying AI to Accreditation and Certification Process

The Joint Commission, which sets healthcare quality and safety standards for more than 80% of US hospitals, will collaborate with Palantir Technologies to apply its next-generation AI platform to the accreditation and certification process. This initiative is designed to streamline these processes.

“The Joint Commission is committed to building the accreditation and certification process of the future, today,” says Alex Karp, co-founder and chief executive officer of Palantir Technologies, in a release. “This work will improve global health outcomes by utilizing AI to drive performance improvements around the world.”

Palantir’s approach is already having an impact on the healthcare industry with its innovation supporting institutions including the Cleveland Clinic, Tampa General, and Nebraska Medicine, among other healthcare systems. The integration of AI has led to reductions in patient wait times, improvements in clinical decision-making, and streamlined reimbursement processes.

“Through our partnership with Palantir, we have seen significant improvement in care coordination, clinical outcomes, and the patient experience,” says John Couris, president and CEO of Tampa General Hospital, in a release. “Given the scale and reach of The Joint Commission, I’m excited to see more of these success stories across the industry to achieve better healthcare outcomes for all.”

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ECRI Adds Tools to Help Health Leaders Quickly Judge New Treatments https://24x7mag.com/standards/regulations/ecri-institute/ecri-tools-help-health-leaders-quickly-judge-new-treatments/ Tue, 20 May 2025 14:27:24 +0000 https://24x7mag.com/?p=389826 Clinical evidence assessments now include data visualization features and equity insights to help healthcare leaders quickly evaluate the safety and effectiveness of treatments.

ECRI has expanded offerings in its clinical evidence assessments (CEAs) to give healthcare providers, researchers, and payors a clearer, at-a-glance view of the safety and effectiveness of healthcare interventions and treatments.

Using a process based in the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) methodology, ECRI researchers are continually evaluating a variety of emerging and trending topics in healthcare—from new wound care products and obesity treatments to AI-enabled medical devices and digital health innovations.

ECRI CEAs are unbiased reports that guide healthcare providers and payors to the most clinically superior options. The reports inform clinical quality improvement and patient safety initiatives. They also support evidence-based practice decisions by identifying the best available evidence to align with clinician expertise and patient preferences. The assessments include a one-page summary that is meant to quickly inform decision makers of the state of the evidence around a product or intervention. 

‘Separate Fact from Fiction’

This summary was recently expanded to add data visualization features, including patient-oriented outcomes that are color-coded to align with ECRI’s top-line evidence rating. This illustrates ECRI’s confidence levels in the available clinical studies based on how they were designed and used to collect the pertinent outcomes data.

“Healthcare decision makers are inundated daily with new technologies making bold claims of clinical superiority and outcome improvement. They have very limited time to separate fact from fiction and make informed decisions,” says ECRI’s director of clinical evidence, Evan LeGault, in a release. “Right up front, our expanded assessments show the strength and quality of the evidence so our partners know right away whether they can trust the results. These reports help decision makers feel confident in their choices with a new level of transparency in the findings. They also help value analysis teams make the best purchasing decisions.” 

ECRI CEA reports outline the potential impact of the intervention on the health system in terms of cost, infrastructure, and care. They also transparently appraise each study and calculate the risk of bias, a critical component for clinicians and payors who seek to understand if the results of a controlled trial can be replicated in a real-world treatment environment. In addition, a new section on equity considerations describes the extent to which the technology or intervention may exacerbate, mitigate, or have no effect on health disparities in terms of patient representation in clinical trials, burden of care, patient-level barriers, and implementation barriers. 

Recent CEAs conducted by ECRI cover:

  • Video-based patient monitoring for preventing falls
  • Female external catheters for reducing urinary tract infections
  • Reducing hospital-acquired infections
  • Pulsed field ablation for treating atrial fibrillation
  • Skin substitutes for treating pressure injuries
  • Comparative effectiveness of sleep apnea treatments
  • Pulse oximeter accuracy

“Medical misinformation abounds right now. We named it one of our top 10 patient safety concerns this year,” says Shannon Davila, MSN, RN, CIC, CPHQ, FAPIC, executive director of ECRI’s Total Systems Safety, in a release. “Our expanded assessments are especially critical in today’s healthcare environment to help our partners avoid unnecessary risk and make the best decisions for their patients and institutions. Our goal is to expedite the time-consuming and labor-intensive research needed to reach a safe conclusion.”

Photo caption: Evidence bar for ECRI clinical evidence assessments

Photo credit: ECRI

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HHS, FDA Want to Slash Health Care Rules in 10-to-1 Deregulation Plan https://24x7mag.com/standards/regulations/hhs-fda-want-slash-health-care-rules-10-1-deregulation-plan/ Tue, 13 May 2025 17:11:30 +0000 https://24x7mag.com/?p=389732 The agencies are asking stakeholders to weigh in on a sweeping deregulatory initiative that will eliminate 10 regulations for every one introduced.

The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) today announced the launch of a public Request for Information to identify and eliminate outdated or unnecessary regulations as part of a 10-to-1 deregulation plan. The initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency, in alignment with President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation.”

Under the directive, HHS Secretary Robert F. Kennedy, Jr has committed the department to a “10-to-1” deregulatory policy: For every new regulation proposed, at least 10 existing regulatory actions will be rescinded. The effort is proposed as a way to lower the cost of living, remove bureaucratic barriers, and allow health care providers to devote more time and resources to patient care.

“To Make America Healthy Again, we must free our doctors and caregivers to do what they do best—prevent and treat chronic disease,” says Kennedy in a release. “We cannot allow their time and talent to be wasted on bureaucratic red tape and paperwork.”

Under the Executive Order, HHS will implement the following measures:

  • The 10-to-1 deregulation rule: For every new regulation introduced, at least 10 existing regulations must be eliminated.
  • Regulatory cost cap: The total cost of all new regulations in fiscal year 2025 must be significantly less than zero.
  • Expanded scope: The order applies not only to formal regulations but also to guidance documents, memoranda, policy statements, and similar directives.
  • Radical transparency: HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset, promoting greater transparency and accountability.

“This initiative is about restoring common sense to health care regulation,” says FDA commissioner Marty Makary, MD, MPH, in a release. “By cutting outdated red tape, we can lower costs, increase access to innovation, and let clinicians spend more time with patients—not paperwork. We welcome public input to help identify reforms that truly make a difference.”

The 60-day public comment period opens today. Stakeholders are encouraged to submit their ideas for deregulatory actions through the Regulations.gov docket (AHRQ-2025-0001) or the newly launched online portal at Regulations.gov/Deregulation. The portal includes tools to assist users in drafting proposals that HHS may formally consider.

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Senate Bill Seeks to Curb Unwarranted Imaging, Reinstate AUC Program https://24x7mag.com/standards/regulations/senate-bill-seeks-curb-unwarranted-imaging-reinstate-auc-program/ Fri, 09 May 2025 18:03:37 +0000 https://24x7mag.com/?p=389705 The American College of Radiology backs the ROOT Act, which would resume the Appropriate Use Criteria program for advanced diagnostic imaging, aiming to reduce unnecessary radiation exposure and lower Medicare costs.

The American College of Radiology (ACR) is urging Congress to pass the Radiology Outpatient Ordering Transmission (ROOT) Act (S.1692) to promote value-based care, help Americans avoid unwarranted imaging and radiation exposure, and reduce Medicare spending on low-value imaging.

Introduced in the United States Senate by Sen Marsha Blackburn (R-TN) and Sen Catherine Cortez Masto (D-NV), the bipartisan ROOT Act would amend the Protecting Access to Medicare Act (PAMA) of 2014, to ease and allow implementation of PAMA requirements that providers consult physician-developed appropriate use criteria (AUC) prior to ordering advanced diagnostic imaging for Medicare beneficiaries. The bill reflects input from multiple medical societies and stakeholders.

Congress mandated that the PAMA Imaging AUC program be implemented in 2017, but regulatory interpretation of the statute has caused delays. The Centers for Medicare and Medicaid Services (CMS) declared an “indefinite pause” to the AUC program in the 2023 Medicare Physician Fee Schedule Final Rule despite the agency’s acknowledgement of the program’s potential benefits—including more than $700 million in annual Medicare savings.

ROOT Act technical changes to PAMA aim to ensure that CMS implements the AUC program without delay and in a manner that is least burdensome to providers and patients. Such changes include:

  • Replacing a “real time” claims processing requirement with a provider attestation that they consulted a qualified AUC program prior to ordering an advanced imaging study.
    • Compliance data would be collected (subject to CMS review/audit) – and reviewed by hospitals/health systems to educate providers and help manage utilization.
  • Providing additional provider exclusions within the existing PAMA statute – including:
    • Ordering providers who participate in clinical trials.
    • Small and rural practices (as defined by CMS).
  • Ensuring appropriate oversight and compliance mechanisms by adding a review study (based on several years of collected data) to help Congress and the Administration at such time to determine any needed measures to improve the program.

According to the ARC, AUC-based clinical decision support systems enable providers to access AUC and order exams in real time (at the point of care) and do not delay care nor interfere in doctor-patient decision-making. Providers are not required to order a specific exam recommended by AUC but to show that they consulted AUC prior to ordering.

“If the ROOT Act is not passed, AUC program benefits, including reduced unwarranted imaging, increased patient safety, more patient-focused care, and significant savings to Medicare beneficiaries and the Medicare system will remain unrealized,” reads a release from ARC.

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New Data Tool Tracks Country of Origin to Spot Healthcare Tariff Risk https://24x7mag.com/standards/regulations/ecri-institute/new-data-tool-tracks-country-origin-spot-healthcare-tariff-risk/ Fri, 02 May 2025 14:18:30 +0000 https://24x7mag.com/?p=389616 ECRI’s tool helps health systems identify products affected by tariffs and find safe, functionally equivalent alternatives to maintain supply continuity.

ECRI launched a new country of origin data insights tool to provide transparency and decision support for eligible clients navigating the impacts of tariffs. The Supply Chain Navigator is designed to equip healthcare leaders to make strategic purchasing decisions to achieve continuity of care in an uncertain market.

More than 4,000 health system supply chain teams leverage ECRI’s datasets. Many of those teams reported to ECRI they’re concerned about how tariffs will impact pricing and availability of critical personal protection equipment (PPE) from China, like face masks, gloves, and isolation gowns. ECRI’s new insights are designed to alleviate that concern and pave the way for other targeted insights as additional supply disruptions emerge.

“Together we are ensuring health systems can continue securing supplies that are critical for their patients and workforce without interruption and without paying needlessly high prices or compromising on safety,” says Stuart Morris-Hipkins, chief solutions officer at ECRI, in a release. “Our datasets allow us to pinpoint where clients’ current products are manufactured and isolate those impacted by tariffs to identify safe alternatives that are functionally equivalent.”

Pinpointing Where Supplies and Devices are Manufactured

Historically it has been a challenge to pinpoint, at scale, exactly where medical supplies and devices are manufactured, since it’s common for individual parts to originate from plants around the world and to be assembled at different locations. That is known as “country of origin” data, which hasn’t been readily available in the past, adding another layer of complexity to navigating tariffs. The new insights tackle this perennial problem in supply chain management by providing a curated view of country of origin, customized to certain origin sources and product categories with an emphasis on PPE.

“We’re now able to show our partners their level of risk and exposure in key product categories based on the tariffs,” says Alison Maguire, ECRI’s vice president of sales, Americas, in a release. “We also flag supplies that have been identified as hazardous or subject to a recall or lengthy backorders. We then create a mitigation plan that shifts their procurement strategies in real-time.”

Morris-Hipkins adds, “The tariffs are adding volatility to an already vulnerable healthcare supply chain. It’s not just a business issue—it’s a patient safety issue. History has proven, from the COVID-19 pandemic to natural disasters that disrupted the supply chain, instability often forces healthcare providers to turn to unvetted or unsafe sources for supplies. We are actively working with our partners to build greater resilience into their sourcing strategies to ensure uninterrupted, safe care.”

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AdvaMed Pushes for Zero-for-Zero Tariff Model in Medtech Trade https://24x7mag.com/standards/regulations/advamed-pushes-zero-zero-tariff-model-medtech-trade/ Mon, 28 Apr 2025 12:45:07 +0000 https://24x7mag.com/?p=389550 AdvaMed’s president says a reciprocal zero-for-zero tariff model would ensure fair competition and patient access.

Scott Whitaker, president and CEO of AdvaMed, a medical technology association, is calling for a reciprocal “zero-for-zero” model with respect to tariffs among US trading partners for medical technologies. 

In an interview with Joe Mullings of the Mullings Group, Whitaker stated that tariff-free trade is critical to maintaining the competitive nature of the medtech industry, which keeps prices down and enables patients to have access to a variety of medtech.  

“If we can get to a [reciprocal] zero-for-zero model, [based on a] humanitarian exemption, that’s the best place for everyone to land,” Whitaker says in the interview. “I know there’s a bigger issue at play here on trade imbalances, but on behalf of patients…I think that’s the place where we need to land. 

“It looks like China is going to have their own set of exemptions from tariffs. It feels like an element of that is going to be in medtech, and we’ve argued really aggressively with Chinese officials that they need to exempt medtech products on behalf of patients as well,” Whitaker continues. “So, we’re starting to see some movement there. 

“Then, as you look to Europe, we’ve been making the argument in every country, but particularly in Europe…why don’t we just all move to a [reciprocal] zero-for-zero tariff model? Zero tariffs from Europe on us, though they’re already really low—zero tariffs from the US to Europe…We feel very confident…just let us compete fairly, evenly, no tariffs—let us serve patients as best we can. Let’s impact peoples’ lives, and the best companies are going to win. That’s the way the system should work.” 

Since the beginning of the tariff debate, AdvaMed has called for an exemption for medtech, noting the US is a global leader in medtech innovation and manufacturing and that medtech is essential to patient care nationwide and globally.

Whitaker recently outlined why medtech warrants flexibility from tariffs in a Baltimore Sun op-ed. A recent Financial Times news story explores the supply chain complexity of key medtech products and how tariffs would upend the provision of component parts and ultimately the finished goods upon which patients rely. 

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