Health Law Advisor, in an analysis of the Biden Administration’s executive order on AI.

Radiology is starting to look closely at cloud-based PACS as an alternative to on-premises digital image management. We discuss this emerging trend in the latest edition of The Imaging Wire Show, with our guests including Amy Thompson of Signify Research; Jay Kikut, MD, of University of Vermont Medical Center; Reed Smoller of Bay Medical Management; and Keyvan Nouri, MD, of Bay Imaging Consultants.

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Artificial Intelligence

Unpacking the Biden Administration’s New AI Order

It seems like watershed moments in AI are happening on a weekly basis now. This time, the big news is the Biden Administration’s sweeping executive order that directs federal regulation of AI across multiple industries – including healthcare. 

The order comes as AI is becoming a clinical reality for many applications. 

• The number of AI algorithms cleared by the FDA has been surging, and clinicians – particularly radiologists – are getting access to new tools on an almost daily basis.

But AI’s rapid growth – and in particular the rise of generative AI technologies like ChatGPT – have raised questions about its future impact on patient care and whether the FDA’s existing regulatory structure is suitable for such a new technology. 

• For example, the New York Times this week published a critique of FDA AI regulation that focused in particular on its use in radiology. 

The executive order appears to be an effort to get ahead of these trends. When it comes to healthcare, its major elements are summarized in a succinct analysis of the plan by Health Law Advisor. In short, the order: 

• Calls on HHS to work with the VA and Department of Defense to create an HHS task force on AI within 90 days
• Requires the task force to develop a strategic plan within a year that could include regulatory action regarding the deployment and use of AI for applications such as healthcare delivery, research, and drug and device safety
• Orders HHS to develop a strategy within 180 days to determine if AI-enabled technologies in healthcare “maintain appropriate levels of quality” – basically, a review of the FDA’s authorization process
• Requires HHS to set up an AI safety program within a year, in conjunction with patient safety organizations
• Tells HHS to develop a strategy for regulating AI in drug development

Most analysts are viewing the executive order as the Biden Administration’s attempt to manage both risk and opportunity. 

• The risk is that AI developers lose control of the technology, with consequences such as patients potentially harmed by inaccurate AI. The opportunity is for the US to become a leader in AI development by developing a long-term AI strategy. 

The Takeaway

The question is whether an industry that’s as fast-moving as AI – with headlines changing by the week – will lend itself to the sort of centralized long-term planning envisioned in the Biden Administration’s executive order. Time will tell.

The Challenges of Poor Medical Imaging Data

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Why AI in Radiology Is a Game-Changer

What are the benefits of AI in radiology? Quite simply, they are game-changing and will drive improved hospital efficiency, according to this article that features Blackford Analysis CEO Ben Panter. 

The Wire

• ACS Expands Lung Screening Criteria: CT lung cancer screening continues to build momentum. The American Cancer Society this week expanded its guidelines on who should get screening, lowering the starting age to 50 from 55 and raising the upper limit to 80 from 74. It also reduced its smoking history requirement from 30+ pack-years to 20+, and removed its requirement on years since quitting. The ACS revision now matches the USPSTF’s 2021 guidelines, but some groups continue to advocate for screening criteria more tailored to individual risk. 

• Annalise Launches AI Triage Package: Annalise.ai has launched Annalise Triage, a new package of triage-focused algorithms for the US market. The new package includes 12 of the company’s FDA-cleared findings, including five for chest X-ray studies and seven for non-contrast CT brain exams. Annalise Triage is designed to help radiologists triage imaging studies and prioritize those with suspected critical findings; the launch illustrates the growing role of triage-based AI in helping radiologists work more efficiently by focusing on exams most likely to have pathology.

• Ontario Lowers Breast Screening Age: The provincial government of Ontario, Canada has lowered the starting age for breast screening from 50 to 40, and Ontario women in their 40s can now self-refer for mammography without requiring a doctor’s letter. The Ontario Association of Radiologists estimates the lower age will save the lives of 200 Ontario women a year. Canadian provinces have been moving to a younger screening age even as Canadian authorities review national guidelines that currently call for screening to start at 50. 

• Riverain Signs UTMB: Riverain Technologies has signed an agreement to install its lung visualization software at University of Texas Medical Branch (UTMB). UTMB will be using Riverain’s ClearRead CT Vessel Suppress, Detect, and Compare solutions to improve detection of pulmonary nodules and enhance workflow for CT lung scans. ClearRead CT has FDA clearance for concurrent reading, so clinicians can view ClearRead images next to the original series simultaneously. UTMB joins other recent customers for Riverain including Strategic Radiology and Dayton VA Medical Center. 

• The Cost of Multidisciplinary Conferences: A new study in JACR puts a dollar value on the cost to radiology departments when radiologists are assigned to present cases at multidisciplinary conferences. Researchers surveyed radiologists at the University of Wisconsin-Madison, finding they spent 3.4k hours annually on multidisciplinary conferences, with each event costing $929 and adding up to $1.2M annually – nearly two full-time radiologists. What’s more, the costs are not reimbursable and can increase burnout; the researchers recommended exploration of billing codes for unreimbursed radiologist time.

• 4DMedical Expands Down Under: Respiratory imaging developer 4DMedical has signed a deal to make its XV technology for functional lung imaging available in Australia and New Zealand through an agreement with Integral Diagnostics, which operates 71 imaging sites. 4DMedical’s products will be offered using a SaaS automated workflow, with both fluoroscopy-enabled XV LVAS software and CT-based LVAS applications. 4DMedical debuted its technology at RSNA 2022 and has been signing clinical partners as part of its commercial roll-out. The company also has a relationship with I-MED Radiology Network in Australia. 

• COVID Clinician Exodus? The number of physicians planning to reduce their clinical hours doubled during the COVID-19 pandemic compared to previous years. In Mayo Clinic Proceedings, 40% of 1.3k physicians surveyed in 2021 said they would “likely” or “definitely” reduce clinical hours in the next 12 months, compared to 16% in 2011 and 20% in 2014. The figure was slightly higher in radiology (43%), but only 44 radiologists were surveyed. The numbers underscore the pandemic’s impact on physician job satisfaction and could hint at future workforce shortages.

• HAP Lands New England Breast Center: Revenue cycle management company Healthcare Administrative Partners (HAP) has landed a contract to provide its services to Breast Center of New England in Lee, New Hampshire. HAP will provide all core revenue cycle services on behalf of the facility, including billing, coding, carrier credentialing, business intelligence, and MIPS measure assurance services. The deal adds to HAP’s growing roster of customers in New England. 

• Reducing Contrast Reactions: In Radiology, researchers from South Korea offer a strategy for reducing recurrent reactions to iodinated contrast media for X-ray and CT exams. Researchers tested different strategies in 1.1k patients who had hypersensitivity reactions in 3.8k contrast administrations, finding a nearly 50% reduction in hypersensitivity reaction when switching to a low-osmolar contrast medium with a different carbamoyl side chain from the agent that caused the original reaction (odds ratio=0.51). Premedication with corticosteroids also reduced reactions, but not as much (OR=0.72).

• Kaiser Hit with Fine after MRI Accident: A Kaiser Permanente hospital in Northern California that was the scene of an MRI accident that injured a nurse in February has been hit with an $18k fine by California OSHA. A door between a patient prep room and the scanner room was reportedly left open, and as the nurse in the prep room wheeled the patient toward the door she and the patient were pulled against the scanner by the system’s magnetic pull on the metal gurney. 

• Real-World Data Firm Goes Public: Real-world data firm OneMedNet has gone public via special-purpose acquisition company (SPAC) Data Knights Acquisition. The company offers OneMedNet iRWD, which provides curated regulatory-grade imaging real-world data for both healthcare and life sciences applications. The company has a network of over 200 providers that supplies de-identified data that can be used for research, device development, or regulatory applications. 

• Selfies Create Diagnostic Challenges: Patients are increasingly submitting selfie images to their physicians, but differences between smartphones in how selfies are presented can complicate diagnostic efforts. In JAMA Neurology, researchers describe the case of an 18-year-old woman whose selfies suggested left-sided facial flushing, but whose MRI exams showed right-sided pathology. The discrepancy is because Apple devices show images in mirrored format (left is left) but save images in traditional format (left is right). A surgical scar helped clinicians correct the discrepancy and diagnose her condition as Horner syndrome.

Join Industry Leaders for a Lunch & Learn at RSNA

In this Lunch & Learn presentation sponsored by PocketHealth, learn how industry leaders have improved population health, patient experiences, and operational efficiencies. Register for free!

Going Mobile with MRI Just Got Easier

Mobile MRI can help you deliver healthcare to your patients wherever they are. Find out in this article how the new Magnetom Viato.Mobile scanner from Siemens Healthineers makes going mobile with MRI easier than ever.

Benefits of Cloud and AI for Medical Imaging

Check out this white paper from Merge by Merative to learn how a cloud-first approach for modern imaging solutions can ensure accessibility and efficiency, addressing the pressing need for change in radiology.

The Resource Wire

• DASA and CARPL.ai’s Pediatric AI Evaluation: When Sao Paolo’s Diagnosticos da America SA (DASA, the world’s fourth largest diagnostics company) set out to evaluate Qure.ai’s QXR solution for their pediatric chest X-ray workflows, they leveraged CARPL.ai’s platform to streamline their evaluation. See how it worked here.

• The Journey to Cloud-Based PACS: Radiology is looking closely at cloud-based PACS as an alternative to on-premises digital image management. We discuss this emerging trend with key opinion leaders who have made the switch with Visage Imaging in the latest edition of The Imaging Wire Show.

• A Comprehensive AI Copilot: Gleamer is dedicated to pioneering the future of medical imaging by building a comprehensive AI copilot that will pave the way for precision medicine. Learn more about the company and its solutions. 

• Gain Clarity at Speed in MRI: Acquire images faster per MRI machine per day with Stage from SpinTech MRI. Learn how Stage reduces the time for MRI brain protocols by 30% for your most common exams. 

• The Intersection of Health Technology and Business: How are the worlds of health technology and business intersecting? In this episode of The Radiology Report, Intelerad Medical Systems President Morris Panner sits down with Medality CEO Daniel Arnold to explore his career and discuss the evolution of the industry.

• Change Healthcare’s Secure Cloud: Did you know one-quarter of healthcare organizations have experienced a cyber-attack in the last year? This Change Healthcare animation explains how third party-certified cloud-native enterprise imaging can help secure IT infrastructure that might be exposed with re-platformed imaging systems.

• What’s the ROI of AI? Radiology thought leaders discussed AI’s return on investment in a session from SIIM 2023. We covered some of the high points in this interview with Matt Lungren, MD, and Sander Kloet of Nuance Communications. 

• The Difference Is in the Details: Riverain Technologies has developed the capability to create synthetic nodules automatically and place them in relevant anatomical contexts. Hear Chief Science Officer Jason Knapp explain the company’s unique position in this video. 

• AMRIC’s Multimodality Approach to Medical Imaging: AMRIC is a new premium imaging clinic on Manhattan’s Upper East Side. Learn about their multimodality approach to medical imaging and why they turned to United Imaging for cutting-edge CT, MRI, and molecular imaging technology. 

• Efficiency Unleashed with Image Acceleration: Discover unrivaled acceleration in image acquisition and the latest synthetic imaging innovation by Subtle Medical in this presentation at RSNA 2023 by Suzie Bash, MD, at the AI Theater at 11 am Sunday November 26.

• AI in Radiology and the Considerations for Regulation: AI in healthcare has grown quickly, as have discussions about AI regulation. Listen to this on-demand webinar from Bayer and Calantic Digital Solutions to hear expert perspectives on the current and future state of AI governance in healthcare and radiology.

• Exploring the Full Potential of Photon-Counting CT: The potential of photon-counting CT is creating excitement in radiology. New detector technology along with AI and imaging reconstruction techniques will push the frontiers of CT and promise game-changing innovations Read how GE HealthCare is exploring the full potential of photon-counting CT.

• Get a Sneak Peak at RSNA 2023: Join Intelerad on November 14 at 2pm ET for a behind-the-scenes webinar on the latest innovations at RSNA 2023. Learn how the company’s technology can help support your enterprise imaging goals. 

• Improving the Patient Experience: How is Clearpath improving the healthcare experience for patients? Learn more about the company and its solutions for ditching the disc when sharing images and records with patients. 

• The Benefits of AI-Automated Echo: Us2.ai just published what might be the most comprehensive paper we’ve seen on AI echo, detailing the benefits of AI-automated echocardiography, the global need for more scalable and flexible CVD assessments, and how its technology is fit for the future.