From the July 2019 issue of DOTmed HealthCare Business News magazine
Luke Delaney, general manager of automated breast ultrasound at GE Healthcare, says personalization via risk stratification to determine the most appropriate screening exam for each patient is also a must.
“If we want to build the right tools that can be used at the right point of care pathway to find as many cancers as possible, while reducing recalls and false positives, our research investments must not be modality specific,” he said. “Rather, the need is to understand how they can be used at the right point in the care pathway to have the biggest impact.”
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One way this can be achieved, he adds, is with AI, which can provide clinical decision support, lesion identification and characterization tools, as well as the ability to prescribe multiple examinations based on risk factors.
Mo Abdolell, CEO of AI software developer Densitas, says that in its current state, AI is capable of providing stronger support to healthcare providers that aligns with the guidelines of organizations such as the American College of Radiology.
“AI has reached the unique ability to move beyond the traditional physics models that conventional breast density algorithms rely on, and augment them by applying AI principles that allow evaluation algorithmically of all mammograms in the manner that radiologists actually visually perceive them,” he said. “AI is uniquely positioned to deliver breast density assessments that are highly aligned with ACR's BI-RADS fifth edition breast density classification scale guidance, something that physics models alone cannot do as effectively.”
Federal versus state law
No final rule has yet been issued, with the FDA still developing the reporting language. Even after it’s announced, the rule will not go into effect for 18 months. Pushkin, who does not anticipate a new reporting requirement before 2021, says this makes it difficult, right now at least, to determine its impacts on individual state laws.
“States with no inform laws will now have to comply with and include the required information in the lay letters,” she said. “States like Maryland, whose existing density inform law indicates that the law becomes inapplicable if a federal regulatory standard under the MQSA is adopted, will have to abide by the FDA final language. For remaining states with laws, under the MQSA, all facilities would have to follow that federal reporting requirement. However, the MQSA also explicitly states that nothing in it limits the authority of any state to enact state laws relating to mammography that are at least as stringent as the MQSA or regulations under the MQSA.”
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