A new survey asked technology leaders how their systems could be streamlined.
Artificial intelligence (AI) has great potential to improve healthcare, but until now, moving these technologies from the drawing board to the patient’s bedside has been a slow and arduous task. To better understand why, researchers from the University of Miami Miller School of Medicine, technology innovator Covered By Group, and Weill Cornell Medicine are a small group of digital health and healthcare AI founders and executives. to gain insight into what the current system could look like. Improved. The result is Medical Internet Research Journal.
“While some AI technologies have been implemented clinically, most of them have been provided by large conglomerates such as Google and Amazon,” said lead author and interim chair of the Department of Informatics and Health Data Sciences. Dr. Azizi Seishas says: About research. “Few early-stage startups, which generate the bulk of innovation, are on board. We want to understand the barriers they face and how we can help them overcome them. I wanted to know.”
AI is already revolutionizing research, revealing protein structures once thought unpredictable. In hospitals, these technologies could help humans, such as identifying early-stage cancers in scans or using vital signs confluence to predict the likelihood that her ICU patient will code within 30 minutes of her. clinicians may be able to detect patterns that may be missed.
Integrating digital health and AI into clinical practice
To understand why AI is being introduced into clinics in such a gradual manner, researchers formed a focus group of early-stage digital health and healthcare professionals, including venture capitalists, founders and CEOs. organized. Their responses indicated that the hospital system and technology start-ups he split into two distinct cultures. One is good vigilance (first and foremost, do no harm) and the other is an urgent effort to spread new technology. The two communities share goals, but often lack a common language to achieve them.
One of the main problems facing startups is the diverse procurement approaches found in different hospital systems. There is no single protocol. Rather, companies must learn how to operate each system individually.
“The procurement process in the healthcare system is highly fragmented,” said Dr. Iredia Olaye, CEO of Covered By Group, researcher at Weill Cornell Medicine, and lead author of the study. “As a result, early-stage companies face greater barriers to integrating digital health and AI into clinical practice than late-stage technology conglomerates. The lack of knowledge that people and providers bring into the process is a barrier to successful integration.”
In some cases, companies forgo access to the main healthcare system and market their products directly to employers and consumers.
“The problem with this approach is that it requires the initiative of physicians and other clinical staff to achieve truly integrated patient care,” says Dr. Olay. “Consumers will benefit from physicians’ insights into which technologies are most helpful when it comes to digital health and AI at home.”
Challenges in the regulatory approval process
Another barrier is the cost of conducting randomized clinical trials. Startups face catch 22. Testing may not recoup costs. Without clinical trials, regulatory approval would never be obtained.
At the public policy level, the authors urge the Food and Drug Administration (FDA) and other agencies in the United States and abroad to review their guidelines to better support these innovative technologies. FDA’s 510(k) clearance, which governs devices that are substantially similar to existing technology, was created a decade ago, long before many AI and digital technologies emerged.
“It’s inconsistent,” says Dr. Seisius. “FDA needs to update its processes to better distinguish between AI, digital health, and medical devices, and to provide clearer guidelines for businesses and the healthcare system.”
Through its Division of Informatics and Health Data Sciences and other groups, Miller College of Medicine is exploring ways to accelerate the transition of AI to the clinic. Most emerging health tech companies do not have chief scientific officers or chief medical officers, making it difficult to organize clinical studies. Academic institutions like the Miller School help enable clinical research and provide expertise to expedite FDA approval.
“Technology companies have entered the healthcare industry with the intention of changing the way we do things, but many of them have failed because they are not familiar with patient care,” said Dr. Sashas. “But that’s just our wheelhouse. To move forward, we need to add an infrastructure of innovation and technology to successfully integrate and implement these solutions into healthcare.”
