"Between 12 to 18 million Americans every year will experience some sort of diagnostic error," said Paul Cerrato, a journalist and researcher. "So the question is: Why such a huge number? And what can we do better in terms of reinventing the tools so they catch these conditions more effectively?" Cerrato is co-author, alongside Dr. John Halamka, newly minted president of Mayo Clinic Platform, of the new HIMSS Book Series edition, Reinventing Clinical Decision Support: Data Analytics, Artificial Intelligence, and Diagnostic Reasoning. At HIMSS20, the two of them will discuss the book, and the bigger picture around CDS tools that are fast being transformed by the advent of artificial intelligence, machine learning and big data analytics.

In a move that could help win over some skeptics about the value and efficacy of AI in clinical care, The American Diabetes Association, in its new set of clinical standards, recognizes the use of autonomous artificial intelligence for the screening of some medical conditions. WHY IT MATTERS The ADA's new 2020 Standards of Medical Care in Diabetes includes language noting that "AI systems that detect more than mild diabetic retinopathy and diabetic macular edema authorized for use by the FDA represent an alternative to traditional screening approaches." The clinical standards – published earlier this month in the peer-reviewed journal Diabetes Care – represent a new source for evidence-based best practices, consulted by hospitals and health systems, physicians, insurers and quality organizations. While acknowledging that autonomous AI can be an alternative to traditional screening, however, the ADA specifies that it feels the "benefits and optimal utilization of this type of screening have yet to be fully determined." In addition, it cautions that "artificial intelligence systems should not be used for patients with known retinopathy, prior retinopathy treatment, or symptoms of vision impairment."

The nation's leading association that fights against diabetes released a new set of clinical standards that for the first time include the use of autonomous artificial intelligence (AI). The American Diabetes Association (ADA)'s 2020 Standards of Medical Care in Diabetes states that, "AI systems that detect more than mild diabetic retinopathy and diabetic macular edema authorized for use by the FDA represent an alternative to traditional screening approaches." To date, IDx-DR is the first and only FDA-authorized autonomous AI diagnostic system for the detection of diabetic retinopathy and macular edema. It is currently in use at a number of large health systems that each serve tens of thousands of people with diabetes and have struggled to implement diabetic retinopathy eye exams at scale for their large diabetes population. "The ADA's inclusion of our technology in its Standards of Care marks a significant move toward mainstream adoption of autonomous AI in clinical care," said Michael Abramoff, MD, PhD, Founder and Executive Chairman at IDx. "Our early customers are visionary leaders who foresaw that autonomous AI would one day become a standard of care for diabetic retinopathy screening, and taking that leap is paying off for them. Already, health systems that are using IDx-DR have experienced significant improvements in accessibility, efficiency and compliance rates, unleashing massive potential for cost savings and improved patient outcomes."

The US Food and Drug Administration (FDA) has acknowledged the potential impact that artificial intelligence (AI) and machine learning (ML) can have on healthcare. The FDA has been hard at work on the cutting edge of how to regulate transformative AI to ensure patients have access to safe technology that saves lives. Vast amounts of health data are collected every day during routine medical procedures. The development of any form of machine learning relies upon high-quality pools of data to build the necessary algorithms. With so much data available to build algorithms from, the healthcare industry is an accessible field for AI to make a positive impact.

The Food and Drug Administration last year approved its first autonomous, artificially intelligent medical device. In a decision that seemed to take a page from science fiction, the FDA gave the OK to the IDx-DR, a device that uses artificial intelligence to analyze images of the back of a patient's eye to detect if they have diabetic retinopathy. It's the first FDA-approved device to provide a screening decision without requiring a clinician to interpret the results--which means providers who aren't eye specialists, such as primary-care physicians, can rely on it to screen for the eye disease. "Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary-care doctor's office," Dr. Malvina Eydelman, director of the division of ophthalmic and ear, nose and throat devices at the FDA's Center for Devices and Radiological Health, said at the time. "The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed healthcare," she added.

Last year, IDx-DR became the first-ever so-called "autonomous AI" system cleared by the FDA to provide a screening decision without the oversight of a doctor. Since then, IDx Technologies, the company behind the product, has begun to roll out this tool designed to detect diabetic retinopathy. Over 30 million people are living with diabetes in the US alone. "The disease itself is bad," said Michael Abramoff, a University of Iowa ophthalmologist and computer scientist, "but the complications make it even worse." One of those complications is diabetic retinopathy, the leading cause of blindness in American adults.

The FDA today approved what it's calling "the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy." The AI-powered, cloud-based system will be available for use by primary care providers. Over 30 million Americans have diabetes, and diabetic retinopathy--which occurs when blood sugar levels result in damage to retinal blood vessels--is considered mostly preventable. Still, it causes vision loss in tens of thousands of people each year and is the leading cause of blindness among working-age Americans. "Many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis," Malvina Eydelman, MD, said in the FDA's official announcement.

Artificial intelligence (AI) is emerging as a key tool in just about every industry, from marketing to recruitment and beyond. But one particularly powerful application for AI is in health care, where we're already seeing early signs of its potential. Iowa-based Idx is one startup using AI to detect early signs of specific medical conditions. Its first system, IDx-DR, is an AI diagnostic system that analyzes images of the retina for signs of diabetic retinopathy, a complication of diabetes caused by high sugar levels. This means that health care providers, including doctors who are not eye care specialists, can use the IDx-DR system to detect diabetic retinopathy without needing to bring in a specialist clinician to interpret the image scan or results.

Artificial intelligence (AI) is becoming more common for screening, diagnosing and helping treat eye conditions. The technology already is used in online search engines, speech recognition tools and other smart devices. Now, AI is showing promise in healthcare. Massive amounts of data and growing computing power are fueling these advanced, algorithm-based technologies. Several studies show the potential for AI to help doctors detect eye disease.

The first artificial intelligence (AI) diagnostic system to gain clearance from the U.S. Food and Drug Administration beat out all predetermined benchmarks, achieving "high diagnostic accuracy" for patients with certain forms of diabetic retinopathy, according to clinical trial findings. IDx, the developer of the system, IDx-DR, published its results this week in the peer-reviewed journal Nature Digital Medicine. The paper provides an inside look into a technology that could transform how the industry diagnoses diabetic retinopathy, a condition that can cause blindness, bringing the process from the specialist's office to primary care -- without the need for a clinician to interpret the results. READ: First-of-Its-Kind AI Tool for Diabetic Retinopathy Detection Approved by FDA "This is formerly uncharted territory in healthcare, making it especially critical that we ensure the highest level of safety before introducing autonomous AI into patient care," Michael D. Abràmoff, M.D., Ph.D., IDx's founder and president and the study's principal investigator, said in a statement. In April, the FDA cleared IDx-DR, which analyzes images of the eye, for detection of "more than mild" diabetic retinopathy in adults with diabetes.