At the beginning of the artificial intelligence (AI)/machine learning (ML) era, the expectations are high, and experts foresee that AI/ML shows potential for diagnosing, managing and treating a wide variety of medical conditions. However, the obstacles for implementation of AI/ML in daily clinical practice are numerous, especially regarding the regulation of these technologies. Therefore, we provide an insight into the currently available AI/ML-based medical devices and algorithms that have been approved by the US Food & Drugs Administration (FDA). We aimed to raise awareness of the importance of regulatory bodies, clearly stating whether a medical device is AI/ML based or not. Cross-checking and validating all approvals, we identified 64 AI/ML based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any AI/ML-related expressions in the official FDA announcement. The majority (85.9%) was approved by the FDA with a 510(k) clearance, while 8 (12.5%) received de novo pathway clearance and one (1.6%) premarket approval (PMA) clearance. Most of these technologies, notably 30 (46.9%), 16 (25.0%), and 10 (15.6%) were developed for the fields of Radiology, Cardiology and Internal Medicine/General Practice respectively. We have launched the first comprehensive and open access database of strictly AI/ML-based medical technologies that have been approved by the FDA. The database will be constantly updated.
Under the term "digital health", advanced medical technologies, disruptive innovations and digital communication have gradually become inseparable from providing best practice healthcare. While the cost of treating chronic conditions is increasing and doctor shortages are imminent worldwide, the needed transformation in the structure of healthcare and medicine fails to catch up with the rapid progress of the medical technology industry. This transition is slowed down by strict regulations; the reluctance of stakeholders in healthcare to change; and ignoring the importance of cultural changes and the human factor in an increasingly technological world. With access and adoption of technology getting higher, the risk of patients primarily turning to an accessible, but unregulated technological solution for their health problem is likely to increase. In this paper, we discuss how the old paradigm of the paternalistic model of medicine is transforming into an equal level partnership between patients and professionals and how it is aided and augmented by disruptive technologies. We attempt to define what digital health means and how it affects the status quo of care and also the study design in implementing technological innovations into the practice of medicine.
The Internet has become an important health information resource for patients and the general public. Wikipedia, a collaboratively written Web-based encyclopedia, has become the dominant online reference work. It is usually among the top results of search engine queries, including when medical information is sought. Since April 2004, editors have formed a group called WikiProject Medicine to coordinate and discuss the English-language Wikipedia’s medical content. This paper, written by members of the WikiProject Medicine, discusses the intricacies, strengths, and weaknesses of Wikipedia as a source of health information and compares it with other medical wikis. Medical professionals, their societies, patient groups, and institutions can help improve Wikipedia’s health-related entries. Several examples of partnerships already show that there is enthusiasm to strengthen Wikipedia’s biomedical content. Given its unique global reach, we believe its possibilities for use as a tool for worldwide health promotion are underestimated. We invite the medical community to join in editing Wikipedia, with the goal of providing people with free access to reliable, understandable, and up-to-date health information.
Artificial intelligence (A.I.) is expected to significantly influence the practice of medicine and the delivery of healthcare in the near future. While there are only a handful of practical examples for its medical use with enough evidence, hype and attention around the topic are significant. There are so many papers, conference talks, misleading news headlines and study interpretations that a short and visual guide any medical professional can refer back to in their professional life might be useful. For this, it is critical that physicians understand the basics of the technology so they can see beyond the hype, evaluate A.I.-based studies and clinical validation; as well as acknowledge the limitations and opportunities of A.I. This paper aims to serve as a short, visual and digestible repository of information and details every physician might need to know in the age of A.I. We describe the simple definition of A.I., its levels, its methods, the differences between the methods with medical examples, the potential benefits, dangers, challenges of A.I., as well as attempt to provide a futuristic vision about using it in an everyday medical practice.
Artificial intelligence (AI) has the potential to ease the human resources crisis in healthcare by facilitating diagnostics, decision-making, big data analytics and administration, among others. For this we must first tackle the technological, ethical and legal obstacles.The human resource crisis is widening worldwide, and it is obvious that it is not possible to provide care without workforce. How can disruptive technologies in healthcare help solve the variety of human resource problems? Will technology empower physicians or replace them? How can the medical curriculum, including post-graduate education prepare professionals for the meaningful use of technology? These questions have been growing for decades, and the promise of disruptive technologies filling them is imminent with digital health becoming widespread. Authors of this essay argue that AI might not only fill the human resources gap, but also raises ethical questions we need to deal with today.While there are even more questions to address, our stand is that AI is not meant to replace caregivers, but those who use AI will probably replace those who don’t. And it is possible to prepare for that.
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