- FDA Proposes Rules for Devices Using Artificial Intelligence
- Providers Need to Embrace Healthcare Artificial Intelligence
“AI will boost our wellness and health care by improving outcomes, expanding treatment options and providing cost-cutting efficiencies. We must seize the opportunity to realize the potential of AI ethically, strategically and with clear goals,” said CTA CEO and President Gary Shapiro.
The CTA-led group aims to improve efficiencies and reduce healthcare costs using AI. It will examine such AI topics as trustworthiness, ethics, and bias.
“This unique working group represents a diverse set of stakeholders across the ecosystem, including clinicians, manufacturers, regulators, public policy and civil rights organizations. The work produced will provide an informed framework for the use of AI in the context of health care,” Commented Rene Quashie, CTA’s vice president for digital health policy and regulatory affairs.
The group will be co-chaired by Pat Baird, regulatory head of global software standards at Philips, and Jerry Wilmink, chief business officer at CarePredict. It will hold its first meeting in May at the CTA’s Technology and Standards Spring Forum in San Francisco.
The group is trying to get a head of a surge in AI technology in healthcare. In fact, Energias Market Research forecasts that the healthcare AI market will reach close to $20 billion in 2024, a strong compound annual growth rate of $48.7 percent.
Energias observed that healthcare AI is being used in many environments, including clinical labs, research facilities, and hospitals. In addition, advancements in deep learning and wider application of AI have generated increasing AI use in diagnosis and treatment.
As an indication of the increasing use of AI in healthcare, the University of South Carolina has just opened an innovation lab to tackle healthcare challenges through health IT innovation, artificial intelligence, and robotics research.
The university worked with Siemens Healthineers to set up the Innovation Think Tank (ITT) Lab, one of a number of ITT labs Siemens has opened around the world.
The Columbia-based lab has facilities where researchers, faculty members, and students can work on innovation solutions for healthcare applications.
“Centers like this are so important because they bring technology and use it to create something new and do things differently. That involves opening your mind, moving yourself out of your comfort zone, innovative thinking, and collaborating,” said Elizabeth Regan, chair of integrated IT at the university’s College of Engineering and Computing.
“The ITT Lab will allow us to bring people together from a variety of disciplines to share their unique perspectives, which will stimulate innovation and help great ideas become reality,” said Dilek Akgun, director of operations at the ITT Lab.
FDA Proposes Regulations for Healthcare AI Devices
The Food and Drug Administration (FDA) is moving to get out in front of the healthcare AI devices. It recently unveiled a proposed regulatory framework for AI-based medical devices.
The agency is seeking industry feedback on the proposal, with the goal of issuing a draft guidance based on the feedback.
“Our approach will focus on the continually-evolving nature of these promising technologies. We plan to apply our current authorities in new ways to keep up with the rapid pace of innovation and ensure the safety of these devices,” explained FDA Commissioner Scott Gottlieb, MD.
The approach would enable the agency's regulatory oversight to address the iterative nature of these artificial intelligence devices while guaranteeing that its standards for safety and effectiveness are supported, he said.
“I can envision a world where, one day, artificial intelligence can help detect and treat challenging health problems, for example by recognizing the signs of disease well in advance of what we can do today. These tools can provide more time for intervention, identifying effective therapies and ultimately saving lives,” Gottlieb concluded.
