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AI Comes to Healthcare With FDA Approval

As AI permeates every industry, it’s no surprise that healthcare is up next.

The FDA made its official entrance into the world of artificial intelligence (AI) at AcademyHealth’s 2018 Health Datapalooza. Commissioner Scott Gottlieb, MD, announced plans for an improved approach to the AI review process, leveraging the power of machine learning, to keep pace with technological advancements and to support continued innovation in healthcare.

Gottlieb cited that these improved processes, including continuation of the Pre-Cert 1.0 pilot program, could have exponential impact and applications. For starters, organizations with precertification could make small adjustments to their tech without FDA intervention, allowing companies to make improvements as necessary while avoiding costly interruption.

It’s important to note that although Dr. Gottlieb’s comments at Datapalooza err on the side of optimism for the future of AI in healthcare — citing flexibility to keep up with “unique attributes of this rapidly advancing field” — the FDA exists first and foremost to protect patients, and no amount of technological innovation will interfere with that mission.

What does this mean for you?

The FDA’s initiatives to keep up with technological innovation will have a ripple effect on progress throughout the industry. With more efficient regulatory processes in place, innovators will have more incentive to do just that — innovate.

If the FDA follows through, we can expect to see:

  • Increased speed to market. Developers building applications, software, artificial intelligence and machine learning technology who are pre-certified can get products into the hands of patients and providers faster. Healthcare is one of the last highly-regulated industries to take full advantage of the technological revolution. As governing bodies like the FDA begin to adopt and adapt, healthcare will reap the benefits other industries are seeing.
  • Reduced administrative costs. We’ve seen how AI can increase efficiency, streamline workflows and reduce costs across a multitude of industries. By integrating AI-enabled technology throughout health systems, we’ll see a drop in administrative costs as technology automates a range of manual processes, allowing focus to shift back to the patient.
  • Improved patient care. With seemingly limitless storage space, AI and ML equipment can store volumes of data from multiple sources, giving providers a holistic view of a patient while providing suggested treatment based on similar data. Patients and doctors alike will see the benefit of readily available, intelligent equipment.

So, what does the future look like for the FDA?

Gottlieb expects to see an increase in AI-powered tools submitted for FDA approval across a spectrum of health fields, and even suspects that there may be tools already implemented in other industries, like finance, that could be applied in healthcare.

It looks like healthcare — and government — are finally catching on.


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