Artificial Intelligence for imaging has taken root for screening of skin lesions, retinal images, radiology images, and many others including pulmonary scans for Covid pneumonia and 3D mammography (digital breast tomosynthesis (3D mammography) for population-based screening)
The timetable and scope of developments:
Milestones include:
- February 2018:IDx-DR receives Breakthrough Device designation from FDA.
- April 2018:First time FDA issues De Novo authorization for an autonomous AI, IDx-DR, in any field of medicine.
- June 2018:CMS introduces temporary bridge coding, CPT® code 92250-TC, for autonomous AI.
- May 2019: CPT® Editorial Panel creates the first CPT® category 1 code for autonomous AI, 9225X.
- December 2019:American Diabetes Association updates its Standard of Diabetes Care to include autonomous AI for the diabetic eye exam.
- January 2020: 3DermSpot receives Breakthrough Device designation from FDA.
- July 2020:NCQA updates HEDIS to support the use of autonomous AI for closing the diabetic eye exam care gap.
- August 2020:For the first time, U.S. CMS announces Medicare will pay for autonomous AI.
- August 2020: Digital Diagnostics acquires 3Derm Systems, clearing the path toward 3DermSpot availability in EMEA markets.
The scope of applications is widening. Every specialty is searching for a means of accurately diagnosing and screening for disease. For the time being Artificial Intelligence will not eliminate the need for physician input and management.
There are several vendors providing these services in an integrated system. Integrated systems will include hardware and software for image capture of the image(s), such as pulmonary, retina fundus, or skin lesions. Storage and transmission to a digital library, physician, and/or consultant, integration with electronic health record, and charges to the payer.
