The Food and Drug Administration is providing its first guidance on the emerging development of applications for Artificial Intelligence in healthcare.
The FDA released model 1.0 of its software precertification pilot to provide an initial tool to test these programs. The FDA noted that AI and machine learning technology is advancing rapidly. So, the health IT community should move quickly to ensure their safety in practical applications.
The FDA wrote in its working model that software is increasingly used in healthcare to treat and diagnose diseases and conditions. It also aids clinical decision making and manages patient care. Under the recent program announced, software developers would be assessed by FDA or by FDA-accredited third party for the rigor of their practices in software designs, testing, clinical assessment and real-world performance monitoring, along with other appropriate capabilities.
This new endeavor aims to provide companies with an optional “Excellence Appraisal” and thus give them a “pre-check” approval. This would help the company’s ability to gain approval for new applications in the future. The pilot will begin testing the safety of AI applications during the first half of the year.
Along with AI and machine learning remote health monitoring system also helps in providing better healthcare solutions.