AI and machine learning technology are advancing rapidly, and the health IT community must move quickly to ensure their safety in practical applications across the healthcare sector.
That’s the message that coming out of the US Food and Drug Administration (FDA) recently as it unveiled its first software precertification pilot program.
“Software is increasingly used in healthcare to treat and diagnose conditions and diseases, aid clinical decision making and manage patient care,” the FDA wrote in its working model (PDF). "Under this program, software developers would be assessed (by FDA or by an FDA-accredited third party) for the rigor of their practices in software design, testing, clinical assessment, and real-world performance monitoring, along with other appropriate capabilities."
The pilot will start testing the safety of AI applications during the first half of the year, and the FDA plans to collect public comments on the plan by March 8.
“The Software Precertification (Pre-Cert) Program is envisioned as a voluntary pathway,” the agency explained, “that embodies a regulatory model more tailored than the current regulatory paradigm to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies. The program goal is to provide more streamlined and efficient regulatory oversight of software-based medical devices from manufacturers who have demonstrated a robust culture of quality and organizational excellence (CQOE) and are committed to monitoring real-world performance.”
To that end, the new program will provide companies with an optional "Excellence Appraisal,” thereby giving them a "pre-check" approval that would support the company's ability to gain approval for new applications in the future.
The FDA noted there will be challenges managing an "agile" regulatory program—one that leaves room for innovation while maintaining safety.
“Unlike manufacturers of hardware devices who modify their products every few months to years, developers of software modify their products in response to real-world performance and user feedback every few weeks to months," the agency wrote. "It is important for public health to address these distinctive aspects of digital health technology.”
The FDA will implement the new model under de novo classification, which is designed to bring new drugs and applications to market exceptionally quickly. On Feb. 7, the agency plans to offer a user session to answer questions from the developer community.