Washington, D.C. – The Medical Imaging & Technology Alliance (MITA) – the leading organization and collective voice of medical imaging and radiopharmaceutical manufacturers, innovators, and product developers – today welcomed President Biden’s executive order on Safe, Secure and Trustworthy Artificial Intelligence (AI) to harness the benefits of AI and mitigate risks.

MITA applauds the Biden Administration for its commitment to encourage developers in all industries to bring safe and effective AI products to the American public. The Food and Drug Administration rigorously regulates and assesses medical device performance, reliability, and safety during premarket review as well as after these products enter the market, ensuring that AI and machine learning (ML) in the medical device industry are safe and effective.

MITA also welcomes the initiative to develop standards, tools, and tests to help ensure that AI systems are safe, secure, and trustworthy. Support from the administration for such projects already underway in medical device AI will allow the industry to maintain its international innovation edge.
“Medical imaging manufacturers follow strict regulatory requirements to ensure AI-enabled medical devices are safe and effective,” said Patrick Hope, MITA’s executive director. “We welcome the President’s executive order which should help to consistent oversight of FDA-regulated algorithms and those that currently aren’t. We look forward to working with the Administration to foster innovation that improves patient care equitably.”

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