Contact: Kelly Broadway, 202-808-8853
kbroadway@health-innovation.org
Washington, D.C. – The Health Innovation Alliance (HIA) submitted comments to the Office of Science and Technology Policy (OSTP) on its request for information regarding regulatory reform or other action the agency needs to take to promote the adoption and innovation of artificial intelligence (AI).
“Artificial intelligence holds immense potential to strengthen and transform our healthcare system – improving patient outcomes, reducing costs, and driving innovation,” said Joel White, President of the Health Innovation Alliance (HIA). “Realizing that potential requires the federal government to foster an environment that supports responsible development and rapid adoption of new technologies while ensuring balanced safeguards and efficient oversight.”
HIA’s comments called for OSTP to take meaningful steps to provide balance by:
- Creating a strong federal regulatory framework for AI to provide nationwide predictability for innovators
- Enforcing existing information blocking requirements
- Realigning current health AI certification frameworks to a risk-based approach
- Ensuring the FDA’s predetermined change control plans process for AI and machine learning-enabled medical devices is used to its fullest potential
- Revising federal authorization processes, like FedRAMP, to minimize burden for innovators
“HIA applauds OSTP for taking the first step to cut red tape and unlock the full potential of AI innovation in health care. We look forward to working with the agency as it charts a path forward,” said White.