ARTIFICIAL INTELLIGENCE

MedTech AI Innovations

Medical technology innovators have been providing AI/ML-enabled devices to the healthcare community for three decades with over 900 technologies authorized by FDA to date. As new technologies emerge, we must maintain an efficient and effective regulatory process, systems that appropriately value these innovations, and promote policies that foster future innovations.

Regulatory Efficiency

The FDA should maintain its long-held position as the chief regulator of emerging AI/ML-enabled technologies. Duplicative efforts threaten patient safety and access

Adequate Reimbursement

The promise of innovative AI/ML-enabled technologies can only be realized through appropriate and adequate reimbursement policies that provide access to patients and providers

A doctor using a tablet

Getting Artificial Intelligence Policy Right

AI in healthcare is helping to expand access, reduce costs, boost innovation, and improve health outcomes. MDMA’s AI related advocacy and engagement is centered upon ensuring FDA’s role as the chief regulator of these technologies within existing frameworks, developing reimbursement models to support healthcare AI technology development and access, raising concerns over the creation of Healthcare AI Assurance Labs, and strengthening and protecting data stewardship policies. As the entire healthcare ecosystem adapts and integrates AI into the day-to-day practice of medicine, the most crucial issue is to ensure patient safety and continue the important work of improving health outcomes.