Hogan Lovells Digital Health brochure 2024 - Flipbook - Page 6
Hogan Lovells
Our team has extensive experience counseling clients on the FDA and EU
implications for new medical technologies, including AI technologies. We assist
clients in determining whether AI products are regulated as medical devices. We
understand the regulatory frameworks at issue, including FDA’s new proposed
framework for regulating AI devices. We have successfully advised our clients
in navigating the unique regulatory issues involved in seeking FDA clearance,
approval, or CE marking for AI-based devices and staying compliant in the
postmarket phase. From inception and marketing authorization to debut and
product maturity, our clients bene昀椀t from guidance that re昀氀ects their business
strategies and legal needs.
We assist clients in developing and executing a reimbursement strategy based on
our signi昀椀cant experience in reimbursement of health care AI. For example, we
assisted our client in obtaining the 昀椀rst-ever national Medicare reimbursement
for an AI system, and have advised on nearly every AI device reimbursed by the
U.S.’ largest federal payer to date. We have also helped clients obtain a series of
landmark advancements in AI reimbursement, including the 昀椀rst-ever Category
1 Current Procedural Terminology (CPT®) code for an Autonomous AI device,
昀椀rst-ever inclusion of arti昀椀cial intelligence in a Healthcare E昀昀ectiveness Data and
Information Set (HEDIS) measure, 昀椀rst-ever Merit-Based Incentive Payment
System (MIPS) quality measure.
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