The White House’s December executive order, “Ensuring a National Policy Framework for Artificial Intelligence,” was intended to simplify AI regulation by pushing states to adopt a single federal standard. Instead, it has created uncertainty—especially for medical device manufacturers navigating AI compliance across multiple jurisdictions.
In a recent AAMI interview with Jen A. Miller, CM Law Partner Reiko Feaver shared practical insights on what this evolving regulatory landscape really means for companies developing and deploying AI-enabled medical technologies.
While the executive order calls for halting state-level AI regulation—and even threatens lawsuits and loss of federal funding—Feaver notes that its impact is limited without supporting federal legislation. With the Senate overwhelmingly rejecting AI preemption legislation, states are continuing to move forward with their own laws, either through new AI-specific statutes or by applying existing frameworks such as consumer protection, privacy, and anti-discrimination laws.
“The true impact hasn’t yet been felt,” Feaver explains, pointing out that a legal showdown between federal and state governments may be on the horizon.
She also notes that federal agencies like the FDA and FTC may still take action in response to the executive order, even in the absence of new laws—adding another layer of complexity for manufacturers.
So, what should medical device companies do now?
According to Feaver, a familiar strategy makes sense: treat AI compliance much like data privacy compliance. Rather than rewriting policies state by state, many companies choose to comply with the most stringent or “reactive” law in their footprint—so long as the cost isn’t prohibitive.
“For most companies, it really doesn’t make sense to change their policies based on every state,” she says.
As AI regulation continues to evolve, Feaver’s guidance underscores a key takeaway: flexibility, risk-based decision-making, and awareness of both state and federal enforcement tools are essential.
CM Law continues to monitor developments closely and advise clients operating at the intersection of AI, healthcare, and regulation. If you have questions, you can contact Reiko here. To read the entire article, please click here.
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