Expanding Medicare Coverage For Digital Health Technologies Gains Support

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

Proposed tariffs on semiconductors from President Donald Trump could significantly raise costs for the US medical device industry. Current domestic production cannot meet demand, spurring concerns about potential price increases for consumers and healthcare systems.

Members of AdvaMed’s digital health tech board of directors discussed the organization’s efforts to aid the Trump administration and Congress in answering AI policy questions, especially as companies deal with mounting regulatory uncertainty.

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?