Government and Policy Sector

The Food and Drug Administration opened a public comment period on a discussion paper outlining potential regulatory frameworks for generative artificial intelligence-enabled medical devices. Comments are due through October 19, 2026. Led by the Digital Health Center of Excellence within the Center for Devices and Radiological Health, the initiative introduces a two-axis risk assessment framework alongside a competency-based premarket evaluation model. The proposed evaluation structure combines non-clinical device benchmarking with clinical confirmation, drawing an analogy to how physicians are trained and credentialed. Unlike traditional software, generative AI systems can accept open-ended inputs, perform multiple tasks, and generate variable outputs, creating distinct challenges including real-world performance degradation and unpredicted behaviors. The discussion paper also addresses risk-proportionate postmarket monitoring and considerations for foundation models and agentic AI systems. Acting FDA Commissioner Kyle Diamantas noted that the effort aligns with administration priorities to accelerate AI-powered medical products to market while upholding safety standards.

ABC and Disney sued the FCC on Tuesday, claiming the agency's demand for early renewal of eight ABC-owned broadcast licenses violates the First Amendment and amounts to retaliation for the network's news coverage and late-night programming critical of President Trump. The FCC, under Chairman Brendan Carr, ordered the accelerated review in April—years before the licenses expire in 2028—citing an ongoing investigation into Disney's diversity, equity and inclusion practices, though the timing followed Trump's public attacks on Jimmy Kimmel over jokes about the First Lady. ABC argues the early renewal process is an "existential threat" and that the FCC is weaponizing its regulatory authority to coerce editorial compliance: the lawsuit states that if the administration prevails, "the message to every media company in the country will be unmistakable: tell only the stories the Administration deems favorable, or face the coercive machinery of the federal government." The network also cited a July incident in which Trump gave a primetime address that ABC and NBC declined to broadcast live, after which it says the FCC intensified pressure. The FCC responded that all broadcasters, including Disney, have a legal obligation to operate in the public interest and accused the company of waging a "campaign of disinformation." FCC Chairman Carr told CNN he had not yet made a final decision on next steps. The lawsuit also challenges a separate FCC effort to subject the morning talk show "The View" to equal-time rules, which ABC says the agency itself exempted the program from more than two decades ago. FCC Commissioner Anna Gomez, the agency's lone Democrat, praised Disney for "finding its courage" and said protecting the First Amendment is not partisan. Legal experts told outlets that ABC has a strong constitutional case, though the outcome could signal whether other media companies will push back against FCC pressure or continue to accommodate the administration.

Treasury Secretary Scott Bessent said the US will impose the "toughest sanctions in history" on Iran, complementing an existing naval blockade in what he called a "one-two punch" designed to collapse the regime. He told CNBC on Thursday that the administration would detail the measures at a press conference scheduled for Monday, and that allies face a binary choice: cooperate or be treated as adversaries. The shift comes after a 60-day ceasefire expired and months of military strikes failed to force Tehran to reopen the Strait of Hormuz. Bessent framed maximum economic pressure as a substitute for large-scale military escalation, saying markets were misinterpreting the strategy. He pressed China—which sources 50% of its energy from the Gulf and buys the overwhelming majority of Iran's seaborne oil—to "get with the programme," though he declined to say whether Beijing would face direct sanctions. The UAE already moved: it severed all trade and financial ties with Iran on Monday after accusing Tehran of firing missiles into its territorial waters. Iran's economy is already fractured—inflation reached sharply elevated levels in July, food prices are significantly higher than a year ago, and shipping costs have risen sharply above baseline due to war-risk surcharges, straining medicine supplies and household budgets. Oil markets reacted immediately: Brent crude climbed past $92 per barrel, up roughly 14% since early August when Bessent had signaled a deal was close and prices hovered near $80.