“Who’s on first? What’s on second. And I Don’t Know is on third.” These are the funny nicknames of baseball players that Abbott and Costello famously rattled off during an old-time comedy skit (worth watching or re-watching here). I was reminded of that skit this week after North Korea fired off a barrage of missiles because President Trump calls North Korean leader Kim Jong Un by the funny (appropriate) nickname – “Rocket Man.” Long before North Korea had missiles, comedians Abbott and Costello debuted their Who’s On First skit in 1938. But they are so iconic that I’m bringing them up in a blog post, in part because they were featured in the 2016 movie Arrival. It is a sci-fi drama about how aliens land on Earth (who are dubbed “Abbott and Costello”) and they call in a linguist to translate what they are saying. Translation is what we are doing for new health policy activity this week, so I will use confusing comedy skits and the aliens-need-translating theme for the One Thoughtful Paragraph.
Some federal health agency news that don’t need as much translation:
- There are two new participants listed for the FDA’s TEMPO (Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices) pilot program: Cadence, a hypertension software developer that supports medication initiation and titration, and Limbic, a developer of a clinician-supervised, AI voice agent for mental health care delivery. As you may recall, the FDA’s TEMPO pilot allows certain device manufacturers participating in the CMMI ACCESS Model to collect real-world evidence for their devices targeting chronic disease that do not yet have FDA authorization. See Maverick’s summary explaining TEMPO and ACCESS here.
- The HHS Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) are holding a conference September 2-3, 2026, to discuss health care cybersecurity and the implementation of the HIPAA Security Rule. Register here.
- FDA’s Center for Devices and Radiological Health is holding a public meeting on September 25, 2026, to discuss how to improve the development of tools and standards the agency uses to evaluate breakthrough medical devices and emerging technologies.
“I’m not so sure I believe in beginnings and endings.” That is what Amy Adams, who plays the linguist-who-can-probably-talk-to-extraterrestrials, says in the movie Arrival. She says it is because her new alien friends don’t do linear time like we do. This could be a theme for what is happening in the health AI space; we are witnessing a lot of activity where beginnings and endings aren’t really a thing. For instance, while so many AI-enabled medical devices are being used by doctors and so many AI-enabled wearables and chatbots are being used by consumers, the discussion is just beginning about how to handle this serious societal shift in our health care system. This week, the FDA Digital Health Center of Excellence (DHCoE) released a 30-page discussion paper about generative AI-enabled medical devices to solicit feedback on regulatory approaches. Also this week, the American Medical Association and the Digital Medicine Society released a five principle-framework about the physician’s role in the tech-enabled care world. Also this week, Epic (our country’s dominant electronic health record company) made several AI-related announcements – including “Ergo” – a tool that blends human clinical judgment with AI to help doctors prep for patients that is reportedly already being used by several big hospital systems. As our team at Maverick Health Policy tries to translate all of this for everyone, I am officially impressed by the life-as-we-know-it-is-changing activity that is happening right now. It reminds me of another Amy Adams-as-alien-linguist line from the Arrival movie: “There are days that define your story beyond your life.”
