Matt dives into a specific healthcare topic to help those in the industry, and those outside of it, better understand the market drivers causing today's healthcare challenges.
On August 5, STAT reported that federal health regulators invited industry and lobbyists to closed-door meetings on clinical AI. Staff from FDA, CMS, and HHS sat down with the companies building AI doctors, got a firsthand look at the products, and started shaping the policy that will govern them. The meetings ran invite-only. No public notice went out. Everyone agreed to Chatham House rules, so participants can describe what happened but cannot say who said it. Then the group opened a one month sprint to write consensus principles for evaluating patient-facing clinical AI.
Read that last sentence again. Principles for evaluating patient-facing AI. Drafted in thirty days. By the people who sell it.
Somewhere in Washington state, a Medicare patient waits two to four times longer than she used to for a procedure, because an algorithm now screens her prior authorization request. Her hospital reported that delay to Senator Maria Cantwell's office in April. She did not get an invitation either.
Pew Research Center surveyed 3,488 US adults from June 22 to June 28 of this year. Seventy-two percent said it matters extremely or very much that a provider tells them when AI touches their care. More than eight in ten want notice when AI is involved in their diagnosis or treatment. Sixty percent said it makes them uncomfortable when they think about how AI might be used in their care. These numbers did not appear in the closed-door meetings. Nobody invited them.
The National Health Council runs a Patient Voices Hub. Dozens of patient advocacy organizations contribute lived experience, data, and policy positions through that platform. The Hub exists precisely so that organized patient perspective can reach regulators during comment periods and rulemaking. Nobody referenced it in the planning documents. Nobody invited them either.
Regulatory policy for technology that touches patients is shaped by the people who sell that technology, then handed to patients as a finished product. The patient is not missing from the conversation because nobody thought to include them. The patient is missing from the conversation because the structure does not require inclusion.
FDA's Digital Health Center of Excellence has a multi-stakeholder framework. CMS has advisory pathways. HHS has patient engagement offices. The architecture for inclusion exists. It was bypassed because convening industry quickly was easier than convening patients authentically.
That is the real policy problem. Not whether the AI works. Not whether the algorithms are biased, though they often are. Not whether the companies act in good faith, though some do not. The real problem is that the people who write the rules are not accountable to the people the rules govern.
The National Academy for State Health Policy tracks state-level AI legislation. Fourteen states passed bills in the last session requiring algorithmic transparency in clinical decision-making. Several of those bills were written with patient advocate testimony as foundational input. The pattern holds: when patients are present in drafting, the resulting policy includes disclosure requirements, appeal rights, and bias audits. When patients are absent, the resulting policy includes voluntary guidelines and industry self-assessment.
The difference is not ideology. The difference is who was in the room.
Patient advocacy organizations with technical capacity should be asking for standing in these processes. Not comment periods that open after the framework is set. Not advisory roles that carry no vote. Standing at the table where the framework is written.
Three things patient advocacy leaders should do before the draft clinical AI principles are finalized:
1. Request the meeting records through FOIA. The Chatham House rules govern what participants say publicly. They do not govern what documents regulators created or received. Request the participant lists, the agenda documents, and any written submissions from the industry participants. You are entitled to them.
2. Submit formal comment through your national health council or umbrella organization, not just your own organization. Regulators count unique organizational voices. A comment from the National Health Council carries structural weight that ten individual organization comments do not, even if the content is identical.
3. Name the absence explicitly. When you submit comment or testify, do not just describe what patients need. Describe who was not in the room and why their absence matters. Regulators respond to political cost. Making the exclusion visible creates political cost.
The meetings already happened. The thirty-day sprint is already running. The framework will be drafted with or without patient input. The question is whether the final policy reflects who was excluded from writing it.
Originally published in The Archo Advocate Brief.
