National Coordinator Keane expects HTI-6 to address wearable and patient-generated data

Dr. Tom Keane, National Coordinator for Health IT, told the a16z Raising Health podcast that the forthcoming HTI-6 rule, which he said appears in the Unified Agenda and which ONC is "hoping to get out this fall," will take into account the migration of patient care and data outside certified health IT. On patient-generated health data, he said ONC wants it to be reliable, interpretable as structured observations, and able to be integrated into electronic health records so clinicians can use it. He added that AI exchange with the EHR should be two way: what an AI collects or guides should flow back to the traditional system, and vice versa.

Two technical points matter for planning. First, Keane noted that two wearables on two wrists can generate different data, so standardization is a precondition for trust. Second, as AI acts as an agent on a patient's behalf, he said there must be a way to check provenance, audit, and trace what the AI did so post-market monitoring can detect drift. He also cited TEFCA at about 1,700,000,000 cumulative transactions and about 200,000,000 a month, per the same interview.

The direction is consistent with what ONC has done elsewhere. Keane said the HTI-5 proposal, now undergoing finalization, would remove the AI model card requirement that took effect January 1, 2025, citing low use: about two queries a month at Oracle, per its public comment letter, and about 50 a month at Epic, as he described it. His stated concern was false assurance from disclosures nobody audited. The signal is a shift from static paperwork toward operational evidence such as traceable agent actions.

The limits are clear. These are statements on a podcast, HTI-6 has not been published, and no requirements, standards or timelines are final. Nothing here obliges an organization to act today.

The move for Chief AI Officers, CIOs and CTOs is a short readiness review. Ask how your team would validate and ingest wearable data into the record, including which device sources you would accept and how you would flag conflicting readings. Then ask how you would log and reconstruct AI agent actions if a regulator, a clinician or a patient asked. Organizations that can answer both will be positioned to use patient-generated data safely and to show their AI is behaving as intended, which protects patients and spares clinicians from reconciling data they cannot trust.

You are an operations advisor to the Chief AI Officer, CIO or CTO of a [type of organization, such as a health system or clinic group].

On the Raising Health podcast episode The Next Era of Health Data: AI, Open APIs, and the End of the EHR Oligopoly, Dr. Tom Keane, National Coordinator for Health IT, said the forthcoming HTI-6 rule, hoped for this fall, will address patient-generated data, which he wants reliable, structured and able to flow into EHRs. He said AI exchange with EHRs should be two way. He cited TEFCA at about 200,000,000 transactions a month and called for ways to audit and trace AI agent actions to detect drift. These are podcast statements. HTI-6 has not been published.

Draft a readiness question set for my team on two areas. First, how we would validate and ingest wearable data into the record, including which device sources we would accept and how we would flag conflicting readings. Second, how we would log and reconstruct AI agent actions if a regulator, a clinician or a patient asked.

Deliver a one-page question list for the executive team with two sections, Wearable Data Intake and AI Agent Logging, five to seven questions each. For each question, name a likely owner and what a good answer would show. Close with open gaps to confirm.

My details: [your organization]; [your EHR]; [wearable or app data sources in use or requested]; [AI agents or tools that act in workflows]; [your current audit logging process].

Use only the facts above and the details I fill in. Cite Raising Health by name for anything attributed to Keane. Flag anything uncertain or needing verification, including any assumption about HTI-6 requirements, standards or timelines, none of which are final. Do not request or include patient data. This is a draft for the team to check, and nothing in it is medical, legal or regulatory advice.