Work with the FDA and ONC (Health IT) to use existing authority to encourage or require patient data access.
Advance near-term progress by pushing FDA and ONC to use existing levers to expand access even before Congress acts. Focus on guidance, approval and post-market expectations, and interoperability standards that ensure device data can flow into health records and be retrieved by patients. Treat this lane as “ground prep”: it should expand access where possible while keeping pressure on Congress for a universal mandate.
Why this works
- Regulators can start moving without waiting for Congress.
- If they frame it under existing patient rights or the FDA’s post-market surveillance authority, they could at least partially enforce it.
- ONC could include device data in “information blocking” rules – meaning if the data is part of the medical record, hospitals must share it with patients on request (some device data does end up in EHRs after clinic visits).
Tech Oversight Project
AdvocacyHolding Big Tech accountable through policy and pressure
Mechanism
About LobbyingHow Tech Oversight Project uses funding
- Identify the strongest existing FDA and ONC levers that can expand device-data access.
- Draft clear guidance and standards language that makes patient access a default expectation.
- Engage agency staff and leadership and align on feasibility, timelines, and scope.
- Push interoperability and portal pathways so patients can retrieve device data through health records.
- Track outcomes and iterate while keeping the legislative push moving in parallel.
Milestones
Checkpoints and the expected timing for each step
- 1
Authority map and agency plan set
0–30 daysPartners agree on the specific FDA/ONC levers and the first deliverables (guidance or standards).
- 2
Draft guidance and standards delivered
1–3 monthsWritten proposals are submitted and agency engagement is active and scheduled.
- 3
Pilot or standards movement tracked
OngoingUpdates show concrete movement toward broader access pathways.
- 4
Regulatory wins integrated with legislation
OngoingEarly regulatory progress supports the case for a universal statutory mandate.