To amend the Federal Food, Drug, and Cosmetic Act to authorize requiring the manufacturers of a covered device to disclose to a patient all patient-specific data that is recorded or transmitted by the device and accessible to the manufacturer, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
Authorizes HHS to require covered device manufacturers to provide patients with patient-specific data that the device records or transmits and the manufacturer can access.
Who Benefits and How
Patients using covered medical devices could gain better access to device-generated personal data and clearer information about manufacturer data practices.
Who Bears the Burden and How
Medical device manufacturers could face new disclosure, website, and request-processing obligations if HHS issues implementing regulations.
Key Provisions
- Authorizes HHS to require covered device manufacturers to disclose patient-specific data on request.
- Allows regulations to require understandable formatting, public notices about collected data, and published request methods.
- Directs HHS to consider existing FDA guidance on sharing patient-specific device information.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
Authorizes HHS to require covered device manufacturers to provide patients with patient-specific data that the device records or transmits and the manufacturer can access.
Key Policy Areas
Healthcare, Technology, Government Operations
Primary Purpose
Authorizes HHS to require covered device manufacturers to provide patients with patient-specific data that the device records or transmits and the manufacturer can access.
Policy Domains
Main Provisions
Identified Gains
Contextual inference, no direct clause citation- Patients seeking access to data generated by covered medical devices
Contextual inference, no direct clause citation
Identified Costs
Contextual inference, no direct clause citation- Medical device manufacturers subject to future patient-data disclosure rules
Contextual inference, no direct clause citation
Legislative Progress
IntroducedMs. Sherrill introduced the following bill; which was referred to …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Patients seeking access to data generated by covered medical devices
Medical device manufacturers subject to future patient-data disclosure rules
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology