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.

12/16/2024, 7:32 PM
Referred to the House Committee on Energy and Commerce.
Bill 118 hr 10406, also known as the Patient Data Access Act, aims to amend the Federal Food, Drug, and Cosmetic Act to allow for the disclosure of patient-specific data recorded or transmitted by medical devices to the patients themselves. This bill would require manufacturers of covered devices to provide patients with access to any data that is accessible to the manufacturer.

The purpose of this legislation is to empower patients by giving them more control over their own health information. By allowing patients to access the data collected by their medical devices, they can better understand their own health conditions and make more informed decisions about their care.

The bill does not specify which devices would be considered "covered devices," but it is likely to include a wide range of medical devices that collect and transmit patient data, such as pacemakers, insulin pumps, and continuous glucose monitors. Overall, the Patient Data Access Act seeks to promote transparency and patient autonomy in healthcare by ensuring that patients have access to the data generated by their own medical devices.
Congress
118

Number
HR - 10406

Introduced on
2024-12-12

# Amendments
0

Sponsors
+5

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and Summary

Referred to the House Committee on Energy and Commerce.
Bill 118 hr 10406, also known as the Patient Data Access Act, aims to amend the Federal Food, Drug, and Cosmetic Act to allow for the disclosure of patient-specific data recorded or transmitted by medical devices to the patients themselves. This bill would require manufacturers of covered devices to provide patients with access to any data that is accessible to the manufacturer.

The purpose of this legislation is to empower patients by giving them more control over their own health information. By allowing patients to access the data collected by their medical devices, they can better understand their own health conditions and make more informed decisions about their care.

The bill does not specify which devices would be considered "covered devices," but it is likely to include a wide range of medical devices that collect and transmit patient data, such as pacemakers, insulin pumps, and continuous glucose monitors. Overall, the Patient Data Access Act seeks to promote transparency and patient autonomy in healthcare by ensuring that patients have access to the data generated by their own medical devices.
Alternative Names
Official Title as IntroducedTo 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.

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Recent Activity

Latest Action12/12/2024
Referred to the House Committee on Energy and Commerce.