Us Congress 2023-2024 Regular Session

Us Congress House Bill HB10406

Caption

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.

Impact

The proposed legislation would have significant implications for patient rights in the healthcare system. By requiring device manufacturers to provide access to personal health data, the bill champions patient autonomy in understanding and managing their health. It is expected that this increased data access may facilitate better patient-provider relationships and improve health outcomes since patients can be better informed about their health conditions and the performance of their devices.

Summary

House Bill 10406, titled the 'Patient Device Data Access Act of 2024,' seeks to amend the Federal Food, Drug, and Cosmetic Act to mandate that manufacturers of covered medical devices disclose all patient-specific data recorded or transmitted by those devices, upon request by the patient. This legislation underscores the importance of patient access to their own data, aiming to enhance transparency and empower patients regarding their medical information. Provisions of the bill would require that the disclosure be in a format understandable to patients and allow requests for data in preferred formats where practicable.

Contention

While the bill is primarily aimed at enhancing transparency, it is anticipated that it may generate debate among stakeholders in the healthcare industry. Concerns may arise from manufacturers regarding the logistics and potential risks involved in disclosing sensitive patient data, including privacy issues and the implications of data mismanagement. Additionally, discussions may focus on how such requirements might impact the innovation in device manufacturing and the overall cost of medical care. The balance between patient access to information and the protection of proprietary device data could lead to further scrutiny and potential amendments to the bill.

Companion Bills

No companion bills found.

Previously Filed As

US SB5510

A bill to amend title XI of the Social Security Act to require pharmaceutical and device manufacturers to publicly disclose covered payments made to patient advocacy organizations.

US HB10473

To prevent covered vehicle manufacturers from accessing, selling, or otherwise selling certain covered vehicle data, and for other purposes.

US HB10370

To amend the Federal Food, Drug, and Cosmetic Act to establish certain labeling requirements for caffeine, and for other purposes.

US SB5579

A bill to prevent covered vehicle manufacturers from accessing, selling, or otherwise selling certain covered vehicle data, and for other purposes.

US HB10409

To address the high costs of health care services, prescription drugs, and health insurance coverage in the United States, and for other purposes.

US HB10364

To safeguard children from harmful app services accessible through app stores across the United States, to provide parents with parental controls, to provide parents clear and accurate information about apps and their services to ensure proper parental consent is achieved, and for other purposes.

US HB10428

To support and fund the Federal procurement of clean energy products, and for other purposes.

US HB1051

To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

US SB90

Informing Consumers about Smart Devices Act This bill requires manufacturers of internet-connected devices (e.g., smart appliances) that are equipped with a camera or microphone to disclose to consumers prior to purchase that a camera or microphone is part of the device. The bill does not apply to mobile phones, laptops, or other devices that a consumer would reasonably expect to include a camera or microphone.

US HB10544

To specify the treatment of covered non-fungible tokens under the securities laws, and for other purposes.

Similar Bills

CA SB561

Hazardous waste: Emergency Distress Flare Safe Disposal Act.

NH HB1358

Relative to tenant and contract manufacturers of beer, wine, and liquor; allowing pharmacists to administer influenza, COVID-19, and other FDA licensed vaccines without explicit approval from the general court; and, restricting the purchase of real property on or around military installations.

CA AB2754

Alcoholic beverage control.

CA SB1445

Electric mobility manufacturers.

CA SB788

Beer manufacturers: cider and perry.

CA AB326

Electric mobility manufacturers.

CA AB1211

Electric mobility manufacturers.

CA SB1420

Licensed beer manufacturers: nonlicensee products: storage.