H.R. 10406: The Patient Device Data Access Act of 2024
Introduction
On January 18, 2025, the 119th United States Congress introduced H.R. 10406, titled the “Patient Device Data Access Act of 2024.” This bipartisan bill aims to empower patients with access to the data collected by their medical devices.
Purpose
The Patient Device Data Access Act seeks to provide patients with:
- Control over their data: Patients would have the right to access, review, and share data collected by their medical devices with healthcare providers, researchers, or other entities as desired.
- Improved health outcomes: Patient access to their device data can facilitate more informed decision-making, personalized treatments, and better health outcomes.
- Enhanced innovation: Researchers and developers would have access to a wider range of patient data, enabling the development of more innovative medical devices and treatments.
Key Provisions
The bill includes several key provisions:
- Device Data Standards: The Food and Drug Administration (FDA) would establish standards for the collection and sharing of medical device data.
- Patient Consent: Patients must provide explicit consent before their medical device data can be shared with third parties.
- Data Interoperability: Manufacturers of medical devices would be required to develop and implement interoperability standards to ensure that patient data can be easily shared between devices and systems.
- Data Security: The FDA would establish security measures to protect patient data from unauthorized access or misuse.
Background
In recent years, there has been a growing recognition of the importance of patient data in improving healthcare outcomes. However, many patients have limited access to the data collected by their medical devices. This bill addresses this issue by ensuring that patients have ownership and control over their own health data.
Support and Opposition
The Patient Device Data Access Act has received support from patient advocacy groups, healthcare professionals, and the medical device industry. Supporters argue that patient data empowerment is essential for improving health outcomes and advancing medical innovation.
However, some concerns have been raised by privacy advocates. They argue that the bill may inadvertently weaken data privacy protections, leading to potential misuse or discrimination.
Conclusion
The Patient Device Data Access Act of 2024 is a groundbreaking piece of legislation that seeks to revolutionize the way patients access and use their medical device data. By providing patients with ownership and control over their health data, this bill has the potential to improve health outcomes, enhance innovation, and empower individuals in their healthcare decisions. As the bill moves through Congress, it will be closely watched by stakeholders on all sides.
H.R. 10406 (IH) – Patient Device Data Access Act of 2024
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