Patient Access to Medical Device Data: New Right to Information.
This Act authorizes the government to require medical device manufacturers (e.g., pacemakers, monitors) to disclose all patient-specific data recorded or transmitted by these devices upon patient request. This grants citizens the right to demand and receive full health information collected by their implanted or monitoring devices. Manufacturers must also publicly disclose what data they collect and how it can be accessed, increasing transparency and patient control over their own medical data.
Key points
Right to Personal Data: Patients can request access from manufacturers to all data recorded or transmitted by their medical devices (e.g., pacemaker data, pulse oximetry data).
Transparency Obligation: Manufacturers must publish information about what data their devices collect, how it is used, and how patients can access it.
Data Format: Data must be disclosed in a format understandable to the patient and, where practicable, in the patient's preferred format.
Exceptions: Manufacturers are not required to disclose data that is inaccessible to them or would require redesigning the device.
Penalties for Non-Compliance: Introduction of civil penalties for manufacturers who fail to meet the new data disclosure requirements.
Introduced
Citizen Poll