The FDA is encouraging medical equipment manufacturers to release information about their devices to patients. Per the FDA’s draft guidance, device manufacturers should share any patient-specific information recorded, stored, processed, retrieved, and/or derived from their equipment, such as pulse oximeters.
After all, FDA officials assert, having access to such information makes patients more engaged in their care. “The FDA believes that providing patients with access to accurate, useable information about their healthcare when they request it (including the medical products they use and patient-specific information these products generate) will empower patients to be more engaged with their healthcare providers in making sound medical decisions,” the agency wrote in the draft.
The FDA also explained how patient privacy laws, such as the Health Insurance Portability and Accountability Act, don’t prevent manufacturers from disclosing data about the device to the person utilizing it. Instead, the FDA wrote: “These protections are intended to prevent manufacturers from sharing this information with covered entities (e.g., health plans, healthcare providers that electronically transmit health information) without the patient’s consent. However, these protections are not intended to prevent a device manufacturer from sharing patient-specific information with the affected patient.”
The FDA is encouraging interested parties to comment on the draft at www.regulations.gov. All comments must be submitted online by August 9.