FDA guidance urges device makers to share data with patient users


After hearing stories of patients frustrated that they could not obtain the data being produced by implanted devices such as pacemakers, the U.S. Food and Drug Administration has released draft guidance on the topic.

Manufacturers had argued that their customers were doctors and hospitals and that providing such information to patients would require FDA approval. At the same time, some device makers have been trying to monetize the data from devices, such as cardiac monitors.

The guidance makes clear that HIPAA does not preclude sharing that data with the patient.

According to the FDA, “manufacturers may share patient-specific information [recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device, consistent with the intended use of that medical device] with patients at the patient’s request, without obtaining additional premarket review before doing so.”

This information may include recorded patient data, device usage or output statistics, provider inputs and information about alarms or malfunctions. It does not include interpretations of the data beyond that reported to the healthcare provider.

However, the guidance encourages device makers to consider the best way to present the data so that it will be clear and not misunderstood.

"These considerations relate to the content of information provided, the context in which patient information from medical devices should be understood, and the need for access to additional, follow-up information from the manufacturer or a healthcare provider," it states.

To learn more:
- here's the guidance (.pdf)