But the FDA is not referring to diagnostic assessment, or specifically, “any interpretations of data aside from those interpretations of data normally reported by the device to the patient or the patient’s health care provider.”

In addition, the agency advised that this information may be shared “with patients at the patient’s request, without obtaining additional pre-market review before doing so.”


One part of the guidance, however, raised some concern. The FDA document stated that HIPAA's protections “are intended to prevent manufacturers from sharing this information with covered entities (e.g., health plans, health care providers that electronically transmit health information) without the patient’s consent.”

This appeared to be problematic to attorney Wagner. For one thing, the information “from a medical device is accessible by the patient’s health care provider and patients can contact their health care provider to obtain such information,” the guidance stated, in seeming contradiction of its own consent guidance.

For another, HIPAA was not intended to keep patient device data from providers, according to the attorney. It is “just wrong” and “doesn't make sense,” she told Bloomberg.

That questionable information aside, Wagner told the news service that the FDA guidance seemed “very much aligned” with HIPAA.

“One thing HIPAA provides is a right of access to medical records. This is very much following in line with that standard,” she noted.

But a free flow of data needs context in order to avoid confusing or alarming patients. The FDA also stressed that manufacturers should “ensure that the information provided is interpretable and useful to the patient, and to prevent the disclosure of confusing or unclear information that could be misinterpreted” by adding context to make the data clearer to a lay audience.

“The manufacturer may choose to provide supplementary instructions, materials or references to aid patient understanding,” it advised, noting, “for example, if a patient requests a history of his own blood pressure measurements from a device, the data should include all available data up through the most recent measurement.”

In another example, the agency suggested, “if information is being provided regarding the activity of a pacemaker, information regarding the circumstances under which an electrical impulse is delivered by the device may provide helpful context.”

A final caveat about sharing data information for manufacturers: confirm that the person requesting information is the patient, advised Wagner.

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