The conversation about patient access to data ties back to a 2012 piece in The Wall Street Journal. In the article, Elizabeth Hoff, general manager of Medtronic’s data business, said the company couldn’t provide patients the medical device data implanted inside their own bodies because regulators prohibited it.
The FDA’s draft guidance document addresses this claim by clarifying the agency’s views on patient access. The document explains that while patients can often access their device data through their providers, they can also contact device manufacturers to acquire the data. Although not generally required to, manufacturers may share patient-specific information with patients upon request without obtaining additional premarket review before doing so.
The agency also addresses HIPAA rules, saying these protections are not intended to prevent a device manufacturer from sharing patient-specific information with the affected patient.
The FDA suggests device manufacturers take into consideration the best way to share data “to ensure it is useable by patients and to avoid the disclosure of confusing or unclear information that could be misinterpreted,” according to the document.
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