FDA finalizes guidance on medical device data systems

The Food and Drug Administration won't enforce regulations on computer systems used to store, display or collect medical data because they pose a low risk to patients, according to a final guidance document. 

The move is expected to smooth the way for interoperability by lowering the burden on developers of medical device data systems (MDDS) to comply with agency requirements.

Medical device data systems (MDDS) are defined as hardware or software products that transfer, store, display or convert the format of medical device products. These systems do not modify the data, do not control any other connected devices and do not include any devices involved in active patient monitoring. The guidance applies to medical image storage devices and medical image communications devices as well.

Bakul Patel, senior policy adviser to the director of the Center for Devices and Radiological Health at FDA, said when the draft guidance was issued that it allows MDDS developers to focus on improving interoperability with other medical devices. He added that the guidance is consistent with the health IT risk-based framework issued in April in conjunction with the Office of the National Coordinator for Health IT and the Federal Communications Commission as mandated by the Food and Drug Administration Safety and Innovation Act.

At that time, Attorney Brad Thompson, of Epstein Becker Green, who serves as general counsel for both the mHealth Regulatory Coalition and the CDS Coalition, said the guidance was consistent with the notion that the FDA is getting out of broad health IT management, passing those duties off to the ONC.

In email to FierceHealthIT, he called the final draft "remarkable" in many ways.

"The implications are profound, both for MDDS-type software, but also for what it suggests about the future for health information technology generally," he wrote. "FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software.  It's exciting, because it means that innovation in this space can truly flourish."

To learn more:
- read the guidance (.pdf)

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