Last month the Food & Drug Administration (FDA) announced still further relaxation of its oversight over anything qualifying as a “medical device data system,” or MDDS. The announcement should come as welcome news to a great many hospitals and physicians.
In its June 30 “Draft Guidance for Industry & Food & Drug Administration Staff,” the agency noted that electronic health information offers hope for improving health care and making it safer. That hope depends on medical devices being interoperable with one another and with varying kinds of health information technology. That’s why the FDA has decided not to enforce the regulations that technically apply to these devices—regulations that could otherwise involve “registration and listing, pre-market review, post-market reporting and quality system regulation.”
So what is an MDDS? The essence of an MDDS is that it handles electronic information but doesn’t change the information and doesn’t control any medical device. So an MDDS might transfer information, store it or translate it into a different format, but it couldn’t react to the information by changing the setting on a medical device. For example, an MDDS could record and store readings on a patient’s ventilator and could transfer that information to other devices, but if the device could change the ventilator settings—say, in reaction to a reading—it would not be an MDDS and would not qualify under the new guidance.
Who benefits from this new guidance? It’s not the manufacturers of these devices. They’re still required to comply with FDA processes and regulations. The real beneficiaries are hospitals and physicians that create custom software or modify portions of software or hardware in order to establish or enhance the interoperability of systems and devices used in the delivery of health care.