EMRs, other tools count as medical devices

A rule from the Food and Drug Administration (FDA) is causing healthcare providers to reassess what is considered a medical device and what the classification might mean in terms of liability and reporting requirements.

The FDA issued a long-awaited final rule reclassifying Medical Device Data Systems (MDDS) as class I, 510(k)-exempt, medical devices in February. The final rule comes almost three years after the Agency's Feb. 8, 2008, issuance of a proposed rule seeking to classify MDDS as class I, 510(k)-exempt.

Now that the rule is final, companies involved in manufacturing and developing MDDSs have to implement a system to comply with these new rules since their products are now subject to FDA regulation. They have until April 2012 to comply.

That might sound like a problem for manufacturers, not healthcare providers. However, in some circumstances, hospitals and health systems can be obligated to comply, particularly if you develop your own software for electronic medical records (EMRs), personal health records (PHRs), and similar systems, says Yarmela Pavlovic, JD, an attorney with law firm of Hogan Lovells in Philadelphia. "The FDA is saying that anything that fits into the category of healthcare information technology — and that includes software used in the hospital, electronic charts, or pretty much anything used in a hospital to treat patients — is a medical device," Pavlovic says. "For years there wasn't any action on these products, so this rule is a first step into the technology space."

This rule can also apply to healthcare providers creating their own software, Pavlovic says.

"Some have argued that they should not fall under the FDA's jurisdiction. Hospitals, for example, are heavily regulated by other sectors of the government, but not FDA," Pavlovic says. "For a long time the FDA has left hospitals alone to do what they wanted, and this is the first time they've been considered medical device manufacturers. If a healthcare organization creates a program or significantly modifies one from a manufacturer, they could be a manufacturer for FDA purposes."

The good news is that the FDA has said it is not actively enforcing the rule as it applies to EMRs and PHRs, Pavlovic says.

"Meanwhile, other sectors of the government have been discussing whether to regulate those products and how to enforce standards," she says. "I think there is a lot of government debate about that. The Institute of Medicine is currently studying patient IT products, and the FDA has said they're going to wait until that report is released — probably this winter — before they start enforcing the rule with health IT."

Sources

Yarmela Pavlovic, JD, Hogan Lovells, Philadelphia, PA. Telephone: (267) 675-4618. E-mail: yarmela.pavlovic@hoganlovells.com.