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FDA calls for classifying health IT products by patient-safety risk level

The Food and Drug Administration proposed regulating health information technologies based on their potential risks to patient safety, rather than by the technology platform they utilize.

The federal agency stayed close to recommendations made by stakeholders when developing the report (PDF) outlining how health IT products should be regulated.“We believe a limited, narrowly tailored approach that primarily relies on ONC-coordinated activities and private sector capabilities is prudent,” according to the report. “We also recommend that no new or additional areas of FDA oversight are needed.”

Administrative health IT products, such as billing and claims software and inventory management systems, would fall into a low-risk category.

Medication management, provider order entry, most clinical-decision support software and other health management IT products would go into a second low-risk category. This category of products is rapidly changing, said Dr. Joe Smith, chief medical and scientific officer of the San Diego-based West Health Institute. The proposal that the FDA will not regulate products in this category is likely beneficial for developers and manufacturers.

The federal agencies “wisely chose not to write crisp, rigid regulation,” Smith said. “They're sending some of the burden to the community, with guidelines, and that's right.”

Medical device systems including software for bedside monitor alarms and radiation treatment that pose risks to patient safety would be put into a third category. The FDA would continue to regulate these products.

“This proposed strategy will facilitate innovation, protect patients and support FDA's focused oversight on higher risk technology, similar to medical devices that are currently regulated,” said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

The proposed framework seeks to protect patient safety and avoid regulatory duplication. It is required by a provision in the Food and Drug Administration Safety and Innovation Act of 2012, HHS said in a news release. HHS' Office of the National Coordinator for Health IT and the Federal Communications Commission also were involved in the development of the report.

The report is available for public comment and HHS also plans to convene a public meeting within the next 90 days.

A workgroup in September finalized its recommendations to the ONC Health IT Policy Committee, which later adopted the recommendations.

Others agree that the proposal is a plus for industry, at least in terms of providing clarity about what products will be regulated and by what government agency.

“In years past, rumors would fly about possible regulatory moves which sent chills through the industry,” said Dr. Harry Greenspun, senior adviser for Deloitte Center for Health Solutions. “The information on mobile devices and apps should also give some comfort and guidance to developers.”

Follow Jaimy Lee on Twitter: @MHjlee
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