"For a few years now, folks in industry have been asking FDA to define that line with greater clarity. FDA has that project on its to-do list, but has been very slow to respond," he said. Thompson adds that the plan acknowledges the need to move forward, but provides "no details on how or how fast" it will do that.

The Medical Imaging & Technology Alliance (MITA) praised the report, which determined that the FDA will continue to be the regulating body for the medical imaging informatics field.
Gail Rodriguez, executive director of MITA, said it will promote innovation in HIT products, avoid regulatory duplication and protect patients.

"In a fast-paced, technological world, it is critical that regulatory frameworks support the implementation of innovation for patients," Rodriguez said.

While there was regulation of HIT before, this report creates a clearer regulatory structure, according to Rodriguez. "HIT is very complicated and diverse so this is a very welcome development," she said.

Joel White, executive director of the Health IT Now Coalition, said in a statement that he was pleased the report addressed the needs for "interoperability of technologies to improve safety."

"It also includes suggestions for a better environment for reporting medical errors and problems associated with technologies," White said. "These suggestions are steps in the right direction toward creating a risk-based framework, based on a technology's functionality, so these innovations can safely and effectively improve patient outcomes and lower costs."

The agencies will seek comments and schedule a public meeting within 90 days before adopting the guidelines in the report.

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