Earlier this year, the ONC, the Federal Communications Commission and the Food and Drug Administration have released a proposed strategy and framework for the regulation of health IT products. The proposed regulatory strategy would divide health IT products into three categories with different levels of oversight: those used for more administrative functions, such as billing software; those used for health management, such as clinical decision support software; and those used as medical devices, such as computer-aided detection software.
In its official comments on the proposed framework, HIMSS advocates for a fourth category: devices with pharmacy, diagnostics and procedural health IT functions, affecting areas including medication management, radiology, labs and surgery.
These devices are "critical" to patient safety, according to the comments, because of an increasingly heavily reliance to manage orders and medications with IT. Because labs, pharmacies and the like often have their own IT networks and systems, creating another category for these devices will help reduce safety issues while allowing these products to benefit from best safety practices from other health IT devices.
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