Feds Pitch Risk-Based Health IT Regulatory Framework

Feds Pitch Risk Based Health IT Regulatory Framework   mHealth HHS healthcare IT FDA On Thursday, the U.S. Department of Health and Human Services released a draft report that puts forward a proposed strategy and recommendations for a health information technology (health IT) framework.

Per the details shared during a joint media briefing yesterday, the framework in question aims to promote “product innovation” while maintaining “appropriate patient protections” and avoiding regulatory duplication.

The report, which exists to “clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it,” was developed by the U.S. Food and Drug Administration (FDA) with the assistance of two other federal agencies: HHS’ Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC).

“The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” said HHS Secretary Kathleen Sebelius.

This proposed strategy indicates that health IT products would be classified into three categories. The categories would be based on the function and risk level of the underlying product.

According to the HHS:

  • The first category, products with administrative health IT functions, poses little or no risk to patient safety and as such requires no additional oversight. They include software for billing and claims processing, scheduling, and practice and inventory management.
  • The second category, products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.
  • The third category, products with medical device health IT functions are a narrowly defined group that could potentially pose greater risks to patients if they do not preform as intended. The draft report proposes that FDA continue regulating these products, which include computer-aided detection software, software for bedside monitor alarms, and radiation treatment software.

In repose to the proposal, National Coordinator for Health IT Karen DeSalvo said that the ONC “welcomes comment on the draft report and stands ready to collaborate with stakeholders to ensure that health IT is designed and used with both innovation and patient safety in mind.”

The FDA is now seeking public comment on the draft document, which can be found in its entirety here.

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