New FDASIA report outlines health IT guidelines

A report from the FDA has attempted to outline important operating principles for healthcare IT.

Understanding of healthcare IT structures requires a means of noting the differences in categories and applications. The recent FDASIA (Food and Drug Administration Safety and Innovation Act) health IT report looked at some of the measures that are needed to try and coordinate implementation more thoroughly.

As the report states in its opening lines, the wrong approach to healthcare IT can actually end up causing harm. To combat this, representatives from various government agencies came together to set out the definitions and goals that health IT should be held to.

Among the many different provisions listed in this document are a category system that helps define different types of health IT "functionalities" by group, and a list of five principles for IT networks to respond to that could provide "a framework intended to promote innovation and protect patient safety."

A theme of the document was collaboration, not only between the different agencies behind this report but between the health industry and those defined as "stakeholders."

Part of its goal, as stated in the report's conclusion, is to "continue active engagement with stakeholders" as better health IT standards are pursued.

The Wall Street Journal recently noted that the FDA decided it would not devote oversight to healthcare IT resources such as billing, although it will maintain regulatory control over medical devices. The source notes that EHR producers may appreciate the more lax approach in this area.

But that is all the more reason to have proper medical litigation support when contending with the issues that such records can generate.

Since these guidelines are approved by the Department of Health and Human Services, they might serve as a launching point for further HIT improvements.

392 thoughts on “New FDASIA report outlines health IT guidelines

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