Expansion of Health IT under Stimulus Legislation May Prompt Increased FDA Regulatory Activity

January 2009
Venulex Legal Summaries;2009 Q1, Special section p1
The article discusses the increase in funding for health information technology (HIT) provided under the American Recovery and Reinvestment Act of 2009, which is said to potentially incite increased U.S. Food and Drug Administration (FDA) regulation. It is said that HIT and electronic health records (EHRs) are considered by the FDA to be under its jurisdiction if such systems use medical devices in transmitting data or provide support for clinical decision-making. It is speculated that increased FDA regulation may hinder adoption of such technologies.


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