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

The American Recovery and Reinvestment Act of 2009 (the stimulus bill) brings new focus and billions in funding for the development and use of health information technology (HIT), including the use of electronic health records (EHRs) and the development of a nationwide HIT infrastructure. After an on-again, off-again approach toward promoting and standardizing HIT and EHR, there is now some real funding associated with this federal initiative.

What may not be obvious, however, is that the expanded use of HIT and EHR systems is likely to increase FDA interest in the safety and effectiveness of such systems, and thus hasten its efforts to establish regulatory policy in this area. Consequently, companies hoping to profit from the new funding for HIT and EHR systems will need to keep abreast of FDA developments for HIT, and determine whether their products are subject to FDA regulation.

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