Certification, accreditation, conformity assessment; call it what you will, but some type of program to assure health information technology products meet certain benchmarks for safety is coming. And the federal government, while being a player and helping to facilitate, clearly is throwing the ball to stakeholders to get it done.
The new proposed regulatory framework for HIT safety favors a voluntary program that can be performed by the private sector or government. Private sector assessments may have advantages such as increased efficiency, promotion of consumer transparency and economic competition, and reduced government costs, according to the report from the Food and Drug Administration, Office of the National Coordinator for HIT and Federal Communications Commission. But government assessments may be more appropriate in assuring the safety and health of consumers. Which way to go should be decided with broad input from stakeholders, report authors say.
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