An Institute of Medicine committee issued a report on HIT safety in November 2011 that was reluctant to embrace FDA regulation, but committee member Richard Cook, M.D. dissented. For Cook, the question of whether the U.S. Food and Drug Administration should regulate health information technology systems is a no-brainer, according to a Health Data Management article.
But, according to the article, there's plenty of room for debate over if and how the FDA and an alphabet soup of agencies and committees should take action. The Institute of Medicine committee stop short of recommending regulation, citing saying the FDA's lengthy process for giving market clearance to products could stifle innovation. However, the committee warned that if the industry did not self-police, regulation could be on the way.
Read the article.
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