Bipartisan Policy Center's Health Innovation Initiative: Health IT Industry Officials Lying To Regulators With Impunity?

InformaticsMD | Health Care Renewal | February 14, 2013

...A statement that health IT has a "lower risk profile" compared to other regulated healthcare sectors such as devices or drugs, in order to seek continued and extraordinary regulatory accommodations, is remarkable.  It is either reckless regarding something that the statement's makers should know, or should have made it their business to know - or a deliberate prevarication with forethought.

The report did attempt to shroud the declarative "lower risk profile" in a sugar coating through misdirection, citing the need to take into account "several factors" including:

"the level of risk of potential patient harm, the degree of direct clinical action on patients, the opportunity for clinician involvement, the nature and pace of its development, and the number of factors beyond the development stage that impact its level of safety in implementation and use."

These "factors" speak to a higher level of potential risk, not lower, and are a justification for stronger regulatory oversight, not weaker.  I would opine that there is a possibility that health IT. through which almost all transactions of care need to pass (e.g., orders, results reporting, recording and review of observations, finding, diagnoses, prognoses, treatment plans, etc.), could have a higher risk profile than one-off devices or drugs.  Health IT affects every patient, not just those under a specific therapy or using a specific device or drug...