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Appendix E: Dissenting Statement: Health IT Is a Class III Medical Device
Pages 193-198

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From page 193...
... to exer cise its authority to regulate health IT, including all electronic health records (EHRs) and associated components, and health information exchanges, as Class III medical devices.
From page 194...
... Health IT is a medical device and FDA is or should be its regulatory body. The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act established three regulatory classes for medical devices.
From page 195...
... . The amendments define a Class III device as "one that supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury." Class III includes obvious high-risk devices such as external cardiac defibrillators (21 CFR 870.5310)
From page 196...
... Accidents involving health IT are complex events that require substantial forensic skill to detect and describe. The impact of health IT on system safety is most easily understood in cases of overt computer outages (sometimes described as system "crashes")
From page 197...
... And the willingness to embrace this optimism to the extent of making large-scale investments in these systems and only later asking what their impact might be on patient safety borders on recklessness. Mounting an effort to bring device regulation to health IT will be challenging and demands both added resources and new methodologies for FDA.


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