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FDA risks disaster without a stronger hand in health IT regulation

Ashley Gold, Politico, 7/18/14

NOT EVERYONE IS HAPPY WITH THE FDASIA REPORT. HERE ARE THE DISSIDENTS: Although industry, information professionals and many patient groups support the FDA’s hands-off approach to regulating health IT, many commenters on the federal IT framework believe the agency risks disaster unless it shows a stronger hand. The comment period for the FDA Safety and Innovation Act framework closed last week with 172 organizations and individuals contributing remarks to the docket. A total of 127 were published Monday, most of them for the first time. The framework was presented in April by FDA, FCC, and HHS’ Office of the National Coordinator for Health IT. More than 50 of the comments came from registered nurses as part of a campaign by National Nurses United, the largest U.S. nurses union. The group has strongly criticized the implementation of electronic health records, especially clinical decision support software, which provides clinicians with alerts and medical advice. The nurses describe computer crashes, hours wasted on electronic forms instead of caring for patients, and data fields that make it impossible to accurately express a patient’s condition. But there were also criticisms from techies and tech firms, such as UL, the certification company.

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