In a letter to HHS Secretary Kathleen Sebelius, leaders from the Healthcare Information and Management Systems Society recommend a holistic approach to Food and Drug Administration regulation of health IT.
"Based on an extensive review of existing board-approved HIMSS policy statements and work published by industry experts and the FDASIA Work Group, we observe health IT products used primarily for the subsequent transmission, storage or management of data, including most electronic health records and clinical decision support systems, according to their current capabilities, neither fit the definition of, nor would be appropriately regulated as, medical devices," wrote HIMSS President and CEO Steve Lieber and HIMSS Board of Directors Chair Scott MacLean.
Because much of health IT would not be considered a medical device, the letter suggests a new, risk-based regulatory framework for this technology that takes into account intended use, a cost/benefit analysis of proposed oversight and an emphasis on shared responsibility between providers and vendors.
"Any regulatory or oversight framework should recognize that health IT is part of a complex patient care ecosystem involving providers, product developers, vendors, a wide array of use cases and consumers as patients and caregivers," states the letter, stressing the importance of stakeholder input from across the industry on HHS' final decision.
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