J Am Med Inform Assoc - A risk-based regulatory framework for health IT: recommendations of the FDASIA working group.

Tópicos

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Resumo

The Secretary of Health and Human Services (HHS) acting through the Food and Drug Administration (FDA), and in collaboration with the Federal Communications Commission (FCC) and Office of the National Coordinator for Health IT (ONC) was tasked with delivering a report on an appropriate, risk-based regulatory framework for health information technology (IT). An expert stakeholder group was established under the auspices of the Health IT Policy Committee to help provide input into the development of this framework, including how healthcare IT systems could be stratified in terms of risk and recommendations about how the regulatory requirements currently in place should be adapted. In this paper, we summarize the public deliberations and final public report of the expert stakeholder group, and conclude with key suggestions intended to address the charge to recommend the features of a risk-based regulatory framework that promote innovation, protect patient safety, and avoid regulatory duplication.

Resumo Limpo

secretari health human servic hhs act food drug administr fda collabor feder communic commiss fcc offic nation coordin health onc task deliv report appropri riskbas regulatori framework health inform technolog expert stakehold group establish auspic health polici committe help provid input develop framework includ healthcar system stratifi term risk recommend regulatori requir current place adapt paper summar public deliber final public report expert stakehold group conclud key suggest intend address charg recommend featur riskbas regulatori framework promot innov protect patient safeti avoid regulatori duplic

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