Division of Pharmacy, School of Medicine, Pharmacy and Health, The University of Durham, Stockton-on-Tees, UK Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA Harvard Medical School, Boston, Massachusetts, USA Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, USA.
J Am Med Inform Assoc. 2014 Oct;21(e2):e181-4. doi: 10.1136/amiajnl-2014-002638. Epub 2014 Apr 24.
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.
卫生与公众服务部部长(HHS)经食品和药物管理局(FDA)授权,并与联邦通信委员会(FCC)和国家卫生信息技术协调办公室(ONC)合作,负责提交一份关于医疗信息技术(IT)适当的、基于风险的监管框架的报告。在卫生信息技术政策委员会的主持下成立了一个专家利益相关者小组,以帮助为该框架的制定提供投入,包括如何根据风险对医疗保健 IT 系统进行分层,以及关于如何调整现有监管要求的建议。在本文中,我们总结了专家利益相关者小组的公开审议和最终公开报告,并以旨在解决建议促进创新、保护患者安全和避免监管重复的基于风险的监管框架的特征的关键建议作为结论。