Can You Diagnose Me Now? A Proposal to Modify FDA's Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database System.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2015-01-01
Stephen McInerney
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引用次数: 0

Abstract

Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) has the authority to regulate a much broader spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if FDA has the statutory. authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, FDA published guidance on Mobile Medical Applications; in it, the Agency limited its oversight to a small subset of medical-related mobile applications, referred to as "mobile medical applications." For the guidance to be effective, FDA must continue to work directly with all actors--including innovators, doctors, and patients--as the market for mobile health applications continues to develop. This Article argues that FDA should adopt a two-step plan--a pre-market notification program and a mobile medical application database--to aid in the successful implementation of its 2013 guidance. By doing so, FDA will ensure that this burgeoning market can reach its fullest potential.

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你现在能诊断我吗?通过上市前通知和应用程序数据库系统修改FDA智能手机移动健康应用程序法规的建议。
移动应用程序为未来的医疗保健提供了无限的可能性。然而,这些变化也引发了对患者安全的担忧。根据《联邦食品、药品和化妆品法案》(FDCA),美国食品和药物管理局(FDA)有权监管比听诊器或起搏器等传统医疗设备更广泛的产品。监管问题不在于FDA是否有法律规定。管理与健康相关的软件的权力,而是如何行使其监管权力。2013年9月,FDA发布了移动医疗应用指南;在其中,该机构将其监管范围限制在一小部分与医疗相关的移动应用程序,称为“移动医疗应用程序”。为了使指南有效,随着移动医疗应用市场的不断发展,FDA必须继续与所有参与者(包括创新者、医生和患者)直接合作。本文认为,FDA应采取两步计划——上市前通知程序和移动医疗应用数据库——以帮助成功实施其2013年指南。通过这样做,FDA将确保这个新兴市场能够充分发挥其潜力。
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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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