PLoS medicine
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In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.
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Jennifer Prah Ruger argues for a more multidemensional assessment of financial protection in health, which can better capture health expenditures and the full burden of health cost burdens.
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Unni Karunakara and Frances Stevenson argue that humanitarian policy and practice must adapt to ensure that the needs of older people in humanitarian emergencies are addressed.
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Peter Bloland and colleagues from the US CDC lay out the agency's priorities for health systems strengthening efforts.
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Review Meta Analysis
How does medical device regulation perform in the United States and the European union? A systematic review.
Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings. ⋯ Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.