The Milbank quarterly
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The Milbank quarterly · Mar 2018
Legal Barriers to the Growth of Health Information Exchange-Boulders or Pebbles?
Policy Points: Historically, in addition to economic and technical hurdles, state and federal health information privacy laws have been cited as a significant obstacle to expanding electronic health information exchange (HIE) in the United States. Our review finds that over the past decade, several helpful developments have ameliorated the legal barriers to HIE, although variation in states' patient consent requirements remains a challenge. Today, health care providers' complaints about legal obstacles to HIE may be better understood as reflecting concerns about the economic and competitive risks of information sharing.
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The Milbank quarterly · Dec 2017
Better Measurement for Performance Improvement in Low- and Middle-Income Countries: The Primary Health Care Performance Initiative (PHCPI) Experience of Conceptual Framework Development and Indicator Selection.
Policy Points: Strengthening accountability through better measurement and reporting is vital to ensure progress in improving quality primary health care (PHC) systems and achieving universal health coverage (UHC). The Primary Health Care Performance Initiative (PHCPI) provides national decision makers and global stakeholders with opportunities to benchmark and accelerate performance improvement through better performance measurement. ⋯ Findings from future assessment activities will further amplify cross-country comparisons and peer learning to improve PHC. New indicators and sources of data are needed to better understand PHC system performance in LMICs.
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The Milbank quarterly · Sep 2017
Comparative StudyComparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.
Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously.
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The Milbank quarterly · Sep 2017
Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.
Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients.
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The Milbank quarterly · Jun 2017
Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.
Policy Points: Randomized trials-the gold standard of evaluating effectiveness-constitute a small minority of existing evidence on agents given accelerated approval. One-third of randomized trials are in therapeutic areas outside of FDA approval and less than half evaluate the therapeutic benefits of these agents but use them instead as common backbone treatments. ⋯ For most agents, no substantial time lag is apparent between the average start dates of randomized trials evaluating their effectiveness and those using them as part of background therapies. There appears to be a tendency for therapeutic agents receiving accelerated approval to quickly become an integral component of standard treatment, despite potential shortcomings in their evidence base.