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  1.  4
    Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway.Jessica N. Holtzman & Daniel B. Kramer - 2018 - Journal of Law, Medicine and Ethics 46 (4):1034-1039.
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  2.  14
    Informed consent and compulsory medical device registries: ethics and opportunities.Daniel B. Kramer & Efthimios Parasidis - 2022 - Journal of Medical Ethics 48 (2):79-82.
    Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from (...)
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    Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California.Emily A. Largent, Govind Persad, Michelle M. Mello, Danielle M. Wenner, Daniel B. Kramer, Brownsyne Tucker Edmonds & Monica Peek - 2021 - American Journal of Public Health 1 (1):e1-e8.
    California has focused on health equity in the state’s COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California’s 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier’s test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 residents must (...)
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    Mandates for Shared Decisions: Means to which Ends?Daniel B. Kramer - 2021 - Journal of Law, Medicine and Ethics 49 (4):630-632.
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