Healthcare Regulatory Decision Summary

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HHS finalizes regulatory review rule, though more

(4 days ago) WebThe Trump administration on Friday finalized a rule requiring HHS to review existing regulations, with some exceptions, every 10 years based on their real-world impact. If not reviewed and

https://www.healthcaredive.com/news/hhs-finalizes-regulatory-review-rule-though-more-lenient-than-proposed/593062/

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Real-world evidence for regulatory decision-making: …

(4 days ago) WebReal-world evidence (RWE) continues to receive global attention with growing use in supporting regulatory decision-making for drugs and biologics. …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10643567/

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Artificial Intelligence & Medical Products - U.S. Food …

(1 days ago) WebThis paper describes four areas of focus for CBER, CDER, CDRH, and OCP regarding the development and use of AI across the medical product life cycle. (see Figure 1). 1 For …

https://www.fda.gov/media/177030/download

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Regulatory Compliance In Healthcare: What Is It & Importance

(Just Now) WebRegulatory compliance in healthcare means all healthcare stakeholders, including providers, payers, vendors, non-governmental organizations, not-for-profit …

https://kodjin.com/blog/regulatory-compliance-in-healthcare/

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Regulatory Decision Summaries - Canada.ca

(6 days ago) WebRegulatory Decision Summary Documents. RDSs for prescription drugs (pharmaceuticals and biologics) are available in the Drug and Health Product Portal ( …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/regulatory-decision-summary.html

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Real-World Data: Assessing Electronic Health Records and …

(7 days ago) WebGUIDANCE DOCUMENT. Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory

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Healthcare Regulatory Measures Support Optimal Care

(1 days ago) WebAccess digital content about how data can empower informed decision making. Videos . Watch videos about the digital future of healthcare, quality …

https://www.healthcatalyst.com/insights/healthcare-regulatory-measures-support-optimal-care

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Healthcare Policy: What Is It and Why Is It Important?

(3 days ago) WebHealthcare policy is an integral aspect of the U.S. healthcare system—one that helps shape and protect the health and well-being of our population. Policy impacts …

https://www.usa.edu/blog/healthcare-policy/

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Regulatory quality and COVID-19: The use of regulatory

(Just Now) WebThis brief discusses the different approaches by governments during the pandemic to using regulatory management tools, including regulatory impact …

https://www.oecd.org/coronavirus/policy-responses/regulatory-quality-and-covid-19-the-use-of-regulatory-management-tools-in-a-time-of-crisis-b876d5dc/

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Healthcare Regulatory Check-up December 2022 - McDermott …

(4 days ago) WebThis issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between November 21 and December 31, 2022, including recent …

https://www.mwe.com/insights/healthcare-regulatory-check-up-december-2022/

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The imperative for regulatory oversight of large language models …

(Just Now) WebThe regulation of GPT-4 and generative AI in medicine and healthcare without damaging their exciting and transformative potential is a timely and critical …

https://www.nature.com/articles/s41746-023-00873-0

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Making Good Decisions in Healthcare with Multi-Criteria Decision

(9 days ago) WebHealthcare decision making is usually characterized by a low degree of transparency. The demand for transparent decision processes can be fulfilled only when …

https://link.springer.com/article/10.1007/s40258-015-0203-4

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Non-Discrimination in Healthcare Final Rule imposes diligence

(6 days ago) WebTwo federal agencies under the US Department of Health and Human Services (HHS) – the Office for Civil Rights (OCR) and the Centers for Medicare and …

https://www.dlapiper.com/en-us/insights/publications/2024/04/non-discrimination-in-healthcare-final-rule-imposes-diligence-obligations-on-medicare

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Maximizing the Value of Real-World Data and Real-World

(Just Now) WebUse of real-world data (RWD) is gaining wide attention. To bridge the gap between diverse healthcare stakeholders and to leverage the impact of Chinese real …

https://link.springer.com/article/10.1007/s40290-024-00520-3

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Notice: Regulatory Decision Summaries and Submissions Under …

(4 days ago) WebRegulatory Decision Summaries will complement a continuum of transparency and openness initiatives including the Submissions Under Review list and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/regulatory-decision-summary/drugs/notice-regulatory-decision-summaries-submissions-under-review.html

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UnitedHealthcare Regulatory & Key Initiatives Summary

(6 days ago) WebRegulatory & Key Initiatives Summary 2024. Name. Summary. Effective Date. Client Action. UHC Action. Out-of-Pocket Maximums. All in-network member cost-sharing, …

https://www.uhc.com/content/dam/uhcdotcom/en/HealthReform/PDF/Provisions/reform-external-grid-regulatory-and-key-initiatives-summary.pdf

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Regulatory Decision Summary

(2 days ago) WebRegulatory Decision Summary - - Health Canada. Regulatory Decision Summary for . Medicinal ingredient(s): Therapeutic area: Type of submission: Control number: What …

https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00928

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Regulatory Decision Summary - Drug and Health Product Register

(7 days ago) WebReview Decisions . Summary Safety Review; Summary Basis of Decision; Regulatory Decision Summary; Submit a report . Report a side effect; Report a serious adverse …

https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary-medical-device-detail.php?lang=en&linkID=RDS10170

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Rights & Protections HealthCare.gov

(5 days ago) WebThe health care law offers rights and protections that make coverage more fair and easy to understand. Some rights and protections apply to plans in the Health Insurance …

https://www.healthcare.gov/health-care-law-protections/

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Search Page - Drug and Health Product Register

(8 days ago) WebHealth Canada's Summary Basis of Decision (SBD) documents outline the scientific and regulatory considerations that factor into Health Canada regulatory decisions related …

https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailOne.php?linkID=SBD00387

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Search Page - Drug and Health Product Register

(7 days ago) WebReview Decisions . Summary Safety Review; Summary Basis of Decision; Regulatory Decision Summary; Submit a report . Report a side effect; Report a serious adverse …

https://hpr-rps.hres.ca/reg-content/regulatory-decision-summary.php

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Medicaid Program; Ensuring Access to Medicaid Services

(7 days ago) WebD. Burden Summary; IV. Regulatory Impact Analysis; A. Statement of Need; 1. Medicaid Advisory Committee Strategies to enhance access to health care …

https://www.federalregister.gov/documents/2024/05/10/2024-08363/medicaid-program-ensuring-access-to-medicaid-services

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