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Highest European Court Confirms: No Presumption of Confidentiality Over Documents Submitted in Marketing Authorization Dossier

Data Matters

On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application. Background.

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Regulatory Update: NAIC Summer 2021 National Meeting

Data Matters

The amendment is consistent with Rule 18f-4 under the Securities and Exchange Commission (SEC) Investment Company Act of 1940 related to the use of derivatives by registered investment companies, including funds, which the SEC adopted in October 2020. short sale borrowings. reverse repurchase agreements or similar financing.

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The benefits of AI in healthcare

IBM Big Data Hub

Artificial intelligence is used in healthcare for everything from answering patient questions to assisting with surgeries and developing new pharmaceuticals, benefitting both patients and healthcare systems. How does artificial intelligence benefit healthcare? AI can also improve accessibility. According to the U.S.

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Regulatory Update: NAIC Summer 2018 National Meeting

Data Matters

This work is part of a broader discussion occurring at the Health Insurance and Managed Care (B) Committee and within its related working groups regarding health care cost drivers, including pharmaceutical costs. This post summarizes the highlights from this meeting. NAIC Continues its Evaluation of Insurers’ Use of Big Data .