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Opill’s FDA Approval: Implications for Pharmaceutical Regulation and Access to Care

Bill of Health

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent. It was a long time coming.

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President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

C&M Health Law

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. These requirements would also apply to state Medicaid fee-for-service programs.

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FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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KHN’s ‘What the Health?’: Medicaid Machinations

Kaiser Health News

How many health-related items can be accomplished depends largely on how much money Congress agrees to spend overall, as it hashes out the annual federal spending bills. Bottom line: Health priorities are competing for a pot of money, but it’s unclear how large that pot will be. Some insiders describe it as a traffic jam.

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HIMSSCast: Predicting what's next for health IT, mobile tech and health system finances

Healthcare It News

Talking points: The future of the Public Health Emergency and the flexibilities it allows. A "perfect storm" of financial stress for hospitals and health systems. FDA and evolving regulations for digital therapeutics, software as a medical device. Like what you hear? Labor shortages and supply chain challenges.

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Preparing for the End of the Public Health Emergency

YouCompli

In this article, she discusses several issues that hospitals and health systems need to consider as a result of the scheduled end of the COVID-19 public health emergency. Department of Health & Human Services (HHS) reports that 80% of the U.S. population previously received at least one COVID-19 vaccination.

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How a National Emergency Can Bring the Monkeypox Outbreak Under Control

Bill of Health

On August 4, 2022, Health and Human Services (HHS) Secretary Xavier Becerra declared monkeypox a national public health emergency (PHE). Absent considerable public health interventions, considerably greater numbers of U.S. Monkeypox is America’s newest emergency—and not a moment too soon. Justifying a national PHE.

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