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After the Public Health Emergency: Implications for Medicare and …

WebOn January 30, 2020, the Biden Administration announced that it intends to allow the COVID-19 national emergency and public health emergency (collectively, …

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URL: https://www.engage.hoganlovells.com/knowledgeservices/news/after-the-public-health-emergency-implications-for-medicare-and-us-federal-health-care-policies/

HHS ONC proposes new AI / ML requirements for certified Health IT

WebThe U.S. Department of Health & Human Services (HHS) Office of the National Coordinator (ONC) posted a proposed rule entitled, “Health Data, Technology, …

Category: Health Go Health

CMS finalizes regulation specifying all covered prescriptions drugs …

WebOn April 2, 2024, the Centers for Medicare & Medicaid Services (CMS) released the 2025 Notice of Benefit and Payment Parameters (NBPP) final rule (Final …

Category: Health Go Health

New FDA electronic records guidance prioritizes Digital Health

WebOn March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, …

Category: Food Go Health

The Genesis case: The beginning of the end of HRSA’s “patient

WebThe U.S. District Court for the District of South Carolina decision granting Genesis Health Care’s motion for summary judgment in its litigation against the Health …

Category: Health Go Health

The False Claims Act Guide: 2023 and the road ahead

WebThe “but-for causation” circuit split widens. In 2023, courts continued to grapple with the causation standard used to identify claims “resulting from” violations of …

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Court puts health care providers on notice that illegal kickbacks …

WebCourt puts health care providers on notice that illegal kickbacks can trigger significant damages. 3 April 2021. The United States Court of Appeals for the Fourth …

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U.S. Department of Justice rescinds longstanding policy governing

WebOn 3 February 2023 the Department of Justice (DOJ) announced that it is withdrawing from certain policy statements related to antitrust enforcement in health care. Specifically, …

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New Washington consumer health privacy policy guidance may …

WebAdding to the list of heightened privacy and data protection requirements imposed on consumer health data and other categories of sensitive personal data, the …

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After the Public Health Emergency: FDA plans to revise COVID-19 …

WebOn March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will …

Category: Food Go Health

Unraveling the complexities of collaborations between pharma …

WebDigital therapeutics (DTx) have emerged as an interesting addition to conventional pharmacological solutions, offering innovative ways to improve patient …

Category: Health Go Health

FTC challenges first hospital merger under new Merger Guidelines

WebOn January 25, 2024 the Federal Trade Commission (FTC) sued to block Novant Health (Novant) from acquiring two North Carolina hospitals, Lake Norman Regional Medical …

Category: Medical Go Health

OEHHA finalizes new Proposition 65 regulation governing …

WebThe Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65 (Prop 65), recently finalized a …

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The “Borne Mission” Report analysis: Between hope and …

WebIn January 2023, Prime Minister Elisabeth Borne launched a mission on the regulation of healthcare products. The report, crucial for the overall pharmaceutical …

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Biden Administration publishes request for comment on kids …

WebThe National Telecommunications and Information Administration (NTIA) published a request for comment (RFC) seeking input on a broad series of questions …

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Advertising and communication on medical devices: France’s long …

Web16 March 2022. The French ministerial order laying down the Charter on the quality of professional practices for the presentation, information or promotion of medical devices …

Category: Medical Go Health

Regulation of drug and medical device advertising in China: an …

WebLayers of complexity. When it comes to commercializing and promoting pharmaceutical products and medical devices, China 1 has proven to be one of the most lucrative, but …

Category: Medical Go Health

Long-awaited Indonesian Health Law finally comes into force

WebLong-awaited Indonesian Health Law finally comes into force. A new Health Law came into force in Indonesia on 8 August 2023. The new law (Law No.17 of 2023 on …

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French administrative Supreme Court refuses to stop Microsoft …

WebOn October 14, 2020, the French Administrative Supreme Court (Conseil d’Etat) published its decision in a lawsuit requesting that the French health data platform (Health Data …

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