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New FDA electronic records guidance prioritizes Digital …

WEBOn March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, …

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URL: https://www.engage.hoganlovells.com/knowledgeservices/news/new-fda-electronic-records-guidance-prioritizes-digital-health-technology-oversight/

After the Public Health Emergency: Implications for …

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

Category: Health Go Health

HHS ONC proposes new AI / ML requirements for …

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

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2024 outlook: Advancing AI innovations in patient care

WEB12 April 2024. Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of …

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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 …

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The Genesis case: The beginning of the end of HRSA’s …

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 …

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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 …

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US Senator report urges congressional action to …

WEBIn September, Senator Cassidy issued a request to help identify solutions to modernize HIPAA and ensure all U.S. health data is properly safeguarded. On February …

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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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OIG’s first-ever General Compliance Program Guidance …

WEBHHS OIG released its first ever General Compliance Program Guidance (GCPG): a comprehensive document that applies to all individuals and entities involved …

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New Washington consumer health privacy policy …

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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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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Advertising and communication on medical devices: …

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 …

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Hogan Lovells Engage Health Law

WEBThis website is operated by Hogan Lovells International LLP, whose registered office is at Atlantic House, Holborn Viaduct, London, EC1A 2FG. For further details of Hogan Lovells International LLP and the international legal practice that comprises Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses ("Hogan

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Private equity In health care: In the antitrust crosshairs

WEBTransactions and other investments in the health care industry by private equity firms are a hot enforcement topic at both the U.S. Federal Trade Commission …

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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 regulation that addresses when acrylamide in cooked or heat processed foods creates an exposure requiring a warning under Prop 65. The new regulation takes effect April 1, 2023. …

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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 regarding children’s online health and safety. The questions address: (1) the nature of health, safety, and privacy harms to minors arising from online platform use; (2) industry …

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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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JPM2023 will be an event like no other. How can you make the …

WEBThe annual J.P. Morgan Healthcare Conference (JPM), Biotech Showcase, and ancillary meetings are back, live and in-person, in January 2023, providing a unique …

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