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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, …

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URL: https://www.engage.hoganlovells.com/knowledgeservices/news/hhs-onc-proposes-new-ai-ml-requirements-for-certified-health-it/

AI Health Law Policy Summit 2024

WEBJoin Hogan Lovells on 1 - 2 May 2024 for our 3rd annual AI Health Law & Policy Summit. In this informative and interactive program, our thought leaders and …

Category: Health Go Health

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 …

Category: Health Go Health

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 …

Category: Health Go Health

Medical Device and Technology Regulatory

WEBHogan Lovells has you covered. We operate on a global scale, coordinating among lawyers in offices in all of the world’s major medical markets to sequence and …

Category: Medical Go Health

Cybil Roehrenbeck Washington, D.C. Hogan Lovells

WEBAs a partner in the Government Relations and Public Affairs group, Cybil Roehrenbeck leads the firm's health care lobbying practice. Cybil helps clients effectively present their …

Category: Health Go Health

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 …

Category: Health Go Health

The regulation of telemedicine in South Africa

WEBIt is widely expected that telemedicine services will gain more traction and prominence in the South African health care environment in the coming months and …

Category: Medicine Go Health

Hogan Lovells 2024 M&A Outlook

WEBWe begin 2024 with measured optimism for an increase in M&A transactions both by volume and value. Strategic investors, bolstered by surging C-suite confidence, …

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HHS finalizes Part 2 substance use disorder rules enhancing …

WEBThe U.S. Department of Health and Human Services (HHS) has finalized amendments to more closely align the Part 2 substance use disorder (SUD) regulations …

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Direct vs. Consequential Lost Profits

WEBAEP Power Mktg., 487 F.3d 89 (2d Cir. 2007). In Orester, plaintiff sought lost profits from a tire manufacturer who had breached the parties’ exclusive distribution agreement. As the …

Category: Health Go Health

New Medical Devices Regulation in Spain

WEBOn 23 March 2023 the new Spanish Medical Devices Regulation (Spanish MDR) came into force. After a lengthy wait, the medical devices industry (and any other …

Category: Medical 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 …

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浅谈美国保健品市场的法规要求及应对策略

WEBT 操 echnology ~ 32 食品安全导刊 2017年7月保健品在美国通常被称为膳食补充剂或饮食补充剂（dietary supplements）。膳食补充剂虽然不能像药品一样标明具体适应症，但可 …

Category: Supplements 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

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 …

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Reagan-Udall Foundation issues report with recommendations for

WEBBackground. FDA’s Human Foods Program (the Program) has been the subject of intense scrutiny throughout 2022. Criticism began in the wake of a large-scale …

Category: Food Go Health

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

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

Italian Sunshine Act and transparency in the health sector

WEBIntroduction to the Italian Sunshine Act. On June 26 th, 2022, following a three-year-long legislative process, Law no. 62/2022 (“Italian Sunshine Act”) entered …

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CMS Issues Final Guidance on the Inflation Reduction Act (IRA) …

WEBThe Centers for Medicare & Medicaid Services (CMS) issued its final guidance on the Drug Price Negotiation Program established by the IRA. Online here we analyze …

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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