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FDA Publishes Digital Health Technology Framework

WebOn Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies …

Actived: 6 days ago

URL: https://lifesciences.mofo.com/topics/fda-publishes-digital-health-technology-framework

Skinny Labels Back in Focus after HHS Report on Addressing Drug …

WebSkinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated …

Category: Health Go Health

FDA on Use of AI/ML in Drug Development: Five Key Takeaways

WebHere are five key takeaways: 1. FDA Acknowledges that AI/ML Applications Exist for Each Stage of Drug Development. AI/ML may have applications for use in all …

Category: Health Go Health

States Extend Scope of Regulatory Oversight of Health Care Entities

WebThe proliferation of private investor-backed management of health care practices continues to draw scrutiny from regulators into the impact on patient care, …

Category: Health Go Health

EUAs and the FDA’s Fight Against COVID-19: An Evolving Landscape

WebChristine Lentz, a Morrison & Foerster summer associate in our San Diego office, contributed to the writing of this article.. The outbreak of the COVID-19 pandemic …

Category: Health Go Health

U.S. Government Launches Billion-Dollar Biomedical Agency

WebU.S. Government Launches Billion-Dollar Biomedical Agency. As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has …

Category: Medical Go Health

Software as a Medical Device in Europe

WebThe COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological …

Category: Health Go Health

Software as a Medical Device in Europe

WebMedical purpose. Non-medical purpose. Prevention or diagnosis of disease or injury. Patient medical education (e.g., giving general health tips)Treatment or …

Category: Medical Go Health

European Commission Q&A on the interplay between the Clinical …

WebIn response to the opinion of European Data Protection Board (EDPB) (see our alert), the European Commission has issued its Question and Answers on the …

Category: Health Go Health

FDORA Passage Brings Significant Changes to FDA’s Drug, Device, …

WebThe Consolidated Appropriations Act for 2023 was signed into law on December 29, 2022 and includes the Food and Drug Omnibus Reform Act (FDORA). …

Category: Food Go Health

The Diagnostics Dilemma: Securing and Protecting Diagnostic …

WebWhile many life sciences companies are built on platforms involving the development of diagnostic products and methods that underlie personalized medicine …

Category: Medicine Go Health

Digitalization of German Healthcare System to Receive Legislative …

WebDigitalization of German Healthcare System to Receive Legislative Boost in 2024. By: Robert Grohmann and Philip Radlanski. It is no secret that the healthcare …

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FDA Uses EUAs Broadly In The Fight Against Covid-19

WebOn February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic …

Category: Food Go Health

New York Enacts Material Healthcare Transactions Notice …

WebOn May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the …

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EHR Vendor Settles Kickback Allegations to the Tune of $18.25 …

WebOn January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena …

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China’s new administrative regulations on human genetic …

WebThe Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, went into …

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FDA Clinical Decision Support Software vs. EU’s Medical Device

WebIn follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of …

Category: Medical Go Health

FTC Issues Updated Health Products Claims Guidance

WebOn December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first …

Category: Health Go Health