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Virtual and Digital Health Digest Publications and Presentations

WEBFurther, AI continues to be the number one funding priority in the digital health world, with 40% of first quarter total funding in digital health for 2024 going to AI …

Actived: 9 days ago

URL: https://www.arnoldporter.com/en/perspectives/publications/2024/04/virtual-and-digital-health-digest

HHS Modifies the HIPAA Privacy Rule To Protect Reproductive …

WEBOn April 26, 2024, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a final rule to provide new protections for the …

Category: Health Go Health

Virtual and Digital Health Digest Publications and Presentations

WEBDr. Beatriz San Martin. Emma Elliston, Ph.D. Ana González-Lamuño. Rachel Mower. Alison H. Peters. Katie Brown. Mickayla A. Stogsdill. Shama Aktar. This digest …

Category: Health Go Health

Virtual and Digital Health Digest

WEBWelcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This edition primarily covers February 2023 highlights across the virtual …

Category: Health Go Health

FDA Releases Significantly Revised Final Clinical Decision Support

WEBOn September 28, 2022, the US Food and Drug Administration (FDA or Agency) released a string of long-awaited revised and finalized guidance documents …

Category: Food Go Health

Healthcare Capabilities Arnold & Porter

WEBArnold & Porter is a healthcare powerhouse with more than 200 attorneys with extensive and deep capabilities built on over 50 years of prominence in the field. We provide …

Category: Health Go Health

ONC Final Rule on Health Data, Technology, and Interoperability …

WEBOn January 9, 2024, the Office of the National Coordinator for Health Information Technology (ONC), part of the Department of Health and Human Services (HHS), …

Category: Health Go Health

Virtual and Digital Health Digest Publications and Presentations

WEBThis push-pull dynamic between digital health innovation and government regulation is key to evaluating regulatory risks in today’s shifting legal landscape. This …

Category: Health Go Health

Virtual and Digital Health Digest

WEBEmma Elliston, Ph.D. Alison H. Peters. Welcome to the first installment of Arnold & Porter’s Virtual and Digital Health Digest. This inaugural edition covers …

Category: Health Go Health

Update: Use of Real-World Evidence in FDA Approvals and …

WEBReal-world evidence (RWE)—clinical evidence on the use and benefits or risks of a medical product derived from real-world data (RWD)—has become an …

Category: Medical Go Health

In Case You Missed It: Regulatory and Enforcement Trends in …

WEBConsumer demand for health and wellness products has seen vast growth in recent years. The COVID-19 pandemic and its aftermath has also resulted in broader …

Category: Health Go Health

HHS Takes an Important Step to Form a Biopharmaceutical …

WEBThe Biomedical Advanced Research and Development Authority (BARDA), an office the Department of Health and Human Services (HHS), recently announced 1 …

Category: Medical Go Health

Relaxed Regulations Leads to a Surge in Telehealth Use . . . and a

WEBA recent study by US Department of Health and Human Services’ Office of Health Policy, however, shows that telehealth has exploded in recent years, with the …

Category: Health Go Health

FDA Intends To Regulate Many Clinical Labs as Medical Device

WEBOn May 6, 2024, the U.S. Food and Drug Administration (FDA or the Agency) published its highly anticipated final rule, which was formally published in the Federal …

Category: Food Go Health

HHS Proposes Rules Prohibiting Discriminatory Health Care …

WEBOn August 3, 2022, President Biden signed an Executive Order directing the Secretary of the US Department of Health and Human Services (HHS) to “consider all appropriate …

Category: Health Go Health

Addressing CBRN Threats and Promoting Responsible AI in …

WEBEnsure Quality of AI Technologies in the Health Sector: The EO directs the HHS Secretary, in consultation with relevant agencies, to determine whether AI-enabled …

Category: Health Go Health

New Rule Specifies Medicare Secondary Payer Penalties for Failure …

WEBOn October 10, the Centers for Medicare & Medicaid Services (CMS) issued a final rule, “Medicare Secondary Payer and Certain Civil Money Penalties” (Final Rule), …

Category: Health Go Health

FDA Announces Draft Guidance to Continue Implementing …

WEBThe draft RIE Guidance replaces the similar COVID-19-pandemic-related guidance issued in April 2021, titled, “Remote Interactive Evaluations of Drug …

Category: Health Go Health

Safe Harbors to the Anti-Kickback Statute

WEBOn November 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule, "Revisions to Safe Harbors under the Anti …

Category: Health Go Health

Life Sciences & Healthcare Regulatory

WEBDecades of Experience: Our global team has handled the most challenging life sciences and healthcare regulatory matters, from high-profile global regulatory investigations to …

Category: Health Go Health

OIG Publishes General Compliance Program Guidance for the …

WEBOn November 6, the Department of Health and Human Services Office of Inspector General (OIG) released a “General Compliance Program Guidance” (GCPG). …

Category: Health Go Health

Personal Health Information Privacy and COVID-19: HIPAA and …

WEBfor public health purposes to public health authorities (e.g., to the CDC and state health agencies, as well as their employees, contractors, or other persons or …

Category: Health Go Health

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