Remove topics department-of-health-and-human-services-hhs
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Executive Order for Advancing Biotechnology and Biomanufacturing Innovation Signed by President Biden

LexBlog IP

The objective of the Executive Order is to “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.” ” Data Initiative.

Privacy 52
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HHS Seeks to Strengthen Protections of Reproductive Health Information with Proposed Changes to HIPAA

LexBlog IP

Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. On April 12, 2023, the U.S.

Privacy 52
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HHS Finalizes Updates to “Part 2” Regulations to Align Disclosure Rules with HIPAA and Promote More Coordinated Substance Use Disorder Care 

LexBlog IP

This post was co-authored by Yelena Greenberg , a member Robinson+Cole’s Health Law Group. HHS is now proposing to scale back those rules slightly, in accordance with statutory changes to federal law governing the privacy of SUD records in the 2020 “CARES Act” legislation enacted in response to COVID-19.

Privacy 52
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HHS Proposes Rule to Align Part 2 Records and HIPAA

LexBlog IP

Key proposed changes align the use and disclosure of Part 2 treatment records with the HIPAA requirements, as follows: Disclosure: A single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations (TPO) of Part 2 records. Comments are being accepted for 60 days from publication.

Privacy 52
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Biosimilars 2021 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

Introduction. 2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also exhibited continued growth, with multiple biosimilar developers reporting strong sales of biosimilars through 2021.

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Sixth Circuit Dismisses Online Jawboning Case–Changizi v. DHHS

Technology & Marketing Law Blog

The Fifth Circuit ruled that some government agencies unconstitutionally coerced or encouraged social media services to remove constitutionally protected speech, and it enjoined those agencies from ongoing censorship. The opinion was a major and potentially troubling development in Internet Law, so I planned to blog it. (It’s