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Jan 7, 2025 | 
mondaq.com | Dianne J. Bourque |Pat G. Ouellette
Last fall at the Safeguarding Health Information: BuildingAssurance Through HIPAA Security 2024 conference, U.S. Departmentof Health & Human Services Office for Civil Rights (OCR)promised that before year's end, it would publish amendments tothe Health Insurance Portability and Accountability Act of 1996(HIPAA) Security Rule. On December 27, 2024, OCR made good on thatpromise and released an unpublished version of the SecurityRule amendments proposal.
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Dec 31, 2024 | 
jdsupra.com | Pat G. Ouellette
Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would publish amendments to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. On December 27, 2024, OCR made good on that promise and released an unpublished version of the Security Rule amendments proposal.
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Oct 11, 2024 | 
mondaq.com | Benjamin M. Zegarelli |Pat G. Ouellette
The Department of Health and Human Services (HHS) Office for
Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled "The Evolving
Landscape of Human Research with AI – Putting Ethics to
Practice" (the Workshop). The Workshop broadly covered current
uses of artificial intelligence (AI) across human subject research
as well as the various legal and ethical considerations for these
uses.
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Oct 10, 2024 | 
jdsupra.com | Pat G. Ouellette |Benjamin M. Zegarelli
The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice” (the Workshop). The Workshop broadly covered current uses of artificial intelligence (AI) across human subject research as well as the various legal and ethical considerations for these uses.
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Oct 9, 2024 | 
lexology.com | Benjamin M. Zegarelli |Pat G. Ouellette
The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice” (the Workshop). The Workshop broadly covered current uses of artificial intelligence (AI) across human subject research as well as the various legal and ethical considerations for these uses.
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Sep 18, 2024 | 
mondaq.com | Pat G. Ouellette |Abdie Santiago
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Mintz is a general practice, full-service Am Law 100 law firm with more than 600 attorneys. We are headquartered in Boston and have additional US offices in Los Angeles, Miami, New York City, San Diego, San Francisco, and Washington, DC, as well as an office in Toronto, Canada.
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way.
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Sep 17, 2024 | 
natlawreview.com | Abdie Santiago |Pat G. Ouellette |James G. Gatto |A.J. Dhaliwal
Skip to main content September 17, 2024 Volume XIV, Number 261 Legal Analysis. Expertly Written. Quickly Found.
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Sep 17, 2024 | 
lexology.com | Abdie Santiago |Pat G. Ouellette
As we enter into the final months of 2024, new developments in the administration of the 340B Drug Pricing Program signal that additional reform may be on the way. Although recent revisions to the 340B program’s administrative dispute resolution (ADR) process represented a positive development in program reform, many questions remain as to how the Health Resources and Services Administration (HRSA) along with Congress may resolve stakeholder concerns with the drug pricing program’s future.
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Jul 31, 2024 | 
lexology.com | Theresa C. Carnegie |Rachel Alexander |Madison Castle |Xavier G. Hardy |Stephnie A. John |Alison Peters | +8 more
The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively monitors these developments to provide you with this PBM Policy and Legislative Update. This update builds on prior issues and highlights federal and state activity from January 2024 through June 2024.
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Jul 31, 2024 | lexology.com | Theresa C. Carnegie |Rachel Alexander |Madison Castle |Xavier G. Hardy |Stephnie A. John |Alison Peters | +8 more
The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team actively monitors these developments to provide you with this PBM Policy and Legislative Update. This update builds on prior issues and highlights federal and state activity from January 2024 through June 2024.
