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Dec 18, 2024 | 
jdsupra.com | Benjamin M. Zegarelli
Every year, Mintz provides analysis of the regulatory developments that impact public companies as they prepare for their fiscal year-end filings with the Securities and Exchange Commission and their annual shareholder meetings. This memorandum discusses key considerations to keep in mind as you embark upon the year-end reporting process in 2025.
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Oct 30, 2024 | 
natlawreview.com | Benjamin M. Zegarelli
Skip to main content October 30, 2024 Volume XIV, Number 304 Legal Analysis. Expertly Written. Quickly Found.
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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 | 
natlawreview.com | David Ettinger |Jenny Li |Benjamin M. Zegarelli
On October 3, 2024, the U.S. Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) announced a monetary penalty of $240,000 against Providence Medical Institute (“Providence”) stemming from violations of the Health Insurance Portability and Accountability Act (“HIPAA”) Security Rule in relation to a series of ransomware attacks against a California orthopedics practice acquired by Providence in 2016.
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Oct 9, 2024 | 
natlawreview.com | David Ettinger |Jenny Li |Benjamin M. Zegarelli
Claudia Sheinbaum made history last week as Mexico’s first female president and laid out her vision to promote clean energy and increase investment in the infrastructure sector. In contrast to the previous administration, during her inauguration speech, Sheinbaum committed to consume fewer fossil fuels and promote electromobility.
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Oct 9, 2024 | 
natlawreview.com | 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 4, 2024 | 
lexology.com | Joanne S. Hawana |Benjamin M. Zegarelli
Agencies across the federal government continue to grapple with how to respond to the directives in President Biden’s October 2023 executive order on artificial intelligence, including the Food and Drug Administration (FDA) and its parent agency the Department of Health and Human Services (DHHS).
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Aug 12, 2024 | 
mondaq.com | Benjamin M. Zegarelli |Joanne S. Hawana |Matthew Tikhonovsky
On August 6, the Food and Drug Administration (FDA) and
Clinical Trials Transformation Initiative (CTTI) held a joint
workshop to explore "Artificial Intelligence in Drug &
Biological Product Development."
The workshop featured speakers and panelists from the FDA,
academia, the industry, and public interest groups, who nearly all
agreed that greater regulatory clarity is needed around AI in drug
development, as well as greater public awareness of and trust in
AI.
