On July 10, 2025 — in a move it characterized as “radical transparency” — the U.S. Food and Drug Administration (FDA or Agency) published over 200 Complete Response Letters (CRLs), which are issued when the Agency determines that it will not approve a New Drug Application (NDA) or Biologics License Application (BLA). We analyze the implications of this development for life sciences companies and their investors.
https://datamatters.sidley.com/wp-content/uploads/sites/2/2025/05/MN-24013-Data-Matters-Blog-Imagery-Refresh_B_4.jpg606833Rebecca K. Woodhttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngRebecca K. Wood2025-07-14 10:04:272025-07-14 10:04:27FDA Release of Complete Response Letters Raises Confidentiality, Disclosure Questions But Offers Insights for Development
On June 27, 2025, the U.S. Supreme Court issued its opinion in Free Speech Coalition, Inc. v. Paxton, a groundbreaking decision with significant implications for online content regulation. The Court upheld a Texas statute — House Bill 1181 (HB 1181) — requiring commercial websites that host a substantial amount of sexually explicit material to verify users’ ages before granting access. In doing so, the Court applied intermediate scrutiny and upheld the statute as a constitutionally permissible measure to protect minors from harmful content.
https://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.png00Lauren M. De Lillyhttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngLauren M. De Lilly2025-07-08 10:15:552025-07-08 10:15:55Texas Age Verification Law Upheld: U.S. Supreme Court Balances Free Speech and Child Protection in the Digital Age
The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) Draft Report offers comprehensive principles and best practices, translating global artificial intelligence (AI) requirements — such as those in the EU Artificial Intelligence Act (EU AI Act) — into practical guidance for pharmacovigilance (PV). In the U.S., where no overarching AI legislation exists, the report can guide lawmakers, regulators, and other stakeholders as they develop approaches to using AI in PV. The consultation period for the draft report is currently open, and interested parties are encouraged to take advantage of this opportunity by providing comments on the draft report by June 6, 2025.
https://datamatters.sidley.com/wp-content/uploads/sites/2/2025/02/MN-24013-Data-Matters-Blog-Imagery-Refresh_B_7.jpg606833Torrey Copehttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngTorrey Cope2025-06-02 15:46:542025-06-02 15:48:51Artificial Intelligence in Pharmacovigilance: Eight Action Items for Life Sciences Companies
On May 9, 2025, the U.S. Copyright Office released a “pre-publication” version of Part III of its highly anticipated Report on Copyright and Artificial Intelligence (AI) (Report). The Report provides a technical overview of how generative AI models are developed, trained, and deployed and how U.S. copyright law, particularly the fair use doctrine, should apply in the context of training generative AI models. The prepublication report states that it was released “in response to congressional inquiries and expressions of interest from stakeholders” and that “[a] final version will be published in the near future, without any substantive changes expected in the analysis or conclusions.”
https://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.png00Lauren M. De Lillyhttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngLauren M. De Lilly2025-05-28 13:20:202025-05-28 13:20:20Generative AI Meets Copyright Scrutiny: Highlights from the Copyright Office’s Part III Report
On April 9, 2025, U.S. Sens. Mike Rounds, Republican of South Dakota, and Martin Heinrich, Democrat of New Mexico, introduced a bill titled the Health Tech Investment Act (S 1399). The proposed bill would amend Title XVIII of the Social Security Act to create a Medicare payment system for algorithm-based healthcare services (AHBS), defined in the proposed legislation as services delivered through FDA-cleared or -approved devices that use artificial intelligence (AI), machine learning, or similar software to yield clinical outcomes for use by healthcare professionals to diagnose and treat diseases.
https://datamatters.sidley.com/wp-content/uploads/sites/2/2025/01/MN-24013-Data-Matters-Blog-Imagery-Refresh_B_10.jpg606833Elizabeth Hardcastlehttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngElizabeth Hardcastle2025-05-14 09:05:492025-05-13 16:01:27Medicare Reimbursement Pathway for AI-Enabled Medical Devices Considered in Senate’s Health Tech Investment Act
The National Association of Insurance Commissioners (NAIC) held its Spring 2025 National Meeting (Spring Meeting) March 23–26, 2026. This Sidley Update summarizes the highlights from this meeting in addition to interim meetings held in lieu of taking place during the Spring Meeting. Highlights include continued development of guidance on asset adequacy testing for reinsurance transactions, efforts to develop revisions to the Long-Term Care Insurance Multistate Rate Review Framework, and consideration of amendments to the NAIC’s Purposes and Procedures Manual regarding private letter rating rationale reports.
https://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.png00Sara N. Africanohttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngSara N. Africano2025-05-08 10:25:452025-05-08 10:25:45Regulatory Update: National Association of Insurance Commissioners Spring 2025 National Meeting
The European Union’s (“EU”) Digital Operational Resilience Act (“DORA”) became effective on 17 January 2025. Since then, financial entities (such as banks, insurance companies and investment firms) and their ICT third-party service providers operating in the EU have been – directly or indirectly – subject to the new regime. One of the first key DORA compliance deadlines, for financial entities to register their ICT service providers with competent EU Member State authorities, is coming into effect across most of the member states this month.
https://datamatters.sidley.com/wp-content/uploads/sites/2/2024/11/MN-24013-Data-Matters-Blog-Imagery-Refresh_A_12.jpg606833Anila Rayanihttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngAnila Rayani2025-04-15 09:46:142025-04-15 09:46:14Financial Entities in the EU: Time to Register Your ICT Third-Party Service Providers under DORA
On April 9, 2025 the European Commission adopted a communication on the so-called AI Continent Action Plan – its strategy to shape the next phase of AI development in Europe, with consultation to follow. The Commission’s declared objective is to transform the EU into a global leader in AI by fostering innovation, ensuring trustworthy AI, and enhancing competitiveness while safeguarding democratic values and cultural diversity. Keep monitoring Data Matters for more on the Commission’s consultation, when available. (more…)
https://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.png00Elisabetta Righinihttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngElisabetta Righini2025-04-11 11:32:332025-04-11 11:38:35EU Commission Publishes AI Continent Action Plan and Seeks Input
FDA Release of Complete Response Letters Raises Confidentiality, Disclosure Questions But Offers Insights for Development
On July 10, 2025 — in a move it characterized as “radical transparency” — the U.S. Food and Drug Administration (FDA or Agency) published over 200 Complete Response Letters (CRLs), which are issued when the Agency determines that it will not approve a New Drug Application (NDA) or Biologics License Application (BLA). We analyze the implications of this development for life sciences companies and their investors.
(more…)
Rebecca K. Wood
Washington, D.C.
rwood@sidley.com
Raj D. Pai
Washington, D.C.
rpai@sidley.com
Torrey Cope
Washington, D.C.
tcope@sidley.com
Christopher A. Fanelli
Washington, D.C.
cfanelli@sidley.com
Sara B. Brody
San Francisco, Palo Alto
sbrody@sidley.com
Carlton Fleming
San Francisco, Palo Alto
cfleming@sidley.com
Francesca E. Brody
New York
fbrody@sidley.com
Jaclyn G. Fonteyne
Washington, D.C.
jaclyn.fonteyne@sidley.com
Kevin A. Sforza
Washington, D.C.
ksforza@sidley.com
Texas Age Verification Law Upheld: U.S. Supreme Court Balances Free Speech and Child Protection in the Digital Age
On June 27, 2025, the U.S. Supreme Court issued its opinion in Free Speech Coalition, Inc. v. Paxton, a groundbreaking decision with significant implications for online content regulation. The Court upheld a Texas statute — House Bill 1181 (HB 1181) — requiring commercial websites that host a substantial amount of sexually explicit material to verify users’ ages before granting access. In doing so, the Court applied intermediate scrutiny and upheld the statute as a constitutionally permissible measure to protect minors from harmful content.
(more…)
Lauren M. De Lilly
Los Angeles
ldelilly@sidley.com
Nima H. Mohebbi
Century City
nima.mohebbi@sidley.com
Rollin A. Ransom
Los Angeles
rransom@sidley.com
Randi Singer
New York, Palo Alto
randi.singer@sidley.com
Kristina Martinez
Los Angeles
kmartinez@sidley.com
Artificial Intelligence in Pharmacovigilance: Eight Action Items for Life Sciences Companies
The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) Draft Report offers comprehensive principles and best practices, translating global artificial intelligence (AI) requirements — such as those in the EU Artificial Intelligence Act (EU AI Act) — into practical guidance for pharmacovigilance (PV). In the U.S., where no overarching AI legislation exists, the report can guide lawmakers, regulators, and other stakeholders as they develop approaches to using AI in PV. The consultation period for the draft report is currently open, and interested parties are encouraged to take advantage of this opportunity by providing comments on the draft report by June 6, 2025.
(more…)
Torrey Cope
Washington, D.C.
tcope@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Eva von Mühlenen
Geneva
emuhlenen@sidley.com
Andrew James
Washington, D.C.
ajames@sidley.com
Generative AI Meets Copyright Scrutiny: Highlights from the Copyright Office’s Part III Report
On May 9, 2025, the U.S. Copyright Office released a “pre-publication” version of Part III of its highly anticipated Report on Copyright and Artificial Intelligence (AI) (Report). The Report provides a technical overview of how generative AI models are developed, trained, and deployed and how U.S. copyright law, particularly the fair use doctrine, should apply in the context of training generative AI models. The prepublication report states that it was released “in response to congressional inquiries and expressions of interest from stakeholders” and that “[a] final version will be published in the near future, without any substantive changes expected in the analysis or conclusions.”
(more…)
Lauren M. De Lilly
Los Angeles
ldelilly@sidley.com
Nima H. Mohebbi
Century City
nima.mohebbi@sidley.com
Rollin A. Ransom
Los Angeles
rransom@sidley.com
Randi Singer
New York, Palo Alto
randi.singer@sidley.com
Kristina Martinez
Los Angeles
kmartinez@sidley.com
Christina H. Strohmann
Los Angeles
cstrohmann@sidley.com
Medicare Reimbursement Pathway for AI-Enabled Medical Devices Considered in Senate’s Health Tech Investment Act
On April 9, 2025, U.S. Sens. Mike Rounds, Republican of South Dakota, and Martin Heinrich, Democrat of New Mexico, introduced a bill titled the Health Tech Investment Act (S 1399). The proposed bill would amend Title XVIII of the Social Security Act to create a Medicare payment system for algorithm-based healthcare services (AHBS), defined in the proposed legislation as services delivered through FDA-cleared or -approved devices that use artificial intelligence (AI), machine learning, or similar software to yield clinical outcomes for use by healthcare professionals to diagnose and treat diseases.
(more…)
Elizabeth Hardcastle
Washington, D.C.
ehardcastle@sidley.com
Meenakshi Datta
Chicago
mdatta@sidley.com
Ellie L. DeGarmo
Washington, D.C.
ellie.degarmo@sidley.com
Regulatory Update: National Association of Insurance Commissioners Spring 2025 National Meeting
The National Association of Insurance Commissioners (NAIC) held its Spring 2025 National Meeting (Spring Meeting) March 23–26, 2026. This Sidley Update summarizes the highlights from this meeting in addition to interim meetings held in lieu of taking place during the Spring Meeting. Highlights include continued development of guidance on asset adequacy testing for reinsurance transactions, efforts to develop revisions to the Long-Term Care Insurance Multistate Rate Review Framework, and consideration of amendments to the NAIC’s Purposes and Procedures Manual regarding private letter rating rationale reports.
(more…)
Sara N. Africano
Chicago
safricano@sidley.com
Stephanie H. Dobecki
Chicago
sdobecki@sidley.com
Ellen M. Dunn
New York
edunn@sidley.com
Andrew R. Holland
New York
aholland@sidley.com
Michael L. Rosenfield
Los Angeles
mrosenfield@sidley.com
Chris H. Burusco
Los Angeles
cburusco@sidley.com
Jacob A. Grossman
Chicago
jgrossman@sidley.com
Financial Entities in the EU: Time to Register Your ICT Third-Party Service Providers under DORA
The European Union’s (“EU”) Digital Operational Resilience Act (“DORA”) became effective on 17 January 2025. Since then, financial entities (such as banks, insurance companies and investment firms) and their ICT third-party service providers operating in the EU have been – directly or indirectly – subject to the new regime. One of the first key DORA compliance deadlines, for financial entities to register their ICT service providers with competent EU Member State authorities, is coming into effect across most of the member states this month.
(more…)
Anila Rayani
Lauren Cuyvers
Brussels
lcuyvers@sidley.com
William RM Long
London
wlong@sidley.com
EU Commission Publishes AI Continent Action Plan and Seeks Input
On April 9, 2025 the European Commission adopted a communication on the so-called AI Continent Action Plan – its strategy to shape the next phase of AI development in Europe, with consultation to follow. The Commission’s declared objective is to transform the EU into a global leader in AI by fostering innovation, ensuring trustworthy AI, and enhancing competitiveness while safeguarding democratic values and cultural diversity. Keep monitoring Data Matters for more on the Commission’s consultation, when available. (more…)
Elisabetta Righini
Brussels
erighini@sidley.com
Francesca Blythe
London
fblythe@sidley.com
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