Earlier this month, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), released a new Frequently Asked Question (FAQ) related to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, which establishes national standards to safeguard “protected health information” or “PHI.”
https://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.png00Elizabeth Hardcastlehttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngElizabeth Hardcastle2025-08-29 12:18:232025-08-29 12:18:23New Digital Health Ecosystem and HIPAA Flexibilities Facilitate Sharing of Patient Health Information
Sidley lawyers David Lashway, John Woods, Jennifer Seale, and Francesca Blythe have authored the chapter “Complying with regulatory requirements and SEC guidance” within The Guide to Cyber and Data Privacy Investigations – Fourth Edition. (more…)
https://datamatters.sidley.com/wp-content/uploads/sites/2/2025/05/MN-24013-Data-Matters-Blog-Imagery-Refresh_A_16.jpg606833David Lashwayhttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngDavid Lashway2025-08-21 09:00:452025-08-20 16:38:46The Guide to Cyber and Data Privacy Investigations – Fourth Edition
The new UK Data (Use and Access) Act 2025 came into force on June 19. Applying in phases through June 2026, the Act will reform, in part, how the UK regulates personal and non-personal data.
https://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.png00Francesca Blythehttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngFrancesca Blythe2025-08-05 15:26:352025-08-05 16:00:25The UK Data (Use and Access) Act 2025: Implications For Financial Services
The European Commission (Commission) has launched a public consultation on a proposed new law — the Digital Fairness Act (DFA) — aimed at strengthening consumer protection in digital markets. The goal is to fill perceived regulatory “gaps” left by recent EU digital regulations, including the Digital Services Act (DSA) and Digital Markets Act (DMA).
https://datamatters.sidley.com/wp-content/uploads/sites/2/2025/05/MN-24013-Data-Matters-Blog-Imagery-Refresh_B_12.jpg606833Ken Dalyhttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngKen Daly2025-08-01 12:05:132025-08-01 12:06:54EU Consults on Digital Fairness Act: Big Changes Ahead for Consumer-Facing Platforms
During the first half of 2025, state legislators and regulators have been working overtime to enact new data privacy laws and expand existing laws, all of which are likely to have an impact on businesses in the remainder of the year and into 2026. These efforts reflect key themes such as increased regulation of teen data and social media platforms, enhanced restrictions on the collection and sale of geolocation and biometric data, simplified opt-out mechanisms for tracking technologies, and broader obligations concerning consumer health data and data minimization. In parallel, significant regulatory activity surrounding AI has emerged, including a new federal AI Action Plan and proposed amendments to the CCPA addressing automated decision-making technologies, alongside a wave of new state AI laws.
https://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.png00Colleen Theresa Brownhttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngColleen Theresa Brown2025-07-31 16:45:042026-01-23 12:11:43A Mid-Year Privacy Check-In – Important Developments and New Compliance Obligations for Privacy Laws
On July 23, 2025, the Trump administration released its much-anticipated AI Action Plan, outlining 90 federal policy positions across three key pillars: Accelerating Innovation, Building American AI Infrastructure, and Leading in International Diplomacy and Security. These pillars are designed to guide near-term action and are underpinned by three cross-cutting priorities: protecting and promoting American workers, ensuring that artificial intelligence (AI) systems are trustworthy and free from ideological bias, and safeguarding AI from misuse, theft, or other risks posed by malicious actors. The scope of the AI Action Plan demonstrates the far-reaching impact of AI, with policy positions affecting not only technology but also trade, national security, cybersecurity, energy, labor, education, environmental regulation, antitrust, science, and financial markets.
https://datamatters.sidley.com/wp-content/uploads/sites/2/2025/05/MN-24013-Data-Matters-Blog-Imagery-Refresh_A-21.jpg606833Colleen Theresa Brownhttps://datamatters.sidley.com/wp-content/uploads/sites/2/2022/09/sidleyLogo-e1643922598198.pngColleen Theresa Brown2025-07-30 16:54:462026-01-23 12:12:25The Trump Administration’s 2025 AI Action Plan – Winning the Race: America’s AI Action Plan – and Related Executive Orders
The California Privacy Protection Agency (Agency) on Thursday, July 24, 2025, approved a comprehensive set of new California Consumer Privacy Act (CCPA) regulations that the Agency has been developing for over four years. Before taking effect, the proposed regulations must still be approved by California’s Office of Administrative Law (OAL). It is possible some of these provisions may change with the OAL’s review, which must be completed within 30 business days after the Agency submits to the OAL its final rulemaking package. However, many expect that most of the proposed regulations will pass OAL review. If approved, several of the proposed regulations would be effective as of January 1, 2026. (more…)
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
New Digital Health Ecosystem and HIPAA Flexibilities Facilitate Sharing of Patient Health Information
Earlier this month, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), released a new Frequently Asked Question (FAQ) related to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, which establishes national standards to safeguard “protected health information” or “PHI.”
(more…)
Elizabeth Hardcastle
Washington, D.C.
ehardcastle@sidley.com
Rina Mady
Chicago
rmady@sidley.com
Meenakshi Datta
Chicago
mdatta@sidley.com
Ellie L. DeGarmo
Washington, D.C.
ellie.degarmo@sidley.com
The Guide to Cyber and Data Privacy Investigations – Fourth Edition
Sidley lawyers David Lashway, John Woods, Jennifer Seale, and Francesca Blythe have authored the chapter “Complying with regulatory requirements and SEC guidance” within The Guide to Cyber and Data Privacy Investigations – Fourth Edition. (more…)
David Lashway
Washington D.C.
dlashway@sidley.com
John Woods
Washington, D.C.
jwoods@sidley.com
Jennifer B. Seale
Washington, D.C.
jseale@sidley.com
Francesca Blythe
London
fblythe@sidley.com
The UK Data (Use and Access) Act 2025: Implications For Financial Services
The new UK Data (Use and Access) Act 2025 came into force on June 19. Applying in phases through June 2026, the Act will reform, in part, how the UK regulates personal and non-personal data.
(more…)
Francesca Blythe
London
fblythe@sidley.com
Eleanor Dodding
London
edodding@sidley.com
Paida Manhambara
London
pmanhambara@sidley.com
EU Consults on Digital Fairness Act: Big Changes Ahead for Consumer-Facing Platforms
The European Commission (Commission) has launched a public consultation on a proposed new law — the Digital Fairness Act (DFA) — aimed at strengthening consumer protection in digital markets. The goal is to fill perceived regulatory “gaps” left by recent EU digital regulations, including the Digital Services Act (DSA) and Digital Markets Act (DMA).
(more…)
Ken Daly
Brussels
kdaly@sidley.com
Elisabetta Righini
Brussels
erighini@sidley.com
Monika Zdzieborska
London
mzdzieborska@sidley.com
Bethany Wise
A Mid-Year Privacy Check-In – Important Developments and New Compliance Obligations for Privacy Laws
During the first half of 2025, state legislators and regulators have been working overtime to enact new data privacy laws and expand existing laws, all of which are likely to have an impact on businesses in the remainder of the year and into 2026. These efforts reflect key themes such as increased regulation of teen data and social media platforms, enhanced restrictions on the collection and sale of geolocation and biometric data, simplified opt-out mechanisms for tracking technologies, and broader obligations concerning consumer health data and data minimization. In parallel, significant regulatory activity surrounding AI has emerged, including a new federal AI Action Plan and proposed amendments to the CCPA addressing automated decision-making technologies, alongside a wave of new state AI laws.
(more…)
Colleen Theresa Brown
Washington, D.C.
ctbrown@sidley.com
Sheri Porath Rockwell
Century City
sheri.rockwell@sidley.com
Sasha Hondagneu-Messner
New York
shondagneumessner@sidley.com
The Trump Administration’s 2025 AI Action Plan – Winning the Race: America’s AI Action Plan – and Related Executive Orders
On July 23, 2025, the Trump administration released its much-anticipated AI Action Plan, outlining 90 federal policy positions across three key pillars: Accelerating Innovation, Building American AI Infrastructure, and Leading in International Diplomacy and Security. These pillars are designed to guide near-term action and are underpinned by three cross-cutting priorities: protecting and promoting American workers, ensuring that artificial intelligence (AI) systems are trustworthy and free from ideological bias, and safeguarding AI from misuse, theft, or other risks posed by malicious actors. The scope of the AI Action Plan demonstrates the far-reaching impact of AI, with policy positions affecting not only technology but also trade, national security, cybersecurity, energy, labor, education, environmental regulation, antitrust, science, and financial markets.
(more…)
Colleen Theresa Brown
Washington, D.C.
ctbrown@sidley.com
Michael E. Borden
Washington, D.C.
mborden@sidley.com
Jen Fernandez
Washington, D.C.
jen.fernandez@sidley.com
Sharon Flanagan
San Francisco, Palo Alto
sflanagan@sidley.com
Michael C. Hochman
Washington, D.C.
michael.hochman@sidley.com
David Lashway
Washington D.C.
dlashway@sidley.com
California Privacy Protection Agency Advances Substantial Rulemaking – Cyber Audits, Risk Assessments, New Automated Decisionmaking Technologies Rights, and More
The California Privacy Protection Agency (Agency) on Thursday, July 24, 2025, approved a comprehensive set of new California Consumer Privacy Act (CCPA) regulations that the Agency has been developing for over four years. Before taking effect, the proposed regulations must still be approved by California’s Office of Administrative Law (OAL). It is possible some of these provisions may change with the OAL’s review, which must be completed within 30 business days after the Agency submits to the OAL its final rulemaking package. However, many expect that most of the proposed regulations will pass OAL review. If approved, several of the proposed regulations would be effective as of January 1, 2026. (more…)
Sheri Porath Rockwell
Century City
sheri.rockwell@sidley.com
Colleen Theresa Brown
Washington, D.C.
ctbrown@sidley.com
Thomas D. Cunningham
Chicago
tcunningham@sidley.com
Sasha Hondagneu-Messner
New York
shondagneumessner@sidley.com
Stephanie Y. Lim
New York
stephanie.lim@sidley.com
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
Upcoming Events
AI and Patent Law: Navigating a Changing Landscape
Resources