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Insight

First Lawsuit Filed Under Washington’s My Health My Data Act

by Thora Johnson, Sundeep Kapur, Emily S. Tabatabai, Aravind Swaminathan and Peter Graham
4 minute read | February.24.2025

On February 10, 2025, a Washington state resident filed a lawsuit against Amazon under the Washington My Health My Data Act.

Insight

Telehealth Transformation: Innovating Mental Health Care
Life Sciences Snapshot – Q1 2025

11 minute read | February.19.2025

Life Sciences Snapshot – Q1 2025 – A Quarterly Report on Financing Trends

U.S. life sciences VC rebounded in 2024 with rising deal and exit value. Orrick’s Life Sciences Snapshot breaks down the key trends.

Insight

State Attorneys General on Applying Existing State Laws to AI

by Andrew Cook
17 minute read | February.18.2025

State AGs have broad enforcement authority under existing consumer protection and UDAAP laws to regulate potential consumer harm caused by AI.

Insight

Proposed HIPAA Security Rule Update: What It Means for Cybersecurity in Health Care

by Thora Johnson, Alyssa Wolfington and Michaela Frai
6 minute read | January.27.2025

The Department of Health and Human Services’ OCR issued a notice of proposed rulemaking (NPRM) to update the HIPAA Security Rule.

Insight

U.S. Data Localization Law Coming Soon: What Life Science Companies Need to Know

by Thora Johnson, Georgia C. Ravitz and Cosmas Robless
2 minute read | January.24.2025

The DOJ has finalized a set of prohibitions and restrictions on cross-border transfers of certain U.S. data to China and other “Countries of Concern” ...

Insight

The Download: A Private Sector Model for Responsible AI in Healthcare & Why Value-Based Care Is Good Business

4 minute read | January.23.2025

In this Life Sciences & Healthtech edition of The Download, we take on key trends with the Coalition for Health AI, Aledade and BofA Securities.

Insight

FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions

by Georgia C. Ravitz, Shari Esfahani, Stephen Thau, Thora Johnson, Jeremy D. Sherer and Amy M. Joseph
2 minute read | January.13.2025

The FDA issued draft guidance on assessing AI model credibility for drug safety, effectiveness, and quality in regulatory decisions.

Insight

FDA Issues Draft Guidance on AI-Enabled Medical Devices

by Georgia C. Ravitz, Shari Esfahani, Stephen Thau, Thora Johnson, Jeremy D. Sherer and Amy M. Joseph
3 minute read | January.07.2025

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.

Insight

Health Tech Regulatory Trends to Watch in 2025

by Thora Johnson, Georgia C. Ravitz and Amy M. Joseph
7 minute read | January.03.2025

ai and healthcare - healthtech - digital life sciences icons

Orrick's Life Sciences team explores how the healthcare industry is bracing for significant developments in regulation and litigation in a recent ...

Insight

DEA Issues Third Extension of Telemedicine Prescribing Flexibilities

by Amy M. Joseph, Jeremy D. Sherer, Melania Jankowski and Anna Booth
2 minute read | January.02.2025

The Third Extension allows providers to continue prescribing controlled substances without a prior in-person examination through December 31, 2025.

Insight

Life Sciences Snapshot – Q4 2024 – A Quarterly Report on Financing Trends

14 minute read | December.20.2024

Healthtech Horizons: Navigating Regulation, Investment, and Strategy in a Transforming Market

Insight

The Sunshine Act: 10 Things to Know

by Amy M. Joseph and Emily Brodkin
5 minute read | December.11.2024

For some medical device companies and GPOs, reporting financial info to the U.S. government is now a routine part of business.