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Illinois Enacts Law Regulating AI with Sweeping Implications for Behavioral Health Delivery

Illinois enacted the Wellness and Oversight for Psychological Resources Act, establishing standards for the use of AI technology in the provision of therapy and psychotherapy services. The Act aims to protect consumers by...more

Privacy and Security Considerations of Mounting the “21st Century Healthcare Experience” Promised by the CMS HealthTech Ecosystem

At a recent “Make HealthTech Great Again” event, the White House and the Centers for Medicare and Medicaid Services (CMS) announced the launch of a digital health technology ecosystem in partnership with private sector...more

What Pro Sports Leagues and Teams Need to Know About Wearable Health Devices

Wearable health technology is rapidly transforming the landscape of professional sports. From heart rate monitors and GPS trackers to biometric gloves and brain health sensors, these devices are now commonplace in...more

Navigating Privacy Gaps and New Legal Requirements for Companies Processing Genetic Data

Interest in genetic data is on the rise, driven by the growth of direct-to-consumer (DTC) genetic testing and its value for AI in drug development and personalized medicine. Historically, gaps in privacy laws have sometimes...more

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

HealthTech Due Diligence: Key Privacy/Security Factors

Join Thora Johnson and Jeremy Sherer to learn about: Evaluating compliance through privacy notices Key questions to address, from leadership accountability to employee training...more

4 Healthcare Regulatory Fundraising Fundamentals

Jeremy Sherer and Thora Johnson share insight on: Key due diligence considerations for healthtech companies State and federal regulations aimed at virtual care delivery...more

What’s the U.S. Legal Landscape for Health Data?

Thora Johnson and Alexandra Wood discuss: Key federal regulation including HIPAA The patchwork at the state level, including a growing number of state consumer health privacy laws...more

From Federal to State: Building the New Life Sciences Capital Stack | Life Sciences Snapshot – Q3 2025

This year, U.S. VC funding into the life sciences sector has cooled: Q1 softness was followed by a decade low in VC transactions in Q2. Despite the moderation in dealmaking volume, investors continued to deploy sizable...more

A Framework for Growth: Privacy/Security by Design

Thora Johnson shares simple guidance on: Data management for privacy compliance Ensuring data security through storage and retention practices...more

What the Latest CCPA Settlement Means for Your Compliance Strategy

On July 1, 2025 the California Attorney General announced the largest CCPA settlement to date, totaling $1.55 million. The settlement, which is awaiting court approval, was the result of an investigation by the California...more

Montana Expands Health Care Privacy Law to Include Mental Health Digital Services

The Montana Legislature recently passed an update to the state’s Uniform Health Care Information Act (the Act), which creates standards for privacy and security of health care information maintained by Montana health care...more

How Shifting Trade Dynamics Are Reshaping U.S. Healthcare | Life Sciences Snapshot – Q2 2025

Q1 2025 marked another strong quarter for life sciences VC financing, but the industry faces unique headwinds amid ongoing shake-ups in regulatory leadership and US trade relationships. Key takeaways for Q1 2025 include: •...more

Virginia Enacts Amendment to Protect Reproductive and Sexual Health Privacy

Virginia recently enacted an amendment to its state Consumer Protection Act to regulate the processing of Virginia consumers’ reproductive and sexual health information. Specifically, SB 754 prohibits businesses from...more

Data Privacy in Sports: Key Takeaways

Sports teams, leagues, agents and venues collecting personal information from athletes, fans and sponsors must comply with evolving privacy regulations. Here are key takeaways from a conversation Orrick recently hosted with...more

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

On February 10, 2025, a Washington state resident filed a lawsuit on behalf of herself and similarly situated individuals against Amazon under the Washington My Health My Data Act (MHMD). This is the first lawsuit brought...more

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

Q4 2024 marked the conclusion of a turnaround year for life sciences venture investment. After two consecutive years of declining activity and macroeconomic uncertainty, the dust has settled, and investment is back on the...more

6 Things to Know About New York's Health Information Privacy Act

Earlier this year, the New York legislature passed the New York Health Information Privacy Act (New York HIPA), establishing strict requirements for handling health data. The legislation shares similarities with Washington’s...more

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

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” (for now, Cuba, Iran, North Korea, Russia, and Venezuela), as well as to...more

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

Recently, the Department of Health and Human Services’ Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to update the Health Insurance Portability and Accountability Act (HIPAA) Security Rule—the...more

US Data Localization Law Coming Soon: DOJ Issues Final Rule on Certain Data Transfers to “Countries of Concern”

The Department of Justice has finalized prohibitions and restrictions on cross-border transfers of certain data to China and other “Countries of Concern” (as defined below). It seeks to address what is, in the U.S....more

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

The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more

FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

Health Tech Regulatory Trends to Watch in 2025

Republished with Permission In this Law360 article, partners Thora Johnson, Georgia Ravitz and Amy Joseph explore the notable trends to watch in health tech regulation this coming year. The article observes that the...more

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

Since the previous quarter’s Life Sciences Snapshot, robust dealmaking activity in Q3 has launched YTD life sciences VC deal activity to near parity with 2023 figures, firmly positioning 2024 as the year to break the two-year...more

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