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
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
2/24/2025
/ Biometric Information ,
Class Action ,
Consent ,
Consumer Privacy Rights ,
Consumer Protection Laws ,
Data Collection ,
Data Privacy ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Personal Data ,
Privacy Laws ,
State Privacy Laws
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
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
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
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
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
1/21/2025
/ Artificial Intelligence ,
China ,
Cuba ,
Data Privacy ,
Data Security ,
Department of Justice (DOJ) ,
International Data Transfers ,
International Emergency Economic Powers Act (IEEPA) ,
Iran ,
National Security ,
Personal Data ,
Russia
The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality.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
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.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
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
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
This report series examines quarterly trends in life sciences venture investment. Key findings for Q2 2024 include: • Life sciences VC deal value reached $10.6 billion in Q2 2024, up more than 30% from Q1, which brings the...more
The Texas Attorney General is once again signaling the office’s intent to enforce the state’s privacy and consumer protection laws. According to a June 2024 press release, Texas Attorney General Ken Paxton “launched a major...more
Generative AI is converging with every sector – and health care is no exception. With it, companies should keep up with the array of laws and regulations – existing and envisioned – that govern its use. Read on for highlights...more
The Federal Trade Commission (FTC) has updated its Health Breach Notification Rule that applies to non-HIPAA, consumer health data. Among the revisions, the FTC expanded or introduced key definitions and modified the...more
7/31/2024
/ Breach Notification Rule ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Security ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
PHI ,
Popular
U.S. antitrust enforcers launched a flurry of initiatives in the first half of 2024 to identify and prevent antitrust and other violations in life sciences and health care. Among these are two cross-agency Requests for...more
This report series examines quarterly trends in life sciences venture investment. Key findings for Q1 2024 include: • Life sciences VC deal value in Q1 totaled $7.8 billion, which represents a 22.1% increase in value from Q4...more
The Cybersecurity and Infrastructure Security Agency (CISA), a division of the Department of Homeland Security, has proposed a rule that would govern whether, when, and how companies in critical infrastructure sectors report...more
Legislators in Colorado have passed the first law in the United States meant to protect a consumer’s brainwaves. While advances in neurotechnology such as brain-computer interfaces that can translate a person’s thoughts into...more
The Department of Health and Human Services (HHS), through the Office for Civil Rights (OCR), has issued a final rule updating the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in an effort to...more
Two new privacy laws regulating consumer health data in Nevada and Washington take effect March 31. These novel laws take an expansive view of “consumer health data” and cover much more data than you may expect....more
This report series examines quarterly trends in life sciences venture investment. Key findings for Q4 2023 include: • Life sciences VC deal value in Q4 2023 totaled $6.6 billion, representing a 25.0% decrease from the prior...more
The U.S. Department of Health & Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights (OCR), has announced a final rule (the Rule) updating the...more
The average cost of a data breach has reached an all-time high of $4.45 million, according to IBM. Regulatory requirements, scrutiny, and enforcement have continued to expand. As we kick off 2024, here are the key action...more
The Department of Health and Human Services Office of Inspector General (HHS-OIG) has issued new general compliance program guidance, marking the first time the agency has released this type of “reference guide for the health...more