Life sciences companies racing to harness artificial intelligence often stumble into preventable traps that can derail innovation and create lasting legal exposure. ...more
8/14/2025
/ Artificial Intelligence ,
Biotechnology ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management ,
Strategic Planning
The Supreme Court's decision in McLaughlin Chiropractic Associates v. McKesson Corporation seismically shifts how courts will evaluate FCC interpretations of the TCPA, creating new compliance challenges for healthcare...more
7/16/2025
/ Consent ,
Enforcement ,
FCC ,
Health Care Providers ,
Healthcare ,
Loper Bright Enterprises v Raimondo ,
McLaughlin Chiropractic Associates Inc v McKesson Corporation ,
Regulatory Requirements ,
SCOTUS ,
TCPA ,
Telecommunications ,
Text Messages
The femtech sector's evolution presents opportunities for tech, healthcare, and life sciences companies that are both vast and largely untapped. What began as a narrow focus on period-tracking applications has blossomed into...more
Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more
6/27/2025
/ Artificial Intelligence ,
Clinical Trials ,
FDA Approval ,
Healthcare ,
Investment ,
Investment Opportunities ,
Medical Devices ,
Mobile Apps ,
Mobile Health Apps ,
Regulatory Requirements ,
Software Developers ,
Technology Sector ,
Venture Capital
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
1/15/2025
/ Artificial Intelligence ,
Comment Period ,
Compliance ,
Data Management ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management
California’s healthcare ecosystem may soon experience significant regulatory changes as Assembly Bill 3129 (AB 3129) heads to Gov. Gavin Newsom's desk for approval....more
9/24/2024
/ Acquisitions ,
Asset Transfer ,
Change in Control ,
Corporate Practice of Medicine ,
Governor Newsom ,
Hart-Scott-Rodino Act ,
Health Care Providers ,
Healthcare Facilities ,
Hedge Funds ,
Investors ,
Joint Venture ,
Mergers ,
Pending Legislation ,
Private Equity ,
Private Equity Firms ,
Regulatory Requirements ,
State Attorneys General ,
Threshold Requirements
On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more
2/7/2024
/ Artificial Intelligence ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Final Rules ,
Health Information Technologies ,
Healthcare ,
Information Sharing ,
Information Technology ,
ONC ,
Regulatory Requirements ,
Reporting Requirements ,
Transparency