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
In one of the largest philanthropic initiatives ever dedicated to women’s health, the Gates Foundation announced a $2.5 billion commitment to close long-standing gaps in care, research, investments and data collection focused...more
8/11/2025
/ Bill Gates ,
Contraceptives ,
Funding Opportunities ,
Gender Equity ,
Innovation ,
Investment ,
Medical Research ,
Public Health ,
Reproductive Healthcare Issues ,
Research and Development ,
Research Funding
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
On June 18, 2025, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction in Purl v. HHS halting enforcement of the U.S. Department of Health and Human Services’ (HHS) April 2024...more
6/27/2025
/ Appeals ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Judicial Authority ,
Preliminary Injunctions ,
Privacy Laws ,
Reproductive Healthcare Issues ,
Substance Abuse
Last year saw growing investment in digital health startups addressing women+ health needs—but women still lag behind men when it comes to adopting these new technologies, according to a new report from Rock Health....more
The U.S. Drug Enforcement Administration (DEA) recently announced new rules that will impact telemedicine practices, especially concerning remote prescribing of controlled substances....more
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
On September 28, California Gov. Gavin Newsom signed Senate Bill 1120 Health Care Coverage: Utilization Review into law, amending § 1367.01 of the Health and Safety Code and § 10123.135 of the state’s Insurance Code....more
11/8/2024
/ Amended Legislation ,
Artificial Intelligence ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Duty of Oversight ,
Employer Group Health Plans ,
Governor Newsom ,
Health and Safety ,
Health Insurance ,
Insurance Code ,
Medicare Advantage Organizations (MAOs) ,
New Legislation ,
Penalties ,
Qualified Health Plans
Walking away from Digital Health Counsel 2024 AI Summit, the stunning impact that AI and data-powered innovation are making on healthcare is undeniable. Organized by Ogden Murphy Wallace and sponsored by Fenwick, the summit...more
On Saturday, September 28, California Gov. Gavin Newsom vetoed a controversial bill that would have restricted private equity and hedge fund healthcare transactions in the state....more
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 May 31, 2024, more than four months after the February 2024 Change Healthcare ransomware attack, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) updated its Change Healthcare FAQs. ...more
On Thursday, June 13, the Supreme Court maintained access to the abortion pill, mifepristone. This medication, in conjunction with misoprostol, was used in nearly two-thirds of all U.S. abortion and miscarriage treatments...more
6/17/2024
/ Abortion ,
Article III ,
Dobbs v. Jackson Women’s Health Organization ,
Food and Drug Administration (FDA) ,
Medical Necessity ,
Patient Access ,
Pregnancy ,
Prescription Drugs ,
Reproductive Healthcare Issues ,
Roe v Wade ,
SCOTUS ,
Standing
On April 26, 2024, the U.S. Department of Health and Human Services (HHS) implemented a Final Rule enhancing the HIPAA Privacy Rule to safeguard reproductive health care privacy. Given the recent Dobbs decision, HHS expressed...more
5/31/2024
/ Business Associates ,
Covered Entities ,
Dobbs v. Jackson Women’s Health Organization ,
Effective Date ,
Electronic Protected Health Information (ePHI) ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
PHI ,
Popular ,
Reproductive Healthcare Issues
Coming off the heels of the $100 million Sprint for Women’s Health, menopause care and treatment grabbed the spotlight on Capitol Hill on May 2, 2024. ...more
More than two months after the February 2024 Change Healthcare cyber-ransom attack, the healthcare industry continues to grapple with the fallout, creating significant challenges, disruptions, and outages to the healthcare...more
5/6/2024
/ American Hospital Association ,
Compliance ,
Cyber Attacks ,
Cybersecurity Information Sharing Act (CISA) ,
Data Breach ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Hospitals ,
NIST ,
Personal Information ,
PHI ,
Policies and Procedures ,
Popular ,
Risk Management ,
Security and Privacy Controls ,
Sensitive Personal Information ,
United Health Group
regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...more
What is the new Washington My Health My Data Act (MHMDA)?
MHMDA aims to provide stronger privacy protections for “consumer health data” by:
- Requiring additional disclosures for the collection, use, and sharing of...more
The first stage of First Lady Dr. Jill Biden’s White House Initiative on Women’s Health Research kicked off on March 6, 2024, when the Department of Health and Human Services ARPA-H Sprint for Women’s Health held a proposer...more
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
Women, non-binary people, and other marginalized groups comprise more than half the world’s population, but healthcare in the United States and many places across the globe is woefully inadequate at responding to their...more
It’s no secret that Democrats are traditionally trustbusters, but the Biden Administration is taking things to a whole new level, bringing novel—and arguably weak—cases that nonetheless slow or block tie-ups among healthcare...more
12/13/2023
/ Acquisitions ,
Antitrust Division ,
Biden Administration ,
Competition ,
Enforcement ,
Federal Trade Commission (FTC) ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform
The proliferation of health apps and connected devices that allow individuals to track their health conditions, treatment, medications, fitness, fertility, sleep, mental health, diet and other vital areas has led to increased...more
3/30/2023
/ Advertising ,
Breach Notification Rule ,
Civil Monetary Penalty ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Federal Trade Commission (FTC) ,
FTC Act ,
Health Technology ,
HIPAA Privacy Rule ,
Medical Devices ,
OCR ,
PHI ,
Popular