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The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more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Draft Guidance ,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
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
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
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