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EU DORA: What SMBs and Software Vendors Need to Know
- May 15, 2026
- Posted by: rob
- Category: Data Privacy & Cybersecurity
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CNIL Recommendations on Applying the GDPR to AI System Development
- April 26, 2026
- Posted by: rob
- Categories: AI & Technology Law, Data Privacy & Cybersecurity
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EDPB Opinion 28/2024: How GDPR Applies to AI Model Training
- April 20, 2026
- Posted by: rob
- Categories: AI & Technology Law, Data Privacy & Cybersecurity
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What do US Businesses that Deploy Third-Party Generative AI need to know about the EU AI Act?
- March 25, 2026
- Posted by: rob
- Category: AI & Technology Law
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SEC Recordkeeping Rules and AI-Generated Content: What Financial Firms Must Retain
The SEC’s recordkeeping enforcement campaign cost financial institutions over $600 million in penalties — and AI-generated content faces the same analytical framework. This post explains what broker-dealers and investment advisers must retain under Rules 17a-4 and 204-2, and what a compliance audit should cover in 2026.
September 26, 2026 Read more -
AI in Drug Discovery: IP, Regulatory Validation, and Licensing Considerations
AI is transforming drug discovery, but it raises complex legal questions around patent inventorship, FDA regulatory validation, and licensing agreement structure. This post works through all three systematically for biotech companies, pharma licensors, and their counsel.
September 25, 2026 Read more -
AI and Biobank Consent: Why Historical Consent Forms Don’t Cover AI Training
Biobanks hold millions of samples collected under consent forms that predate AI — but pharmaceutical companies need that data for AI drug discovery training. This post examines the Common Rule and HIPAA consent gaps, the IP risks they create, and the remediation strategies institutions must deploy now.
September 24, 2026 Read more -
Algorithmic Bias in Clinical Trial Patient Recruitment: FDA Diversity Guidance and AI Tools
AI patient recruitment tools trained on historically non-diverse datasets can systematically exclude underrepresented populations — directly undermining FDA’s FDORA diversity action plan requirements. This post examines the algorithmic bias risks, the regulatory exposure, and what sponsors must do to stay compliant.
September 23, 2026 Read more
