Candice Andalia

Creative counsel for health care regulatory and compliance

Candice Andalia counsels clients on health care regulatory and compliance matters with an emphasis on privacy and cybersecurity, artificial intelligence (AI) and other health care technologies. She leverages her past role as a government attorney at the U.S. Department of Health & Human Services to provide practical, industry-informed guidance.

Candice has extensive experience with creative problem solving and risk management, and provides authoritative and actionable advice for complex, high-stakes matters. Clients appreciate her ability to translate technical scientific and medical concepts into accessible language for varied audiences, including judges, juries, government counsel and legislators.

• Counsels clients on compliance with GDPR, CCPA, HIPAA, ITAR, FCPA, AKS and other legal obligations regulated by FDA, USDA and/or HHS.
• Advises businesses regarding legal and regulatory issues throughout the product development life cycle.
• Supports risk assessments and internal audits.

• Obtained a victory for a pharmaceutical manufacturer in nationwide class action asserting negligent manufacture.
• Successfully defended a biologics manufacturer in a class action alleging defective design.
• Represented pharmaceutical and medical device manufacturers during federal investigations.
• Settled a heavily contested breach of contract claims and counterclaims involving a milestone agreement for an investigational new drug.