Ricky C. Benjamin

Background

About Ricky C. Benjamin

Biomedical Industry Guidance Biometric Information Counseling CCPA Guidelines Certificate of Need (CON) Guidance Change of Ownership (CHOW) Transactions Commercialization of Drugs, Devices and Biologics Corporate Practice of Medicine Guidelines Cybersecurity Policies & Procedures Data Privacy & Security Deceptive or Unfair Trade Practice Allegations Defense Drafting Physician/Hospital Employment & Independent Contractor Agreements Drafting Professional Services & Management Agreements FDA, FDCA Enforcement Actions & Investigations FTC Investigations & Regulations GDPR Compliance Hospital & Health System Acquisition Transactions (FQHCs and RHCs Requirements) Incident Management & Litigation Intellectual Property Licensing (Copyrights, Trademarks, Trade Secrets) Medical Device Industry Guidance Medicare/Medicaid - Fraud, Waste & Abuse: Audits/Counseling Pharmaceutical Industry Guidance Physical & Electronic Security Risk Assessment Privacy & Security Training Product Launch Guidance Products Liability Litigation Regulatory Matters & Government Investigations SaaS, SaMD Agreements Stark & Anti-Kickback Regulatory Guidelines Supply Chain Management Contracting/PBMs Transactions in Life Sciences Qui Tam Whistleblower & False Claims Act Counseling & Litigation Lifes Sciences & Healthcare counseling representing Pharmaceutical, Biotechnology, Medical Device companies, Health Systems, Hospitals & Physicians. Practice focus on advising pharmaceutical, biotechnology, medical device and diagnostic companies on regulatory, compliance, transactional and litigation matters involving FDA, FDCA, FTC, DOJ, OIG, CMS, HIPAA and the FCPA. Advises clients on the regulation of medical device software (including the FDA's regulation of AI/ML), software as a service (SaaS), premarket approval and clearance strategies, regulatory exclusivity strategies, advertising and promotional review matters, sales and marketing guidelines, supply chain requirements, and cGMP compliance. Assists clients with responding to FDA and Department of Justice investigations and enforcement actions, including Stark and Anti-kickback laws (state and federal), Corporate Practice of Medicine guidelines, Merger & Acquisition deal structure, due diligence and representations & warranties advice. Draft Compliance Plans, implement Compliance Programs, defend investigations by CMS, FDA, FTC, DOJ, & OIG in Qui Tam actions involving Fraud & Abuse, Unfair Trade Practices, and inadequate data security protocols. Responsible for compliance program policies, procedures, training, auditing and monitoring.