Biomedical Industry GuidanceBiometric Information CounselingCCPA GuidelinesCertificate of Need (CON) GuidanceChange of Ownership (CHOW) TransactionsCommercialization of Drugs, Devices and Biologics Corporate Practice of Medicine GuidelinesCybersecurity Policies & ProceduresData Privacy & SecurityDeceptive or Unfair Trade Practice Allegations DefenseDrafting Physician/Hospital Employment & Independent Contractor AgreementsDrafting Professional Services & Management AgreementsFDA, FDCA Enforcement Actions & InvestigationsFTC Investigations & RegulationsGDPR ComplianceHospital & Health System Acquisition Transactions (FQHCs and RHCs Requirements)Incident Management & LitigationIntellectual Property Licensing (Copyrights, Trademarks, Trade Secrets)Medical Device Industry GuidanceMedicare/Medicaid - Fraud, Waste & Abuse: Audits/CounselingPharmaceutical Industry GuidancePhysical & Electronic Security Risk AssessmentPrivacy & Security Training Product Launch GuidanceProducts Liability LitigationRegulatory Matters & Government InvestigationsSaaS, SaMD AgreementsStark & Anti-Kickback Regulatory GuidelinesSupply Chain Management Contracting/PBMsTransactions in Life SciencesQui Tam Whistleblower & False Claims Act Counseling & LitigationLifes 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.
Listed skills include Fraud, Healthcare Compliance, Hipaa, Medical Malpractice, and 21 others.