Healthcare and Clinical Compliance

Healthcare and Clinical Compliance

Kendall PC understands the range of challenges facing healthcare and clinical practices in this era of growing scrutiny and enforcement from disputes over intellectual property (IP) adherence to constantly evolving government regulation and trade challenges. Kendall PC healthcare and clinical compliance lawyers help companies balance legal compliance with their business objectives and navigate through the current environment of U.S. Food and Drug Administration (FDA), U.S. Drug Enforcement Agency (DEA), U.S. Federal Trade Commission (FTC), U.S. Health and Human Services (HHS), Department of Justice (DOJ), and state laws and regulations. 

We offer comprehensive regulatory and compliance services to clients throughout the healthcare and clinical spaces, including:

  • Hospitals
  • Health systems
  • Healthcare providers
  • Academic medical centers
  • Contract research organizations (CROs) 
  • Specialty and retail pharmacies 
  • Research institutions
  • Life science companies

For more information about our healthcare and clinical compliance practice, contact Kendall PC online or at (484) 414-4093. Our healthcare and clinical compliance lawyers serve companies and organizations throughout the United States and across the globe.

Comprehensive Services for Healthcare and Clinical Compliance

The healthcare and clinical compliance team at Kendall PC understands the business and legal intricacies that healthcare, clinical, and life sciences companies face on a daily basis. Our experienced attorneys provide practical, business-centric guidance and work closely with clients to structure their transactions, relationships, contracts, business strategies, and compliance programs to comply with an ever-developing legal and regulatory framework involving the Federal Food, Drug and Cosmetic Act, Affordable Care Act, Physician Self-Referral (Stark) Law, Anti-Kickback Statute, False Claims Act, and Federal Corrupt Practices Act.

Kendall PC’s healthcare and clinical compliance service offerings are multifaceted and tailored to each client’s unique needs. Our healthcare and clinical compliance practice provides general corporate compliance development and management services, as well as clinical research compliance development and management services tailored to the unique legal, regulatory and policy risks specific to the healthcare and clinical sectors. In addition to overall corporate and clinical compliance support, we have extensive experience designing, implementing, and monitoring compliance programs designed to address the myriad of legal, regulatory, and policy intricacies that form the framework for healthcare and clinical entity compliance, including clinical research. 

Our team of dedicated healthcare and clinical compliance attorneys offers deep sector knowledge, legal expertise, and commercial and government insight on subject-matter-specific fraud and abuse compliance and clinical compliance matters.

Compliance Program Development and Management 

The healthcare and clinical compliance team of attorneys at Kendall PC advises on a wide range of compliance topics to guide our healthcare and clinical organizations through the evolving legal compliance requirements and governmental oversight employed by the U.S. Food and Drug Administration (FDA), U.S. Federal Trade Commission (FTC), U.S. Health and Human Services (HHS), and Department of Justice (DOJ). We work with our clients to implement effective and cost-efficient compliance strategies tailored to protect our clients’ interests, including: 

  • Designing, implementing, and monitoring compliance programs
  • Assessing and mitigating risk 
  • Detecting and investigating potential misconduct
  • Remediating compliance issues

Learn more about our corporate compliance practice

Fraud and Abuse Compliance 

Our healthcare and clinical compliance team has deep experience advising clients on a broad range of fraud and abuse compliance issues. As a result of our long and deep work in the area, Kendall PC attorneys have extensive knowledge of governing fraud and abuse laws and regulations, broad-based practical experience with their application, and an intimate understanding of government regulators and enforcement authorities. 

We regularly provide compliance guidance and counseling to clients on:

  • Federal Anti-Kickback Statute
  • State anti-kickback laws
  • The False Claims Act
  • Debarment and exclusion
  • Healthcare fraud and abuse-related regulatory issues. 

The seasoned healthcare and compliance attorneys at Kendall PC also have wide-ranging experience in:

  • Physician Self-Referral (Stark) Law
  • Fee-splitting
  • Corporate practice of medicine
  • Licensure
  • Confidentiality of information
  • Enrollment and reimbursement matters
  • Other healthcare compliance issues

Clinical Compliance 

Our healthcare and clinical compliance attorneys additionally counsel on complying with applicable regulatory requirements and industry best practices across the board, from clinical contracting and Good Clinical Practice (GCP) to HIPAA compliance, FDA field inspections for clinical and non-clinical research, and reimbursement advice. 

Contact Our Healthcare and Clinical Compliance Lawyers Today

For more information about our healthcare and clinical compliance practice, contact the healthcare and clinical compliance lawyers at Kendall PC now online or at (484) 414-4093. Our distinguished firm proudly serves small, midsized, and emerging businesses throughout the United States and across the globe.

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