Our Services

Regulatory & Legal Compliance

• FDA Law and Regulatory Advising Consulting

We offer expert guidance on FDA regulations, ensuring compliance with federal requirements for healthcare products and services.

• Ethics and Privilege Counseling

  Our consulting services include ethics counseling to help healthcare organizations navigate complex legal and ethical considerations.

• Mandatory HIPAA/HITECH Manuals, Policies, Compliance Development and Creation

We develop and implement required HIPAA and HITECH compliance manuals, policies, and procedures to safeguard patient information.

• Mandatory Risk Assessment

Our team conducts thorough risk assessments to identify potential threats and implement strategies for risk mitigation.

• Data Breach Response Compliance

We assist healthcare organizations in responding to data breaches, ensuring compliance with federal and state regulations.

Operational Excellence & Compliance

• Healthcare Process, Workflow, and Efficiency Improvement

We analyze and optimize healthcare operations to streamline processes, reduce inefficiencies, and enhance patient care.

• Healthcare Program Planning, Integrity, Fidelity, and Evaluation/Modification

We assist healthcare organizations in the strategic planning, implementation, and refinement of healthcare programs to ensure effectiveness, integrity, and alignment with industry best practices. Our approach focuses on maintaining program fidelity while allowing for necessary modifications to enhance efficiency and patient outcomes.

Patient Safety & Risk Management

• Patient Safety Work Product (PSWP) Program Development (PSES) and Training

We assist in developing and implementing Patient Safety Evaluation Systems (PSES) to protect Patient Safety Work Product (PSWP), ensuring compliance with federal regulations.

• Patient Safety Organization (PSO) Creation/Development and Training

Our team provides comprehensive support in establishing and managing Patient Safety Organizations (PSOs), ensuring adherence to best practices and regulatory requirements.

Quality Improvement

• Quality Data Reporting and Reimbursement (MIPS/MACRA)

We guide healthcare providers through the complexities of the Merit-based Incentive Payment System (MIPS) and the Medicare Access and CHIP Reauthorization Act (MACRA) for optimized reporting and reimbursement.

Emergency Preparedness & Response

• Emergency Response Planning

We assist in developing emergency response plans to ensure organizations are prepared for a range of crises and disruptions.

• Disaster Recovery & Business Continuity

We create and implement business continuity strategies to help organizations recover quickly from emergencies and maintain operations.

Audit & Investigation Support

• Government Payor Investigation Response

We provide expert assistance in responding to government payor investigations, ensuring compliance and mitigating potential risks.

• Audit Response Education and Training

Our training programs prepare healthcare providers for audits by ensuring they understand regulatory requirements and response strategies.

• Compliance and Regulatory Training

  We provide required training on:

  • Fraud, Waste, and Abuse (F/W/A)

  • HIPAA compliance

  • Occupational Safety and Health Administration (OSHA) regulations

  • Federal Trade Commission (FTC) guidelines

  • Drug Enforcement Administration (DEA) compliance

  • Corporate Integrity Agreements (CIA) and Corrective Action Plans (CAP)

  • Ethics, Code of Conduct, and other mandatory compliance requirements

Why Work with Us?

Trusted Expertise & Proven Results

• Industry Expertise: Our team consists of seasoned professionals with extensive experience in healthcare compliance, patient safety, and regulatory advising.

• Customized Solutions: We tailor our services to meet the unique needs of your healthcare organization, ensuring effective and practical solutions.

• Regulatory Compliance Assurance: Stay ahead of evolving regulations with our expert guidance on HIPAA, HITECH, FDA, OSHA, and other compliance requirements.

• Proven Track Record: We have successfully helped numerous healthcare providers navigate complex challenges, improve operational efficiency, and enhance patient safety.

• Comprehensive Training Programs: Our training sessions ensure your team is well-prepared for audits, risk assessments, and compliance challenges.

• Strategic Guidance for Growth: Beyond compliance, we help healthcare organizations optimize workflows, improve patient outcomes, and achieve long-term success.