Law Offices of

Joshua Ari Van De Riet, JD, LLM, CHC, RAC

FDA Regulatory, Healthcare Compliance, Market Access and Reimbursement, Privacy

Law Offices of

Joshua Ari Van De Riet, JD, LLM, CHC, RAC

Healthcare regulatory law

Protecting innovation and ensuring regulatory compliance across the healthcare sector.
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FDA Regulatory
Market Access
Healthcare Compliance
Reimbursement
Privacy
Transactional
FDA Regulatory
Market Access
Healthcare Compliance
Reimbursement
Privacy
Transactional

FDA Regulatory

Van De Riet Law provides strategic legal and regulatory counsel to companies operating in highly regulated industries, including pharmaceuticals, biotechnology, medical devices, diagnostics, dietary supplements, digital health, and other FDA-regulated sectors. The firm advises clients throughout the product lifecycle, from early-stage development and regulatory strategy through commercialization, post-market compliance, and enforcement matters.

Services include regulatory pathway assessments, FDA classification and market entry strategies, legislative and regulatory analysis, labeling and promotional review, quality system compliance, clinical and research-related regulatory support, and representation in matters involving FDA, U.S. Customs and Border Protection, and other regulatory authorities. By combining regulatory insight with practical business experience, the firm helps clients navigate legal and compliance challenges, manage risk, and bring innovative products to market efficiently and successfully.

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Healthcare Compliance

Van De Riet Law provides comprehensive healthcare and life sciences compliance support focused on helping companies design, implement, and maintain effective internal governance frameworks — including tailored Standard Operating Procedures (SOPs), compliance manuals, and corporate policies aligned with applicable FDA requirements, healthcare fraud and abuse laws, and industry best practices. The firm also participates in Medical, Legal, and Regulatory (MLR) review processes to support compliant review of promotional, scientific, and educational materials in accordance with FDA, FTC, and industry standards, and advises on day-to-day and strategic compliance matters across commercial and medical functions — including state and federal transparency reporting obligations under the Sunshine Act, Anti-Kickback Statute and False Claims Act risk mitigation, and broader fraud and abuse counseling.
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Market Access

Van De Riet Law advises pharmaceutical and life sciences companies on pharmaceutical pricing transparency and reporting obligations at both the state and federal levels — including the preparation and submission of Wholesale Acquisition Cost (WAC) reports and compliance with evolving state drug price increase reporting laws across multiple jurisdictions.

This includes helping organizations interpret complex and varying disclosure requirements, establish internal processes for data collection and validation, and meet recurring reporting deadlines in a consistent and defensible manner. The firm also provides counsel on federal transparency obligations under the Open Payments program, including the identification and classification of reportable transfers of value to physicians, teaching hospitals, and other covered recipients.

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Reimbursement

Van De Riet Law advises life sciences and healthcare companies on public and private reimbursement considerations impacting commercialization, coverage, and patient access. The firm provides strategic guidance relating to Medicare, Medicaid, commercial payer dynamics, coding, coverage positioning, and reimbursement-related compliance risks to support successful market adoption and sustainable product access.
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Privacy

Van De Riet Law advises healthcare providers, life sciences companies, and digital health organizations on privacy, data protection, and healthcare information governance. The firm provides guidance on compliance with HIPAA requirements, including privacy, security, and breach notification obligations, as well as counseling on the rapidly evolving landscape of state privacy laws governing consumer health data, biometric information, and other sensitive personal data.

The firm also supports clients in structuring and operationalizing compliant data-sharing relationships through the drafting and negotiation of Business Associate Agreements (BAAs), and conducts privacy audits and risk assessments to identify compliance gaps and strengthen internal controls.

In addition, Van De Riet Law advises on healthcare data governance frameworks and provides strategic counsel to digital health and technology companies on the compliant development and deployment of innovative health data-driven products and services.

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Transactional

Van De Riet Law provides practical business counsel in support of research collaborations, clinical trials, technology development, and commercial operations — including the negotiation and drafting of confidentiality agreements, clinical trial agreements, material transfer agreements, and other strategic commercial arrangements. The firm works closely with clients to develop legally sound and operationally practical solutions that promote innovation, manage regulatory exposure, protect proprietary assets, and facilitate strategic partnerships in highly regulated healthcare and life sciences environments.
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