Your Questions, Answered

At KAP Healthcare Law, we know navigating legal complexities can raise many questions. Our FAQ page is designed to provide clear, concise answers to the most common inquiries about healthcare and FDA law. Whether you’re looking for guidance or clarity, we’re here to help.
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Why do I need a healthcare or FDA attorney?

Healthcare is the most regulated industry in America, second only to companies overseen by the FDA. This includes how businesses need to be set up, what can and cannot be contained in agreements, compliant marketing and billing, and many other issues. Anyone but a healthcare or FDA attorney will be untrained and unable to properly represent healthcare clients. Even well-intentioned lawyers with years of contract and business experience can put healthcare clients in serious legal jeopardy without knowing it. Always get a healthcare attorney if you are a healthcare business.

KAP is a cut above other lawyers and law firms. 

Broad Expertise. Most healthcare or FDA attorneys specialize in one type of provider or topic in healthcare – hospitals, pharmaceuticals, hospice, HIPAA, supplements, etc. At KAP, we have a broad range of experience representing nearly every type of provider in the industry as well as expertise in most of the laws and regulations affecting healthcare businesses. 

Responsiveness. Far too many people have the same complaint about lawyers: that they are unresponsive and late on deliverables. We at KAP are responsive to our clients through customized service, timely communication, and timely delivery of projects and documents. 

National Presence. We are a national healthcare firm, so we are able to represent clients no matter their location or needs. 

Reasonable Billing. We are unique in that we offer the expertise of a large Washington, D.C. law firm but at a reasonable price that all healthcare businesses can afford – from startups to a large multimillion-dollar enterprises.

Healthcare and FDA. The fields of healthcare and FDA law are very closely related and often overlap. For example, pharmaceuticals and medical devices touch healthcare and are governed by the FDA. We have expertise in both areas to provide our clients with a full range of assistance.

While we have a very broad range of expertise, we do specialize in some specific areas of healthcare and FDA law. Fraud and Abuse, Compliance, MSOs, and Med Spas are four of the specialties we focus on. However, we still have deep experience with all types of healthcare and FDA law.

It depends on the client’s needs. Some clients only need a review of existing documents, others need a complete company set up with all the documents and a compliance program to boot. We will only give you the services you need and ask for. You can get a better idea of cost after a free consultation with a client support specialist. 

GENERAL QUESTIONS

Navigating legal challenges in healthcare and FDA compliance can be complex. Whether you are a startup seeking guidance on regulatory approval or an established business needing legal support, our firm is here to help. Below are answers to some of the most common legal questions businesses face when dealing with healthcare regulations, FDA approval, and compliance matters.
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HEALTHCARE QUESTIONS

Healthcare law can be intricate, with evolving regulations and industry standards. In this section, we address frequently asked questions to help you better understand key legal issues, from compliance requirements to operational challenges.
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What is the Anti-Kickback Statute, and why is it important?
The Anti-Kickback Statute is a federal law designed to prevent fraud and abuse in healthcare. It prohibits offering, paying, soliciting, or receiving anything of value to induce or reward referrals for services covered by federal healthcare programs. Violating this law can lead to severe penalties, including fines and criminal charges.
HIPAA compliance involves safeguarding patient information, implementing proper data security measures, and maintaining privacy policies. Regular staff training, risk assessments, and secure systems for handling medical records are essential to avoid violations.
Stark Laws prohibit physicians from referring patients to entities with which they or their family members have a financial relationship, unless an exception applies. These laws aim to prevent conflicts of interest and ensure ethical practices in healthcare.
Mergers and acquisitions require careful legal planning, including due diligence, regulatory compliance, and contract negotiations. Consulting with a healthcare attorney ensures the process is smooth, compliant, and aligned with your business goals.
Employment agreements should address key areas such as compensation, benefits, restrictive covenants, termination clauses, and compliance with healthcare laws. Tailoring these agreements protects both the practice and the employee.
Marketing in healthcare is regulated to ensure accuracy and prevent misleading claims. All materials should comply with FDA and FTC guidelines and avoid unsubstantiated claims about treatments or services.
What types of products require FDA approval?
Products such as drugs, medical devices, biologics, food additives, and certain cosmetics may require FDA approval. We can help you navigate the approval process specific to your product.
During an inspection, it’s crucial to provide accurate information and maintain proper documentation. Our team can help you prepare for inspections and respond to any findings.
A 510(k) is a premarket submission to demonstrate that a medical device is safe and effective and substantially equivalent to a legally marketed device. We assist with preparing and submitting 510(k) applications.
Labels must include accurate, non-misleading information and comply with FDA regulations. We help ensure your product labels meet all requirements.
Responding promptly and comprehensively is essential. We can help craft a response, address issues, and implement corrective actions to avoid further enforcement.
GMP refers to FDA regulations ensuring products are consistently manufactured and controlled according to quality standards. Compliance is critical to avoid recalls or enforcement actions, and we can guide you in implementing GMP.

FDA LAW QUESTIONS

Navigating FDA regulations requires specialized knowledge and careful attention to detail. Here, we provide answers to common questions about FDA compliance, product approvals, labeling, inspections, and more, so you can stay informed and confident.
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