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Regulatory compliance impacts any business, but it affects healthcare companies and providers to a unique degree. A healthcare business has to follow regulations for employment, healthcare, business, controlled substances, taxes, and more. Noncompliance can cause issues for your patients, employees, reputation, and your company’s future. The most effective way to avoid noncompliance is establishing a plan with a New York healthcare regulatory compliance lawyer.
A preemptive compliance plan assesses your company and all the regulations it must meet. It helps minimize the risk of noncompliance by making a plan for compliance at each level of your business. At Weiss Zarett Brofman Sonnenklar & Levy, P.C., we help you create a plan that considers the unique industry and location regulatory needs of your company. Whether you are beginning a company or have one established, our firm can help.
The seasoned attorneys at our firm work directly with you and never pass your case on to less experienced employees. We know how important your license, reputation, and business are in your life, and we protect it fiercely. We offer you comprehensive legal care from dedicated professionals.
Our firm is on top of any changes made to healthcare regulation so that we can help you adapt your compliance plan. We aim to mitigate the risk of noncompliance. If noncompliance issues do occur, we can represent you in court. We have experience with local courts like the 10th Judicial District Courts serving Long Island and other JDCs throughout the state.
Some of the federal laws that are essential for healthcare regulatory compliance include:
State laws and local laws can also affect healthcare providers and businesses. A healthcare business has to consider all these regulations and their changing landscape. At Weiss Zarett Brofman Sonnenklar & Levy, P.C., we have a deep understanding of these requirements in New York and how they affect businesses like yours. When you hire a healthcare regulatory compliance lawyer, you help protect your future.
Our firm can help with many different areas of compliance for healthcare providers and facilities, including:
From 2020 to 2025, the state of New York issued 7,079 physician licenses. Healthcare businesses and the medical professionals they employ must remain on top of licensure and certification to continue to practice. It’s important for businesses to ensure renewal and ensure that practitioners in the business also comply with licensure and certification requirements.
There were 805 adverse actions in New York related to licensure or certification in 2025. Two hundred seventy-five of those adverse actions were against physician licenses, 155 were against therapist and counselor licenses, and 88 were against practical nurse licenses.
The FDA, the Drug Enforcement Administration, and the Environmental Protection Agency all have regulations that impact controlled substances, including their use, storage, and disposal. Failing to meet the requirements put in place by these agencies and any state-level agencies can lead to administrative, civil, or even criminal consequences.
These laws exist to prevent fraud and abuse in the healthcare system.
The Stark Law, or the physician self-referral law, exists to prevent providers from referring patients to services that are paid by governmental healthcare programs and that the provider or a family member gets a financial benefit from. The AKS prohibits providers from receiving any form of financial or personal benefit for referring patients to a service covered by a governmental healthcare program.
HIPAA and HITECH laws exist to protect patient data security. Regulations outline how medical records are stored and transferred, how data breaches are reported, the creation of high-security programs, and how electronic payments must be handled.
Five regulations that impact healthcare practices include 1) the FCA that prohibits false claims to the government, 2) the Stark Law, or self-referral law, that prevents providers from referring patients to services the provider gets financial benefits from, 3) the AKS, which prohibits providers from providing rewards for certain referrals, 4) FDA medication and product regulations, and 5) HIPAA regulations meant to protect patient privacy.
There are many other regulations that affect healthcare practices.
Healthcare regulatory compliance is the process that healthcare providers, businesses, and entities must follow to ensure they meet all state, local, and federal laws for their industry. This includes regulations for business law, healthcare law, employment law, and more.
Effective regulatory compliance creates a plan that maintains compliance from the ground up to avoid future issues with regulatory bodies. Following regulations is crucial to avoid civil or criminal issues with your business.
Three main aspects of healthcare compliance include patient safety, service billing, and patient privacy.
Patient safety is protected by proper licensure and certification, clean environment requirements, and reporting poor healthcare. Service billing regulation ensures that coding and billing are followed properly to avoid fraud. Patient privacy is protected by ensuring information is stored and managed securely. There are many other aspects of healthcare compliance, but these areas cover a majority of regulation.
Some of the most common compliance issues in healthcare are issues with licensure, even minor issues likely failing to renew on time, and issues involving billing and coding unbundling services or upcoding. Other compliance issues are in employment law, like wage and hour requirements. Data privacy and violations of HIPAA and HITECH are also a common area of noncompliance.
At Weiss Zarett Brofman Sonnenklar & Levy, P.C., our attorneys understand the complexities and interaction between healthcare, business, and other regulatory laws. We can help you navigate your healthcare regulatory compliance case. Get in touch with our firm today and protect your healthcare company.
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