Regulatory Compliance
Guidance & Analysis
Everything our clients want to do is regulated by State and Federal laws. We make sure our clients know what the regulatory compliance obstacles are and how to succeed as a healthcare business in this landscape.
The Florida Healthcare Law Firm regularly counsels clients on regulatory compliance with Federal and State Anti-Kickback statutes (Patient Brokering Act) and provides in-depth guidance and analysis to healthcare providers on issues arising out of federal self-referral laws. Whether you require a brief explanation or a full-blown analysis and legal opinion, we will assist you in determining the most appropriate and effective manner in which to proceed.
- Marketing Arrangements
- Medical Directorships
- Leases between Providers
- Corporate Structure
- Purchase & Sale Transactions
- Compensation Arrangements
The Florida Healthcare Law Firm is a reliable resource to help you navigate increasingly complex and ever-changing fraud and abuse laws.
- Complex Business Arrangement Structure
- Transaction or Venture Unwind
- Due Diligence Reviews
- Compensation Arrangements of any kind
- Internal Investigations & Self Disclosures
- Group Purchasing Safe Harbors
- Financial Relationships with Physicians
Fee splitting is a common issue faced by providers in compensation situations, particularly in the presence of percentage-based fee arrangements. Violations of fee splitting statutes can create serious issues for all parties involved. The Florida Healthcare Law Firm can help to prevent you from becoming a victim.
The Florida Healthcare Law Firm regularly counsels clients on regulatory compliance with Federal and State “anti-dumping” regulations.
- Providers who receive a subpoena or notice that they are subject to an EMTALA investigation
- Hospitals & Medical Staffs that are developing EMTALA policies
- Hospitals investigating possible compliance errors
- OIG & AHCA Investigations/Prosecutions
We assist clients with issues related to complex patient information privacy regulations and technical aspects related to the Health Insurance Portability and Accountability Act (HIPAA) and Florida’s Information Protection Act (FIPA). Protecting patient data is critical component to regulatory compliance. Our team can provide you with what you need to maintain compliance with these intricate and demanding burdens.
- HIPAA Privacy Policies and Procedures
- HIPAA Security Policies and Procedures
- OIG Corporate Integrity Agreements
- Business Associate Agreements
- HIPAA Training & Education
- Breach Reporting
The Florida Healthcare Law Firm regularly counsels clients on the Federal Stark Law, including provision of in-depth guidance to help healthcare providers understand their obligations under federal self-referral laws.
- Marketing Arrangements
- Medical Directorships
- Leases between Providers
- Corporate Structure
- Purchase & Sale Transactions
- Compensation Arrangements
Emerging Industry
Peptide Industry
The peptide industry continues to evolve under increasing scrutiny from federal and state regulators. Whether you’re launching a peptide company, operating a wellness clinic, manufacturing products, or expanding a telehealth platform, regulatory compliance is critical to protecting your business. Our healthcare attorneys provide strategic legal guidance on FDA considerations, advertising and marketing compliance, business structuring, contracts, licensing, risk management, and operational best practices—helping peptide-focused businesses confidently navigate today’s complex regulatory landscape while positioning themselves for long-term success.
There are no off the shelf solutions when it comes to starting a new stem cell business or adding a new component to a practice. Between navigating regulations, receiving training, and marketing the service, there’s a lot to address in a short time. Trying to do it all yourself? You may be a highly trained clinician, but given healthcare’s ever-changing regulatory environment, seeking out experienced counsel at the outset will save lots of time and money in the long run.
Medical Marijuana & CBD
Senate Bill 8A, Chapter 2017-232, Laws of Florida, is an act relating to the medical use of marijuana (the “Act”). As the Department of Health develops rules pursuant to the Act, it will be vitally important that qualified physicians keep abreast of developing or newly implemented rules to ensure compliance with the Act to allow the physician to develop a healthy, compliant practice related to prescribing medical marijuana.
