Credit: Caitlin A. Koppenhaver
A significant legal change in Florida is on the horizon that could directly impact providers and practices offer stem cell therapies. Beginning July 1, 2025, Florida’s House Bill 1617 (2025) goes into effect, allowing certain licensed healthcare professionals to administer stem cell treatments, but only under strict conditions. With these new allowances come clear responsibilities, especially when it comes to patient notification and informed consent. Now is the time to ensure your documentation and protocols are up to date to stay compliant and protect your practice.
House Bill 1617 (2025) authorizes certain licensed physicians in Florida (Specifically Chapters 458 and 459, therefore this includes Ch.458- MD’s, and Ch. 459, DO’s) to perform stem cell therapies that have not been approved by the United States Food and Drug Administration (FDA), but only under limited and defined circumstances. These therapies may only be administered when they fall within the provider’s scope of practice and are specifically related to orthopedics, wound care, or pain management. The legislation imposes clear limitations on the types of stem cells permitted, expressly excluding fetal-derived cells, embryonic tissue from abortions, and adipose-derived mesenchymal stem cells (stem cells from fat tissue).
All stem cells used under this statute must be manufactured in FDA-certified clean room environments that utilize high-efficiency air filtration systems to reduce the risk of contamination. Additionally, the retrieval, processing, and storage of these stem cells must take place in facilities that are both FDA-registered and accredited by recognized organizations such as the National Marrow Donor Program or the American Association of Tissue Banks, among others that the statute lists.
The bill mandates strict patient notification and informed consent procedures. Health care providers must deliver a written notice to patients, in a specific font and size, and clearly displayed in the provider’s office, advising that the stem cell therapies being offered are not FDA-approved. The bill includes specific verbiage for this notice:
(4) A health care provider who conducts stem cell therapy pursuant to this section shall provide a patient who is being treated with stem cell therapy with the following written notice before performing the therapy:
“THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.”
Important: This notice must also be included in any advertisement for the stem cell therapy. In any form of advertisement, the notice must be clearly legible and in a font size no smaller than the largest font size used in the advertisement.
Prior to the provider performing stem cell therapy, treatment, providers are required to obtain a consent form signed by the patient. The consent form must include:
1. The nature and character of the proposed treatment, including the treatment’s United States Food and Drug Administration approval status.
2. The anticipated results of the proposed treatment.
3. The recognized possible alternative forms of treatment.
4. The recognized serious possible risks, complications, and anticipated benefits involved in the treatment and in the recognized possible alternative forms of treatment, including nontreatment.
The legislation exempts providers engaged in FDA-approved investigational drug or device trials and those operating under contract with accredited institutions recognized for their expertise in stem cell therapy. Any violation of the statute may result in disciplinary action by the relevant regulatory board or agency. The Department of Health is responsible for adopting rules to implement this law, which takes effect on July 1, 2025.
As we approach the July 1 effective date, it’s important to take a proactive approach. Updating your informed consent forms, office signage, and any related advertising isn’t just a legal requirement—it’s an opportunity to reinforce patient trust and uphold ethical standards in your care. Making these changes now will help you avoid regulatory issues down the line and ensure you’re ready to responsibly offer these advanced therapies within the scope of the new law.
