Why Informed Consent Is Essential for Med Spas
This article was originally published by Much Shelist, P.C. Read it on the Much website.
Fenton Jurkowitz has closed its operations. Benjamin Fenton, Nick Jurkowitz, Henry Fenton, Herbert Weinberg, Nishka Khanna, and Anne Schneider are now attorneys at Much. As we enter this exciting chapter, we thank our clients and friends for their support. Our attorneys continue to represent health care companies in matters ranging from complex litigation and compliance to license defense and transactions, now with the full-service capabilities of the Much platform.
As aesthetic medicine continues to expand, medical spas are increasingly blending clinical treatments with a spa-like environment. Yet despite the relaxed atmosphere, med spas are still practicing medicine. That means they are subject to the same legal and ethical standards that govern traditional healthcare settings. Chief among these obligations is the duty to obtain proper informed consent.
For medical spa owners, supervising physicians, and other licensed providers, understanding and implementing a compliant informed-consent process is critical to protect patient autonomy and safety. It also acts as an important safeguard against legal and regulatory issues.
Why Informed Consent Matters
When a patient has an aesthetic or wellness procedure, they trust the provider with their well-being. Healthcare professionals must legally and ethically explain the procedure to patients. They should discuss its risks and benefits, alternatives, and expected outcomes. This information must be clear and easy for patients to understand.
While the principles of informed consent are well established, the regulatory landscape governing medical spas is very complex. The intersection of medicine, cosmetics, and consumer services means that:
- State practice-of-medicine laws vary significantly
- Regulations evolve rapidly, often in response to new technology and new treatment trends
- Non-physician ownership or involvement can create additional risk, particularly when delegated medical services are involved
Because of these complexities, medical spas should often review their informed-consent practices. They should work with experienced healthcare lawyers to meet state and federal requirements.
Informed Consent: More Than a Signature
From a legal standpoint, informed consent is not merely a signed form; it is a process. A compliant process typically includes:
- A clear explanation of the procedure
- Disclosure of risks, potential complications, and expected results
- Alternatives (including the option of no treatment)
- Post-treatment expectations and care instructions
Verbal discussions should always accompany written materials. Although a signed document is important evidence of consent, it cannot replace a thorough conversation. Many practices choose to go beyond minimum requirements by documenting each discussion in the patient’s medical record. This precaution often proves invaluable if a dispute arises.
Off-Label Uses: What Providers Should Know
Off-label use of medications and devices is common in aesthetic medicine and is legally allowed when performed by a qualified, licensed provider using sound medical judgment. Contrary to what some may assume, off-label use does not significantly change the legal standards for informed consent.
However, from a risk-management standpoint, many practices choose to disclose off-label use as part of the consent conversation. This level of transparency:
- Builds patient trust
- Minimizes misunderstandings
- Strengthens the provider’s legal position if treatment results are challenged
Clinical Research: A Higher Standard
When a provider does clinical research or enrolls med spa patients in studies, the informed-consent process is stricter. These situations create federal rules under 45 C.F.R. §§ 46.116 and 46.117. They also require oversight from an Institutional Review Board (IRB).
Research-related informed consent must:
- Be written in plain, non-technical language
- Clearly identify the investigational nature of the treatment
- Explain risks, benefits, alternatives, and confidentiality protections
- Identify appropriate contacts for questions or concerns
- Emphasize the voluntary nature of participation and the patient’s right to withdraw
For med spas that conduct or participate in clinical research, legal guidance is essential. Failure to follow these requirements can trigger significant liability and regulatory consequences.
State-Specific Requirements
There is no specific California law that details what informed consent should include. However, court cases require that patients receive information about at least:
- The nature of the treatment
- The risks, complications, and expected benefits, including the likelihood of success
- Any alternative to the recommended treatment, including the alternative of no treatment, and its risks and benefits
Negligence Claims
Most patients file lawsuits about informed consent under state negligence laws. They claim that the provider did not meet the required standard of care.
To cover all their bases, it is recommended that med spas should:
- Review their informed-consent procedures regularly
- Update forms and scripts as regulations evolve
- Review new laws and regulations
- Consult healthcare attorneys when adding new services, technologies, or delegation models
A Trend Toward Greater Transparency
Today’s aesthetic patients are increasingly informed, engaged, and eager to understand the treatments they choose. As a result, informed-consent expectations both from regulators and consumers are likely to continue increasing.
Providers who take a proactive approach benefit in several ways:
- Stronger patient relationships
- Clearer expectations and fewer misunderstandings
- Better documentation
- Reduced legal exposure if complications arise
Ultimately, transparency is both a professional responsibility and a practical safeguard.
Practical Tips for a Strong Informed-Consent Process
To support compliance and minimize risk, medical spas and healthcare providers should consider the following best practices:
- Treat informed consent as an ongoing conversation, not a single form.
- Use plain, patient-friendly language, avoiding medical jargon or legalese.
- Describe the full patient experience, including how the procedure works, expected downtime, and realistic outcomes.
- Explain foreseeable risks and potential complications, including rare but serious possibilities.
- Discuss alternatives, including the option to decline treatment.
- Address confidentiality by determining whether you must share information with third parties.
- Clarify what happens if a treatment-related injury occurs, including the extent of available care or compensation.
- Provide appropriate contact information, ensuring at least one contact is not part of the treating team.
- Document everything, including the conversation, questions asked, and educational materials provided.
- Regularly review and update consent forms and procedures to comply with evolving state and federal standards.
Contact a Medical Spa Attorney Today
Given the fast-changing regulatory landscape in aesthetic medicine, med spas, and supervising physicians should work closely with experienced healthcare attorneys to ensure their informed-consent processes are robust, compliant, and well-documented. Doing so significantly reduces risk and fosters the trust that is essential to high-quality patient care.
At Fenton Jurkowitz Law Group, our experienced med spa lawyers specialize in guiding healthcare practices through current and upcoming healthcare data security laws to protect your medical spa license (California). For more information on how hiring a medical spa attorney can give you peace of mind, contact us at (310) 444-5244 or fill out the form on our website today.