Starting a Women’s health business involves navigating various legal considerations to further compliance and protect the business and its clients. In this blog, we will discuss some key legal considerations for starting a women’s health business.

  1. Regulatory Compliance: Ensure compliance with all relevant state and federal laws and regulations governing healthcare services. This includes licensing requirements, privacy laws such as HIPAA, and regulations specific to women’s health services.
  2. Corporate Structure: Choose an appropriate legal structure for the business, such as a sole proprietorship, partnership, corporation, limited liability company (LLC) or professional limited liability company (PLLC). Each structure has different legal and tax implications, and states vary as to what is required. In many states, non-physicians would need an MSO/MSA structure to start this kind of business.
  3. Professional Liability Insurance: Obtain professional liability insurance (also called malpractice insurance) to protect the business and its practitioners from lawsuits related to malpractice or negligence. Obtain general liability insurance for your brick-and-mortar and commercial vehicle insurance if the business will be mobile.
  4. Contracts: Create written contracts to establish the terms of service with clients, agreements with suppliers, and employment contracts with staff. Ensure that contracts are clear, legally binding, protect the business’s interests, and comply with state laws.
  5. Informed Consent: Patients must give informed consent before receiving medical services or treatments. Ensure that patients understand what they are signing, including the risks, benefits, and alternatives to any proposed treatments. Do not use the consents provided by non-lawyers.
  6. Patient Privacy: Protect patient privacy and comply with laws such as the Health Insurance Portability and Accountability Act (HIPAA). Safeguard patient medical records and personal information from unauthorized access or disclosure.
  7. Advertising and Marketing: Ensure all advertising and marketing materials comply with relevant laws and regulations. Avoid making false or misleading statements, or guarantees regarding the services offered or their efficacy.
  8. Employment Law: Comply with state and federal employment laws regarding hiring, wages, benefits, and workplace safety. Provide a safe and harassment-free work environment for employees.
  9. Medical Malpractice: Implement policies and procedures to minimize the risk of medical malpractice claims. Provide adequate training and supervision for staff, maintain accurate medical records, and follow established standards of care. 
  10. Compliance with Anti-Discrimination Laws: Ensure compliance with anti-discrimination laws, including laws prohibiting discrimination based on gender, race, ethnicity, religion, or disability. Provide equal access to services for all patients.
  11. Telemedicine Regulations: If offering telemedicine services, comply with state and federal regulations specific to telehealth, including licensure requirements, patient consent, and privacy protections.
  12. Reproductive Rights: Stay informed about laws and regulations related to reproductive rights and women’s healthcare, including access to contraception, abortion services, and fertility treatments.
  13. State and Local Regulations: Be aware of state and local regulations that may apply to women’s health businesses, such as zoning laws, business licensing requirements, and regulations specific to healthcare providers.
  14. Continuing Education: Through training and continued education, ensure that practitioners and staff stay up-to-date with the latest developments in women’s health care.
  15. Compliance with Standards of Care: Adhere to established standards of care in women’s health, as defined by professional medical organizations and regulatory bodies. Make sure that good faith examinations of patients are being done by an appropriate licensed prescriber.

Consulting with experienced legal professionals familiar with healthcare law can provide further guidance tailored to the specific needs and circumstances of the women’s health business. The attorneys at Lengea have the knowledge, skills, and determination to help you build your healthcare business. If you are ready to get started or have questions, please click here to schedule a complimentary fifteen-minute Zoom consultation with one of our attorneys.