Demystifying Informed Consent & Patient Registration

1. Informed Consent Generally. 

Informed consent reflects the legal proposition that patients have the right to make decisions about their care and treatment on sufficient, reliable, and meaningful information. Ideally, informed consent should be arrived at via a collaborative and interactive process between a healthcare provider and their patient(s), with plentiful opportunity for patient questions and discussion. A primary goal of informed consent is simple: to foster transparency and understanding in every patient considering care. And while the concept of informed consent may be intuitive for most healthcare providers, how to obtain it–and what methodical processes should be included–can entail nuance. 

2. What happens without informed consent, and why should I care? 

Providing care without informed consent can expose the rendering provider(s) to avoidable liability and risk, including patient lawsuits and industry regulators. The thinking goes that, by providing care without consent that is also informed, a patient cannot possibly understand significant underlying risks. Without understanding such risks, the patient is deprived a meaningful opportunity to participate in their own care–something against principles of self-determination and autonomy. 

3. What should go into an informed consent? 

Generally, informed consent must be obtained before care is provided. This makes it fit naturally into a healthcare provider’s patient registration and intake process. And while variables like specialty, procedure, patient attributes, and more require tailoring informed consent documents and processes, the documents below are often included as primary ‘ingredients’ to a strong informed consent when part of the patient registration and intake process: 

1. Informed consent.
   • Scope of practice. 
   • Disclaimers for limits of care and services.
   • Discussion of care risks.
   • Discussion of care benefits. 
   • What to do in case of a medical emergency.
   • Telehealth consent. 
   • AI Consent. 
   • Disclosure of third-party relationships, such as revenue-cycle management and EMR vendors.
   • Financial Policies & Payment Agreement. Note that you may need to comply with transparency in pricing and good-faith estimate laws in certain circumstances, and make specific disclosures regarding insurance, payment requirements, etc.
   • Any other information pertinent to care and the operations underlying it. 
2. Patient Notice of Non-Discrimination. 
3. Patient Rights and Responsibilities. 
4. HIPAA Notice of Privacy Practices.
5. State-and/or-Practice-Specific Disclosures & Requirements. 

4. How do I obtain an Informed Consent? Informed Consent Action Plan. 

1. Draft the documents. You have several options to accomplish this. 
   • First, you can pull tentative drafts from your Electronic Medical Record (EMR) or Electronic Health Record system (EHR). EMRs/EHRs often have resource libraries that contain various informed consent documents and examples.
   • Have a qualified healthcare attorney draft them. While one size does not fit all with respect to informed consent documents, they often contain similar attributes and provisions. A good healthcare attorney will be able to start from some sort of base and tailor to meet your specific needs. 

2. Review the documents with qualified healthcare counsel. While there is no need to reinvent the wheel in many cases, there is almost always a need to refine it. This is because documents contained in such resource libraries or found on the internet are often missing key provisions needed for your specialty(ies), state(s), patient population(s), etc. 

3. Conduct a mock patient registration and informed consent process(es). Once you have created your patient registration process, conducting a mock patient intake–ideally, with a healthcare lawyer with meaningful experience in the area–will expose legal blind spots and weaknesses. These can be, and often are, fixed through quick adjustments. 

4. Implement the patient registration and informed consent process(es). This means coaching staff appropriately on how to work with each patient. Remember important things like secure data storage, privacy protocols when intaking each patient, EMS response and protocol, and how to answer questions. 

5. Monitor implementation of the informed consent and patient registration and intake process(es). A healthcare process is only as good as its implementation. Revisiting the informed consent and patient intake and registration processes will provide quality assurance so that nothing falls through the cracks. 

The content of this post is not legal advice and is not tailored to any specific situation. Because informed consent and patient registration requirements vary with multiple factors, you should seek competent healthcare counsel to ensure your operations are compliant with applicable laws and regulations. This information is current only as of March 18, 2026.