The difference between implied and explicit consent

Under HIPAA, implied consent is inferred from situational context or a patient’s actions, allowing healthcare providers to use or disclose personal health information (PHI) for treatment, payment, and healthcare operations without explicit authorization. In contrast, explicit consent involves a clear, documented agreement from the patient. It is often required to use PHI beyond routine activities, such as marketing, research, or sharing information with third parties. Explicit consent creates transparency and gives patients control over disclosures of their health information.

Patient consent in healthcare

Patient consent is an ethical obligation that reflects respect for patient autonomy. Healthcare providers must ensure patients understand and agree to the treatment and use of their PHI. The consent process promotes a collaborative relationship between the patient and provider, helping patients make informed decisions. 

According to a study from StatPearls, “Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body. Implicit in providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process.”. 

HIPAA regulations and consent

The HIPAA Privacy Rule outlines how PHI can be used and disclosed, with patient consent as a key element in managing health information. The HHS clarifies that "A covered entity is permitted, but not required, to use and disclose protected health information, without an individual's authorization, for the following purposes or situations: (1) To the Individual (unless required for access or accounting of disclosures); (2) Treatment, Payment, and Health Care Operations; (3) Opportunity to Agree or Object; (4) Incident to an otherwise permitted use and disclosure; (5) Public Interest and Benefit Activities; and (6) Limited Data Set for the purposes of research, public health or health care operations.". 

HIPAA recognizes the need for implied and explicit consent, depending on the context. Implied consent is sufficient for routine treatment, payment, and healthcare operations (TPO). However, HIPAA requires explicit consent for other uses such as marketing or research. Explicit consent involves obtaining written authorization from the patient, clearly detailing how their information will be used and for what purpose. 

Understanding implied consent

In implied consent, the practitioner assumes agreement based on a patient’s actions or the care context. It is not explicitly communicated but is inferred from the situation. For instance, when a patient visits a healthcare provider for a routine check-up, their consent to receive treatment and share information necessary for that treatment is understood without the need for explicit agreement. Implied consent allows PHI to be used for treatment or care without extensive documentation. 

Situations where implied consent applies

• Treatment: When a patient undergoes a medical procedure or examination, it is understood that their information will be used to provide and coordinate care.
• Payment: Healthcare providers can share PHI with insurance companies or other entities involved in billing and payment processes without explicit consent.
• Healthcare operations: Implied consent allows healthcare providers to use patient information for quality assessment, staff training, and operational audits as long as it is within the scope of routine operations.

Related: What is HIPAA’s treatment, payment, and operations (TPO) exception?

Legal and ethical considerations

Although implied consent is legally permissible under HIPAA for certain uses, it is not without risks. The absence of explicit documentation can lead to disputes about what the patient has agreed to. The ambiguity can create challenges if questions arise regarding the use or disclosure of PHI.

Healthcare providers must carefully assess when implied consent is appropriate and ensure that it is only used in correct contexts. Transparent communication with patients about how their information will be used helps mitigate the risks associated with implied consent.

Understanding explicit consent

Explicit consent, also known as express consent, requires a clear and direct agreement from the patient, usually documented in writing. This form of consent removes any ambiguity by ensuring that the patient actively acknowledges and agrees to the specific use of their PHI. Explicit consent is required for activities that involve significant use or disclosure of health information beyond routine care.

Situations requiring explicit consent

1. Marketing: Explicit consent is required if PHI is used for marketing purposes, including if a healthcare provider wants to send promotional materials or engage in other marketing activities. The consent must detail the specific information being used and the purpose of the marketing.
2. Research: Researchers must obtain explicit consent before using PHI in studies, except in certain cases where de-identified data is used. Patients should be allowed to opt-out. 
3. Disclosures to third parties: When PHI is shared with third parties for purposes unrelated to routine treatment, payment, or healthcare operations, explicit consent is required. Third parties include pharmaceutical companies or other organizations not related to treatment.
4. Psychotherapy notes: HIPAA provides special protection for psychotherapy notes, requiring explicit patient consent for their use or disclosure. These notes are generally not used for treatment, payment, or healthcare operations, necessitating careful handling and specific authorization.

Legal and ethical considerations

Explicit consent protects patient rights and ensures transparency. HIPAA helps prevent unauthorized use of PHI and promotes trust between patients and providers by requiring a written agreement. Obtaining explicit consent also involves careful documentation and clear communication, ensuring that patients fully understand and agree to how their information will be used.

Related: How to get consent for texting and emailing patients

Comparing implied and explicit consent

Key differences

The primary difference between implied and explicit consent is communication and documentation requirements. Implied consent is inferred from the patient’s actions and the situation, whereas explicit consent requires a direct, documented agreement. Implied consent is appropriate for routine activities, while explicit consent is necessary for more sensitive or significant uses of PHI.

When to use each type of consent

Healthcare providers should use implied consent for routine care-related activities where patient agreement is naturally understood. Explicit consent should be sought for non-routine purposes such as marketing, research, or sharing information with third parties not involved in the patient’s care. 

Potential consequences of misunderstanding consent

Misunderstanding or misapplying consent types can cause legal violations and damage the provider's reputation. For example, using implied consent when explicit consent is required can result in HIPAA breaches and legal consequences. 

Best practices for providers

• Ensuring compliance with HIPAA: Healthcare providers should implement clear policies and procedures for obtaining and documenting patient consent to comply with HIPAA. Organizations should train staff and ensure that all necessary authorizations are obtained and recorded properly.
• Educating patients: Patients should be informed about their rights and the consent process under HIPAA. Clear explanations about when their consent is implied and explicit consent is required to prevent misunderstandings and ensure patients are comfortable with how their information is used.
• Documentation and record-keeping: Providers should ensure explicit consent is documented and securely stored. For implied consent, it is good practice to document the context and rationale for its use, especially in cases where there might be ambiguity about the patient’s agreement.

Related: HIPAA Compliant Email: The Definitive Guide. 

FAQs

How does HIPAA address the use of psychotherapy notes compared to other types of PHI?

Psychotherapy notes are given special protection under HIPAA and generally require explicit consent for their use or disclosure, unlike other types of PHI which may be covered under implied consent for routine purposes.

Read more: HIPAA, psychotherapy notes, and other mental health records

Is verbal consent considered valid under HIPAA?

While verbal consent can be a component of the consent process, HIPAA generally requires written documentation for explicit consent to ensure clarity and compliance, especially for non-routine uses of PHI.

Can a patient withdraw their consent after it has been given?

Yes, patients can withdraw their consent at any time, and healthcare providers must respect this decision by ceasing the use or disclosure of the patient’s PHI per the withdrawn consent.