HIPAA compliant informed consent in elective care

Healthcare providers must use HIPAA compliant forms to obtain patients’ informed consent before an elective procedure. These forms can be tailored to patients’ understanding so patients can rest assured that their decision is appropriate and that their privacy will be well-protected.

What is elective surgery?

“Elective surgery is a term that is inherently ill-defined, but most consider elective procedures to be either nonessential or nonemergent,” explains a book on current therapy of trauma and surgical critical care.

Examples include, “removing a mole or wart and having kidney stones removed. It may also be done if other forms of treatment aren't working,” adds Johns Hopkins Medicine.

Informed consent in elective surgery

In elective surgical procedures, "Informed consent refers to a voluntary permission granted by a patient or participant after adequate understanding of all forms of risks associated with the various procedures and treatments,” explains a study on the adequacy of informed consent in elective surgical procedures.

Patient must be informed about the risks, benefits, and alternatives to treatment, so they are competent to make independent decisions regarding their care. 

However, behind the legalities of informed consent, the quality of patient understanding can vary. The study elaborates, "Though a patient may fulfill all the aspects of consent by completing an informed consent form, research indicates poor execution of the [consent] process by ill-informed patients with little comprehension.” 

Therefore, the gap between the consent form and the patient's understanding can only be addressed with well-structured and clear consent forms, especially when protected health information (PHI) comes into question.

HIPAA and patient consent

Patient consent forms must adhere to the Health Insurance Portability and Accountability Act (HIPAA). HIPAA compliant forms, like Paubox Forms, use advanced security measures, including encryption, access controls, and audit trails to safeguard PHI.

Moreover, Paubox Forms are customizable, so healthcare providers can tailor the form according to patients’ literacy levels, allowing patients to make informed decisions regarding their elective procedure. 

Improving consent through HIPAA compliant forms

HIPAA compliant forms directly bridge the gap in the study where "the lack of information in the informed consent forms critically affects the quality and adequacy of the [informed consent], thus posing ethical and legal challenges."

Ultimately, it improves ethical informed consent practices and reduces the legal risks of breaching HIPAA regulations.

Steps for obtaining informed consent in elective procedures

• Use a HIPAA compliant form: Providers must use a HIPAA compliant form to prevent PHI, like health conditions and treatment details, from falling into unauthorized hands.
• Include procedure details: Since “Lack of information in informed consent forms critically affects quality and adequacy of [informed consent," the form must include information about the procedure, risks, alternatives, and expected outcomes in simple language.
• Include educational aids: HIPAA compliant forms can also include support tools like frequently asked questions, or visual aids to enhance patient understanding of the procedure and risk.
• Check patient understanding: Providers can ask the patient follow-up questions to check if the patient has understood the information on the consent form. Additionally, they should allow the patient to ask questions or discuss their apprehensions before signing the HIPAA compliant form.
• Document the process: Providers must document the consent process along with the educational material and discussion provided to satisfy their legal and ethical obligations.

FAQs

Who must comply with HIPAA?

HIPAA applies to healthcare providers, health plans, healthcare clearinghouses, and business associates who handle protected health information (PHI).

What is protected health information (PHI)?

PHI includes any information related to a person's health status, healthcare, or payment for healthcare that can be linked to an individual, such as names, addresses, birthdates, and medical records.

Do all patient forms need to be HIPAA compliant?

Yes, any form that collects, stores, or transmits PHI must be HIPAA compliant to protect patient privacy and security.