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Patient Consent – What Is It and When It Is Required?

Michael Nikitin

CTO & Co-founder AIDA, CEO Itirra

Published on February 14, 2023

Health Insurance Portability and Accountability Act (HIPAA) is a federal law that protects the privacy and security of Protected Health Information (PHI). As a result, it is vital that healthcare providers and organizations follow HIPAA regulations when obtaining and using patient health information. One important aspect of HIPAA is patient consent, which involves obtaining permission from patients to use or disclose their health information.

What is patient consent under HIPAA?

HIPAA patient consent is a process by which a patient gives permission to a healthcare provider or organization to use and disclose their protected health information (PHI) for specific purposes. Under HIPAA, patients have the right to control the use and disclosure of their PHI, and healthcare providers and organizations are required to obtain patient consent before using or disclosing PHI for purposes other than treatment, payment, or healthcare operations.


HIPAA patient consent must be obtained in writing, and it must specify the types of PHI that may be used and disclosed, the purposes for which the PHI may be used and disclosed, and the individuals or entities that may receive the PHI. Patients have the right to revoke their consent at any time, and healthcare providers and organizations must honor this revocation if they have not yet acted on the consent.

Patient consent challenges

One of the challenges of obtaining patient consent is ensuring that patients fully understand the consequences of giving or withholding their consent. Healthcare providers and organizations must ensure that patients understand what information will be used or disclosed and for what purposes before obtaining their consent. Additionally, patients must be informed of their right to revoke their consent at any time.


Obtaining HIPAA patient consent can present several challenges for healthcare providers and organizations, including:

Keeping information confidential

One challenge of obtaining patient consent is ensuring that patients’ health information is protected and kept confidential. HIPAA requires healthcare providers and organizations to implement appropriate safeguards to protect patient health information, including technical, physical, and administrative safeguards.

Keeping consent forms up-to-date

Consent forms must be updated periodically to reflect changes in HIPAA regulations and the patient’s health information. This can be a challenge for healthcare providers and organizations, as they must keep track of when consent forms need to be updated and make sure that the necessary updates are made.

Managing emergency situations

In emergencies, obtaining written consent from patients may not be possible. This can be a challenge for healthcare providers and organizations, as they must ensure that they have the necessary processes and procedures to obtain emergency consent and document the circumstances under which it was obtained.

Maintaining compliance

Keeping up with HIPAA regulations and ensuring that patient consent processes and procedures are in compliance can be challenging for healthcare providers and organizations. HIPAA regulations constantly change, and healthcare providers and organizations must stay informed about the latest requirements and updates.

Balancing privacy and patient care

In some cases, obtaining patient consent may conflict with providing timely and effective patient care. Healthcare providers and organizations must strike a balance between obtaining patient consent and providing the best possible care to their patients.


Overall, obtaining HIPAA patient consent can be challenging. Still, it is essential to ensure that patients have control over their health information and that their privacy and security are protected. Healthcare providers and organizations must have appropriate processes and procedures to obtain and manage patient consent and stay informed about the latest HIPAA regulations and requirements.

Best practices for obtaining patient consent

Healthcare providers and organizations must also follow HIPAA regulations when obtaining patient consent. For example, consent forms must be written in plain language and clearly explain what information will be used or disclosed, for what purposes, and who will receive it. Additionally, consent forms must be updated periodically to reflect changes in HIPAA regulations and the patient’s health information.


Best practices for obtaining and managing HIPAA patient consent include:

Obtaining written consent

Written consent is the most secure and effective way to obtain patient consent under HIPAA. Healthcare providers and organizations should use a HIPAA-compliant authorization form that clearly explains what information will be used or disclosed, for what purposes, and who will receive it.

Ensuring patient understanding

Before obtaining patient consent, healthcare providers and organizations must ensure that patients understand the consequences of giving or withholding their consent. This includes explaining what information will be used or disclosed, for what purposes, and who will receive it.

Providing easy-to-understand information

Consent forms and other materials used to obtain patient consent must be written in plain language and be easily understood by patients.

Implementing safeguards

Healthcare providers and organizations must implement appropriate safeguards to protect patient health information, including technical, physical, and administrative safeguards.

Updating forms regularly

Consent forms must be updated periodically to reflect changes in HIPAA regulations and the patient’s health information. Healthcare providers and organizations must keep track of when consent forms need to be updated and make sure that the necessary updates are made.

Documenting emergency situations

In emergencies, healthcare providers and organizations must document the circumstances under which they obtained emergency consent.

Providing patients with options

Patients have the right to revoke their consent at any time, and healthcare providers and organizations must comply with this request. Patients should be given the option to choose how their health information is used and disclosed.

Staying informed about HIPAA regulations

HIPAA regulations are constantly changing, and healthcare providers and organizations must stay informed about the latest requirements and updates.


By following these best practices, healthcare providers and organizations can help ensure that they are obtaining HIPAA patient consent in a manner that protects patient privacy and security while providing the best possible care to their patients.

Penalties for violating patient consent under HIPAA

Violating HIPAA patient consent requirements can result in significant penalties for healthcare providers and organizations, such as:

Civil Monetary Penalties (CMPs)

The Department of Health and Human Services (HHS) may impose civil monetary penalties on entities that violate HIPAA regulations, including patient consent requirements. The penalty amount depends on the nature and severity of the violation and can range from $100 to $50,000 per violation, with an annual maximum of $1.5 million for identical violations.

Criminal penalties

Certain HIPAA violations can result in criminal penalties, including fines of up to $50,000 and/or imprisonment of up to one year for an individual or fines of up to $100,000 for an organization.

Loss of federal funding

Healthcare providers and organizations that receive federal funding, such as Medicare or Medicaid, may lose their funding if they are found to be in violation of HIPAA regulations.

Loss of reputation

HIPAA violations can damage the reputation of healthcare providers and organizations and can harm the trust that patients have in these entities.

Legal actions

Patients may take legal action against healthcare providers and organizations that violate HIPAA regulations, including patient consent requirements. This can result in significant financial damages and legal fees.


It is essential for healthcare providers and organizations to take HIPAA patient consent requirements seriously and ensure that they are in compliance with these regulations. This can help to protect patient privacy, promote patient trust, and avoid penalties for violating HIPAA regulations.

Conclusion

Overall, obtaining HIPAA patient consent can present several challenges for healthcare providers and organizations, but it is essential for protecting patient privacy and security and for ensuring that patients have control over their own health information. By implementing best practices and staying informed about HIPAA regulations, healthcare providers and organizations can help overcome these challenges and obtain HIPAA patient consent in a way that protects patient privacy and security while providing the best possible care to their patients.


The healthcare industry has been greatly impacted by HIPAA, but through following modern IT security standards, healthcare providers can minimize risks to their PHI. Unfortunately, weak encryption, insecure communication methods, and inadequate access controls are frequent issues with healthcare software. Even seemingly small actions, like sending a push notification, can result in a HIPAA violation. It can be a challenge to create secure, HIPAA-compliant software.


At Itirra, we understand the importance of building secure software for healthcare companies. Our team has a wealth of experience creating comprehensive healthcare solutions. Reach out to us today to learn how we can help you maintain HIPAA compliance while building software for your business.