The HIPAA Complaints Process: What Your Practice Must Document and How You Must Respond (§ 164.530(d))

Under HIPAA, patients have the right to file complaints if they believe their privacy rights have been violated. Section 164.530(d) of the Privacy Rule mandates that covered entities must have clear procedures for receiving, documenting, and responding to those complaints. Small practices often fail to formalize this process or mistakenly ignore informal grievances. This article offers a practical guide to establishing a complaint response process that meets HIPAA requirements, minimizes legal risk, and preserves patient trust.

Many small healthcare practices view patient complaints as simple service issues, not realizing that some of those concerns may trigger HIPAA obligations. Under § 164.530(d), every covered entity must:

• Provide a means for patients to file HIPAA complaints

• Respond appropriately

• Document the complaint and outcome

• Ensure no retaliation for filing

Even if a complaint seems minor, like overheard conversations or misplaced faxes, it must be addressed properly. This article walks you through how to do that.

What does § 164.530(d) Require?

HIPAA requires that covered entities:

1. Provide a process for individuals to make complaints about potential HIPAA violations

2. Document all complaints and their resolutions

3. Respond to each complaint in a timely and appropriate manner

4. Prohibit retaliation against individuals for filing complaints

These requirements apply regardless of the size of your practice.

A complaint may fall under HIPAA when it relates to:

• Improper access or disclosure of PHI

• Denial of access to medical records

• Inadequate privacy practices (e.g., leaving charts visible)

• Failure to provide Notice of Privacy Practices

• Improper response to restriction or amendment requests

Not all complaints will meet this threshold, but they must be screened, logged, and reviewed to determine if they do.

In 2022, a patient visiting a small OB-GYN clinic witnessed a clear breach of confidentiality. While waiting for their appointment, the patient overheard the clinic’s receptionist discussing another patient’s sensitive pregnancy test results aloud in the reception area, where other patients could easily hear. Disturbed by this breach of privacy, the patient approached the receptionist and voiced their concern directly, expecting it to be taken seriously and addressed promptly.

Unfortunately, instead of documenting the complaint or escalating the matter to a supervisor, the receptionist dismissed the patient’s concerns as “not a big deal.” No further action was taken to investigate or resolve the issue internally.

Feeling that their privacy rights had been violated and that the clinic was indifferent to the complaint, the patient filed a formal grievance with the Office for Civil Rights (OCR). During the subsequent investigation, OCR uncovered several compliance failures:

• The clinic lacked a formal process to receive and handle HIPAA complaints, leaving patients without a clear channel to report privacy concerns.

• There was no documentation of the patient’s verbal complaint, violating HIPAA requirements for recording and tracking privacy incidents.

• Staff had not been trained on how to properly recognize, document, and escalate HIPAA-related concerns or breaches.
  
  

As a result, the clinic entered into a resolution agreement with OCR that included a $20,000 financial settlement. Additionally, the clinic was mandated to develop and implement a comprehensive corrective action plan focusing on complaint management and staff training. All employees were required to undergo retraining on HIPAA privacy policies and proper complaint escalation procedures.

Lesson: This case illustrates that even a casual verbal complaint from a patient can evolve into a serious enforcement issue if mishandled. Prompt recognition, documentation, and appropriate response to all HIPAA-related concerns are essential to maintaining patient trust and avoiding costly penalties.

Establishing a Complaint Process in Your Practice

1. Designate a Responsible Individual

Your practice should assign the Privacy Official or HIPAA Contact Person to receive and manage complaints.

2. Develop a Written Procedure

Your process should include:

• How patients can file complaints (in person, by mail, or electronically)

• Who receives and reviews the complaint

• What steps are taken to investigate

• Expected timeline for resolution

Include this policy in your HIPAA compliance manual.

3. Create a Standard Complaint Form

While HIPAA doesn’t require a specific form, having a template helps:

• Log patient informatio

• Describe the nature of the complaint

• Assign it to the right person

• Track resolution steps

Ensure staff knows how to fill it out, even when a complaint is made verbally.

4. Document Everything

HIPAA requires you to retain documentation for at least six years. That includes:

• The complaint itself

• Any investigation notes

• Actions taken

• Final resolution

• Communication with the patient

5. Ensure Non-Retaliation

Your policy must explicitly state that no patient will face retaliation for filing a HIPAA complaint.

This includes:

• Refusing future care

• Charging extra fees

• Treating the patient differently

• Disclosing PHI in retaliation

Do I have to report every complaint to HHS?

No. You're only required to respond to the complaint internally. However, if the patient files with OCR, you must cooperate in any investigation.

Can the complaint be anonymous?

Yes. Patients may file anonymously, but your ability to investigate may be limited without details.

What if I resolve the issue on the spot?

You should still document the event. Even quick resolutions require internal records.

Can I designate a third party to handle complaints?

You can involve a HIPAA-compliant vendor or attorney, but you remain responsible for ensuring the process meets HIPAA standards.

• 45 CFR § 164.530(d): Complaints Requirement

• HHS Guidance on Patient Rights and Complaints

• OCR Complaint Portal

• OCR Case Examples and Settlements

Section 164.530(d) of the HIPAA Privacy Rule doesn’t leave room for interpretation: every covered entity must have a process in place to receive, investigate, and respond to complaints regarding the use or disclosure of protected health information (PHI). Just as importantly, patients and staff must be protected from any form of retaliation when they raise a concern.

For small medical or dental practices, this requirement is not just a formality. It’s an opportunity to strengthen patient trust, improve internal procedures, and reduce the risk of serious violations going unnoticed.

Unfortunately, many small offices either don’t have a complaint process, or they rely on vague, undocumented methods that fail under scrutiny. In OCR investigations, it’s common to see practices penalized not just for the privacy breach itself, but for lacking any record of how patient complaints were received or handled.

To stay compliant and build a culture of respect, your next steps should include:

• Build a simple, written HIPAA complaint policy. It should explain how patients and staff can report concerns, who receives them, and how they will be addressed.

• Train your staff regularly. Everyone, from front desk personnel to billing staff, should know how to recognize a HIPAA-related complaint and the steps to escalate it appropriately.

• Document every complaint and your response. Keep a log that includes dates, details, outcomes, and any follow-up actions taken. This not only shows compliance but also helps identify recurring issues.

• Emphasize non-retaliation. Patients and staff must feel safe to report concerns. Make it clear in your Notice of Privacy Practices and your internal training that no one will be punished or treated unfairly for doing the right thing.

Remember: this isn’t just about checking a box. It’s about honoring your patients’ right to privacy and ensuring your practice lives up to that promise. A strong complaint process sends a clear message, that your practice listens, takes responsibility, and puts patient rights first.