How to File a Patient Safety Confidentiality Complaint

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and its associated Rule are designed to encourage healthcare providers to report medical errors and patient safety events by offering robust confidentiality protections for related information, known as Patient Safety Work Product (PSWP). These protections prohibit the unauthorized disclosure of PSWP, which may identify patients, providers, or reporters. The cost component for filing a patient safety confidentiality complaint is generally administrative, as there are no direct medical or procedural fees involved. Key cost considerations may include potential legal consultation or document preparation fees if you seek professional assistance with the complaint. To better understand any potential expenses, request itemized estimates from any professionals consulted during the process.

Cost Breakdown

• Filing the Complaint: No fee required for submitting to the Office for Civil Rights (OCR).
• Legal or Professional Assistance: Optional costs if you choose to consult an attorney or patient advocate (fees vary).
• Document Preparation: Minimal, typically self-service using downloadable forms at no charge.

Associated Costs

• Legal consultation (optional): May range from $100–$500 per hour depending on expertise and region.
• Copying/printing paperwork: Usually a nominal fee if not done at home.
• Postage (if mailing forms): Minimal, typically under $10.

Insurance & Payment Advice

• Health insurance does not cover costs related to filing patient safety confidentiality complaints.
• Most individuals file directly with the OCR without cost, but professional assistance fees are out-of-pocket.
• If you work with an attorney or advocate, request a detailed, itemized estimate before services begin.

Frequently Asked Questions

• What is Patient Safety Work Product (PSWP)? PSWP refers to information collected or developed to report and analyze patient safety events, which is protected by federal confidentiality laws.
• Is there a fee to file a patient safety confidentiality complaint? No, there is no fee to file a complaint with the Office for Civil Rights (OCR).
• Can I file a complaint myself or do I need a lawyer? You can file a complaint yourself using the provided forms; legal assistance is optional and may incur costs.
• What costs might I incur when filing a complaint? Possible costs include legal consultation fees, document preparation, and postage if you mail the forms.
• Does insurance cover any costs associated with filing a complaint? No, health insurance does not cover administrative or legal costs related to filing complaints.
• How do I access the complaint forms? The forms are available for download online at no charge.
• What information is required to file a complaint? You will need details about the alleged disclosure, including dates, involved parties, and documentation if available.
• What happens after I file a complaint? The OCR will review the complaint and may contact you for additional information or clarification.
• How long does the complaint process take? Processing times vary, but you will typically receive an acknowledgment and follow-up instructions within several weeks.
• What if I need help filling out the forms? You may contact a patient advocate, legal professional, or the OCR for guidance; assistance may involve additional costs.

About Patient Safety Confidentiality

OCR enforces the confidentiality provisions of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and the Patient Safety and Quality Improvement Rule (Patient Safety Rule). Together, the Patient Safety Act and Rule establish a voluntary system for Patient Safety Organizations (PSOs) to collect and analyze medical error and patient safety event data. To encourage provider reporting, the Patient Safety Act and Rule include Federal privilege and confidentiality protections for patient safety work products (PSWP). Information submitted to, and developed by, these PSOs is protected as PSWP. 

What is PSWP?

PSWP is any information:

• Assembled or developed by a health care provider for reporting to a Patient Safety Organization (PSO) that is listed by the HHS Agency for Healthcare Research and Quality (AHRQ) and is documented as being within the provider’s patient safety evaluation system for reporting to a PSO
• Developed by a PSO for the conduct of patient safety activities
• Identifies or constitutes the deliberations, or analysis of, or identifies the fact of reporting pursuant to a patient safety evaluation system

PSWP may identify patients, health care providers and individuals that report medical errors or other patient safety events.  This PSWP is confidential and may only be disclosed in certain very limited situations.  

Complaint Requirements

Anyone can file a patient safety confidentiality complaint. If you believe that a person or organization shared PSWP, you may file a complaint with OCR.  Your complaint must:

• Be filed in writing: sent by mail, fax or e-mail 
• Name the person that is the subject of the complaint and describe the act or acts believed to be in violation of the Patient Safety Act requirement to keep PSWP confidential
• Be filed within 180 days of when you knew or should have known that the act complained of occurred, however OCR may waive the 180-day time limit for “good cause” shown

File a Patient Safety Confidentiality Complaint

File a Complaint Using the Patient Safety Confidentiality Complaint Form Package

Open and fill out the Patient Safety Confidentiality Complaint Form – PDF and Consent Form Package – PDF in PDF format. You will need Adobe Reader software to fill out the complaint and consent forms. You may either:

• Print and mail or fax the completed complaint and consent forms to the appropriate OCR regional office
• Email the completed complaint and consent forms to OCRComplaint@hhs.gov (Please note that communication by unencrypted email presents a risk that personally identifiable information contained in such an email, may be intercepted by unauthorized third parties)

File a Complaint Without Using Our Patient Safety Confidentiality Complaint Package

If you prefer, you may submit a written complaint in your own format by either:

• Mail or fax to the appropriate OCR regional office
• Email to OCRComplaint@hhs.gov

Be sure to include:

• Your name
• Full address
• Telephone numbers (include area code)
• E-mail address (if available)
• Name, full address and telephone number of the person, agency, or organization you believe violated your (or someone else’s) health information privacy rights or committed another violation of the Privacy or Security Rule
• Brief description of what happened, including how, why, and when you believe a person impermissibly disclosed patient safety work product  
• Any other relevant information
• Your signature and date of complaint

You may also include:

• If you need special accommodations for us to communicate with you about this complaint
• Contact information for someone who can help us reach you if we cannot reach you directly
• If you have filed your complaint somewhere else and where you’ve filed

How OCR Investigates Your Complaint

OCR will investigate complaints that allege potential violations of the Rule. To the extent practicable, OCR will provide technical assistance and seek informal resolution of complaints involving the inappropriate sharing of PSWP through voluntary compliance from the responsible person, entity, or organization. When OCR is unable to achieve an informal resolution of an indicated violation through such voluntary compliance, the Secretary may impose a CMP of up to $11,000 for each knowing and reckless disclosure of PSWP that is in violation of the confidentiality provisions.