HHS’ Office for Civil Rights Settles HIPAA Right of Access Investigation with Azul Vision, Inc.: Corrective action / RA

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Navigate to: HIPAA for Professionals Regulatory Initiatives Privacy Summary of the Privacy Rule Guidance Combined Text of All Rules HIPAA Related Links Security Security Rule NPRM Summary of the Security Rule Security Guidance Cyber Security Guidance Breach Notification Breach Reporting Guidance Reports to Congress Regulation History Compliance & Enforcement Enforcement Rule Enforcement Process Enforcement Data Resolution Agreements Case Examples Audit Reports to Congress State Attorneys General Special Topics Parental Access Mental and Behavioral Health Change Healthcare Cybersecurity Incident FAQs HIPAA and COVID-19 HIPAA and Reproductive Health HIPAA and Final Rule Notice HIPAA and Telehealth HIPAA and FERPA Research Public Health Emergency Response Health Information Technology Health Apps Patient Safety Covered Entities & Business Associates Business Associate Contracts Business Associates Training & Resources FAQs for Professionals Other Administrative Simplification Rules Substance Use Disorder Confidentiality Azul Vision, Inc. Resolution Agreement and Corrective Action Plan RESOLUTION AGREEMENTI. RecitalsParties. The Parties to this Resolution Agreement ("Agreement") are:The United States Department of Health and Human Services, Office for Civil Rights ("HHS"), which enforces the Federal standards that govern the privacy of individually identifiable health information (45 C.F.R Part 160 and Subparts A and E of Part 164, the ''Privacy Rule"), the Federal standards that govern the security of electronic individually identifiable health information (45 C.F.R Part 160 and Subparts A and C of Part 164, the "Security Rule"), and the Federal standards for notification in the case of breach of unsecured protected health information (45 C.F.R Part 160 and Subparts A and D of 45 C.F.R Part 164, the "Breach Notification Rule"). HHS has the authority to conduct compliance reviews and investigations of complaints alleging violations of the Privacy, Security, and Breach Notification Rules (the "HIPAA Rules") by covered entities and business associates, and covered entities and business associates must cooperate with HHS compliance reviews and investigations. See 45 C.F.R §§ 160.306(c), 160.308, and 160.310(b).Azul Vision, Inc. (“Azul Vision”) is a Covered Entity as defined at 45 C.F.R. § 160.103 and therefore is required to comply with the HIPAA Rules. Azul Vision is a health care provider that provides optometry and ophthalmology services across 31 clinics in California.Factual Background and Covered Conduct. On April 27, 2023, OCR received a complaint alleging that Azul Vision is not in compliance with the Privacy Rule. The complaint alleged that Azul Vision failed to provide the Complainant with access to her protected health information (PHI) in response to her January 9, 2023, request for access to her records. Azul Vision did not fulfill the request for Complainant’s access to her PHI until January 6, 2025.HHS’s investigation of the complaint indicated a potential violation of the following provision of the HIPAA Rules (“Covered Conduct”):The requirement to provide timely access to PHI about an individual in a designated records set. See 45 C.F.R. § 164.524(b).No Admission. This Agreement is not an admission of liability by Azul Vision.No Concession. This Agreement is not a concession by HHS that Azul Vision is not in violation of the HIPAA Rules and not liable for civil money penalties (“CMPs”).Intention of Parties to Effect Resolution. This Agreement is intended to resolve OCR Transaction Number 23-526909 and any violations of the HIPAA Rules related to the Covered Conduct specified in paragraph I.2 of this Agreement. In consideration of the Parties’ interest in avoiding uncertainty, burden, and expense of further investigation and formal proceedings, the Parties agree to resolve this matter according to the Terms and Conditions below.II. Terms and ConditionsPayment. HHS has agreed to accept, and Azul Vision has agreed to pay HHS, the amount of $50,000 (“Resolution Amount”). Azul Vision agrees to pay the Resolution Amount on the Effective Date of this Agreement as defined in paragraph II.14 pursuant to written instructions to be provided by HHS.Corrective Action Plan. Azul Vision has entered into and agrees to comply with the Corrective Action Plan (“CAP”), attached as Appendix A, which is incorporated into this Agreement by reference. If Azul Vision breaches the CAP and fails to cure the breach as set forth in the CAP, then Azul Vision will be in breach of this Agreement and HHS will not be subject to the Release set forth in paragraph II.8 of this Agreement.Release by HHS. In consideration of and conditioned upon Azul Vision’s performance of its obligations under this Agreement, HHS releases Azul Vision from any actions it may have against Azul Vision under the HIPAA Rules arising out of or related to the Covered Conduct associated with the compliance review identified in paragraph I.2 of this Agreement. HHS does not release Azul Vision from, nor waive any rights, obligations, or causes of action other than those arising out of or related to the Covered Conduct associated with the compliance review and referred to in this paragraph. This release does not extend to actions that may be brought under section 1177 of the Social Security Act, 42 U.S.C. § 1320d-6.Agreement by Released Parties. Azul Vision shall not contest the validity of its obligation to pay, nor the amount of, the Resolution Amount or any other obligations agreed to under this Agreement. Azul Vision waives all procedural rights granted under Section 1128A of the Social Security Act (42 U.S.C. § 1320a- 7a) and 45 C.F.R. Part 160 Subpart E, and HHS claims collection regulations at 45 C.F.R. Part 30, including, but not limited to, notice, hearing, and appeal with respect to the Resolution Amount.Binding on Successors. This Agreement is binding on Azul Vision and its successors, heirs, transferees, and assigns.Costs. Each Party to this Agreement shall bear its own legal and other costs incurred in connection with this matter, including the preparation and performance of this Agreement.No Additional Releases. This Agreement is intended to be for the benefit of the Parties only, and by this instrument the Parties do not release any claims against or by any other person or entity.Effect of Agreement. This Agreement constitutes the complete agreement between the Parties. All material representations, understandings, and promises of the Parties are contained in this Agreement. Any modifications to this Agreement shall be set forth in writing and signed by all Parties.Execution of Agreement and Effective Date. The Agreement shall become effective (i.e., final and binding) upon the date of signing of this Agreement and the CAP by the last signatory (“Effective Date”)Tolling of Statute of Limitations. Pursuant to 42 U.S.C. § 1320a-7a(c)(1), a CMP must be imposed within six (6) years from the date of the occurrence of the violation. To ensure that this six-year period does not expire during the term of this Agreement, Azul Vision agrees that the time between the Effective Date of this Agreement (as set forth in Paragraph 14) and the date the Agreement may be terminated by reason of Azul Vision’s breach, plus one-year thereafter, will not be included in calculating the six (6) year statute of limitations applicable to the violations which are the subject of this Agreement. Azul Vision waives and will not plead any statute of limitations, laches, or similar defenses to any administrative action relating to the Covered Conduct associated with the compliance review identified in paragraph I.2 that is filed by HHS within the time period set forth above, except to the extent that such defenses would have been available had an administrative action been filed on the Effective Date of this Agreement.Disclosure. HHS places no restriction on the publication of the Agreement. In addition, HHS may be required to disclose material related to this Agreement to any person upon request consistent with the applicable provisions of the Freedom of Information Act, 5 U.S.C. § 552, and its implementing regulations, 45 C.F.R. Part 5.Execution in Counterparts. This Agreement may be executed in counterparts, each of which constitutes an original, and all of which shall constitute one and the same agreement.Authorizations. The individual(s) signing this Agreement on behalf of Azul Vision represent and warrant that they are authorized by Azul Vision to execute this Agreement. The individual(s) signing this Agreement on behalf of HHS represent and warrant that they are signing this Agreement in their official capacities and that they are authorized to execute this Agreement.[SIGNATURES ON FOLLOWING PAGE]For Azul Vision/s/Michael SturgillCFO/COOAzul Vision, Inc.Date: 08/12/2026For the United States Department of Health and Human Services/s/Jamie Rahn BallayRegional ManagerOffice for Civil RightsDate: 08/13/2026APPENDIX ACORRECTIVE ACTION PLANBETWEEN THEDEPARTMENT OF HEALTH AND HUMAN SERVICESANDAZUL VISIONI. PreambleAzul Vision, Inc. (“Azul Vision”) hereby enters into this Corrective Action Plan (“CAP”) with the United States Department of Health and Human Services, Office for Civil Rights (“HHS”). Contemporaneously with this CAP, Azul Vision is entering into a Resolution Agreement (“Agreement”) with HHS, and this CAP is incorporated by reference into the Resolution Agreement as Appendix A. Azul Vision enters into this CAP as part of consideration for the release set forth in paragraph II.8 of the Agreement.II. Contact Persons and SubmissionsContact PersonsAzul Vision has identified the following individual as its authorized representative and contact person regarding the implementation of this CAP and for receipt and submission of notifications and reports:Rosa MontielDirector of Support Servicesrmontiel@azulvision.comHHS has identified the following individual as its authorized representative and contact person with whom Azul Vision is to report information regarding the implementation of this CAP:Jamie Rahn BallayRegional ManagerOffice for Civil RightsAzul Vision and HHS agree to promptly notify each other of any changes in the contact persons or the other information provided above.Proof of Submissions. Unless otherwise specified, all notifications and reports required by this CAP may be made by any means, including certified mail, overnight mail, or hand delivery, electronic mail, provided that there is proof that such notification was received. For purposes of this requirement, internal facsimile confirmation sheets do not constitute proof of receipt. If sent by electronic mail, then an acknowledgement by the individual addressee shall be required for proof of receipt of such notification.III. Effective Date and Term of CAPThe Effective Date for this CAP shall be calculated in accordance with paragraph II.14 of the Agreement (“Effective Date”). The period for compliance (“Compliance Term”) with the obligations assumed by Azul Vision under this CAP shall begin on the Effective Date of this CAP and end two (2) years from the Effective Date, unless HHS has notified Azul Vision under Section VIII hereof of its determination that Azul Vision breached this CAP. In the event HHS notifies Azul Vision of a breach under section VIII hereof, the Compliance Term shall not end until HHS notifies Azul Vision that HHS has determined Azul Vision failed to meet the requirements of section VIII.C of this CAP and issues a written notice of intent to proceed with an imposition of a civil money penalty against Azul Vision pursuant to 45 C.F.R. Part 160. After the Compliance Term ends, Azul Vision shall still be obligated to: (a) submit the final Annual Report as required by section VI; and (b) comply with the document retention requirement in section VII. Nothing in this CAP is intended to eliminate or modify Azul Vision’s obligation to comply with the document retention requirements in 45 C.F.R. § 164.316(b) and § 164.530(j).IV. TimeIn computing any period of time prescribed or allowed by this CAP, all days referred to shall be calendar days. The day of the act, event, or default from which the designated period of time begins to run shall not be included. The last day of the period so computed shall be included, unless it is a Saturday, a Sunday, or a legal holiday, in which event the period runs until the end of the next day which is not one of the aforementioned days.V. Corrective Action ObligationsAzul Vision agrees to the following:Policies and Procedures for Individual Access to Protected Health InformationWithin thirty (30) days of the Effective Date, Azul Vision shall review, and to the extent necessary, revise its policies and procedures to comply with the Federal Standards that govern the privacy of individually identifiable health information (45 C.F.R. Part 160 and Subparts A and E of Part 164, the “Privacy Rule”). Such policies and procedures shall include, but not be limited to, the right of access to protected health information (45 C.F.R. § 164.524), including the reasonable, cost-based fee Azul Vision will impose for access.Within sixty (60) days of the Effective Date, Azul Vision shall distribute the Policies and Procedures to all workforce members, and to new workforce members on or before the later of the end of the aforementioned sixty (60) day period or within thirty (30) days of their beginning of service as necessary and appropriate for the performance of their job duties.Azul Vision shall require, at the time distribution of such Policies and Procedures, a signed written of electronic initial compliance certification from workforce members stating that the workforce members have read, understand, and shall abide by such Policies and Procedures.Azul Vision shall assess, update, and revise, as necessary, the Policies and Procedures at least annually or as needed.Access Request Status RequirementsWithin ninety (90) calendar days of the Effective Date and every ninety (90) calendar days thereafter while under the Term of this CAP, Azul Vision shall submit to HHS a list of requests for access to protected health information received by Azul Vision, including the date request received, date request completed, format requested, format provided, number of pages (if provided in paper format), and cost (excluding postage).If Azul Vision denied any request for access, in whole or in part, Azul Vision shall submit to HHS all documentation consistent with 45 C.F.R. § 164.524(d).Right of Access TrainingAzul Vision shall provide training on the right of access (45 C.F.R. § 164.524) and Azul Vision’s policies and procedures implementing the right of access, for each workforce member within ninety (90) days from the Effective Date and at least once every twelve (12) months thereafter. Azul Vision shall also provide such training to each new member of the workforce or relevant new business associate within thirty (30) days of their beginning of service.Each workforce member who is required to attend right of access training shall certify, in electronic or written form, that he or she has received the training. The training certification shall specify the date training was received. All course materials shall be retained in compliance with section VII.Azul Vision shall review the right of access training at least annually, and, where appropriate, update the training to reflect changes in Federal law or HHS guidance, any issues discovered during audits or reviews, and any other relevant developments.Reportable EventsDuring the Compliance Term, Azul Vision shall, upon receiving information that a workforce member may have failed to comply with its access policies and procedures, promptly investigate this matter. If Azul Vision determines, after review and investigation, that a member of its workforce has failed to comply with these policies and procedures, Azul Vision shall notify HHS in writing within thirty (30) days. Such violations shall be known as Reportable Events. The report to HHS shall include the following information:A complete description of the event, including the relevant facts, the persons involved, and the provision(s) of the policies and procedures implicated; andA description of the actions taken and any further steps Azul Vision plans to take to address the matter to mitigate any harm, and to prevent it from recurring, including application of appropriate sanctions against workforce members who failed to comply with its Privacy Rule policies and procedures.VI. Annual ReportsThe one (1) year period after the Effective Date and each subsequent one (1) year period during the course of the Compliance Term shall be known as a “Reporting Period.” Within sixty (60) calendar days after the close of each corresponding Reporting Period, Azul Vision shall submit a report to HHS regarding Azul Vision compliance with this CAP for each corresponding Reporting Period (“Annual Report”). The Annual Report shall include:An attestation signed by an owner or officer of Azul Vision attesting that the Policies and Procedures were reviewed, revised, and distributed as required by Section V.A.An attestation signed by an owner or officer of Azul Vision attesting that all members of the workforce have completed the training required by section V.C during the Reporting Period;A summary of Reportable Events (defined in section V.D), if any, the status of any corrective and preventative action(s) relating to all such Reportable Events, or an attestation signed by an officer or director of Azul Vision stating that no Reportable Events occurred during the Compliance Term.An attestation signed by an owner or officer of Azul Vision attesting that he or she has reviewed the Annual Report, has made a reasonable inquiry regarding its content and believes that, upon such inquiry, the information is accurate and truthful.VII. Document RetentionAzul Vision shall maintain for inspection and copying, and shall provide to HHS, upon request, all documents and records relating to compliance with this CAP for six (6) years from the Effective Date.VIII. Requests for Extensions and Breach ProvisionsAzul Vision is expected to fully and timely comply with all provisions contained in this CAP.Timely Written Requests for Extensions. Azul Vision may, in advance of any due date set forth in this CAP, submit a timely written request for an extension of time to perform any act required by this CAP. A “timely written request” is defined as a request in writing received by HHS at least five (5) calendar days prior to the date such an act is required or due to be performed.Notice of Breach of this CAP and Intent to Impose Civil Monetary Penalty. The parties agree that a breach of this CAP by Azul Vision constitutes a breach of the Agreement. Upon a determination by HHS that Azul Vision has breached this CAP, HHS may notify Azul Vision of: (1) Azul Vision’s breach; and (2) HHS’ intent to impose a CMP, pursuant to 45 C.F.R. Part 160, or other remedies, for the Covered Conduct set forth in paragraph I.2 of the Agreement and for any other conduct that constitutes a violation of the HIPAA Privacy, Security, and Breach Notification Rules (“Notice of Breach and Intent to Impose CMP”).Azul Vision Response. Azul Vision shall have thirty (30) calendar days from the date of receipt of the Notice of Breach and Intent to Impose CMP to demonstrate to HHS’ satisfaction that:Azul Vision is in compliance with the obligations of the CAP that HHS cited as the basis for the breach;the alleged breach has been cured; orthe alleged breach cannot be cured within the thirty (30) day period, but that: (a) Azul Vision has begun to take action to cure the breach; (b) Azul Vision is pursuing such action with due diligence; and (c) Azul Vision has provided to HHS a reasonable timetable for curing the breach.Imposition of CMP. If at the conclusion of the thirty (30) day period, Azul Vision fails to meet the requirements of section VIII.C of this CAP to HHS’s satisfaction, HHS may proceed with the imposition of the CMP against Azul Vision pursuant to 45 C.F.R. Part 160 for any violations of the Covered Conduct set forth in paragraph 2 of the Agreement and for any other act or failure to act that constitutes a violation of the HIPAA Rules. HHS shall notify Azul Vision in writing of its determination to proceed with the imposition of the CMP.[Signatures on Following Page]For Azul Vision:/s/Michael SturgillCFO/COOAzul Vision, IncDate: 08/12/2026For the United States Department of Health and Human Services/s/Jamie Rahn BallayRegional ManagerOffice for Civil RightsDate: 08/13/2026 Content last reviewed August 27, 2026