Resolution Agreement with Vision Upright MRI

RESOLUTION AGREEMENT

I. Recitals

  1. Parties. The Parties to this Resolution Agreement (“Agreement”) are:
    1. 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).
    2. Vison Upright MRI LLC (VUM) is a covered entity, as defined by 45 C.F.R. § 160.103, and therefore is required to comply with the HIPAA Rules. VUM is a health care provider, conducting magnetic resonance imaging (MRI) and related services. It operates one facility in San Jose, California.
    3. HHS and VUM shall together be referred to herein as the “Parties.”

  2. Factual Background and Covered Conduct.

    VUM maintains a picture and archiving communications system (PACS) server containing medical images including x-rays, MRI, and CT scans. OCR obtained information alleging that PHI maintained or stored by VUM was accessible via the internet and disclosed as the result of an unsecure PACS server. On December 1, 2020, HHS notified VUM of its investigation into VUM’s compliance with the applicable Federal Standards for Privacy of Individually Identifiable Health Information and/or the Security Standards for the Protection of Electronic Protected Health Information (45 C.F.R. Parts 160 and 164, Subparts A, C, and E, the Privacy and Security Rules), and the Breach Notification Rule (45 C.F.R. Parts 160 and 164, Subpart D).

    HHS’s investigation indicated that the following conduct occurred (“Covered Conduct”):

    1. VUM has never conducted an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of the electronic protected health information that it holds. See 45 C.F.R. § 164.308(a)(1)(ii)(A).
    2. VUM failed to notify affected individuals of a breach within 60 days of discovery of the breach (see 45 C.F.R. § 164.404(a)).
  3. No Admission. This Agreement is not an admission of liability by VUM.
  4. No Concession. This Agreement is not a concession by HHS that VUM is not in violation of the HIPAA Rules and not liable for civil money penalties.
  5. Intention of Parties to Effect Resolution. This Agreement is intended to resolve OCR Transaction Number 21-404385 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 the uncertainty, burden, and expense of formal proceedings, the Parties agree to resolve this matter according to the Terms and Conditions below.

II. Terms and Conditions

  1. Payment. HHS has agreed to accept, and VUM has agreed to pay HHS, the amount of $25,000 (“Resolution Amount”). VUM agrees to pay the Resolution Amount in one lump sum on the Effective Date of this Agreement as defined in paragraph II.14 by automated clearing house transaction pursuant to written instructions to be provided by HHS.
  2. Corrective Action Plan. VUM 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 VUM breaches the CAP and fails to cure the breach as set forth in the CAP, then VUM 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.
  3. Release by HHS. In consideration of and conditioned upon VUM’s performance of its obligations under this Agreement, HHS releases VUM from any actions it may have against VUM under the HIPAA Rules arising out of or related to the Covered Conduct identified in paragraph I.2 of this Agreement. HHS does not release VUM from, nor waive any rights, obligations, or causes of action other than those arising out of or related to the Covered Conduct 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.
  4. Agreement by Released Parties. VUM 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. VUM 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.
  5. Binding on Successors. This Agreement is binding on VUM and its successors, heirs, transferees, and assigns.
  6. 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.
  7. 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.
  8. 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. 
  9. Execution of Agreement and Effective Date. The Agreement shall become effective (e., final and binding) upon the date of signing of this Agreement and the CAP by the last signatory (Effective Date).
  10. Tolling of Statute of Limitations. Pursuant to 42 U.S.C. § 1320a-7a(c)(1), a civil money penalty (“CMP”) must be imposed within six 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, VUM 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 VUM’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. VUM waives and will not plead any statute of limitations, laches, or similar defenses to any administrative action relating to the covered conduct 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.
  11. Disclosure. HHS places no restriction on the publication of the Agreement. This Agreement and information related to this Agreement may be made public by either Party.
  12. 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. 
  13. Authorizations. The individual(s) signing this Agreement on behalf of VUM represents and warrants that they are authorized 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.

For Vison Upright MRI LLC

/s/ 02/12/2025

Dr. Matthew Janzeh, Managing Member Date

For the United States Department of Health and Human Services

/s/ 02/12/2025

Andrea Oliver Date
Regional Manager
Office for Civil Rights, Rocky Mountain Region
 

Appendix A

CORRECTIVE ACTION PLAN
BETWEEN THE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
VISION UPRIGHT MRI LLC

  1. Preamble

    Vision Upright MRI LLC (VUM) 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, VUM is entering into a Resolution Agreement (Agreement) with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A. VUM enters into this CAP as part of the consideration for the release set forth in paragraph II.8 of the Agreement. 

  2. Contact Persons and Submissions

    1. Contact Persons 

      VUM 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:

      Blake Bush
      828 South Bascom Ave, Suite 110
      San Jose, CA 95128
      REDACTED

      Dr. Matthew Janzen
      828 South Bascom Ave, Suite 110
      San Jose, CA 95128
      REDACTED

      HHS has identified the following individual as its authorized representative and contact person with whom VUM is to report information regarding the implementation of this CAP:

      Andrea Oliver, Regional Manager
      Office for Civil Rights, Rocky Mountain Region
      U.S. Department of Health and Human Services
      1961 Stout Street, Room 08-148
      Denver, Colorado 80294
      Voice Phone (303) 844-7915

      VUM and HHS agree to promptly notify each other of any changes in the contact person or the other information provided above.

    2. 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, electronic mail, or hand delivery, 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.

  3. Effective Date and Term of CAP

    The 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 VUM 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 VUM under section VIII hereof of its determination that VUM has breached this CAP. In the event of such a notification by HHS under section VIII hereof, the Compliance Term shall not end until HHS notifies VUM that it has determined that the breach has been cured. After the Compliance Term ends, VUM 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 VUM’s obligation to comply with the document retention requirements in 45 C.F.R. §§ 164.316(b) and 164.530(j).

  4. Time

    In 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.

  5. Corrective Action Obligations

    VUM agrees to the following:

    1. Breach Notification
      1. Within sixty (60) calendar days of the Effective Date, VUM shall provide OCR its draft breach notification to all individuals whose PHI was maintained on the PACS server before it was secured in December 2020 in a manner consistent with the requirements of 45 C.F.R. § 164.404. Upon OCR’s approval of the breach assessment and breach notification, VUM shall issue the approved individual notification to affected individuals and provide evidence of this notification to HHS.
      2. Within sixty (60) calendar days of the Effective Date, VUM shall provide draft media notification to OCR. Upon OCR’s approval, VUM will provide the approved media notification relating to the breach of PHI that was maintained on the PACS server before it was secured in December 2020 in a manner consistent with the requirements of 45 C.F.R. § 164.406. VUM shall provide evidence of this notification and the identity of the media outlets to which it was sent to HHS.
      3. Within sixty (60) calendar days of the Effective Date, VUM shall submit a breach report to HHS in relation to the breach of PHI that was maintained on the PACS server before it was secured in December 2020 in a manner consistent with the requirements of 45 C.F.R. § 164.408. VUM shall provide evidence of this notification to HHS.
    2. Conduct a Risk Analysis
      1. VUM shall conduct and complete an accurate and thorough analysis of security risks and vulnerabilities that incorporates all electronic equipment, data systems, programs and applications controlled, administered, owned, or shared by VUM that contain, store, transmit or receive VUM electronic protected health information (ePHI). As part of this process, VUM shall include a complete inventory of all electronic equipment, data systems, off-site data storage facilities, and applications that contain or store ePHI which will then be incorporated in its risk analysis. The risk analysis will include vulnerability scans and penetration testing.
      2. Within 60 calendar days of the Effective Date, VUM shall submit to HHS the scope and methodology by which it proposes to conduct the risk analysis. HHS shall notify VUM whether the proposed scope and methodology is or is not consistent with 45 C.F.R. § 164.308 (a)(l)(ii)(A).
      3. VUM shall provide evidence that it completed the risk analysis to HHS within 60 days of HHS’ approval of the scope and methodology for HHS’ review.
      4. Upon submission by VUM, HHS shall review and recommend changes to the aforementioned risk analysis. Upon receiving HHS’ recommended changes, VUM shall have 30 calendar days to submit a revised risk analysis. This process will continue until HHS provides final approval of the risk analysis.
      5. VUM shall no less than annually and on an ongoing basis, conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by VUM, affiliates that are owned, controlled, or managed by VUM; and document the security measures VUM implemented or is implementing to sufficiently reduce the identified risks and vulnerabilities to a reasonable and appropriate level. Subsequent risk analyses and corresponding management plans shall be submitted for review by HHS in the same manner as described in this section until the conclusion of the CAP.
    3. Develop and Implement a Risk Management Plan
      1. VUM shall develop an enterprise-wide risk management plan to address and mitigate any security risks and vulnerabilities identified in the risk analysis specified in section V.B.1 above. The risk management plan shall include a process and timeline for VUM’s implementation, evaluation, and revision of its risk remediation activities.
      2. Within 60 calendar days of HHS’ final approval of the risk analysis described in section V.B.1 above, VUM shall submit a risk management plan to HHS for HHS’ review and approval. HHS shall approve, or, if necessary, require revisions to VUM’s risk management plan.
      3. Upon receiving HHS’ notice of required revisions, if any, VUM shall have 30 calendar days to revise the risk management plan accordingly and forward for review and approval. This process shall continue until HHS approves the risk management plan.
      4. Within 60 calendar days of HHS’ approval of the risk management plan, VUM shall finalize and officially adopt the risk management plan in accordance with its applicable administrative procedures.
    4. Policies and Procedures
      1. VUM shall develop, maintain, and revise, as necessary, its written policies and procedures to comply with the Federal Standards for the Privacy of Individually Identifiable Health Information and the Security Standards for the Protection of Electronic Protected Health Information (45 C.F.R. Parts 160 and 164, Subparts A, C, and E, the Privacy and Security Rules), and the Breach Notification for Unsecured Protected Health Information Regulations (45 C.F.R. Parts 160 and 164, Subpart D, the Breach Notification Rule) (collectively “HIPAA Rules”) to address:
        1. Breach Assessment and Notification Obligations - 45 C.F.R. § 164.402 et. seq.
        2. Risk Analysis - 45 C.F.R. § 308(a)(1)(ii)(A); and
        3. Risk Management - 45 C.F.R. § 308(a)(1)(ii)(B).
      2. VUM shall provide such policies and procedures to HHS within 60 calendar days of receipt of HHS’ approval of the risk management plan required by paragraph V.C. above.
      3. Upon receiving HHS’ notice of required revisions, if any, VUM shall have 30 calendar days to revise the policies and procedures accordingly and provide the revised policies and procedures to HHS for review and approval. This process shall continue until HHS approves the policies and procedures.
      4. Within 60 calendar days of HHS’ approval of the policies and procedures, VUM shall implement such policies and procedures.
    5. Distribution of Policies and Procedures
      1. Upon HHS’ approval of policies and procedures in Section V.D., VUM shall distribute the approved policies and procedures to all members of the workforce who have access to ePHI during VUM’s reoccurring annual training or within 60 calendar days of HHS’ approval of such policies, whichever comes first. VUM shall also distribute such policies and procedures to new workforce members whose job duties involve access to ePHI within 30 days of their beginning service.
      2. VUM shall require, at the time of distribution of such policies and procedures, a signed written or electronic initial compliance certification from all workforce members stating that such workforce members have read, understand, and shall abide by such policies and procedures.
      3. VUM shall assess, update, and revise, as necessary, the policies and procedures at least annually during the Compliance Term (and more frequently if appropriate). VUM shall provide any revised policies and procedures to HHS for review and approval. Within 30 days of any approved substantive revisions by HHS, VUM shall distribute such revised policies and procedures to all members of its workforce and shall require new compliance certifications.
      4. VUM shall not provide any member of its workforce with access to ePHI if that workforce member has not signed or provided the written or electronic certification required by paragraph 2 of this
    6. Reportable Events
      1. During the Compliance Term, VUM shall, upon learning that a workforce member likely failed to comply with its policies and procedures described in Section V.D., promptly investigate this matter. If VUM, after review and investigation, determines that a member of its workforce has failed to comply with its policies and procedures, VUM shall report such events to HHS as provided in Section VI.B.1.c on a quarterly basis. Such violations shall be known as Reportable Events. The report to HHS shall include the following:
        1. A complete description of the event, including the relevant facts, the persons involved, and the applicable provision(s) of VUM’s Privacy, Security, and Breach Notification Policies and Procedures; and
        2. A description of the actions taken and any further steps VUM plans to take to address the matter to mitigate any harm, and to prevent it from recurring, including the application of appropriate sanctions against workforce members who failed to comply with its Privacy, Security, and Breach Notification Policies and Procedures.
        3. If no Reportable Events occur during the Compliance term, VUM shall so inform HHS in the Implementation Report as specified in Section VI below.
    7. Training
      1. VUM shall provide HHS with copies of VUM’s training materials on the privacy and security of ePHI and breach notification for all members of the workforce that have access to ePHI within thirty (30) calendar days of receiving HHS’ final approval of policies and procedures described in Section V.D. 
      2. Upon receiving HHS’ notice of required revisions, if any, VUM shall have thirty (30) calendar days to revise the training materials accordingly and provide the revised training materials to HHS for review and approval. This process shall continue until HHS approves the training materials.
      3. Upon receiving approval from HHS of any training materials, VUM shall provide training on the approved training materials for each workforce member who has access to ePHI within thirty (30) calendar days of HHS’ approval and annually thereafter.
      4. VUM shall also provide such training to each new member of the workforce within thirty (30) calendar days of their beginning of service. Each workforce member who is required to attend 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.
      5. VUM shall review the 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, or any other relevant developments.
  6. Implementation Report and Annual Reports
    1. Implementation Report. 
      1. Within one hundred twenty (120) calendar days after the receipt of HHS’s approval of the policies and procedures required by section V.D., VUM shall submit a written report to HHS summarizing the status of its implementation of the requirements of this CAP. This report, known as the “Implementation Report,” shall include:
        1. An attestation signed by an owner or officer of VUM attesting that the policies and procedures approved by HHS in section V.D. are being implemented;
        2. An attestation signed by an owner or officer of VUM attesting that all members of the workforce have completed the initial training required by section V.G;
        3. An attestation signed by an owner or officer of VUM stating that he or she has reviewed the Implementation Report, has made a reasonable inquiry regarding its content and believes that, upon such inquiry, the information is accurate and truthful.
    2. Annual Reports.  
      1. The 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, VUM shall submit a report to HHS regarding VUM’s compliance with this CAP for each corresponding Reporting Period (“Annual Report”).
        1. An attestation signed by an owner or officer of VUM attesting that all members of the workforce have completed the training required by section V.G during the Reporting Period;
        2. An attestation signed by an owner or officer of VUM attesting that any revision(s) to the policies and procedures required by section V.D were finalized and adopted within thirty (30) calendar days of HHS’ approval of the revision(s), which shall include a statement affirming that VUM distributed the revised policies and procedures to all appropriate members of VUM’s workforce within sixty (60) calendar days of HHS’ approval of the revision(s);
        3. A summary of Reportable Events (defined in V.F), if any, the status of any corrective and preventative action(s) relating to all such Reportable Events, or an attestation signed by an owner or officer of VUM stating that no Reportable Events occurred during the Compliance Term.
        4. An attestation signed by an owner or officer of VUM 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.

  7. Document Retention

    VUM 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.

  8. Requests for Extensions and Breach Provisions
    1. Timely Written Requests for Extensions. VUM 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. This requirement may be waived by HHS only.
    2. Notice of Breach of this CAP and Intent to Impose Civil Monetary Penalty. The parties agree that a breach of this CAP by VUM constitutes a breach of the Agreement. Upon a determination by HHS that VUM has breached this CAP, HHS may notify VUM of: (1) VUM’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”).
    3. VUM’s Response. VUM 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:
      1. VUM is in compliance with the obligations of the CAP that HHS cited as the basis for the breach;
      2. The alleged breach has been cured; or
      3. The alleged breach cannot be cured within the 30-day period, but that: (a) VUM has begun to take action to cure the breach; (b) VUM is pursuing such action with due diligence; and (c) VUM has provided to HHS a reasonable timetable for curing the breach.
    4. Imposition of CMP. If at the conclusion of the 30-day period, VUM fails to meet the requirements of this CAP to HHS’ satisfaction, HHS may proceed with the imposition of the CMP against VUM pursuant to 45 C.F.R. Part 160 for any violations of the Covered Conduct set forth in paragraph 1.2 of the Agreement and for any other act or failure to act that constitutes a violation of the HIPAA Rules. HHS shall notify VUM in writing of its determination to proceed with the imposition of the CMP.

For Vison Upright MRI LLC

/s/ 02/12/2025

Dr. Matthew Janzeh, Managing Member Date

For the United States Department of Health and Human Services

/s/ 02/12/2025

Andrea Oliver Date
Regional Manager
Office for Civil Rights, Rocky Mountain Region

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