Heritage Valley Health System Resolution Agreement and Corrective Action Plan

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. Heritage Valley Health System (“HVHS”), which is a covered entity, as defined at 45 C.F.R. § 160.103, and therefore is required to comply with the HIPAA Rules. HVHS is an integrated delivery network providing comprehensive health care for residents of Allegheny, Beaver, Butler and Lawrence counties, in Pennsylvania, eastern Ohio, and the panhandle of West Virginia. As a medical provider which transmits health information in electronic form in connection with a transaction for which HHS has adopted standards, HVHS is a covered entity that is required to comply with the Security Rules.
    3. HHS and HVHS shall together be referred to herein as the “Parties.”
  2. Factual Background and Covered Conduct. On October 31, 2017, OCR initiated a compliance review of HVHS after media reports that HVHS had experienced a data security incident. The evidence gathered by OCR in its compliance review demonstrates HVHS’s noncompliance with the Security Rule. HHS’ investigation identified potential violations of the following provisions (“Covered Conduct”):
    1. The requirement to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity and availability of all of its electronic protected health information (ePHI). (See 45 C.F.R. § 164.308(a)(1)(ii)(A)).
    2. The requirement to establish and implement policies and procedures for responding to an emergency or other occurrence, such as a fire, vandalism, system failure, and natural disaster, that damages systems that contain ePHI (See 45 C.F.R. § 164.308(a)(7)).
    3. The requirement to implement technical policies and procedures for electronic information systems that maintain ePHI to allow access only to those persons or software programs that have been granted access rights as specified in § 164.308(a)(4) (See 45 C.F.R. § 164.312(a)(1)).
  3. No Admission. This Agreement is not an admission, concession or evidence of liability by HVHS.
  4. No Concession. This Agreement is not a concession by HHS that HVHS is not in violation of the HIPAA Rules and not liable for civil money penalties (“CMPs”).
  5. Intention of Parties to Effect Resolution. This Agreement is intended to resolve OCR Transaction Number: 18-286616 and any potential 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 further investigation and 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 HVHS has agreed to pay HHS, the amount of $950,000 (“Resolution Amount”). HVHS agrees to pay the Resolution Amount in one lump sum within two (2) days of 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. HVHS 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 HVHS breaches the CAP and fails to cure the breach as set forth in the CAP, then HVHS 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 HVHS’s performance of its obligations under this Agreement, HHS releases HVHS from any actions it may have against HVHS 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 HVHS 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. HVHS 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. HVHS 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 HVHS 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 (i.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 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, HVHS agrees that the time between the Effective Date of this Agreement (as set forth in paragraph II.14) and the date the Agreement may be terminated by reason of HVHS’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. HVHS waives and will not plead any statute of limitations, laches, or similar defenses to any administrative action relating to the Factual Background and 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. 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.
  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 HVHS represent and warrant that they are authorized by HVHS 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 Heritage Valley Health System

/s/

Norman F. Mitry
President and CEO

02/19/2024

Date

For the United States Department of Health and Human Services

/s/

Jamie Rahn Ballay
Regional Manager
Office for Civil Rights

02/20/2024

Date

Corrective Action Plan

Between the

U.S Department of Health and Human Services

And

Heritage Valley Health System

I. Preamble

Heritage Valley Health System (“HVHS”) 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, HVHS is entering into a Resolution Agreement (“Agreement”) with HHS, and this CAP is incorporated by reference into the Resolution Agreement as Appendix A. HVHS enters into this CAP as part of consideration for the release set forth in paragraph II.8 of the Agreement.

II. Contact Persons and Submissions

  1. Contact Persons

    HVHS 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:

    Robert C. Swaskoski
    Vice President Enterprise Risk Management and Chief Security Officer
    Heritage Valley Health System, Inc.
    720 Blackbum Road
    Sewickley, PA 15143
    Phone: 724-773-2127
    Fax: 412-749-7400

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

    Jamie Rahn Ballay, Regional Manager 
    Mid-Atlantic Region
    Office for Civil Rights
    U.S. Department of Health and Human Services

    HVHS and HHS agree to promptly notify each other of any changes in the contact persons 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, 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.

III. 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 HVHS under this CAP shall begin on the Effective Date of this CAP and end three (3) years from the Effective Date, unless before the end of the three year period, HHS has notified HVHS under Section VIII.B hereof of its determination that HVHS breached this CAP. In the event HHS notifies HVHS of a breach under section VIII.B hereof, the Compliance Term shall not end until HHS notifies HVHS that HHS has determined HVHS 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 HVHS pursuant to 45 C.F.R. Part 160. After the Compliance Term ends, HVHS 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 HVHS’s obligation to comply with the document retention requirements in 45 C.F.R. § 164.316(b) and § 164.530(j).

IV. 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.

V. Corrective Action Obligations

HVHS agrees to the following:

  1. Security Management Process
    1. HVHS shall conduct a comprehensive and thorough Risk Analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of PHI held by HVHS. This Risk Analysis shall incorporate all HVHS facilities, whether owned or rented, and evaluate the risks to the PHI on all of its electronic equipment, data systems, and applications controlled, administered or owned by HVHS or any HVHS entity, that contain, store, transmit, or receive PHI. Prior to conducting the Risk Analysis, HVHS shall develop a complete inventory of all of its facilities, electronic equipment, data systems, and applications that contain or store ePHI that will then be incorporated into its Risk Analysis.
    2. Within sixty (60) calendar days of the Effective Date, HVHS shall submit to HHS the scope and methodology by which it proposes to conduct the risk analysis. HHS shall notify HVHS whether the proposed scope and methodology is or is not consistent with 45 C.F.R. § 164.308 (a)(l)(ii)(A).
    3. HVHS shall provide the Risk Analysis, consistent with section V.A.1, to HHS within one hundred and twenty (120) days of HHS’s approval of the scope and methodology described in paragraph V.A.2. for HHS’ review. Upon submission by HVHS, HHS shall review and recommend changes to the Risk Analysis within sixty (60) days of its receipt. If HHS requires revisions to the Risk Analysis, HHS shall provide HVHS with a detailed, written explanation of such required revisions and with comments and recommendations so that HVHS may prepare a revised Risk Analysis. Upon receiving HHS’s recommended changes, HVHS shall have sixty (60) days in which to revise its Risk Analysis accordingly, and then submit the revised Risk Analysis to HHS for review and approval. This submission and review process shall continue until HHS approves the Risk Analysis.
    4. HVHS shall develop an enterprise-wide Risk Management Plan to address and mitigate any security risks and vulnerabilities found in the Risk Analysis described above in paragraph V.A.1. The Risk Management Plan shall include a process and timeline for HVHS’s implementation, evaluation, and revision of its risk remediation activities. HVHS may submit a Risk Management Plan currently underway for consideration by HHS for compliance with this provision.
    5. Within ninety (90) days of HHS’ final approval of the Risk Analysis described in section V.A.3 above, HVHS shall submit HVHS’ Risk Management Plan for HHS’ review. Within sixty (60) days of its receipt of HVHS’ Risk Management Plan, HHS will inform HVHS whether HHS approves the Risk Management Plan or HHS requires revisions. If HHS requires revisions to the Risk Management Plan, HHS shall provide HVHS with a written explanation of the basis of its revisions, including comments and recommendation that HVHS can use to prepare a revised Risk Management Plan. Upon receiving HHS’s notice of required revisions, if any, HVHS shall have sixty (60) days in which to revise its Risk Management Plan accordingly and submit the revised Risk Management Plan to HHS for review and approval. This submission and review process shall continue until HHS approves the Risk Management Plan. Within sixty (60) days of HHS’s approval of the Risk Management Plan, HVHS shall finalize and officially adopt the Risk Management Plan in accordance with its applicable administrative procedures.
    6. HVHS shall review the Risk Analysis annually and shall also promptly update the Risk Analysis in response to environmental or operational changes affecting the security of ePHI. Following an update to the Risk Analysis, HVHS shall assess whether its existing security measures are sufficient to protect its electronic PHI, and revise its risk management plan, policies and procedures, and training materials, as needed.
  2. Policies and Procedures
    1. HVHS shall review and develop, maintain, and revise, as necessary, its written policies and procedures to address the Minimum Content set forth in Section V.D. to achieve compliance with the Federal standards that govern the privacy and security of individually identifiable health information (45 C.F.R. Part 160 and 164, Subpart C (the “Security Rule”).
    2. HVHS shall provide the policies and procedures identified in section V.B.1 above to HHS for review and approval within sixty (60) days of HHS’ approval of the Risk Management Plan, as required by V.A.5. Upon receiving any recommended changes to such policies and procedures from HHS, HVHS shall have forty-five (45) days to revise such policies and procedures accordingly and provide the revised policies and procedures to HHS for review and approval. This process shall continue until HHS approves such policies and procedures.
    3. HVHS shall adopt (in accordance with its applicable administrative procedures) the policies and procedures approved by HHS pursuant to section V.B.2 within thirty (30) days of receipt of HHS’ approval.
  3. Distribution and Updating of Policies and Procedures
    1. HVHS shall distribute (in accordance with its applicable administrative procedures) the policies and procedures identified in Section V.B to all members of the workforce and all business associates that have access to PHI within thirty (30) days of the adoption of such policies pursuant to Section V.B.3 and to new members of the workforce and new business associates that have such access within thirty (30) days of their start date.
    2. HVHS shall provide proof of the distribution and/or postings of policies and procedures described in C.1 above to HHS within thirty (30) days of such distribution or posting.
    3. HVHS shall assess, update, and revise, as necessary, the policies and procedures at least annually (and more frequently if appropriate). HVHS shall provide any substantively revised policies and procedures identified in Section V.B to HHS for review and approval within thirty (30) days of revision. Within thirty (30) days of HHS’s approval of such substantive revisions, HVHS shall distribute the revised policies and procedures to all members of its workforce and business associates, as appropriate, in accordance with its applicable administrative procedures.
  4. Minimum Content of the Policies and Procedures
    1. The Policies and Procedures subject to this CAP shall include policies and procedures that address the following Security Rule provisions:
      1. Risk Analysis---45 C.F.R. § 164.308(a)(1)(ii)(A), including provisions to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of ePHI held by HVHS and to conduct the accurate and thorough assessment at least on an annual basis.
      2. Risk Management---45 C.F.R. § 164.308(a)(1)(ii)(B), including provisions to implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level to comply with § 164.306(a).
      3. Information System Activity Review---45 C.F.R. § 164.308(a)(1)(ii)(D), including procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.
      4. Password Management---45 C.F.R. § 164.308(a)(5)(ii)(D), including procedures for creating, changing, and safeguarding passwords.
      5. Access Control—45 C.F.R. § 164.312(a)(1), including provisions to address access between systems, such as network or portal segmentation, provisions to limit access to ePHI to individuals and software programs granted access rights, and provisions to enforce password management requirements, such as password age, and encryption and decryption.
      6. Contingency Planning---45 C.F.R. § 164.308(a)(7), including provisions that address responding to an emergency or other occurrence that damages systems that contain ePHI specifically a comprehensive Data Backup Plan, Disaster Recovery Plan, Emergency Mode Operation Plan, and following an assessment whether such is reasonable and appropriate, provisions related to testing and revision procedures and applications and data criticality analysis.
      7. Business Associate Agreements---45 C.F.R. § 164.308(b), including provisions to document satisfactory assurances from business associates through a written contract or other arrangement with the business associate that meets the requirements of § 164.314(a).
  5. Reportable Events
    1. During the Compliance Term, HVHS shall, upon learning that a workforce member (or business associate) likely failed to comply with its policies and procedures described in Section V.B, promptly investigate this matter. If HVHS, after review and investigation, determines that a member of its workforce or a business associate has failed to comply with its policies and procedures and such failure was material, HVHS shall report the event to HHS as provided in section VI.B.3. 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 HVHS’s policies and procedures described in Section V.B; and
      2. A description of the actions taken and any further steps HVHS plans to take to address the matter to mitigate any harm, and to prevent it from recurring, including application of any appropriate sanctions against workforce members who failed to comply with its policies and procedures described in Section V.B. If no Reportable Events occur during the Compliance term, HVHS shall so inform HHS in the Annual Report as specified in Section VI below.
  6. Training
    1. HVHS shall provide HHS with HIPAA Security Rule training materials for all members of the workforce that have access to PHI within thirty (30) days of HHS approval of HVHS policies and procedures pursuant to section V.B.2.
    2. Upon receiving notice from HHS specifying any recommended changes, HVHS shall have thirty (30) days to revise its training materials accordingly and provide the revised training materials to HHS for review and approval.
    3. Within sixty (60) days after receiving HHS’ final approval and at least every 12 months thereafter, HVHS shall provide training for each workforce member who has access to PHI. HVHS shall also provide such training to each new member of the workforce who has access to PHI within 30 days of their start date and in accordance with HVHS’s applicable administrative procedures.
    4. 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. HVHS 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, and any other relevant developments.

VI. Implementation Report and Annual Reports

  1. Implementation Report. Within one hundred twenty (120) days after HVHS’ adoption of the training materials specified in Section V.F above, HVHS shall submit a written report with the documentation described below to HHS for review and approval (“Implementation Report”). The Implementation Report shall include:
    1. An attestation signed by an officer of HVHS attesting that the policies and procedures described in Section V.B are being implemented, have been distributed to all appropriate members of the workforce in accordance with HVHS’s applicable administrative procedures and business associates;
    2. A copy of all training materials used for the training required by this CAP, a description of the training, including a summary of the topics covered, the length of the session(s) and a schedule of when the training session(s) were held;
    3. An attestation signed by an officer of HVHS attesting that all members of the workforce have completed the initial training required by this CAP and have executed the training certifications required by Section V.F.4;
    4. An attestation signed by an officer of HVHS listing all HVHS locations (including locations and mailing addresses), the corresponding name under which each location is doing business, the corresponding phone numbers and fax numbers, and attesting that each such location has complied with the obligations of this CAP; and
    5. An attestation signed by an officer of HVHS 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. The one-year period beginning on the Effective Date and each subsequent one-year period during the course of the period of compliance obligations shall be referred to as “the Reporting Periods.” HVHS also shall submit to HHS Annual Reports with respect to the status of and findings regarding HVHS’s compliance with this CAP for each of the three (3) Reporting Periods. HVHS shall submit each Annual Report to HHS no later than sixty (60) days after the end of each corresponding Reporting Period. The Annual Report shall include:
    1. A schedule, topic outline, and copies of the training materials for the training programs attended in accordance with this CAP during the Reporting Period that is the subject of the report;
    2. An attestation signed by an officer of HVHS attesting that it is obtaining and maintaining written training certifications from all persons that require training that they received training pursuant to the requirements set forth in this CAP;
    3. A summary of Reportable Events (defined in Section V.E.1) identified during the Reporting Period and the status of any corrective and preventative action relating to all such Reportable Events;
    4. An attestation signed by an officer of HVHS 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 Retention

HVHS 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. Breach Provisions

HVHS is expected to fully and timely comply with all provisions contained in this CAP.

  1. Timely Written Requests for Extensions

    HVHS 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 days prior to the date such an act is required or due to be performed. This requirement may be waived by OCR 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 HVHS constitutes a breach of the Agreement. Upon a determination by HHS that HVHS has breached this CAP, HHS may notify HVHS of: (1) HVHS’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 any other conduct that constitutes a violation of the HIPAA Privacy, Security, or Breach Notification Rules (“Notice of Breach and Intent to Impose CMP”).
  3. HVHS’s Response. HVHS shall have thirty (30) days from the date of receipt of the Notice of Breach and Intent to Impose CMP to demonstrate to HHS’ satisfaction that:
    1. HVHS 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 thirty-day period, but that: (a) HVHS has begun to take action to cure the breach; (b) HVHS is pursuing such action with due diligence; and (c) HVHS has provided to HHS a reasonable timetable for curing the breach.
  4. Imposition of CMP. If at the conclusion of the thirty-day period, HVHS fails to meet the requirements of Section VIII.C. of this CAP to HHS’ satisfaction, HHS may proceed with the imposition of a CMP against HVHS pursuant to 45 C.F.R. Part 160 for any violations of the Covered Conduct set forth in paragraph I.2 of the Agreement and for any other act or failure to act that constitutes a violation of the HIPAA Rules. HHS shall notify HVHS in writing of its determination to proceed with the imposition of a CMP pursuant to 45 C.F.R. Part 160.

For Heritage Valley Health System

/s/

Norman F. Mitry
President and CEO

02/19/2024

Date

For United States Department of Health and Human Services

/s/

Jamie Rahn Ballay
Regional Manager
Office for Civil Rights

02/20/2024

Date

Content created by Office for Civil Rights (OCR)
Content last reviewed