St. Joseph's Medical Center 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).
      
      St. Joseph's Medical Center (SJMC) is a covered entity, as defined at 45 C.F.R. § 160.103, and therefore is required to comply with the HIPAA Rules. SJMC is a 194 bed, not-for profit, academic medical center located in Yonkers, New York that provides a full range of health services.
      
      HHS and SJMC shall together be referred to herein as the "Parties."
2. Factual Background and Covered Conduct.
   
   OCR's investigation found that on April 20, 2020, SJMC impermissibly allowed a reporter from the Associated Press (AP) to observe three (3) patients who were being treated for COVID. The evidence supports that SJMC allowed the reporter access to the patients and their clinical information. The disclosures were not made pursuant to a permissible purpose under or as required by the Privacy Rule and were made without first obtaining valid authorizations from the affected individuals. On April 28, 2020, HHS notified SJMC of HHS' investigation regarding SJMC's compliance with the Privacy Rule based on information contained in the AP article.
   
   HHS's investigation indicated that the following conduct occurred ("Covered Conduct"):
    
   1. SJMC impermissibly disclosed the protected health information of its patients to a reporter from the Associated Press. See 45 C.F.R. § 164.502(a).
3. No Admission. This Agreement is not an admission of liability by SJMC.
4. No Concession. This Agreement is not a concession by HHS that SJMC 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 HHS TN 20-380759 and any violations of the HIPAA Rules related to the Covered Conduct specified in paragraph 1.2 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

6. Payment.  HHS has agreed to accept, and SJMC has agreed to pay HHS, the amount of $80,000("Resolution Amount"). SJMC agrees to pay the Resolution Amount on the Effective Date of this Agreement as defined in paragraph 11.14 pursuant to written instructions provided oy HHS.
7. Corrective Action Plan. SJMC has entered into and agrees to comply with the Corrective Action Plan ("CAP"), attached as Appendix A, which incorporated into this Agreement by reference. If SJMC breaches the CAP and fails to cure the breach as set forth in the CAP, then SJMC will be in breach of this Agreement and HHS will not be subject to the Release set forth in paragraph 11.8 of this Agreement.
8. Release by HHS. In consideration of and conditioned upon SJMC's performance of its obligations under this Agreement, HHS releases SJMC from any actions it may have against SJMC under the HIPAA Rules arising out of or related to the Covered Conduct identified in paragraph 1.2 of this Agreement. HHS does not release SJMC 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.
9. Agreement by Released Parties. SJMC shall not contest the validity of his obligation to pay, nor the amount of, the Resolution Amount  or any other obligations agreed  to under this Agreement. SJMC 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.
10. Binding on Successors. This Agreement is binding on SJMC and their successors, heirs, transferees, and assigns.
11. 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.
12. 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.
13. 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.
14. 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).
15. Tolling of Statute of Limitations. Pursuant to 42 U.S.C. § 1320a-7a(c)(l), 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, SJMC agrees that the time between the Effective Date of this Agreement and the date the Agreement may be terminated by reason of SJMC'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. SJMC 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 1.2 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.
16. Disclosure.  HHS places no restriction on the publication of the Agreement.
17. 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.
18. Authorizations. The individual(s) signing this Agreement on behalf of SJMC represents and warrants that they are authorized to execute this Agreement and bind SJMC, as set forth in paragraph I.1.b. 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 Covered Entity

/s/                                                                                                                      
President and CEO                                           
Saint Joseph's Medical Center                                         

Date: 08/17/2023

For the United States Department of Health and Human Services

/s/                                                                                          
Linda C. Colon, Regional Manager                                                          
Eastern and Caribbean Region, Office for Civil Rights    

Date: 08/22/2023

Appendix A
CORRECTIVE ACTION PLAN BETWEEN THE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND
ST. JOSEPH'S MEDICAL CENTER

I. Preamble

St. Joseph's Medical Center (hereinafter known as "SJMC") 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, SJMC is entering into the Agreement with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A. SJMC enters into this CAP as part of consideration for the release set forth in paragraph 11.8 of the Agreement. Capitalized terms without definition in this CAP shall have the same meaning assigned to them under the Agreement.

II. Contact Persons and Submissions

1.  Contact Persons
   
   SJMC 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:
   
   Mr. Frank Hagan Chief Financial Officer
   Saint Joseph's Medical Center 127 South Broadway
   Yonkers, NY 10701
   
   Email: fhagan@saintjosephs.org
   Voice Phone: (914) 378-7550
   
   HHS has identified the following individual as its authorized representative and contact person with whom SJMC is to report information regarding the implementation of this CAP:
   
   Linda C. Colon, Regional Manager Eastern and Caribbean Region Office for Civil Rights
   U.S. Department of Health and Human Services 26 Federal Plaza, Suite 3312
   New York, New York 10278
   Voice Phone (212) 264-4136
   
   SJMC 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.

III. Effective Date and Term of CAP

The Effective Date for this CAP shall be calculated in accordance with paragraph III of the Agreement ("Effective Date"). The period for compliance ("Compliance Term") with the obligations assumed by SJMC 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 SJMC under section VIII hereof of its determination that SJMC 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 SJMC that it has determined that the breach has been cured. After the Compliance Term ends, SJMC 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.

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

SJMC agrees to the following:

1. Policies and Procedures
   1. SJMC shall review and, to the extent necessary, develop, maintain, and revise its written privacy policies and procedures ("Policies and Procedures") to comply with the Federal standards that govern the privacy of individually identifiable health information. (45 C.F.R. Parts 160 and 164, Subpart E of 45 C.F.R. Part 164). SJMC's Policies and Procedures shall include, but not be limited to, the minimum content set forth in section V.C.
   2. Within ninety (90) days following the Effective Date of the Agreement, SJMC shall provide such Policies and Procedures, consistent with section V.A. above, to HHS for review and approval. Upon receiving any required changes to such Policies and Procedures from HHS, SJMC shall have thirty (30) 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 such Policies and Procedures.
   3. Within thirty (60) days after receiving HHS's final approval of any revisions to the Policies and Procedures described in Sections V.A. and V.C., SJMC shall implement and distribute the Policies and Procedures to all appropriate workforce members.
2. Distribution and Updating of Policies and Procedures
   1. SJMC shall distribute the Policies and Procedures identified in Sections V.A. and V.C. to all members of the workforce within sixty (60) days of HHS's approval of such Policies and Procedures and to new members of the workforce within sixty
      (60) days of their beginning of service.
   2. SJMC shall require, at the time of distribution of the Policies and Procedures, a signed written or electronic initial compliance certification from all members of the workforce, stating that the workforce members have read, understand, and shall abide by such Policies and Procedures.
   3. SJMC shall assess, update, and revise, as necessary, the Policies and Procedures at least annually. SJMC shall provide the revised Policies and Procedures to HHS for review and approval. Within thirty (30) days of HHS's approval of any substantive revisions, SJMC shall distribute such revised Policies and Procedures to all members of its workforce and shall require new compliance certifications.
   4. SJMC shall not provide any member of its workforce with access to PHI if that workforce member has not signed or provided the written or electronic certification required by Sections V.B.2. and V.E.5.
3. Minimum Content of the Policies and Procedures
   
   At a minimum, the Policies and Procedures shall include measures to address the following Privacy Rule provisions:
   1. A specific prohibition on the use or disclosure of protected health information (PHI) by SJMC workforce members, agents, and business associates to any person or entity planning, coordinating, or engaging in photography, video recording, or audio recording without the prior, written, authorization of the patient who is the subject of the PHI sought to be disclosed, or of the personal representative of said patient.
   2. A process for evaluating and approving authorizations requesting the use or disclosure of PHI by SJMC before allowing third parties to have access to patients' PHI and treatment areas or other areas of SJMC where PHI will be accessible in written, electronic, oral, or other visual or audio form.
   3. Internal reporting procedures requiring all SJMC workforce members to report any violations of the Privacy or Security Rules or SJMC's privacy and security policies and procedures to the designated Privacy Officer, at the earliest possible time. Such procedures shall require SJMC to promptly investigate and address all reports received in a timely manner.
   4. A requirement that a SJMC workforce member actively monitor all photography, video recording, and audio recording conducted on SJMC premises by a third party including for purposes not related to medical treatment or health care operations in compliance with the Privacy Rule.
   5. Identification of SJMC personnel or representatives who workforce members, agents, or business associates may contact in the event of any inquiry or concern regarding compliance with HIPAA in relation to these activities.
   6. Measures providing that upon receiving information that a member of its workforce may have violated these policies and procedures, SJMC shall promptly investigate and address the violation in an appropriate and timely manner.
   7. Application of appropriate sanctions (which may include re-training or other instructive corrective action, depending on the circumstances) against members of SJMC's workforce, including supervisors and managers, who fail to comply with SJMC's Policies and Procedures.
   8. Policies and procedures to comply with the Breach Notification Rule; including SJMC's internal reporting procedures which will require all workforce members to report to the designated person or office at the earliest possible time any potential violations of the Privacy, Security or Breach Notification Rules or of SJMC's privacy and security policies and procedures. Such reporting procedures shall require SJMC to promptly investigate and address all received reports in a timely manner. (45 C.F.R. § 164.400, et. seq.)
4. Reportable Events
   1. During the Compliance Term, SJMC shall, upon learning that a workforce member likely failed to comply with its Policies and Procedures described in section V.A., will promptly investigate this matter. If SJMC, after review and investigation, determines that a member of its workforce has failed to comply with its Policies and Procedures, SJMC shall report such events to HHS as provided in section VI.B.4. 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 SJMC 's Privacy, Security, and Breach Notification Policies and Procedures; and
      2. A description of the actions taken and any further steps SJMC 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, Security, and Breach Notification Policies and Procedures.
   2. If no Reportable Events occur during the Compliance term, SJMC shall so inform HHS in the Implementation Report as specified in Section VI below.
5. Training
   1. All members of SJMC's workforce, shall receive training on SJMC's policies and procedures to comply with the Privacy and Security Rules, including the specific items referenced in Section V.C. within 30 days of the implementation of the policies and procedures, or within 30 days of when they become a member of the workforce of SJMC.
   2. SJMC shall provide HHS with training materials for all members of the workforce and management that have access to PHI to include specific training related to its new Policies and Procedures described under Sections V.A. l and V.C. above, within sixty (60) days after HHS approves SJMC 's Policies and Procedures per Section V.A.2 above.
   3. Upon receiving notice from HHS specifying any required changes, SJMC shall make the required changes and provide revised training materials to HHS within thirty (30) days.
   4. Within sixty (60) days after receiving HHS's final approval and at least every twelve (12) months thereafter, SJMC shall provide training for all members of SJMC's workforce, including SJMC's Privacy Officer and leadership, of SJMC's policies and procedures to comply with the Privacy and Security Rules. SJMC shall also provide such training to new members of the workforce within thirty (30) days of their beginning of service.
   5. Each workforce member shall certify, in electronic or written form, that he or she has received and understands the required training. The training certification shall specify the date training was received. All course materials shall be retained in compliance with Section VII.
   6. SJMC shall review the privacy 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.
   7. SJMC shall not provide access to PHI to any member of its workforce if that workforce member has not signed or provided the written or electronic certification required by section V.E.5.

VI. Implementation Report and Annual Reports

1. Implementation Report.     Within one hundred twenty (120) calendar days after the receipt of HHS's approval of the policies and procedures required by section V.A, SJMC shall submit a written report to HHS summarize 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 SJMC attesting that the policies and procedures approved by HHS in section V.A are being implemented, have been distributed to all appropriate members of the workforce, and that SJMC has obtained all of the compliance certifications required by sections V.B.2. and V.E.5;
   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 owner or officer of SJMC 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.E.5.;
   4. An attestation signed by an owner or officer of SJMC 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 (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, SJMC shall submit a report to HHS regarding SJMC's compliance with this CAP for each corresponding Reporting Period ("Annual Report").
   1. An attestation signed by an officer or owner of SJMC attesting that any revision(s) to the policies and procedures required by section V.A. were finalized and adopted within thirty (30) calendar days of HHS' s approval of the revision(s), which shall include a statement affirming that SJMC distributed the revised policies and procedures to all appropriate members of SJMC's workforce within sixty (60) calendar days of HHS's approval of the revision(s);
   2. An attestation signed by an owner or officer of SJMC attesting that all members of the workforce have completed the training required by section V.E. during the Reporting Period;
   3. An attestation signed by an owner or officer of SJMC 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;
   4. A summary of Reportable Events (defined in 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 SJMC stating that no Reportable Events occurred during the Compliance Term.
   5. An attestation signed by an owner or office of SJMC 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

SJMC 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

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

1. Timely Written Requests for Extensions. SJMC 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.
2. Notice of Breach of this CAP and Intent to Impose Civil Monetary Penalty. The parties agree that a breach of this CAP by SJMC constitutes a breach of the Agreement. Upon a determination by HHS that SJMC has breached this CAP, HHS may notify SJMC of: (1) SJMC's breach; and (2) HHS's intent to impose a civil money penalty (CMP), pursuant to 45 C.F.R. Part 160, or other remedies, for the Covered Conduct set forth in paragraph 1.2 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. SJM Response. SJMC 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's satisfaction that:
   1. SJMC 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) SJMC has begun to take action to cure the breach; (b) SJMC is pursuing such action with due diligence; and (c) SJMC has provided to HHS a reasonable timetable for curing the breach.
4. Imposition of CMP. If at the conclusion of the 30-day period, SJMC 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 SJMC 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 SJMC in writing of its  determination to proceed with the imposition of the CMP pursuant to 45 C.F.R. Part 160.

For St. Joseph's Medical Center

/s/
President and CEO
Saint Joseph's Medical Center                                   

Date:   08/17/2023
 
For the United States Department of Health and Human Services

/s/                                                                  
Linda C. Colon                                                            
Regional Manager                                                        
Office for Civil Rights, Eastern & Caribbean Region

Date: 08/22/2023