Regional Women’s Health Group, LLC 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. Regional Women’s Health Group, LLC (“RWHG”),¹ is a covered entity, as defined at 45 C.F.R. § 160.103, and therefore is required to comply with the HIPAA Rules. RWHG is a network of women’s health care providers providing services in New Jersey, Pennsylvania, Ohio, Indiana, and Kentucky. As a medical provider which transmits health information in electronic form in connection with a transaction for which HHS has adopted standards, RWHG is a covered entity that is required to comply with the Security Rules.
3. HHS and RWHG shall together be referred to herein as the “Parties.”

2. Factual Background and Covered Conduct. On August 30, 2021, OCR initiated an investigation of RWHG pursuant to a Breach Report dated December 3, 2020, and an Addendum Breach Report dated May 13, 2021. OCR’s investigation revealed that RWHG² was subject to a cyberattack that potentially impacted the protected health information of over 37,000 patients. The evidence gathered by OCR during the investigation indicates RWHG’s noncompliance with the Security Rule.

HHS’ investigation indicated potential violations of the following provision (“Covered Conduct”):

1. RWHG failed to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information that it holds. See 45 C.F.R. § 164.308(a)(1)(ii)(A).

3. No Admission. This Agreement is not an admission of liability by RWHG.

4. No Concession. This Agreement is not a concession by HHS that RWHG 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 21-426165 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 further investigation and 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 RWHG has agreed to pay HHS the amount of $320,000 (“Resolution Amount”). RWHG 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.

7. Corrective Action Plan. RWHG 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 RWHG breaches the CAP and fails to cure the breach as set forth in the CAP, then RWHG 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.

8. Release by HHS. In consideration of and conditioned upon RWHG’s performance of its obligations under this Agreement, HHS releases RWHG from any actions it may have against RWHG 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 RWHG 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. RWHG 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. RWHG 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 RWHG and its 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)(1), a civil money penalty (“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, RWHG 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 RWHG’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. RWHG 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.

16. Disclosure. HHS places no restriction on the publication of the Agreement.

16. 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.

17. Authorizations. The individual(s) signing this Agreement on behalf of RWHG represent and warrant that they are authorized by RWHG 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 Regional Women’s Health Group, LLC

/s/
Thomas Dardarian, D.O., President
Regional Women’s Health Group, LLC

Date: 8/26/2025

For U.S. Department of Health and Human Services

 /s/
Jamie Rahn Ballay, Regional Manager
Office for Civil Rights
Mid-Atlantic Region
Date: 8/28/2025
 

Appendix A

CORRECTIVE ACTION PLAN

BETWEEN THE

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES AND

REGIONAL WOMEN’S HEALTH GROUP, LLC

I.     Preamble

Regional Women’s Health Group, LLC (hereinafter “RWHG”) 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, RWHG is entering into a Resolution Agreement (“Agreement”) with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A. RWHG enters into this CAP as part of the consideration for the release set forth in Paragraph II.8 of the Agreement.

II.     Contact Persons and Submissions

A. Contact Persons.

RWHG 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:

Leisa O’Flynn, D.O.
Owner – RWHG
227 Laurel Road, Suite 300
Voorhees, NJ 08043
REDACTED

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

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

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

B. 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 RWHG 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 RWHG under Section IX hereof of its determination that RWHG has breached this CAP. In the event of such a notification by HHS under Section IX hereof, the Compliance Term shall not end until HHS notifies RWHG that it has determined that the breach has been cured. After the Compliance Term ends, RWHG shall still be obligated to: (a) submit the final Annual Report as required by Section VII; and (b) comply with the document retention requirement in Section VIII.

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

RWHG agrees to the following:

A. Conduct a Risk Analysis

1. RWHG shall conduct and complete an accurate and thorough analysis of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (“ePHI”) held by RWHG. This risk analysis shall incorporate all RWHG facilities, whether owned or rented, and evaluate the risks to ePHI in all of its electronic equipment, data systems, programs and applications controlled, administered, owned, or shared by RWHG or its affiliates that are owned, controlled or managed by RWHG that contain, store, transmit or receive ePHI. As part of this process, RWHG 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 thirty (30) calendar days of the Effective Date, RWHG shall submit to HHS the scope and methodology by which it proposes to conduct the risk analysis. HHS shall notify RWHG whether the proposed scope and methodology is or is not consistent with 45 C.F.R. § 164.308 (a)(l)(ii)(A).
3. RWHG shall provide the risk analysis, consistent with paragraph V.A.1., to HHS within one hundred eighty (180) days of HHS' approval of the scope and methodology described in Paragraph V.A.2 for HHS' review.
4. Upon submission by RWHG, HHS will inform RWHG whether HHS approves or disapproves of the risk analysis. If HHS disapproves of the risk analysis, HHS shall provide RWHG with technical assistance, as necessary, regarding the basis for the disapproval so that RWHG may prepare a revised risk analysis. Upon receiving HHS’ recommended changes, RWHG shall have sixty (60) calendar days to submit a revised risk analysis to HHS for review and approval. This submission and review process will continue until HHS provides final approval of the risk analysis.
5. RWHG shall annually conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by RWHG including affiliates that are owned, controlled, or managed by RWHG. Subsequent risk analyses shall be submitted for review by HHS in the same manner as described in this Section until the conclusion of the CAP.

B. Develop and Implement a Risk Management Plan

1. RWHG 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.A. above. The risk management plan shall include a process and timeline for RWHG’s implementation, evaluation, and revision of its risk remediation activities.
2. Within ninety (90) calendar days of HHS’ final approval of the risk analysis described in Section V.A. above, RWHG shall submit a risk management plan to HHS for HHS’ review and approval. HHS will inform RWHG whether HHS approves the risk management plan or requires revisions. If HHS requires revisions to the risk management plan, HHS will provide RWHG with a written explanation of the basis for its revisions, including comments and recommendations that RWHG can use to prepare a revised risk management plan.
3. Upon receiving HHS’ notice of required revisions, if any, RWHG shall have sixty (60) calendar days to revise the 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.
4. Within thirty (30) calendar days of HHS’ approval of the risk management plan, RWHG shall finalize and officially adopt the risk management plan in accordance with its applicable administrative procedures.
5. In conjunction with RWHG’s annual risk analysis submission to HHS described in Section V.A. above, RWHG shall annually document the security measures RWHG implemented or is implementing to sufficiently reduce the identified risks and vulnerabilities in its subsequent risk analyses to a reasonable and appropriate level. Subsequent corresponding risk management plans shall be submitted for review by HHS in the same manner as described in this section until the conclusion of the CAP.

C. Policies and Procedures

1. RWHG shall review, and as necessary, develop, or revise written policies and procedures to address the Minimum Content set forth in Section V.D. to comply with the HIPAA Rules.
2. RWHG shall provide the policies and procedures identified in Section V.C.1 above to HHS for review and approval within sixty (60) days of HHS’ approval of the risk management plan, as required by Section V.B. Upon receiving any recommended changes to such policies and procedures from HHS, RWHG 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. RWHG shall adopt (in accordance with its applicable administrative procedures) the policies and procedures approved by HHS pursuant to this Section within thirty (30) days of receipt of HHS’ approval.

D. 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 and Breach Notification 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 RWHG and to conduct the accurate and thorough assessment 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 provisions to implement procedures to regularly review records of information system activity, such as audit logs, access reports, and security incident tracking reports.
   4. Security Incident Procedures---45 C.F.R. § 164.308(a)(6), including implementing policies and procedures to address security incidents.
   5. Breach Notification Procedures---45 C.F.R. § 164.400-414, including implementing policies and procedures to comply with the Breach Notification Rules.

E. Implement Process for Evaluating Environmental and Operational Changes consistent with 45 C.F.R. § 164.308(a)(8)

1. Within sixty (60) days of the Effective Date, RWHG shall develop a process to evaluate any environmental or operational changes that affect the security of the PHI held by RWHG, which may include acquisitions, mergers, sales, divestments relating to RWHG facilities or other changes to RWHG’s corporate structure. HHS shall review and recommend changes to the proposed process.
2. Upon receiving HHS’ recommended changes, RWHG shall have sixty (60) days to provide a revised process to HHS for review and approval.
3. Within ninety (90) days of receiving HHS’ approval, RWHG shall implement its process, including distributing to workforce members with responsibility for performing such evaluations.

VI.     Reportable Events - During the Compliance Term, RWHG shall, upon learning that a workforce member likely failed to comply with its policies and procedures described in Section V.C., promptly investigate this matter. If RWHG, after review and investigation, determines that a member of its workforce has failed to comply with its policies and procedures, RWHG shall report such events to HHS as provided in this section. 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 RWHG’s Privacy, Security, and Breach Notification policies and procedures; and
2. A description of the actions taken and any further steps RWHG 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 Privacy, Security, and Breach Notification policies and procedures.
3. If no Reportable Events occur during the Compliance Term, RWHG shall so inform HHS in the Annual Report(s) as specified in Section VII below.

VII.     Implementation Report and Annual Reports

A. Implementation Report – Within one-hundred twenty (120) calendar days after the receipt of HHS’ approval of all the policies and procedures required by Section V.C., RWHG 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 RWHG attesting that the risk management plan approved by HHS in Section V.B. is being implemented;
2. An attestation signed by an owner or officer of RWHG attesting that the policies and procedures approved by HHS in Section V.C. are being implemented and have been distributed to all appropriate members of the workforce;
3. An attestation signed by an owner or officer of RWHG attesting that all practice locations owned, acquired by, merged with, or otherwise under RWHG’s control have completed a risk analysis required by Section V.A; and
4. An attestation signed by an owner or officer of RWHG 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.

B. Annual Reports – The one (1) year period beginning on 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, RWHG shall submit a report to HHS regarding RWHG’s compliance with this CAP for each corresponding Reporting Period. This report, known as the “Annual Report,” shall include:

1. An attestation signed by an officer or owner of RWHG attesting that any revision(s) to the risk management plan required by Section V.B. were adopted and implemented;
2. A summary of Reportable Events (defined in Section VI.), 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 owner of RWHG stating that no Reportable Events occurred during the Reporting Period;
3. An accounting of any practice locations acquired by RWHG or merged with RWHG within the Reporting Period and an attestation signed by an owner or officer of RWGH that RWHG has complied with its Axia Mergers and Acquisitions Technical Transition Standard policy as to each newly acquired practice location; and
4. An attestation signed by an owner or officer of RWHG 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.

VIII.    Document Retention

RWHG 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.

IX.     Breach Provisions

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

A. Timely Written Requests for Extensions. RWHG 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.

B. Notice of Breach of this CAP and Intent to Impose Civil Monetary Penalty (CMP). The parties agree that a breach of this CAP by RWHG constitutes a breach of the Agreement. Upon a determination by HHS that RWHG has breached this CAP, HHS may notify RWHG of: (1) RWHG’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”).

C. RWHG Response. RWHG 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. RWHG 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) RWHG has begun to take action to cure the breach; (b) RWHG is pursuing such action with due diligence; and (c) RWHG has provided HHS a reasonable timetable for curing the breach.

D. Imposition of CMP. If at the conclusion of the 30-day period, RWHG fails to meet the requirements of Section IX.C of this CAP to HHS’ satisfaction or the Parties cannot agree to a mutual resolution per section IX.C., HHS may proceed with the imposition of the CMP against RWHG 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 RWHG in writing of its determination to proceed with the imposition of the CMP pursuant to 45 C.F.R. Part 160. RWHG reserves all rights to dispute HHS’ determination, in law and equity. HHS must offset any CMP amount levied under this section by the amounts already paid by RWHG, in lieu of CMPs under this Resolution Agreement. Any such offset will apply only to Covered Conduct up to and including the Effective Date.

For Regional Women’s Health Group, LLC

/s/                        
Thomas Dardarian, D.O., President
Regional Women’s Health Group, LLC

Date: 8/26/2025

For U.S. Department of Health and Human Services

/s/
Jamie Rahn Ballay
Regional Manager
Office for Civil Rights
Mid-Atlantic Region
Date: 8/28/2025

Endnotes

¹ RWHG operates using the trade name, Axia Women’s Health.

² The breach incident occurred at RWHG’s locations known as Sincera Reproductive Medicine.