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                              B. Steven L. Hardy, D.D.S., LTD (“Paradise”) Resolution Agreement and Corrective Action Plan


    

    

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B. Steven L. Hardy, D.D.S., LTD (“Paradise”) Resolution Agreement and Corrective Action Plan








  
  
    

  
      





**Resolution Agreement**

**I. Recitals**

**Parties**.  The Parties to this Resolution Agreement (“Agreement”) are:

	The United States Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”), which enforces the Federal standards that govern the privacy of individually identifiable health information (45 Code of Federal Regulations (“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).
		Steven L Hardy, D.D.S., Ltd., doing business as Paradise Family Dental (“the Practice”) meets the definition of “covered entity” under 45 C.F.R. § 160.103 and therefore is required to comply with the HIPAA Rules.
	**Factual Background and Covered Conduct**.  The Complainant alleged that the Practice failed to provide her with timely access to her and her minor child’s protected health information (“PHI”). Complainant is her child’s personal representative. 
	HHS’s investigation found that, on April 11, 2020, Complainant emailed the Practice a request for access to copies of her and her minor child’s PHI. On April 14, 2020, the Practice sent a reply email to Complainant explaining that the office was closed and offered to email the requested PHI to her if Complainant confirmed the email address to which it should send the PHI. On May 4, 2020, Complainant sent the Practice an email confirming the email address to which it could send the PHI. After Complainant made several subsequent requests, the Practice required Complainant to submit a written request with her handwritten signature before it would provide the requested PHI. Complainant submitted a written request with her handwritten signature on December 4, 2020, and the Practice sent Complainant copies of her and her minor child’s PHI on December 31, 2020.
	HHS’s investigation indicated that the following “Covered Conduct” occurred:

	The Practice failed to provide timely access to PHI.   *See*45 C.F.R. § 164.524(b).
	**No Admission**.  This Agreement is not an admission of liability by the Practice.
	**No Concession**.  This Agreement is not a concession by HHS that the Practice is not in violation of the HIPAA Rules and not liable for civil money penalties.
	**Intention of Parties to Effect Resolution**.  This Agreement is intended to resolve OCR
	Transaction Number: 21-401013 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**

**Payment**.  HHS has agreed to accept, and the Practice has agreed to pay HHS, the amount of **$25,000******(“Resolution Amount”).  The Practice agrees to pay the Resolution Amount on the Effective Date of this Agreement as defined in paragraph II.14 pursuant to written instructions to be provided by HHS.
	**Corrective Action Plan**.  The Practice 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 the Practice breaches the CAP and fails to cure the breach as set forth in the CAP, then the Practice will be in breach of this Agreement and HHS will not be subject to the Release set forth in paragraph II.8 of this Agreement.
	**Release by HHS**.  In consideration of and conditioned upon the Practice’s performance of its obligations under this Agreement, HHS releases the Practice from any actions it may have against the Practice 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 the Practice 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 United States Code (“U.S.C.”) § 1320d-6.
	**Agreement by Released Parties**.  The Practice 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. The Practice waives all procedural rights granted under Section 1128A of the Social Security Act (42 U.S.C. § 1320a- 7a) and 45 C.F.R. Part 160 Subpart E, and HHS claims collection regulations at 45 C.F.R. Part 30, including, but not limited to, notice, hearing, and appeal with respect to the Resolution Amount.
	**Binding on Successors**.  This Agreement is binding on the Practice and its successors, heirs, transferees, and assigns.
	**Costs**.  Each Party to this Agreement shall bear its own legal and other costs incurred in connection with this matter, including the preparation and performance of this Agreement.
	**No Additional Releases**.  This Agreement is intended to be for the benefit of the Parties only and by this instrument the Parties do not release any claims against or by any other person or entity.
	**Effect of Agreement**.  This Agreement constitutes the complete agreement between the Parties.  All material representations, understandings, and promises of the Parties are contained in this Agreement.  Any modifications to this Agreement shall be set forth in writing and signed by all Parties.
	**Execution of Agreement and Effective Date**.  The Agreement shall become effective (***i.e.***, final and binding) upon the date of signing of this Agreement and the CAP by the last signatory (“Effective Date”).
	**Tolling of Statute of Limitations**. Pursuant to 42 U.S.C. § 1320a-7a(c)(1), a 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, the Practice agrees that the time between the Effective Date of this Agreement and the date the Agreement may be terminated by reason of the Practice’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.  The Practice 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.
	**Disclosure**.  HHS places no restriction on the publication of the Agreement.  In addition, HHS may be required to disclose material related to this Agreement to any person upon request consistent with the applicable provisions of the Freedom of Information Act, 5 U.S.C. § 552, and its implementing regulations, 45 C.F.R. Part 5.
	**Execution in Counterparts**.  This Agreement may be executed in counterparts, each of which constitutes an original, and all of which shall constitute one and the same agreement.
	**Authorizations**.  The individual(s) signing this Agreement on behalf of the Practice represents and warrants that they are authorized to execute this Agreement and bind the Practice 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 Paradise Family Dental**

Steven Hardy, DDS
Owner
Paradise Family Dental (the Practice)

Date: 8/8/2022

**For United States Department of Health and Human Services**

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

Date: 8/9/2022

**Appendix A**

**Corrective Action Plan**

**Between the**

**Department of Health and Human Services**

**And**

**Paradise Family Dental**

**I. Preamble**

B. Steven L Hardy, D.D.S., Ltd. (“the Practice”) 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, the Practice is entering into the Agreement with HHS, and this CAP is incorporated by reference into the Agreement as Appendix A.  The Practice enters into this CAP as part of consideration for the release set forth in paragraph II.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**

**Contact Persons**
	The Practice 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:
	Steven Hardy, DDS   
	Owner
	Paradise Family Dental (the Practice)
	6825 Aliante Parkway
	North Las Vegas, Nevada  89084
	email
	Telephone: (702) 294-2739

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

	Andrea Oliver, Regional Manager
	Office for Civil Rights, Rocky Mountain Region
	Department of Health and Human Services
	1961 Stout Street, Room 08.148
	Denver, Colorado 80294Andrea.Oliver@hhs.gov****
	Telephone: (303) 844-7915
	Facsimile: (303) 844-2025

	The Practice and HHS agree to promptly notify each other of any changes in the contact person or the other information provided above.
	**Proof of Submissions**
	Unless otherwise specified, all notifications and reports required by this CAP may be made by any means, including certified mail, overnight mail, 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 II.14 of the Agreement (“Effective Date”). The period for compliance (“Compliance Term”) with the obligations assumed by the Practice 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 the Practice under Section VIII hereof of its determination that the Practice 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 the Practice that it has determined that the breach has been cured.  After the Compliance Term ends, the Practice 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 the Practice’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**

The Practice agrees to the following:

**Right of Access**

	Within thirty (30) days of the Effective Date, the Practice shall develop its policy and procedures related to the right of access to protected health information (“PHI”) to reflect satisfactory compliance with 45 C.F.R. §§ 164.530(j) and 164.524.  The Practice’s policy and procedures shall address, but not be limited to, the Covered Conduct specified in paragraph I.2 of the Agreement.
		The Practice shall provide such access policy and procedures, consistent with paragraph 1 above, to HHS within sixty (60) days of the Effective Date for review and approval. Upon receiving any recommended changes to such policy and procedures from HHS, the Practice shall have thirty (30) days to revise such policy and procedures accordingly and provide the revised policy and procedures to HHS for review and approval.  This process shall continue until HHS approves such policy and procedures.
		The Practice shall implement any revised access policy and procedures within thirty (30) days of receipt of HHS’s approval.
	**Notice of Privacy Practices**
	Within thirty (30) days of the Effective Date, the Practice shall review and revise its Notice of Privacy Practices to reflect satisfactory compliance with 45 C.F.R. § 164.520(b).  The Practice’s revised Notice of Privacy Practices shall address, but not be limited to, the Covered Conduct specified in paragraph I.2 of the Agreement.
		The Practice shall provide such Notice of Privacy Practices, consistent with paragraph 1 above, to HHS within sixty (60) days of the Effective Date for review and approval. Upon receiving any recommended changes to such Notice of Privacy Practices from HHS, the Practice shall have thirty (30) days to further revise its Notice of Privacy Practices accordingly and provide the revised Notice of Privacy Practices to HHS for review and approval.  This process shall continue until HHS approves the Practice’s Notice of Privacy Practices.
		The Practice shall implement its revised Notice of Privacy Practices within thirty (30) days of receipt of HHS’s approval. Implementation shall include publishing the Notice of Privacy Practiceson the Practice’s website, distributing the Notice of Privacy Practices to all new patients, and making the Notice of Privacy Practices  available on request to all persons.
	**Distribution and Updating of Policy and Procedures**
	The Practice shall distribute the access policy and procedures identified in Section V.A to workforce members within thirty (30) days of HHS approval of such revised policy, if any, and to new workforce members within thirty (30) days of their beginning of service.
		The Practice shall require, at the time of distribution of such revised policy and procedures, a signed written or electronic initial compliance certification from all appropriate workforce members stating that the workforce members have read, understand, and shall abide by such policy and procedures.
		The Practice shall assess, update, and revise, as necessary, the policy and procedures at least annually or as needed. The Practice shall provide such revised policy and procedures to HHS for review and approval. Within thirty (30) days of the effective date of any approved substantive revisions, the Practice shall distribute such revised policy and procedures to workforce members and shall require new compliance certifications.
	**Minimum Content of Policy and Procedures**
	The Policy and Procedures shall include, but not be limited to:
	Develop, review, and update as necessary the Practice’s policy regarding individuals’ right of access to PHI to ensure timely and comprehensive response to requests for copies of records, including individuals’ requests for access directing the Practice to transmit copies directly to a designated third party, and a denial process consistent with the Privacy Rule.
		Protocols for training all of the Practice’s workforce members that are involved in receiving or fulfilling access requests as necessary and appropriate to ensure compliance with the policy and procedures provided for in Section V.A above.
		Application of appropriate sanctions against the Practice’s workforce members who fail to comply with the policy and procedures provided for in subparagraph (1) above.
	**Training**
	The Practice shall provide HHS with training materials per Section V.C above for all workforce members within sixty (60) days of the approval of its policy and procedures and revised Notice of Privacy Practices per Section V.A and V.B.
		Upon receiving the notice from HHS specifying any required changes, the Practice shall make the required changes and provide revised training materials to HHS within thirty (30) days.  This process shall continue until HHS approves such training materials.
		Upon receiving approval from HHS of any revised training materials, the Practice shall provide training on any revised training materials to all of the Practice’s workforce members to the extent that their job duties relate to receiving, reviewing, processing, or fulfilling individual requests for access to records within ninety (90) days of HHS’s approval and annually thereafter.  These workforce members include: all managers and supervisors, all Health Information Management staff, all compliance department staff, and all legal department staff. The Practice shall also provide such training to each new workforce member within thirty (30) 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.
		The Practice 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.
	**Reportable Events******
	During the Compliance Term, the Practice shall, upon receiving information that a workforce member may have failed to comply with the policy and procedures described in Section V.A, promptly investigate this matter. If the Practice determines after review and investigation, that a workforce member has failed to comply with the policy and procedures, the Practice shall notify HHS in writing within thirty (30) days and in the Annual Report, as set forth in Section VI.B.  Such violations shall be known as Reportable Events. The report to HHS shall include the following information:
		A complete description of the event, including the relevant facts, the persons involved, and the provision(s) of the policy and procedures implicated; and
			A description of the actions taken and any further steps the Practice plans to take to address the matter to mitigate any harm, and to prevent it from recurring, including application of appropriate sanctions against workforce members who failed to comply with its Privacy Rule policies and procedures.
		If no Reportable Events have occurred within a Reporting Period, as defined in Section VI.A, the Practice shall so inform HHS in its Annual Report for that Reporting Period in accordance with Section VI.C. of this CAP.**VI. Implementation Report and Annual Reports**

**Implementation Report**
	Within one hundred twenty (120) days after the receipt of HHS’s approval of the policy and procedures required by Section V.A.1, the Practice 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:
	An attestation signed by an owner or officer of the Practice stating that the policy and procedures approved by HHS in Section V.A are implemented;
		An attestation signed by an owner or officer of the Practice stating that the Notice of Privacy Practicesapproved by HHS in Section V.B is implemented;
		An attestation signed by an owner or officer of the Practice attesting that all workforce members have completed the initial training required by Section V.E;
		An attestation signed by an owner or officer of the Practice 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.
	**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) days after the close of each corresponding Reporting Period, the Practice shall submit a report to HHS regarding the Practice’s compliance with this CAP for the Reporting Period (“Annual Report”). The Annual Report shall include:
	An attestation signed by an owner or officer of the Practice attesting that all workforce members have completed the training required by Section V.D during the Reporting Period;
		An attestation signed by an owner or officer of the Practice attesting that any revision(s) to the policy and procedures required by Section V.A were finalized and adopted within thirty (30) days of HHS’s approval of the revision(s), which shall include a statement affirming that the Practice distributed the revised policy and procedures to all appropriate workforce members within sixty (60) days of HHS’s approval of the revision(s);
		An attestation signed by an owner or officer of the Practice attesting that any revision(s) to the Notice of Privacy Practices required by Section V.B was implemented within thirty (30) days of HHS’s approval of the revision(s), which shall include a statement affirming that the Practice published the Notice of Privacy Practiceson the Practice’s website, distributed the Notice of Privacy Practices to all new patients, and made the Notice of Privacy Practices available on request to all persons within sixty (60) days of HHS’s approval of the revision(s);
		A summary of Reportable Events (defined in Section 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 the Practice stating that no Reportable Events occurred during the Compliance Term; and
		An attestation signed by an owner or officer of the Practice 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**

The Practice shall maintain for inspection and copying, and shall provide to HHS, upon request, all documents and records relating to compliance with this CAP for six (6) years from the Effective Date.

**VIII. Requests for Extensions and Breach Provisions**

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

**Timely Written Requests for Extensions**.  The Practice 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) days prior to the date such an act is required or due to be performed. This requirement may be waived by HHS only.
	**Notice of Breach of This CAP and Intent to Impose CMP**. The Parties agree that a breach of this CAP by the Practice constitutes a breach of the Agreement.  Upon a determination by HHS that the Practice has breached this CAP, HHS may notify the Practice’s Contact of: (1) the Practice’s breach; and (2) HHS’s intent to impose a CMP pursuant to 45 C.F.R. Part 160, 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).
	**The Practice’s Response**.  If the Practice is named in a Notice of Breach and Intent to Impose CMP, the Practice shall have thirty (30) days from the date of receipt of the Notice of Breach and Intent to Impose CMP to demonstrate to HHS’s satisfaction that:
	The Practice is in compliance with the obligations of the CAP that HHS cited as the basis for the breach;
		The alleged breach has been cured; or
		The alleged breach cannot be cured within the thirty (30) day period, but that the Practice: (a) has begun to take action to cure the breach; (b) is pursuing such action with due diligence; and (c) has provided to HHS a reasonable timetable for curing the breach.
	**Imposition of CMP**.  If at the conclusion of the thirty (30) day period, the Practice fails to meet the requirements of Section VIII.C of this CAP to HHS’s satisfaction, HHS may proceed with the imposition of a CMP against the Practice pursuant to the rights and obligations set forth in 45 C.F.R. Part 160 for any violations of the HIPAA Rules applicable to 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 the Practice’s Contact in writing of its determination to proceed with the imposition of a CMP pursuant to 45 C.F.R. §§ 160.312(a)(3)(i) and (ii).**For the Practice**

Steven Hardy, DDS
Owner, Paradise Family Dental (the Practice)

Date: 8/8/2022

**For United States Department of Health and Human Services**

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

Date: 8/9/2022

                    
  


Content created by Office for Civil Rights (OCR) Content last reviewed September 20, 2022Back to top
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