August 28, 2016

August 26, 2016

Office for Civil Rights Launches Phase 2 HIPAA Audit Program with Pre-Audit Screening Surveys

Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entities have reported that the U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently sent pre-audit screening surveys to a pool of covered entities that may be selected for a second phase of audits (Phase 2 Audits) of compliance with the HIPAA Privacy, Security and Breach Notification Standards, as required by the Health Information Technology for Economic and Clinical Health Act (HITECH Act). OCR had originally planned to issue these screening surveys in the summer of 2014.

Unlike the pilot audits conducted in 2011 and 2012 (Phase 1 Audits), which focused on covered entities, OCR is conducting Phase 2 Audits of both covered entities and business associates. The Phase 2 Audit program will focus on areas of greater risk to the security of protected health information (PHI) and on pervasive non-compliance based on OCR’s Phase I Audit findings and observations, rather than a comprehensive review of all of the HIPAA Standards. OCR also intends for the Phase 2 Audits to identify best practices and uncover risks and vulnerabilities that OCR has not identified through other enforcement activities. OCR has stated that it will use the Phase 2 Audit findings to identify technical assistance that it should develop for covered entities and business associates. In circumstances where an audit reveals a serious compliance concern, OCR may initiate a compliance review of the audited organization that could lead to civil money penalties.

The following sections describe the Phase 2 Audit program and identify steps that covered entities and business associates should take to prepare for Phase 2 Audits.

Selection of Phase 2 Audit Recipients

Based on prior statements from OCR about the Phase 2 Audits, the surveys recently issued to covered entities appear to indicate that OCR has randomly selected a pool of 550 to 800 covered entities through the National Provider Identifier database and America’s Health Insurance Plans’ databases of health plans and health care clearinghouses. The survey requests organization and contact information.  

OCR has said that based on the survey responses, it will select approximately 350 covered entities, including 232 health care providers, 109 health plans and 9 health care clearinghouses, for Phase 2 Audits. OCR will then notify and send data requests to the 350 selected covered entities. The data requests will ask the covered entities to identify and provide contact information for their business associates. OCR will select the business associates that will participate in the Phase 2 Audits from this pool. OCR had previously indicated that compliance audits of business associates would begin in 2015 and continue into 2016, but this timeframe will likely be pushed back based on the delay in the Phase II Audits of covered entities.

Audit Process

OCR will audit approximately 150 of the 350 selected covered entities and 50 of the selected business associates for compliance with the Security Standards, 100 covered entities for compliance with the Privacy Standards, and 100 covered entities for compliance with the Breach Notification Standards. 

Covered entities and business associates will have two weeks to respond to OCR’s audit request. The data requests will specify content and file organization, file names and any other document submission requirements. OCR will only consider current documentation that is submitted on time. OCR has indicated that auditors will not have an opportunity to contact the entity for clarifications or to request additional information, so it is critical that the documents accurately reflect the program. Failure to respond to a request could lead to a referral to the applicable OCR Regional Office for a compliance review. The Phase 2 Audits are expected to take place over three years.

OCR previously stated that the Phase 2 HIPAA Audits would be conducted as “desk audits” rather than onsite visits. In more recent statements, however, OCR has indicated that while most Phase 2 Audits will be desk audits, OCR will also conduct some onsite, comprehensive audits. OCR has said that it will make the Phase 2 Audit protocol available on its website so that organizations may use it for internal compliance assessments.

The Phase 2 Audits will target HIPAA Standards that were frequent sources of non-compliance in the Phase 1 Audits, including risk analysis and risk management, content and timeliness of breach notifications, notice of privacy practices, individual access, the Privacy Standards’ reasonable safeguards requirement, workforce member training, device and media controls, and transmission security. OCR projects that later Phase 2 Audits will focus on the Security Standards’ encryption and decryption requirements, facility access control, breach reports and complaints, and other areas identified by earlier Phase 2 Audits. Phase 2 Audits of business associates will focus on risk analysis, risk management and breach reporting to covered entities.

OCR will present the organization with a draft audit report to allow management to comment before the report is finalized. OCR will then take into account management’s response and issue a final report.

What Should You Do to Prepare for the Phase 2 Audits?

Covered entities and business associates should take the following steps to ensure that they are prepared for a potential Phase 2 Audit:

  • Confirm that the organization has recently completed a comprehensive assessment of potential security risks and vulnerabilities to the organization (Risk Assessment)

  • Confirm that all action items identified in the Risk Assessment have been completed or are on a reasonable timeline to completion

  • Ensure that the organization has a complete inventory of business associates and their contact information for purposes of the Phase 2 Audit data requests

  • If the organization has not implemented any of the Security Standards’ addressable implementation standards for any of its information systems, confirm that the organization has documented (1) why any such addressable implementation standard was not reasonable and appropriate, and (2) all alternative security measures that were implemented

  • Ensure that the organization has implemented a breach notification policy that accurately reflects the content and deadline requirements for breach notification under the Breach Notification Standards

  • For health care provider and health plan covered entities, ensure that the organization has a compliant Notice of Privacy Practices and not only a website privacy notice

  • Ensure that the organization has reasonable and appropriate safeguards in place for PHI that exists in any form, including paper and verbal PHI

  • Confirm that workforce members have received training on the HIPAA Standards that are necessary or appropriate for workforce members to perform their job duties

  • Confirm that the organization maintains an inventory of information system assets, including mobile devices (even in a bring-your-own-device environment)

  • Confirm that all systems and software that transmit electronic PHI employ encryption technology, or that the organization has a documented risk analysis supporting the decision not to employ encryption

  • Confirm that the organization has adopted a facility security plan for each physical location that stores or otherwise has access to PHI, in addition to a security policy that requires a physical security plan

  • Review the organization’s HIPAA security policies to identify any actions that have not been completed as required (physical security plan, disaster recovery plan, emergency access procedures, etc.)

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About this Author

Daniel F. Gottlieb, Health Care Industry Attorney, McDermott Will Emery Law firm
Partner

Daniel Gottlieb is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  Daniel represents a wide range of health care industry clients, including health care providers, health information technology vendors, pharmaceutical companies, medical device companies, and health plans.  He has extensive experience in advising clients on compliance with federal and state health care laws as well as representing health care industry clients in mergers, acquisitions, joint ventures, and...

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Partner

Ryan S. Higgins is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office. He focuses his practice on representing hospitals, health systems, private equity firms and platform companies, and other health care organizations in corporate and transactional matters, including mergers, acquisitions, joint ventures, and management arrangements. He also focuses a significant portion of his practice on representing health care organizations in matters involving health information privacy and security and HIPAA compliance.

312-984-2052
Edward G. Zacharias, McDermott Will Emery Law firm, Healthcare Industry Attorney
Associate

Edward G. Zacharias is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Boston office.  Edward provides regulatory and transactional representation to health systems, academic medical centers, physician group practices, HMOs, faculty practice plans, nursing facilities and a variety of other health care clients.  He represents clients in connection with acquisitions, joint ventures, strategic affiliations, conversions to tax exempt status, HIPAA compliance, fraud and abuse and Stark, reimbursement,...

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