While we do not know the exact nature and scope of the imminent HIPAA audits, we do know that HIPAA compliance and the verification of compliance (the audit) can be a very daunting process that mandates a great deal of preparation and organization. Beyond getting legally compliant, HIPAA covered entities and business associates need to consider how to practically and efficiently track and illustrate this compliance should they find an OCR investigator knocking at the door.

We have asked Alan Heyman, Managing Director of Cyber Security Auditors & Administrators LLC (CSA2) to discuss how certain applications can facilitate the response to a HIPAA audit, including minimizing the time staff needs to be involved. The following is an excerpt from Alan’s discussion of this issue:

For many health care providers and other covered entities, compliance with HIPAA and other data privacy and security requirements is a multifaceted and ongoing process of assessing changing risks, policy development and implementation across various departments, conducting and tracking training of workforce members, monitoring compliance, managing vendors and vendor agreements, responding the customer complaints and so on. When an OCR auditor is on the doorstep, pulling evidence of all of these efforts together would likely sap an already thin workforce of most covered entities. When various segments of the covered entity are not coordinated, the files are incomplete, and the persons leading the effort are in disarray, the auditor is likely to suspect there are substantial deficiencies and adjust the audit accordingly.

It is not difficult to imagine the Privacy Officer having to go from department to department asking, among other things:

  • Where are the current policies and procedures for your department concerning privacy and security?

  • Would you please send me the training sign-in sheets for your group? Why was that group not trained?

  • Where are the signed copies of the business associate agreements? Is this all of them?

  • Where can I find a copy of the risk assessment for your department? Is it updated?

  • How was that complaint resolved? Were there any others?

  • Do you have all of the documents for the data breach that affected the radiology department?

  • Can you send me your evaluation logs and what changes you have made based upon those efforts?

It is also not difficult to imagine how much easier this process would be if the covered entity’s compliance efforts were tracked, maintained and documented in a single environment. An environment that would, for example

  • Allow different departments/groups to log on an update their compliance efforts,

  • Secure email notification/reminders for maintenance to update all required analysis, training, network architecture diagrams, etc.,

  • Digital repository for all required employee affidavits, training sign-in sheets and managed with email notification for maintenance and updating,

  • Maintain and track policy changes via secure email notification/reminders to all departments and employees from Privacy Officer or legal counsel,

  • Track and document responses to patient complaints,

  • Digitize interactive system for updating and obtaining required commentary from all required departments and Business Associates to establish and audit trail for creating “defensible position” to regulators.

  • Centralize administration for permissions to all employees, advisors or Business Associates access to read only, print, edit, etc., with watermark capabilities on all printed and viewed documents.

  • Centralize reporting dashboard status of all projects as well as the ability to digitally feed approved 3rd party software analytic results for centralized viewing to permission based participants with email notification of updates.

  • Prepare for post-breach requirements in a pre-breach environment allowing reduction in costs of time sensitive response.

Such a tool also could be designed to permit the auditor limited access to conduct the audit with less effort on the part of the privacy officer or his or her staff. While certainly not required under HIPAA, organizing compliance in this way would simplify the compliance process and put the covered entity in a much better position to survive an OCR audit with minimal effort.


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Photo of Joseph J. Lazzarotti Joseph J. Lazzarotti

Joseph J. Lazzarotti is a principal in the Berkeley Heights, New Jersey, office of Jackson Lewis P.C. He founded and currently co-leads the firm’s Privacy, Data and Cybersecurity practice group, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP)…

Joseph J. Lazzarotti is a principal in the Berkeley Heights, New Jersey, office of Jackson Lewis P.C. He founded and currently co-leads the firm’s Privacy, Data and Cybersecurity practice group, edits the firm’s Privacy Blog, and is a Certified Information Privacy Professional (CIPP) with the International Association of Privacy Professionals. Trained as an employee benefits lawyer, focused on compliance, Joe also is a member of the firm’s Employee Benefits practice group.

In short, his practice focuses on the matrix of laws governing the privacy, security, and management of data, as well as the impact and regulation of social media. He also counsels companies on compliance, fiduciary, taxation, and administrative matters with respect to employee benefit plans.

Privacy and cybersecurity experience – Joe counsels multinational, national and regional companies in all industries on the broad array of laws, regulations, best practices, and preventive safeguards. The following are examples of areas of focus in his practice:

  • Advising health care providers, business associates, and group health plan sponsors concerning HIPAA/HITECH compliance, including risk assessments, policies and procedures, incident response plan development, vendor assessment and management programs, and training.
  • Coached hundreds of companies through the investigation, remediation, notification, and overall response to data breaches of all kinds – PHI, PII, payment card, etc.
  • Helping organizations address questions about the application, implementation, and overall compliance with European Union’s General Data Protection Regulation (GDPR) and, in particular, its implications in the U.S., together with preparing for the California Consumer Privacy Act.
  • Working with organizations to develop and implement video, audio, and data-driven monitoring and surveillance programs. For instance, in the transportation and related industries, Joe has worked with numerous clients on fleet management programs involving the use of telematics, dash-cams, event data recorders (EDR), and related technologies. He also has advised many clients in the use of biometrics including with regard to consent, data security, and retention issues under BIPA and other laws.
  • Assisting clients with growing state data security mandates to safeguard personal information, including steering clients through detailed risk assessments and converting those assessments into practical “best practice” risk management solutions, including written information security programs (WISPs). Related work includes compliance advice concerning FTC Act, Regulation S-P, GLBA, and New York Reg. 500.
  • Advising clients about best practices for electronic communications, including in social media, as well as when communicating under a “bring your own device” (BYOD) or “company owned personally enabled device” (COPE) environment.
  • Conducting various levels of privacy and data security training for executives and employees
  • Supports organizations through mergers, acquisitions, and reorganizations with regard to the handling of employee and customer data, and the safeguarding of that data during the transaction.
  • Representing organizations in matters involving inquiries into privacy and data security compliance before federal and state agencies including the HHS Office of Civil Rights, Federal Trade Commission, and various state Attorneys General.

Benefits counseling experience – Joe’s work in the benefits counseling area covers many areas of employee benefits law. Below are some examples of that work:

  • As part of the Firm’s Health Care Reform Team, he advises employers and plan sponsors regarding the establishment, administration and operation of fully insured and self-funded health and welfare plans to comply with ERISA, IRC, ACA/PPACA, HIPAA, COBRA, ADA, GINA, and other related laws.
  • Guiding clients through the selection of plan service providers, along with negotiating service agreements with vendors to address plan compliance and operations, while leveraging data security experience to ensure plan data is safeguarded.
  • Counsels plan sponsors on day-to-day compliance and administrative issues affecting plans.
  • Assists in the design and drafting of benefit plan documents, including severance and fringe benefit plans.
  • Advises plan sponsors concerning employee benefit plan operation, administration and correcting errors in operation.

Joe speaks and writes regularly on current employee benefits and data privacy and cybersecurity topics and his work has been published in leading business and legal journals and media outlets, such as The Washington Post, Inside Counsel, Bloomberg, The National Law Journal, Financial Times, Business Insurance, HR Magazine and NPR, as well as the ABA Journal, The American Lawyer, Law360, Bender’s Labor and Employment Bulletin, the Australian Privacy Law Bulletin and the Privacy, and Data Security Law Journal.

Joe served as a judicial law clerk for the Honorable Laura Denvir Stith on the Missouri Court of Appeals.