According to a Bloomberg article, the second phase of HIPAA audits by the Office for Civil Rights (OCR), originally set to commence in 2014, may be coming soon. This update came at a HIPAA conference co-hosted by OCR during which OCR Director Jocelyn Samuels said the agency was in the process of confirming contact information of those entities that would be audited. Reason for the delay – budgetary limitations and gaps in personnel.

Covered entities and business associates have been hearing about a second phase of HIPAA audits and a permanent OCR audit program since the OCR pilot program back in 2011 and 2012. But inaction by the agency should not delay an organization’s preparedness. Perhaps more likely than an OCR audit, a covered entity or business associate may experience a data breach affecting protected health information (PHI). Most recently, Excellus Healthcare experienced a breach affecting 10.5 million. In the case of a breach, a resulting OCR investigation/compliance review and findings of inadequate compliance with the privacy or security rules could result in far more dire consequences to the organization than what might follow an audit.

Reports about the upcoming audit program indicate some key areas of focus by the OCR. These also are areas that OCR has raised numerous times in settlements with covered entities following data breach investigations.

  • Has a risk assessment been carried out and documented?
  • Are written policies and procedures in place that address the privacy and security standards, and vulnerabilities identified in the assessment?
    • Strong “practices” are not enough – they need to be in writing.
  • Is an incident response plan in place for responding to breaches of unsecured PHI?
  • Are adequate safeguards in place for mobile devices and storage media?
    • Your doctors, nurses and staff have their own devices – do you have a BYOD policy that incorporates HIPAA issues, not just data security?
  • Is a training program in place, with documented training for new workforce members and periodically for all workforce members?
  • Is a compliant Notices of Privacy Practices provided to patients?
    • Have you checked your website lately? Many covered healthcare providers only provide hardcopies of these Notices in the office without realizing that they may need to have the Notice prominently available on the practice’s website.
  • Do you have appropriate agreements in place with business associates?

It is anticipated that most of the audits will be “desk audits.” This means that an OCR investigator will not be coming to visit you in person, but will be asking for documents. The investigator will want to see that the assessment has taken place, that the policies have been adopted, that the training has been conducted, that the notices have been delivered, etc. Operational compliance (that is, are you doing what compliant policies say you should be doing) may not always be 100%, but having the right documents in place can go a long way toward helping you survive an OCR audit, whether in connection with the long-awaited second phase of audits, or following a data breach.

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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.