A healthcare provider delivering pain management services in Florida and other states faces a $1.19 million civil monetary penalty from the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR). The OCR investigation stems from a data breach, but not the type of breach we are used to seeing in the news – it was not a ransomware attack, business email compromise, or some other type of attack by an unknown hacker. Similar to many other OCR enforcement actions, however, a lack of basic safeguards under the Security Rule drove the penalty.

According to the OCR:

  • On May 3, 2018, the covered entity retained an independent contractor to provide business consulting services.
  • The contractor’s services ceased in August of 2018.
  • On February 20, 2019, the covered entity discovered that on three occasions, between September 7, 2018, and February 3, 2019, the contractor impermissibly accessed the provider’s electronic medical record (EMR) system and accessed the electronic protected health information (ePHI) of approximately 34,310 individuals. The contractor used that information to generate approximately 6,500 false Medicare claims.
  • On February 21, 2019, the covered entity terminated the independent contractor’s access to its systems, and in early April of that same year filed a breach report with OCR. The report described that the compromised PHI included names, addresses, phone numbers, email addresses, dates of birth, Social Security numbers, chart numbers, insurance information, and primary care information.

Evidently, the contractor continued to have access to the covered entity’s information systems for 6 months following the point at which services ended, according to the OCR.

“Current and former workforce can present threats to health care privacy and security—risking continuity of care and trust in our health care system,” said OCR Director Melanie Fontes Rainer. “Effective cybersecurity and compliance with the HIPAA Security Rule means being proactive in reviewing who has access to health information and responding quickly to suspected security incidents.” 

The OCR commenced an investigation and reported findings that the covered entity:

  • did not conduct a thorough and accurate risk analysis prior to the breach incident, or until September 30, 2022, more than three years after the incident,
  • had not implemented policies and procedures to regularly review records of information system activity containing ePHI,
  • did not implement termination procedures designed to remove access to ePHI for workforce members who had separated, and
  • did not implement policies and procedures addressing access to workstations.

It is worth noting that the $1.19 million penalty comes after a reduction for “Recognized Security Practices.” Recall that following an amendment enacted in 2022, the HITECH Act now requires the OCR to take into account Recognized Security Practices in connection with certain enforcement and audit activities under the HIPAA Security Rule. In short, if a covered entity can demonstrate Recognized Security Practices as being in place continuously for the 12 months prior to a security incident, a reduction in the amount of civil monetary may be warranted.

In this case, OCR provided the covered entity an opportunity to adequately demonstrate that it had RSPs in place. The covered entity did and OCR applied a reduction to the penalty.

Regulated entities, including healthcare providers, often cite to “controls” they have in place, believing they are sufficient to address their compliance obligations. This application of the rule for Recognized Security Practices is a good example of why that is not the case. That is, while it is important to maintain good controls, those efforts still need to be measured against the applicable compliance requirements, such as set forth under the HIPAA Security Rule.

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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.