As the healthcare sector continues to be a top target for cyber criminals, the Office for Civil Rights (OCR) issued proposed updates to the HIPAA Security Rule (scheduled to be published in the Federal Register January 6). It looks like substantial changes are in store for covered entities and business associates alike, including healthcare providers, health plans, and their business associates.

According to the OCR, cyberattacks against the U.S. health care and public health sectors continue to grow and threaten the provision of health care, the payment for health care, and the privacy of patients and others. In 2023, the OCR has reported that over 167 million people were affected by large breaches of health information, a 1002% increase from 2018. Further, seventy nine percent of the large breaches reported to the OCR in 2023 were caused by hacking. Since 2019, large breaches caused by successful hacking and ransomware attacks have increased 89% and 102%.

The proposed Security Rule changes are numerous and include some of the following items:

  • All Security Rule policies, procedures, plans, and analyses will need to be in writing.
  • Create, maintain a technology asset inventory and network map that illustrates the movement of ePHI throughout the regulated entity’s information systems on an ongoing basis, but at least once every 12 months.
  • More specificity needed for risk analysis. For example, risk assessments must be in writing and include action items such as identification of all reasonably anticipated threats to ePHI confidentiality, integrity, and availability and potential vulnerabilities to information systems.
  • 24 hour notice to regulated entities when a workforce member’s access to ePHI or certain information systems is changed or terminated.
  • Stronger incident response procedures, including: (I) written procedures to restore the loss of certain relevant information systems and data within 72 hours, (II) written security incident response plans and procedures, including testing and revising plans.
  • Conduct compliance audit every 12 months.
  • Business associates to verify Security Rule compliance to covered entities by a subject matter expert at least once every 12 months.
  • Require encryption of ePHI at rest and in transit, with limited exceptions.
  • New express requirements would include: (I) deploying anti-malware protection, and (II) removing extraneous software from relevant electronic information systems.
  • Require the use of multi-factor authentication, with limited exceptions.
  • Require review and testing of the effectiveness of certain security measures at least once every 12 months.
  • Business associates to notify covered entities upon activation of their contingency plans without unreasonable delay, but no later than 24 hours after activation.
  • Group health plans must include in plan documents certain requirements for plan sponsors: comply with the Security Rule; ensure that any agent to whom they provide ePHI agrees to implement the administrative, physical, and technical safeguards of the Security Rule; and notify their group health plans upon activation of their contingency plans without unreasonable delay, but no later than 24 hours after activation.

After reviewing the proposed changes, concerned stakeholders may submit comments to OCR for consideration within 60 days after January 6, by following the instructions outlined in the proposed rule. We support clients with respect to developing and submitting comments they wish to communicate to help shape the final rule, as well as complying with the requirements under the rule once made final.

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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.